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Fibromyalgia Impact Questionnaire (FIQ) References with Abstracts from 1991 to 2008

 

       (1)    de Andrade SC, de Carvalho RF, Soares AS, de Abreu Freitas RP, de Medeiros Guerra LM, Vilar MJ. Thalassotherapy for fibromyalgia: a randomized controlled trial comparing aquatic exercises in sea water and water pool. Rheumatol Int 2008; .
Abstract: The aim of this study was to evaluate the effectiveness of aerobic exercise in water pool compared with aerobic exercise performed in sea by women with fibromyalgia (FM). A total of 46 patients were randomly allocated into two groups: pool group (23 patients) and sea group (23 patients) that performed the same aerobic exercise program. Patients were evaluated baseline and after 12 weeks using: VAS, number of tender points, FIQ, SF-36, PSQI, and BDI. Both groups improved significantly in post-treatment for all the evaluated variables. There were no significant differences between two groups, except for BDI (F = 2.418, P < 0.0001). Aerobic exercise program performed in water (pool or sea) was effective for patients with FM. However, sea water exercises have been shown to bring more advantages related to emotional aspects. Then, exercise performed sea water (thalassotherapy) is an option for effective treatment with low cost for patients with FM

       (2)    Bigatti SM, Hernandez AM, Cronan TA, Rand KL. Sleep disturbances in fibromyalgia syndrome: relationship to pain and depression. Arthritis Rheum 2008; 59(7):961-7.
Abstract: OBJECTIVE: This study is an examination of sleep, pain, depression, and physical functioning at baseline and 1-year followup among patients with fibromyalgia syndrome (FMS). Although it is clear that these symptoms are prevalent among FMS patients and that they are related, the direction of the relationship is unclear. We sought to identify and report sleep problems in this population and to examine their relationship to pain, depression, and physical functioning. METHODS: Patients diagnosed with fibromyalgia were recruited from a Southern California health maintenance organization and evaluated according to American College of Rheumatology criteria in the research laboratory. Six hundred patients completed the baseline assessment and 492 completed the 1-year assessment. Measures included the Center for Epidemiologic Studies Depression Scale, the McGill Pain Questionnaire, the Pittsburgh Sleep Quality Index, and the Fibromyalgia Impact Questionnaire. RESULTS: The majority of the sample (96% at baseline and 94.7% at 1 year) scored within the range of problem sleepers. Path analyses examined the impact of baseline values on 1-year values for each of the 4 variables. No variable of interest predicted sleep, sleep predicted pain (beta = 0.13), pain predicted physical functioning (beta = -0.13), and physical functioning predicted depression (beta = -0.10). CONCLUSION: These findings highlight the high prevalence of sleep problems in this population and suggest that they play a critical role in exacerbating FMS symptoms. Furthermore, they support limited existing findings that sleep predicts subsequent pain in this population, but also extend the literature, suggesting that sleep may be related to depression through pain and physical functioning

       (3)    Mease PJ, Arnold LM, Crofford LJ, Williams DA, Russell IJ, Humphrey L et al. Identifying the clinical domains of fibromyalgia: contributions from clinician and patient delphi exercises. Arthritis Rheum 2008; 59(7):952-60.
Abstract: OBJECTIVE: In evaluating the effectiveness of fibromyalgia (FM) therapies, it is important to assess the impact of those therapies on the full array of domains considered important by both clinicians and patients. The objective of this research was to identify and prioritize the key clinically relevant and important domains impacted by FM that should be evaluated by outcome assessment instruments used in FM clinical trials, and to approach consensus among clinicians and patients on the priority of those domains to be assessed in clinical care and research. METHODS: Group consensus was achieved using the Delphi method, a structured process of consensus building via questionnaires together with systematic and controlled opinion feedback. The Delphi exercises involved 23 clinicians with expertise in FM and 100 patients with FM as defined by American College of Rheumatology criteria. RESULTS: The Delphi exercise revealed that the domains ranked most highly by patients were similar to the domain rankings by clinicians. Pain was consistently ranked highest by both panels. Fatigue, impact on sleep, health-related quality of life, comorbid depression, and cognitive difficulty were also ranked highly. Stiffness was ranked highly by patients but not clinicians. In contrast, side effects was important to clinicians but was not identified as important in the patient Delphi exercise. CONCLUSION: The clinician and patient Delphi exercises identified and ranked key domains that need to be assessed in FM research. Based on these results, a conceptual framework for measuring patient-reported outcomes is proposed

       (4)    Arnold LM, Russell IJ, Diri EW, Duan WR, Young JP, Jr., Sharma U et al. A 14-week, Randomized, Double-Blinded, Placebo-Controlled Monotherapy Trial of Pregabalin in Patients With Fibromyalgia. J Pain 2008; .
Abstract: The purpose of the study was to assess the efficacy and safety of pregabalin monotherapy in patients with fibromyalgia in a randomized, double-blinded, placebo-controlled trial. After 1 week of single-blinded administration of placebo, 750 patients meeting American College of Rheumatology criteria for fibromyalgia were randomly assigned to pregabalin (300 mg/d, 450 mg/d, 600 mg/d) or placebo, administered twice daily for 14 weeks. The primary outcome variable was comparison of end point mean pain scores, derived from daily diary ratings of pain intensity (0 to 10 scale), between each of the pregabalin groups and the placebo group. If positive, additional primary efficacy parameters included the Patient Global Impression of Change (PGIC) and the Fibromyalgia Impact Questionnaire (FIQ) total score. Compared with placebo-treated patients, mean changes in pain scores at the end point in pregabalin-treated patients were significantly greater (P < .001: 300 mg/d, -0.71; 450 mg/d, -0.98; 600 mg/d, -1.00). Compared with placebo, significantly more pregabalin-treated patients reported improvement on PGIC (P < .01 for all 3 pregabalin doses) and significant improvements in total FIQ score for the 450 mg/d (P = .004) and the 600 mg/d (P = .003) doses. Compared with placebo, all 3 doses of pregabalin were associated with significant improvement in sleep. The most commonly reported pregabalin-related adverse events were dizziness and somnolence, which tended to be dose-related. PERSPECTIVE: This randomized, placebo-controlled trial of 300, 450, and 600 mg/d of pregabalin monotherapy demonstrated that all 3 doses were efficacious for up to 14 weeks for the treatment of fibromyalgia and were well tolerated by most patients. These results provide evidence that pregabalin is an important treatment option for patients with fibromyalgia

       (5)    Staud R, Koo EB. Are cannabinoids a new treatment option for pain in patients with fibromyalgia? Nat Clin Pract Rheumatol 2008; 4(7):348-9.
Abstract: Preliminary studies suggest that the synthetic cannabinoid nabilone might be an effective therapy in patients with fibromyalgia. Skrabek et al. performed a double-blind, randomized, placebo-controlled clinical trial to analyze the effects of nabilone on pain and quality of life in patients with fibromyalgia. After 4 weeks of treatment (0.5 mg once daily in week 1, 0.5 mg twice daily in week 2, 0.5 mg in the morning and 1 mg in the evening in week 3, and 1 mg twice daily in week 4), patients who received nabilone (n = 15) experienced significant improvements in clinical pain, measured on a visual analog scale (P <0.02), Fibromyalgia Impact Questionnaire score (P <0.02) and the 10-point anxiety scale of the Fibromyalgia Impact Questionnaire (P <0.02). After a 4-week wash-out period at the end of the trial, all benefits were lost in the nabilone cohort, which returned to their baseline levels of pain and quality of life. Patients who received placebo (n = 18) experienced no change throughout the study. Although nabilone was not associated with serious adverse effects, some patients did experience drowsiness, dry mouth, vertigo and ataxia as a result of treatment

       (6)    Sendur OF, Tastaban E, Turan Y, Ulman C. The relationship between serum trace element levels and clinical parameters in patients with fibromyalgia. Rheumatol Int 2008; .
Abstract: We examined the association between serum trace elements and clinical findings such as number of sensitive tender points, severity of fatigue and functional status in patients with fibromyalgia (FM). Thirty-two patients diagnosed as having FM according to the ACR 1990 criteria and 32 normal healthy controls (NHC) were included in this study. The demographic data, disease duration, number of tender points and accompanying symptoms (fatigue, sleep disorders, headache, paresthesia, irritable bowel syndrome, sicca symptoms, Raynaud's phenomena) of the patients were noted. Visual analog scale (10 cm) was implemented to estimate daily severity of pain and fatigue. Fibromyalgia impact questionnaire was used for functional assessment. Serum selenium (mug/dL) and serum zinc (mug/dL) levels were measured by atomic absorption spectrometer. Serum magnesium (mmol/L) level was measured by the original kits of Abbott Aeroset auto-analyzer. The mean age of patients in FM group and NHC were calculated as 42.9 (SD = 7.7) years and 41.3 (SD = 9.7) years, respectively. Serum levels of zinc (P = 0.001) and magnesium (P = 0.002) were significantly decreased by FM groups, whereas there was no considerable difference with selenium levels of both groups (P > 0.05). Association between serum zinc level and number of tender points (P = 0.008) and that between fatigue and magnesium level (P = 0.003) was found as meaningful. According to the results of this study, it was asserted that serum magnesium and zinc levels may play an important role in the pathophysiology of FM

       (7)    Emad Y, Ragab Y, Zeinhom F, El-Khouly G, bou-Zeid A, Rasker JJ. Hippocampus Dysfunction May Explain Symptoms of Fibromyalgia Syndrome. A Study with Single-Voxel Magnetic Resonance Spectroscopy. J Rheumatol 2008; 35(7):1371-7.
Abstract: OBJECTIVE: (1) To investigate dysfunction of hippocampus in patients with fibromyalgia syndrome (FM) using proton magnetic resonance spectroscopy (1H-MRS), and to compare these findings with healthy controls. (2) To correlate levels of metabolites obtained with aspects of cognition, depression, and sleep symptoms in the patient group. METHODS: The case-control study was performed in 15 female patients, who met American College of Rheumatology criteria for classification of FM, and 10 healthy age-matched female controls. Patients and controls were receiving no medications known to affect cognitive functioning or central nervous system metabolites before their participation in the study. In all patients and controls, 1H-MRS was used to assess N-acetylaspartate (NAA), choline (Cho), creatine (Cr), and their ratios from both hippocampi. Levels of metabolites and their ratios were determined and the findings compared between the groups. All patients and controls underwent psychological assessment to assess cognitive function, depression, and structured sleep interview with sleep diary; Fibromyalgia Impact Questionnaire (FIQ), number of tender points, and visual analog scale (VAS) for pain were assessed in all patients. RESULTS: NAA levels of right and left hippocampi differed significantly between patients and controls (p < 0.05). Cho levels in the right hippocampus were higher in the patient group than in controls (p = 0.005), while no differences were found with respect to Cr levels in both hippocampi. NAA/Cho and NAA/Cr ratios differed significantly between patients and controls (p <0.05), while the Cho/Cr ratio showed no differences. Significant correlations were found between language score and right Cho and right Cr levels (p = 0.041, p = 0.006, respectively), while no significant correlations were found between metabolites and their ratios with FIQ, VAS for pain, or number of tender points. CONCLUSION: The hippocampus was dysfunctional in patients with FM, as shown by lower NAA levels compared to controls, representing neuronal or axonal metabolic dysfunction. As the hippocampus plays crucial roles in maintenance of cognitive functions, sleep regulation, and pain perception, we suggest that metabolic dysfunction of hippocampus may be implicated in the appearance of these symptoms associated with this puzzling syndrome

       (8)    Rau J, Ehlebracht-Konig I, Petermann F. [Impact of a motivational intervention on coping with chronic pain : Results of a controlled efficacy study.]. Schmerz 2008; .
Abstract: BACKGROUND: For effective self-management of chronic pain changes of cognitive and behavioral attitudes are required. The readiness to change can be described within the framework of the transtheoretical model (TTM) and is facilitated through motivational interviewing. This prospective study evaluated the effectiveness of brief motivational interviewing by telephone for the variables self-efficacy, cognitive and behavioral coping and psychological strain through chronic pain over a period of 9 months. METHODS: Different questionnaires, the self-efficacy expectations (ASES-D), cognitive, behavioral coping and psychological strain through chronic pain (FESV) and the German version of the pain stages of change questionnaires (PSOCQ), the FF-STABS were distributed to 147 patients at a rehabilitation clinic (indications: fibromyalgia syndrome, rheumatoid arthritis, ankylosing spondylitis). The intervention group participants received 3 telephone calls at intervals of 2 months with a follow-up time of 9 months after first study admission. At the end of the study 91 patients were enrolled for analysis (drop out rate 38%). To evaluate the effects of treatment nonparametric-analysis for longitudinal data was used. RESULTS AND CONCLUSION: The analysis showed significant positive effects in the intervention group for cognitive coping (U-value -2.423; p=0.015 group x time-effect) and for coping with emotional strains of chronic pain (subscale anxiety: U-value -2.3618; p=0.018; subscale anger: U-value 2.8638; p=0.004; group x time-effect). No significant effects were shown for self-efficacy expectations and behavioral coping with pain. Further explorative analysis of subgroups revealed slightly better treatment effects for patients with rheumatoid arthritis and ankylosing spondylitis than for those with fibromyalgia syndrome

       (9)    Rodero B, Garcia J, Casanueva B, Sobradiel N. Imagined exposure as treatment of catastrophizing in fibromyalgia. A pilot study. Actas Esp Psiquiatr 2008; 36(4):223-6.
Abstract: Introduction. We want to assess the effectiveness of a new approach (imagined exposure) for the Cognitive Behavioural Treatment (CBT) in fibromyalgia. Study design. Quasi-experimental design of a temporary nature in a single group with pre and post and with/without treatment. Subjects and methods. Fibromyalgia (FM) patients, who met the American College of Rheumatology's criteria for FM. In this study eight people took part, seven females and one male, selected from FM Cantabria Association. The CBT consisted of 11 group sessions and lasted 15 weeks. All patients were evaluated before and after the program. The data were based on the following scales: visual-analog scale (VAS) for pain intensity, the Fibromyalgia Impact Questionnaire (FIQ), the Pain Catastrophizing Scale (PCS) and the Hospital Anxiety and Depression Scale (HADS). Results. Despite finding improvements in every variable, no significant differences were found between pre and postreatment in VAS, HADS and FIQ. However, after treatment, significant differences were found in PCS (p 0.05), and its three subscales. Moreover, rate decrease in rumination was higher after imagined exposure. Conclusion. These results suggest that CBT is effective either in catastrophizing decreasing or in rumination. Imagined exposure may enhance the results in particular cases. Further studies with larger samples are needed to confirm these results. Key words: Pain. Catastrophizing. Rumination. Cognitive-behavioural therapy. Actas Esp Psiquiatr 2008;36(4):223-226

     (10)    Miller A, Doll H, David J, Wass J. Impact of musculoskeletal disease on quality of life in long-standing acromegaly. Eur J Endocrinol 2008; 158(5):587-93.
Abstract: OBJECTIVE: To provide rheumatological assessment of patients with long-standing acromegaly and investigate the impact of musculoskeletal disease on quality of life. DESIGN: Cross-sectional observational study. METHODS: Fifty-eight patients diagnosed with acromegaly at least 5 years previously were interviewed and examined by a rheumatologist. Each patient completed the short form-36 (SF-36), arthritis impact measurement scales 2 (AIMS2) and acromegaly quality of life questionnaires (AcroQol). RESULTS: Fifty-two out of 58 (90%) reported musculoskeletal pain, with 29 (50%) reporting neck pain. Hip osteoarthritis was present in 49 (84%) and knee osteoarthritis in 20 (34%). Half the patients (52%) reported sleep disturbance, but only 2 (3.5%) had fibromyalgia. Ten (17.2%) had previously undergone carpal tunnel decompression. Fifty-one (88%) patients had consulted their general practioner and 31 (54%) complementary therapists. SF-36, AIMS2 and AcroQol scores were lower in patients with musculoskeletal pain. CONCLUSIONS: This study of musculoskeletal problems in patients with acromegaly reports systematic rheumatological examination, use of medical services and quality of life scores. Musculoskeletal problems should be routinely addressed in acromegaly by both endocrinologist and rheumatologist and a multidisciplinary approach taken to management

     (11)    Pamuk GE, Pamuk ON, Set T, Harmandar O, Yesil N. An increased prevalence of fibromyalgia in iron deficiency anemia and thalassemia minor and associated factors. Clin Rheumatol 2008; .
Abstract: In this study, we evaluated the prevalence of fibromyalgia (FM) in iron deficiency anemia (IDA) and thalassemia minor (TM) patients and associated factors. In addition, we investigated the prevalence of IDA in outpatients with fibromyalgia, and its effect on clinical findings. The study included 205 IDA, 40 TM patients and 100 healthy controls. FM was diagnosed according to 1990 ACR criteria. Whole blood count, biochemical tests, and serum iron parameters were determined. Pain, fatigue, and FM Impact Questionnaire (FIQ) functional item scores were assessed in FM subjects. In addition, the prevalence of IDA in FM patients diagnosed at the Rheumatology Outpatient Clinic was determined. The prevalences of FM in IDA (17.6%) and TM (20%) groups were higher than in controls (6%; p values 0.006 and 0.025, respectively). When IDA patients with FM were compared to those without FM, it was seen that a higher percentage were females, married, and a higher percentage had history of pica (all p values < 0.05). Serum hemoglobin and iron parameters did not differ between IDA patients with and without FM. IDA was detected in 48 (24.5%) of 196 FM patients. FM patients without IDA had higher sleep disturbance scores (p = 0.012) and longer duration of FM (p = 0.045). FM was a common finding in patients with IDA and TM. FM was associated with female sex and history of pica in IDA patients, and not associated with serum hemoglobin and selected iron parameters. The presence of FM in TM had no association with any of the above-mentioned parameters

     (12)    Eyigor S, Ozdedeli S, Durmaz B. The prevalence of generalized soft tissue rheumatic conditions in Turkish medical students. J Clin Rheumatol 2008; 14(2):65-8.
Abstract: OBJECTIVE: To assess the prevalence of generalized soft tissue rheumatism (GSTR) in medical students in Izmir, Turkey. METHODS: Medical students from each grade of Medical School of Ege University, Izmir, Turkey, were evaluated by a survey and physical examination for GSTR including fibromyalgia (FM) syndrome, myofascial pain syndrome (MPS), benign joint hypermobility syndrome (BJHS), and chronic fatigue syndrome. FM Impact Questionnaire was assessed in FM diagnosed students. Short Form-36 (SF-36) was obtained from each student to determine the quality of life. RESULTS: Among the participants (n = 306), 191 were women (62.4%) and 115 were men (37.6%) and mean age was 20.23 +/- 1.56. Fifty-eight students (19%) were diagnosed with a GSTR. The distributions of the diagnoses were: 6 (2%) FM, 21 (6.9%) MPS, 28 (9.2%) BJHS, 1 (0.3%) chronic fatigue syndrome, and 2 students (0.7%) had both BJHS and MPS. Fifty-three (27.7%) women and 5 (4.3%) men were diagnosed with a GSTR (P < 0.01). Mean FM Impact Questionnaire score was 50.8 in FM diagnosed students. Physical role, vitality, and mental subscores of SF-36 were significantly lower in the students having a GSTR (P < 0.05). CONCLUSION: This is the first study performed in medical students to find out the prevalence of generalized soft tissue rheumatic conditions. Although medical students are under high stress due to hard training, the prevalence of GSTR in medical students was found similar to previous reports in the general population

     (13)    Tomas-Carus P, Gusi N, Hakkinen A, Hakkinen K, Leal A, Ortega-Alonso A. Eight months of physical training in warm water improves physical and mental health in women with fibromyalgia: a randomized controlled trial. J Rehabil Med 2008; 40(4):248-52.
Abstract: OBJECTIVE: To evaluate the feasibility of 8 months of supervised exercise therapy in warm water and its effects on the impact of fibromyalgia on physical and mental health and physical fitness in affected women. METHODS: Thirty women with fibromyalgia were randomly assigned to an exercise therapy group (n = 15) or a control group (inactive) (n = 15). The impact of fibromyalgia on physical and mental health was assessed using the Fibromyalgia Impact Questionnaire and the anxiety state with State-Trait Anxiety Inventory. Physical fitness was measured using the following tests: Canadian Aerobic Fitness; hand-grip dynamometry; 10-metre walking; 10-step stair-climbing and blind 1-leg stance. RESULTS: After 8 months of training, the exercise therapy group improved compared with the control group in terms of physical function (20%), pain (8%), stiffness (53%), anxiety (41%), depression (27%), Fibromyalgia Impact Questionnaire total scores (18%), State-Trait Anxiety Inventory score (22%), aerobic capacity (22%), balance (30%), functional capacity for walking (6%), stair-climbing with no extra weight (14%) and stair-climbing 10 kg-weighted (25%). CONCLUSION: Eight months of supervised exercise in warm water was feasible and led to long-term improvements in physical and mental health in patients with fibromyalgia at a similar magnitude to those of shorter therapy programmes

     (14)    Holtgrefe K, McCloy C, Rome L. Changes associated with a quota-based approach on a walking program for individuals with fibromyalgia. J Orthop Sports Phys Ther 2007; 37(12):717-24.
Abstract: STUDY DESIGN: Single-subject, multiple-baseline design across 3 subjects. OBJECTIVE: To investigate the use of a quota-based approach to prescribing a walking program for individuals with fibromyalgia (FM). BACKGROUND: Exercise has been found to be beneficial for individuals with FM. What has not been determined is the best way to implement an exercise program that does not increase FM symptoms. METHODS AND MEASURES: Three women with FM were randomly assigned a baseline period of 5, 6, or 7 weeks, which served as the control phase, followed by an intervention period consisting of an 8-week walking program. The walking program progression was prescribed using a quota-based approach. Weekly outcome measures were the Fibromyalgia Impact Questionnaire (FIQ), Arthritis Self-Efficacy Scale (ASES), and SF-36v2 (acute). A 6-minute walk test was recorded twice: at the start of the baseline phase (after a trial phase) and at the end of the intervention phase. RESULTS: Subjects 1 and 3 had a significant decrease in the symptoms associated with FM during the intervention phase (FIQ, P<.05), but no significant increase in self-efficacy (ASES). They increased their walking distances used for exercise by 640 and 480 m, respectively. Subject 2 had no significant improvements in her symptoms of FM. Despite a significant decrease in ASES (P<.05), walking distance used for exercise by subject 2 increased by 2080 m. Six-minute walk test distances increased 76, 32, and 106 m for subjects 1, 2, and 3, respectively. CONCLUSIONS: Prescribing a walking program using a quota-based exercise prescription resulted in increasing the distance walked for 3 subjects. It also decreased symptoms associated with FM in 2 of the 3 subjects, but did not increase self-efficacy

     (15)    Tander B, Cengiz K, Alayli G, Ilhanli I, Canbaz S, Canturk F. A comparative evaluation of health related quality of life and depression in patients with fibromyalgia syndrome and rheumatoid arthritis. Rheumatol Int 2008; 28(9):859-65.
Abstract: The aim of this study was to compare health related quality of life (HRQoL) and assess functional and psychological status in rheumatoid arthritis (RA), fibromyalgia syndrome (FS) patients and controls (each 30 subjects). Demographic characteristics, pain and sleep disturbance by Visual Analog Scale, depression by Beck Depression Inventory (BDI), disease impact by fibromyalgia impact questionnaire, DAS-28, and HRQoL by SF-36 were gathered. The FS group scored significantly worser than the RA group with respect to physical role, social functioning and bodily pain subscales of SF-36. The scores of all SF-36 subscales were significantly lower in FS and RA patients than controls except mental health score. All of the subscales of SF-36 were negatively correlated with BDI scores in FS patients. In RA group, the DAS-28 scores were inversely correlated with all of SF-36 subscales. In conclusion, presence of comorbid depression must be taken into account when determining HRQoL in FS and RA. Essentials improving the HRQoL are management of depression in FS and control of disease activity in RA

     (16)    Mease PJ, Russell IJ, Arnold LM, Florian H, Young JP, Jr., Martin SA et al. A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. J Rheumatol 2008; 35(3):502-14.
Abstract: OBJECTIVE: To evaluate the efficacy and safety of pregabalin for symptomatic relief of pain associated with fibromyalgia (FM) and for management of FM. METHODS: This multicenter, double-blind, placebo-controlled trial randomly assigned 748 patients with FM to receive placebo or pregabalin 300, 450, or 600 mg/day (dosed twice daily) for 13 weeks. The primary outcome variable for study objective 1, symptomatic relief of pain associated with FM, was comparison of endpoint mean pain scores between each pregabalin group and placebo. The outcome variable for study objective 2, management of FM, included endpoint mean pain scores, Patient Global Impression of Change (PGIC), and Fibromyalgia Impact Questionnaire (FIQ)-Total Score. Secondary outcomes included assessments of sleep, fatigue, and mood disturbance. RESULTS: Patients in all pregabalin groups showed statistically significant improvement in endpoint mean pain score and in PGIC response compared with placebo. Improvements in FIQ-Total Score for the pregabalin groups were numerically but not significantly greater than those for the placebo group. Compared with placebo, all pregabalin treatment groups showed statistically significant improvement in assessments of sleep and in patients' impressions of their global improvement. Dizziness and somnolence were the most frequently reported adverse events. CONCLUSION: Pregabalin at 300, 450, and 600 mg/day was efficacious and safe for treatment of pain associated with FM. Pregabalin monotherapy provides clinically meaningful benefit to patients with FM

     (17)    Evcik D, Yigit I, Pusak H, Kavuncu V. Effectiveness of aquatic therapy in the treatment of fibromyalgia syndrome: a randomized controlled open study. Rheumatol Int 2008; 28(9):885-90.
Abstract: The aim of this study was to investigate the efficacy of aquatic exercises in fibromyalgia syndrome (FMS). A total of 63 patients were included and allocated to two groups. Group I (n = 33) received an aquatic exercise program and Group II (n = 30) received a home-based exercise program for 60 min, 3x a week, over 5 weeks. Patients were evaluated for pain (visual analogue scale, VAS), number of tender points (NTP), Beck depression inventory (BDI), and functional capacity (fibromyalgia impact questionnaire, FIQ). All assessment parameters were measured at baseline, and at weeks 4, 12, and 24. There were statistically significant differences in FIQ and NTP in both groups at the end and during follow-up (P < 0.05). Group I showed a statistically significant decrease in BDI scores after 4 and 12 weeks (P < 0.05) that remained after 24 weeks (P < 0.001). In Group II, a significant decrease in BDI scores was observed at the end and during follow-up (P < 0.001). Also, a significant improvement was found in VAS at weeks 4 and 12 in both groups (P < 0.001). The average of reduction in pain scores was 40% in Group1 and 21% in Group II. However, this was still significant at week 24 only in the aquatic therapy group. A comparison of the two groups showed no statistically significant difference for FIQ, NTP, and BDI scores except VAS (P < 0.001) Our results showed that both aquatic therapy and home-based exercise programs have beneficial effects on FIQ, BDI, and NTP. In pain management, only aquatic therapy seems to have long-term effects

     (18)    Couto CI, Natour J, Carvalho AB. Fibromyalgia: its prevalence and impact on the quality of life on a hemodialyzed population. Hemodial Int 2008; 12(1):66-72.
Abstract: Fibromyalgia syndrome (FMS) is characterized by widespread musculoskeletal pain. It has negative effects on quality of life and has been poorly investigated in specific populations. Our aim was to determine the prevalence of FMS in Brazilian hemodialysis (HD) patients and to investigate its effects on the quality of life. We investigated 311 patients on HD who were submitted to physical examination towards the classification of FMS. All subjects from FMS and control groups were submitted to laboratorial investigation and completed questionnaires of quality of life. The prevalence of FMS was 3.9%, which was close to that of the general population. Most patients were females and from non-Caucasian races. No difference between FMS and control groups was observed regarding race, dialysis adequacy, nutritional status and level of schooling. Ionized calcium was higher in the FMS group than in the control group. There was no association between FMS and secondary hyperparathyroidism. On the other hand, FMS was associated with worse quality of life, depression and anxiety. In conclusion, the prevalence of FMS in HD patients was similar to that of the general population. It was associated with decreasing quality of life in HD patients, in addition to higher degrees of depression and anxiety. No laboratory tests could identify FMS patients on HD. Fibromyalgia syndrome subsequently follows without a well-established mechanism of pathogenesis, and seems to be due to multifactorial causes. Its true impact on the quality of life of HD patients deserves more attention by nephrologists

     (19)    Jones KD, Burckhardt CS, Deodhar AA, Perrin NA, Hanson GC, Bennett RM. A six-month randomized controlled trial of exercise and pyridostigmine in the treatment of fibromyalgia. Arthritis Rheum 2008; 58(2):612-22.
Abstract: OBJECTIVE: A subset of fibromyalgia (FM) patients have a dysfunctional hypothalamic-pituitary-insulin-like growth factor 1 (IGF-1) axis, as evidenced by low serum levels of IGF-1 and a reduced growth hormone (GH) response to physiologic stimuli. There is evidence that pyridostigmine (PYD) improves the acute response of GH to exercise in FM patients. The purpose of this study was to evaluate the clinical effectiveness of 6 months of PYD and group exercise on FM symptoms. METHODS: FM patients were randomized to 1 of the following 4 groups: PYD plus exercise, PYD plus diet recall but no exercise, placebo plus exercise, and placebo plus diet recall but no exercise. The primary outcome measures were the visual analog scale (VAS) score for pain, tender point count, and total myalgic score. Secondary outcome measures were the total score on the Fibromyalgia Impact Questionnaire (FIQ) and FIQ VAS scores for individual symptoms (fatigue, poor sleep, stiffness, and anxiety), as well as quality of life (QOL) and physical fitness (lower body strength/endurance, upper and lower body flexibility, balance, and time on the treadmill). RESULTS: A total of 165 FM patients completed baseline measurements; 154 (93.3%) completed the study. The combination of PYD and exercise did not improve pain scores. PYD groups showed a significant improvement in sleep and anxiety in those who completed the study and in QOL in those who complied with the therapeutic regimen as compared with the placebo groups. Compared with the nonexercise groups, the 2 exercise groups demonstrated improvement in fatigue and fitness. PYD was generally well tolerated. CONCLUSION: Neither the combination of PYD plus supervised exercise nor either treatment alone yielded improvement in most FM symptoms. However, PYD did improve anxiety and sleep, and exercise improved fatigue and fitness. We speculate that PYD may have improved vagal tone, thus benefiting sleep and anxiety; this notion warrants further study

     (20)    Huber A, Suman AL, Biasi G, Carli G. Predictors of psychological distress and well-being in women with chronic musculoskeletal pain: two sides of the same coin? J Psychosom Res 2008; 64(2):169-75.
Abstract: OBJECTIVE: To date, few results on well-being in chronic-pain patients have been published, while several studies in patients without pain have indicated that well-being may not be equivalent to absence of psychological distress. The aim of the present study was to investigate the relationship between psychological distress and well-being and to identify the predictors of each in patients with chronic nonmalignant pain. METHODS: Sixty-nine women with chronic multiregional musculoskeletal pain, 41 of whom met American College of Rheumatology criteria for fibromyalgia, completed questionnaires on pain, fatigue, stiffness, physical disability (Fibromyalgia Impact Questionnaire), psychological distress [Multidimensional Affect and Pain Survey (MAPS), Symptom Check List-90 (SCL-90), State-Trait Anxiety Inventory Form Y2 (STAI-Y2)], and hedonic and eudaimonic well-being (MAPS). RESULTS: Patients reported increased amounts of psychological distress (STAI-Y2 and SCL-90) compared to healthy people. Multiple regression analysis of patient data demonstrated that higher psychological distress was related to higher age, more intense pain, a higher positive tender point count, and more physical disability. Well-being (both hedonic and eudaimonic aspects) decreased with higher disability, but was independent of age, pain intensity, and number of positive tender points. Bivariate correlations showed that psychological distress was moderately related to eudaimonic well-being and strongly related to positive affect, an aspect of hedonic well-being. CONCLUSION: In patients with chronic musculoskeletal pain, self-reports of well-being and low psychological distress only partially overlap with each other and are differently related to major patient symptoms, supporting the relevance of the concept of well-being to chronic-pain research and a need for further studies in this field

     (21)    Verbunt JA, Pernot DH, Smeets RJ. Disability and quality of life in patients with fibromyalgia. Health Qual Life Outcomes 2008; 6:8.:8.
Abstract: BACKGROUND: Patients with fibromyalgia often feel disabled in the performance of daily activities. Psychological factors seem to play a pronounced disabling role in fibromyalgia.The objectives of the study are: Firstly, to investigate contributing factors for disability in fibromyalgia. Secondly, to study psychological distress in patients with fibromyalgia as compared to other nonspecific pain syndromes. And finally, to explore the impact of fibromyalgia on a patient's quality of life. METHODS: In this cross sectional study, explaining factors for disability were studied based on a regression analysis with gender, mental health, physical and social functioning as independent variables. For the assessment of disability in fibromyalgia the FIQ was used. The levels of psychological distress in patients with fibromyalgia, Complex Regional Pain Syndrome (CRPS) and chronic low back pain (CLBP) were compared based on scores on the Symptom Checklist (SCL90). Quality of life of patients with fibromyalgia was compared with scores (SF36) of both patients with fibromyalgia and other health conditions as derived from the literature. RESULTS: Disability in fibromyalgia seemed best explained by a patients mental health condition (beta = -0.360 p = 0.02). The level of psychological distress was higher in patients with fibromyalgia as compared to patients with CRPS or CLBP (p < 0.01). The impact of fibromyalgia on quality of life appeared to be high as compared to the impact of other health conditions. CONCLUSION: Patients with fibromyalgia report a considerable impact on their quality of life and their perceived disability level seems influenced by their mental health condition. In comparison with patients with other pain conditions psychological distress is higher

     (22)    Sarzi-Puttini P, Atzeni F, Di FM, Lama N, Batticciotto A, Iannuccelli C et al. Anti-polymer antibodies are correlated with pain and fatigue severity in patients with fibromyalgia syndrome. Autoimmunity 2008; 41(1):74-9.
Abstract: OBJECTIVE: To investigate the prevalence of antipolymer antibody (APA) in patients with fibromyalgia (FM) and to examine its association with FM severity symptoms. METHODS: The study population consisted of 79 FM patients and 75 controls: 32 with psoriatic arthritis and 43 with rheumatoid arthritis APA levels were indirectly assayed using a commercial ELISA kit from Corgenix (Westmister, Colorado, USA). Optical density (OD) values were recorded on duplicates of each of the reference and patient samples. Among clinical variables we investigated pain, measured according to visual analog scales (VAS: 0-100), fatigue, stiffness, anxiety, depression, all measured by VAS (0-100), and health status measured by Fibromyalgia Impact Questionnaire (FIQ). RESULTS: Sixteen of the 79 FM patients (20.3%) and 12/78 controls (15.4%) were positive for APAs (P = 0.536). Following ROC analysis, area under curve (AUC) was 0.49 (95% CI: 0.40, 0.58). Focusing on FM patients, we observed a correlation between APA titre and pain (tau: - 0.221; P = 0.020) and fatigue (tau: - 0.205; P = 0.032) at univariate analysis. Binomial regression analysis, controlling for clinical and demographic variables, showed that pain (PPR: 0.923; P = 0.007) and fatigue (PPR: 0.948; P = 0.024) were significantly associated with APA test sensitivity. CONCLUSIONS: APA test exhibited a low sensitivity in FM patients and it did not distinguish this group of patients from the controls enrolled in this study. Interestingly, positive APA test prevalence increased with less severe pain or fatigue

     (23)    Naring GW, van LW, Geenen R. Somatoform dissociation and traumatic experiences in patients with rheumatoid arthritis and fibromyalgia. Clin Exp Rheumatol 2007; 25(6):872-7.
Abstract: OBJECTIVE: Trauma and dissociation tend to be interrelated. The objective of this study was to examine the frequency of traumatic experiences and somatoform dissociation in patients with fibromyalgia syndrome (FMS) or rheumatoid arthritis (RA), two conditions that are both characterized by pain and disability. METHODS: Patients with a diagnosis of FMS (2 male, 26 female; mean age 42 +/- 11 years) or RA (5 male, 46 female; mean age 46 +/- 10 years) completed the Fibromyalgia Impact Questionnaire (FIQ), the Somatoform Dissociation Questionnaire (SDQ), and the Traumatic Experience Checklist (TEC). RESULTS: Patients with FMS reported significantly higher levels of various forms of traumatization and dissociation than patients with RA. In patients with FMS, but not in patients with RA, there was a significant correlation between traumatization and dissociative symptoms. A possible dissociative disorder was indicated in 10% of the patients with FMS and 2% of the patients with RA. CONCLUSION: Traumatization experiences are frequent in FMS, but as compared to conversion disorder or dissociative identity disorder only a small subgroup of patients with FMS or RA shows the combination of traumatization and somatoform dissociation. The observation of somatoform dissociation calls for a broad treatment approach with a special role of the psychologist or psychiatrist

     (24)    Munguia-Izquierdo D, Legaz-Arrese A. Exercise in warm water decreases pain and improves cognitive function in middle-aged women with fibromyalgia. Clin Exp Rheumatol 2007; 25(6):823-30.
Abstract: OBJECTIVES: To compare the cognitive function performance in patients with fibromyalgia (FM) with respect healthy controls and to evaluate the short-term efficacy of exercise therapy in a warm, chest-high pool on pain and cognitive function in women with FM. METHODS: Sixty middle-aged women with FM were randomly assigned to either an exercise training group (n = 35) to perform 3 sessions per week of aquatic training (32 degrees C) including mobility, aerobic, strengthening, and relaxation exercises for 16 weeks, or a control group (n = 25). Twenty-five healthy women matched for age, weight, body mass index, and educational and physical activity levels were recruited. Pain was assessed in patients using a syringe calibrated like a pressure dolorimeter, and a visual analog scale. The severity of FM was evaluated using the Fibromyalgia Impact Questionnaire. Cognitive function was measured in healthy individuals and patients using several standardized neuropsychological tests. All patients were measured at baseline and post-treatment. RESULTS: At baseline, the healthy group evidenced cognitive performance that was significantly superior to the group of patients with FM in all of the neuropsychological tests. The exercise group significantly improved their pain threshold, tender point count, self-reported pain, severity of FM, and cognitive function, while in the control group the differences were not significant. CONCLUSION: An exercise therapy three times per week for 16 weeks in a warm-water pool is an adequate treatment to decrease the pain and severity of FM well as to improve cognitive function in previously unfit women with FM and heightened painful symptomatology

     (25)    da Silva GD, Lorenzi-Filho G, Lage LV. Effects of yoga and the addition of Tui Na in patients with fibromyalgia. J Altern Complement Med 2007; 13(10):1107-13.
Abstract: OBJECTIVES: This study aimed to verify whether techniques of yoga with and without the addition of Tui Na might improve pain and the negative impact of fibromyalgia (FMS) on patients' daily life. DESIGN: Forty (40) FMS women were randomized into two groups, Relaxing Yoga (RY) and Relaxing Yoga plus Touch (RYT), for eight weekly sessions of stretching, breathing, and relaxing yogic techniques. RYT patients were further submitted to manipulative techniques of Tui Na. OUTCOME MEASURE: Outcome measures comprised the Fibromyalgia Impact Questionnaire (FIQ), pain threshold at the 18 FMS tender points, and a verbal graduation of pain assessed before treatment and on the followup. The visual analog scale (VAS) for pain was assessed before and after each session and on the follow-up. RESULTS: Seventeen (17) RYT and 16 RY patients completed the study. Both RY and RYT groups showed improvement in the FIQ and VAS scores, which decreased on all sessions. The RYT group showed lower VAS and verbal scores for pain on the eighth session, but this difference was not maintained on the follow-up. Conversely, RY VAS and verbal scores were significantly lower just on the follow-up. CONCLUSIONS: These study results showed that yogic techniques are valid therapeutic methods for FMS. Touch addition yielded greater improvement during the treatment. Over time, however, RY patients reported less pain than RYT. These results suggest that a passive therapy may possibly decrease control over FMS symptoms

     (26)    Duncan B, White A, Rahman A. Acupuncture in the treatment of fibromyalgia in tertiary care--a case series. Acupunct Med 2007; 25(4):137-47.
Abstract: AIMS: Fibromyalgia is a common cause of chronic widespread pain. The benefit of medication is often limited by its side effects, and the improvements obtained with exercise and education are inconsistent. Many patients seek acupuncture treatment, which is reported to be helpful in some cases. This study aimed to explore the acceptability and benefits of acupuncture offered in the setting of a tertiary referral clinic. METHODS: An open, uncontrolled observational study was conducted among patients who met the usual fibromyalgia criteria and who had a pain score of at least 30 on a 100mm Visual Analogue Scale (VAS). Patients were allowed to continue other treatments but not to introduce new ones. Acupuncture was given using a Western approach according to a protocol developed by consensus. Patients were offered eight treatments in eight weeks. Outcome measures included VAS of pain intensity and Fibromyalgia Impact Questionnaire (range 0 - 100), and were taken before and after treatment, and at 14, 20 and 34 weeks from enrolment. RESULTS: Twenty four eligible patients were enrolled in a 12 month period. Baseline mean pain VAS score for these 24 patients was 74 (SD 18) and mean Fibromyalgia Impact Questionnaire score 78 (SD 12.4). Only 14 patients completed the course of treatment within about 10 weeks. Compliance was poor in the remaining patients because of difficulty attending clinic, and in two cases because of exacerbation of pain. Completion of outcome measures was variable and therefore the analysis of data is limited. Five patients scored at least 20% reduction in Fibromyalgia Impact Questionnaire score which is a clinically relevant improvement. Two of these scored at least 50% reduction. CONCLUSION: Acupuncture appears to offer symptomatic improvement to some patients with fibromyalgia in a tertiary clinic who have failed to respond to other treatments. In view of its safety, further acupuncture research is justified in this population

     (27)    Nieddu ME, Menza L, Baldi F, Frediani B, Marcolongo R. [Efficacy of Cellfood(R)'s therapy (deutrosulfazyme) in fibromyalgia.]. Reumatismo 2007; 59(4):316-21.
Abstract: OBJECTIVE: To assess the efficacy of Cellfood(R)'s therapy in the treatment of fibromyalgia. METHODS: This study was a single-blind, cross-over, randomized placebo-controlled trial. Forty female were selected from 320 cases investigated in the period 2003-2005 of June. To be included in this study, it was required that the diagnosis of fibromyalgia was made by a specialist in according to the ACR classification criteria of 1990. The patient's age was between 35-47 years, the choice of criteria were the absence of improvements with the conventional therapy and the normality of medical check-up. The patients were divided into two different-groups of thirty-one and nine subjects, each-one (group A) treated with Cellfood(R) for six months in according to the Eurodream's scheme, and each-other (group B) treated with placebo for three months and successively with Cellfood(R) for three months. Besides we have estimated the tender points with algometer and the health status of women with the Fibromyalgia Impact Questionnaire (FIQ) at the baseline (T0) and at three (T1) and six month (T2). RESULT: The group A had an appreciable improvement of the parameters at T1 statistically significant compared to the group B, while we observed a stability of they at T2 on the group A and an improvement of the parameters of the group B statistically non significant compared to each-one. CONCLUSION: Our result suggest that the Cellfood(R)'s therapy improve fibromyalgia symptoms and health-related quality of life

     (28)    Ribel-Madsen S, Christgau S, Gronemann ST, Bartels EM, nneskiold-Samsoe B, Bliddal H. Urinary markers of altered collagen metabolism in fibromyalgia patients. Scand J Rheumatol 2007; 36(6):470-7.
Abstract: OBJECTIVE: To assess the metabolism of collagen in fibromyalgia (FM) patients, and to compare the occurrence of collagen metabolism markers to the severity of FM symptoms. METHODS: Morning urine was collected from 27 FM women fulfilling the American College of Rheumatology (ACR) criteria for FM, and from seven controls. FM patients completed the Fibromyalgia Impact Questionnaire (FIQ). Bone mineral density (BMD), isokinetic muscle strength in knee and elbow, and hand-grip strength were measured. Urinary concentrations of collagen type I cross-linked C-telopeptide (CTX-I) and collagen type II cross-linked C-telopeptide (CTX-II) were determined by enzyme-linked immunosorbent assay (ELISA). Pyridinoline (Pyd) and deoxypyridinoline (Dpd) were determined by liquid chromatography, and hydroxyproline (Hyp) by spectrophotometry. All concentration data were normalized to creatinine. RESULTS: Mean values in the FM group and the control group, respectively, were: urinary CTX-I 246.8 and 337.5 microg/mmol (p = 0.060); CTX-II 110.4 and 185.1 ng/mmol (p = 0.035); Pyd 56.1 and 52.3 nmol/mmol (NS); Dpd 15.1 and 14.0 nmol/mmol (NS); Pyd : Dpd ratio 4.05 and 3.96 (NS); Hyp 26.1 and 21.1 micromol/mmol (NS). Significant inverse correlations were seen between CTX-I and the intensity of fatigue, and between CTX-II and anxiety. An inverse correlation between CTX-I and muscle strength was apparent, but relied on extreme values from one patient, and no significant correlation was found between CTX-I or CTX-II and tender points or BMD in the FM group. CONCLUSIONS: Low urinary concentrations of CTX-II and CTX-I and normal levels of Pyd and Dpd were found in FM, but their relationship to the intensity of FM symptoms was unclear

     (29)    Cuatrecasas G, Riudavets C, Guell MA, Nadal A. Growth hormone as concomitant treatment in severe fibromyalgia associated with low IGF-1 serum levels. A pilot study. BMC Musculoskelet Disord 2007; 8:119.:119.
Abstract: BACKGROUND: There is evidence of functional growth hormone (GH) deficiency, expressed by means of low insulin-like growth factor 1 (IGF-1) serum levels, in a subset of fibromyalgia patients. The efficacy of GH versus placebo has been previously suggested in this population. We investigated the efficacy and safety of low dose GH as an adjunct to standard therapy in the treatment of severe, prolonged and well-treated fibromyalgia patients with low IGF-1 levels. METHODS: Twenty-four patients were enrolled in a randomized, open-label, best available care-controlled study. Patients were randomly assigned to receive either 0.0125 mg/kg/d of GH subcutaneously (titrated depending on IGF-1) added to standard therapy or standard therapy alone during one year. The number of tender points, the Fibromyalgia Impact Questionnaire (FIQ) and the EuroQol 5D (EQ-5D), including a Quality of Life visual analogic scale (EQ-VAS) were assessed at different time-points. RESULTS: At the end of the study, the GH group showed a 60% reduction in the mean number of tender points (pairs) compared to the control group (p < 0.05; 3.25 +/- 0.8 vs. 8.25 +/- 0.9). Similar improvements were observed in FIQ score (p < 0.05) and EQ-VAS scale (p < 0.001). There was a prompt response to GH administration, with most patients showing improvement within the first months in most of the outcomes. The concomitant administration of GH and standard therapy was well tolerated, and no patients discontinued the study due to adverse events. CONCLUSION: The present findings indicate the advantage of adding a daily GH dose to the standard therapy in a subset of severe fibromyalgia patients with low IGF-1 serum levels. TRIAL REGISTRATION: NCT00497562 (ClinicalTrials.gov)

     (30)    Ayan C, Martin V, onso-Cortes B, Alvarez MJ, Valencia M, Barrientos MJ. Relationship between aerobic fitness and quality of life in female fibromyalgia patients. Clin Rehabil 2007; 21(12):1109-13.
Abstract: OBJECTIVE: To determine whether there is a direct link between quality of life and aerobic capacity among female fibromyalgia patients. DESIGN: Cross-section study. SETTING: University of Leon.Subjects: Twenty-nine women belonging to the Leon Fibromyalgia and Chronic Fatigue Association. MAIN MEASUREMENTS: Aerobic capacity and quality of life were measured by means of the Six-Minute Walk Test and the Fibromyalgia Impact Questionnaire. Outcome measures included heart rate and rate of perceived fatigue and dypsnoea. RESULTS: The average distance walked was 432.8 (61.2) m and the total average Fibromyalgia Impact Questionnaire score was 47.5 (18.9). Only item 1 of the Fibromyalgia Impact Questionnaire, physical function, showed any statistically significant link with the distance walked, which had no statistically significant relationship with any of the variables studied. CONCLUSION: The physical fitness of women with fibromyalgia, as determined by the Six-Minute Walk Test and the Fibromyalgia Impact Questionnaire, has no direct relation with quality of life as the patients perceive it

     (31)    Walitt B, Roebuck-Spencer T, Bleiberg J, Foster G, Weinstein A. Automated neuropsychiatric measurements of information processing in fibromyalgia. Rheumatol Int 2008; 28(6):561-6.
Abstract: Aberrant central neurological functioning is believed to contribute to the abnormal sensations of fibromyalgia (FM). Most patients with FM complain of diminished cognitive function. This study sought to compare objective cognitive function between FM and healthy controls at baseline and to determine if symptomatic improvement was related to objective cognitive improvement. Automated neuropsychological assessment metrics (ANAM) was used to quantify neurocognitive function. Performance on ANAM was compared between subjects with FM, musculoskeletal pain, and pain-free controls. Ten separate FM subjects completed an 8-week comprehensive treatment program. Serial testing with ANAM and the Fibromyalgia Impact Questionnaire was conducted. Statistical analysis was performed using repeated Wilcoxon signed rank tests. No differences were noted on ANAM between controls and subjects with pain disorders. A clinical improvement (FIQ median change 33.9, P = 0.002) was noted with treatment without concomitant change in ANAM scores. No cognitive impairment in FM was demonstrated using ANAM

     (32)    Arnold LM, Crofford LJ, Martin SA, Young JP, Sharma U. The effect of anxiety and depression on improvements in pain in a randomized, controlled trial of pregabalin for treatment of fibromyalgia. Pain Med 2007; 8(8):633-8.
Abstract: OBJECTIVE: To assess symptoms of anxiety and depression in a large cohort of fibromyalgia patients and to determine the impact of these symptoms on response of pain to pregabalin treatment. DESIGN: Patients completed the Hospital Anxiety and Depression Scale at the baseline visit in a randomized, controlled trial of pregabalin for treatment of fibromyalgia. Mean anxiety and depression subscale scores were calculated, and proportions of patients by symptom severity were determined. The difference between the proportion of patients reporting anxiety and depression at baseline was tested using McNemar's test. Baseline anxiety and depression were evaluated as covariates by including them-as interaction terms with treatment-in an ancova model. A path analysis evaluated the association between improvements in anxiety and depression and pain relief. RESULTS: In total, 529 patients were enrolled. Significantly more patients reported anxiety symptoms (71%) than depressive symptoms (56%) (P < 0.0001). Improvement in pain symptoms with pregabalin compared with placebo did not depend linearly on baseline anxiety or depression scores. By path analysis, 75% of the pain reduction was not explained by improvements in anxiety and depressive symptoms. CONCLUSIONS: Anxiety symptoms were more common than depressive symptoms in this cohort. Our results suggest patients with fibromyalgia should be routinely assessed for the presence of both anxiety and depression. The pain treatment effect of pregabalin did not depend on baseline anxiety or depressive symptoms, suggesting pregabalin improves pain in patients with or without these symptoms. Much of the pain reduction appears to be independent of improvements in anxiety or mood symptoms

     (33)    Rooks DS, Gautam S, Romeling M, Cross ML, Stratigakis D, Evans B et al. Group exercise, education, and combination self-management in women with fibromyalgia: a randomized trial. Arch Intern Med 2007; 167(20):2192-200.
Abstract: BACKGROUND: Self-management has increasingly been recommended as part of standard care for fibromyalgia, a common, poorly understood condition with limited treatment options. Data that assess popular self-management recommendations are scarce. We evaluated and compared the effectiveness of 4 common self-management treatments on function, symptoms, and self-efficacy in women with fibromyalgia. METHODS: A total of 207 women with confirmed fibromyalgia were recruited from September 16, 2002, through November 30, 2004, and randomly assigned to 16 weeks of (1) aerobic and flexibility exercise (AE); (2) strength training, aerobic, and flexibility exercise (ST); (3) the Fibromyalgia Self-Help Course (FSHC); or (4) a combination of ST and FSHC (ST-FSHC). The primary outcome was change in physical function from baseline to completion of the intervention. Secondary outcomes included social and emotional function, symptoms, and self-efficacy. RESULTS: Improvements in the mean Fibromyalgia Impact Questionnaire score in the 4 groups were -12.7 for the ST-FSHC group, -8.2 for the AE group, -6.6 for the ST group, and -0.3 for the FSHC group. The ST-FSHC group demonstrated greater improvement than the FSHC group (mean difference, -12.4; 95% confidence interval [CI], -23.1 to -1.7). The ST-FSHC (mean difference, 13.6; 95% CI, 2.3 to 24.9) and AE (mean difference, 13.1; 95% CI, 1.6 to 25.6) groups had similar improvements in physical function scores on the 36-Item Short-Form Health Survey. Bodily pain scores on the 36-Item Short-Form Health Survey improved in the ST-FSHC (14.8), AE (13.2), and ST (5.7) groups. Social function, mental health, fatigue, depression, and self-efficacy also improved. The beneficial effect on physical function of exercise alone and in combination with education persisted at 6 months. CONCLUSIONS: Progressive walking, simple strength training movements, and stretching activities improve functional status, key symptoms, and self-efficacy in women with fibromyalgia actively being treated with medication. The benefits of exercise are enhanced when combined with targeted self-management education. Our findings suggest that appropriate exercise and patient education be included in the treatment of fibromyalgia

     (34)    Roizenblatt S, Fregni F, Gimenez R, Wetzel T, Rigonatti SP, Tufik S et al. Site-specific effects of transcranial direct current stimulation on sleep and pain in fibromyalgia: a randomized, sham-controlled study. Pain Pract 2007; 7(4):297-306.
Abstract: OBJECTIVE: To investigate whether active anodal transcranial direct current stimulation (tDCS) (of dorsolateral prefrontal cortex [DLPFC] and primary motor cortex [M1]) as compared to sham treatment is associated with changes in sleep structure in fibromyalgia. METHODS: Thirty-two patients were randomized to receive sham stimulation or active tDCS with the anode centered over M1 or DLPFC (2 mA, 20 minutes for five consecutive days). A blinded evaluator rated the clinical symptoms of fibromyalgia. All-night polysomnography was performed before and after five consecutive sessions of tDCS. RESULTS: Anodal tDCS had an effect on sleep and pain that was specific to the site of stimulation: such as that M1 and DLPFC treatments induced opposite effects on sleep and pain, whereas sham stimulation induced no significant sleep or pain changes. Specifically, whereas M1 treatment increased sleep efficiency (by 11.8%, P = 0.004) and decreased arousals (by 35.0%, P = 0.001), DLPFC stimulation was associated with a decrease in sleep efficiency (by 7.5%, P = 0.02), an increase in rapid eye movement (REM) and sleep latency (by 47.7%, P = 0.0002, and 133.4%, P = 0.02, respectively). In addition, a decrease in REM latency and increase in sleep efficiency were associated with an improvement in fibromyalgia symptoms (as indexed by the Fibromyalgia Impact Questionnaire). Finally, patients with higher body mass index had the worse sleep outcome as indexed by sleep efficiency changes after M1 stimulation. INTERPRETATION: Our findings suggest that one possible mechanism to explain the therapeutic effects of tDCS in fibromyalgia is via sleep modulation that is specific to modulation of primary M1 activity

     (35)    Peleg R, Ablin JN, Peleg A, Neumann L, Rabia RA, Buskila D. Characteristics of fibromyalgia in Muslim Bedouin women in a primary care clinic. Semin Arthritis Rheum 2008; 37(6):398-402.
Abstract: BACKGROUND: Fibromyalgia (FM) has been described and studied in various sociocultural settings in both developed and developing countries. OBJECTIVES: To study the clinical manifestations of FM and to describe its effect on quality of life in the unique setting of Muslim Bedouin women in the southern Israel Negev desert area. METHODS: One hundred two Bedouin women were recruited from a primary health care clinic in the Negev area. All patients fulfilled American College of Rheumatology criteria for the diagnosis of FM. Tenderness was assessed by manual dolorimetry and the fibromyalgia impact questionnaire was utilized to estimate the severity of FM symptoms. Anxiety and depression were assessed by the Arthritis Impact Measurement Scales subscales and quality of life was evaluated by the SF-36 questionnaire. RESULTS: The study population was characterized by a low educational level, a high rate of consanguinity, a high number of children per mother, and a high rate of polygamy. There was a high frequency of classic FM symptoms such as pain and fatigue, as well as anxiety and depression. The overall impact of FM on quality of life was exceedingly high (8.9 on a scale of 0 to 10). CONCLUSIONS: FM is relatively common in the unique setting of Muslim Bedouin women and has a very significant impact on their quality of life as well as on their dependents. Physicians involved in the primary care of this population should be attentive to the manifestations of FM and related disorders

     (36)    Skrabek RQ, Galimova L, Ethans K, Perry D. Nabilone for the treatment of pain in fibromyalgia. J Pain 2008; 9(2):164-73.
Abstract: A randomized, double-blind, placebo-controlled trial was conducted to determine the benefit of nabilone in pain management and quality of life improvement in 40 patients with fibromyalgia. After a baseline assessment, subjects were titrated up on nabilone, from 0.5 mg PO at bedtime to 1 mg BID over 4 weeks or received a corresponding placebo. At the 2- and 4-week visits, the primary outcome measure, visual analog scale (VAS) for pain, and the secondary outcome measures, number of tender points, the average tender point pain threshold, and the Fibromyalgia Impact Questionnaire (FIQ), were evaluated. After a 4-week washout period, subjects returned for reassessment of the outcome measures. There were no significant differences in population demographics between groups at baseline. There were significant decreases in the VAS (-2.04, P < .02), FIQ (-12.07, P < .02), and anxiety (-1.67, P < .02) in the nabilone treated group at 4 weeks. There were no significant improvements in the placebo group. The treatment group experienced more side effects per person at 2 and 4 weeks (1.58, P < .02 and 1.54, P < .05), respectively. Nabilone appears to be a beneficial, well-tolerated treatment option for fibromyalgia patients, with significant benefits in pain relief and functional improvement. PERSPECTIVE: To our knowledge, this is the first randomized, controlled trial to assess the benefit of nabilone, a synthetic cannabinoid, on pain reduction and quality of life improvement in patients with fibromyalgia. As nabilone improved symptoms and was well-tolerated, it may be a useful adjunct for pain management in fibromyalgia

     (37)    Vargas-Alarcon G, Fragoso JM, Cruz-Robles D, Vargas A, Vargas A, Lao-Villadoniga JI et al. Catechol-O-methyltransferase gene haplotypes in Mexican and Spanish patients with fibromyalgia. Arthritis Res Ther 2007; 9(5):R110.
Abstract: Autonomic dysfunction is frequent in patients with fibromyalgia (FM). Heart rate variability analyses have demonstrated signs of ongoing sympathetic hyperactivity. Catecholamines are sympathetic neurotransmitters. Catechol-O-methyltransferase (COMT), an enzyme, is the major catecholamine-clearing pathway. There are several single-nucleotide polymorphisms (SNPs) in the COMT gene associated with the different catecholamine-clearing abilities of the COMT enzyme. These SNPs are in linkage disequilibrium and segregate as 'haplotypes'. Healthy females with a particular COMT gene haplotype (ACCG) producing a defective enzyme are more sensitive to painful stimuli. The objective of our study was to define whether women with FM, from two different countries (Mexico and Spain), have the COMT gene haplotypes that have been previously associated with greater sensitivity to pain. All the individuals in the study were female. Fifty-seven Mexican patients and 78 Spanish patients were compared with their respective healthy control groups. All participants filled out the Fibromyalgia Impact Questionnaire (FIQ). Six COMT SNPs (rs2097903, rs6269, rs4633, rs4818, rs4680, and rs165599) were genotyped from peripheral blood DNA. In Spanish patients, there was a significant association between three SNPs (rs6269, rs4818, and rs4680) and the presence of FM when compared with healthy controls. Moreover, in Spanish patients with the 'high pain sensitivity' haplotype (ACCG), the disease, as assessed by the FIQ, was more severe. By contrast, Mexican patients displayed only a weak association between rs6269 and rs165599, and some FIQ subscales. In our group of Spanish patients, there was an association between FM and the COMT haplotype previously associated with high pain sensitivity. This association was not observed in Mexican patients. Studies with a larger sample size are needed in order to verify or amend these preliminary results

     (38)    varez-Nemegyei J, Negreros-Castillo A, Nuno-Gutierrez BL, varez-Berzunza J, cocer-Martinez LM. [Ericksonian hypnosis in women with fibromyalgia syndrome]. Rev Med Inst Mex Seguro Soc 2007; 45(4):395-401.
Abstract: BACKGROUND: Fibromyalgia syndrome (FS) is a chronic, painful, generalized musculoskeletal disorder in which some efficacy for the conventional hypnosis modality has been claimed. Objective: to assess the efficacy of the Ericksonian modality hypnosis in FS management. MATERIAL AND METHODS: Forty-three FS female patients (44 +/- 4.7 years old) were included. They were randomized to receive for six months: Ericksonian hypnosis (EH; 20 subjects) or a sham-hypnosis (SH; 23 subjects). Every month, patient and physician global disease assessment, tender point count and the Fibromyalgia Impact Questionnaire (FIQ) were measured. RESULTS: During the follow-up, we did not find inter-group differences for the rate of change related to the baseline values for the patient and physician global disease assessment and the FIQ scores. At the third month (4.0 +/- 4.6 vs. 0.6 +/- 3.1; p = 0.02), and at the fourth month (5.0 +/- 4.6 vs. 0.8 +/- 4.0; p = 0.03) of follow-up, the participants who received EH had a significant reduction of the tender point count after adjustment for patient's age. CONCLUSIONS: Despite no effect was noted on the functional status and the patient and physician global assessment, EH produced a reduction in the number of tender points in FS. Thus, HE may be an adjuvant treatment for the management of FS patients

     (39)    Arnold LM, Pritchett YL, D'Souza DN, Kajdasz DK, Iyengar S, Wernicke JF. Duloxetine for the treatment of fibromyalgia in women: pooled results from two randomized, placebo-controlled clinical trials. J Womens Health (Larchmt ) 2007; 16(8):1145-56.
Abstract: BACKGROUND: To assess the efficacy (in particular, in pain, functional impairment, and quality of life) and safety and tolerability (incidence of adverse events, discontinuation rates, changes in laboratory findings, and vital signs) of duloxetine in female patients with fibromyalgia. METHODS: Data were pooled from two placebo-controlled clinical trials of similar design (randomized, 12-week, and double-blind), comparing duloxetine 60 mg a day (q.d.) or 60 mg twice daily (b.i.d.) (n = 326) with placebo (n = 212), in women who met the American College of Rheumatology criteria for primary fibromyalgia. RESULTS: Compared with the patients receiving placebo, duloxetine-treated female patients demonstrated a significantly greater improvement in the Brief Pain Inventory (BPI) average pain severity score and in the Fibromyalgia Impact Questionnaire (FIQ) total score, beginning at week 1 and continuing through week 12 (p < 0.001). Duloxetine was superior to placebo on all efficacy measures, including mean tender point threshold, Clinical Global Impression of Severity, Patient Global Impression of Improvement, and average interference from pain scores. The duloxetine-treated group was superior to placebo on all quality of life and functional measures, including each domain of the Medical Outcomes Study Short Form-36 (SF-36). A direct treatment effect of duloxetine on pain reduction was demonstrated and shown to be independent of secondary improvement in mood (based on BPI average pain score). Significantly more duloxetine-treated patients reported treatment-emergent adverse events (296 [90.8%] duloxetine-treated and 165 [77.8%] placebo-treated, p < 0.001). Rates of serious adverse events were similar between duloxetine-treated and placebo-treated patients. CONCLUSIONS: The pooled results of these studies demonstrate that duloxetine is a safe and efficacious treatment for both the pain and functional impairment associated with fibromyalgia in female patients, while significantly improving quality of life

     (40)    Ubago Linares MC, Ruiz-Perez I, Bermejo Perez MJ, Olry dL-L, Hernandez-Torres E, Plazaola-Castano J. Analysis of the impact of fibromyalgia on quality of life: associated factors. Clin Rheumatol 2008; 27(5):613-9.
Abstract: We analysed the impact of fibromyalgia (FM) on the functional capacity of patients suffering this syndrome and identified factors that are associated with greater disease impact. We performed a cross-sectional descriptive telephone survey on all patients diagnosed with fibromyalgia during 2003 in a university hospital in Spain. Variables studied were socio-demographic, job, clinical, health and psycho-social characteristics of patients diagnosed with FM and impact of FM on them. Disease impact was measured by means of the Fibromyalgia Impact Questionnaire (FIQ). The rest of variables were collected by means of an expressly designed questionnaire. The relation between FIQ score and the other variables was performed with a bivariate analysis, using several tests depending on the variables involved. To analyse the factors associated with greatest disease impact, a multivariate linear regression model was designed. The average FIQ score for the sample was 63.6. Having a larger number of children, being tired and being in a depressed mood were the symptoms that most affected activities of daily living. A diagnosis of any mental illness, reference to repercussion on the family environment, a lower self-rated health and having consulted more specialists before FM diagnosis were associated with a higher impact after adjusting according to all the variables in the model. It can be confirmed that the FIQ is a useful instrument for measuring the impact of FM on quality of life. Identifying factors that determine the extent of its impact will enable more effective therapeutic strategies to be designed

     (41)    Gursoy S, Erdal E, Sezgin M, Barlas IO, Aydeniz A, Alasehirli B et al. Which genotype of MAO gene that the patients have are likely to be most susceptible to the symptoms of fibromyalgia? Rheumatol Int 2008; 28(4):307-11.
Abstract: The objective of this study was to analyze the genotype distributions and allele frequencies for the MAO-A and MAO-B polymorphism of the MAO gene among the patients with fibromyalgia syndrome (FS). One hundred and seven fibromyalgia patients and 90 unrelated healthy subjects were included into the study. Genomic DNA of 107 FS patients and 90 healthy control subjects were analyzed by polymerase chain reaction. Polymorphism of the MAO gene was: 1-1, 1-3, 3-3, 3-4. The "allele 3" had a 2.7 to 4.8-fold increased transcription activity than the "allele 1". The frequencies of the genotypes of the patients with FS and healthy controls were compared. Although no significant difference was found in genotypes of patients and controls (P = 0.0559), it is likely that "allele 3" could be a more riskful factor for FS than "allele 1" (P = 0.033). Fibromyalgia impact questionnaire was administered to FS group as well as control group. One of our findings is that, the patients whose genotype 3-3 may be mostly affected by the symptoms of FS. In conclusion, it seems plausible to say that MAOA-dependent metabolism of the biological amines may be partly related to high-activated MAO-A, allele 3, in the occurrence of FS among Turkish population

     (42)    Passard A, Attal N, Benadhira R, Brasseur L, Saba G, Sichere P et al. Effects of unilateral repetitive transcranial magnetic stimulation of the motor cortex on chronic widespread pain in fibromyalgia. Brain 2007; 130(Pt 10):2661-70.
Abstract: Non-invasive unilateral repetitive transcranial magnetic stimulation (rTMS) of the motor cortex induces analgesic effects in focal chronic pain syndromes, probably by modifying central pain modulatory systems. Neuroimaging studies have shown bilateral activation of a large number of structures, including some of those involved in pain processing, suggesting that such stimulation may induce generalized analgesic effects. The goal of this study was to assess the effects of unilateral rTMS of the motor cortex on chronic widespread pain in patients with fibromyalgia. Thirty patients with fibromyalgia syndrome (age: 52.6 +/- 7.9) were randomly assigned, in a double-blind fashion, to two groups, one receiving active rTMS (n = 15) and the other sham stimulation (n = 15), applied to the left primary motor cortex in 10 daily sessions. The primary outcome measure was self-reported average pain intensity over the last 24 h, measured at baseline, daily during the stimulation period and then 15, 30 and 60 days after the first stimulation. Other outcome measures included: sensory and affective pain scores for the McGill pain Questionnaire, quality of life (assessed with the pain interference items of the Brief Pain Inventory and the Fibromyalgia Impact Questionnaire), mood and anxiety (assessed with the Hamilton Depression Rating Scale, the Beck Depression Inventory and the Hospital Anxiety and Depression Scale). We also assessed the effects of rTMS on the pressure pain threshold at tender points ipsi- and contralateral to stimulation. Follow-up data were obtained for all the patients on days 15 and 30 and for 26 patients (13 in each treatment group) on day 60. Active rTMS significantly reduced pain and improved several aspects of quality of life (including fatigue, morning tiredness, general activity, walking and sleep) for up to 2 weeks after treatment had ended. The analgesic effects were observed from the fifth stimulation onwards and were not related to changes in mood or anxiety. The effects of rTMS were more long-lasting for affective than for sensory pain, suggesting differential effects on brain structures involved in pain perception. Only few minor and transient side effects were reported during the stimulation period. Our data indicate that unilateral rTMS of the motor cortex induces a long-lasting decrease in chronic widespread pain and may therefore constitute an effective alternative analgesic treatment for fibromyalgia

     (43)    Mannerkorpi K, Rivano-Fischer M, Ericsson A, Nordeman L, Gard G. Experience of physical activity in patients with fibromyalgia and chronic widespread pain. Disabil Rehabil 2008; 30(3):213-21.
Abstract: PURPOSE: Patients with fibromyalgia (FM) and chronic widespread pain (CWP) find physical activity troublesome. The purpose was to develop a questionnaire to investigate the experience of physical activity in FM and CWP populations. METHOD: A questionnaire was developed from a qualitative study. After that, a total of 204 patients with FM or CWP completed the questionnaire. A factor analysis was conducted and the internal consistency was investigated. The relationship between the factors and pain, health status (the Fibromyalgia Impact Questionnaire, FIQ), distress (the Hospital Anxiety and Distress scale, HAD) and leisure time physical activity (the Leisure Time Physical Activity Instrument, LTPAI) was investigated. RESULTS: Five factors were identified: Physical Relaxation (PR), Well-being (WB), Activity Beliefs (AB), Activity-related Symptoms (AS) and Activity Habits (AH). Cronbach's alpha ranged from 0.57 to 0.86. The PR showed a correlation (rho 0.28, p < 0.01) with the FIQ Pain. The AS showed a correlation (rho 0.25, p < 0.01) with the FIQ total score, while the AH showed a correlation with the HAD Depression (0.26, p < 0.01) and with strenuous physical activity (LTPAI) (-0.32, p < 0.01). CONCLUSION: A new instrument was developed to study the experience of physical activity in persons with long-lasting pain. Five factors were identified using factor analysis, and three of them showed fair associations with FM symptoms, distress or physical activity

     (44)    Bazzichi L, Giacomelli C, De FF, Giuliano T, Rossi A, Doveri M et al. Antipolymer antibody in Italian fibromyalgic patients. Arthritis Res Ther 2007; 9(5):R86.
Abstract: The objectives of the present study were to evaluate the presence of antipolymer antibody (APA) seropositivity in 285 Italian patients affected by primary fibromyalgia (FM) and to verify whether APA levels correlate with disease severity and with cytokine levels.APA levels were determined on serum samples by an indirect ELISA kit that detects IgG APA. Cytokines (IL-1, IL-6, IL-8, IL-10 and TNFalpha) were measured by ELISA in plasma. The impact of FM on the quality of life was estimated using the Fibromyalgia Impact Questionnaire, while pain severity was evaluated using a visual analogic scale. Patients were also characterized by the presence of tiredness, stiffness, nonrestorative sleep, anxiety, depression, tension headache, irritable bowel syndrome, temporomandibular dysfunction and Raynaud's phenomena. Using a cut-off value of 30 U, APA-positive values were detected in 60 FM patients (21.05%) and in 15 healthy control individuals (15.00%) without significant differences among their levels or the percentage of seropositivity. FM patients with moderate and severe symptoms had slightly higher APA levels with respect to patients with mild symptoms. APA-seropositive patients exhibited significant correlations between APA levels and the Fibromyalgia Impact Questionnaire estimate (P = 0.042), tiredness (P = 0.003) and IL-1 levels (P = 0.0072). In conclusion, APA cannot be considered a marker of disease in Italian FM patients. The presence of APA, however, might permit the identification of a subset of FM patients with more severe symptoms and of patients who may respond differently to different therapeutic strategies

     (45)    Al-Allaf AW. Work disability and health system utilization in patients with fibromyalgia syndrome. J Clin Rheumatol 2007; 13(4):199-201.
Abstract: BACKGROUND: Fibromyalgia syndrome (FMS) usually affects women of working age. We expect significant work-related disability in association with FMS. Because of the variety of symptoms, these patients often have multiple visits to their general practitioners with many referrals and visits to various specialists. OBJECTIVE: To investigate the impact of fibromyalgia on working disability and health system utilization. METHOD: This was a case-control study comparing fibromyalgia outpatient attendees with controls attending nonrheumatology outpatient clinics in Eastern Scotland. One hundred thirty-six patients with FMS and 152 age- and sex-matched controls completed a postal questionnaire about their working history and attendance at various outpatient clinics and general practitioners' visits. RESULTS: Significant number of patients with FMS (46.8%) reported that they lost their job because of the disease, compared with only 14.1% of controls (P < 0.00001). There was no significant difference in health system utilization between patients with FMS and other clinic controls in a subset of patients surveyed. CONCLUSION: Fibromyalgia is significantly associated with reports of working disability. Reasons for this decreased employment need to be investigated. The impact on the health system appeared to be the same as for patients with known specific organic diseases with regard to the number of general practitioner or hospital visits

     (46)    Tander B, Atmaca A, Aliyazicioglu Y, Canturk F. Serum ghrelin levels but not GH, IGF-1 and IGFBP-3 levels are altered in patients with fibromyalgia syndrome. Joint Bone Spine 2007; 74(5):477-81.
Abstract: INTRODUCTION: Both hypothalamo-pituitary-insulin-like growth factor-1 (IGF-1) axis and ghrelin levels may be altered in fibromyalgia syndrome (FMS) due to increased somatostatin tone. The aim of this study is to compare hypothalamo-pituitary-IGF-1 axis, ghrelin concentrations and their relations in premenopausal women with FMS and premenopausal healthy controls. METHODS: Seventy-five women (47 FMS and 28 healthy women) were enrolled in the study. Fasting plasma glucose, serum growth hormone (GH), insulin, C-peptide, IGF-1, insulin-like growth factor binding protein-3 (IGFBP-3) and ghrelin levels were measured. Depressive symptoms were assessed using beck depression inventory. Pain intensity and sleep disturbance were recorded on a visual analog scale. The activity of daily living was assessed by fibromyalgia impact questionnaire. RESULTS: There were no significant differences in GH, IGF-1, IGFBP-3, glucose, insulin, and C-peptide levels between patients and controls (p>0.05), whereas ghrelin levels were significantly lower in patients than controls (p<0.05). Ghrelin levels were not correlated with GH, IGF-1, IGFBP-3, glucose, insulin, and C-peptide levels while they were positively correlated with tender point score and sleep disturbance score and negatively correlated with pain intensity score. CONCLUSION: Our results suggest that low levels of ghrelin in FMS are not related to the changes in hypothalamo-pituitary-IGF-1 axis but may be related to some symptoms of FMS. Our results need to be clarified by further studies

     (47)    Babu AS, Mathew E, Danda D, Prakash H. Management of patients with fibromyalgia using biofeedback: a randomized control trial. Indian J Med Sci 2007; 61(8):455-61.
Abstract: OBJECTIVE: Fibromyalgia syndrome (FMS) is a chronic rheumatological condition which could be characterized by generalized pain and fatigue. Cognitive and behavioral therapy has been found to be a suitable technique in the management of FMS. This study intends to evaluate the efficacy of electromyography (EMG) biofeedback to reduce pain in patients with FMS. MATERIALS AND METHODS: A randomized controlled trial involving two groups of FMS patients, one receiving EMG biofeedback and the other a sham biofeedback, was carried out. The assessment tools included in the study were fibromyalgia impact questionnaire (FIQ), visual analogue scale (VAS), six-minute walk test (SMWT) and number of tender points; and tenderness of each tender point was done for both the groups. STATISTICS: A Student's 't' test was used to study the test for significance. RESULTS: After using biofeedback, the mean VAS scores and the mean number of tender points were found to be 3 out of 10 and 6 out of 18 respectively. Subjective analysis from both groups showed improvement in physical and psychological realms. Statistical significance. CONCLUSION: Biofeedback as a treatment modality reduces pain in patients with FMS, along with improvements in FIQ, SMWT and the number of tender points

     (48)    Yazici Y. Monitoring outcomes of arthritis and longitudinal data collection in routine care using a patient questionnaire that incorporates a clinical note on one piece of paper. Best Pract Res Clin Rheumatol 2007; 21(4):629-36.
Abstract: Patient questionnaires are the quantitative tools available to rheumatologists to monitor their patients' health status and responses to therapy. The Health Assessment Questionnaire (HAQ) and its derivatives have been shown to be the most significant predictors of functional and work disability, costs, joint replacement surgery, and mortality; generally at higher levels of significance than joint counts, radiographs, and laboratory tests. Every encounter of a patient with a rheumatologist provides an opportunity to collect data. Yet patient questionnaires, which can be used in all rheumatic diseases, including osteoarthritis, systemic lupus erythematosus, fibromyalgia, scleroderma, and ankylosing spondylitis, are not included in routine care by most rheumatologists. Questionnaires can be adapted to include a simple subjective-objective-assessment-plan (SOAP) clinical encounter note that helps with data entry and also provides all the necessary information for clinical decision making in one sheet of paper. Data that are feasible to collect in clinical care provide the optimal approach to assessing quantitatively how patients are doing. If data are not collected and recorded, that opportunity, on that day, is lost forever. Rheumatologists would find it valuable to adapt questionnaires to the care they provide for all their patients, to document and improve the care they provide, and add quantitative data to standard clinical care

     (49)    van Wilgen CP, Bloten H, Oeseburg B. Results of a multidisciplinary program for patients with fibromyalgia implemented in the primary care. Disabil Rehabil 2007; 29(15):1207-13.
Abstract: PURPOSE: Fibromyalgia is a syndrome of unknown origin with a high prevalence. Multimodal approaches seem to be the treatment of choice in fibromyalgia. A multidisciplinary program was developed and implemented for patients with fibromyalgia in the primary care setting. The program included education (seven sessions) and physical therapy (25 sessions). METHOD: Patients were referred to the program by their general practitioner or by a medical specialist. A prospective non-controlled treatment study was performed, patients were evaluated before, after and three months after the program (single group time series design). The following measurements were performed: The Fibromyalgia Impact Questionnaire, RAND 36, the Pain Coping and Cognition List, the Tampa scale for kinesiophobia, two physical tests and a qualitative evaluation. Data of 65 patients with fibromyalgia were analysed, of whom 97% were female. The mean age was 44 and the mean duration of pain was nine years. RESULTS: Data of 65 patients with fibromyalgia were analysed, patients significantly improved on the domains feeling good, pain, fatigue, stiffness, quality of life, catastrophizing and on the physical tests. CONCLUSION: The multidisciplinary program fibromyalgia implemented in primary care seems feasible and the results are promising

     (50)    Carville SF, rendt-Nielsen S, Bliddal H, Blotman F, Branco JC, Buskila D et al. EULAR evidence-based recommendations for the management of fibromyalgia syndrome. Ann Rheum Dis 2008; 67(4):536-41.
Abstract: OBJECTIVE: To develop evidence-based recommendations for the management of fibromyalgia syndrome. METHODS: A multidisciplinary task force was formed representing 11 European countries. The design of the study, including search strategy, participants, interventions, outcome measures, data collection and analytical method, was defined at the outset. A systematic review was undertaken with the keywords "fibromyalgia", "treatment or management" and "trial". Studies were excluded if they did not utilise the American College of Rheumatology classification criteria, were not clinical trials, or included patients with chronic fatigue syndrome or myalgic encephalomyelitis. Primary outcome measures were change in pain assessed by visual analogue scale and fibromyalgia impact questionnaire. The quality of the studies was categorised based on randomisation, blinding and allocation concealment. Only the highest quality studies were used to base recommendations on. When there was insufficient evidence from the literature, a Delphi process was used to provide basis for recommendation. RESULTS: 146 studies were eligible for the review. 39 pharmacological intervention studies and 59 non-pharmacological were included in the final recommendation summary tables once those of a lower quality or with insufficient data were separated. The categories of treatment identified were antidepressants, analgesics, and "other pharmacological" and exercise, cognitive behavioural therapy, education, dietary interventions and "other non-pharmacological". In many studies sample size was small and the quality of the study was insufficient for strong recommendations to be made. CONCLUSIONS: Nine recommendations for the management of fibromyalgia syndrome were developed using a systematic review and expert consensus

     (51)    McVeigh JG, Finch MB, Hurley DA, Basford JR, Sim J, Baxter GD. Tender point count and total myalgic score in fibromyalgia: changes over a 28-day period. Rheumatol Int 2007; 27(11):1011-8.
Abstract: Tender point count (TPC) is central to fibromyalgia syndrome (FMS), and with total myalgic score (TMS) is often used to monitor the patient's condition. This study aimed to determine the stability of TPC and TMS over time, and to examine how well these measures reflected patients' perceptions of their condition. Twenty-four patients with FMS completed the Fibromyalgia Impact Questionnaire (FIQ) and a visual analogue scale (VAS) measuring well-being, at entrance into the study, and 7 and 28 days later. There was no significant change in TPC (P = 0.074), FIQ score (P = 0.291) or VAS (P = 0.079) of well-being with time. However, mean TMS score did change over time (P = 0.021). There was no correlation between total FIQ score and the other measures (all P-values > 0.05). The significant change in TMS over time may reflect the natural fluctuation in the clinical presentation of FMS

     (52)    Walitt B, Roebuck-Spencer T, Esposito G, Atkins F, Bleiberg J, Foster G et al. The effects of multidisciplinary therapy on positron emission tomography of the brain in fibromyalgia: a pilot study. Rheumatol Int 2007; 27(11):1019-24.
Abstract: Aberrant central neurological functioning is believed to contribute to the abnormal sensations of fibromyalgia (FM). This pilot study sought to determine if alterations in regional brain metabolism from baseline occur in FM after undergoing a multidisciplinary therapeutic regimen. Regional brain metabolic activity was estimated using (18)F-fluorodeoxyglucose positron emission tomography ((18)FDG PET). Nine participants with FM received an 8-week comprehensive treatment program. Serial testing with (18)FDG PET and the Fibromyalgia Impact Questionnaire were performed. Statistical analysis was performed using repeated Wilcoxon signed rank tests. A clinical improvement (FIQ median change 20.68, P = 0.005) was noted with treatment. With treatment, increases in brain metabolism were noted in various components of the limbic system (P = 0.004-0.1). An increase in limbic metabolism was noted with concomitant symptomatic improvement, suggesting that the limbic system attenuates FM symptoms

     (53)    Matsutani LA, Marques AP, Ferreira EA, Assumpcao A, Lage LV, Casarotto RA et al. Effectiveness of muscle stretching exercises with and without laser therapy at tender points for patients with fibromyalgia. Clin Exp Rheumatol 2007; 25(3):410-5.
Abstract: OBJECTIVE: To assess the efficiency of a treatment composed of muscle stretching exercises, associated or not to laser therapy at tender points, for patients with fibromyalgia (FM), in view of bettering their quality of life. METHODS: Twenty FM patients were randomly assigned to two groups: one submitted to laser therapy and stretching (LSG, n=10), and the other only to stretching exercises (SG, n=10). The visual analog scale of pain (VAS) and dolorimetry at tender points were used to assess pain; life quality was evaluated by means of the Fibromyalgia Impact Questionnaire (FIQ) and the 36-item Short-Form Health Survey (SF-36). RESULTS: After the treatment program, both in LSG and SG were detected pain reduction, higher pain threshold at tender points (all p<0.01), lower mean FIQ scores, and higher SF-36 mean scores (all p<0.05). No significant differences were found between both groups. CONCLUSION: The stretching exercises program proposed is efficient to reduce pain and painful sensibility at tender points, thus enhancing patients' quality of life. Laser therapy has not shown advantages when added to muscle stretching exercises

     (54)    Tomas-Carus P, Hakkinen A, Gusi N, Leal A, Hakkinen K, Ortega-Alonso A. Aquatic training and detraining on fitness and quality of life in fibromyalgia. Med Sci Sports Exerc 2007; 39(7):1044-50.
Abstract: PURPOSE: To evaluate the effects of a 12-wk period of aquatic training and subsequent detraining on health-related quality of life (HRQOL) and physical fitness in females with fibromyalgia. METHODS: Thirty-four females with fibromyalgia were randomly assigned into two groups: an exercise group, who exercised for 60 min in warm water, three times a week (N = 17); and a control group, who continued their habitual leisure-time activities (N = 17). HRQOL was assessed using the Short Form 36 questionnaire and the Fibromyalgia Impact Questionnaire. Physical fitness was measured using the following tests: Canadian Aerobic Fitness, hand grip dynamometry, 10-m walking, 10-step stair climbing, and blind one-leg stance. Outcomes were measured at baseline, after treatment, and after 3 months of detraining. RESULTS: After 12 wk of aquatic exercise, significant positive effects of aquatic training were found in physical function, body pain, general health perception, vitality, social function, role emotional problems and mental health, balance, and stair climbing. After the detraining period, only the improvements in body pain and role emotional problems were maintained. CONCLUSION: The present water exercise protocol improved some components of HRQOL, balance, and stair climbing in females with fibromyalgia, but regular exercise and higher intensities may be required to preserve most of these gains

     (55)    Fioravanti A, Perpignano G, Tirri G, Cardinale G, Gianniti C, Lanza CE et al. Effects of mud-bath treatment on fibromyalgia patients: a randomized clinical trial. Rheumatol Int 2007; 27(12):1157-61.
Abstract: The efficacy of balneotherapy in fibromyalgia syndrome (FS) has been well demonstrated, while controlled studies using mud packs are lacking. We performed a randomized clinical trial to evaluate the effects and the tolerability of mud-bath treatment in FS patients, who are poor responders to pharmacological therapy. Eighty patients with primary FS, according to ACR criteria, were randomly allocated to two groups: 40 were submitted to a cycle of 12 mud packs and thermal baths, and 40 were considered as controls. At baseline, after thermal treatment and after 16 weeks, patients were evaluated by FIQ, tender points count, VAS for "minor" symptoms, AIMS1 and HAQ. Control patients were assessed at the same time periods. A significant improvement of all evaluation parameters after mud-bath therapy and after 16 weeks was observed. Mud packs were well tolerated and no drop-outs were recorded. Our results suggest the efficacy and the tolerability of mud-bath treatment in primary FS

     (56)    Bazzichi L, Rossi A, Giuliano T, De FF, Giacomelli C, Consensi A et al. Association between thyroid autoimmunity and fibromyalgic disease severity. Clin Rheumatol 2007; 26(12):2115-20.
Abstract: Our objectives were to investigate thyroid abnormalities and autoimmunity in 120 patients affected by fibromyalgia (FM) and to study their relationships with clinical data and symptoms. Thyroid assessment by means of antithyroglobulin antibodies, antithyroid peroxidase antibodies, free triiodo-thyronine, free thyroxine, and thyroid stimulating hormone analyses was carried out. The clinical parameters "Fibromyalgia Impact Questionnaire", pain, tender points, fatigue, and other symptoms, and the presence of depression or anxiety disorders were evaluated. The basal thyroid hormone levels of FM patients were in the normal range, while 41% of the patients had at least one thyroid antibody. Patients with thyroid autoimmunity showed a higher percentage of dry eyes, burning, or pain with urination, allodynia, blurred vision, and sore throat. Correlations found between thyroid autoimmunity and age or with the presence of depression or anxiety disorders were not significant. However, in the cohort of post-menopausal patients, the frequency of thyroid autoimmunity was higher with respect to pre-menopausal patients. In conclusion, autoimmune thyroiditis is present in an elevated percentage of FM patients, and it has been associated with the presence of typical symptoms of the disease

     (57)    Aloush V, Ablin JN, Reitblat T, Caspi D, Elkayam O. Fibromyalgia in women with ankylosing spondylitis. Rheumatol Int 2007; 27(9):865-8.
Abstract: Fibromyalgia (FM), pre-dominantly found in women, may accompany other pre-existing rheumatic diseases. The association between FM and ankylosing spondylitis (AS) is uncertain. We evaluated FM in women with AS. Eighteen women with AS were compared with 18 men with AS (controls) for age, duration of symptoms, time to diagnosis, degree of sacroiliac involvement, history of peripheral arthritis, patient global assessment, Health Assessment Questionnaire, Fibromyalgia Impact Questionnaire, level of diffuse pain, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Functional Index (BASFI). Physical examination included the number of tender points and enthesitis sites, Schober test, distance between occiput and wall, chest expansion, lateral spinal flexion, and intermalleolar distance. Inflammatory activity was measured by the erythrocyte sedimentation rate (ESR). Of all tested parameters, the ones with significant differences between the groups were time between symptom onset and AS diagnosis (longer for women), FM incidence and the number of tender points and enthesitis sites (higher for women), BASDAI (higher in women and correlated with FM and the number of tender points but not with ESR), and BASFI and BASDAI scores (increased in FM patients). FM was present in 50% of women with AS and associated with higher disease activity indices (BASDAI and BASFI) and not related to severity of physical findings or ESR. The reliability of well-accepted assessment tools of AS, such as BASDAI and BASFI, in evaluating AS activity in women may be called into question due to a confounding effect of FM

     (58)    Patkar AA, Masand PS, Krulewicz S, Mannelli P, Peindl K, Beebe KL et al. A randomized, controlled, trial of controlled release paroxetine in fibromyalgia. Am J Med 2007; 120(5):448-54.
Abstract: PURPOSE: We investigated the efficacy and tolerability of paroxetine controlled release, a selective serotonin reuptake inhibitor in fibromyalgia. METHODS: After excluding patients with current major depression and anxiety disorders, 116 subjects with fibromyalgia were enrolled in a 12-week, randomized, double-blind, placebo-controlled, trial of paroxetine controlled release (12.5-62.5 mg/day). The primary outcome measure was proportion of responders as defined as a> or =25% reduction in scores on the Fibromyalgia Impact Questionnaire (FIQ) from randomization to end of treatment. Secondary outcome measures included changes in FIQ scores, Clinical Global Impression -Improvement (CGI-I) and Severity (CGI-S) scores, Visual Analogue Scale for pain scores, number of tender points, and scores on the Sheehan Disability Scale (SDS). RESULTS: Significantly more patients in paroxetine controlled release group (57%) showed a> or =25% reduction in FIQ compared to placebo (33%) (P=.016). Paroxetine controlled release was significantly superior to placebo in reducing the FIQ total score (P =.015). The CGI-I ratings significantly favored the drug over placebo (P<.005). The improvements on other secondary outcome measures between the 2 groups were not statistically significant. Drowsiness, dry mouth, blurred vision, genital disorders, and anxiety were reported more frequently with paroxetine controlled release. The mean dose of paroxetine controlled release was 39.1 mg/day. CONCLUSIONS: Paroxetine controlled release appears to be well-tolerated and improve the overall symptomatology in patients with fibromyalgia without current mood or anxiety disorders. However, its effect on pain measures seems to be less robust

     (59)    Iverson GL, Le PJ, Koehler BE, Shojania K, Badii M. Test of Memory Malingering (TOMM) scores are not affected by chronic pain or depression in patients with fibromyalgia. Clin Neuropsychol 2007; 21(3):532-46.
Abstract: Neuropsychologists routinely give effort tests, such as the Test of Memory Malingering (TOMM). When a person fails one of these tests, the clinician must try to determine whether the poor performance was due to suboptimal effort or to chronic pain, depression, or other problems. Participants were 54 community-dwelling patients who met American College of Rheumatology criteria for fibromyalgia (FM). In addition to the TOMM, they completed the Beck Depression Inventory-Second Edition, Multidimensional Pain Inventory-Version 1, Oswestry Disability Index-2.0, British Columbia Cognitive Complaints Inventory, and the Fibromyalgia Impact Questionnaire. The majority endorsed at least mild levels of depressive symptoms (72%), and 22% endorsed "severe" levels of depression. The average scores on the TOMM were 48.8 (SD = 1.9, range = 40-50) for Trial 1, 49.8 (SD = 0.5, range = 48-50) for Trial 2, and 49.6 (SD = 0.9, range = 45-50) for Retention. Despite relatively high levels of self-reported depression, chronic pain, and disability, not a single patient failed the TOMM. In this study, the TOMM was not affected by chronic pain, depression, or both

     (60)    Calandre EP, Morillas-Arques P, Rodriguez-Lopez CM, Rico-Villademoros F, Hidalgo J. Pregabalin augmentation of quetiapine therapy in the treatment of fibromyalgia: an open-label, prospective trial. Pharmacopsychiatry 2007; 40(2):68-71.
Abstract: INTRODUCTION: Quetiapine has been shown to improve fibromyalgia symptoms, especially sleep disturbance, fatigue, morning stiffness, and mental well-being, but lacks an effect on pain. The purpose of this study was to evaluate if pregabalin, which has shown antialgic activity in fibromyalgia, added to quetiapine treatment additionally improved fibromyalgia symptomatology. METHODS: This was an open-label, 12-week study. Pregabalin was administered to 19 female fibromyalgia patients at a starting dose of 75 mg/day subsequently adjusted in according to the drug's efficacy and tolerability. Outcome measures included the Fibromyalgia Impact Questionnaire (FIQ), the Pittsburgh Sleep Quality Index, the Beck Depression Inventory, the State and Trait Anxiety Inventory, and the SF-12 Health Survey. RESULTS: Data analysis was done on the Intention-To-Treat sample which included 18 patients. Pregabalin significantly improved the pain and tiredness after awakening subscales of the FIQ as well as the physical component of the SF-12. Six patients withdrew from the study, 3 because of side effects. CONCLUSIONS: Our results suggest that the use of pregabalin can be a useful augmentation strategy in fibromyalgia patients partially responding to quetiapine

     (61)    Okamoto T, Hashimoto K, Aoki S, Ohashi M. Cerebral blood flow in patients with diffuse axonal injury--examination of the easy Z-score imaging system utility. Eur J Neurol 2007; 14(5):540-7.
Abstract: To evaluate the utility of easy Z-score imaging system (eZIS) in 27 diffuse axonal injury (DAI) cases. Twenty-seven DAI patients were examined with an magnetic resonance imaging (MRI) T2* sequence and with eZIS (seven women, 20 men; age range, 19-35 years; median age: 26.6 years). In this investigation, we excluded patients who exhibited complications such as acute subdural hematoma, acute epidural hematoma, intracerebral hematoma, or brain contusion. We examined the neuropsychological tests and correlated with findings from MRI/eZIS. Furthermore, we evaluated the degree of ventricular enlargement in the bifrontal cerebroventricular index (CVI). Patients were divided into two groups: the enlargement group (bifrontal CVI > 35%, 12 patients) and the non-enlargement group (bifrontal CVI < 35%, 15 patients). All of the patients showed cognitive deficits as observed from the neuropsychological test results. Fifteen out of 27 patients by MRI T1/T2 weighted images and fluid attenuated inversion recovery (FLAIR), 22 out of 27 patients by MRI T2* weighted images and 24 out of 27 patients by eZIS showed abnormal findings. In MRI T2* weighted imaging, the white matter from the frontal lobe, corpus callosum, and brainstem showed abnormal findings. With eZIS, 22 patients (81.5%) showed blood flow degradation in the frontal lobe, and 12 patients (44.4%) in cingulate gyrus. In the enlargement group, Functional Independence Measure, Mini-Mental State Examination, Verbal IQ (VIQ)/Full Scale IQ (FIQ), Trail Making Test-B (TMT-B), and Non-paired of Miyake Paired Test were significantly lower. Amongst 12 patients without ventricular enlargement who had no abnormal findings in MRI T1/T2 weighted images and FLAIR, abnormal findings were detectable in seven patients with MRI T2* weighted imaging and to 10 patients with eZIS. Results of the MRI examination alone cannot fully explain DAI frontal lobe dysfunction. However, addition of the eZIS-assisted analysis derived from the single photon emission computed tomography (SPECT) data enabled us to understand regions where blood flow was decreased, i.e., where neuronal functions conceivably might be reduced

     (62)    Arnold LM, Goldenberg DL, Stanford SB, Lalonde JK, Sandhu HS, Keck PE, Jr. et al. Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial. Arthritis Rheum 2007; 56(4):1336-44.
Abstract: OBJECTIVE: To assess the efficacy and safety of gabapentin in patients with fibromyalgia. METHODS: A 12-week, randomized, double-blind study was designed to compare gabapentin (1,200-2,400 mg/day) (n=75 patients) with placebo (n=75 patients) for efficacy and safety in treating pain associated with fibromyalgia. The primary outcome measure was the Brief Pain Inventory (BPI) average pain severity score (range 0-10, where 0=no pain and 10=pain as bad as you can imagine). Response to treatment was defined as a reduction of >or=30% in this score. The primary analysis of efficacy for continuous variables was a longitudinal analysis of the intent-to-treat sample, with treatment-by-time interaction as the measure of effect. RESULTS: Gabapentin-treated patients displayed a significantly greater improvement in the BPI average pain severity score (P=0.015; estimated difference between groups at week 12=-0.92 [95% confidence interval -1.75, -0.71]). A significantly greater proportion of gabapentin-treated patients compared with placebo-treated patients achieved response at end point (51% versus 31%; P=0.014). Gabapentin compared with placebo also significantly improved the BPI average pain interference score, the Fibromyalgia Impact Questionnaire total score, the Clinical Global Impression of Severity, the Patient Global Impression of Improvement, the Medical Outcomes Study (MOS) Sleep Problems Index, and the MOS Short Form 36 vitality score, but not the mean tender point pain threshold or the Montgomery Asberg Depression Rating Scale. Gabapentin was generally well tolerated. CONCLUSION: Gabapentin (1,200-2,400 mg/day) is safe and efficacious for the treatment of pain and other symptoms associated with fibromyalgia

     (63)    Wigers SH, Finset A. [Rehabilitation of chronic myofascial pain disorders]. Tidsskr Nor Laegeforen 2007; 127(5):604-8.
Abstract: BACKGROUND: Chronic musculoskeletal pain of diffuse origin affects many, and at a significant cost. Evidence-based guidelines for therapeutic interventions are presented and exemplified. MATERIAL AND METHODS: 200 patients with chronic myofascial pain and/or fibromyalgia who participated in a 4-week multidimensional rehabilitation programme, were included in the study. The programme included education and pain management in a cognitive setting, various forms of aerobic exercises, myofascial pain treatment, relaxation and medication as needed. The patients filled in questionnaires on arrival, at follow-up after six and 12-months and at discharge. They completed visual analogue scales (pain, fatigue, sleep problems, depression), the Nottingham Health Profile, the Fibromyalgia Impact Questionnaire, global subjective improvement, and during the follow-up period also the physical activity level, changes in quality of life and occupational workload. Work capacity, a tender point count and whether patients met the diagnostic criteria for fibromyalgia were assessed at baseline and at discharge. RESULTS: Significant improvements were seen in all variables throughout the follow-up period. 30% of the fibromyalgia patients no longer met the diagnostic criteria at discharge. There was a significant increase in quality of life over time. After one year, more patients had returned to work and fewer were off sick, but there was also an increased number on disability pensions. The majority did exercise training on a regular basis. INTERPRETATION: Our findings confirm the existing evidence-based guidelines by showing that multidimensional rehabilitation is an effective intervention for patients with widespread chronic pain. It is a challenge for health politicians to change today's common practice towards that described in evidence-based guidelines

     (64)    Ang D, Kesavalu R, Lydon JR, Lane KA, Bigatti S. Exercise-based motivational interviewing for female patients with fibromyalgia: a case series. Clin Rheumatol 2007; 26(11):1843-9.
Abstract: The objective of the study is to determine the effects of motivational interviewing (MI), a novel technique of behavioral counseling to promote exercise, on pain and physical function in patients with fibromyalgia (FMS). Patients who met the American College of Rheumatology criteria for FMS and had a visual analog pain score of > or =6 were enrolled in a single group intervention pilot study. Participants received two supervised exercise sessions and an exercise prescription. Thereafter, six exercise-based MI phone calls were made over a 10-week period. Assessments were done at baseline, week 12 (immediate postintervention) and week 30 (follow-up). The primary endpoints were changes from baseline in the fibromyalgia impact questionnaire (FIQ)-pain and physical impairment at week 30. Secondary measures were brief pain inventory (BPI)-pain severity and BPI-pain interference, the number of exercise minutes (NEM) per week, and the arthritis impact measurement scale (AIMS)-depression. The 19 enrolled female participants had a mean age of 52.2 +/- 9.1 years, mean disease duration of 7.5 +/- 5.0 years, and a mean FIQ-pain score of 7.7 +/- 1.4. By week 30, there was significant improvement in both FIQ-pain (-2.6 +/- 2.6, p < 0.001) and FIQ-physical impairment (-1.3 +/- 2.1, p = 0.01). Likewise, BPI-pain severity and pain interference were reduced by -2.4 +/- 2.1 (p < 0.001) and -2.4 +/- 2.0 (p < 0.001), respectively. While the median NEM per week increased from 0 to 32 min (p = 0.001) at week 30, AIMS-depression score was unchanged. In this pilot study, we conclude that telephone-delivered MI to promote exercise was associated with an improvement in patient's level of pain and physical impairment

     (65)    Jespersen A, Dreyer L, Kendall S, Graven-Nielsen T, rendt-Nielsen L, Bliddal H et al. Computerized cuff pressure algometry: A new method to assess deep-tissue hypersensitivity in fibromyalgia. Pain 2007; 131(1-2):57-62.
Abstract: The aim of this study was to evaluate the use of computerized cuff pressure algometry (CPA) in fibromyalgia (FM) and to correlate deep-tissue sensitivity assessed by CPA with other disease markers of FM. Forty-eight women with FM and 16 healthy age-matched women were included. A computer-controlled, pneumatic tourniquet cuff was placed over the gastrocnemius muscle. The cuff was inflated, and the subject rated the pain intensity continuously on an electronic Visual Analogue Scale (VAS). The subject stopped the inflation at the pressure-pain tolerance and the corresponding VAS-score was determined (pressure-pain limit). The pressure at which VAS firstly exceeded 0 was defined as the pressure-pain threshold. Other disease markers (FM only): Isokinetic knee muscle strength, tenderpoint-count, myalgic score, Beck Depression Inventory, and Fibromyalgia Impact Questionnaire. Student's T-test was used to compare pressure-pain threshold and pressure-pain tolerance and the Mann-Whitney test to compare pressure-pain limit. Pearson's correlation was used to detect linear relationships. Pressure-pain threshold and pressure-pain tolerance assessed by CPA were significantly lower in FM compared to healthy controls. There was no difference in pressure-pain limit. CPA-parameters were significantly correlated to isokinetic muscle strength where more hypersensitivity resulted in lower strength. Pressure-pain threshold and pressure-pain tolerance assessed by CPA were significantly lower in patients with FM indicating muscle hyperalgesia. CPA was associated with knee muscle strength but not with measures thought to be influenced by psychological distress and mood

     (66)    Stuifbergen AK, Phillips L, Voelmeck W, Browder R. Illness perceptions and related outcomes among women with fibromyalgia syndrome. Womens Health Issues 2006; 16(6):353-60.
Abstract: PURPOSE: Fibromyalgia syndrome (FMS) is characterized by widespread musculoskeletal pain, multiple tender points, and fatigue, and affects 3-6 million Americans, 75% of whom are female. The purpose of the present study was to examine the illness perceptions of women with FMS using Leventhal's common sense self-regulation model. DESIGN: Ninety-one women with FMS took part in this study. Pearson correlations and stepwise multiple regressions were used to assess relationships among variables and explanation of variance in the outcomes of health behaviors, FMS impact, and subjective physical and mental health. RESULTS: Participants viewed their FMS as chronic with a somewhat fluctuating course, having serious consequences in their lives, and difficult to understand in a coherent fashion. The women tended to find their FMS emotionally distressing and unamenable to personal control or efficacious treatment. Emotional representations explained 41% of the variance in mental health scores and 17% in reported health behaviors. CONCLUSIONS: Overall, this sample of women with FMS had fairly negative perceptions of their illness. As suggested by Leventhal's model, cognitive and emotional representations predicted different outcomes. Interventions that address psychological as well as the physical components of the illness experience may offer benefits for women with FMS

     (67)    Vargas A, Vargas A, Hernandez-Paz R, Sanchez-Huerta JM, Romero-Ramirez R, mezcua-Guerra L et al. Sphygmomanometry-evoked allodynia--a simple bedside test indicative of fibromyalgia: a multicenter developmental study. J Clin Rheumatol 2006; 12(6):272-4.
Abstract: BACKGROUND: One of the 2 classification criteria for fibromyalgia (FM) is the presence of tender points on specific anatomic sites. It has been established that these tender points reflect a state of generalized allodynia (defined as pain resulting from a stimulus that does not normally provoke pain). Patients with FM often describe pain elicitation during blood pressure testing (sphygmomanometry). OBJECTIVE: The objective of this study was to define if a universally used clinical test, sphygmomanometry, is helpful in the identification of patients with FM. METHODS: The authors conducted a prospective multicenter study in 3 different public rheumatology outpatient services. Each center studied 20 patients with FM, 20 with rheumatoid arthritis, 20 with osteoarthritis, and 20 healthy individuals. The following question was asked of each participant: "When I take your blood pressure, tell me if the cuff's pressure brings forth pain." The blood pressure cuff was inflated at an approximate rate of 10 mm Hg per second up to 180 mm Hg or to the point when pain was elicited. RESULTS: Sixty-nine percent of patients with FM had sphygmomanometry-evoked allodynia in contrast to 10% of patients with osteoarthritis, 5% with rheumatoid arthritis, and 2% of healthy individuals (P < 0.001). The mean blood pressure value at which allodynia was elicited was lower in patients with FM (143 +/- 40 mm Hg) when compared with the other 3 groups (176 +/- 11 mm Hg) or higher (P < 0.001). In patients with FM, there was a significant negative correlation between the blood pressure value at which allodynia developed and total Fibromyalgia Impact Questionnaire (FIQ) score, number of tender points, and the FIQ visual analog scales for pain intensity and fatigue (P < 0.05). The test yields a diagnostic sensitivity for FM of 0.7, specificity 0.96, positive predictive value 0.86, and negative predictive value 0.91. CONCLUSIONS: In this developmental study of patients attending rheumatology clinics, the generation of pain during blood pressure testing was strongly associated with the diagnosis of FM. This robust linkage probably reflects a tautologic phenomenon. A sine qua nonelement for FM diagnosis is the presence of tender points in discrete anatomic sites. These tender points in turn reflect a state of generalized mechanical allodynia that can be locally elicited by the cuff pressure during blood pressure testing. Sphygmomanometry is a simple bedside test that may be useful in the recognition of patients with FM. Blood pressure testing is a universal procedure in all clinical environments. Based on our results, we suggest searching for FM features in any person who has sphygmomanometry-evoked allodynia

     (68)    Fregni F, Gimenes R, Valle AC, Ferreira MJ, Rocha RR, Natalle L et al. A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia. Arthritis Rheum 2006; 54(12):3988-98.
Abstract: OBJECTIVE: Recent evidence suggests that fibromyalgia is a disorder characterized by dysfunctional brain activity. Because transcranial direct current stimulation (tDCS) can modulate brain activity noninvasively and can decrease pain in patients with refractory central pain, we hypothesized that tDCS treatment would result in pain relief in patients with fibromyalgia. METHODS: Thirty-two patients were randomized to receive sham stimulation or real tDCS with the anode centered over the primary motor cortex (M1) or the dorsolateral prefrontal cortex (DLPFC) (2 mA for 20 minutes on 5 consecutive days). A blinded evaluator rated the patient's pain, using the visual analog scale for pain, the clinician's global impression, the patient's global assessment, and the number of tender points. Other symptoms of fibromyalgia were evaluated using the Fibromyalgia Impact Questionnaire and the Short Form 36 Health Survey. Safety was assessed with a battery of neuropsychological tests. To assess potential confounders, we measured mood and anxiety changes throughout the trial. RESULTS: Anodal tDCS of the primary motor cortex induced significantly greater pain improvement compared with sham stimulation and stimulation of the DLPFC (P < 0.0001). Although this effect decreased after treatment ended, it was still significant after 3 weeks of followup (P = 0.004). A small positive impact on quality of life was observed among patients who received anodal M1 stimulation. This treatment was associated with a few mild adverse events, but the frequency of these events in the active-treatment groups was similar to that in the sham group. Cognitive changes were similar in all 3 treatment groups. CONCLUSION: Our findings provide initial evidence of a beneficial effect of tDCS in fibromyalgia, thus encouraging further trials

     (69)    Chen KW, Hassett AL, Hou F, Staller J, Lichtbroun AS. A pilot study of external qigong therapy for patients with fibromyalgia. J Altern Complement Med 2006; 12(9):851-6.
Abstract: OBJECTIVES: Although qigong is an important part of Traditional Chinese medicine (TCM) based on a philosophy similar to acupuncture, few studies of qigong exist in the Western medicine literature. To evaluate qigong therapy as a modality in treating chronic pain conditions such as fibromyalgia syndrome (FMS), we report a pilot trial of 10 women with severe FMS who experienced significant improvement after external qigong therapy (EQT). DESIGN: Ten patients with FMS completed five to seven sessions of EQT over 3 weeks with pre- and posttreatment assessment and a 3-month follow-up. Each treatment lasted approximately 40 minutes. OUTCOME MEASURES: Tender point count (TPC) and Fibromyalgia Impact Questionnaire (FIQ) were the primary measures. McGill Pain Questionnaire (MPQ), Beck Depression Inventory (BDI), anxiety, and self-efficacy were the secondary outcomes. RESULTS: Subjects demonstrated improvement in functioning, pain, and other symptoms. The mean TPC was reduced from 136.6 to 59.5 after EQT treatment; mean MPQ decreased from 27.0 to 7.2; mean FIQ from 70.1 to 37.3; and mean BDI from 24.3 to 8.3 (all p < 0.01). Many subjects reported reductions in other FMS symptoms, and two reported they were completely symptom-free. Results from the 3-month follow-up indicated some slight rebound from the post-treatment measures, but still much better than those observed at baseline. CONCLUSIONS: Treatment with EQT resulting in complete recovery for some FMS patients suggests that TCM may be very effective for treating pain and the multiplicity of symptoms associated with FMS. Larger controlled trials of this promising intervention are urgently needed

     (70)    Amital D, Fostick L, Polliack ML, Segev S, Zohar J, Rubinow A et al. Posttraumatic stress disorder, tenderness, and fibromyalgia syndrome: are they different entities? J Psychosom Res 2006; 61(5):663-9.
Abstract: OBJECTIVES: Many features of fibromyalgia syndrome (FMS) resemble those of posttraumatic stress disorder (PTSD). The goal of this study was to investigate the comorbidity of FMS and PTSD in a cohort of men following an intensive, initial, defined traumatic event. METHODS: One hundred twenty-four males (55 patients with PTSD, 20 patients with major depression, and 49 controls) were evaluated for the presence of FMS. The major traumatic events in all PTSD patients were combat-related. Each individual completed questionnaires characterizing his disease, disabilities, and quality of life. RESULTS: Forty-nine percent of PTSD patients, compared to 5% of major depression patients and none of normal controls, fulfilled the American College of Rheumatology criteria for FMS (P<.0001). Significant correlations were detected between tender points and measured parameters in the PTSD group. CONCLUSIONS: In male patients, PTSD is highly associated with FMS. The degree and impact of these disorders are also highly related

     (71)    Rosado ML, Pereira JP, da Fonseca JP, Branco JC. [Cultural adaptation and validation of the "Fibromyalgia Impact Questionnaire"--Portuguese version]. Acta Reumatol Port 2006; 31(2):157-65.
Abstract: The aim of this study was to translate the Fibromyalgia Impact Questionnaire (FIQ) into Portuguese (Portugal) and to evaluate its reliability and validity by use with Portuguese--speaking patients with Fibromyalgia. After translating the FIQ into Portuguese we administered it to 68 patients with Fibromyalgia together with an informed consent, a Portuguese version of the Health Assessment Questionnaire (HAQ) and a formulary with the socio-demographic characteristics and duration of the complaints. The content validity was assessed with a panel of experts, with high consensus. In the concurrent validity, we obtained significant correlations between the FIQ first item and the HAQ [r = 0,531 (p = 0,001)]. Cronbach's alpha was 0,814, indicating an acceptable level of internal consistency. In conclusion, the Portuguese version of the FIQ is a reliable and valid instrument for measuring health status and physical functioning in Portuguese patients with Fibromyalgia. This instrument is available for use in the clinical practice

     (72)    Katz RS, Heard AR, Mills M, Leavitt F. The Prevalence and Clinical Impact of Reported Cognitive Difficulties (Fibrofog) in Patients With Rheumatic Disease With and Without Fibromyalgia. J Clin Rheumatol 2004; 10(2):53-8.
Abstract: Cognitive dysfunction in patients with rheumatic disease encompasses a range of impairment. Their prevalence, co-occurrence, and impact on symptom severity were assessed in 57 patients with fibromyalgia (FMS) and 57 patients with rheumatic disease without FMS. Information pertaining to memory decline, mental confusion, and speech difficulty was extracted from questions embedded in a health questionnaire and a blind retrospective chart review. Pain, morning stiffness, fatigue, and sleep difficulty were established on a 0- to 100-mm visual analog scale. Variables of mental confusion, fatigue, tension, depression, anger, and vigor were assessed using the Profile of Mood States.Compared with the non-FMS sample, patients with FMS complained more often of memory decline (70.2-24.6%), mental confusion (56.1-12.3%), and speech difficulty (40.4-3.5%). Memory decline and mental confusion were coupled more often in patients with FMS (50.9-8.8%). Patients with FMS with this combination of cognitive problems reported more pain (76.0-45.4%), stiffness (79.7-43.7%), fatigue (79.6-52.6%), and disturbed sleep (59.2-36.6%) compared with patients with FMS with memory problems alone. Patients with rheumatic disease substantially differ in cognitive vulnerability, with patients with FMS at considerably higher risk for cognitive difficulty. More importantly, the prevalence of a combined disturbance in memory and mental clarity is high and closely associated with the perception of increased illness severity and diminished mental health in FMS. That this linkage has the possibility of having a great deal to do with an important clinical variant of FMS underscores the need for greater clinical recognition of this underrecognized pattern and for further research.Patients with fibromyalgia frequently report memory and concentration problems, especially if asked about them. Clinicians could judge these complaints as similar to adult attention deficit syndrome and reassure the patient. Trying medication to improve attention and concentration is sensible but untested in fibromyalgia

     (73)    Calandre EP, Hidalgo J, Rico-Villademoros F. Use of ziprasidone in patients with fibromyalgia: a case series. Rheumatol Int 2007; 27(5):473-6.
Abstract: Atypical antipsychotics may be useful in chronic pain treatment. The objective of the present study was to assess the effect of ziprasidone in fibromyalgia management. Ziprasidone was administered to 32 fibromyalgia patients at a dose of 20 mg/day, subsequently adjusted according to clinical response and tolerability. Fibromyalgia Impact Questionnaire (FIQ), Pittsburgh Sleep Quality Index (PSQI), a Clinical Global Impression improvement scale (CGIi), and a scale evaluating the severity of fibromyalgia symptoms were administered at 4 week intervals for 12 weeks. Drug adverse reactions were recorded. Ten patients withdrew from the study. The CGIi showed 32% of responders. FIQ and PSQI scores showed a non-statistically significant decrease. The conditions of stiffness, anxiety and sadness improved significantly. Most frequent side effects included sleep disturbances, headache, tremor, and rigidity. Although ziprasidone does not seem an especially useful adjunct drug in fibromyalgia, it could be tried on patients who are markedly anxious and/or depressed

     (74)    Ardic F, Ozgen M, Aybek H, Rota S, Cubukcu D, Gokgoz A. Effects of balneotherapy on serum IL-1, PGE2 and LTB4 levels in fibromyalgia patients. Rheumatol Int 2007; 27(5):441-6.
Abstract: The purpose of this study was to investigate the clinical effects of balneotherapy in the treatment of Fibromyalgia Syndrome (FMS) and to determine if balneotherapy influences serum levels of inflammation markers, IL-1, PGE2 and LTB4. 24 primary fibromyalgia female patients diagnosed according to American College of Rheumatology criteria were included to the study. Their ages ranged between 33 and 55 years. FMS patients were randomly assigned in two groups as, group 1 (n = 12) and group 2 (n = 12). Group 1 received 20-min bathing, once in a day for five days per week. Patients participated in the study for 3 weeks (total of 15 sessions) in Denizli. Group 2 did not receive balneotherapy. FMS patients were evaluated by tenderness measurements (tender point count and algometry), Visual Analogue Scale, Beck's Depression Index, Fibromyalgia Impact Questionnaire. Ten healthy women recruited group three as the controls. Serum PGE2, LTB4 and IL1-alpha levels were measured in all three groups. The biochemical measurements and clinical assessments were performed before and at the end of general period of therapy. Statistically significant alterations in algometric score, Visual Analogue score, Beck's Depression Index and PGE2 levels (P < 0.001), numbers of tender points (P < 0.01) and Fibromyalgia Impact Questionnaire score (P < 0.05) were found after the balneotherapy between group 1 and 2. Mean PGE2 level of FMS patients were higher compared to healthy control group (P < 0.0001) and decreased after the treatment period, only in group 1 (P < 0.05). As in the group 2 and 3, detectable IL-1 and LTB4 measurements were insufficient, statistical analysis was performed, only in group 1. After balneotherapy IL-1 and LTB4 significantly decreased in group 1 (P < 0.05). In conclusion, balneotherapy is an effective choice of treatment in patients with FMS relieving the clinical symptoms, and possibly influencing the inflammatory mediators

     (75)    Tastekin N, Birtane M, Uzunca K. Which of the three different tender points assessment methods is more useful for predicting the severity of fibromyalgia syndrome? Rheumatol Int 2007; 27(5):447-51.
Abstract: Digital palpation, myalgic scoring and dolorimetry are frequently used to count tender points in fibromyalgia syndrome. We aimed to investigate the probable relation between tender points count and fibromyalgia impact questionnaire and to assess which of the tender point counting methods is the most successful in predicting the severity of the disease. Tender point areas of 36 patients with fibromyalgia syndrome were assessed with three methods which are myalgic scoring, digital and dolorimetric tender points counting methods. Fibromyalgia impact questionnaire was used to measure the disease severity. The correlation between each of the assessment methods and fibromyalgia impact questionnaire was investigated. The mean count of digitally evaluated tender points was 14.86 +/- 2.67 and by dolorimetry was 11.81 +/- 4.48. The mean total myalgic score was found to be 24.61 +/- 8.91. All of the tender point evaluation methods correlated positively with each other (P < 0.01). Fibromyalgia impact questionnaire score was also correlated with only digital palpation tender point count of these three evaluation methods (r = 0.427, P < 0.05). Digital tender point count seemed to be sufficient for assessment, and there is no need for an additional instrument for tender point evaluation

     (76)    Zucker DR, Ruthazer R, Schmid CH, Feuer JM, Fischer PA, Kieval RI et al. Lessons learned combining N-of-1 trials to assess fibromyalgia therapies. J Rheumatol 2006; 33(10):2069-77.
Abstract: OBJECTIVE: Applying population research to individual treatment requires understanding the connections between patient-specific characteristics, population-based studies, and treatment responses. Conducting practice-based research using individual-focused (N-of-1) trials may aid this process. We combined N-of-1 trials to compare fibromyalgia therapies and to assess the feasibility and outcomes of this approach for practice-based effectiveness research. METHODS: Community- and center-based rheumatologists enrolled patients with fibromyalgia syndrome in randomized, double-blind, multi-crossover, N-of-1 trials comparing amitriptyline and the combination amitriptyline and fluoxetine. Fibromyalgia Impact Questionnaire outcomes were used for the individuals' treatment and combined across patients for sample-based analyses. Outcomes were compared with results from more standard trial designs. RESULTS: Eight rheumatologists enrolled 58 patients in N-of-1 trials. Most physicians and patients had not previously participated in clinical trials. Using several analytic methods, the pooled results showed a better outcome score (mean difference: -6.1 +/- 2.0 to -8.0 +/- 3.7 points) in patients taking combination therapy. These population results are similar to published outcomes from a more traditional crossover trial. Neither practice type nor patient characteristics were significantly associated with the observed treatment-effect variation. Most participants, irrespective of selected treatment, felt their individual N-of-1 trials were helpful. CONCLUSION: Implementation of the combined N-of-1 methodology is feasible in rheumatology practices and results confirm greater fibromyalgia improvement with combination therapy. This research approach broadens participation, although our trials' specifics likely influenced enrollment eligibility. In addition to individual benefits, combining N-of-1 trial data provides population research benefits. This patient-focused approach should be further explored to bridge research and practice

     (77)    Cacace E, Ruggiero V, Anedda C, Denotti A, Minerba L, Perpignano G. [Quality of life and associated clinical distress in fibromyalgia]. Reumatismo 2006; 58(3):226-9.
Abstract: OBJECTIVES: Fibromyalgia (FM) is a syndrome characterized by chronic, diffuse musculoskeletal pain and by a low pain threshold at specific anatomical points (tender points). Numerous other conditions (Irritable bowel syndrome, tension-type headache, migraine headaches, etc.) may overlap with FM. Aim of this study was to evaluate the quality of life and associated clinical distress in patients with FM. METHODS: 53 females affected by primary fibromyalgia and 40 healthy females were examined were examined by an experienced rheumatologist and interviewed using the Fibromyalgia Impact Questionnaire (FIQ). Clinical monitoring included Visual Analogue Scale for pain and pain pressure threshold measurements. RESULTS: Mean FIQ scores were 66.39+/-14.94 in FM patients and 13.15+/-5.37 in control subjects and the difference was statistically significant. Among associated clinical distress higher frequencies have been found for paraesthesia (87%), sleep disturbance (72%), tension type headache (70%), oto-vestibule syndrome (72%) and irritable colon (60%). An R.O.C. bend was developed in the presence of paraesthesias and oto-vestibule syndromes at the same time. This allowed us to identify a FIQ cut off value of 66.85 so FM patients were divided into 2 groups according to their FIQ scores: severe degree and mild or slight degree. CONCLUSIONS: Based on our data, it would appear possible to use a FIQ value equal to or higher than 66.85 for the clinical picture of FM to be classified as severe

     (78)    Hammond A, Freeman K. Community patient education and exercise for people with fibromyalgia: a parallel group randomized controlled trial. Clin Rehabil 2006; 20(10):835-46.
Abstract: OBJECTIVE: To evaluate the effects of a community patient education -exercise programme, using a cognitive-behavioural approach, for people with fibromyalgia. DESIGN: A randomized, parallel group trial with assessments at 0, 4 and 8 months. SETTING: Community leisure centres. SUBJECTS: People with fibromyalgia (n=183) attending a rheumatology outpatient department at a large district general hospital. INTERVENTIONS: Participants were randomized to a patient education-exercise group (n=97) or relaxation (attention control) group (n=86). MAIN MEASURES: The Fibromyalgia Impact Questionnaire (0-80; lower score means better health). Secondary outcomes included: the Arthritis Self-Efficacy Scale(pain and other symptoms subscales: 1 -10 scale; higher scores mean greater self-efficacy) and self-reported improvement. RESULTS: Fifty participants withdrew or were unable to attend and 133 completed and returned baseline questionnaires: patient education group (n=71); relaxation group (n=62); 120/133 participants were women. Average age was 48.53 (SD 10.89) years. Follow-up ranged between 73 and 82% of questionnaires returned. At four months, there was a difference in average changes in total Fibromyalgia Impact Questionnaire scores between the two groups: patient education group--3.38 (SD 9.35); relaxation group 0.3 (SD 8.85); P=0.02. Arthritis Self-Efficacy Scale scores were significantly higher in the patient education group: pain 0.59 (SD 1.45)compared to the relaxation group's--0.12 (SD 1.22); P=0.003; other symptoms (patient education group 0.72 (SD 1.33); relaxation group 0.03 (SD 1.16); P=0.002). At eight months these differences were no longer apparent. Forty-seven per cent in the patient education group self-reported improvement compared with 13% in the relaxation group (chi2=13.65; P=0.0001). CONCLUSION: Short-term improvements resulted from the education -exercise programme but were not sustained. Appropriate selection may improve efficacy

     (79)    Liedberg GM, Burckhardt CS, Henriksson CM. Young women with fibromyalgia in the United States and Sweden: perceived difficulties during the first year after diagnosis. Disabil Rehabil 2006; 28(19):1177-84.
Abstract: PURPOSE: The major symptoms of fibromyalgia (FM)--pain, tiredness, disrupted sleep, and muscle weakness--severely impact everyday activities, including the paid work role of women who have had FM for a long time. There are no prospective studies on young and newly diagnosed women with FM. The aim of the present study was to describe and compare difficulties young and newly diagnosed women in Sweden and the United States experienced during their first year after diagnosis. METHOD: Three interviews, 6 months apart, were conducted, with 49 Swedish and 45 US women between the ages of 18 and 39. Five open-ended questions were asked concerning physical, psychological and social difficulties and limitations, and factors that increased or decreased their difficulties and limitations. At interviews 2 and 3 the women were also asked about ways of preventing their difficulties. The answers were written down and analysed by a content analysis approach. RESULTS: Consistent categories of difficulties were reported: symptoms, movements, activities, moods, social network, external factors and coping strategies. More US women were working outside their homes than were their Swedish counterparts and they expressed more difficulties compared with the Swedish women. CONCLUSIONS: In general, difficulties decreased and coping strategies increased over the 1-year period in both groups of newly diagnosed, young women

     (80)    Mielenz T, Jackson E, Currey S, DeVellis R, Callahan LF. Psychometric properties of the Centers for Disease Control and Prevention Health-Related Quality of Life (CDC HRQOL) items in adults with arthritis. Health Qual Life Outcomes 2006; 4:66.:66.
Abstract: BACKGROUND: Measuring health-related quality of life (HRQOL) is important in arthritis and the SF-36v2 is the current state-of-the-art. It is only emerging how well the Centers for Disease Control and Prevention (CDC) HRQOL measures HRQOL for people with arthritis. This study's purpose is to assess the psychometric properties of the 9-item CDC HRQOL (4-item Healthy Days Core Module and 5-item Healthy Days Symptoms Module) in an arthritis sample using the SF-36v2 as a comparison. METHODS: In Fall 2002, a cross-sectional study acquired survey data including the CDC HRQOL and SF-36v2 from 2 North Carolina populations of adult patients reporting osteoarthritis, rheumatoid arthritis, and fibromyalgia; 2182 (52%) responded. The first item of both the CDC HRQOL and the SF-36v2 was general health (GEN). All 8 other CDC HRQOL items ask for the number of days in the past 30 days that respondents experienced various aspects of HRQOL. Exploratory principal components analyses (PCA) were conducted on each sample and the combined samples of the CDC HRQOL. The multitrait-multimethod matrix (MTMM) was used to compute correlations between each trait (physical health and mental health) and between each method of measurement (CDC HRQOL and SF36v2). The relative contribution of the CDC HRQOL in predicting the physical component summary (PCS) and the mental component summary (MCS) was determined by regressing the CDC HRQOL items on the PCS and MCS scales. RESULTS: All 9 CDC HRQOL items loaded primarily onto 1 factor (explaining 57% of the item variance) representing a reasonable solution for capturing overall HRQOL. After rotation a 2 factor interpretation for the 9 items was clear, with 4 items capturing physical health (physical, activity, pain, and energy days) and 3 items capturing mental health (mental, depression, and anxiety days). All of the loadings for these two factors were greater than 0.70. The CDC HRQOL physical health factor correlated with PCS (r = -.78, p < 0.0001) and the mental health factor correlated with MCS (r = -.71, p < 0.0001). The relative contribution of the CDC HRQOL in predicting PCS was 73% (R2 = .73) when GEN was included in the CDC HRQOL score and 65% (R2 = .65) when GEN was removed. The relative contribution of the CDC HRQOL in predicting MCS was 56% (R2 = .56) when GEN was included and removed. CONCLUSION: The CDC HRQOL appears to have strong psychometric properties in individuals with arthritis in both community-based and subspecialty clinical settings. The 9 item CDC HRQOL is a reasonable measure for overall HRQOL and the two subscales, representing physical and mental health, are reasonable when the goal is to examine those aspects

     (81)    Okumus M, Gokoglu F, Kocaoglu S, Ceceli E, Yorgancioglu ZR. Muscle performance in patients with fibromyalgia. Singapore Med J 2006; 47(9):752-6.
Abstract: INTRODUCTION: Fibromyalgia (FMS) is a syndrome expressed by chronic widespread body pain which leads to reduced physical function and frequent use of healthcare services. This study was performed to examine the muscle performance comprising abdominal and lumbar muscle strength, and measurement of chest expansion in osteoporotic patients with FMS; to evaluate the relation between muscle performance, pain severity, clinical findings and physical activity; and to compare the results with the osteoporotic control group. METHODS: 44 osteoporotic women with FMS and 46 osteoporotic women who were physically inactive underwent measurements of three parameters: abdominal and lumbar muscle strength, and chest expansion. Student's t-test was used for statistical analysis. RESULTS: The strength of lumbar muscles and measurement of chest expansion were significantly decreased in the FMS patients as compared to the controls (p-value is less than 0.001). However, lumbar and abdominal muscles strength was low in both patients and controls. CONCLUSION: Our results indicate that osteoporotic patients with FMS have impairment in strength of lumbar and abdominal muscles and in measurement of chest expansion. Further studies are needed to investigate the mechanism of reduced muscle performance and the effects of aerobic exercise in this patient group

     (82)    Havermark AM, Langius-Eklof A. Long-term follow up of a physical therapy programme for patients with fibromyalgia syndrome. Scand J Caring Sci 2006; 20(3):315-22.
Abstract: The purpose of this study was to evaluate, in a long-term perspective, the impact of a physical therapy-based educational programme on patients with fibromyalgia syndrome (FMS). The programme includes information about the syndrome, information about pain and muscle physiology, training in warm water, stretching, body awareness therapy and relaxation in groups of 15 patients twice weekly, 2 hours during 10 weeks. A total of 240 patients with FMS participated in the study before and immediately after the programme and at a follow up with a mean of 35 months after the programme. Health status as measured with the Fibromyalgia Impact Questionnaire was answered by the patients at all three measurement points. Questionnaires concerning self-care, self-motivation and sense of coherence (SOC) were distributed at the follow up. The results showed a significant improvement on several symptoms when comparing before and after the programme, and at the time of follow up the patients' rated well-being was still improved. The results also showed that the patients' pretreatment perception of symptoms, well-being and SOC are predictors to the perception of general health at the follow up of a physical therapy programme. The conclusion is that a physical therapy programme for patients with FMS may have a positive impact on patients' general well-being but not on other symptoms

     (83)    Birtane M, Uzunca K, Tastekin N, Tuna H. The evaluation of quality of life in fibromyalgia syndrome: a comparison with rheumatoid arthritis by using SF-36 Health Survey. Clin Rheumatol 2007; 26(5):679-84.
Abstract: Musculoskeletal disorders are the most common causes of deterioration in quality of life (QOL). We in this study aimed to assess (1) the impact of fibromyalgia syndrome (FS) on QOL comparing with that of rheumatoid arthritis (RA) patients and control subjects and (2) the impact of these two musculoskeletal disorders on various components of QOL using SF-36 Health Survey. Thirty-five patients with RA, 30 patients with FS, and 30 voluntary control subjects were included in the study. The groups were comparable in terms of demographic characteristics. QOL was evaluated by using Short-Form (SF)-36 Health Survey in all study participants, and Fibromyalgia Impact Questionnaire (FIQ), which is a specific health-status instrument for FS, was used in FS patients. Physical functioning, physical role, social functioning, bodily pain, general health, vitality, emotional role, and mental health scores were significantly lower in RA and FS patients than in control subjects (p<0.05). The between-groups comparisons revealed that FS patients had significantly lower mental health scores than RA patients (49.87 vs 62.51, respectively), (p<0.001). Total FIQ score correlated significantly with physical functioning, physical role, and bodily pain in FS patients. All parameters of SF-36 Health Survey except for social functioning correlated significantly with some of the variables of FIQ. FS has a negative impact on QOL, like RA. Furthermore, mental health was more severely affected in FS patients when compared with RA patients

     (84)    Eksioglu E, Yazar D, Bal A, Usan HD, Cakci A. Effects of Stanger bath therapy on fibromyalgia. Clin Rheumatol 2007; 26(5):691-4.
Abstract: The purpose of this study was to assess the effectiveness of Stanger bath on the treatment of fibromyalgia (FM). Fifty women with FM were randomly divided into two groups. The first group (n=25) was treated with amitriptyline, 10 mg/day for 8 weeks, and Stanger bath, 20 min daily for ten sessions. The second group (n=25) only had amitriptyline, 10 mg/day for 8 weeks. In the first group the assessment parameters were measured before (t1), at the end (t2), and 2 months after the hydrotherapy (t3). In the second group these parameters were examined before (T1) and 2 months after the treatment (T2). Patients were evaluated by number of tender points and Fibromyalgia Impact Questionnaire (FIQ) scores. There was significant improvement in number of tender points between t1 and t2 (P<0.01) and t1 and t3 (P<0.001) in the Stanger bath group. In addition, there was significant improvement in FIQ scores between t1 and t2 (P<0.001) and t1 and t3 (P<0.01) in the Stanger bath group. In the second group we observed significant improvement in FIQ scores and tender point numbers between T1 and T2 (P=0.00). We did not find any difference between groups in tender point number percent change (p=0.074). However, we observed statistically significant improvement in percent change of FIQ scores in Stanger bath group (-30+/-16.7) when compared to group 2 (-19.3+/-13) (p=0.016). We conclude that Stanger bath therapy when combined with amitriptyline has a long lasting effect and better outcome in FM patients

     (85)    Lee SS, Yoon HJ, Park YW. Antipolymer antibody is not associated with fibromyalgia in Korean female patients. Rheumatol Int 2006; 27(1):73-7.
Abstract: To examine the levels of antipolymer antibody (APA) in Korean female patients with fibromyalgia (FM) and to determine whether the levels of APA correlate with FM severity. Serum samples from patients with FM (n = 69), patients with rheumatoid arthritis (RA) (n = 71), and controls (n = 75) were assayed for APA. All of the subjects were female, and the controls were age-matched healthy volunteers. FM tender point counts and scores were examined, and FM patients were asked to complete a Korean version of the Fibromyalgia Impact Questionnaire (FIQ), the State-Trait Anxiety Inventory (STAI), and the Beck Depression Inventory (BDI). APA-positive samples were detected in five (7.2%) of the 69 FM patients, seven (9.9%) of the 71 RA patients, and four (5.3%) of the 75 controls. The prevalence of seropositivity and the level of APA in FM patients did not differ from those in RA patients and controls. The proportion positive for APA was not higher for FM patients with severe symptoms than for FM patients with mild symptoms. There was a negative association between the APA level and age. The APA level in FM patients was not correlated with age at diagnosis, age at symptom onset, disease duration, education, tender point counts and scores, FIQ, STAI, or BDI. The prevalence of APA in Korean FM patients was quite low. Owing to the low prevalence of APA in this study, the APA assay did not distinguish FM patients with severe symptoms from those with mild symptoms

     (86)    Hidalgo J, Rico-Villademoros F, Calandre EP. An open-label study of quetiapine in the treatment of fibromyalgia. Prog Neuropsychopharmacol Biol Psychiatry 2007; 31(1):71-7.
Abstract: The aim of this exploratory study was to systematically assess the potential effectiveness and tolerability of quetiapine, an atypical antipsychotic, for the treatment of patients with fibromyalgia. This was a unicentre, open-label study conducted in thirty-five outpatients, 18 years or older, who met the ACR criteria for fibromyalgia and who had not satisfactorily responded to their previous fibromyalgia treatment. Quetiapine, flexibly dosed (25-100 mg/day), was added to their original treatment regimen for 12 weeks. The primary outcome measure was the mean change from baseline to endpoint in the Fibromyalgia Impact Questionnaire (FIQ) total score. Secondary efficacy measures included mean changes from baseline to endpoint in the scores of the Clinical Global Impression (CGI) of Severity scale, Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory (BDI), State-Trait Anxiety Inventory (STAI), 12-Item Short Form Health Survey (SF-12), and individual items of the FIQ. Thirty (85.7%) patients (mean age 47+/-7.9, 93.3% females) had a postbaseline evaluation and constituted the intent-to-treat efficacy sample. Mean FIQ total score decreased significantly by 10.2 points from a baseline of 63.2 to 53.0 at study endpoint (p<0.001). A statistically significant reduction was observed in FIQ stiffness and FIQ fatigue subscores but not in FIQ pain subscore. Large effect sizes were observed for the FIQ total (1.04), CGI-severity (1.00) and PSQI (1.07), while moderate effect sizes (i.e.> or =0.50) were encountered in the FIQ fatigue, FIQ stiffness and SF-12 mental component summary. Quetiapine was safely administered and well tolerated. Despite the lack of effect on pain, the significant and relevant improvement in overall efficacy measures and quality of life suggests that quetiapine may be a valuable drug for treatment of patients with fibromyalgia that should be further tested in double-blind, placebo-controlled trials

     (87)    Wennemer HK, Borg-Stein J, Gomba L, Delaney B, Rothmund A, Barlow D et al. Functionally oriented rehabilitation program for patients with fibromyalgia: preliminary results. Am J Phys Med Rehabil 2006; 85(8):659-66.
Abstract: OBJECTIVE: To evaluate function and disability in patients with fibromyalgia before and after participation in a functionally oriented, multidisciplinary, 8-wk treatment program. DESIGN: A total of 23 patients who met American College of Rheumatology criteria for the diagnosis of fibromyalgia were enrolled in the study. Outcome measures included: range of motion, 6-min walk test, a modified Fibromyalgia Impact Questionnaire, a modified SF-36 Physical Functioning Scale, and the Fibromyalgia Health Assessment Questionnaire. Pretreatment and posttreatment scores were analyzed using paired t tests. RESULTS: All subjects completed the program, and there were no reported injuries. Three subjects failed to complete the survey instruments at the conclusion of the study. Intention to treat analysis including these subjects was carried out but did not significantly change results. For the remaining subjects (n = 20), a significant improvement was found on the Physical Functioning Scale (P = 0.01). Trends toward improvement on the Fibromyalgia Impact Questionnaire (P = 0.40) and Fibromyalgia Health Assessment Questionnaire (P = 0.14) were seen but did not achieve statistical significance. Range of motion testing revealed significant improvements in lumbar spine extension (P < 0.001), straight-leg raise (P < 0.001), cervical spine flexion (P < 0.01), cervical spine rotation (P < 0.05), and cervical spine side bending (P < 0.05). Distance traveled during the 6-min walk test increased significantly (P < 0.01), whereas perceived exertion as measured by the Borg scale did not change. There were no injuries or other adverse consequences of the program. CONCLUSIONS: This study utilized multiple functional outcome measures to demonstrate improved function and decreased disability in patients with fibromyalgia. Our patients reported significantly improved physical function after participation in the 8-wk intensive multidisciplinary treatment program. This progressive, functionally based exercise training program was well tolerated by all participants and outlines an effective exercise prescription for patients with fibromyalgia. Fibromyalgia patients in this study responded favorably to a treatment program that focused on function instead of pain

     (88)    Armstrong DJ, Meenagh GK, Bickle I, Lee AS, Curran ES, Finch MB. Vitamin D deficiency is associated with anxiety and depression in fibromyalgia. Clin Rheumatol 2007; 26(4):551-4.
Abstract: Fibromyalgia is a complex problem in which symptoms of anxiety and depression feature prominently. Low levels of vitamin D have been frequently reported in fibromyalgia, but no relationship was demonstrated with anxiety and depression. Seventy-five Caucasian patients who fulfilled the ACR criteria for fibromyalgia had serum vitamin D levels measured and completed the Fibromyalgia Impact Questionnaire (FIQ) and Hospital Anxiety and Depression Score (HADS). Deficient levels of vitamin D was found in 13.3% of the patients, while 56.0% had insufficient levels and 30.7% had normal levels. Patients with vitamin D deficiency (<25 nmol/l) had higher HADS [median, IQR, 31.0 (23.8-36.8] than patients with insufficient levels [25-50 nmol/l; HADS 22.5 (17.0-26.0)] or than patients with normal levels [50 nmol/l or greater; HADS 23.5 (19.0-27.5); Kruskal-Wallis ANOVA on ranks p<0.05]. There was no relationship with global measures of disease impact or musculoskeletal symptoms. Vitamin D deficiency is common in fibromyalgia and occurs more frequently in patients with anxiety and depression. The nature and direction of the causal relationship remains unclear, but there are definite implications for long-term bone health

     (89)    Cogan J, Camus M, Saucier JF, Arsenault P, Demers J. A new application of sound resonance technology therapy for the treatment of fibromyalgia: a retrospective analysis. Complement Ther Clin Pract 2006; 12(3):206-12.
Abstract: OBJECTIVE: Chart review to evaluate the effectiveness of a three-phase sound resonance technology therapy (SRTT) protocol for the treatment of fibromyalgia. RESULTS: Initial FIQ scores of 159 consecutive patients ranged from 24 to 80 (mean=58). After Phase 1, ( approximately 1 month into the protocol), FIQ scores had decreased on average by 26 points (n=128, 95% CI 23-30, p<.001). After phase 3 of the protocol 53 patients completed an FIQ questionnaire and the mean decrease in FIQ score was 38 points (95% CI 32-44, p=.004). CONCLUSIONS: This retrospective analysis suggests considerable and rapid relief of the symptoms of fibromyalgia following the use of the three-phase SRTT treatment protocol, which appears to be maintained over several years. Although these results are not conclusive they are remarkable as no other therapy reported in the scientific literature seems as efficacious for fibromyalgia. A follow-up study using an RCT design is warranted

     (90)    Schley M, Legler A, Skopp G, Schmelz M, Konrad C, Rukwied R. Delta-9-THC based monotherapy in fibromyalgia patients on experimentally induced pain, axon reflex flare, and pain relief. Curr Med Res Opin 2006; 22(7):1269-76.
Abstract: OBJECTIVE: Fibromyalgia (FM) is a chronic pain syndrome characterized by a distinct mechanical hyperalgesia and chronic pain. Recently, cannabinoids have been demonstrated as providing anti-nociceptive and anti-hyperalgesic effects in animal and human studies. Here, we explored in nine FM patients the efficacy of orally administered delta-9-tetrahydrocannabinol (THC) on electrically induced pain, axon reflex flare, and psychometric variables. RESEARCH DESIGN AND METHods: Patients received a daily dose of 2.5-15 mg of delta-9-THC, with a weekly increase of 2.5 mg, as long as no side effects were reported. Psychometric variables were assessed each week by means of the West Haven-Yale Multidimensional Pain Inventory (MPI), Pittsburgh Sleep Quality Index (PSQI), Medical outcome survey-short form (MOS SF-36), the Pain Disability Index (PDI), and the Fibromyalgia Impact Questionnaire (FIQ). In addition, patients recorded daily, in a diary, their overall pain intensity on a numeric scale. Each week, pain and axon reflex flare was evoked experimentally by administration of high intensity constant current pulses (1 Hz, pulse width 0.2 ms, current increase stepwise from 2.5-12.5 mA every 3 minutes) delivered via small surface electrodes, attached to the volar forearm skin. MAIN OUTCOME MEASURES: Daily pain recordings by the patient, experimentally induced pain, and axon reflex flare recorded by a laser Doppler scanner. RESULTS: Five of nine FM patients withdrew during the study due to adverse side effects. Delta-9-THC had no effect on the axon reflex flare, whereas electrically induced pain was significantly attenuated after doses of 10-15 mg delta-9-THC (p < 0.05). Daily-recorded pain of the FM patients was significantly reduced (p < 0.01). CONCLUSIONS: This pilot study demonstrated that a generalized statement that delta-9-THC is an analgetic drug cannot be made. However, a sub-population of FM patients reported significant benefit from the delta-9-THC monotherapy. The unaffected electrically induced axon reflex flare, but decreased pain perception, suggests a central mode of action of the cannabinoid

     (91)    Bazzichi L, Giannaccini G, Betti L, Mascia G, Fabbrini L, Italiani P et al. Alteration of serotonin transporter density and activity in fibromyalgia. Arthritis Res Ther 2006; 8(4):R99.
Abstract: The aim of the study was to evaluate the kinetic parameters of a specific serotonin transporter (SERT) and serotonin uptake in a mentally healthy subset of patients with fibromyalgia. Platelets were obtained from 40 patients and 38 healthy controls. SERT expression and functionality were evaluated through the measurement of [3H]paroxetine binding and the [3H]serotonin uptake itself. The values of maximal membrane binding capacity (Bmax) were statistically lower in the patients than in the healthy volunteers, whereas the dissociation constant (Kd) did not show any statistically significant variations. Moreover, a decrease in the maximal uptake rate of SERT (Vmax) was demonstrated in the platelets of patients, whereas the Michaelis constant (Km) did not show any statistically significant variations. Symptom severity score (tiredness, tender points index and Fibromyalgia Impact Questionnaire) were negatively correlated with Bmax and with Vmax, and positively correlated with Km. A change in SERT seems to occur in fibromyalgic patients, and it seems to be related to the severity of fibromyalgic symptoms

     (92)    Martin DP, Sletten CD, Williams BA, Berger IH. Improvement in fibromyalgia symptoms with acupuncture: results of a randomized controlled trial. Mayo Clin Proc 2006; 81(6):749-57.
Abstract: OBJECTIVE: To test the hypothesis that acupuncture improves symptoms of fibromyalgia. PATIENTS AND METHODS: We conducted a prospective, partially blinded, controlled, randomized clinical trial of patients receiving true acupuncture compared with a control group of patients who received simulated acupuncture. All patients met American College of Rheumatology criteria for fibromyalgia and had tried conservative symptomatic treatments other than acupuncture. We measured symptoms with the Fibromyalgia Impact Questionnaire (FIQ) and the Multidimensional Pain Inventory at baseline, immediately after treatment, and at 1 month and 7 months after treatment. The trial was conducted from May 28, 2002, to August 18, 2003. RESULTS: Fifty patients participated in the study: 25 in the acupuncture group and 25 in the control group. Total fibromyalgia symptoms, as measured by the FIQ, were significantly improved in the acupuncture group compared with the control group during the study period (P = .01). The largest difference in mean FIQ total scores was observed at 1 month (42.2 vs 34.8 in the control and acupuncture groups, respectively; P = .007). Fatigue and anxiety were the most significantly improved symptoms during the follow-up period. However, activity and physical function levels did not change. Acupuncture was well tolerated, with minimal adverse effects. CONCLUSION: This study paradigm allows for controlled and blinded clinical trials of acupuncture. We found that acupuncture significantly improved symptoms of fibromyalgia. Symptomatic improvement was not restricted to pain relief and was most significant for fatigue and anxiety

     (93)    Zijlstra TR, Taal E, van de Laar MA, Rasker JJ. Validation of a Dutch translation of the fibromyalgia impact questionnaire. Rheumatology (Oxford) 2007; 46(1):131-4.
Abstract: OBJECTIVES: To validate a Dutch translation of the fibromyalgia impact questionnaire (FIQ). Materials and METHODS: Data were taken from two randomized clinical trials on Spa treatment and venlafaxine in fibromyalgia (FM). Participants completed the Dutch FIQ and a set of validated questionnaires for general health (RAND-36), depression (Beck depression inventory, BDI), pain (McGill pain questionnaire, MPQ) and fatigue (checklist individual strength, CIS). Internal consistency within the FIQ item 'physical functioning' was studied using Cronbach's alpha. Test-retest reliability was studied with intra-class-correlation (ICC) in a subsample of 76 control subjects over a 3 month period without specific intervention. Construct validity was evaluated by correlating the FIQ to other questionnaires. Sensitivity to change was studied using standardized response means (SRM). RESULTS: The study sample consisted of 213 women and 11 men (mean age 47 yrs, mean disease duration 11 yrs). Cronbach's alpha for the item 'physical functioning' was 0.91, indicating high internal consistency. Test-retest reliability was acceptable, with ICC ranging from 0.45 for 'morning tiredness' to 0.71 for 'physical function'. FIQ correlated significantly with the RAND-36, with Spearman's rho ranging from -0.60 to -0.70 for items measuring the same concept. Similar patterns of correlation were seen with MPQ, BDI and CIS. Sensitivity to change was sufficient, with SRM after Spa treatment ranging from 0.3 for 'work days missed' to 0.9 for 'days felt good'. Similar SRM were found in the venlafaxine trial for patients reporting general improvement. CONCLUSION: The Dutch FIQ is a valid instrument for measuring health status in FM, showing sufficient reliability, construct validity and responsiveness

     (94)    Vandvik PO, Lydersen S, Farup PG. Prevalence, comorbidity and impact of irritable bowel syndrome in Norway. Scand J Gastroenterol 2006; 41(6):650-6.
Abstract: OBJECTIVE: To study the prevalence of irritable bowel syndrome (IBS) and its comorbidity in a Norwegian adult population. MATERIAL AND METHODS: In 2001, 11,078 inhabitants (aged 30-75 years) in Oppland County were invited to take part in a public health survey. A total of 4622 subjects (42%) completed the questionnaires on symptoms of IBS (Rome II criteria), comorbidity, health-care visits and medications. The impact of comorbidity on global health, working disability and use of health-care resources in subjects with IBS was explored by stepwise logistic regression. RESULTS: The population prevalence of IBS was 388/4622 (8.4% (95% CI: 7.6-9.4%)) with a female predominance and an age-dependent decrease. The proportion who had consulted for IBS ranged from 51% among 30-year-olds to 79% in 75-year-olds (p=0.05). IBS was associated with musculoskeletal complaints (OR = 2.4-3.4 for six different items), fibromyalgia (OR = 3.6 [2.7-4.8]), mood disorder (OR = 3.3 (2.6-4.3)), reduced global health (OR = 2.6 (2.1-3.2)), working disability (OR = 1.6 (1.2-2.1)), more frequent health-care visits and use of medications (OR 1.7-2.3). When controlling for comorbidity, reduced global health (OR = 1.5 (1.1-2.0)) and use of alternative health care (OR = 1.7 (1.3-2.4)) remained associated with IBS. Severity of abdominal pain/discomfort was a predictor of having to seek a physician for IBS (OR = 1.3 (1.2-1.5)). CONCLUSIONS: Symptoms of IBS were reported by 8% of Norwegian adults and had resulted in consultations with physicians for the majority in the long run. Subjects with IBS in the community were characterized by frequent somatic and psychiatric comorbidity. Their observed reduced health, working disability and increased use of health resources were largely explained by comorbid symptoms and disorders

     (95)    Arguelles LM, Afari N, Buchwald DS, Clauw DJ, Furner S, Goldberg J. A twin study of posttraumatic stress disorder symptoms and chronic widespread pain. Pain 2006; 124(1-2):150-7.
Abstract: Previous studies of the association between posttraumatic stress disorder (PTSD) and chronic widespread pain (CWP) or fibromyalgia have not examined the role of familial or genetic factors. The goals of this study were to determine if symptoms of PTSD are related to CWP in a genetically informative community-based sample of twin pairs, and if so, to ascertain if the association is due to familial or genetic factors. Data were obtained from the University of Washington Twin Registry, which contains 1042 monozygotic and 828 dizygotic twin pairs. To assess the symptoms of PTSD, we used questions from the Impact of Events Scale (IES). IES scores were partitioned into terciles. CWP was defined as pain located in 3 body regions lasting at least 1 week during the past 3 months. Random-effects regression models, adjusted for demographic features and depression, examined the relationship between IES and CWP. IES scores were strongly associated with CWP (P<0.0001). Compared to those in the lowest IES tercile, twins in the highest tercile were 3.5 times more likely to report CWP. Although IES scores were associated with CWP more strongly among dizygotic than among monozygotic twins, this difference was not significant. Our findings suggest that PTSD symptoms, as measured by IES, are strongly linked to CWP, but this association is not explained by a common familial or genetic vulnerability to both conditions. Future research is needed to understand the temporal association of PTSD and CWP, as well as the physiological underpinnings of this relationship

     (96)    Fengler RK, Jacobs JW, Bac M, van Wijck AJ, van Meeteren NL. Action potential simulation (APS) in patients with fibromyalgia syndrome (FMS): a controlled single subject experimental design. Clin Rheumatol 2007; 26(3):322-9.
Abstract: OBJECTIVES: Action potential simulation (APS) is becoming a popular method of pain reduction. Nevertheless, little is known about the efficacy of this relatively new treatment. The aim of this study was to investigate whether APS helps to reduce pain, improves patients' perception of daily functioning and social participation in patients with fibromyalgia syndrome (FMS). MATERIALS AND METHODS: Ten patients with FMS according to the American College of Rheumatology (ACR) criteria entered this double blind crossover single-case study. In a period of 20 weeks, the patients underwent two treatment periods of 4 weeks, one with verum and one with placebo, at random, in a double blind fashion. Outcome measures were evaluated on a weekly basis. Primary outcome measure was pain measured with the Fibromyalgia Impact Questionnaire (FIQ) questions 4 and 5, the number of tender points and the total tender point pain intensity score. Both visual inspection and statistical analysis were done to analyse the data from this single-subject design. RESULTS: Performing visual inspection and statistical analysis, no positive results of the APS treatment were found in this study. Remarkable is the fact that placebo APS had significantly better results than verum APS. CONCLUSIONS: In this single-case study with ten patients (all female), APS was not a helpful method to reduce pain, to improve patients' perception of daily functioning and social participation in patients with FMS

     (97)    Hooper MM, Stellato TA, Hallowell PT, Seitz BA, Moskowitz RW. Musculoskeletal findings in obese subjects before and after weight loss following bariatric surgery. Int J Obes (Lond) 2007; 31(1):114-20.
Abstract: OBJECTIVE: To determine the point prevalence of painful musculoskeletal (MSK) conditions in obese subjects before and after weight loss following bariatric surgery. DESIGN: Longitudinal, interventional, unblended.Subjects:Forty-eight obese subjects (47 women, one man, mean age 44+/-9 years; mean body mass index (BMI) 51+/-8 kg/m(2)) recruited from an academic medical center bariatric surgery program. MEASUREMENTS: Comorbid medical conditions; MSK findings; BMI; Western Ontario McMaster Osteoarthritis Index (WOMAC) for pain, stiffness and function; and SF-36 for quality of life. METHODS: Consecutive subjects were recruited from the University Hospitals of Cleveland Bariatric Surgery Program. Musculoskeletal signs and symptoms and non-MSK comorbid conditions were documented at baseline and at follow-up. Subjects completed the SF-36 and the WOMAC questionnaires. Analyses were carried out for each MSK site, fibromyalgia syndrome (FMS) and for the cumulative effect on the spine, upper and lower extremities. The impact of change in comorbid medical conditions, BMI, physical and mental health domains of the SF-36 on the WOMAC pain subscale score was evaluated. SF-36 outcomes were compared to normal published controls. RESULTS: Forty-eight subjects were available for baseline and a follow-up assessment 6-12 months after gastric bypass surgery. They lost an average of 41+/-15 kg and the mean BMI decreased from 51+/-8 to 36+/-7 kg/m(2). Baseline comorbid medical conditions were present in 96% before surgery and 23% after weight loss. There was an increased prevalence of painful MSK conditions at baseline compared to general population frequencies. Musculoskeletal complaints had been present in 100% of obese subjects before, and 23% after weight loss. The greatest improvements occurred in the cervical and lumbar spine, the foot and in FMS (decreased by 90, 83, 83 and 92%, respectively). Seventy-nine percent had upper extremity MSK conditions before and 40% after weight loss. Before surgery, 100% had lower extremity MSK conditions and only 37% did after weight loss. The WOMAC subscale and composite scores all improved significantly, as did the SF-36((R)). Change in BMI was the main factor impacting the WOMAC pain score. CONCLUSION: There was a higher frequency of multiple MSK complaints, including non-weight-bearing sites compared to historical controls, before surgery, which decreased significantly at most sites following weight loss and physical activity. These benefits may improve further, as weight loss may continue for up to 24 months. The benefits seen with weight loss indicate that prevention and treatment of obesity can improve MSK health and function

     (98)    Unlu E, Ulas UH, Gurcay E, Tuncay R, Berber S, Cakci A et al. Genital sympathetic skin responses in fibromyalgia syndrome. Rheumatol Int 2006; 26(11):1025-30.
Abstract: The study was designed to investigate the autonomic dysfunction in fibromyalgia syndrome (FMS) by recording sympathetic skin response (SSR) from palmar, plantar and genital regions. The second aim was to evaluate the relation between sexual problems and autonomic dysfunction in FMS. SSR potential was recorded from palmar, plantar and genital regions in 28 married, female FMS patients and 18 married, healthy females. Fibromyalgia Impact Questionnaire (FIQ) was used to show the clinical severity and functional disability in FMS patients. Glombok Rust Inventory of Sexual Satisfaction (GRISS), a 28-item questionnaire, was used to assess the existence and severity of sexual problems. Beck test was used to evaluate anxiety and depression. The amplitude of SSR recorded from palmar, plantar and genital regions was lower than in the control subjects (P < 0.05). GRISS (total and subscale), Beck test and FIQ scores of FMS patients were higher than in the control subjects (P < 0.05). No correlation was found between the SSR potential and GRISS scores. The results of our study reveal that abnormality in SSR recorded from palmar, plantar and genital regions reflects the abnormality in the autonomic nervous system (ANS) of FMS patients. These patients have more sexual problems than healthy subjects, and we think this finding is related to increased anxiety and depression in these patients

     (99)    Singh BB, Wu WS, Hwang SH, Khorsan R, Der-Martirosian C, Vinjamury SP et al. Effectiveness of acupuncture in the treatment of fibromyalgia. Altern Ther Health Med 2006; 12(2):34-41.
Abstract: CONTEXT: Fibromyalgia syndrome (FMS) is a prevalent musculoskeletal disorder associated with pain, mood state alteration, and disability. A structured and effective treatment plan for palliative care has not been established. The genesis of FMS is not clear. FMS occurs primarily in adult women. DESIGN: Using a quasi-experimental clinical design and following the criteria of the American College of Rheumatology (ACR), for FMS, 21 participants completed the study. The mean age was 53.6 years. The data were collected at baseline and at 1 and 2 months. Acupuncture treatments included 17 points for FMS symptoms, and 8 outcome measures were collected. RESULTS: The Fibromyalgia Impact Questionnaire (FIQ) showed significant differences at 1 and 2 months. For the SF-12, 3 subscales showed significant differences between baseline and 2 months. Four of 6 items were significantly changed. The mean number of general health symptoms was significantly decreased by 2 months. For the Catastrophe Index, significant differences were found for baseline vs 2 months. Pain threshold scores were significantly different at end of treatment for 5 bilateral tender points. There was significant improvement in Beck Depression items for both 1- and 2-month periods. In a multivariate regression model, 5 covariates were included--age, number of weeks in treatment, number of doctors treating, number of general symptoms, and baseline FIQ score. The results indicated significant age effect. This analysis showed that the higher the FIQ score, the more positive the change experienced by study participants. Number of weeks in treatment, number of doctors who treated, and total number of general health symptoms did not have a significant effect on outcomes. CONCLUSIONS: Significant improvement was experienced by participants at 8 weeks of treatment. Acupuncture treatment as delivered was effective at reducing FMS symptoms in this outcome study

   (100)    Pamuk ON, Cakir N. The frequency of thyroid antibodies in fibromyalgia patients and their relationship with symptoms. Clin Rheumatol 2007; 26(1):55-9.
Abstract: We determined the frequency of thyroid autoantibodies in fibromyalgia (FM) patients and the relationship between FM symptoms and these antibodies. Euthyroid 128 FM patients, 64 rheumatoid arthritis (RA) patients, and 64 healthy control subjects were included in the study. The sociodemographic features and the clinical features of FM patients were determined. By using a visual analog scale, patients were questioned about the severity of FM-related symptoms. All patients were administered with Duke-Anxiety Depression (Duke-AD) scale, the physical function items of the fibromyalgia impact questionnaire scale. Thyroid autoimmunity was defined as the presence of detectable antithyroglobulin (TgAb) and/or antithyroid peroxidase (TPOAb) antibodies by the immunometric methods. Patients with a connective tissue disorder, hypo- or hyperthyroidism, and patients who had psychiatric treatment within the last 6 months were not included into the study. The frequencies of thyroid autoimmunity in FM (34.4%) and RA (29.7%) patients were significantly higher than controls (18.8%) (p<0.05). Twenty-six (20.3%) FM patients had positive TgAb and 31 (24.2%) had positive TPOAb. When patients with thyroid autoimmunity were compared to others, it was seen that the mean age, the percentage of postmenopausal patients, the frequency of dryness of the mouth, and the percentage of patients with a previous psychiatric treatment were higher in this group (p<0.05). FM patients had thyroid autoimmunity similar to the frequency in RA and higher than controls. Age and postmenopausal status seemed to be associated with thyroid autoimmunity in FM patients. The presence of thyroid autoimmunity had no relationship with the depression scores of FM patients

   (101)    Garcia-Campayo J, Pascual A, Alda M, Marzo J, Magallon R, Fortes S. The Spanish version of the FibroFatigue Scale: validation of a questionnaire for the observer's assessment of fibromyalgia and chronic fatigue syndrome. Gen Hosp Psychiatry 2006; 28(2):154-60.
Abstract: OBJECTIVE: To examine some of the psychometric properties of the Spanish version of the FibroFatigue Scale (FFS). METHODS: FFS was administered to 120 patients diagnosed with fibromyalgia and chronic fatigue syndrome. Internal consistency was evaluated by using Cronbach's alpha, test-retest reliability with weighted kappa and construct validity by correlations among FFS, the Fibromyalgia Impact Questionnaire (FIQ), the EuroQol 5D (EQ-5D) and the Hospital Anxiety and Depression Scale (HADS). The interrater reliability was tested using analysis of variance with patients and raters as independent factors. RESULTS: Internal consistency (alpha) was .88, test-retest reliability was .91, and interrater reliability was .93. Significant correlations were obtained between overall FFS and the FIQ (.55, P<.01), the EQ-5D (-.48, P<.01) and the HADS depression subscale (.25, P<.01), but not with the HADS anxiety subscale. CONCLUSION: These results support the reliability and validity of the data obtained with the Spanish version of the FSS

   (102)    Arnold LD, Bachmann GA, Rosen R, Kelly S, Rhoads GG. Vulvodynia: characteristics and associations with comorbidities and quality of life. Obstet Gynecol 2006; 107(3):617-24.
Abstract: OBJECTIVE: This case-control survey compared health history and health care use of women with vulvodynia with a control group reporting absence of gynecologic pain. METHODS: Women with a clinically assessed diagnosis of vulvodynia and asymptomatic controls were matched for age and mailed a confidential survey that evaluated demographics, health history, use of the health care system, and history of vulvodynia. Participants were all current or former ambulatory patients within a university health care system. RESULTS: Of the 512 questionnaires mailed to valid addresses, 70% (n = 91) of cases and 72% (n = 275) of controls responded, with 77 cases and 208 controls meeting eligibility criteria. Women with vulvodynia reported a substantial negative impact on quality of life, with 42% feeling out of control of their lives and 60% feeling out of control of their bodies. Forty-one percent indicated a severe impact on their sexual lives. When comorbidities were evaluated individually and adjusted for age, fibromyalgia (odds ratio 3.84, 95% confidence interval 1.54-9.55) and irritable bowel syndrome (odds ratio 3.11, 95% confidence interval 1.60-6.05) were significantly associated with vulvodynia. On a multivariate level, vulvodynia was correlated with a history of chronic yeast vaginitis and urinary tract infections. CONCLUSION: This survey highlights the psychological distress associated with vulvodynia and underscores the need for prospective studies to investigate the relationship between chronic bladder and vaginal infections as etiologies for this condition. As well, the association of vulvodynia with other comorbid conditions, such as fibromyalgia and irritable bowel syndrome, needs to be further evaluated. LEVEL OF EVIDENCE: II-2

   (103)    Menzies V, Taylor AG, Bourguignon C. Effects of guided imagery on outcomes of pain, functional status, and self-efficacy in persons diagnosed with fibromyalgia. J Altern Complement Med 2006; 12(1):23-30.
Abstract: OBJECTIVES: (1) To investigate the effects of a 6-week intervention of guided imagery on pain level, functional status, and self-efficacy in persons with fibromyalgia (FM); and (2) to explore the dose-response effect of imagery use on outcomes. DESIGN: Longitudinal, prospective, two-group, randomized, controlled clinical trial. SETTING AND SUBJECTS: The sample included 48 persons with FM recruited from physicians' offices and clinics in the mid-Atlantic region. INTERVENTION: Participants randomized to Guided Imagery (GI) plus Usual Care intervention group received a set of three audiotaped guided imagery scripts and were instructed to use at least one tape daily for 6 weeks and report weekly frequency of use (dosage). Participants assigned to the Usual Care alone group submitted weekly report forms on usual care. MEASURES: All participants completed the Short-Form McGill Pain Questionnaire (SF-MPQ), Arthritis Self- Efficacy Scale (ASES), and Fibromyalgia Impact Questionnaire (FIQ), at baseline, 6, and 10 weeks, and submitted frequency of use report forms. RESULTS: FIQ scores decreased over time in the GI group compared to the Usual Care group (p = 0.03). Ratings of self-efficacy for managing pain (p = 0.03) and other symptoms of FM also increased significantly over time (p = < 0.01) in the GI group compared to the Usual Care group. Pain as measured by the SF-MPQ did not change over time or by group. Imagery dosage was not significant. CONCLUSIONS: This study demonstrated the effectiveness of guided imagery in improving functional status and sense of self-efficacy for managing pain and other symptoms of FM. However, participants' reports of pain did not change. Further studies investigating the effects of mind-body interventions as adjunctive self-care modalities are warranted in the fibromyalgia patient population

   (104)    Assis MR, Silva LE, Alves AM, Pessanha AP, Valim V, Feldman D et al. A randomized controlled trial of deep water running: clinical effectiveness of aquatic exercise to treat fibromyalgia. Arthritis Rheum 2006; 55(1):57-65.
Abstract: OBJECTIVE: To compare the clinical effectiveness of aerobic exercise in the water with walking/jogging for women with fibromyalgia (FM). METHODS: Sixty sedentary women with FM, ages 18-60 years, were randomly assigned to either deep water running (DWR) or land-based exercises (LBE). Patients were trained for 15 weeks at their anaerobic threshold. Visual analog scale of pain, Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory, Short Form 36 Health Survey (SF-36), and a patient's global assessment of response to therapy (PGART) were measured at baseline, week 8, and week 15. Statistical analysis included all patients. RESULTS: Four patients dropped out from each group. Both groups improved significantly at week 15 compared with baseline, with an average 36% reduction in pain intensity. For PGART, 40% of the DWR group and 30% of the LBE group answered "much better" at posttreatment. FIQ total score and FIQ depression improvements in the DWR group were faster (week 8) than the LBE group and kept improving (week 15; P < 0.05). Only the DWR group showed improvements in SF-36 role emotional (P = 0.006). No significant between-group differences were observed for peak oxygen uptake and other outcomes. CONCLUSION: DWR is a safe exercise that has been shown to be as effective as LBE regarding pain. However, it has been shown to bring more advantages related to emotional aspects. Aerobic gain was similar for both groups, regardless of symptom improvement. Therefore, DWR could be studied as an exercise option for patients with FM who have problems adapting to LBE or lower limbs limitations

   (105)    Ubago Linares MC, Ruiz P, I, Bermejo Perez MJ, Olry de Labry LA, Plazaola CJ. [Clinical and psychosocial characteristics of subjects with fibromyalgia. Impact of the diagnosis on patients' activities]. Rev Esp Salud Publica 2005; 79(6):683-95.
Abstract: BACKGROUND: Little is known today about the characteristics of individuals diagnosed with fibromyalgia, their degree of disability and the health system response system response to this condition. The objectives of this work include: to establish the sociodemographic, clinical and psychosocial profile of male and female patients with fibromyalgia. To describe the response they receive from the health service, and to study the repercussions of this syndrome on the daily activities of subjects who suffer it, including its effects on their work environment. METHODS: Descriptive cross-sectional study. The information was received from telephone interviews of individuals diagnosed with fibromyalgia in the Hospital Universitario Virgen de las Nieves in Granada during 2003. RESULTS: 92.1% of those interviewed were women. Fibromyalgia caused work absenteeism in 31.4% of cases; and 64% regarded their health as poor or very poor. Fibromyalgia was associated with other diseases in 52.3% of cases. The family doctor is the specialist consulted before diagnosis in 92.1% of cases. A total of 50.5% had a history of psychiatric disorders, these were still present at the time of interview in 36.4%. Around 71% of the sample received family support, and 70.1% of cases considered the disease to seriously affect their environment. CONCLUSIONS: Fibromyalgia was mainly diagnosed in women. Subjects with this syndrome have a poor perception of their own health and work situation, and it negatively affects their family environment

   (106)    Mannerkorpi K, Svantesson U, Broberg C. Relationships between performance-based tests and patients' ratings of activity limitations, self-efficacy, and pain in fibromyalgia. Arch Phys Med Rehabil 2006; 87(2):259-64.
Abstract: OBJECTIVE: To investigate the relationship between performance-based tests, ratings of activity limitations, self-efficacy, and pain in fibromyalgia. DESIGN: Descriptive. SETTING: University hospital. PARTICIPANTS: Sixty-nine women with fibromyalgia (mean age, 45+/-7.8y). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The patients completed 4 performance-based tests focusing on muscle power function and 3 unloaded arm movements. The patients rated their activity limitations by means of the subscales of physical function (PF) and pain on the Fibromyalgia Impact Questionnaire (FIQ), the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), and the Arthritis Self-Efficacy Scale (ASES). Spearman correlation coefficient (rho) and multivariate regression analysis were conducted. RESULTS: The highest correlations were found between the 6-minute walk test (6MWT) (rho range, -.48 to .68) and the activity limitations and between hand grip strength (rho range, -.34 to .57) and the activity limitations. The regression analysis indicated that hand grip strength explained 25% of the variation in the SF-36 PF scale. The 6MWT plus endurance of the shoulder muscles explained 24% of the variation in the FIQ PF scale and the 6MWT plus active abduction of the shoulder explained 48% of the variation in the ASES function scale. Correlations between the performance-based tests and the activity limitations tended to be higher than those between performance and pain. CONCLUSIONS: The majority of the performance-based tests and the patients' subjective ratings of activity limitations showed significant relationships. The 6MWT and hand grip strength, reflecting activity limitations in the SF-36, FIQ, and ASES, are recommended for use in clinical research and in the clinical examination when planning treatment for patients with fibromyalgia

   (107)    Gordon C, Emiliozzi C, Zartarian M. Use of a mechanical massage technique in the treatment of fibromyalgia: a preliminary study. Arch Phys Med Rehabil 2006; 87(1):145-7.
Abstract: OBJECTIVE: To investigate how a mechanical massage technique (LPG technique) could contribute to the treatment of fibromyalgia. DESIGN: Feasibility study. SETTING: A single center. PARTICIPANTS: Ten women having a preexisting diagnosis of fibromyalgia based on American College of Rheumatology criteria were enrolled. INTERVENTION: Subjects received a total of 15 sessions of mechanical massage administered by a physical therapist once a week. MAIN OUTCOME MEASURES: The Fibromyalgia Impact Questionnaire and a physical examination scoring tender points (number, pain intensity). Evaluations were conducted at the screening visit, after 7 sessions (V7), and after completion of 15 sessions (V15). RESULTS: Most of the parameters (pain intensity, physical function, number of tender points) showed a significant improvement at V15 compared with screening. CONCLUSIONS: The findings suggest the possibility that the studied intervention might be associated with positive outcomes in women with fibromyalgia, and support the need for a controlled clinical trial to determine its efficacy

   (108)    Arnold LM, Rosen A, Pritchett YL, D'Souza DN, Goldstein DJ, Iyengar S et al. A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder. Pain 2005; 119(1-3):5-15.
Abstract: This was a 12-week, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of duloxetine, a selective serotonin and norepinephrine reuptake inhibitor, in 354 female patients with primary fibromyalgia, with or without current major depressive disorder. Patients (90% Caucasian; mean age, 49.6 years; 26% with current major depressive disorder) received duloxetine 60 mg once daily (QD) (N=118), duloxetine 60 mg twice daily (BID) (N=116), or placebo (N=120). The primary outcome was the Brief Pain Inventory average pain severity score. Response to treatment was defined as >or=30% reduction in this score. Compared with placebo, both duloxetine-treated groups improved significantly more (P<0.001) on the Brief Pain Inventory average pain severity score. A significantly higher percentage of duloxetine-treated patients had a decrease of >or=30% in this score (duloxetine 60 mg QD (55%; P<0.001); duloxetine 60 mg BID (54%; P=0.002); placebo (33%)). The treatment effect of duloxetine on pain reduction was independent of the effect on mood and the presence of major depressive disorder. Compared with patients on placebo, patients treated with duloxetine 60 mg QD or duloxetine 60 mg BID had significantly greater improvement in remaining Brief Pain Inventory pain severity and interference scores, Fibromyalgia Impact Questionnaire, Clinical Global Impression of Severity, Patient Global Impression of Improvement, and several quality-of-life measures. Both doses of duloxetine were safely administered and well tolerated. In conclusion, both duloxetine 60 mg QD and duloxetine 60 mg BID were effective and safe in the treatment of fibromyalgia in female patients with or without major depressive disorder

   (109)    Ozgocmen S, Ozyurt H, Sogut S, Akyol O, Ardicoglu O, Yildizhan H. Antioxidant status, lipid peroxidation and nitric oxide in fibromyalgia: etiologic and therapeutic concerns. Rheumatol Int 2006; 26(7):598-603.
Abstract: We proposed to assess the oxidant/antioxidant status, lipid peroxidation and nitric oxide (NO) in untreated fibromyalgia (FM) patients and controls. The effect of amitriptyline (A, 20 mg daily) and sertraline (S, 100 mg daily) treatment on patients' superoxide dismutase (SOD), xanthine oxidase (XO), adenosine deaminase (ADA) enzyme activities, thiobarbituric acid reactive substances (TBARS) and NO levels was investigated. Thirty female patients with primary FM and age-matched 16 healthy female controls were included. Patients received an 8-week course of treatment with either A or S. FM patients had higher serum levels of TBARS (particularly malondialdehyde) and lower levels of nitrite compared to controls whereas enzyme activities were similar. A and S significantly improved Fibromyalgia Impact Questionnaire (FIQ) pain scores, Hamilton anxiety and depression rating scales. But neither A nor S had significant effects on measured oxidative stress parameters, except SOD activity that was significantly reduced after S treatment. Total myalgic scores negatively correlated with XO activity, and depression scales negatively correlated with levels of TBARS. Our results indicate that patients with FM are under oxidative stress. These findings represent a rationale for further research assessing the effect of free radical scavengers or antioxidant agents like vitamins and omega-3 fatty acids on peripheral and central mechanisms in FM

   (110)    Bennett R. The Fibromyalgia Impact Questionnaire (FIQ): a review of its development, current version, operating characteristics and uses. Clin Exp Rheumatol 2005; 23(5 Suppl 39):S154-S162.
Abstract: The Fibromyalgia Impact Questionnaire (FIQ) was developed in the late 1980s by clinicians at Oregon Health & Science University in an attempt to capture the total spectrum of problems related to fibromyalgia and the responses to therapy. It was first published in 1991 and since that time has been extensively used as an index of therapeutic efficacy. Overall, it has been shown to have a credible construct validity, reliable test-retest characteristics and a good sensitivity in demonstrating therapeutic change. The original questionnaire was modified in 1997 and 2002, to reflect ongoing experience with the instrument and to clarify the scoring system. The latest version of the FIQ can be found at the web site of the Oregon Fibromyalgia Foundation (www.myalgia.com/FIQ/FIQ). The FIQ has now been translated into eight languages, and the translated versions have shown operating characteristics similar to the English version

   (111)    Lee SS, Yoon HJ, Chang HK, Park KS. Fibromyalgia in Behcet's disease is associated with anxiety and depression, and not with disease activity. Clin Exp Rheumatol 2005; 23(4 Suppl 38):S15-S19.
Abstract: OBJECTIVE: To determine the prevalence of fibromyalgia (FM) in Korean patients with Behcet's disease (BD) and to evaluate the association between FM and clinical and psychological variables. METHODS: Seventy patients with BD were examined for FM tender points and asked to complete a Korean version of the Fibromyalgia Impact Questionnaire (FIQ). Disease activity was measured using the erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and a clinical activity score, which was calculated by summing the clinical manifestations. The State-Trait Anxiety Inventory (STAI) and Beck Depression Inventory (BDI) were used for psychometric scoring. RESULTS: Twenty-six BD patients (37.1%) met the American College of Rheumatology criteria for FM. The patients who met the criteria for FM were more frequently female, less frequently employed, and less well educated. Age, disease duration, clinical manifestations, medication, and measures of disease activity did not differ between BD patients with and without FM. Nevertheless, BD patients with FM had higher STAI and BDI scores than did patients without FM (all p < 0.05). FM tender points were significantly correlated with the STAI and BDI, and not with disease activity variables. The FIQ scores were also strongly correlated with the STAI and BDI scores, and not with disease activity. CONCLUSION: FM was very common among BD patients and was associated with the presence of anxiety and depression, and not with disease activity

   (112)    Wood PB, Kablinger AS, Caldito GS. Open trial of pindolol in the treatment of fibromyalgia. Ann Pharmacother 2005; 39(11):1812-6.
Abstract: BACKGROUND: Evidence suggests that fibromyalgia is related to both chronic sympathetic hyperactivity and decreased levels of serotonin. OBJECTIVE: To examine the efficacy of pindolol, a mixed serotonin (5-HT)(1A) presynaptic autoreceptor/beta-adrenergic receptor antagonist, in the treatment of fibromyalgia. METHODS: An open trial was conducted using 20 female patients who met the American College of Rheumatology criteria for fibromyalgia. Treatment was initiated with pindolol 7.5 mg/day and titrated to a maximum dose of 15 mg/day for a total of 90 days. Primary outcome measures were tender point analysis and the Fibromyalgia Impact Questionnaire (FIQ). Anxiety and depression were measured with the Hamilton Depression and Anxiety Scales and Beck Depression Inventory. RESULTS: There was significant improvement in primary outcome measures, including Tender Point Count (mean +/- SD, 16.3 +/- 2.2 vs 12.3 +/- 5.0; F = 8.9; p < 0.001), Tender Point Score (24.4 +/- 5.7 vs 17.5 +/- 9.4; F = 7.8; p < 0.001), and FIQ (45.3 +/- 10.8 vs 35.0 +/- 15.0; F = 5.6; p < 0.005). The depression and anxiety scores did not change significantly among women who completed the study, while the impact on cardiovascular parameters was clinically insignificant. CONCLUSIONS: While the current results are encouraging, further studies are needed to determine whether pindolol might be effective in the treatment of fibromyalgia. Limitations of this study include small group size and lack of placebo control

   (113)    Dobkin PL, Abrahamowicz M, Fitzcharles MA, Dritsa M, da CD. Maintenance of exercise in women with fibromyalgia. Arthritis Rheum 2005; 53(5):724-31.
Abstract: OBJECTIVE: To identify predictors of maintenance of exercise for women with fibromyalgia (FM). METHODS: Women with FM who had been randomized to the exercise arm of a clinical trial were studied prospectively during and 3 months following treatment. Subjects completed exercise logs weekly and returned the data via postal mail. Outcome variables were duration of aerobic and stretching exercises. Two separate multivariate models for longitudinal data were built with adjustment for in-treatment adherence and time. Pretreatment characteristics (self efficacy, pain, disability, stress, exercise barriers and benefits, and age) and changes during treatment (pain, disability, stress, and exercise barriers and benefits) were considered potential predictors of exercise maintenance. RESULTS: Stretching significantly decreased in the 3 months following treatment. High stress at baseline and increases in stress during treatment were associated with poor maintenance of stretching. Disability at baseline (measured with the Fibromyalgia Impact Questionnaire), an increase in barriers to exercise during treatment, and increases in upper-body pain during treatment were associated with worse maintenance of aerobic exercise in the 3 months following treatment. CONCLUSION: The maintenance of an exercise program in women with FM appears to be contingent on being able to deal with stress, pain, barriers to exercise, and disability

   (114)    Asenlof P, Denison E, Lindberg P. Idiographic outcome analyses of the clinical significance of two interventions for patients with musculoskeletal pain. Behav Res Ther 2006; 44(7):947-65.
Abstract: This study adopted a perspective of the individual to define domains of everyday life for the analysis of clinically meaningful change. The purpose was to compare the clinical significance of two interventions for patients with musculoskeletal pain, applying an idiographic outcome measure, The Patient Goal Priority Questionnaire, in combination with the Jacobson and Truax methodology [(1991). Clinical significance: A statistical approach to defining meaningful change in psychotherapy research. Journal of Consulting and Clinical Psychology, 67 (3), 300-307] for determination of clinical significance. The concurrent validity of the outcome variables behavioral performance, satisfaction with behavioral performance, and fulfilled pre-treatment expectations was also studied. Eighty-two patients, randomized to either individually tailored behavioral medicine treatment (experimental group) or physical exercise therapy (control group) were evaluated at baseline and 3 months post-treatment regarding behavioral treatment goals. The experimental intervention had high impact on participants' performance of their highest ranked everyday life activities, and resulted in larger proportions of clinically significant outcomes compared with controls. The concurrent validity of the outcomes was high for those reporting clinically significant changes, but more generally, there was a moderate agreement across outcome categories. The individual should be the unit for analyses of clinical significance to enhance the ecological validity of the construct. Further development of idiographic outcome measures is necessary, as is the inclusion in pain intervention research

   (115)    Bennett RM, Schein J, Kosinski MR, Hewitt DJ, Jordan DM, Rosenthal NR. Impact of fibromyalgia pain on health-related quality of life before and after treatment with tramadol/acetaminophen. Arthritis Rheum 2005; 53(4):519-27.
Abstract: OBJECTIVE: To assess health-related quality of life (HRQOL) in patients with moderate-to-severe fibromyalgia pain compared with the general population, and to assess the relationship between pain severity and HRQOL before and after treatment with an analgesic. METHODS: Data were obtained from a randomized, double-blind study of patients with moderate-to-severe fibromyalgia pain. Patients received either tramadol/acetaminophen or placebo 4 times/day as needed for 91 days. HRQOL was measured with the Short Form 36 Health Survey (SF-36) and the Fibromyalgia Impact Questionnaire (FIQ). Baseline HRQOL scores were compared with a national sample of noninstitutionalized adults and a sample of patients with impaired HRQOL due to congestive heart failure. Patients with fibromyalgia were divided into tertiles by change in pain severity, and SF-36 scores were compared across the tertiles. Mean changes in SF-36 and FIQ scores were compared between treatment groups. RESULTS: Patients with fibromyalgia scored lower than the US norm on all SF-36 scales (P < 0.0001) and lower than patients with congestive heart failure on most scales. More severe pain was associated with greater impairment of HRQOL compared with less severe pain (P < 0.0001). Patients in the highest tertile for improved pain severity had greater improvement in HRQOL scores than patients in the lower tertiles. Compared with patients who received placebo (n = 157), patients treated with tramadol/acetaminophen (n = 156) showed greater improvement on SF-36 physical functioning, role physical, bodily pain, and physical summary scales, as well as FIQ scales for ability to do job, pain, and stiffness (P < 0.01). CONCLUSION: Moderate-to-severe fibromyalgia pain significantly impairs HRQOL, and effective pain relief in these patients significantly increases HRQOL

   (116)    Holman AJ, Myers RR. A randomized, double-blind, placebo-controlled trial of pramipexole, a dopamine agonist, in patients with fibromyalgia receiving concomitant medications. Arthritis Rheum 2005; 52(8):2495-505.
Abstract: OBJECTIVE: To assess the efficacy and safety of pramipexole, a dopamine 3 receptor agonist, in patients with fibromyalgia. METHODS: In this 14-week, single-center, double-blind, placebo-controlled, parallel-group, escalating-dose trial, 60 patients with fibromyalgia were randomized 2:1 (pramipexole:placebo) to receive 4.5 mg of pramipexole or placebo orally every evening. The primary outcome was improvement in the pain score (10-cm visual analog scale [VAS]) at 14 weeks. Secondary outcome measures were the Fibromyalgia Impact Questionnaire (FIQ), the Multidimensional Health Assessment Questionnaire (MDHAQ), the pain improvement scale, the tender point score, the 17-question Hamilton Depression Inventory (HAM-d), and the Beck Anxiety Index (BAI). Patients with comorbidities and disability were not excluded. Stable dosages of concomitant medications, including analgesics, were allowed. RESULTS: Compared with the placebo group, patients receiving pramipexole experienced gradual and more significant improvement in measures of pain, fatigue, function, and global status. At 14 weeks, the VAS pain score decreased 36% in the pramipexole arm and 9% in the placebo arm (treatment difference -1.77 cm). Forty-two percent of patients receiving pramipexole and 14% of those receiving placebo achieved > or =50% decrease in pain. Secondary outcomes favoring pramipexole over placebo included the total FIQ score (treatment difference -9.57) and the percentages of improvement in function (22% versus 0%), fatigue (29% versus 7%), and global (38% versus 3%) scores on the MDHAQ. Compared with baseline, some outcomes showed a better trend for pramipexole treatment than for placebo, but failed to reach statistical significance, including improvement in the tender point score (51% versus 36%) and decreases in the MDHAQ psychiatric score (37% versus 28%), the BAI score (39% versus 27%), and the HAM-d score (29% versus 9%). No end points showed a better trend for the placebo arm. The most common adverse events associated with pramipexole were transient anxiety and weight loss. No patient withdrew from the study because of inefficacy or an adverse event related to pramipexole. CONCLUSION: In a subset of patients with fibromyalgia, approximately 50% of whom required narcotic analgesia and/or were disabled, treatment with pramipexole improved scores on assessments of pain, fatigue, function, and global status, and was safe and well-tolerated

   (117)    da CD, Abrahamowicz M, Lowensteyn I, Bernatsky S, Dritsa M, Fitzcharles MA et al. A randomized clinical trial of an individualized home-based exercise programme for women with fibromyalgia. Rheumatology (Oxford) 2005; 44(11):1422-7.
Abstract: OBJECTIVE: To determine the efficacy of a 12-week individualized home-based exercise programme on physical functioning, pain severity and psychological distress for women with fibromyalgia (FM). METHODS: Seventy-nine women with a primary diagnosis of FM were randomized to a 12-week individualized home-based moderate-intensity exercise programme or to a usual care control group. Outcomes were functional capacity (Fibromyalgia Impact Questionnaire), pain severity and psychological distress. Outcomes were measured at study entry, at the end of the 12-week intervention, and at 3 and 9 months following completion of the intervention. RESULTS: On the basis of intention-to-treat analyses, a significant improvement in functional capacity at 3 and 9 months following treatment for participants in the exercise group who were more functionally disabled at study entry was observed. At both 3 and 9 months post-treatment, the mean estimated benefit of the intervention was more than 10 points [-12.3 (95% CI, -21.9 to -2.8); -10.8 (95% CI, -21.5 to -0.2)]. Compared with the control group, statistically significant improvements in upper body pain were evident in the exercise group at post-treatment. These between-group differences in upper body pain were maintained at 3 and 9 months post-treatment. No statistically significant group differences on lower body pain and psychological distress were found. CONCLUSIONS: Home-based exercise, a relatively low-cost treatment modality, has the potential to improve important health outcomes in FM

   (118)    Bergman S. Psychosocial aspects of chronic widespread pain and fibromyalgia. Disabil Rehabil 2005; 27(12):675-83.
Abstract: PURPOSE: To study the impact on health status as measured by SF-36 in groups of subjects having chronic musculoskeletal pain with different degree of generalization: No chronic pain (NCP), chronic regional pain (CRP), chronic widespread pain (CWP), CWP with a stricter 'Manchester' definition (CWP-M), and clinically defined fibromyalgia (FM). The study also examines the association between psychosocial and lifestyle background variables, and these pain-groups. METHOD: A cross-sectional study with a postal survey to 3928 subjects, constituting a representative sample of the adult general population, followed by clinical examination in a selected group of subjects with CWP. CWP and FM were diagnosed according to ACR 1990 fibromyalgia criteria. Health status was measured by SF-36 Health Survey. RESULTS: Patients with CWP, CWP-M, and FM were found to present with more severe impairment of health status than the other two population groups. Several psychosocial factors, such as belonging to a lower socio-economic group, being an immigrant, living in a compromised housing area, having lower educational level, experiencing lower social support and having a family history of chronic pain, were associated with the populations with CWP and FM. CONCLUSIONS: The spectrum of impact on health and association to background variables, with respect to a stricter definition of CWP, indicates that these factors are important to attend to in the understanding and management of CWP and FM

   (119)    Tikiz C, Muezzinoglu T, Pirildar T, Taskn EO, Frat A, Tuzun C. Sexual dysfunction in female subjects with fibromyalgia. J Urol 2005; 174(2):620-3.
Abstract: PURPOSE: We investigated sexual function in females with fibromyalgia (FM) and evaluate whether coexistent major depression (MD) has an additional negative effect on sexual function. MATERIALS AND METHODS: A total of 100 female subjects were enrolled in the study, including 40 with FM only, 27 with FM plus MD and 33 healthy volunteers as a control group. The diagnosis of MD was made according to Structured Clinical Interview for Diagnostic and Statistical Manual-IV interview and the Hamilton Depression Rate Scale was used to grade depression. Widespread pain and quality of life were assessed with the Lattinen Pain Scale and Fibromyalgia Impact Questionnaire, respectively. The Female Sexual Function Index (FSFI) was used to assess sexual dysfunction. RESULTS: All subjects were comparable in age, occupation and education. Mean FSFI total score +/- SD was significantly decreased in the FM and FM plus MD groups compared with that in healthy controls (21.83 +/- 5.84 and 22.43 +/- 7.0 vs 28.10 +/- 6.52, respectively, p = 0.001). However, the FSFI score was not significantly different between patients with FM only and FM plus MD (p >0.05). Correlation analysis revealed a negative moderate correlation between total Lattinen pain score and FSFI score in the FM only and FM plus MD groups (r = -0.366, p = 0.047 and r = -0.403, p = 0.018, respectively). FSFI score did not correlate with FIQ and HDRS scores (p >0.05). CONCLUSIONS: This study demonstrates that female patients with FM have distinct sexual dysfunction compared with healthy controls and coexistent MD has no additional negative effect on sexual function. Thus, female subjects with FM should be evaluated in terms of sexual function to provide better quality of life

   (120)    Donmez A, Karagulle MZ, Tercan N, Dinler M, Issever H, Karagulle M et al. SPA therapy in fibromyalgia: a randomised controlled clinic study. Rheumatol Int 2005; 26(2):168-72.
Abstract: OBJECTIVE: The aim of the present study is to evaluate the effectiveness of spa therapy in the management of fibromyalgia. METHODS: Thirty women with fibromyalgia were randomly assigned to either a spa therapy group or a control group. The spa therapy group (n = 16) had spa treatment for 2 weeks in addition to their medical treatment. The control group (n = 14) continued to have their medical treatment and/or daily exercises. An investigator who was blinded for the intervention assessed all the patients for 9 months. Improvements in Fibromyalgia Impact Questionnaire (FIQ), pain and number of tender points were primary outcomes. Secondary outcome measures were improvement in sleep disturbance, fatigue, gastrointestinal symptoms, anxiety, Beck Depression Inventory and patient's global evaluation. RESULTS: the spa group was found to be superior to the control group at the end of intervention in terms of FIQ, pain, tender point count, fatigue and patients' global assessment. This superiority remained for 6 months in FIQ, 1 month in pain and tender point count. CONCLUSION: It was concluded that the addition of spa therapy to medical therapy has both short- and long-term beneficial effects in female patients with fibromyalgia

   (121)    Burckhardt CS, Jones KD. Effects of chronic widespread pain on the health status and quality of life of women after breast cancer surgery. Health Qual Life Outcomes 2005; 3:30.:30.
Abstract: BACKGROUND: Most research and treatment of post-breast cancer chronic pain has focused on local or regional pain problems in the operated area. The purpose of this pilot study was to compare and contrast the pain characteristics, symptom impact, health status, and quality of life of post-breast cancer surgery women with regional chronic pain versus those with widespread chronic pain. METHODS: A cross-sectional, descriptive design compared two groups of women with chronic pain that began after surgery: regional pain (n = 11) and widespread pain (n = 12). Demographics, characteristics of the surgery, as well as standardized questionnaires that measured pain (Brief Pain Inventory (BPI), Short Form McGill Pain Questionnaire (MPQ-SF)), disease impact (Fibromyalgia Impact Questionnaire (FIQ), Functional Assessment of Cancer Therapy-Breast (FACT-B)), health status (Medical Outcomes Short Form (SF-36)) and quality of life (Quality of Life Scale (QOLS)) were gathered. RESULTS: There were no significant differences between the groups on any demographic or type of surgery variable. A majority of both groups described their pain as aching, tender, and sharp on the MPQ-SF. On the BPI, intensity of pain and pain interference were significantly higher in the widespread pain group. Differences between the two groups reached statistical significance on the FIQ total score as well as the FACT-B physical well-being, emotional well-being and breast concerns subscales. The SF-36 physical function, physical role, and body pain subscales were significantly lower in the widespread pain group. QOLS scores were lower in the widespread pain group, but did not reach statistical significance. CONCLUSION: This preliminary work suggests that the women in this study who experienced widespread pain after breast cancer surgery had significantly more severity of pain, pain impact and lower physical health status than those with regional pain

   (122)    Ofluoglu D, Berker N, Guven Z, Canbulat N, Yilmaz IT, Kayhan O. Quality of life in patients with fibromyalgia syndrome and rheumatoid arthritis. Clin Rheumatol 2005; 24(5):490-2.
Abstract: The objective of this study was to determine and compare the quality of life (QOL) of patients with fibromyalgia syndrome (FS) and rheumatoid arthritis (RA) and to assess patients' psychological and functional status in each group. This prospective study included 62 female FS patients and 60 female RA patients diagnosed by the American College of Rheumatology criteria. The Turkish translations of the Arthritis Impact Measurement Scale II (AIMS II) and Beck Depression Index (BDI) were given to all of the patients and they were asked to complete the two questionnaires. The scores of AIMS II, pain, and QOL were evaluated in the FS and RA groups. There were no statistically significant differences between the FS and RA groups (p>0.05) in terms of QOL. The affect subgroup scores of the AIMS II and BDI were highly correlated in the FS and RA groups (p<0.002, r=0.85 and p<0.05, r=0.80, respectively). The results show that the QOL is negatively but similarly affected in FS and RA groups

   (123)    Mannerkorpi K, Arndorw M. Efficacy and feasibility of a combination of body awareness therapy and qigong in patients with fibromyalgia: a pilot study. J Rehabil Med 2004; 36(6):279-81.
Abstract: OBJECTIVE: To evaluate the effects of body awareness therapy combined with qigong for patients with fibromyalgia. DESIGN: A controlled randomized pilot study. SUBJECTS: Thirty-six female patients with fibromyalgia were randomized to either qigong plus body awareness therapy (n = 19) or a control group (n = 17). METHODS: The programme was conducted once a week over a period of 3 months. The outcome measures were an observational method called the Body Awareness Rating Scale, the Fibromyalgia Impact Questionnaire and 2 tests of physical function. An interview was conducted with the patients in the treatment group. RESULTS: Seven patients in each group (39%) were lost to the post-test examination. The inter-group analysis revealed a significant improvement in movement harmony for the treatment group (p = 0.03), while no differences were found in the Fibromyalgia Impact Questionnaire or the functional tests. The intra-group analysis revealed an improvement in movement harmony for the treatment group (p = 0.01), while the total score of the Fibromyalgia Impact Questionnaire deteriorated (p = 0.04) in the control group. The interviews indicated that several patients had experienced exacerbation of symptoms while standing still, and/or difficulty in concentrating on the movements. CONCLUSIONS: Although improvement in movement harmony occurred in the patients completing the treatment programme, no improvement was found for fibromyalgia symptoms or physical function

   (124)    Zijlstra TR, van de Laar MA, Bernelot Moens HJ, Taal E, Zakraoui L, Rasker JJ. Spa treatment for primary fibromyalgia syndrome: a combination of thalassotherapy, exercise and patient education improves symptoms and quality of life. Rheumatology (Oxford) 2005; 44(4):539-46.
Abstract: OBJECTIVES: To study the effect of a combination of thalassotherapy, exercise and patient education in people with fibromyalgia. METHODS: Patients with fibromyalgia, selected from a rheumatology out-patient department and from members of the Dutch fibromyalgia patient association, were pre-randomized to receive either 2(1/2) weeks of treatment in a Tunisian spa resort, including thalassotherapy, supervised exercise and group education (active treatment) or treatment as usual (control treatment). Primary outcome measure was health-related quality of life, measured with the RAND-36 questionnaire. Secondary measures included the Fibromyalgia Impact Questionnaire, the McGill Pain Questionnaire, the Beck Depression Inventory, tender point score and a 6-min treadmill walk test. RESULTS: Fifty-eight participants receiving the active treatment reported significant improvement on RAND-36 physical and mental component summary scales. For physical health, differences from the 76 controls were statistically significant after 3 months, but not after 6 and 12 months. A similar pattern of temporary improvement was seen in the self-reported secondary measures. Tender point scores and treadmill walk tests improved more after active treatment, but did not reach significant between-group differences, except for walk tests after 12 months. CONCLUSIONS: A combination of thalassotherapy, exercise and patient education may temporarily improve fibromyalgia symptoms and health-related quality of life

   (125)    Pagano T, Matsutani LA, Ferreira EA, Marques AP, Pereira CA. Assessment of anxiety and quality of life in fibromyalgia patients. Sao Paulo Med J 2004; 122(6):252-8.
Abstract: CONTEXT: Fibromyalgia is a syndrome characterized by chronic, diffuse musculoskeletal pain, and by a low pain threshold at specific anatomical points. The syndrome is associated with other symptoms such as fatigue, sleep disturbance, morning stiffness and anxiety. Because of its chronic nature, it often has a negative impact on patients' quality of life. OBJECTIVE: To assess the quality of life and anxiety level of patients with fibromyalgia. TYPE OF STUDY: Cross-sectional. SETTING: Rheumatology outpatient service of Hospital das Clinicas (Medical School, Universidade de Sao Paulo). METHODS: This study evaluated 80 individuals, divided between test and control groups. The test group included 40 women with a confirmed diagnosis of fibromyalgia. The control group was composed of 40 healthy women. Three questionnaires were used: two to assess quality of life (FIQ and SF-36) and one to assess anxiety (STAI). They were applied to the individuals in both groups in a single face-to-face interview. The statistical analysis used Student's t test and Pearson's correlation test (r), with a significance level of 95%. Also, the Pearson chi-squared statistics test for homogeneity, with Yates correction, was used for comparing schooling between test and control groups. RESULTS: There was a statistically significant difference between the groups (p = 0.000), thus indicating that fibromyalgia patients have a worse quality of life and higher levels of anxiety. The correlations between the three questionnaires were high (r = 0.9). DISCUSSION: This study has confirmed the efficacy of FIQ for evaluating the impact of fibromyalgia on the quality of life. SF-36 is less specific than FIQ, although statistically significant values were obtained when analyzed separately, STAI showed lower efficacy for discriminating the test group from the control group. The test group showed worse quality of life than did the control group, which was demonstrated by both FIQ and SF-36. Even though STAI was a less efficient instrument, it presented significant results, showing that fibromyalgia patients presented higher levels of anxiety, both on the state and trait scales. Thus, patients with fibromyalgia had higher levels of tension, nervousness, preoccupation and apprehension, and higher propensity towards anxiety. CONCLUSION: The three instruments utilized showed efficiency in evaluating fibromyalgia patients. FIQ was found to be the most efficient instrument for discriminating and assessing the impact of fibromyalgia on their quality of life. It can be concluded that such patients have a worse quality of life and higher levels of anxiety

   (126)    Reisine S, Fifield J, Walsh S, Dauser D. Employment and quality of life outcomes among women with fibromyalgia compared to healthy controls. Women Health 2004; 39(4):1-19.
Abstract: The purpose of this study was to assess the effects of paid employment on health related quality of life among women with fibromyalgia compared to a group of women who were otherwise healthy. Participants were recruited from 118 rheumatology practices randomly sampled from the membership of the American College of Rheumatology. Three hundred and sixty-five patients were referred to the study and 287 completed a telephone interview. At the end of each interview, participants were asked to nominate 2 individuals to serve as control subjects. Because of lagging enrollment of control subjects, we initiated an additional method of asking control subjects to nominate controls. Of 381 control subjects nominated for the study, 286 or 75% completed the initial interview. As with patients, controls completed a computer assisted phone interview with a trained interviewer similar to that of the patient. The mean age of women with FMS was 47 years, most were married (59.6%), 87.8% were of white race and non-Hispanic ethnicity, 47.7% were employed, had an average of 14 years of education and household annual incomes generally exceeded $20,000, with 40.4% having incomes in excess of $50,000. There we no significant differences between women with FMS and those without FMS on these characteristics. Women with FMS had significantly worse physical and mental health related quality of life measured by SF-12 Physical (PCS) and Mental (MCS) Component Summary Scores; those who were not employed had significantly worse PCS scores but there were no differences by employment for MCS. Ordinal regression analysis adjusting for demographic characteristics showed that there were significant main effects for condition and employment on PCS in that those with FMS and those who were not employed had worse PCS scores. Initially, we also found an interaction effect between condition and employment in that the beneficial effects of employment was restricted to the FMS cases. However, when adjustments were made for the double nesting design, the interaction effect was no longer significant. For MCS, FMS cases had significantly worse health related quality of life, but there were no main effects for employment and no interactions were significant. Our results concur with findings in community studies that employed women report better quality of life than those not employed, but only for the physical dimension of quality of life. The findings regarding MCS are intriguing in that women with FMS are not very different from controls and that employment has little effect on the mental health component of quality of life

   (127)    Oliver K, Cronan TA. Correlates of physical activity among women with fibromyalgia syndrome. Ann Behav Med 2005; 29(1):44-53.
Abstract: BACKGROUND: Fibromyalgia (FMS) is a chronic pain syndrome of unknown origin that lacks standardized treatment. However, participation in physical activity (PA) benefits people with FMS. Despite the psychosocial and health benefits that can be gained through PA, the correlates of PA among people with FMS remain poorly understood. PURPOSE: The purpose of this study was to identify and compare the effects of cross-sectional and longitudinal correlates of PA among women with FMS. METHODS: Participants were 187 female members of a HMO with a confirmed diagnosis of FMS. They were administered a battery of questionnaires assessing potential correlates of PA. These correlates were suggested by social cognitive theory and the transtheoretical model, and have been repeatedly associated with PA among the general population. RESULTS: Multivariate analyses indicated that self-efficacy for PA and the behavioral processes of change were the strongest discriminators among PA adopters, maintainers, quitters, and those who were sedentary. Enjoyment of PA, barriers to PA, the impact of FMS, and the environment also significantly discriminated among these groups. Longitudinally, changes in self-efficacy were significantly associated with changes in PA. CONCLUSIONS: These findings suggest that self-efficacy may play a critical role in both the present and long-term PA of women with FMS. They also lend additional support to the role of social cognitive and transtheoretical variables in discriminating among levels of PA

   (128)    Marques AP, Ferreira EA, Matsutani LA, Pereira CA, Assumpcao A. Quantifying pain threshold and quality of life of fibromyalgia patients. Clin Rheumatol 2005; 24(3):266-71.
Abstract: The most typical symptom of fibromyalgia (FM) is diffuse pain, and pain at specific points-tender points-is crucial for its diagnosis. By comparing healthy individuals and FM patients, this study was aimed at assessing pain and quality of life of Brazilian females with FM, while seeking for a correlation between pain threshold and quality of life. A total of 178 women were evaluated: 124 were FM patients and 54 were healthy women. Pain threshold at tender points was quantified by dolorimetry, and diffuse pain by means of the visual analogue scale (VAS); the Fibromyalgia Impact Questionnaire (FIQ) was used to evaluate quality of life. Statistical treatment of the data allowed for proposing two indexes: a pain threshold index (PT) and a quality of life one (QOL). PT is the lowest value among all pain thresholds measured at the 18 tender points; QOL is the mean of responses to the FIQ and VAS. Both indexes were tested and showed significant differences between the test and control groups. By pairing pain threshold values of each tender point in the test and control groups, it was found that the most sensitive points matched between the two groups, that is, the most sensitive anatomic spots in a healthy individual are also likely to be the most sensitive points in a person with FM. This suggests that a stimulus that provokes slight discomfort to a healthy person may produce more pain in FM patients--which may bear implications for FM clinical treatment. In this sample of Brazilian women, FM patients had both lower pain threshold and worse quality of life than healthy women

   (129)    Gowans SE, Dehueck A, Voss S, Silaj A, Abbey SE. Six-month and one-year followup of 23 weeks of aerobic exercise for individuals with fibromyalgia. Arthritis Rheum 2004; 51(6):890-8.
Abstract: OBJECTIVE: To measure mood and physical function of individuals with fibromyalgia, 6 and 12 months following 23 weeks of supervised aerobic exercise. METHODS: This is a followup report of individuals who were previously enrolled in 23 weeks of land-based and water-based aerobic exercise classes. Outcomes included the 6-minute walk test, Beck Depression Inventory (BDI), State-Trait Anxiety Inventory, Arthritis Self-Efficacy Scale (ASES), Fibromyalgia Impact Questionnaire (FIQ), tender point count, patient global assessment score, and exercise compliance. Outcomes were measured at the start and end of the exercise classes and 6 and 12 months later. RESULTS: Analyses were conducted on 29 (intent-to-treat) or 18 (efficacy) subjects. Six-minute walk distances and BDI total scores were improved at followup (all analyses). BDI cognitive/affective scores were improved at the end of 23 weeks of exercise (both analyses) and at the 12-month followup (efficacy analysis only). BDI somatic scores were improved at 6-month (both analyses) and 12-month followup (intent-to-treat only). FIQ and ASES function were improved at all followup points. ASES pain was improved in efficacy analyses only (all followup points). Tender points were unchanged after 23 weeks of exercise and at followup. Exercise duration at followup (total minutes of aerobic plus anaerobic exercise in the preceding week) was related to gains in physical function (6- and 12-month followup) and mood (6-month followup). CONCLUSION: Exercise can improve physical function, mood, symptom severity, and aspects of self efficacy for at least 12 months. Exercising at followup was related to improvements in physical function and perhaps mood

   (130)    Thieme K, Turk DC, Flor H. Comorbid depression and anxiety in fibromyalgia syndrome: relationship to somatic and psychosocial variables. Psychosom Med 2004; 66(6):837-44.
Abstract: OBJECTIVE: The prevalence as well as predictors of psychiatric disorders (Diagnostic and Statistical Manual of Mental Disorders, 4th edition [DSM-IV] axis I and II) in patients with fibromyalgia syndrome (FMS) was evaluated.METHOD: One-hundred fifteen patients with FMS participated in the Structured Clinical Interview for DSM-IV to assess current mental disorders. In addition, patients completed standardized questionnaires regarding pain, pain impact, anxiety, depression, posttraumatic stress disorder-like symptoms, and sexual and physical abuse. RESULTS: Patients were grouped into one of three psychosocial subgroups based on responses to the Multidimensional Pain Inventory (MPI)-Dysfunctional (DYS), Interpersonally Distressed (ID), and Adaptive Copers (AC). Axis I diagnoses were present in 74.8% of the participants overall with the DYS subgroup mainly reporting anxiety and the ID group mood disorders. The AC group showed little comorbidity. Axis II diagnoses were present in only 8.7% of the FMS sample.CONCLUSION: These results suggest that FMS is not a homogeneous diagnosis, but shows varying proportions of comorbid anxiety and depression dependent on psychosocial characteristics of the patients. The results demonstrate the importance of not treating patients with FMS as a homogeneous group. Assessment should not only examine the presence of widespread pain and the number of tender points, but also the presence of affective distress. Treatment should focus both on physical and emotional dysfunction

   (131)    Turk DC, Robinson JP, Burwinkle T. Prevalence of fear of pain and activity in patients with fibromyalgia syndrome. J Pain 2004; 5(9):483-90.
Abstract: Patients with fibromyalgia syndrome (FMS) report pain, fatigue, emotional distress, activity avoidance, and disability. The role of fear of pain and activity in FMS patients has received only limited attention. FMS patients (N = 233) underwent examinations by a physician, physical therapist, and psychologist and completed measures of fear of pain and activity, disability, depressive mood, impact, and pain. Patients with high levels of fear of pain and activity (38.6%) reported greater disability (t = 4.02, P < .001), depressed mood (t = -4.14, P < .001), pain severity (t = -2.71, P < .01), and lower treadmill performance (t = -2.39, P < .05) than patients with low fear. Patients classified on the Multidimensional Pain Inventory as Dysfunctional reported greater fear than Interpersonally Distressed patients and Adaptive Copers (F = 8.13, P < .001). Only 50% of Dysfunctional patients, however, met the criterion of high fear, whereas 23.4% of Adaptive Copers met this criterion. Demographic factors, perceived disability, and Multidimensional Pain Inventory subgroup significantly predicted fear of pain and activity, accounting for 21.2% of the variance. Fear of pain and activity is prevalent among FMS patients. Treatment should address patient fears, because it might reduce disability and rates of nonadherence and attrition from outcome studies. PERSPECTIVE: Fear of movement is a significant concern for chronic pain sufferers because these behaviors maintain pain and increase disability. This study examined the role of fear in FMS, including associations between fear of pain/movement, pain severity, depressed mood, physical performance, and disability in FMS subgroups

   (132)    Solomon L, Reeves WC. Factors influencing the diagnosis of chronic fatigue syndrome. Arch Intern Med 2004; 164(20):2241-5.
Abstract: BACKGROUND: Most of what is believed about chronic fatigue syndrome (CFS) is based on clinic-based studies. These studies may not reflect CFS cases in the population. METHODS: We used data from a population-based study of CFS to identify factors associated with receiving a CFS diagnosis. Wichita, Kan, residents were screened by random-digit dialing. Eligible individuals completed a telephone interview. Respondents meeting CFS criteria were invited for a clinical evaluation to confirm CFS. We analyzed all persons with confirmed CFS. The main outcomes of this study, prevalence and incidence of CFS, are published elsewhere. Herein, we present an exploratory analysis with previous CFS diagnosis as the outcome, predicted by demographic and symptom characteristics. RESULTS: We confirmed CFS in 90 subjects; 14 (16%) had been previously diagnosed as having CFS. Persons in the middle- vs the higher-income group were more likely to have been diagnosed as having CFS (9 [29%] of 31 subjects vs 3 [8%] of 39 subjects; P = .03), as were those with sudden vs gradual fatigue onset (7 [41%] of 17 subjects vs 4 [6%] of 64 subjects; P < .01), those reporting tender lymph nodes (7 [33%] of 21 subjects vs 7 [10%] of 69 subjects; P = .02), and those reporting a sore throat (6 [35%] of 17 subjects vs 8 [11%] of 73 subjects; P = .02). Only 17 (21%) of 81 subjects had sudden fatigue onset, and tender lymph nodes (reported in 21 [23%] of 90 subjects) and a sore throat (reported in 17 [19%] of 90 subjects) were the least common symptoms. CONCLUSION: Most cases of CFS in the population are unrecognized by the medical community; persons diagnosed as having CFS may be different from persons with CFS in the general population

   (133)    Friedberg F. Eye movement desensitization in fibromyalgia: a pilot study. Complement Ther Nurs Midwifery 2004; 10(4):245-9.
Abstract: The purpose of this study was to investigate the effectiveness of eye movement desensitization (EMD) for the relief of pain, fatigue and anxiety and depression in fibromyalgia patients. Six Caucasian female patients (mean age=43.2 yr) participated in two treatment sessions. Outcome assessments included the Fibromyalgia Impact Questionnaire, Fatigue Scale, Beck Anxiety Inventory, and Beck Depression Inventory. In-session process measures included thermal biofeedback monitoring and subjective units of discomfort ratings of pain, stress, and fatigue. Four out of six subjects were considered treatment responders. Thermal biofeedback monitoring revealed an average increase in hand temperature of 5.4 degrees indicating a relaxation effect. At treatment termination, average scores decreased on the measures of anxiety (28.6%), depression (29.9%), fibromyalgia impact (12.6%), and fatigue (11.5%). At the 3-month follow-up assessment, total reductions in average scores from pre-treatment baseline reflected further improvements on measures of anxiety (45.8%), depression (31.6%), fibromyalgia impact (19.2%), and fatigue (26.7%). Because EMD produced a somewhat automatic relaxation response with minimal patient participation, it may be especially useful when standard relaxation techniques fail

   (134)    Rivera J, Gonzalez T. The Fibromyalgia Impact Questionnaire: a validated Spanish version to assess the health status in women with fibromyalgia. Clin Exp Rheumatol 2004; 22(5):554-60.
Abstract: OBJECTIVE: To translate, adapt, validate and assess the sensitivity to change of a Spanish version of the Fibromyalgia Impact Questionnaire (FIQ-S). METHODS: The FIQ-S was adapted following the translation and back-translation methodology. Female patients with fibromyalgia (FM) were invited to participate. Reliability was analyzed by the Spearman correlation coefficient between test and retest. Internal consistency was checked by the Cronbach's alpha coefficient. Construct validity was analyzed comparing FIQ-S with: HAQ, FHAQ, SF-36, SCL90-R, and the visual analogue scale for pain. Sensitivity to change was assessed in an 8-week randomized trial of exercise therapy. Feasibility was analyzed by the time taken in completing the FIQ-S and the proportion of patients able to complete the questionnaire. RESULTS: Translation was concordant. Adaptation affected at 4 sub-items of physical function. One-hundred and two FM patients completed the protocol. Mean age was 48.7 years with a mean of 9.2 years of evolution. Test-retest correlations were between 0.61-0.85 (p < 0.0001). Internal consistency showed alpha = 0.82 for all items and alpha = 0.86 for the sub-items of physical function. Significant correlations (p < 0.0001) were found between the FIQ-S items and HAQ, FHAQ, SF-36 and SCL90-R. For patients treated with the exercise program, the pre-treatment FIQ-S score was 52.0 +/- 11.5 and the post-treatment score was 40.8 +/- 13.7 (p < 0.003). Mean time for completing FIQ-S was 3.3 minutes. In 4% of the patients external help was needed. CONCLUSION: The FIQ-S is a reliable, valid and responsive to changes questionnaire for measuring health status and physical function in Spanish speaking FM patients

   (135)    Arnold LM, Lu Y, Crofford LJ, Wohlreich M, Detke MJ, Iyengar S et al. A double-blind, multicenter trial comparing duloxetine with placebo in the treatment of fibromyalgia patients with or without major depressive disorder. Arthritis Rheum 2004; 50(9):2974-84.
Abstract: OBJECTIVE: To assess the efficacy and safety of duloxetine, a serotonin and norepinephrine reuptake inhibitor, in subjects with primary fibromyalgia, with or without current major depressive disorder. METHODS: This study was a randomized, double-blind, placebo-controlled trial conducted in 18 outpatient research centers in the US. A total of 207 subjects meeting the American College of Rheumatology criteria for primary fibromyalgia were enrolled (89% female, 87% white, mean age 49 years, 38% with current major depressive disorder). After single-blind placebo treatment for 1 week, subjects were randomly assigned to receive duloxetine 60 mg twice a day (n = 104) or placebo (n = 103) for 12 weeks. Co-primary outcome measures were the Fibromyalgia Impact Questionnaire (FIQ) total score (score range 0-80, with 0 indicating no impact) and FIQ pain score (score range 0-10). Secondary outcome measures included mean tender point pain threshold, number of tender points, FIQ fatigue, tiredness on awakening, and stiffness scores, Clinical Global Impression of Severity (CGI-Severity) scale, Patient Global Impression of Improvement (PGI-Improvement) scale, Brief Pain Inventory (short form), Medical Outcomes Study Short Form 36, Quality of Life in Depression Scale, and Sheehan Disability Scale. RESULTS: Compared with placebo-treated subjects, duloxetine-treated subjects improved significantly more (P = 0.027) on the FIQ total score, with a treatment difference of -5.53 (95% confidence interval -10.43, -0.63), but not significantly more on the FIQ pain score (P = 0.130). Compared with placebo-treated subjects, duloxetine-treated subjects had significantly greater reductions in Brief Pain Inventory average pain severity score (P = 0.008), Brief Pain Inventory average interference from pain score (P = 0.004), number of tender points (P = 0.002), and FIQ stiffness score (P = 0.048), and had significantly greater improvement in mean tender point pain threshold (P = 0.002), CGI-Severity (P = 0.048), PGI-Improvement (P = 0.033), and several quality-of-life measures. Duloxetine treatment improved fibromyalgia symptoms and pain severity regardless of baseline status of major depressive disorder. Compared with placebo-treated female subjects (n = 92), duloxetine-treated female subjects (n = 92) demonstrated significantly greater improvement on most efficacy measures, while duloxetine-treated male subjects (n = 12) failed to improve significantly on any efficacy measure. The treatment effect on significant pain reduction in female subjects was independent of the effect on mood or anxiety. Duloxetine was safely administered and well tolerated. CONCLUSION: In this randomized, controlled, 12-week trial (with a 1-week placebo lead-in phase), duloxetine was an effective and safe treatment for many of the symptoms associated with fibromyalgia in subjects with or without major depressive disorder, particularly for women, who had significant improvement across most outcome measures

   (136)    Gulec H, Sayar K, Topbas M, Karkucak M, Ak I. [Alexithymia and anger in women with fibromyalgia syndrome]. Turk Psikiyatri Derg 2004; 15(3):191-8.
Abstract: OBJECTIVE: Fibromyalgia syndrome is characterized by both somatic and psychic symptoms and it is suggested that psychic factors contribute to the clinical presentation of this syndrome. This study was planned to have a better understanding of fibromyalgia through elaborating the role of alexithymia and anger in the pathogenesis of this illness. METHOD: The study was carried out in the Physical Therapy and Rehabilitation outpatient clinic with 101 women with fibromyalgia syndrome, 30 women with rheumatoid arthritis and 59 healthy women with no current or past medical history. The subjects were evaluated by the Visual Analog Scale, Toronto Alexithymia Scale-20 items, Spielberger State-Trait Anger Inventory, Beck Depression Scale, Fibromyalgia Impact Questionnaire and a sociodemographic data form. RESULTS: All these groups were similar to each other in means of age, years of education, marital and economical status. In the fibromyalgia syndrome group, the scores of anxiety and anger-in were calculated significantly higher than other groups. The depression and alexithymia scores were found higher than healthy group. DISCUSSION: These findings suggest that fibromyalgia patients suffer more anxiety and anger toward oneself, which is anger-in, than rheumatoid arthritis patients. Though the patient groups were more alexithymic than the healthy group, alexitimia scores of the two patient groups were not different. This situation suggest that anger-in, which is suppressed and unexpressed anger style is a part of the fibromyalgia syndrome together as well as high anxiety

   (137)    Blacker CV, Greenwood DT, Wesnes KA, Wilson R, Woodward C, Howe I et al. Effect of galantamine hydrobromide in chronic fatigue syndrome: a randomized controlled trial. JAMA 2004; 292(10):1195-204.
Abstract: CONTEXT: There is no established pharmacological treatment for the core symptoms of chronic fatigue syndrome (CFS). Galantamine hydrobromide, an acetyl cholesterone inhibitor, has pharmacological properties that might benefit patients with CFS. OBJECTIVE: To compare the efficacy and tolerability of galantamine hydrobromide in patients with CFS. DESIGN, SETTING, AND PATIENTS: Randomized, double-blind trial conducted June 1997 through July 1999 at 35 outpatient centers in the United Kingdom (n = 17), United States (n = 14), the Netherlands (n = 2), Sweden (n = 1), and Belgium (n = 1) involving 434 patients with a clinical diagnosis of CFS (modified US Centers for Disease Control and Prevention criteria). INTERVENTIONS: A total of 89 patients were randomly assigned to receive 2.5 mg of galantamine hydrobromide; 86 patients, 5.0 mg; 91 patients, 7.5 mg; and 86 patients, 10 mg (these patients received medicine in the tablet form 3 times per day); a total of 82 patients received matching placebo tablets 3 times per day. MAIN OUTCOME MEASURES: The primary efficacy variable was the global change on the Clinician Global Impression Scale after 4, 8, 12, and 16 weeks of treatment. Secondary outcomes were changes in core symptoms of CFS on the Chalder Fatigue Rating Scale, the Fibromyalgia Impact Questionnaire, and the Pittsburgh Sleep Quality Index; changes in quality of life on the Nottingham Health Profile; and assessment of plasma-free cortisol levels and cognitive performance on a computer-based battery of tests. RESULTS: After 16 weeks, there were no statistically significant differences between any of the galantamine or placebo groups in clinical condition on the Clinician Global Impression Scale, or for any of the secondary end points. Exploratory regression analysis failed to detect any consistent prognostic factor that might have influenced the primary or any secondary outcome measures. CONCLUSION: This trial did not demonstrate any benefit of galantamine over placebo in the treatment of patients with CFS

   (138)    Jensen MP, Nielson WR, Turner JA, Romano JM, Hill ML. Changes in readiness to self-manage pain are associated with improvement in multidisciplinary pain treatment and pain coping. Pain 2004; 111(1-2):84-95.
Abstract: A patient's readiness to adopt a self-management approach to pain has been hypothesized to increase during multidisciplinary pain treatment and to impact pain coping responses. The Pain Stages of Change Questionnaire (PSOCQ; [J Pain (1997) 227]) was designed to assess four components of readiness to self-manage pain: pre-contemplation, contemplation, action, and maintenance. We tested three hypotheses concerning this construct in two different samples of patients with chronic pain: (1) readiness to self-manage pain, as assessed by the PSOCQ, would increase from pre-multidisciplinary pain treatment to post-treatment and follow-up; (2) changes in readiness to self-manage pain measured pre-treatment to post-treatment and follow-up would be associated with changes in the use of pain coping strategies; and (3) increases in readiness to self-manage pain would be associated with improvement in multidisciplinary pain treatment. The findings supported all three hypotheses. We discuss the implications of the findings for understanding motivational issues in the self-management of pain

   (139)    Huuhka MJ, Haanpaa ML, Leinonen EV. Electroconvulsive therapy in patients with depression and fibromyalgia. Eur J Pain 2004; 8(4):371-6.
Abstract: The effect of electroconvulsive therapy (ECT) on depression and other symptoms of fibromyalgia was studied in a prospective 3-month trial in 13 patients with fibromyalgia and concomitant depression. All the patients met the DSM-IV diagnostic criteria for Major Depressive Disorder and fulfilled the American College of Rheumatology diagnostic criteria for fibromyalgia. The Montgomery and Asberg Depression Rating Scale (MADRS) and the clinical global impression scale (CGI) were used to assess the severity of depression and the clinical change of the patients. The fibromyalgia impact questionnaire (FIQ) was used to evaluate the severity of the fibromyalgia symptoms. The intensity of pain was evaluated using a 6-point scale (0=no pain, 5=very severe pain), and tender point palpation. All assessments were performed at baseline and at follow-up visits, which took place one week, one month and three months after ECT. There was a significant improvement in depression after ECT according to MADRS. Using CGI, six patients were much or very much improved, while four patients were minimally improved and three patients had no change. There was significant improvement in four out of ten FIQ item scores, "feel good", "fatigue", "anxiety" and "depression". No significant change was found in the FIQ item scores "physical function", "pain", "stiffness" and "morning tiredness" or number of tender points and self-reported pain. We conclude that ECT is a safe and effective treatment for depression in fibromyalgia patients, but has no effect on the pain or other physical symptoms of these patients

   (140)    Picavet HS, Hoeymans N. Health related quality of life in multiple musculoskeletal diseases: SF-36 and EQ-5D in the DMC3 study. Ann Rheum Dis 2004; 63(6):723-9.
Abstract: OBJECTIVE: To examine the health related quality of life of persons with one or more self reported musculoskeletal diseases, as measured by the short form 36 item health status survey (SF-36) and the Euroqol questionnaire (EQ-5D). METHODS: A sample of Dutch inhabitants aged 25 years or more (n = 3664) participated in a questionnaire survey. Twelve lay descriptions of common musculoskeletal diseases were presented and the subjects were asked whether they had ever been told by a physician that they had any of these. Their responses were used to assess the prevalence of these conditions. Commonly used scores of SF-36 and descriptive scores from EQ-5D are presented, along with standardised differences between disease groups and the general population. RESULTS: SUBJECTS: with musculoskeletal diseases had significantly lower scores on all SF-36 dimensions than those without musculoskeletal disease, especially for physical functioning (SF-36 score (SE), 75.2 (0.5) v 87.8 (0.5)); role limitations caused by physical problems (67.1 (0.9) v 85.8 (0.8)); and bodily pain (68.5 (0.5) v 84.1 (0.5)). The worst health related quality of life patterns were found for osteoarthritis of the hip, osteoporosis, rheumatoid arthritis, and fibromyalgia. Those with multiple musculoskeletal diseases had the poorest health related quality of life. Similar results were found for EQ-5D. CONCLUSIONS: All musculoskeletal diseases involve pain and reduced physical function. The coexistence of musculoskeletal diseases should be taken into account in research and clinical practice because of its high prevalence and its substantial impact on health related quality of life

   (141)    Bae SC, Lee JH. Cross-cultural adaptation and validation of the Korean fibromyalgia impact questionnaire in women patients with fibromyalgia for clinical research. Qual Life Res 2004; 13(4):857-61.
Abstract: Our aim was to translate and cross-culturally adapt the fibromyalgia impact questionnaire into Korean (KFIQ), and then evaluate its reliability and validity. The FIQ was translated into Korean by three translators and then independently translated back into English by three different translators. A total of 62 women patients with fibromyalgia (FM) were studied for the psychometric properties of the KFIQ. The mean age of the patients was 47.1 (25-73) years, and all were female. The mean KFIQ score was 48.3 (17-91), and the mean Korean health assessment questionnaire (KHAQ) score was 0.4 (0-1.7). The test-retest reliability of the KFIQ yielded an intraclass correlation coefficient of 0.85 (0.53-0.96). For the construct validity, the Spearman rank correlations of KFIQ with patient global assessments using visual analog scale (pain, 0.58; morning stiffness, 0.45; fatigue, 0.48; depression, 0.43; anxiety, 0.56; global well-being, 0.46; disease severity, 0.49; impact on life, 0.51), KHAQ (0.44), and tender points (0.60) were high and statistically significant. The KFIQ might be a reliable and valid instrument for measuring health status and physical functioning in Korean women patients with FM, but needs further study

   (142)    Kendall SA, Schaadt ML, Graff LB, Wittrup I, Malmskov H, Krogsgaard K et al. No effect of antiviral (valacyclovir) treatment in fibromyalgia: a double blind, randomized study. J Rheumatol 2004; 31(4):783-4.
Abstract: OBJECTIVE: To investigate the effect of an antiviral compound, valacyclovir, on pain and tenderness in patients with the fibromyalgia (FM) syndrome. METHODS: Sixty patients were randomized into a double blind, placebo controlled 6 week trial. Primary outcome was pain intensity change (on visual analog scale). Secondary outcome measures were tender points (myalgic score) and Fibromyalgia Impact Questionnaire (FIQ). RESULTS: Fifty-two patients completed the study. The numbers of dropouts due to adverse events were equal in valacyclovir (2) and placebo (2) groups. The effect of valacyclovir on pain and tenderness and FIQ did not differ from placebo. CONCLUSION: Valacyclovir cannot be recommended as a therapy for FM at this point

   (143)    Redondo JR, Justo CM, Moraleda FV, Velayos YG, Puche JJ, Zubero JR et al. Long-term efficacy of therapy in patients with fibromyalgia: a physical exercise-based program and a cognitive-behavioral approach. Arthritis Rheum 2004; 51(2):184-92.
Abstract: OBJECTIVE: To analyze the long-term efficacy of 2 interventions for female fibromyalgia (FM) patients: 1) cognitive-behavioral therapy (CBT), and 2) a physical exercise (PE)-based strategy. METHODS: We conducted a prospective, long-term, randomized, parallel clinical trial. The outcome variables are physical activity, aerobic capacity, and results of the Fibromyalgia Impact Questionnaire (FIQ), Short Form 36, Beck Anxiety and Depression Inventory, Chronic Pain Self-Efficacy Scale, and Chronic Pain Coping Inventory. All were measured at baseline, posttreatment, 6 months, and 1 year. The duration of both treatments was 8 weeks. RESULTS: Some items of the FIQ and some strategies to cope with pain improved significantly in both groups after treatment. All variables measuring functional capacity improved significantly in the PE group, whereas only physical activity of the vertebral column improved in the CBT group. There were no differences in anxiety, depression, and self efficacy after treatment in either group. After 1 year of followup, most of the parameters had returned to baseline values in both groups. However, in the PE group, functional capacity remained significantly better. CONCLUSIONS: PE and CBT improve clinical manifestations in FM patients only for short periods of time. Improvement in self efficacy and physical fitness are not associated with improvement in clinical manifestations

   (144)    Sarzi-Puttini P, Atzeni F, Turiel M, Furlan R, Vulpio L, Carrabba M et al. The Italian version of the Fibrofatigue Scale, a reliable tool for the evaluation of fibromyalgia symptoms. J Psychosom Res 2004; 56(2):213-6.
Abstract: Objective: To validate a translated Italian version of the Fibrofatigue Scale (FFS). Methods: The Italian version of FFS was administered to 60 patients affected by fibromyalgia (FM) (57 patients were interviewed again 10 days later) together with the Italian version of the Fibromyalgia Impact Questionnaire (FIQ), the Stanford Health Assessment Questionnaire (HAQ) and the Medical Outcome Survey Short Form-36 (SF-36). All patients were asked about the severity of pain today (10-cm visual analogue scale) and the duration of symptoms. Test-retest reliability was assessed using Spearman correlations. Internal consistency was evaluated with Cronbach's alpha of reliability. Construct validity of the FFS was evaluated by correlations among the FFS, the FIQ and the subscales of the SF-36. Results: Mean duration of symptoms was 7.6 years, and mean age of participants was 56.3 years. Test-retest reliability was between 0.70 and 0.95 for the single items as well as for the total FFS and other components. Internal consistency was 0.90 for the overall FFS. Significant correlations were obtained between the FFS items and the SF-36. Conclusions: The Italian FFS is a reliable and valid instrument for detecting and measuring functional disability and symptoms severity in Italian patients with FM

   (145)    Cedraschi C, Desmeules J, Rapiti E, Baumgartner E, Cohen P, Finckh A et al. Fibromyalgia: a randomised, controlled trial of a treatment programme based on self management. Ann Rheum Dis 2004; 63(3):290-6.
Abstract: OBJECTIVE: To evaluate the efficacy of a treatment programme for patients with fibromyalgia (FM) based on self management, using pool exercises and education. METHODS: Randomised controlled trial with a 6 month follow up to evaluate an outpatient multidisciplinary programme; 164 patients with FM were allocated to an immediate 6 week programme (n = 84) or to a waiting list control group (n = 80). The main outcomes were changes in quality of life, functional consequences, patient satisfaction and pain, using a combination of patient questionnaires and clinical examinations. The questionnaires included the Fibromyalgia Impact Questionnaire (FIQ), Psychological General Well-Being (PGWB) index, regional pain score diagrams, and patient satisfaction measures. RESULTS: 61 participants in the treatment group and 68 controls completed the programme and 6 month follow up examinations. Six months after programme completion, significant improvements in quality of life and functional consequences of FM were seen in the treatment group as compared with the controls and as measured by scores on both the FIQ (total score p = 0.025; fatigue p = 0.003; depression p = 0.031) and PGWB (total score p = 0.032; anxiety p = 0.011; vitality p = 0.013,). All four major areas of patient satisfaction showed greater improvement in the treatment than the control groups; between-group differences were statistically significant for "control of symptoms", "psychosocial factors", and "physical therapy" No change in pain was seen. CONCLUSION: A 6 week self management based programme of pool exercises and education can improve the quality of life of patients with FM and their satisfaction with treatment. These improvements are sustained for at least 6 months after programme completion

   (146)    Bellamy N, Sothern RB, Campbell J. Aspects of diurnal rhythmicity in pain, stiffness, and fatigue in patients with fibromyalgia. J Rheumatol 2004; 31(2):379-89.
Abstract: OBJECTIVE: To determine diurnal rhythm characteristics of pain, stiffness, and fatigue in self-ratings performed by patients with fibromyalgia (FM). METHODS: Twenty-one women with FM made self-measurements of pain, stiffness, and fatigue on 100 mm horizontal visual analog scales at 6 prespecified timepoints at home for 10 consecutive days. Linear and multiple regressions were performed on the original data and the 24-hour means vs FM classifiers (age, disease duration, tender points, dolorimetry score, Fibromyalgia Impact Questionnaire score), respectively. Data were analyzed for 24-hour and 7-day time-effects by ANOVA and for diurnal and weekly rhythms by the cosinor technique. RESULTS: Individual ratings for pain, stiffness, and fatigue correlated highly with each other throughout the day and over the days of the week. Of the FM classifiers, dolorimetry score was found to be inversely related to the pain, stiffness, and fatigue scores. For the group of subjects with a low dolorimetry score (< 2.25 kg), a significant diurnal rhythm was found in each self-rated variable, with greater pain, stiffness, and fatigue observed in the morning and least in the late afternoon. No rhythm in pain or stiffness was observed in those subjects with a higher threshold for pain (dolorimetry score > 2.25 kg), while fatigue showed the same significant diurnal pattern as in the first group. For the group as a whole, the possible presence of a weekly variation was found with ratings for pain, stiffness, and fatigue higher on Sunday and Monday and lower on Friday. CONCLUSION: Ratings of pain, stiffness, and fatigue in FM are significantly correlated, and show diurnal and possibly weekly rhythmicity, especially when pain threshold is low (dolorimetry score < 2.25 kg), and are thus predictive of each other over these time spans. This has important implications for scheduling activities of daily living, for measurement in clinical trials, and possibly for timing the administration of medications

   (147)    Kendall SA, Brolin-Magnusson K, Soren B, Gerdle B, Henriksson KG. A pilot study of body awareness programs in the treatment of fibromyalgia syndrome. Arthritis Care Res 2000; 13(5):304-11.
Abstract: OBJECTIVE: To compare in a pilot study the effect of two physical therapies, the Mensendieck system (MS) and body awareness therapy (BAT) according to Roxendal, in fibromyalgia patients and to investigate differences in effect between the two interventions. METHODS: Twenty female patients were randomized to either MS or BAT in a program lasting 20 weeks. Evaluations were tender point examination and questionnaires, including visual analog scales (pain intensity at worst site, muscular stiffness, evening fatigue, and global health), Fibromyalgia Impact Questionnaire (FIQ), Coping Strategies Questionnaire, Quality of Life Scales, Arthritis Self-Efficacy Scale (ASES), and disability before, immediately after, and at 6 and 18 months follow-up. RESULTS: The BAT group had improved global health at 18 months follow-up, but lower results than the MS group. The MS group had improved FIQ, ASES other symptoms, and pain at worst site at 18 months follow-up. CONCLUSION: In the present pilot study, MS was associated with more positive changes than BAT

   (148)    Creamer P, Singh BB, Hochberg MC, Berman BM. Sustained improvement produced by nonpharmacologic intervention in fibromyalgia: results of a pilot study. Arthritis Care Res 2000; 13(4):198-204.
Abstract: OBJECTIVE: The aim of this pilot study was to examine the practicality of delivering a package of nonpharmacologic, behavioral-based treatment, previously found to be effective in chronic back pain, to patients with fibromyalgia (FM) and to assess the efficacy of the intervention using a range of outcome measures up to 4 months posttreatment. METHODS: Participants with FM (n = 28) formed a single group for 8 sessions at weekly intervals. Each session comprised an education/cognitive-behavioral component, formal relaxation/meditation training, and instruction in a Chinese movement therapy (Qi Gong). RESULTS: Twenty of 28 subjects completed at least 5 of the 8 sessions. Significant improvement was seen in the Fibromyalgia Impact Questionnaire and a range of other outcome measures including tender points and pain threshold. Improvement was sustained 4 months after the end of the intervention. CONCLUSION: A simple behavioral intervention using large groups can be administered to subjects with FM and appears to produce sustained benefit in a range of outcomes. Controlled trials are currently being planned

   (149)    Taggart HM, Arslanian CL, Bae S, Singh K. Effects of T'ai Chi exercise on fibromyalgia symptoms and health-related quality of life. Orthop Nurs 2003; 22(5):353-60.
Abstract: BACKGROUND: Fibromyalgia (FM), one of the most common musculoskeletal disorders, is associated with high levels of impaired health and inadequate or limited symptom relief. The cause of this complex syndrome is unknown, and there is no known cure. Numerous research results indicate that a combination of physical exercise and mind-body therapy is effective in symptom management. T'ai Chi, an ancient Chinese exercise, combines physical exercise with mindbody therapy. PURPOSE: To investigate the effects of T'ai Chi exercise on FM symptoms and health-related quality of life. DESIGN: Pilot study, one group pre-to-post posttest design. METHODS: Participants with FM (n = 39) formed a single group for 6 weeks of 1-hour, twice weekly T'ai Chi exercise classes. FM symptoms and health-related quality of life were measured before and after exercise. FINDINGS: Twenty-one participants completed at least 10 of the 12 exercise sessions. Although the dropout rate was higher than expected, measurements on both the Fibromyalgia Impact Questionnaire (FIQ) (Buckhardt, Clark, & Bennett, 1991) and the Short Form-36 (SE-36) (Ware & Sherbourne, 1992) revealed statistically significant improvement in symptom management and health-related quality of life. IMPLICATIONS FOR NURSING RESEARCH: Knowledge of interventions to enhance health for the patient with musculoskeletal problems is a National Association of Orthopaedic Nurses priority. Tai Chi is potentially beneficial to patients with FM. Further research is needed to support evidence-based practice

   (150)    Sayar K, Aksu G, Ak I, Tosun M. Venlafaxine treatment of fibromyalgia. Ann Pharmacother 2003; 37(11):1561-5.
Abstract: BACKGROUND: Although the pathophysiology of fibromyalgia is unknown, central monoaminergic transmission may play a role. Antidepressants have proved to be successful in alleviating symptoms of fibromyalgia. Medications that act on multiple neurotransmitters may be more effective in symptom management. OBJECTIVE: To assess the efficacy of venlafaxine, a potent inhibitor of both norepinephrine and serotonin reuptake, in the treatment of patients with fibromyalgia. METHODS: Fifteen patients with fibromyalgia were assessed prior to and after treatment with fixed-dose venlafaxine 75 mg/d. Before initiation of pharmacotherapy, patients were interviewed with the Structured Clinical Interview for Axis I disorders in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition. The study lasted for 12 weeks, and patients were evaluated in weeks 6 and 12. The primary outcome measures were the Fibromyalgia Impact Questionnaire (FIQ) total score and pain score. The anxiety and depression levels of the patients were measured with the Beck Depression, the Beck Anxiety, the Hamilton Anxiety, and the Hamilton Depression scales. RESULTS: There was a significant improvement in the mean intensity of pain (F = 14.3; p = 0.0001) and in the disability caused by fibromyalgia (F = 42.7; p = 0.0001) from baseline to week 12 of treatment. The depression and anxiety scores also decreased significantly from baseline to week 12. The improvement in the FIQ scores did not correlate with the decrease of scores in both patient- and physician-rated depression and anxiety inventories. Change in pain scores also was not correlated with the change in depression and anxiety scores. CONCLUSIONS: Venlafaxine was quite promising in alleviating the pain and disability associated with fibromyalgia. This effect seems to be independent of its anxiolytic and antidepressant properties. Blockade of both norepinephrine and serotonin reuptake might be more effective than blockade of either neurotransmitter alone in the treatment of fibromyalgia

   (151)    Astin JA, Berman BM, Bausell B, Lee WL, Hochberg M, Forys KL. The efficacy of mindfulness meditation plus Qigong movement therapy in the treatment of fibromyalgia: a randomized controlled trial. J Rheumatol 2003; 30(10):2257-62.
Abstract: OBJECTIVE: To test the short and longterm benefits of an 8 week mind-body intervention that combined training in mindfulness meditation with Qigong movement therapy for individuals with fibromyalgia syndrome (FM). METHODS: A total of 128 individuals with FM were randomly assigned to the mind-body training program or an education support group that served as the control. Outcome measures were pain, disability (Fibromyalgia Impact Questionnaire), depression, myalgic score (number and severity of tender points), 6 minute walk time, and coping strategies, which were assessed at baseline and at 8, 16, and 24 weeks. RESULTS: Both groups registered statistically significant improvements across time for the Fibromyalgia Impact Questionnaire, Total Myalgic Score, Pain, and Depression, and no improvement in the number of feet traversed in the 6 minute walk. However, there was no difference in either the rate or magnitude of these changes between the mind-body training group and the education control group. Salutary changes occurring by the eighth week (which corresponded to the end of the mind-body and education control group sessions) were largely maintained by both groups throughout the 6 month followup period. CONCLUSION: While both groups showed improvement on a number of outcome variables, there was no evidence that the multimodal mind-body intervention for FM was superior to education and support as a treatment option. Additional randomized controlled trials are needed before interventions of this kind can be recommended for treatment of FM

   (152)    Altan L, Bingol U, Aykac M, Koc Z, Yurtkuran M. Investigation of the effects of pool-based exercise on fibromyalgia syndrome. Rheumatol Int 2004; 24(5):272-7.
Abstract: OBJECTIVE: The aim of this study was to compare pool-based exercise and balneotherapy in fibromyalgia syndrome (FMS) patients. METHODS: Fifty female patients diagnosed with FMS according to the American College of Rheumatism (ACR) criteria were randomly assigned to two groups: group 1 (n=25) with pool-based exercise, and in group 2 (n=25) balneotherapy was applied in the same pool without any exercise for 35 min three times a week for 12 weeks. In both groups, pre- (week 0) and post-treatment (weeks 12 and 24) evaluation was performed by one of the authors, who was blind to the patient group. Evaluation parameters included pain, morning stiffness, sleep, tender points, global evaluation by the patient and the physician, fibromyalgia impact questionnaire, chair test, and Beck depression inventory. Statistical analysis was done on data collected from three evaluation stages. RESULTS: Twenty-four exercise and 22 balneotherapy patients completed the study. Pretreatment (week 0) measurements did not show any difference between the groups. In group 1, statistically significant improvement was observed in all parameters ( P<0.01) except for the chair test at both weeks 12 and 24. In group 2, week 12 measurements showed significant improvement in all parameters ( P<0.01) except for the chair test and Beck depression inventory. Week 24 evaluation results in group 2 showed significant improvements in pain and fatigue according to visual analogue scale (VAS), 5-point scale, number of tender points, algometric and myalgic scores, and patient and physician global evaluation (P<0.01 and P<0.05, respectively), while improvements were nonsignificant in morning stiffness, sleep, fibromyalgia impact questionnaire (FIQ), chair test, and Beck depression inventory parameters in this group. Comparison of the two groups based on the post-treatment (weeks 12 and 24) percent changes and difference scores relative to pretreatment (week 0) values failed to show a significant difference between the groups for any parameter except Beck depression inventory (P<0.01). CONCLUSION: The results of our study showed that pool-based exercise had a longer-lasting effect on some of the FMS symptoms, but statistical analysis failed to show a significant superiority of pool-based exercise over balneotherapy without exercise. While we believe that exercise is a gold standard in FMS treatment, we also suggest in light of our results that balneotherapy is among the valid treatment options in FMS, and further research regarding the type and duration of the exercise programs is necessary

   (153)    Reisine S, Fifield J, Walsh SJ, Feinn R. Do employment and family work affect the health status of women with fibromyalgia? J Rheumatol 2003; 30(9):2045-53.
Abstract: OBJECTIVE: To assess health status differences of women with fibromyalgia syndrome (FM) who are employed and not employed, and to evaluate whether employment and family work influence the health status of women with FM as it does for women in community studies. METHODS: Participants were 287 women recruited from 118 randomly selected rheumatology practices. They completed telephone interviews that collected data on demographic characteristics, health status, symptoms, family work, and social support. One hundred thirty-seven were employed and 150 were not employed. Formal statistical analysis, including estimation and testing, focused on the relationship between employment and 4 health status measures: Modified Health Assessment Questionnaire (MHAQ), visual analog scale (VAS) for pain on the interview day, number of painful areas, and VAS for fatigue on the interview day. The relationship between employment and these measures was evaluated using analysis of variance, chi-square, linear regression, and ordinal logistic regression. RESULTS: The majority of participants reported high levels of symptoms and poor health status. In the bivariate analyses, employed women reported significantly less pain, less fatigue, and better functional status than those who were not employed. In the multivariate analyses, employment remained a significant factor in explaining number of painful areas, functional status (MHAQ), and fatigue, with employed women reporting better health status than those not employed. Employment was not associated with pain on the day of the interview when other factors were considered in the analysis. The psychological demands of family work were consistently related to all dependent measures of health status, as those with greater psychological demands reported worse health status. CONCLUSION: As in community studies, employed women with FM report better health status than women who are not employed. The demands of family work exert a serious and significant effect on every dimension of health status and should be the focus of greater clinical attention. Further followup will assess whether employment has a protective effect for women with FM as in community studies or whether women with less severe FM tend to remain in the workforce

   (154)    Sarzi-Puttini P, Atzeni F, Fiorini T, Panni B, Randisi G, Turiel M et al. Validation of an Italian version of the Fibromyalgia Impact Questionnaire (FIQ-I). Clin Exp Rheumatol 2003; 21(4):459-64.
Abstract: OBJECTIVE: To validate a translated Italian version of the Fibromyalgia Impact Questionnaire (FIQ). METHODS: The Italian version of the FIQ was administered to 50 patients affected by fibromyalgia (FM) (48 patients filled out the questionnaire again 10 days later) together with the Italian version of the Stanford Health Assessment Questionnaire (HAQ), the Medical Outcomes Survey Short Form-36 (SF-36), and a tender point count (TPC) obtained by summing the score (0-3) of each tender point tested by thumb palpation. All patients were asked about the severity of pain today (10 cm visual analog scale) and the duration of symptoms. Test-retest reliability was assessed using Spearman correlations. Internal consistency was evaluated with Cronbach's alpha of reliability. Construct validity of the FIQ was evaluated by correlations between the HAQ and subscales of the SF-36 as well as the TPC. RESULTS: The mean duration of symptoms was 6.5 years and the mean age of the participants was 57.4 years. Test-retest reliability was between 0.74 and 0.95 for physical functioning as well as for the total FIQ and other components. Internal consistency was 0.90 for the overall FIQ. Significant correlations were obtained between the FIQ items, the HAQ and the SF-36. CONCLUSIONS: The Italian FIQ is a reliable and valid instrument for detecting and measuring functional disability and health status in Italian patients with FM

   (155)    Jensen B, Wittrup IH, Bliddal H, nneskiold-Samsoe B, Faber J. Bone mineral density in fibromyalgia patients--correlation to disease activity. Scand J Rheumatol 2003; 32(3):146-50.
Abstract: OBJECTIVE: To compare bone mass (BMD) in women with fibromyalgia (FM) with healthy females, and to evaluate whether self-reported pain and lack of functional capacity correlate to reduced BMD in FM patients. METHODS: Thirty-one FM patients (20 pre- and 11 postmenopausal) and fourty-one healthy women (30 pre- and 10 postmenopausal) were enrolled in the study. BMD of the lumbar spine and the femoral neck was measured by a DEXA (Norland) scanner. Self reported pain was measured on a Visual Analog Scale (VAS). The Activity of Daily Living (ADL) component of the Fibromyalgia Impact Questionnaire (FIQ-ADL) was used as measure for physical capacity. RESULTS: BMD-lumbar spine and BMD-femoral neck did not differ significantly between FM patients and controls, though premenopausal FM patients tended to have lower BMD-femoral neck (p = 0.09). Self reported pain and FIQ-ADL among FM patients correlated with BMD-femoral neck (r(s) = -0.52, p = 0.003); (r(s) = -0.31, p = 0.09). CONCLUSION: Premenopausal FM patients tended to have lower BMD of hip than controls. Self reported pain correlated negatively to BMD. Thus, the severity of FM might have a negative impact on bone mass

   (156)    Martinez-Lavin M, Lopez S, Medina M, Nava A. Use of the leeds assessment of neuropathic symptoms and signs questionnaire in patients with fibromyalgia. Semin Arthritis Rheum 2003; 32(6):407-11.
Abstract: OBJECTIVE: Neuropathic pain syndrome is characterized by chronic, stimulus-independent pain sensation accompanied by hyperalgesia/allodynia and paresthesia. Fibromyalgia (FM) syndrome displays such features. The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale is an instrument developed and validated to recognize neuropathic pain and set it apart from nociceptive pain. METHODS: This study assessed the responses of patients with FM versus patients with rheumatoid arthritis (RA) to the LANSS Pain Scale questionnaire. Twenty patients with FM and 20 patients with RA answered the Fibromyalgia Impact Questionnaire and LANSS Pain Scale questions related to the following neuropathic sensory disturbance domains: dysesthetic, autonomic, evoked, paroxysmal, and thermal. RESULTS: Pain severity was similar in both groups according to visual analog scale values (5.3 +/- 3.0 for FM v 5.4 +/- 3.1 for RA). There were sharp differences between FM and RA groups in the percentage of affirmative responses to 4 of 5 sensory disturbance questions: dysesthetic (95 v 30), evoked (95 v 35), paroxysmal (90 v 15), and thermal (90 v 20); P <.0001 for each comparison. CONCLUSIONS: The high prevalence of associated sensory disturbances supports the notion that FM is a neuropathic pain syndrome. Clinical Relevance: The LANSS Pain Scale items may become a useful, easily applied bedside test to differentiate FM pain from the nociceptive pain present in RA and in similar arthritic illnesses

   (157)    Bennett RM, Kamin M, Karim R, Rosenthal N. Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled study. Am J Med 2003; 114(7):537-45.
Abstract: PURPOSE: To evaluate the efficacy and safety of a combination analgesic tablet (37.5 mg tramadol/325 mg acetaminophen) for the treatment of fibromyalgia pain. METHODS: This 91-day, multicenter, double-blind, randomized, placebo-controlled study compared tramadol/acetaminophen combination tablets with placebo. The primary outcome variable was cumulative time to discontinuation (Kaplan-Meier analysis). Secondary measures at the end of the study included pain, pain relief, total tender points, myalgia, health status, and Fibromyalgia Impact Questionnaire scores. RESULTS: Of the 315 subjects who were enrolled in the study, 313 (294 women [94%], mean [+/- SD] age, 50 +/- 10 years) completed at least one postrandomization efficacy assessment (tramadol/acetaminophen: n = 156; placebo: n = 157). Discontinuation of treatment for any reason was less common in those treated with tramadol/acetaminophen compared with placebo (48% vs. 62%, P = 0.004). Tramadol/acetaminophen-treated subjects also had significantly less pain at the end of the study (53 +/- 32 vs. 65 +/- 29 on a visual analog scale of 0 to 100, P <0.001), and better pain relief (1.7 +/- 1.4 vs. 0.8 +/- 1.3 on a scale of -1 to 4, P <0.001) and Fibromyalgia Impact Questionnaire scores (P = 0.008). Indexes of physical functioning, role-physical, body pain, health transition, and physical component summary all improved significantly in the tramadol/acetaminophen-treated subjects. Discontinuation due to adverse events occurred in 19% (n = 29) of tramadol/acetaminophen-treated subjects and 12% (n = 18) of placebo-treated subjects (P = 0.09). The mean dose of tramadol/acetaminophen was 4.0 +/- 1.8 tablets per day. CONCLUSION: A tramadol/acetaminophen combination tablet was effective for the treatment of fibromyalgia pain without any serious adverse effects

   (158)    Desmeules JA, Cedraschi C, Rapiti E, Baumgartner E, Finckh A, Cohen P et al. Neurophysiologic evidence for a central sensitization in patients with fibromyalgia. Arthritis Rheum 2003; 48(5):1420-9.
Abstract: OBJECTIVE: To determine whether abnormalities of peripheral and central nociceptive sensory input processing exist outside areas of spontaneous pain in patients with fibromyalgia (FM) as compared with controls, by using quantitative sensory testing (QST) and a neurophysiologic paradigm independent from subjective reports. METHODS: A total of 164 outpatients with FM who were attending a self-management program were invited to participate in the study. Data for 85 patients were available and were compared with those for 40 non-FM controls matched for age and sex. QST was performed using thermal, mechanical, and electrical stimuli at locations of nonspontaneous pain. Pain assessment was 2-fold and included use of subjective scales and the spinal nociceptive flexion reflex (NFR), a specific physiologic correlate for the objective evaluation of central nociceptive pathways. Questionnaires regarding quality of life and the impact of FM were available. RESULTS: Participants were mainly middle-aged women, with a mean disease duration of 8 years. Between-group differences were significant for neurophysiologic, clinical, and quality of life measures. In patients with FM, peripheral QST showed significantly altered cold and heat pain thresholds, and tolerance to cold pain was radically reduced. The median NFR threshold in patients with FM (22.7 mA [range 17.5-31.7]) was significantly decreased compared with that in controls (33 mA [range 28.1-41]). A cutoff value of <27.6 mA for NFR provided sensitivity of 73% and specificity of 80% for detecting central allodynia in the setting of FM. CONCLUSION: Our results strongly, although indirectly, point to a state of central hyperexcitability of the nociceptive system in patients with FM. The NFR can be used to assess central allodynia in FM. It may also help discriminate patients who may benefit from use of centrally acting analgesics

   (159)    Valim V, Oliveira L, Suda A, Silva L, de AM, Barros NT et al. Aerobic fitness effects in fibromyalgia. J Rheumatol 2003; 30(5):1060-9.
Abstract: OBJECTIVE: To compare 2 exercise modalities, aerobic fitness training and stretching exercises, in patients with fibromyalgia (FM) in relation to function, pain, quality of life, depression, and anxiety, and to correlate the cardiorespiratory fitness gain with symptom improvement. METHODS: Seventy-six women with FM between 18 and 60 years old were randomized to either an aerobic program or stretching program, for 20 weeks. They were evaluated at the beginning of the program and after 10 and 20 weeks in relation to the improvement of aerobic fitness, flexibility, function, Fibromyalgia Impact Questionnaire (FIQ), Short-form Health Survey (SF-36), and depression and anxiety levels. Ventilatory anaerobic threshold (VT) and maximum oxygen uptake (VO2max) were determined by expired gas analyses. RESULTS: Aerobic exercise was superior to stretching in relation to VO2 max, VT, function, depression, pain, and the emotional aspects and mental health domains of SF-36. Patients in the stretching group showed no improvement in depression, "role emotional," and "mental health." No association was noted between improvement in aerobic fitness as measured by VT and the improvement of pain, function, or scores in FIQ and SF-36. CONCLUSION: Our results confirm that aerobic exercise is beneficial to patients with FM, but the cardiorespiratory fitness gain is not related to improvement of FM symptoms

   (160)    Perrot S, Dumont D, Guillemin F, Pouchot J, Coste J. Quality of life in women with fibromyalgia syndrome: validation of the QIF, the French version of the fibromyalgia impact questionnaire. J Rheumatol 2003; 30(5):1054-9.
Abstract: OBJECTIVE: To validate a translated and adapted version of the Fibromyalgia Impact Questionnaire (FIQ) for use in French-speaking populations. METHODS: The FIQ was translated into French by 2 independent translators and then back-translated into English to assess the conceptual equivalence. The translated version was tested and adapted by an expert committee to obtain the Questionnaire de mesure d'Impact de la Fibromyalgie (QIF), the French version of the FIQ. We administered the QIF to 102 women with fibromyalgia (FM): 71 women who consulted once, and 31 women who were follow for 3 visits (D0, M1, and M3). The patients were also asked to answer 4 other questionnaires: the McGill Pain Questionnaire, the Medical Outcome Study Short Form-36 (SF-36), the short form of the Arthritis Impact Measurement Scale 2 (AIMS2), and the General Health Questionnaire (GHQ) (for psychiatric assessment). To ensure test-retest reliability, the patients were asked to complete the QIF 7 days after the first visit and to send it back to the investigators by mail. During each visit, all patients were asked about pain intensity. A tender point count was obtained by thumb palpation and the tenderness threshold of each specific point was assessed by a 4-point scale score to determine the global tender point index. RESULTS: No major cultural adaptation was needed to obtain the French version of the FIQ. Test-retest reliability coefficients (intraclass correlation coefficient) for each question ranged from 0.04 to 0.84. Two items from the QIF (number of days when the patient felt good and visual analog scale stiffness) did not reach significant levels of test-retest reliability. Internal validity was good. The QIF score correlated well with the SF-36 and AIMS2 scores. The psychological aspects of the QIF were well correlated with those of GHQ-28. None of the items from the McGill Pain Questionnaire was correlated with QIF items. Similarly the clinical data concerning pain assessment were not correlated with QIF items. CONCLUSIONS: QIF is a valid instrument for measuring functional disability and health status in French women with FM. Some of the items were of a limited reliability, perhaps due to the variability of the multiple aspects of this syndrome

   (161)    Eisinger J. [Clinical evaluation of fibromyalgia]. Rev Med Interne 2003; 24(4):237-42.
Abstract: OBJECTIVES: Fibromyalgia is characterized by diffuse, persistent and unexplained muscle pain associated with tenderness (mechanical allodynia) and unspecific symptoms. Diagnosis criteria as well as pathophysiological mechanisms are still unclear, justifying appropriate questionnaires and clinical investigations. ACTUAL TOPICS: Several questionnaires including visual analogic scales with respect to pain, fatigue, sleep or mood disorders have been used in fibromyalgia such as Fibromyalgia Impact Questionnaire (30 items) and the European List for Fibromyalgia Evaluation (53 items). Similarly several methods have been proposed to evaluate tenderness in fibromyalgia patients: The study of tender points involves their number (normal value < 4/18), or their pain mean intensity score and the sum of their sensitivities defining the tender point index (normal value < 11/72); The average pain threshold (normal value > 4 kg/cm(2)) is more precise, requiring sophisticated devices (mechanical algometers) and physician training; Less complex than pain threshold measurement, more reliable than the tender points number or index, the tensiometer induced myalgia (normal value > 210 mmHg) is probably a promising new alternative way to screen for fibromyalgia. PROSPECTS: Even if further studies are needed, diagnosis approach of fibromyalgia could be improved by new tools such as the European List for Fibromyalgia Evaluation and algotensiometry

   (162)    Pfeiffer A, Thompson JM, Nelson A, Tucker S, Luedtke C, Finnie S et al. Effects of a 1.5-day multidisciplinary outpatient treatment program for fibromyalgia: a pilot study. Am J Phys Med Rehabil 2003; 82(3):186-91.
Abstract: OBJECTIVE: The purpose of this pilot study was to determine the effect of a 1.5-day multidisciplinary fibromyalgia treatment program on impact of illness, depression, and life fulfillment. DESIGN: A sample of 100 consecutive enrollees in a 1.5-day multidisciplinary group outpatient fibromyalgia treatment program between February 14, 2000, and May 9, 2000, in a tertiary medical center was used for this study. The Fibromyalgia Impact Questionnaire, the Life Fulfillment and Satisfaction Scales, and the Center for Epidemiologic Studies Depression Scale were administered to subjects immediately preceding the treatment program and by mail 1 mo after completing the program. RESULTS: The 78 subjects who returned their surveys 1 mo after treatment demonstrated significant improvement in the area of the impact of illness as measured by the Fibromyalgia Impact Questionnaire total score (51.3-44.7, P < 0.002). There was no significant improvement in depressive symptoms (P < 0.056) or the level of life fulfillment (P < 0.53). Subjects with depression improved on the Fibromyalgia Impact Questionnaire to the same degree as those without depression. The 22 nonresponders did not differ significantly from the responders in the variables of sex, age, pretreatment Fibromyalgia Impact Questionnaire score, marital status, educational level, family income, duration of symptoms, or history of depression. CONCLUSIONS: These results suggest that a 1.5-day multidisciplinary fibromyalgia treatment program does have a significant positive effect on the impact of illness among patients with fibromyalgia with or without concomitant depression and may be a cost-effective model for the treatment of these patients

   (163)    Espwall M, Olofsson N. Legitimacy aspects of social network relations in a group of women with undefined musculoskeletal disorder. Women Health 2002; 36(4):85-101.
Abstract: This study was conducted to investigate legitimacy aspects of social network relations in a group of women with undefined musculoskeletal disorder. The aim was to study, from the viewpoint of the patient, the extent to which the symptoms of musculoskeletal disorder have legitimacy within the social network and how this legitimacy affects the patient's social network relations. A structural equation model was used to find the model best fitting the data arising between social support, legitimacy aspects and negative outcomes in the social network relations. The results can be summarised as indicating that illness legitimacy does affect availability of social relations and social support from friends, relatives and family. Of particular importance to this process is the patient's own perception of the legitimacy of her disorder. These results also confirmed previous findings indicating that greater attention should be paid to the impact of negative aspects of social support and its affect on patient health

   (164)    Gowans SE, Dehueck A, Abbey SE. Measuring exercise-induced mood changes in fibromyalgia: a comparison of several measures. Arthritis Rheum 2002; 47(6):603-9.
Abstract: OBJECTIVE: To compare scales measuring exercise-induced changes in mood. METHODS: Mood changes in a randomized, 23-week controlled trial of exercise were assessed using the Beck Depression Inventory (BDI), Center for Epidemiologic Studies Depression Scale (CES-D), State Trait Anxiety Inventory (STAI), Fibromyalgia Impact Questionnaire, and the Mental Health Inventory (MHI). Effect sizes and t-tests were computed on 23-week change scores. Scales were deemed to be confounded if items addressed sleep disturbances, fatigue, or effort (symptoms of both mood disturbances and fibromyalgia). RESULTS: Efficacy (15 exercise subjects) and intent-to-treat analyses (27 exercise subjects) generated medium effects for BDI (total, cognitive), MHI depression (efficacy only), and CES-D (intent-to-treat only) scales. BDI (total, cognitive), MHI (depression, positive affect, total [MHI-5]), and STAI scales distinguished exercise from control subjects at 23 weeks in all analyses. BDI somatic and CES-D scales were deemed to be confounded. CONCLUSION: We recommend the BDI cognitive, STAI, and MHI-5 scales to measure depression, anxiety, and general mood, respectively, in patients with fibromyalgia

   (165)    Gur A, Karakoc M, Erdogan S, Nas K, Cevik R, Sarac AJ. Regional cerebral blood flow and cytokines in young females with fibromyalgia. Clin Exp Rheumatol 2002; 20(6):753-60.
Abstract: OBJECTIVE: To determine whether there is any difference in regional cerebral blood flow (rCBF) and serum cytokine levels and association between clinical parameters and rCBF and serum cytokine levels in young females with fibromyalgia (FM). The other aim was to search whether the depression state has any effect on these two parameters. METHODS: Nineteen women with FM and 20 healthy women had 99mTc-HMPAO brain single-photon-emission computed tomography (SPECT) to evaluate rCBF. Serum interleukin (IL) levels (IL 1 beta, IL 2r, IL 6 and IL 8) were measured. Clinical and psychological evaluation was also carried out in FM patients and healthy controls. RESULTS: The patients with FM had significantly higher radioactivity uptake ratio in right and left caudate nucleus (p = 0.009, p = 0.001, respectively) than healthy controls. There was statistically significant decrease in the 99mTc-HMPAO uptake in the right superior parietal (p = 0.041), gyrus rectalis (p = 0.036) and pons (p = 0.023). FM patients had significantly higher serum IL 2r and IL 8 levels (p = 0.023, p = 0.011, respectively) than controls. Additionally, FM patients had significantly higher Fibromyalgia Impact Questionnaire (FIQ), Health Assessment Questionnaire (HAQ), and Hamilton Depression Rate scale (HDRS) scores (p = 0.000) than controls. Interestingly, the patients with mild depressive symptoms or without (i.e. HDRS-score < or = 16) had significantly higher serum IL 8 levels (p = 0.027) and increased radioactivity uptake ratio in the pons (P = 0.036) than the patients with more severe depressive symptoms (i.e. HDRS-score > 16). With regard to regional cerebral blood flow, significant correlations were detected between RSP and morning stiffness (r = 0.70, p < 0.01) and sleep disturbance (r = -0.53, p < 0.05), and between gyrus rectalis and FIQ score. There were significant correlations between LCN and IL-2 (P = 0.025), between RSP and morning stiffness (P = 0.006), sleep disturbance (P = 0.021) according to multiple regression analysis test. CONCLUSION: This study shows a significant increase in rCBF of caudate nuclei, a reduction in the pons, some cortical regions activity and a increase in IL 8, IL2r levels of young female patients with FM. These findings are more prominent in patients with low HDRS scores

   (166)    Fitzcharles MA, Costa DD, Poyhia R. A study of standard care in fibromyalgia syndrome: a favorable outcome. J Rheumatol 2003; 30(1):154-9.
Abstract: OBJECTIVE: A longitudinal prospective study was undertaken to examine the outcome of fibromyalgia (FM) with standard medical care, as well as factors that might either predict or influence this outcome. METHODS: Eighty-two women with clinical FM were evaluated at baseline and 70 were followed for a mean of 40 months. Patients continued their usual management for FM as prescribed by their own physicians. The primary outcome variable was patient's overall status compared to baseline on a 7 point Likert scale (range 1 = much worse, 7 = much better). Secondary outcome measures included measurements for pain, fatigue, and patient and physician global assessment on a visual analog scale. Additional functional measures were the disease-specific Fibromyalgia Impact Questionnaire (FIQ), and the generic Health Assessment Questionnaire (HAQ). RESULTS: Of 70 (85%) patients who were followed up at 3 years, 33 (47%) reported overall moderate to marked improvement, and the remaining 53% reported either slight improvement, no change, or deterioration. The improved group (n = 33) compared to those that remained the same or worsened (n = 37) showed significant differences for change of score from baseline for tender point count, patient global assessment, sleep disturbance, fatigue, pain, FIQ and HAQ, and were younger, 46 versus 51 years. No other baseline demographic or disease variables discriminated between the 2 groups. The only baseline predictors for a favorable outcome were younger age and less sleep disturbance. CONCLUSION: The overall outcome in this group was favorable, with almost half the sample reporting clinically meaningful improvement in overall FM status. These findings are discussed in terms of their implications regarding current theory on the pathogenesis of FM

   (167)    Walker-Bone K, Palmer KT. Musculoskeletal disorders in farmers and farm workers. Occup Med (Lond) 2002; 52(8):441-50.
Abstract: Farming is a physically arduous occupation and this places farm workers at potential risk of musculoskeletal disorders such as osteoarthritis (OA) of the hip and knee, low back pain (LBP), neck and upper limb complaints, and hand-arm vibration syndrome (HAVS). This review considers the epidemiological evidence concerning such risks. The strongest evidence relates to OA of the hip, for which the public health impact is likely to be considerable. There is also weaker, but suggestive evidence that farmers more often have knee OA and LBP than workers in occupations with fewer physical demands. Tractor drivers, in particular, seem to have more LBP. Relatively little information exists on the risks of soft tissue rheumatism in the limbs and neck. For some outcomes, the link with occupational risk factors (such as heavy loading of joints and whole-body vibration) is sufficient to suggest the course that future prevention should take, but for several outcomes more research is first needed

   (168)    Mannerkorpi K, Ahlmen M, Ekdahl C. Six- and 24-month follow-up of pool exercise therapy and education for patients with fibromyalgia. Scand J Rheumatol 2002; 31(5):306-10.
Abstract: OBJECTIVE: To follow patients with fibromyalgia six and 24 months after they finished a six-month treatment programme. The programme comprised pool exercise therapy, adjusted to the patients' limitations, and education based on their health problems. METHODS: Twenty-six patients were examined six and 24 months after the completion of the treatment programme with the Fibromyalgia Impact Questionnaire (FIQ), SF-36, the 6-minute walk test, and the Grippit measure. The values obtained at the follow-up examinations were compared with the baseline and post-treatment values. RESULTS: As compared with baseline, symptom severity (FIQ, SF-36), physical function (FIQ, SF-36, 6-minute walk test) and quality of life (SF-36) still showed improvements six months after the completion of treatment (p <0.05). Pain (FIQ, SF-36), fatigue (FIQ, SF-36), walking ability, and social function (SF-36) still showed improvements 2 years after the completion of the programme as compared with the baseline values (p < 0.05). No significant changes were found for these variables, when the values obtained at the two follow-up examinations were compared with those of the post-treatment examination. CONCLUSIONS: Improvements in symptom severity, physical function and social function were still found six and 24 months after the completed treatment programme

   (169)    Lindberg L, Iwarsson S. Subjective quality of life, health, I-ADL ability and adaptation strategies in fibromyalgia. Clin Rehabil 2002; 16(6):675-83.
Abstract: OBJECTIVES: To describe subjective quality of life and health, self-perceived instrumental activities of daily living (I-ADL) ability and adaptation strategies, and to explore possible relationships between these variables in fibromyalgia patients. DESIGN: Two instruments were used with fibromyalgia patients: the Fibrositis Impact Questionnaire and 'Living with fibromyalgia - adaptation to chronic disease and handicap', and correlative analyses were performed. SUBJECTS: A sample of 34 patients undergoing rehabilitation (in a specific programme). RESULTS: The majority of the patients used many adaptation strategies, demonstrating some significant relationships with perceived I-ADL ability and subjective quality of life and health. Different symptoms correlated highly significantly with self-perceived ability in I-ADL. CONCLUSION: The significant relationships between adaptation strategies and I-ADL ability and health demonstrated deserve clinical awareness and further research efforts

   (170)    Gur A, Karakoc M, Nas K, Cevik R, Sarac J, Ataoglu S. Effects of low power laser and low dose amitriptyline therapy on clinical symptoms and quality of life in fibromyalgia: a single-blind, placebo-controlled trial. Rheumatol Int 2002; 22(5):188-93.
Abstract: The purpose of this study was to examine the effectiveness of low power laser (LPL) and low-dose amitriptyline therapy and to investigate effects of these therapy modalities on clinical symptoms and quality of life (QOL) in patients with fibromyalgia (FM). Seventy-five patients with FM were randomly allocated to active gallium-arsenide (Ga-As) laser (25 patients), placebo laser (25 patients), and amitriptyline therapy (25 patients). All groups were evaluated for the improvement in pain, number of tender points, skin fold tenderness, morning stiffness, sleep disturbance, muscular spasm, and fatigue. Depression was evaluated by a psychiatrist according to the Hamilton Depression Rate Scale and DSM IV criteria. Quality of life of the FM patients was assessed according to the Fibromyalgia Impact Questionnaire (FIQ). In the laser group, patients were treated for 3 min at each tender point daily for 2 weeks, except weekends, at each point with approximately 2 J/cm(2) using a Ga-As laser. The same unit was used for the placebo treatment, for which no laser beam was emitted. Patients in the amitriptyline group took 10 mg daily at bedtime throughout the 8 weeks. Significant improvements were indicated in all clinical parameters in the laser group (P = 0.001) and significant improvements were indicated in all clinical parameters except fatigue in the amitriptyline group (P = 0.000), whereas significant improvements were indicated in pain (P = 0.000), tender point number (P = 0.001), muscle spasm (P = 0.000), morning stiffness (P = 0.002), and FIQ score (P = 0.042) in the placebo group. A significant difference was observed in clinical parameters such as pain intensity (P = 0.000) and fatigue (P = 0.000) in favor of the laser group over the other groups, and a significant difference was observed in morning stiffness (P = 0.001), FIQ (P = 0.003), and depression score (P = 0.000) after therapy. A significant difference was observed in morning stiffness (P = 0.001), FIQ (P = 0.003), and depression (P = 0.000) in the amitriptyline group compared to the placebo group after therapy. Additionally, a significant difference was observed in depression score (P = 0.000) in the amitriptyline group in comparison to the laser group after therapy. Our study suggests that both amitriptyline and laser therapies are effective on clinical symptoms and QOL in fibromyalgia and that Ga-As laser therapy is a safe and effective treatment in cases with FM. Additionally, the present study suggests that the Ga-As laser therapy can be used as a monotherapy or as a supplementary treatment to other therapeutic procedures in FM

   (171)    Richards SC, Scott DL. Prescribed exercise in people with fibromyalgia: parallel group randomised controlled trial. BMJ 2002; 325(7357):185.
Abstract: OBJECTIVES: To evaluate cardiovascular fitness exercise in people with fibromyalgia. DESIGN: Randomised controlled trial. Setting: Hospital rheumatology outpatients. Group based classes took place at a "healthy living centre." PARTICIPANTS: 132 patients with fibromyalgia. INTERVENTIONS: Prescribed graded aerobic exercise (active treatment) and relaxation and flexibility (control treatment). MAIN OUTCOME MEASURES: Participants' self assessment of improvement, tender point count, impact of condition measured by fibromyalgia impact questionnaire, and short form McGill pain questionnaire. RESULTS: Compared with relaxation exercise led to significantly more participants rating themselves as much or very much better at three months: 24/69 (35%) v 12/67 (18%), P=0.03. Benefits were maintained or improved at one year follow up when fewer participants in the exercise group fulfilled the criteria for fibromyalgia (31/69 v 44/67, P=0.01). People in the exercise group also had greater reductions in tender point counts (4.2 v 2.0, P=0.02) and in scores on the fibromyalgia impact questionnaire (4.0 v 0.6, P=0.07). CONCLUSIONS: Prescribed graded aerobic exercise is a simple, cheap, effective, and potentially widely available treatment for fibromyalgia

   (172)    White KP, Nielson WR, Harth M, Ostbye T, Speechley M. Does the label "fibromyalgia" alter health status, function, and health service utilization? A prospective, within-group comparison in a community cohort of adults with chronic widespread pain. Arthritis Rheum 2002; 47(3):260-5.
Abstract: OBJECTIVE: To determine if assigning the label of fibromyalgia (FM) to individuals with chronic widespread pain has a significant effect on long-term health status, function, and health service utilization.METHODS: In the London Fibromyalgia Epidemiology Study, 100 individuals with FM were identified by screening 3,395 non-institutionalized adults. Only 28 of the 100 had been previously diagnosed with FM; for 72, the diagnostic label was new. All 28 with prediagnosed FM were female compared with 58 of the 72 newly diagnosed cases. In a prospective, within-group comparison, we compared previously non-labeled FM cases at study entry (prelabeling) and at 18 and 36 months followup (postlabeling) with respect to general health status, fibromyalgia-related symptoms, and all items from the Fibromyalgia Impact Questionnaire (FIQ) (including total FIQ score, and several measures of health service utilization) to see if health status, function, and health services utilization had changed, using paired t-tests. We also compared percentage reporting work disability at baseline and 18 months using Pearson's chi(2).RESULTS: Fifty-six (78%) of the original 72 newly diagnosed FM cases were available for reassessment at 18 months, and 43 (60%) at 36 months. Although physical functioning decreased slightly over time, there also was a statistically significant improvement in satisfaction with health, and newly diagnosed FM cases reported fewer symptoms and major symptoms over the long term. No other differences in clinical status or health service use occurred over time.CONCLUSION: The FM label does not have a meaningful adverse affect on clinical outcome over the long term. Further research is necessary to document the short- and long-term effect of labeling in the chronic pain patient

   (173)    Van HB, Neerinckx E, Onghena P, Vingerhoets A, Lysens R, Vertommen H. Daily hassles reported by chronic fatigue syndrome and fibromyalgia patients in tertiary care: a controlled quantitative and qualitative study. Psychother Psychosom 2002; 71(4):207-13.
Abstract: BACKGROUND: This study aimed at providing insight in the frequency, emotional impact and nature of daily hassles, experienced by patients suffering from chronic fatigue syndrome (CFS) and/or fibromyalgia (FM), compared with patients with a chronic organic disease. METHODS: One hundred and seventy-seven CFS/FM patients, 26 multiple sclerosis (MS) and 26 rheumatoid arthritis (RA) patients were investigated within 2-6 months after diagnosis. All patients completed a self-report questionnaire assessing daily hassles and associated distress, a visual analogue scale assessing fatigue and pain and a depression and anxiety questionnaire. RESULTS: CFS/FM patients show a higher frequency of hassles, higher emotional impact and higher fatigue, pain, depression and anxiety levels compared with MS/RA patients. Three hassle themes dominate in the CFS/FM group: dissatisfaction with oneself, insecurity and a lack of social recognition. In contrast, hassles reported by MS/RA patients show a much larger diversity and are not focused on person-dependent problems. CONCLUSIONS: Patients recently diagnosed as suffering from CFS and/or FM are highly preoccupied and distressed by daily hassles that have a severe impact on their self-image, as well as their personal, social and professional functioning. An optimal therapeutic approach of CFS and FM should take account of this heavy psychosocial burden, which might refer to core themes of these patients' illness experience

   (174)    Ostuni P, Botsios C, Sfriso P, Bertagnin A, Cozzi F, Doria A et al. [Prevalence and clinical features of fibromyalgia in systemic lupus erythematosus, systemic sclerosis and Sjogren's syndrome]. Minerva Med 2002; 93(3):203-9.
Abstract: BACKGROUND: We studied the prevalence of fibromyalgia in 3 different groups of patients affected respectively with systemic lupus erythematosus, systemic sclerosis (scleroderma) and primary Sjogren's syndrome. The typical fibromyalgia findings encountered in these diseases were examined. METHODS: We enrolled 250 consecutive outpatients: 100 with systemic lupus erythematosus, 50 with systemic sclerosis, 100 with primary Sjogren's syndrome and 2 control groups (30 healthy subjects and 75 patients with primary fibromyalgia). Fibromyalgia features were evaluated by algometry, VAS for pain, Mc Gill Pain Questionnaire and Fibromyalgia Impact Questionnaire. RESULTS: Fibromyalgia has been found in 1 case (1%) with systemic lupus erythematosus, 1 case with systemic sclerosis (2%), 22 cases (22%) with primary Sjogren's syndrome and in 1 (3.3%) of the healthy controls. The number of tender points was significantly higher (p<0.01) in the patients with Sjogren's syndrome in comparison with the other groups. Fibromyalgic findings were similar in the patients with primary fibromyalgia and Sjogren's syndrome with fibromyalgia, unless for both poor sleep and low algometric thresholds which were more frequently found in primary fibromyalgia (respectively p<0.001 and p=0.05). CONCLUSIONS: Our study suggests that fibromyalgia is relatively frequent in primary Sjogren's syndrome, while in systemic lupus and systemic sclerosis its prevalence is not different from that found in the healthy controls. Typical fibromyalgia findings, except algometric values, were similar between the cases with Sjogren's syndrome plus fibromyalgia and fibromyalgia alone

   (175)    Evcik D, Kizilay B, Gokcen E. The effects of balneotherapy on fibromyalgia patients. Rheumatol Int 2002; 22(2):56-9.
Abstract: Fibromyalgia syndrome (FMS) is a very common rheumatological diagnosis. There are various treatment modalities. This study was planned to investigate the effects of balneotherapy in the treatment of FMS. A total of 42 primary fibromyalgia patients diagnosed according to American College of Rheumatology criteria were included in the study. Their ages ranged between 30 and 55 years. Patients were randomly assigned to two groups. None of them had had a cardiovascular disease before. Group 1 n=22) received 20-min bathing, once a day and five times per week. Patients participated in the study for 3 weeks (total of 15 sessions). Group 2 (n=20) was accepted as the control group. Patients were evaluated by the number of tender points, Visual Analogue Scale for pain, Beck's Depression Index for depression, and Fibromyalgia Impact Questionnaire for functional capacity. Measurements were assessed initially, after the therapy, and at the end of the 6th month. In group 1, there were statistically significant differences in numbers of tender points, Visual Analogue scores, Beck's Depression Index, and Fibromyalgia Impact Questionnaire scores after the therapy program (P<0.001). Also, 6 months later in group 1, there was still an improvement in the number of tender points (P<0.001), Visual Analogue scores, and Fibromyalgia Impact Questionnaire (P<0.005). But there was not a statistical difference in Beck's Depression Index scores compared to the control group (P>0.05). Patients with FMS mostly complain about pain, anxiety, and the difficulty in daily living activities. This study shows that balneotherapy is effective and may be an alternative method in treating fibromyalgia patients

   (176)    Zachrisson O, Regland B, Jahreskog M, Kron M, Gottfries CG. A rating scale for fibromyalgia and chronic fatigue syndrome (the FibroFatigue scale). J Psychosom Res 2002; 52(6):501-9.
Abstract: OBJECTIVE: To construct an observer's rating scale sensitive to change for measuring severity and treatment outcome in fibromyalgia (FM) and chronic fatigue syndrome (CFS) patients. METHODS: A selection of items from the Comprehensive Psychopathological Rating Scale (CPRS) were repeatedly rated and used as outcome measure of a 24-week treatment study. In the study 100 women, fulfilling the criteria for both FM and CFS, received intermittent injections of a staphylococcus toxoid or placebo. Nine CPRS-items with high baseline incidence (cutoff 70%) were extracted and validated against global ratings and the Fibromyalgia Impact Questionnaire (FIQ). The fibromyalgia and chronic fatigue syndrome rating scale (the FibroFatigue scale) was thereafter formed based upon the extracted items and three supplemented ones. The interrater reliability was tested in 27 consecutive patients of both sexes. RESULTS: The FibroFatigue scale is an observer's rating scale with 12 items measuring pain, muscular tension, fatigue, concentration difficulties, failing memory, irritability, sadness, sleep disturbances, and autonomic disturbances (items derived from the CPRS) and irritable bowel, headache, and subjective experience of infection (new items). There was a statistically significant correlation between the CPRS-extracted items and global ratings as well as with the FIQ. The interrater reliability of the new scale was excellent (correlation coefficient.98), irrespective of the patients' gender. CONCLUSION: The FibroFatigue scale seems to be a reliable and valid measuring instrument with capacity to monitor symptom severity and change during treatment of FM/CFS patients

   (177)    King SJ, Wessel J, Bhambhani Y, Sholter D, Maksymowych W. Predictors of success of intervention programs for persons with fibromyalgia. J Rheumatol 2002; 29(5):1034-40.
Abstract: OBJECTIVE: To determine which sociodemographic, psychological, and behavioral characteristics of persons with fibromyalgia (FM) will predict a positive response to treatment; and to determine if subjects classified according to the Multidimensional Pain Inventory (MPI) responded differently to the interventions. METHODS: One hundred twenty-eight women with FM underwent baseline testing and were randomized into one of 3 intervention groups or a control group. After the 12 week program, the subjects were reexamined on the same pretest measures. Stepwise regression analyses were conducted to determine the variables that could significantly predict the change in the dependent variables. A reliability of change index was calculated to determine the proportion of responders and nonresponders. RESULTS: The stepwise regression revealed significant predictor variables for change for all dependent variables except the Fibromyalgia Impact Questionnaire; however, the percentage of the variance in the change scores explained by the independent variables ranged from 4 to 15%. Results from the reliability of change index indicated that no MPI subgroup responded more than another group on any measure. CONCLUSION: Select sociodemographic and psychosocial variables and type of intervention were not strong predictors of improvement in a variety of measures after a treatment program. The low percentage of explained variance may be due to the heterogeneity of FM. Additionally, the low percentage of responders suggests that current forms of treatment are not effective for a large portion of the FM population

   (178)    Sylvain H, Talbot LR. Synergy towards health: a nursing intervention model for women living with fibromyalgia, and their spouses. J Adv Nurs 2002; 38(3):264-73.
Abstract: AIM: The purpose of this study was to develop a consensus-based nursing intervention model for women living with fibromyalgia, their spouses and nurses working in a community health centre in Quebec, Canada. BACKGROUND: Fibromyalgia syndrome, a rheumatic disorder associated with severe chronic pain and fatigue, has a major impact on the lives of individuals and their family. To date, research results on effective interventions are somewhat limited and inconclusive. Few studies take into account the perspective of those who live with this health problem on a day-to-day basis. METHODS: Data were collected mainly in 1999, through in-depth interviews and through group meetings using a qualitative research design, along the lines of the constructivist paradigm. The analysis plan aims for movement between the global and the specific: synthesis and thematic analysis. Analysed data were submitted to all participants throughout the data-collection process, thus allowing for shared constructions. FINDINGS: Results present the general consensus stemming from shared construction in all three groups. The nature of the intervention involves two major elements, support and teaching along with the fundamental importance of believing in the person. The timing of the intervention and the health and social context in which the intervention occurs also emerge as integral parts of the model. Synergy towards health in fibromyalgia emerges as the constitutive pattern composed of the following three elements: personal growth, spousal and professional support. The discussion addresses the model's components and uses an ecological perspective, in order to consider all the contexts that greatly influence the intervention. Empowerment is embedded in this intervention model. CONCLUSIONS: This study shows that research based on partnership allows the integration of perspectives and skills of various actors so as to develop meaningful interventions for both those seeking care and health professionals

   (179)    Kim YA, Lee SS, Park K. Validation of a Korean version of the Fibromyalgia Impact Questionnaire. J Korean Med Sci 2002; 17(2):220-4.
Abstract: The aim of this study was to translate the Fibromyalgia Impact Questionnaire (FIQ) into Korean and to evaluate its reliability and validity for use with Korean-speaking patients with fibromyalgia (FM). After translating the FIQ into Korean, we administered it to 55 patients with FM (28 patients filled out the questionnaire again 7 days later) together with a Korean version of the Health Assessment Questionnaire (HAQ) and the Symptom Checklist-90-Revision (SCL-90-R). The tender-point count (TPC) was calculated from tender points identified by thumb palpation. In addition to sociodemographic characteristics, the severity of relevant current clinical symptoms, e.g., pain intensity, fatigue, and morning stiffness, were assessed by 10-cm visual analog scales (VAS). The test-retest reliability was between 0.466 and 0.780 (total 0.778). Cronbach's alpha was 0.800 for FIQ1 (the first assessment) and 0.857 for FIQ2 (the second assessment), indicating acceptable levels of internal consistency for both assessments. Significant correlations were obtained between the FIQ items, the HAQ, the severity of clinical symptoms, and the subscales of the SCL-90-R. In conclusion, the Korean version of the FIQ is a reliable and valid instrument for measuring health status and physical functioning in Korean patients with FM

   (180)    Rooks DS, Silverman CB, Kantrowitz FG. The effects of progressive strength training and aerobic exercise on muscle strength and cardiovascular fitness in women with fibromyalgia: a pilot study. Arthritis Rheum 2002; 47(1):22-8.
Abstract: OBJECTIVE: To determine the safety, feasibility and consequences of a program of progressive strength training and cardiovascular exercise in women with fibromyalgia syndrome (FMS). METHODS: Fifteen women with confirmed FMS were monitored for injury and exercise compliance, and assessed for muscle strength (1-repetition maximum technique), cardiovascular endurance (6-minute walk test), and functional status (Fibromyalgia Impact Questionnaire [FIQ]) before and after a 20-week exercise intervention. RESULTS: Zero injuries and an 81% compliance rate occurred during training. Improvement was seen in muscle strength of the lower (191 +/- 75 to 265 +/- 67 pounds; P < 0.001) and upper (61 +/- 18 to 76 +/- 18 pounds; P < 0.001) body, 6-minute walk distance (530 +/- 80 to 629 +/- 74 meters; P < 0.001), and in FIQ score (44 +/- 9 to 32 +/- 14; P < 0.01). CONCLUSION: A program of progressive strength training and cardiovascular exercise can be safe, well tolerated, and effective at improving muscle strength, cardiovascular endurance and functional status in women with FMS without exacerbating symptoms. This program may also contribute to a reduction in the severity of several symptoms

   (181)    Johnson B, Hackett A, Roundfield M, Coufopoulos A. An investigation of the validity and reliability of a food intake questionnaire. J Hum Nutr Diet 2001; 14(6):457-65.
Abstract: AIMS: To evaluate the reliability and criterion validity of a food intake questionnaire (FIQ) designed for use in schoolchildren. METHODS: Study of reliability: 98 young people aged 13-14 years attending two schools in deprived areas of Liverpool completed the FIQ on three separate occasions over a 3-month period. VALIDITY STUDY: Ninety-six young people (aged 11-13 years) completed the FIQ and 2 weeks later completed a 3-day food diary (with interview). RESULTS: The FIQ gave consistent response on separate occasions over the 3-month reliability study period. Levels of agreement were consistent between survey combinations. Analysis of variance showed no differences in mean score for food groups between surveys. Pearson correlations for mean scores estimated by separate FIQ ranged from 0.42 for fibre food group to 0.76 for negative marker food group; the majority of the correlations were above 0.5. The data suggested the FIQ should be able to detect a change of +/-10% in eating habits. The validity study provided modest but significant Pearson correlations between energy intake, fat intake as a percentage of energy intake and sugars intake derived from 3-day diaries, and mean scores for the fatty, sugary and negative marker food group assessed by the FIQ. CONCLUSIONS: The results from both studies provide an indication of the FIQ's reliability, and suggest it has criterion validity for fatty and sugary and negative marker foods

   (182)    Arnold LM, Hess EV, Hudson JI, Welge JA, Berno SE, Keck PE, Jr. A randomized, placebo-controlled, double-blind, flexible-dose study of fluoxetine in the treatment of women with fibromyalgia. Am J Med 2002; 112(3):191-7.
Abstract: PURPOSE: To assess the efficacy of fluoxetine in the treatment of patients with fibromyalgia. SUBJECTS AND METHODS: Sixty outpatients (all women, aged 21-71 years) with fibromyalgia were randomly assigned to receive fluoxetine (10-80 mg/d) or placebo for 12 weeks in a double-blind, parallel-group, flexible-dose study. The primary outcome measures were the Fibromyalgia Impact Questionnaire total score (score range, 0 [no impact] to 80) and pain score (score range, 0-10). Secondary measures included the McGill Pain Questionnaire, change in the number of tender points, and total myalgic score. RESULTS: In the intent-to-treat analysis, women who received fluoxetine (mean [+/- SD] dose, 45 +/- 25 mg/d) had significant (P = 0.005) improvement in the Fibromyalgia Impact Questionnaire total score compared with those who received placebo, with a difference of -12 (95% confidence interval [CI]: -19 to -4). They also had significant (P = 0.002) improvement in the Fibromyalgia Impact Questionnaire pain score (difference, -2.2 [95% CI: -3.6 to -0.9]), as well as in the Fibromyalgia Impact Questionnaire fatigue (P = 0.05) and depression (P = 0.01) scores and the McGill Pain Questionnaire (P = 0.01), when compared with subjects who received placebo. Although counts for the number of tender points and total myalgic scores improved more in the fluoxetine group than in the placebo group, these differences were not statistically significant. CONCLUSIONS: In a 12-week, flexible-dose, placebo-controlled trial, fluoxetine was found to be effective on most outcome measures and generally well tolerated in women with fibromyalgia

   (183)    Valim V, Oliveira LM, Suda AL, Silva LE, Faro M, Neto TL et al. Peak oxygen uptake and ventilatory anaerobic threshold in fibromyalgia. J Rheumatol 2002; 29(2):353-7.
Abstract: OBJECTIVE: To compare maximum oxygen uptake and anaerobic threshold in patients with fibromyalgia (FM) and healthy sedentary controls matched by sex, age, weight, and body mass index. METHODS: Fifty women with FM aged 18-60 years and 50 healthy sedentary controls were studied. All were submitted to a maximum treadmill incremental test. Expired gas, ventilatory anaerobic threshold, and maximum oxygen uptake (VO2max) were evaluated. The influence of FM on quality of life was evaluated by questionnaires: the Fibromyalgia Impact Questionnaire and the Medical Outcomes Study Short-Form (SF-36). RESULTS: In patients with FM, the anaerobic threshold and peak oxygen uptake were significantly reduced. Maximum heartbeat rate was significantly lower in FM, indicating submaximum effort. Linear regression data showed a correlation between peak VO2 and the "Role-physical" domain of the SF-36. No such correlations were noted with anaerobic threshold. CONCLUSION: These results confirm the hypothesis of lower physical fitness in patients with FM. Considering that patients with FM do not achieve a maximum effort, ventilatory anaerobic threshold should be considered as a better fitness index than VO2max

   (184)    Cardol M, de Jong BA, van den Bos GA, Beelem A, de G, I, de Haan RJ. Beyond disability: perceived participation in people with a chronic disabling condition. Clin Rehabil 2002; 16(1):27-35.
Abstract: OBJECTIVE: To describe the impact of a chronic disabling condition on participation and to identify variables that may explain perceived restrictions in participation. STUDY DESIGN: Cross-sectional. SETTING: People were recruited from the outpatient clinics of two rehabilitation centres and the rehabilitation department of an academic hospital. SUBJECTS: One hundred and twenty-six people from five diagnostic groups (neuromuscular disease, rheumatoid arthritis, spinal cord injury, stroke, fibromyalgia) participated in the study. METHOD: The IPA (Impact on Participation and Autonomy) questionnaire was used to describe perceived participation. Explanatory variables were studied in terms of sociodemographic factors and health status variables. RESULTS: Some restrictions in participation seem comparable among diagnostic groups, others are specific to one or two groups. People with stroke, rheumatoid arthritis or fibromyalgia perceived more restrictions in participation than people with spinal cord injury or neuromuscular disorders. Emotional distress was the most important factor contributing to restrictions in participation. CONCLUSIONS: Perceived participation remains a complex concept in which many factors are involved. To make a contribution to meaningful participation of people with a chronic disabling condition, rehabilitation treatment should address physical, social, emotional and environmental aspects

   (185)    Heymann RE, Helfenstein M, Feldman D. A double-blind, randomized, controlled study of amitriptyline, nortriptyline and placebo in patients with fibromyalgia. An analysis of outcome measures. Clin Exp Rheumatol 2001; 19(6):697-702.
Abstract: OBJECTIVE: To study the efficacy and tolerability of amitriptyline and nortriptyline in a Brazilian population with fibromyalgia and to evaluate the instruments used to measure the efficacy of the treatment. METHODS: A total of 118 fibromyalgia patients were randomly assigned to 3 groups: amitriptyline (AM, n = 40), nortriptyline (NOR, n =38) and placebo (PL, n = 40), and were blindly given 25 mg at bedtime of the assigned treatment for 8 weeks. Clinical evaluation before and at the end of the study included the number of tender points (NTP), FIQ score (FIQ), and global improvement as reported by the patients on a verbal scale (VSGI). RESULTS: The 3 groups were comparable at baseline for all the parameters studied. After 8 weeks, the 3 groups improved in all parameters: (36.5% AM, 26.7% NOR and 24% PL patients improved on FIQ; 13.9% AM, 19.5% NOR and 8.57% PL patients improved on NTP; 86.5% AM, 72.2% NOR and 57.6% PL patients improved on VSGI). Only the AM group differed from the PL group on VSGI. Side effects were noted among the groups, but none were serious (16 in the AM group, 31 in the NOR group, and 25 in the PL group). CONCLUSION: All three groups improved after treatment. Only the patient's subjective global assessment of improvement differed between the AM patients and the PL group (p < or = 0.03). In fibromyalgia, placebo groups are important in drug trials. Different measures of therapeutic effect are not better than the patient's self assessment

   (186)    Gowans SE, Dehueck A, Voss S, Silaj A, Abbey SE, Reynolds WJ. Effect of a randomized, controlled trial of exercise on mood and physical function in individuals with fibromyalgia. Arthritis Rheum 2001; 45(6):519-29.
Abstract: OBJECTIVE: To evaluate the effect of exercise on mood and physical function in individuals with fibromyalgia. METHODS: Subjects were randomly assigned to an exercise (EX) or control (CTL) group. EX subjects participated in 3 30-minute exercise classes per week for 23 weeks. Subjects were tested at entry and at 6, 12, and 23 weeks. Tests included the Beck Depression Inventory (BDI), 6-minute walk, State-Trait Anxiety Inventory (STAI), Mental Health Inventory (MHI), Fibromyalgia Impact Questionnaire (FIQ), Arthritis Self-Efficacy Scale (ASES), and a measure of tender points and knee strength. RESULTS: Fifty subjects (27 EX, 23 CTL) completed the study, and 31 (15 EX, 16 CTL) met criteria for efficacy analyses. In efficacy analyses, significant improvements were seen for EX subjects in 6-minute walk distances, BDI (total, cognitive/ affective), STAI, FIQ, ASES, and MHI (3 of 5 subscales) scores. These effects were reduced but remained during intent-to-treat analyses. CONCLUSION: Exercise can improve the mood and physical function of individuals with fibromyalgia

   (187)    Donaldson MS, Speight N, Loomis S. Fibromyalgia syndrome improved using a mostly raw vegetarian diet: an observational study. BMC Complement Altern Med 2001; 1:7. Epub;%2001 Sep 26.:7.
Abstract: BACKGROUND: Fibromyalgia engulfs patients in a downward, reinforcing cycle of unrestorative sleep, chronic pain, fatigue, inactivity, and depression. In this study we tested whether a mostly raw vegetarian diet would significantly improve fibromyalgia symptoms. METHODS: Thirty people participated in a dietary intervention using a mostly raw, pure vegetarian diet. The diet consisted of raw fruits, salads, carrot juice, tubers, grain products, nuts, seeds, and a dehydrated barley grass juice product. Outcomes measured were dietary intake, the fibromyalgia impact questionnaire (FIQ), SF-36 health survey, a quality of life survey (QOLS), and physical performance measurements. RESULTS: Twenty-six subjects returned dietary surveys at 2 months; 20 subjects returned surveys at the beginning, end, and at either 2 or 4 months of intervention; 3 subjects were lost to follow-up. The mean FIQ score (n = 20) was reduced 46% from 51 to 28. Seven of the 8 SF-36 subscales, bodily pain being the exception, showed significant improvement (n = 20, all P for trend < 0.01). The QOLS, scaled from 0 to 7, rose from 3.9 initially to 4.9 at 7 months (n = 20, P for trend 0.000001). Significant improvements (n = 18, P < 0.03, paired t-test) were seen in shoulder pain at rest and after motion, abduction range of motion of shoulder, flexibility, chair test, and 6-minute walk. 19 of 30 subjects were classified as responders, with significant improvement on all measured outcomes, compared to no improvement among non-responders. At 7 months responders' SF-36 scores for all scales except bodily pain were no longer statistically different from norms for women ages 45-54. CONCLUSION: This dietary intervention shows that many fibromyalgia subjects can be helped by a mostly raw vegetarian diet

   (188)    Mengshoel AM, Haugen M. Health status in fibromyalgia--a followup study. J Rheumatol 2001; 28(9):2085-9.
Abstract: OBJECTIVE: To examine symptoms, physical function, and nutritional status in patients with fibromyalgia (FM) after 6 to 8 years. METHODS: Of 51 women with FM initially included in exercise and patient education programs 6 and 8 years ago, 33 agreed to participate. Median (range) age was 45.5 years (33-64) and symptom duration 18 years (8-46). Symptoms (visual analog scales), cardiovascular capacity (Aastrand's test), and restriction on daily activities (Fibromyalgia Impact Questionnaire) were measured. Employment status and experience of coping with everyday life were addressed in an interview. Nutritional status was evaluated by anthropometric measurements and dietary intake. RESULTS: All the 33 participants had widespread chronic pain, and 79% had enough tender points to satisfy the FM classification criteria. Compared with initital data there were significant reductions in the number of tender points (p = 0.004) in the exercise group, and in fatigue (p = 0.008) and pain (p = 0.5) in the patient education group. Cardiovascular capacity was within normal limits in 33% of the participants. Currently, 26 performed regular physical activity and of these, 10 were engaged in organized exercise. Seventy-two percent reported regular use of dietary supplements and attached importance to a healthy diet. Still, there was a significant increase in weight and body fat, and 24% were obese (BMI > 30). The coping strategies adopted were adjustments to the new situation and distraction from symptoms. CONCLUSION: No worsening of symptoms and no change in employment status, as well as frequent participation in physical activities, suggests a benign longterm outcome in these patients with FM

   (189)    Poyhia R, da CD, Fitzcharles MA. Pain and pain relief in fibromyalgia patients followed for three years. Arthritis Rheum 2001; 45(4):355-61.
Abstract: OBJECTIVE: To examine the natural clinical course of pain in fibromyalgia (FM) and patients' reports of the use of interventions for pain relief. METHODS: This prospective 3-year study examined pain, and the treatment thereof, in a cohort of 82 women with FM, of whom 59 (72%) were reassessed on 3 subsequent occasions. Pain was measured by the following parameters: visual analog scale (VASpain), tender point count (TP), and the occurrence of widespread pain (WP). Function was assessed by the Health Assessment Questionnaire and the Fibromyalgia Impact Questionnaire, and depression and anxiety by the Arthritis Impact Measurement Scales. All treatments for FM were recorded, and patients identified the treatment that they believed had helped their symptoms of FM. RESULTS: Pain reporting as measured by all parameters decreased significantly for the whole group over the duration of the study. The mean VASpain decreased from 66 to 55, the mean TP count decreased from 13.5 to 10.5, and the number of patients with WP decreased from 100% to 63%. VASpain correlated positively with TP and WP. One third of patients experienced a reduction in pain by at least 30% from baseline as well as a better outcome in overall status of FM. There was a decline in the use of prescribed medications, whereas the use of alternative products increased. Physical treatment modalities were more often perceived to be of benefit than prescribed medications. CONCLUSION: We have observed a spontaneous improvement in pain reporting and less medication use in FM patients, suggesting that the course of this condition may be more favorable than has previously been reported

   (190)    Goulding C, O'Connell P, Murray FE. Prevalence of fibromyalgia, anxiety and depression in chronic hepatitis C virus infection: relationship to RT-PCR status and mode of acquisition. Eur J Gastroenterol Hepatol 2001; 13(5):507-11.
Abstract: BACKGROUND: Musculoskeletal complaints, dry eyes, fatigue and anxiety are common symptoms in patients with hepatitis C virus (HCV) infection, but there are few controlled data evaluating this. AIM: To assess the prevalence of rheumatological disease, fatigue and anxiety in different groups of patients with chronic HCV infection. PATIENTS AND METHODS: Seventy-seven patients with HCV were evaluated. Of these, 49 (64%) had been infected via contaminated anti-D immunoglobulin, 25 (33%) were intravenous drug users (IVDUs), and three were transfusion related; 78% were female. Twenty-five age- and sex-matched controls were also evaluated. Assessment was performed by history, physical examination, the Fibromyalgia Impact Questionnaire (FIQ) and the Hospital Anxiety and Depression Score (HADS). RESULTS: Four (5%) patients fulfilled the criteria for fibromyalgia. All were infected via anti-D immunoglobulin, and three were PCR positive. The mean number of tender points in anti-D patients was 5.0 (+/- 4.07) compared with 2.8 (+/- 2.7) in controls (P= 0.028) and 2.5 (+/- 2.2) in IVDUs (P< 0.004). There was no significant difference in the number of tender points between PCR-positive and PCR-negative patients (P= 0.23). Anxiety and depression scores were significantly higher in anti-D patients (P= 0.0001) and IVDUs (P= 0.005) compared with controls. Forty per cent of the HCV patients had a positive Schirmer test. Forty-two per cent of PCR-positive patients had a positive rheumatoid factor (RF, > 1/80). CONCLUSION: This study reveals a moderate increase in prevalence of fibromyalgia in HCV patients. The number of tender points was related to mode of acquisition but not to PCR status. Anxiety and depression levels are also increased in HCV patients compared with controls. Prevalence of RF was higher in PCR-positive patients compared with controls and those who had cleared the virus

   (191)    Worrel LM, Krahn LE, Sletten CD, Pond GR. Treating fibromyalgia with a brief interdisciplinary program: initial outcomes and predictors of response. Mayo Clin Proc 2001; 76(4):384-90.
Abstract: OBJECTIVES: To evaluate the efficacy of a brief, intense treatment program for fibromyalgia and to determine which patient characteristics are associated with a better treatment response. PATIENTS AND METHODS: Two self-report measures, the Fibromyalgia Impact Questionnaire (FIQ) and the Multidimensional Pain Inventory (MPI), were administered before patients completed treatment and 1 month after participating in the program. The main outcome measure was the difference in FIQ score and MPI scale before and after program participation. RESULTS: Of 139 patients who met the American College of Rheumatology criteria for fibromyalgia, 100 chose to participate in the 1 1/2-day Fibromyalgia Treatment Program at the Mayo Clinic, Rochester, Minn. Of these 100 patients, 74 completed the follow-up surveys. Patients were less affected by fibromyalgia after participation in the treatment program. This was demonstrated by a posttreatment improvement in the total FIQ score (P<.001), the MPI pain severity score (P<.001), and the MPI interference score (P=.01). The 1 patient characteristic found to be significantly associated (P<.001) with a better response to treatment was a high pretreatment level of impairment from fibromyalgia, as measured by the pretreatment FIQ score. CONCLUSIONS: A brief interdisciplinary program for treating fibromyalgia reduced some associated symptoms. Patients more severely affected by fibromyalgia may benefit most from this approach. Clinicians may apply these findings to develop beneficial and convenient treatment programs for patients with fibromyalgia

   (192)    Jentoft ES, Kvalvik AG, Mengshoel AM. Effects of pool-based and land-based aerobic exercise on women with fibromyalgia/chronic widespread muscle pain. Arthritis Rheum 2001; 45(1):42-7.
Abstract: OBJECTIVE: To examine the effects of pool-based (PE) and land-based (LE) exercise programs on patients with fibromyalgia. METHODS: The outcomes were assessed by the Fibromyalgia Impact Questionnaire, the Arthritis Self-Efficacy Scale, and tests of physical capacity. RESULTS: Eighteen subjects in the PE group and 16 in the LE group performed a structured exercise program. After 20 weeks, greater improvement in grip strength was seen in the LE group compared with the PE group (P < 0.05). Statistically significant improvements were seen in both groups in cardiovascular capacity, walking time, and daytime fatigue. In the PE group improvements were also found in number of days of feeling good, self-reported physical impairment, pain, anxiety, and depression. The results were mainly unchanged at 6 months followup. CONCLUSION: Physical capacity can be increased by exercise, even when the exercise is performed in a warm-water pool. PE programs may have some additional effects on symptoms

   (193)    Alfano AP, Taylor AG, Foresman PA, Dunkl PR, McConnell GG, Conaway MR et al. Static magnetic fields for treatment of fibromyalgia: a randomized controlled trial. J Altern Complement Med 2001; 7(1):53-64.
Abstract: OBJECTIVE: To test effectiveness of static magnetic fields of two different configurations, produced by magnetic sleep pads, as adjunctive therapies in decreasing patient pain perception and improving functional status in individuals with fibromyalgia. DESIGN: Randomized, placebo-controlled, 6-month trial conducted from November 1997 through December 1998. SETTING AND SUBJECTS: Adults who met the 1990 American College of Rheumatology criteria for fibromyalgia were recruited through clinical referral and media announcements and evaluated at a university-based clinic. INTERVENTIONS: Subjects in Functional Pad A group used a pad for 6 months that provided whole-body exposure to a low, uniform static magnetic field of negative polarity. Subjects in the Functional Pad B group used a pad for 6 months that exposed them to a low static magnetic field that varied spatially and in polarity. Subjects in two Sham groups used pads that were identical in appearance and texture to the functional pads but contained inactive magnets; these groups were combined for analysis. Subjects in the Usual Care group continued with their established treatment regimens. OUTCOME MEASURES: Primary outcomes were the change scores at 6 months in the following measures: functional status (Fibromyalgia Impact Questionnaire), pain intensity ratings, tender point count, and a tender point pain intensity score. RESULTS: There was a significant difference among groups in pain intensity ratings (p = 0.03), with Functional Pad A group showing the greatest reduction from baseline at 6 months. All four groups showed a decline in number of tender points, but differences among the groups were not significant (p = 0.72). The functional pad groups showed the largest decline in total tender point pain intensity, but overall differences were not significant (p = 0.25). Improvement in functional status was greatest in the functional pad groups, but differences among groups were not significant (p = 0.23). CONCLUSIONS: Although the functional pad groups showed improvements in functional status, pain intensity level, tender point count, and tender point intensity after 6 months of treatment, with the exception of pain intensity level these improvements did not differ significantly from changes in the Sham group or in the Usual Care group

   (194)    Martinez JE, Barauna F, I, Kubokawa K, Pedreira IS, Machado LA, Cevasco G. Evaluation of the quality of life in Brazilian women with fibromyalgia, through the medical outcome survey 36 item short-form study. Disabil Rehabil 2001; %20;23(2):64-8.
Abstract: PURPOSE: The purpose of this study is to assess the impact of Fibromyalgia (FM) on the female patient's quality of life who attended the Rheumatology Outpatient Unit of Sorocaba Hospital Complex and compare it to the quality of life of healthy control group, through the Medical Outcome Study Short-form 36 item Survey (SF36). SUBJECTS: 32 women who fitted the American College of Rheumatology Classification Criteria for Fibromyalgia and 28 healthy women. MATERIALS AND METHODS: The groups were submitted to 'Medical Outcome Study 36 Item Short-form Survey' (SF36). This questionnaire is composed of 8 scales about several aspects of the quality of life. RESULTS: The SF36 scales in the Fibromyalgia group presented the following results: general health--43.3; functional ability--39.4; bodily pain--26.5; physical functioning--14.8 (0-75); vitality--38.5 (5-85); emotional functioning--32.2; mental health--44.2; social functioning--45.1. The SF36 scales in the control group presented the following results: general health--73.2; functional ability--86.6; bodily pain--68.9; physical functioning--82.4; vitality--59.6; emotional functioning--78.5; mental health--67.4; social functioning--77.9. Significant statistics variations in all evaluated scales were presented by the survey group. CONCLUSION: Fibromyalgia has had a negative impact on the quality of life

   (195)    Van HB, Neerinckx E, Lysens R, Vertommen H, Van HL, Onghena P et al. Victimization in chronic fatigue syndrome and fibromyalgia in tertiary care: a controlled study on prevalence and characteristics. Psychosomatics 2001; 42(1):21-8.
Abstract: The authors studied the prevalence and characteristics of different forms of victimization in 95 patients suffering from chronic fatigue syndrome (CFS) or fibromyalgia (FM) compared with a chronic disease group, including rheumatoid arthritis (RA) and multiple sclerosis (MS) patients, and a matched healthy control group. The authors assessed prevalence rates, nature of victimization (emotional, physical, sexual), life period of occurrence, emotional impact, and relationship with the perpetrator by a self-report questionnaire on burdening experiences. CFS and FM patients showed significantly higher prevalences of emotional neglect and abuse and of physical abuse, with a considerable subgroup experiencing lifelong victimization. The family of origin and the partner were the most frequent perpetrators. With the exception of sexual abuse, victimization was more severely experienced by the CFS/FM group. No differences were found between healthy control subjects or RA/MS patients, and between CFS and FM patients. These findings support etiological hypotheses suggesting a pivotal role for chronic stress in CFS and FM and may have important therapeutic implications

   (196)    Sarmer S, Ergin S, Yavuzer G. The validity and reliability of the Turkish version of the Fibromyalgia Impact Questionnaire. Rheumatol Int 2000; 20(1):9-12.
Abstract: This study was undertaken to translate and adapt the Fibromyalgia Impact Questionnaire (FIQ) into the Turkish language and investigate its validity and reliability for Turkish female fibromyalgia (FM) patients. After translation into Turkish, we administered the FIQ and Health Assessment Questionnaire (HAQ) to 51 women with fibromyalgia. As well as sociodemographic characteristics, the severity of relevant clinical symptoms, e.g., pain intensity, fatigue, and sleep disturbance, were assessed by visual analog scales. A tender point score (TPS) was calculated from tender points conducted by thumb palpation. Test-retest reliability, internal consistency, and concurrent and construct validities of FIQ were evaluated. Test-retest reliability and internal consistency were good at 0.81 and 0.72, respectively. Correlation between FIQ and HAQ scores was 0.43, which was low but statistically significant. Significant moderate correlations were obtained between the FIQ items and severity of clinical symptoms (0.63-0.77), except TPS, 0.31. The FIQ is a reliable and valid instrument for measuring functional disability in Turkish female FM patients

   (197)    Hakkinen A, Hakkinen K, Hannonen P, Alen M. Strength training induced adaptations in neuromuscular function of premenopausal women with fibromyalgia: comparison with healthy women. Ann Rheum Dis 2001; 60(1):21-6.
Abstract: OBJECTIVE: To investigate the effects of 21 weeks' progressive strength training on neuromuscular function and subjectively perceived symptoms in premenopausal women with fibromyalgia (FM). METHODS: Twenty one women with FM were randomly assigned to experimental (FM(T)) or control (FM(C)) groups. Twelve healthy women served as training controls (H(T)). The FM(T) and H(T) groups carried out progressive strength training twice a week for 21 weeks. The major outcome measures were muscle strength and electromyographic (EMG) recordings. Secondary outcome measures were pain, sleep, fatigue, physical function capacity (Stanford Health Assessment Questionnaire), and mood (short version of Beck's depression index). RESULTS: Female FM(T) subjects increased their maximal and explosive strength and EMG activity to the same extent as the H(T) group. Moreover, the progressive strength training showed immediate benefits on subjectively perceived fatigue, depression, and neck pain of training patients with FM. CONCLUSIONS: The strength training data indicate comparable trainability of the neuromuscular system of women with FM and healthy women. Progressive strength training can safely be used in the treatment of FM to decrease the impact of the syndrome on the neuromuscular system, perceived symptoms, and functional capacity. These results confirm the opinion that FM syndrome has a central rather than a peripheral or muscular basis

   (198)    Bernard AL, Prince A, Edsall P. Quality of life issues for fibromyalgia patients. Arthritis Care Res 2000; 13(1):42-50.
Abstract: OBJECTIVE: To collect information from patients with fibromyalgia syndrome (FMS) in regard to quality of life, impact of FMS, coping strategies, and what they want from their health care providers. METHODS: Two hundred seventy support group members in Washington, Illinois, and Pennsylvania completed an 85-item questionnaire. RESULTS: On a scale from 1 to 10 (10 being highest positive rating), patients ranked past quality of life as 8.6, present quality of life as 4.8, and future quality of life without FMS as 9.2. Respondents indicated that FMS has had a negative impact on personal relationships, career, and mental health. Many also reported a lack of social support. Most respondents reported a variety of coping responses including talking to friends, praying, exercise, hobbies, relaxation techniques, talking to a professional, and meditation. Patients reported needing more support, better educated health professionals, for people to believe that this disease exists, more funding for research, and better diagnostic tools. CONCLUSIONS: Health care workers need to be cognizant of the effect FMS has on quality of life. Treatment options should not be limited to prescription medication therapy. Patients are using a variety of methods to cope with their FMS symptoms, some positive, but others that are negative, and health care providers need to be alert to negative coping strategies such as alcohol and nonprescription medication abuse

   (199)    Dunkl PR, Taylor AG, McConnell GG, Alfano AP, Conaway MR. Responsiveness of fibromyalgia clinical trial outcome measures. J Rheumatol 2000; 27(11):2683-91.
Abstract: OBJECTIVE: To assess the responsiveness of the Fibromyalgia Impact Questionnaire (FIQ), patient ratings of pain intensity, number of tender points, and total tender point pain intensity score to perceived changes in clinical status in patients with fibromyalgia (FM). METHODS: Using data from a randomized placebo controlled study evaluating efficacy of magnetic therapy in patients with FM, the ability of primary outcomes to detect clinically meaningful changes over a 6 month period was assessed by: (1) degree of association between outcome change scores and patient global ratings of symptom change (Spearman rank-order correlations); (2) ability of these scores to discriminate among groups of patients whose perceived health status had changed to varying degrees (ANOVA); (3) ability of these scores, individually and jointly, to discriminate between patients who had reported improvement and those who did not (logistic regression); (4) effect size, standardized response mean, and Guyatt's statistic were calculated to quantify responsiveness. RESULTS: Correlations showed the outcome measures were moderately responsive to perceived symptomatic change. For FIQ, pain intensity ratings and number of tender points, differences in change scores between globally improved and unchanged groups and between globally improved and worsened groups were significant; for total tender point pain intensity, the globally improved differed from worsened group. FIQ outperformed the other measures in discriminating between patients who reported improvement from those who did not. Summary statistics were consistent with discriminatory analyses, indicating the measures were sensitive to improvement, but relatively unresponsive to decline. CONCLUSION: The FIQ was the most responsive measure to perceived clinical improvement and we recommend its inclusion as a primary endpoint in FM clinical trials

   (200)    Pankoff B, Overend T, Lucy D, White K. Validity and responsiveness of the 6 minute walk test for people with fibromyalgia. J Rheumatol 2000; 27(11):2666-70.
Abstract: OBJECTIVE: To determine the concurrent validity and responsiveness of the 6 minute walk test (6-MWT) as a measure of cardiorespiratory fitness in people with fibromyalgia. METHODS: Subjects completed the 6-MWT, a Fibromyalgia Impact Questionnaire (FIQ), and a peak oxygen consumption (pVO2) exercise test before (n = 28) and after (n = 20) a 12 week exercise program. RESULTS: The correlations between 6-MWT distance and pVO2 before (r = 0.328) and after (r = 0.420) the exercise program were not significant. Significant correlations were obtained between 6-MWT distance and FIQ total (r = -0.494, p < 0.01) and physical impairment (r = -0.403, p < 0.05) scores. Fifteen of 28 subjects completed the exercise program, with significant (p < 0.05) changes in 6-MWT distance (+78 m), pVO2 (+1.8 ml/kg/min), and FIQ total score (-9.9). The change in 6-MWT distance was correlated significantly (p < 0.05) with change in FIQ total score but no change in pVO2. CONCLUSION: The 6-MWT was not a valid predictor of cardiorespiratory fitness. However, it was sensitive to change and was also significantly related to FIQ total score

   (201)    Bramwell B, Ferguson S, Scarlett N, Macintosh A. The use of ascorbigen in the treatment of fibromyalgia patients: a preliminary trial. Altern Med Rev 2000; 5(5):455-62.
Abstract: Twelve female fibromyalgia syndrome (FMS) patients were given 500 mg per day of a blend containing 100 mg ascorbigen and 400 mg broccoli powder in a preliminary, one-month, open-label trial. This group of patients showed a mean 20.1 percent (p=0.044) decrease in their physical impairment score and a mean 17.8 percent (p=0.016) decrease in their total fibromyalgia impact scores as measured by the Fibromyalgia Impact Questionnaire. The mean physical impairment score two weeks post-treatment showed a significant return to near pre-treatment level (p=0.028). Analysis of ten of the patients' mean threshold pain levels at the 18 possible tender points obtained before and at the end of treatment showed a strong trend toward an increase in the mean threshold pain level (p=0.059). The reduced sensitivity to pain and improvement in quality of life measured in this study appear to be clinically relevant and a larger, double-blind study is warranted

   (202)    Meyer BB, Lemley KJ. Utilizing exercise to affect the symptomology of fibromyalgia: a pilot study. Med Sci Sports Exerc 2000; 32(10):1691-7.
Abstract: Fibromyalgia (FM), a rheumatological disorder of unknown origin, is characterized by both physical and psychological symptoms. Although inconclusive results have been reported for most treatment modalities, exercise appears to have universal support for decreasing the myriad of symptoms associated with FM. Weaknesses in the literature, however, prevent conclusive statements regarding exercise prescription and concomitant impact on FM symptomology. PURPOSE: The current pilot study attempted to examine the effect of a 24-wk walking program at predetermined intensities on FM. METHODS: Initial design was a randomized control trial with high- and low-intensity exercise groups, and a control group. Subsequent nonrandomized control trials were based on actual exercise behavior. RESULTS: No differences between initial groups were identified. By collapsing groups, heart rate (HR) decreased (P < 0.05) weeks 0-12. Functional impairments were reduced 54% weeks 0-24, with exercise having a large impact (omega2 = 0.30) on this decrease. By reassigning groups, impact of FM on current health status decreased in the low-intensity group (P < 0.05) and increased in the high-intensity group (P < 0.02) weeks 0-24. Omega squared indicated strong influence of exercise on pain (omega2 = 0.51), with greater pain in the high-intensity group. CONCLUSIONS: A larger number of subjects and direct supervision of the training program to increase compliance is necessary to clarify the effects of a walking program on the manifestations of FM. Results indicate that intensity of the walking program is an important consideration. Individuals with FM can adhere to low-intensity walking programs two to three times per week, possibly reducing FM impact on daily activities

   (203)    Mannerkorpi K, Nyberg B, Ahlmen M, Ekdahl C. Pool exercise combined with an education program for patients with fibromyalgia syndrome. A prospective, randomized study. J Rheumatol 2000; 27(10):2473-81.
Abstract: OBJECTIVE: To evaluate the effects of 6 months of pool exercise combined with a 6 session education program for patients with fibromyalgia syndrome (FM). METHODS: The study population comprised 58 patients, randomized to a treatment or a control group. Patients were instructed to match the pool exercises to their threshold of pain and fatigue. The education focused on strategies for coping with symptoms and encouragement of physical activity. The primary outcome measurements were the total score of the Fibromyalgia Impact Questionnaire (FIQ) and the 6 min walk test, recorded at study start and after 6 mo. Several other tests and instruments assessing functional limitations, severity of symptoms, disabilities, and quality of life were also applied. RESULTS: Significant differences between the treatment group and the control group were found for the FIQ total score (p = 0.017) and the 6 min walk test (p < 0.0001). Significant differences were also found for physical function, grip strength, pain severity, social functioning, psychological distress, and quality of life. CONCLUSION: The results suggest that a 6 month program of exercises in a temperate pool combined with education will improve the consequences of FM

   (204)    Buskila D, Neumann L, Alhoashle A, bu-Shakra M. Fibromyalgia syndrome in men. Semin Arthritis Rheum 2000; 30(1):47-51.
Abstract: OBJECTIVE: Fibromyalgia syndrome (FMS) is uncommon in men and data on its characteristics and severity are limited. The current study was undertaken to determine whether the clinical characteristics and the spectrum of this disorder are similar in men and women. METHODS: Forty men with FMS were matched with 40 women by age and educational level. All subjects were asked about the presence and severity (assessed by visual analog scale) of FMS symptoms; a count of 18 tender points was conducted by thumb palpation, and tenderness thresholds were measured by dolorimetry. Psychological status was assessed by the anxiety and depression subscales of the revised Arthritis Impact Measurement Scales. Quality of life was evaluated by two scales, QOL-16 and SF-36, and physical function was measured by the Fibromyalgia Impact Questionnaire. RESULTS: Men with FMS reported more severe symptoms than women, decreased physical function, and lower quality of life. Women had lower tender thresholds than men; however their mean point counts were similar. CONCLUSION: Although FMS is uncommon in men, its health outcome in our study population was worse than in women. Further studies in larger samples and in diverse ethnocultural populations are needed to confirm this observation

   (205)    Wolfe F, Hawley DJ, Goldenberg DL, Russell IJ, Buskila D, Neumann L. The assessment of functional impairment in fibromyalgia (FM): Rasch analyses of 5 functional scales and the development of the FM Health Assessment Questionnaire. J Rheumatol 2000; 27(8):1989-99.
Abstract: OBJECTIVE: Functional assessment by self-report questionnaire plays an important role in most rheumatic conditions, but psychometric properties of questionnaires have not been studied in fibromyalgia (FM), particularly by Rasch analysis, which allows for examining adequacy of the questionnaire scale. To assess currently used instruments, we examined the Fibromyalgia Impact Scale (FIQ), 4 versions of the Health Assessment Questionnaire (HAQ), and the Medical Outcome Survey Short Form (SF-36). METHODS: More than 2,500 patients from 4 sites (3 US, 1 Israel) completed the FIQ. The HAQ questionnaires were completed by 1438 patients participating in the US National Data Bank for Rheumatic Diseases. Seven hundred sixty patients from Wichita, Kansas, completed the SF-36. Rasch analysis was applied separately to each of these data sets. RESULTS: The FIQ systematically underestimated functional impairment by its handling of activities not usually performed. All questionnaires had problems with non-unidimensionality and ambiguous items when applied to patients with FM. In addition, scales were found to be non-linear. Because of these findings we used the 20 item HAQ questionnaire as an item bank to develop a new questionnaire more suitable for use in FM, the fibromyalgia HAQ (FHAQ). This questionnaire fits the Rasch model well, is relevant, is linear, and has a long, well spaced scale. CONCLUSION: No available functional assessment questionnaire works well in FM. A new questionnaire, the FHAQ, was developed. It has appropriate metric properties and should function well in this condition. Since the FHAQ is a subset of the larger HAQ questionnaire, a new questionnaire is not required; only a different method of scoring is needed. Additional studies regarding sensitivity to change are required to fully validate the FHAQ

   (206)    Offenbaecher M, Waltz M, Schoeps P. Validation of a German version of the Fibromyalgia Impact Questionnaire (FIQ-G). J Rheumatol 2000; 27(8):1984-8.
Abstract: OBJECTIVE: To translate the Fibromyalgia Impact Questionnaire (FIQ) into German and to evaluate its reliability and validity for the use of German speaking patients with fibromyalgia (FM). METHODS: We administered the FIQ to 55 patients with FM (15 patients filled out the questionnaire 10 days later) together with German versions of the Stanford Health Assessment Questionnaire (HAQ), the Medical Outcomes Survey Short Form-36 (SF-36), and a tender point count (TPC). All patients were asked about the severity of pain today (10 cm visual analog scale) and the duration of symptoms. Tenderness thresholds were assessed by dolorimetry at all tender points with a Fisher dolorimeter and laboratory tests were obtained. Test-retest reliability was assessed using Spearman correlations. Internal consistency was evaluated with Cronbach's alpha of reliability. Construct validity of the FIQ was evaluated by correlating the HAQ and subscales of the SF-36 as well as the TPC and the tenderness thresholds. RESULTS: Mean age of participants was 54.3 years and mean duration of symptoms 9.5 years. Test-retest reliability was between 0.62 and 1 for the physical functioning as well as for the total FIQ and other components. Internal consistency was 0.92 for the overall FIQ. Significant correlations were obtained between the FIQ items, the HAQ, and the SF-36. CONCLUSION: The German FIQ is a reliable and valid instrument for measuring functional disability and health status in German patients with FM

   (207)    Anderberg UM, Marteinsdottir I, Theorell T, von KL. The impact of life events in female patients with fibromyalgia and in female healthy controls. Eur Psychiatry 2000; 15(5):295-301.
Abstract: The aim was to investigate if female fibromyalgia patients (FMS) had experienced more negative life events than healthy women. Furthermore, the life events experienced in relation to onset of the FMS were evaluated. Another important area was to investigate the impact of the events experienced in the patients compared to healthy women. A new inventory was constructed to assess life events during childhood, adolescence and in adulthood as well as life events experienced in relation to the onset of the disorder. Forty female FMS patients and 38 healthy age-matched women participated in the study. During childhood or adolescence 51% of the patients had experienced very negative life events as compared to 28% of the controls. Conflict with parents was the most common life event. Before onset, 65% of the patients experienced some negative life event. Economic problems and conflicts with husband/partner were common. During the last year, 51% of the patients had life events which they experienced as very negative, compared to 24.5% of the controls (P < 0.01). Stressful life events in childhood/adolescence and in adulthood seem to be very common in FMS. Furthermore, the life events were experienced as more negative than the life events experienced by healthy controls

   (208)    Neumann L, Press J, Glibitzki M, Bolotin A, Rubinow A, Buskila D. CLINHAQ scale--validation of a Hebrew version in patients with fibromyalgia. Clinical Health Assessment Questionnaire. Clin Rheumatol 2000; 19(4):265-9.
Abstract: Assessment of health status in patients with rheumatic disease, including fibromyalgia (FM), using structured questionnaires has become an important approach to evaluate treatment and outcome. The objectives of this study were to validate a translated version of the Clinical Health Assessment Questionnaire (CLINHAQ) to be used by Hebrew-speaking populations, and specifically to evaluate its usefulness in fibromyalgia syndrome (FM). The CLINHAQ was translated into Hebrew and administered to 90 women with FM along with the Hebrew versions of the Fibromyalgia Impact Questionnaire (FIQ) and the Quality of Life (QOL) Scale. The CLINHAQ includes scales of functional disability, helplessness, anxiety and depression, as well as assessment of current health status and satisfaction with this. All subjects were asked about the presence and severity (assessed by visual analogue scale) of current FM symptoms (pain, fatigue, anxiety etc.); a count of 18 tender points was conducted by thumb palpation, and tenderness thresholds were measured by dolorimetry. Test-retest reliability was assessed by Pearson correlation coefficients, and internal consistency was evaluated with Cronbach's alpha coefficient of reliability. Construct validity was tested by correlating the CLINHAQ items with measures of symptom severity, count of tender point, tenderness thresholds, physical functioning measured by FIQ, and with a score of QOL. Test-retest reliability coefficients ranged from 0.82 to 0.99, and Cronbach's alpha coefficients from 0.725 to 0.929. Significant moderate to high correlations were obtained between most subscales of CLINHAQ and measures of physical functioning, quality of life and severity of FM symptoms. In conclusion, the CLINHAQ is a reliable and valid instrument for measuring health status and physical functioning in Israeli women with FM

   (209)    Sherman JJ, Turk DC, Okifuji A. Prevalence and impact of posttraumatic stress disorder-like symptoms on patients with fibromyalgia syndrome. Clin J Pain 2000; 16(2):127-34.
Abstract: OBJECTIVE: Traumatic events can result in a set of symptoms including nightmares, recurrent and intrusive recollections, avoidance of thoughts or activities associated with the traumatic event, and symptoms of increased arousal such as insomnia and hypervigilance. These posttraumatic stress disorder (PTSD)-like symptoms are frequently observed in persons with chronic pain syndromes. Little is known about how these two phenomena interact with one another. The present study evaluated PTSD-like symptoms in patients with fibromyalgia syndrome (FMS) and examined the relation between PTSD-like symptoms and problems associated with FMS. DESIGN: Ninety-three consecutive patients underwent a comprehensive FMS evaluation and completed self-report questionnaires measuring PTSD-like symptoms, disability, and psychosocial responses to their pain condition. Subjects were divided in two groups based on level of self-reported PTSD-like symptoms. RESULTS: Approximately 56% of the sample reported clinically significant levels of PTSD-like symptoms (PTSD+). The PTSD+ patients reported significantly greater levels of pain (p < 0.01), emotional distress (p < 0.01), life interference (p < 0.01), and disability (p < 0.01) than did the patients without clinically significant levels of PTSD-like symptoms (PTSD-). Over 85% of the PTSD+ patients compared with 50% of the PTSD- patients demonstrated significant disability. Based on response to the Multidimensional Pain Inventory, a significantly smaller percentage of PTSD+ patients were classified as adaptive copers (15%) compared with the PTSD- group (48.2%). CONCLUSIONS: Results suggest that PTSD-like symptoms are prevalent in FMS patients and may influence adaptation to this chronic illness. Clinicians should assess the presence of these symptoms, as the failure to attend to them in treatment may impede successful outcomes

   (210)    Anderberg UM, Marteinsdottir I, von KL. Citalopram in patients with fibromyalgia--a randomized, double-blind, placebo-controlled study. Eur J Pain 2000; 4(1):27-35.
Abstract: The effect of the selective serotonin reuptake inhibitor citalopram was studied in a randomized, double-blind, placebo-controlled, 4-month trial in patients with the fibromyalgia syndrome (FMS) who all fulfilled the American College of Rheumatology criteria. The citalopram doses varied between 20-40 mg daily. Forty female patients, 21 patients in the citalopram and 19 in the placebo group, participated. Assessment of pain, depressive symptoms and physical functioning were made using Visual Analogue Scales (VAS), the Montgomery Asberg Depression Rating Scale (MADRS) and the Fibrositis Impact Questionnaire (FIQ).In the global judgement of improvement, no significant changes were found between the citalopram and placebo groups as concerns pain or well-being, either in the Intention to Treat (ITT) analysis or in the completer analysis. However, among the completers, it was a tendency that more patients in the citalopram group (52.9%) were improved as compared to the placebo group (22.2%) concerning well-being. Furthermore, the results indicated that treatment with citalopram had a significant effect on pain on the VAS after 2 months of treatment compared to baseline. After 4 months, however, the effect had diminished. Measured with the FIQ, significant differences in the pain ratings were seen at the end of the trial. Significant effects on the depressive symptomatology measured by means of the MADRS were seen already after 1 month of treatment and were increasing further at the end of the trial, when a significant difference between the groups was also found

   (211)    Sperber AD, Carmel S, Atzmon Y, Weisberg I, Shalit Y, Neumann L et al. Use of the Functional Bowel Disorder Severity Index (FBDSI) in a study of patients with the irritable bowel syndrome and fibromyalgia. Am J Gastroenterol 2000; 95(4):995-8.
Abstract: OBJECTIVE: The purpose of this study was to evaluate the utility of the Functional Bowel Disorder Severity Index (FBDSI) as a measure of severity of disease among patients with the irritable bowel syndrome (IBS) and matched controls. METHODS: A total of 75 IBS patients and 69 matched controls completed questionnaires on bowel symptoms, health status, quality of life, psychological distress, concerns, anxiety, and sense of coherence. All participants also were tested for fibromyalgia (FS), a functional disorder of the musculoskeletal system. All participants were administered a questionnaire that included the FBDSI. On the basis of their responses to the questionnaire, the controls were subdivided as healthy controls (n = 48) or IBS nonpatients (n = 21). On the basis of the FS classification, 75 IBS patients were subdivided as IBS only (n = 50) or IBS and FS combined (n = 25). RESULTS: The mean FBDSI score was higher for the IBS patients than the controls (100.5+/-12.7 and 23.5+/-3.9, respectively; p < 0.001). IBS nonpatients had an intermediate score of 42.3+/-18.0. Patients with both IBS and fibromyalgia had the highest mean FBDSI score: 138.8+/-31.5. There was no association between FBDSI and age or gender, but FBDSI was significantly associated with other measures of health status. CONCLUSIONS: An association was found between the FBDSI and IBS patient status: IBS nonpatients, patients with IBS only, and patients with both IBS and fibromyalgia had increasingly severe scores. The results provide support for the validity of FBDSI as a measure of illness severity in functional gastrointestinal disorders

   (212)    Dessein PH, Shipton EA, Joffe BI, Hadebe DP, Stanwix AE, Van der Merwe BA. Hyposecretion of adrenal androgens and the relation of serum adrenal steroids, serotonin and insulin-like growth factor-1 to clinical features in women with fibromyalgia. Pain 1999; 83(2):313-9.
Abstract: Neuroendocrine deficiencies have been implicated in fibromyalgia (FM). In the present study, adrenal androgen metabolites and their relationship with health status in FM were investigated. For comparison, serum levels of other implicated neuroendocrine mediators were correlated with health status. Fifty-seven consecutive women with FM completed the Fibromyalgia Impact Questionnaire (FIQ). Fasting blood samples were taken for measurement of dehydroepiandrosterone sulphate (DHEAS), free testosterone (T), cortisol, serotonin and insulin-like growth factor-1. Normal value for DHEAS and T were obtained from 114 controls. DHEAS levels were decreased significantly in pre- and postmenopausal patients (P<0.0001 and P<0.0005, respectively). T levels were decreased significantly in premenopausal and insignificantly in postmenopausal patients (P<0.0001 and P=0.06, respectively). The following correlations between neurohormonal levels and FIQ scores were found: DHEAS (after adjustment for age) vs. pain (P<0.001) and T (after adjustment for age) versus physical functioning (P=0.002). None of the other neurohormonal levels correlated significantly with any of the FIQ scores. IGF-1 levels were lower in the obese patients as compared to those who were non-obese (P=0.03). The BMI correlated positively with pain (P<0. 001) and inversely with DHEAS levels (P=0.006). After further adjustment for BMI, the correlation between age adjusted DHEAS and pain was no longer significant. Hyposecretion of adrenal androgens was documented in FM. This was more pronounced in obese patients. Low serum androgen levels correlated with poor health status in FM. Longitudinal studies are needed to elucidate whether these are cause and/or effect relationships

   (213)    King S, Wessel J, Bhambhani Y, Maikala R, Sholter D, Maksymowych W. Validity and reliability of the 6 minute walk in persons with fibromyalgia. J Rheumatol 1999; 26(10):2233-7.
Abstract: OBJECTIVE: To assess the reliability and construct validity of the 6 minute walk (6MW) in persons with fibromyalgia (FM) and to determine an equation for predicting peak oxygen consumption (pVO2) from the distance covered in 6 minutes. METHODS: Ninety-six women who met the American College of Rheumatology (ACR) criteria for FM were tested on the 6MW and the Fibromyalgia Impact Questionnaire (FIQ). A subset (n = 23) were tested on a separate day for pVO2 during a symptom-limited, incremental treadmill test. Twelve subjects repeated the 6MW five times over 10 days. Heart rate and rating of perceived exertion (RPE) were recorded for each walk. Intraclass correlations were used to determine the reliability of the 6MW. Validity was examined by correlating the 6MW with pVO2 and the FIQ. Body mass index (BMI) and 6MW were independent variables in a stepwise regression to predict pVO2. RESULTS: A significant increase in distance occurred from Walk 1 to Walk 2 (p = 0.000) with the distance maintained on the remaining walks (p = 0.148) The correlations of the 6MW with the FIQ and pVO2 were -0.325 and 0.657, respectively. The regression equation to predict pVO2 from 6MW distance and BMI was: pVO2 (ml/kg/min) = 21.48 + (-0.4316 x BMI) + [0.0304 x distance(m)] (R = 0.76, R2 = 0.66). CONCLUSION: When using the 6MW it is necessary to conduct a practice walk, with the second walk taken as the baseline measure. It was determined from the correlations that the 6MW cannot replace the FIQ as a measure of function. The 6MW may be used as an indicator of aerobic fitness, although obtaining VO2 by means of a graded exercise test is preferable

   (214)    Gowans SE, Dehueck A, Voss S, Richardson M. A randomized, controlled trial of exercise and education for individuals with fibromyalgia. Arthritis Care Res 1999; 12(2):120-8.
Abstract: OBJECTIVE: To evaluate the efficacy of a 6-week exercise and educational program for patients with fibromyalgia. METHODS: Forty-one subjects were randomly assigned to the program or served as waiting list controls. Program outcome was assessed with a 6-minute walk test, the Fibromyalgia Impact Questionnaire, a Self-Efficacy Scale, and a "knowledge" questionnaire (based on information provided during the educational sessions). Waiting list control subjects subsequently completed the program. Program outcome was reassessed 3 or 6 months post-program. RESULTS: The program produced significant improvements in 6-minute walk distance, well-being, fatigue, self-efficacy (for controlling pain and other symptoms), and knowledge. At followup, immediate gains in walk distance, well-being, and self-efficacy were maintained, but gains in fatigue and knowledge were lost. CONCLUSION: Short-term exercise and educational programs can produce immediate and sustained benefits for patients with fibromyalgia. The benefits of our program may be due to exercise or education since both interventions were given

   (215)    Fallon J, Bujak DI, Guardino S, Weinstein A. The Fibromyalgia Impact Questionnaire: a useful tool in evaluating patients with post-Lyme disease syndrome. Arthritis Care Res 1999; 12(1):42-7.
Abstract: OBJECTIVE: To determine the reliability and validity of a modified version of the Fibromyalgia Impact Questionnaire (FIQ) in evaluating patients with post-Lyme disease syndrome (PLDS). METHODS: In this cross-sectional analysis 13 PLDS, 18 fibromyalgia (FM), and 16 healthy controls (n = 47) completed a modified FIQ containing items to evaluate physical impairment, symptom severity, and global well-being. Comparisons between groups were done using analysis of variance with a significance level set at 0.05. RESULTS: PLDS patients demonstrated statistically significantly greater levels of impairment than controls in physical functioning, FIQ total score, global well-being, joint pain, fatigue, depression, ability to perform activities of daily living, and memory/concentration. FM patients demonstrated a statistically significantly greater level of impairment than the control group in all categories, and the scores were significantly higher than the PLDS group in the measurement of physical impairment, FIQ total score, muscle pain, and joint pain. Overall, the instrument possesses good reliability and validity, although adequacy of this instrument to measure impairment in the male PLDS population needs further elucidation. CONCLUSION: The results of this study suggest that the modified FIQ may be a useful tool in evaluating PLDS patients. The findings suggest that there may be some differences in the etiopathology of the symptoms experienced by PLDS and FM patients

   (216)    Jamison J. Stress: the chiropractic patients' self-perceptions. J Manipulative Physiol Ther 1999; 22(6):395-8.
Abstract: BACKGROUND: Psychosocial stress pervades modern life and is known to have an impact on health. Pain, especially chronic back pain, is influenced by stress. Various strategies have been shown to successfully reduce stress and its consequences. OBJECTIVES: This study explores stress as a potential disease trigger among chiropractic patients. METHOD: A descriptive study was undertaken to ascertain the stress perceptions of chiropractic patients. Purposive sampling of chiropractic practices and convenience sampling of patients was undertaken. Patients were allocated to 1 of 4 groups according to their presentation: acute, chronic biomechanical, fibromyalgia, or maintenance care. Participating patients were requested to complete a questionnaire. RESULTS: Of the 138 patients attending 1 of 10 participating chiropractic clinics, more than 30% regarded themselves as moderately to severely stressed, and over 50% felt that stress had a moderate or greater effect on their current problem. Some 71% of patients felt it would be helpful if their chiropractic care included strategies to help them cope with stress, and 44% were interested in taking a self-development program to enhance their stress management skills. CONCLUSION: Patient perceptions are known to be important in health care. A number of chiropractic patients perceive they are moderately or severely stressed. Interventions that reduce stress, or even the patient's perception of being stressed, may be construed as valid, non-specific clinical interventions. It may be timely for chiropractors to actively contemplate including stress management routinely in their clinical care protocols

   (217)    Neumann L, Dudnik Y, Bolotin A, Buskila D. Evaluation of a Hebrew version of the revised and expanded Arthritis Impact Measurement Scales (AIMS2) in patients with fibromyalgia. J Rheumatol 1999; 26(8):1816-21.
Abstract: OBJECTIVE: To validate a translated version of the revised and expanded Arthritis Impact Measurement Scales (AIMS2) to be used by Hebrew speaking populations. METHODS: The AIMS2 was translated into Hebrew and administered to 66 women with fibromyalgia (FM) along with the Hebrew versions of the Fibromyalgia Impact Questionnaire (FIQ) and the Quality of Life (QOL) Scale. All subjects were asked about the presence and severity (assessed by visual analog scale) of FM symptoms (pain, fatigue, anxiety, etc.); a count of 18 tender points was conducted by thumb palpation, and tenderness thresholds were measured by dolorimetry. Test-retest reliability was assessed by Pearson correlation coefficients, and internal consistency was evaluated with Cronbach's alpha coefficient of reliability. Construct validity was tested by correlating the AIMS2 items with measures of symptom severity, count of tender points, tenderness thresholds, physical functioning measured by FIQ, and with a score of QOL. RESULTS: Test-retest reliability coefficients ranged from 0.84 to 0.99, and Cronbach's alpha coefficients from 0.74 to 0.93. Significant moderate to high correlations were obtained between the AIMS2 subscales (except self-care) and measures of physical functioning, quality of life, severity of FM symptoms, and number of tender points. CONCLUSION: The AIMS2 is a reliable and valid instrument for measuring health status and physical functioning in Israeli women with FM

   (218)    Adler GK, Kinsley BT, Hurwitz S, Mossey CJ, Goldenberg DL. Reduced hypothalamic-pituitary and sympathoadrenal responses to hypoglycemia in women with fibromyalgia syndrome. Am J Med 1999; 106(5):534-43.
Abstract: PURPOSE: To perform a detailed comparison of the hypothalamic-pituitary-adrenal axis and the sympathoadrenal system in women with and without fibromyalgia. SUBJECTS AND METHODS: Fifteen premenopausal women who met the 1990 American College of Rheumatology criteria for the diagnosis of fibromyalgia and 13 healthy, premenopausal women were enrolled. We measured baseline 24-hour urinary free cortisol levels and evening and morning adrenocorticotropic hormone (ACTH) and cortisol levels, performed stepped hypoglycemic hyperinsulinemic clamp studies in which serum glucose levels were decreased from 5.0 to 2.2 mmol/L, and compared the effects of infusions of placebo and ACTH. RESULTS: Women with fibromyalgia had normal 24-hour urinary free cortisol levels and normal diurnal patterns of ACTH and cortisol. There was a significant, approximately 30%, reduction in the ACTH and epinephrine responses to hypoglycemia in women with fibromyalgia compared with controls. Prolactin, norepinephrine, cortisol, and dehydroepiandrosterone responses to hypoglycemia were similar in the two study groups. In subjects with fibromyalgia, the epinephrine response to hypoglycemia correlated (P = 0.01) inversely with overall health status as measured by the fibromyalgia impact questionnaire. Graded ACTH infusion revealed similar increases in cortisol in women with fibromyalgia and healthy controls. CONCLUSIONS: Patients with fibromyalgia have an impaired ability to activate the hypothalamic-pituitary portion of the hypothalamic-pituitary-adrenal axis as well as the sympathoadrenal system, leading to reduced ACTH and epinephrine responses to hypoglycemia

   (219)    Goossens ME, Vlaeyen JW, Rutten-van Molken MP, van der Linden SM. Patient utilities in chronic musculoskeletal pain: how useful is the standard gamble method? Pain 1999; 80(1-2):365-75.
Abstract: The main goal of current pain management approaches is to increase the patients' quality of life by improving pain coping skills and by reducing the levels of disability in daily life, often despite persistent pain. Direct measurement of quality of life is of crucial importance in economic evaluation research, in which not only is the estimation of financial costs and benefits included, but so is the evaluation of costs and benefits in terms of changes in health states. The purpose of this study is to compare the psychometric qualities of two instruments for assessing patients' utilities, the rating scale (RS) and the standard gamble (SG). Such instruments are designed for their application in economic evaluation research, but have seldomly been used in chronic pain trials. Both methods provide a single measure between 0 and 1. The relationship between these utility measures and descriptive and domain-specific quality of life measures was examined in 133 fibromyalgia patients and 148 patients with chronic non-specific low back pain. Mean utility score at baseline was 0.43 with the RS and 0.78 for the SG. The correlation between both methods was found to be poor (r = 0.21). Both measures appeared to be fairly stable in a 2-week test-retest period (intra class correlation coefficient (ICC) = 0.74 and 0.77). Scores on the description of patient's own health on six domains, global assessment of change and domain specific measures correlated moderately with the RS scores and low with the SG. Multiple regression analyses demonstrated that 32% of the variance in RS values and only 13% of the variance in SG utilities could be explained by domain-specific measures. These results suggest an acceptable construct validity for the RS but insufficient construct validity for the SG. Valuations of ones own health appear only partially to be related to the assessment of the pain-specific measures and measures of distress. It can be concluded that the RS and domain-specific measures assess partly different, but nevertheless complementary aspects of health-related quality of life. It is therefore recommended to include in economic evaluation studies both domain-specific measures and valuation measures. Finally, in chronic musculoskeletal pain patients, RS scores were found to be more responsive in detecting significant changes in preferences than SG scores. For use in patients with chronic musculoskeletal pain, the RS is preferred to the SG for establishing accurate decisions about the impact of new interventions on their health outcomes

   (220)    White KP, Speechley M, Harth M, Ostbye T. Comparing self-reported function and work disability in 100 community cases of fibromyalgia syndrome versus controls in London, Ontario: the London Fibromyalgia Epidemiology Study. Arthritis Rheum 1999; 42(1):76-83.
Abstract: OBJECTIVE: To compare function and disability in fibromyalgia syndrome (FMS) cases in the community versus controls, and to identify variables predicting poor function and disability. METHODS: We identified 100 FMS cases, 76 pain controls, and 135 general controls in a random survey of 3,395 noninstitutionalized adults. RESULTS: FMS cases reported worse function (P < 0.00001), more days in bed (P < 0.001), and more healthy years of life lost (P < 0.0001). More FMS cases were disabled (P < 0.00001) and receiving pensions (P < 0.00001). Risk factors for disability included middle age and previous heavy manual labor. Pain, fatigue, and weakness were most often claimed to affect the ability to work Variables predicting work disability were the Fibromyalgia Impact Questionnaire (FIQ) score, a prior diagnosis of FMS, nonrestorative sleep, and past heavy physical labor. Variables influencing the FIQ score were the number of major symptoms, self-reported health satisfaction, tender point count, and education level. CONCLUSION: FMS commonly results in loss of function and work disability

   (221)    Ambrogio N, Cuttiford J, Lineker S, Li L. A comparison of three types of neck support in fibromyalgia patients. Arthritis Care Res 1998; 11(5):405-10.
Abstract: OBJECTIVE: To determine the effectiveness of 3 types of neck support for patients with fibromyalgia (FMS) and their preference for the type of support. METHODS: Thirty-five patients with FMS chose the order of application and used each type of neck support for a 2-week period, followed by a 2-week washout. The same schedule was repeated a second time. The neck supports included a Shape of Sleep pillow, two neck ruffs with one standard pillow, and a single standard pillow. All subjects received a physiotherapy treatment and educational program in the home. Outcome measures included visual analog scales (VAS) for neck pain and quality of sleep, the Fibromyalgia Impact Questionnaire (FIQ), and a neck and shoulder pain distribution diagram. RESULTS: Analysis using Friedman's 2-way analysis of variance revealed no significant differences in any outcome measure, although there was a trend towards improvement in the FIQ and VAS neck pain and quality of sleep scores for some patients. Most participants (62.9%) preferred the Shape of Sleep pillow, 20.0% preferred cervical ruffs with one standard pillow, and 17.1% preferred a single standard pillow. CONCLUSIONS: The results of this study are inconclusive due to the small sample size. However, from a patient's perspective, neck support is an important part of a comprehensive physiotherapy program. Most participants preferred the more rigid support of a Shape of Sleep pillow. Further research into the efficacy of the use of neck support in people with FMS is warranted

   (222)    Singh BB, Berman BM, Hadhazy VA, Creamer P. A pilot study of cognitive behavioral therapy in fibromyalgia. Altern Ther Health Med 1998; 4(2):67-70.
Abstract: BACKGROUND: Fibromyalgia is a syndrome characterized by widespread musculoskeletal pain and multiple tender points as well as high levels of self-reported disability and poor quality of life. OBJECTIVES: In this pilot study, a mind-body approach (cognitive-behavioral therapy) was tested that has been successful in treating chronic back pain patients to determine whether it would improve function, decrease perceived pain, and improve mood state for fibromyalgia patients. PARTICIPANTS: 28 patients recruited from the greater Baltimore area. INTERVENTION: Eight weekly sessions, 2 1/2 hours each, with three components: an educational component focusing on the mind-body connection, a portion focusing on relaxation response mechanisms (primarily mindfulness meditation techniques), and a qigong movement therapy session. MAIN OUTCOME MEASURES: Data collection instruments were the Fibromyalgia Impact Questionnaire, the Health Assessment Questionnaire, the Beck Depression Inventory, the Coping Strategies Questionnaire, the helplessness subscale of the Arthritis Attitudes Index, the Medical Outcomes Study Short Form General Health Survey, and a double-anchored 100-mm visual analog scale to assess sleep. RESULTS: Twenty patients completed the study. Standard outcome measures showed significant reduction in pain, fatigue, and sleeplessness; and improved function, mood state, and general health following an 8-week intervention. CONCLUSION: A mind-body intervention including patient education, meditation techniques, and movement therapy appears to be an effective adjunctive therapy for patients with fibromyalgia

   (223)    Finckh A, Morabia A, Deluze C, Vischer T. Validation of questionnaire-based response criteria of treatment efficacy in the fibromyalgia syndrome. Arthritis Care Res 1998; 11(2):116-23.
Abstract: OBJECTIVE: To compare the validity of self-reported questionnaires as response criteria of treatment efficacy in patients with fibromyalgia syndrome. METHOD: At the beginning of the treatment period, 70 fibromyalgia patients, randomly allocated to electro-acupuncture or placebo, underwent a clinical evaluation by rheumatologists and answered 1) a generic quality of life questionnaire--the Psychological General Well-Being Index (PGWB), 2) a specific function and symptom questionnaire, and 3) a pain questionnaire--the Regional Pain Score (RPS). The same evaluation was repeated at the end of the treatment period. Severity of the condition was assessed by a composite outcome score, a combination of different clinical outcome measures forming a clinical severity index. The variations between these questionnaire scores before and after treatment and the variations between the clinical severity indices estimated by clinicians were used as measures of the treatment impact. The first rationale for the validation was a positive correlation between clinical and questionnaire score changes. Another rationale for validation of the new instruments was the ability to identify the different treatment interventions. RESULTS: The correlation between the clinical severity index and the RPS was good (r = 0.62). Moreover, the RPS demonstrated a good discriminant power in detecting patients with effective treatment: it showed a specificity of 74% and a sensitivity of 75%. The PGWB correlated less well with the clinical score and was less discriminant. The specific function and symptom questionnaire showed little additional validity. CONCLUSIONS: Outcomes of syndrome severity such as pain and subjective well-being, as measured by self-reported questionnaires, can be valid instruments to evaluate treatment efficacy in short-term clinical trials. In the current study, the RPS proved to be particularly useful to assess the widespread tenderness of fibromyalgia and demonstrated high discriminative power

   (224)    Schanberg LE, Keefe FJ, Lefebvre JC, Kredich DW, Gil KM. Social context of pain in children with Juvenile Primary Fibromyalgia Syndrome: parental pain history and family environment. Clin J Pain 1998; 14(2):107-15.
Abstract: OBJECTIVE: The purpose of this study was to describe parental pain history and the family environment as it relates to the functional status of children with Juvenile Primary Fibromyalgia Syndrome (JPFS). DESIGN AND OUTCOME MEASURES: Twenty-nine parents of children with JPFS completed a pain history questionnaire, Von Korff Chronic Pain Grading system, and the Family Environment Scale (FES). Twenty-one adolescents with JPFS completed the FES, the Visual Analogue Scale for Pain, the modified Fibromyalgia Impact Questionnaire for Children, the Arthritis Impact Measurement Scales, and the Symptom Checklist-90-Revised. Correlational analyses were performed. RESULTS: Parents of children with JPFS reported multiple chronic pain conditions, including but not limited to fibromyalgia. Parental pain history and the family environment correlated with the health status of adolescents with JPFS. Children with JPFS perceived the family environment as significantly more cohesive than did their parents. Greater incongruence between parent and child responses on the FES positively correlated with greater impairment. CONCLUSIONS: These results suggest that family environment and parental pain history ay be related to how children cope with JPFS. Behavioral interventions targeting the family may improve the long-term functional status of children with JPFS

   (225)    Bennett RM, Clark SC, Walczyk J. A randomized, double-blind, placebo-controlled study of growth hormone in the treatment of fibromyalgia. Am J Med 1998; 104(3):227-31.
Abstract: PURPOSE: The cause of fibromyalgia (FM) is not known. Low levels of insulin-like growth factor 1 (IGF-1), a surrogate marker for low growth hormone (GH) secretion, occur in about one third of patients who have many clinical features of growth hormone deficiency, such as diminished energy, dysphoria, impaired cognition, poor general health, reduced exercise capacity, muscle weakness, and cold intolerance. To determine whether suboptimal growth hormone production could be relevant to the symptomatology of fibromyalgia, we assessed the clinical effects of treatment with growth hormone. METHODS: Fifty women with fibromyalgia and low IGF-1 levels were enrolled in a randomized, placebo-controlled, double-blind study of 9 months' duration. They gave themselves daily subcutaneous injections of growth hormone or placebo. Two outcome measures--the Fibromyalgia Impact Questionnaire and the number of fibromyalgia tender points-were evaluated at 3-monthly intervals by a blinded investigator. An unblinded investigator reviewed the IGF-1 results monthly and adjusted the growth hormone dose to achieve an IGF-1 level of about 250 ng/mL. RESULTS: Daily growth hormone injections resulted in a prompt and sustained increase in IGF-1 levels. The treatment (n=22) group showed a significant improvement over the placebo group (n=23) at 9 months in both the Fibromyalgia Impact Questionnaire score (P <0.04) and the tender point score (P <0.03). Fifteen subjects in the growth hormone group and 6 subjects in the control group experienced a global improvement (P <0.02). There was a delayed response to therapy, with most patients experiencing improvement at the 6-month mark. After discontinuing growth hormone, patients experienced a worsening of symptoms. Carpal tunnel symptoms were more prevalent in the growth hormone group (7 versus 1); no other adverse events were more common in this group. CONCLUSIONS: Women with fibromyalgia and low IGF-1 levels experienced an improvement in their overall symptomatology and number of tender points after 9 months of daily growth hormone therapy. This suggests that a secondary growth hormone deficiency may be responsible for some of the symptoms of fibromyalgia

   (226)    Soderberg S, Lundman B, Norberg A. Living with fibromyalgia: sense of coherence, perception of well-being, and stress in daily life. Res Nurs Health 1997; 20(6):495-503.
Abstract: Fibromyalgia (FM) is a chronic pain syndrome that has a considerable impact on the ill person's daily life. The purpose of this study was to describe levels of sense of coherence (SOC), perceptions of well-being, and stress in daily life in women with FM in comparison with healthy women, and to determine whether SOC is related to perceived levels of stress and well-being. Thirty women with FM were compared with 30 healthy women matched for Type A behavior. The results revealed a complex picture of the women with FM. On the one hand, they reported many symptoms but, on the other, they rated themselves as feeling quite well and experiencing an SOC in life, despite severe problems. The FM women with a stronger SOC perceived greater well-being than those with a weaker SOC. They felt more hopeful, more free, more valuable, and more like others. Results suggest that women with a weaker SOC may need extra support. More research is needed to investigate the experience of living with FM in order to discover what it is that makes life worthwhile despite high symptom levels

   (227)    Walker EA, Katon WJ, Keegan D, Gardner G, Sullivan M. Predictors of physician frustration in the care of patients with rheumatological complaints. Gen Hosp Psychiatry 1997; 19(5):315-23.
Abstract: Recent studies of the doctor-patient relationship have shown that certain patients are perceived as frustrating or difficult by their doctors; however, little is known about the characteristics of these patients that elicit this dissatisfaction. As part of a larger study of rheumatology clinic patients with fibromyalgia or rheumatoid arthritis (N = 68) we used stepwise multiple regression to select the factors most associated with physician frustration while controlling for the effects of other variables. Variable domains included demographics, psychiatric diagnoses, personality factors, functional disability, disease state, and trauma history. These domains as well as individual variables within these domains were systematically evaluated for their unique contribution to the prediction of physician frustration as measured by the Difficult Doctor-Patient Relationship Questionnaire (DDPRQ). Initial bivariate correlates of physician frustration included marital status, current dysthymia and agoraphobia, lifetime panic disorder and obsessive-compulsive disorder, adult rape and physical abuse, somatization disorder, physical and social disability, the presence of fibromyalgia, as well as neuroticism, illness impact, and perceived loss of control. The best multivariable model for estimating frustration magnitude included somatization disorder, perception of lack of control over illness, and a lifetime history of obsessive-compulsive disorder. These factors explained 48% of the variance in DDPRQ score. Physicians in this study were most frustrated with patients who had ongoing preoccupation with multiple medically unexplained physical symptoms as well as the perception of greater impact and lack of control over their illness. These findings suggest that treatment of somatization in patients with chronic symptoms may decrease physician frustration

   (228)    Sorensen J, Bengtsson A, Ahlner J, Henriksson KG, Ekselius L, Bengtsson M. Fibromyalgia--are there different mechanisms in the processing of pain? A double blind crossover comparison of analgesic drugs. J Rheumatol 1997; 24(8):1615-21.
Abstract: OBJECTIVE: Pain was analyzed in patients with fibromyalgia (FM) in a randomized, double blind, crossover study using intravenous (i.v.) administration of different drugs. METHODS: In 18 patients with FM muscle pain to i.v. administration of morphine (0.3 mg/kg), lidocaine (5 mg/kg), ketamine (0.3 mg/kg), or saline was studied. Spontaneous pain intensity, muscle strength, static muscle endurance, pressure pain threshold, and pain tolerance at tender points and non-tender point areas were followed. Drug plasma concentrations and effects on physical functioning ability score (FIQ) were recorded. A personality inventory (KSP) was used to related pain response to personality traits. RESULTS: Thirteen patients responded to one or several of the drugs, but not to placebo. Two patients were placebo responders responding to all 4 infusions. Three were nonresponders responding to no infusions. Seven of the responders had a reduction in pain for 1-5 days. Pressure pain threshold and pain tolerance increased significantly in responders. Plasma concentrations were similar in responders and nonresponders. FIQ values improved significantly after the ketamine infusion. Responders scored higher on KSP scales for somatic anxiety, muscular tension, and psychasthenia compared with healthy controls. CONCLUSION: FM diagnosed according to the American College of Rheumatology criteria seems to include patients with different pain processing mechanisms. A pharmacological pain analysis with subdivision into responders and nonresponders might be considered before instituting therapeutic interventions or research

   (229)    Neumann L, Buskila D. Quality of life and physical functioning of relatives of fibromyalgia patients. Semin Arthritis Rheum 1997; 26(6):834-9.
Abstract: OBJECTIVES: The quality of life (QOL) and health status of fibromyalgia syndrome (FS) patients is impaired, and may adversely affect their close relatives. The aim of