Fibromyalgia Impact Questionnaire (FIQ) References with Abstracts from 1991 to 2010

          (1)    Choy E, Perrot S, Leon T, Kaplan J, Petersel D, Ginovker A et al. A patient survey of the impact of fibromyalgia and the journey to diagnosis. BMC Health Serv Res 2010; 10(1):102.
Abstract: ABSTRACT: BACKGROUND: Fibromyalgia is a painful, debilitating illness with a prevalence of 0.5-5.0% that affects women more than men. It has been shown that the diagnosis of fibromyalgia is associated with improved patient satisfaction and reduced healthcare utilization. This survey examined the patient journey to having their condition diagnosed and studied the impact of the condition on their life. METHODS: A questionnaire survey of 800 patients with fibromyalgia and 1622 physicians in 6 European countries, Mexico and South Korea. Patients were recruited via their physician. RESULTS: Over half the patients (61%) were aged 36-59 years, 84% were women, and the mean time since experiencing fibromyalgia symptoms was 6.5 years. Patients had experienced multiple fibromyalgia symptoms (mean of 7.3 out of 14), with pain, fatigue, sleeping problems and concentration difficulties being the most commonly reported. Most patients rated their chronic widespread pain as moderate or severe and fibromyalgia symptoms were on average "fairly" to "very" disruptive, and had a "moderate" to "strong" impact on patients' lives. 22% were unable to work and 25% were not able to work all the time because of their fibromyalgia. Patients waited on average almost a year after experiencing symptoms before presenting to a physician, and it took an average of 2.3 years and presenting to 3.7 different physicians before receiving a diagnosis of fibromyalgia. Patients rated receiving a diagnosis as somewhat difficult on average and had difficulties communicating their symptoms to the physician. Over one third (35%) felt their chronic widespread pain was not well managed by their current treatment. CONCLUSIONS: This survey provides further evidence that fibromyalgia is characterized by multiple symptoms and has a notable impact on quality of life and function. The diagnosis of fibromyalgia is delayed. Patients wait a significant period of time before presenting to a physician, adding to the prolonged time to diagnosis. Patients typically present with a multitude of symptoms, all resulting in a delay in diagnosis and eventual management. Helping clinicians to diagnose and manage patients with fibromyalgia should benefit both patients and funders of healthcare

       (2)    Kelley GA, Kelley KS, Hootman JM, Jones DL. Exercise and global well-being in community-dwelling adults with fibromyalgia: A systematic review with meta-analysis. BMC Public Health 2010; 10(1):198.
Abstract: ABSTRACT: BACKGROUND: Exercise has been recommended for improving global-well being in adults with fibromyalgia. However, no meta-analysis has determined the effects of exercise on global well-being using a single instrument and when analyzed separately according to intention-to-treat and per-protocol analyses. The purpose of this study was to fill that gap. Methods: Studies were derived from six electronic sources, cross-referencing from retrieved studies and expert review. Dual selection of randomized controlled exercise training studies published between January 1, 1980 and January 1, 2008 and in which global well-being was assessed using the Fibromyalgia Impact Questionnaire (FIQ) were included. Dual abstraction of data for study, subject and exercise program characteristics as well as assessment of changes in global well-being using the total score from the FIQ was conducted. Risk of bias was assessed using the Cochrane bias assessment tool. Random-effects models and Hedge's standardized effect size (g) were used to pool results according to per-protocol and intention-to-treat analyses. Results: Of 1,025 studies screened, 7 representing 5 per-protocol and 5 intention-to-treat outcomes in 473 (280 exercise, 193 control) primarily female (99%) participants 18-73 years of age were included. Small, statistically significant improvements in global well-being were observed for per-protocol (g and 95% confidence interval, -0.39, -0.69 to -0.08) and intention-to-treat (-0.34, -0.53 to -0.14) analyses. No statistically significant within-group heterogeneity was found (per-protocol, Qw = 6.04, p = 0.20, I-squared = 33.8%; intention-to-treat, Qw = 3.19, p = 0.53, I-squared = 0%) and no between-group differences for per-protocol and intention-to-treat outcomes were observed (Qb = 0.07, p = 0.80). Changes were equivalent to improvements of 8.2% for per-protocol analyses and 7.3% for intention-to-treat analyses. Conclusions: The results of this study suggest that exercise improves global well-being in community-dwelling women with fibromyalgia. However, additional research on this topic is needed, including research in men as well as optimal exercise programs for improving global well-being in adults

       (3)    Iannuccelli C, Di FM, Alessandri C, Guzzo MP, Croia C, Di SF et al. Pathophysiology of fibromyalgia: a comparison with the tension-type headache, a localized pain syndrome. Ann N Y Acad Sci 2010; 1193(1):78-83.
Abstract: Fibromyalgia (FM) is thought to occur because of the combination of interactions among neurotransmitters, such as neuropeptide Y (NPY), stressors, hormones, cytokines, and both the immune and sympathetic nervous systems. The aim of this study was to evaluate serum concentrations of cytokines, antipolymer antibodies (APA), and NPY in 51 patients with FM, 25 with tension-type headache (TTH), and 15 healthy controls. Serum concentrations of eight different cytokines, APA and NPY, were measured. Interleukin (IL)-1RA, IL-6, IL-10, and tumor necrosis factor-alpha were higher in serum of FM patients compared with TTH patients and a significant correlation between IL-10 and Fibromyalgia Impact Questionnaire score was observed. There was a significant difference between FM and TTH versus controls in NPY levels, but not in APA levels. Cytokines and NPY take part in pain modulation and even if they are altered in FM they cannot be considered as measurable biomarkers of disease

       (4)    Rodero B, Garcia-Campayo J, Casanueva B, Lopez-Del-Hoyo Y, Serrano-Blanco A, Luciano JV. Validation of the Spanish version of the Chronic Pain Acceptance Questionnaire (CPAQ) for the assessment of acceptance in Fibromyalgia. Health Qual Life Outcomes 2010; 8(1):37.
Abstract: ABSTRACT: BACKGROUND: The aim of this study was to validate a Spanish version of the Chronic Pain Acceptance Questionnaire (CPAQ). Pain acceptance is the process of giving up the struggle with pain and learning to live a worthwhile life despite it. The Chronic Pain Acceptance Questionnaire (CPAQ) is the questionnaire most often used to measure pain acceptance in chronic pain populations. METHODS: A total of 205 Spanish patients diagnosed with fibromyalgia syndrome who attended our pain clinic were asked to complete a battery of psychometric instruments: the Pain Visual Analogue Scale (PVAS) for pain intensity, the Hospital Anxiety and Depression Scale (HADS), the Medical Outcome Study Short Form 36 (SF-36), the Pain Catastrophising Scale (PCS) and Fibromyalgia Impact Questionnaire (FIQ). RESULTS: Analysis of results showed that the Spanish CPAQ had good test-retest reliability (intraclass correlation coefficient 0.83) and internal consistency reliability (Cronbach's : 0.83). The Spanish CPAQ score was significantly correlated with pain intensity, anxiety, depression, pain catastrophising, health status and physical and psychosocial disability. The Scree plot and a Principal Components Factor analysis confirmed the same two-factor construct as the original English CPAQ. CONCLUSION: The Spanish CPAQ is a reliable clinical assessment tool with valid construct validity for the acceptance measurement among a sample of Spanish fibromyalgia patients. This study will make it easier to assess pain acceptance in Spanish populations with fibromyalgia

       (5)    Stuifbergen AK, Blozis SA, Becker H, Phillips L, Timmerman G, Kullberg V et al. A randomized controlled trial of a wellness intervention for women with fibromyalgia syndrome. Clin Rehabil 2010; 24(4):305-18.
Abstract: OBJECTIVE: To examine the effects of a wellness intervention, Lifestyle Counts, for women with fibromyalgia syndrome on the level of self-efficacy for health-promoting behaviours, health-promoting activity and perceived quality of life. DESIGN: A randomized controlled single-blinded trial with treatment and attention-control groups. SETTING: Community in the southwestern United States. SUBJECTS: Convenience sample of 187 women (98 treatment, 89 attention control) with fibromyalgia syndrome (mean age = 53.08 years, SD 9.86). INTERVENTION: The two-phase Lifestyle Counts intervention programme included lifestyle change classes for eight weeks, with goal-setting and telephone follow-up for three months. Participants in the attention-control group were offered an equivalent amount of contact in classes on general disease-related information and health education topics and unstructured follow-up phone calls. Participants were followed for a total of eight months after baseline. OUTCOME MEASURES: Self-report instruments measuring self-efficacy for health behaviours, health-promotion behaviours and health-related quality of life (SF-36 and the Fibromyalgia Impact Questionnaire) were completed at baseline, two months (after the classes), five months (after telephone follow-up) and at eight months. RESULTS: Both groups improved significantly (P<0.05) over time on the measures of self-efficacy, health behaviours, fibromyalgia impact and quality of life. There were significant group x time interactions for scores on the Health Promoting Lifestyle II subscales of physical activity and stress management. CONCLUSIONS: The Lifestyle Counts wellness intervention holds promise for improving health-promoting behaviours and quality of life of women with fibromyalgia syndrome

       (6)    Tishler M, Levy O, Amit-Vazina M. Can fibromyalgia be associated with whiplash injury? A 3-year follow-up study. Rheumatol Int 2010.
Abstract: The objective of this study is to assess the long-term outcome and natural history of a cohort of patients with whiplash injury regarding the development of fibromyalgia. Of the 153 patients who were admitted to the emergency room after whiplash injury in 2004, 126 were reassessed 3 years later. Also, 33 of 53 patients from the original control group of hospitalized patients with fractures were reevaluated. Patients were interviewed by phone and by written forms using a detailed questionnaire. Patients who complained of musculoskeletal symptoms were invited and examined. The study group included 68 men and 58 women, with a mean age of 50.1 +/- 9.7. The control group included 19 men and 14 women with a mean age of 44.2 +/- 10.3. Follow-up period did not differ significantly between the groups 38.3 +/- 2.3 vs. 36.4 +/- 4.2 months. At the end of the follow-up period, three patients in the study group compared with one patient in the control group were diagnosed as having fibromyalgia; all of them were women. The rate of new onset widespread pain increased with time in both groups. Symptoms of dizziness, headaches, fatigue and sleep disturbances improved, as well as the quality of life (QOL) and the Fibromyalgia Impact Questionnaire (FIQ) scores. Insurance claims continued to be more prevalent in the control group. The results of this extended follow-up study confirm previous short-term results showing that whiplash injury and road accident trauma are not associated with an increased risk of fibromyalgia

       (7)    Thomas EN, Blotman F. Aerobic exercise in fibromyalgia: a practical review. Rheumatol Int 2010.
Abstract: The objective of the study was to determine the current evidence to support guidelines for aerobic exercise (AE) and fibromyalgia (FM) in practice, and to outline specific research needs in these areas. Data sources consisted of a PubMed search, 2007 Cochrane Data Base Systematic review, 2008 Ottawa panel evidence-based clinical practice guidelines, as well as additional references found from the initial search. Study selection included randomized clinical trials that compared an aerobic-only exercise intervention (land or pool based) with an untreated control, a non-exercise intervention or other exercise programs in patients responding to the 1990 American College of Rheumatology criteria for FM. The following outcome data were obtained: pain, tender points, perceived improvement in FM symptoms such as the Fibromyalgia Impact Questionnaire total score (FIQ), physical function, depression (e.g., Beck Depression Inventory, FIQ subscale for depression), fatigue and sleep were extracted from 19 clinical trials that considered the effects of aerobic-only exercise in FM patients. Data synthesis shows that there is moderate evidence of important benefit of aerobic-only exercise in FM on physical function and possibly on tender points and pain. It appears to be sufficient evidence to support the practice of AE as a part of the multidisciplinary management of FM. However, future studies must be more adequately sized, homogeneously assessed, and monitored for adherence, to draw definitive conclusions

       (8)    Dogan SK, Aytur YK, Atbasoglu C. Assessment of the relatives or spouses cohabiting with the fibromyalgia patients: is there a link regarding fibromyalgia symptoms, quality of life, general health and psychologic status? Rheumatol Int 2010.
Abstract: It was aimed to investigate the existence of the symptoms related to fibromyalgia in the first-degree relatives or spouses of the patients and to assess the psychologic and general health status of these individuals and the correlation of these with the patients' status. Thirty-seven patients with FS, 32 first-degree relatives or spouses of the patients and 30 healthy subjects as a control group were included. Symptoms related to FS were recorded in all subjects. Fibromyalgia Impact Questionnaire and Nottingham Health Profile were used to assess the components of functional status and quality of life. General health status was evaluated by General Health Questionnaire. Beck Depression Inventory and Beck Anxiety Inventory were used to assess the psychologic status. There were significant differences in the frequency of the symptoms between three groups (P < 0.05). Symptoms and signs related to of relatives/spouses of the patients and healthy controls were found to be significantly lower than those of the patients. GHQ, BAI and BDI scores of patients were found to be significantly higher than relative/spouses and control groups (P < 0.05). There were statistically significant differences between three groups in energy level, pain, sleep and physical abilities subscores of NHP (P < 0.05). No significant differences were detected in NHP subscores between relative/spouses of the patients and controls (P > 0.05). No fibromyalgia symptoms or signs were detected in the relatives/spouses. The general health status, psychologic status and quality of life were found to be not impaired in relatives/spouses of the patients with FS

       (9)    Itoh K, Kitakoji H. Effects of acupuncture to treat fibromyalgia: A preliminary randomised controlled trial. Chin Med 2010; 5:11.
Abstract: ABSTRACT: BACKGROUND: Acupuncture is often used to treat fibromyalgia (FM), but it remains unclear whether acupuncture is effective. This study aims to evaluate the effects of acupuncture on pain and quality of life (QoL) in FM patients. METHODS: Sixteen patients (13 women and 3 men aged 25-63 years) suffering from FM were randomised into two groups: group A (n = 8) received five acupuncture treatments after the fifth week and group B received ten acupuncture treatments. Outcome measures used in this study were pain intensity (visual analogue scale, VAS) and the fibromyalgia impact questionnaire (FIQ). RESULTS: After the fifth week, pain intensity (U = 25.0; P = 0.022) in group B decreased and QoL (U = 24.5; P = 0.026) improved compared to group A. CONCLUSION: The present study suggests that acupuncture treatment is effective to relieve pain for FM patients in terms of QoL and FIQ

     (10)    Lommel K, Kapoor S, Bamford J, Melguizo MS, Martin C, Crofford L. Juvenile primary fibromyalgia syndrome in an inpatient adolescent psychiatric population. Int J Adolesc Med Health 2009; 21(4):571-9.
Abstract: The purpose of this study was to identify the clinical and demographic characteristics of adolescent females admitted to a psychiatric hospital who meet the criteria for Juvenile Primary Fibromyalgia Syndrome (JPFS). METHODS: Participants (n = 62) were adolescent females, ages 12 to 18 years who were admitted to an inpatient psychiatric unit. The participants completed four questionnaires: The Achenbach Youth Self-Report (YSR), the Children's Somatization Inventory (CSI), the Fibromyalgia Impact Questionnaire modified for children (FIQ-C) and the Pain Symptom Questionnaire (PSQ). Then participants were interviewed to assess the Yunus and Masi JPFS criteria. The interview included an examination of 21 (18 bilateral and 3 control) tender points. RESULTS: Of the 62 adolescent females enrolled, 52% (n = 32) met criteria for JPFS (i.e. JPFS cases). Both the FIQ and CSI scores were significantly elevated for JPFS cases as compared with non-cases (p = .0001 and p = .0012 respectively). Cases of JPFS also scored significantly higher on the anxiety, depression, and conduct disorder scales of the YSR. No between-group differences were found in reports of physical or sexual abuse. However, a consistently higher percentage of JPFS cases reported physical or sexual abuse as a child. CONCLUSIONS: Juvenile primary fibromyalgia is highly prevalent in an adolescent inpatient psychiatric unit. This possibility should be taken into consideration when chronic complaints of pain are expressed by patients in this setting, especially in those who have conduct-related issues. The connection between JPFS and abuse history requires further investigation

     (11)    Salaffi F, Sarzi-Puttini P, Ciapetti A, Atzeni F. Assessment instruments for patients with fibromyalgia: properties, applications and interpretation. Clin Exp Rheumatol 2009; 27(5 Suppl 56):S92-105.
Abstract: A comprehensive assessment of the multiple symptom domains associated with fibromyalgia (FM) and the impact of FM on multidimensional aspects of function should form a routine part of the care of FM patients. Clinical trials and long-term clinical registries have used various outcome measures, but the key domains include pain, fatigue, disturbed sleep, physical functioning, emotional functioning, patient global ratings of satisfaction, and their health-related quality of life (HRQL). A number of measures have been ''borrowed'' from the fields of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and adapted to FM, and others are being developed specifically for FM. However, despite the burgeoning theoretical literature and the proliferation of instruments for measuring various health status domains, no unified approach has been developed and there is little agreement concerning the meaning of the results. There is, therefore, still a need for further consensus and the development of a core set of measures and response criteria, more refined measuring instruments, standardised assessor training, cross-cultural adaptations of health status questionnaires, electronic data capture, and the introduction of standardised quantitative measurements into routine clinical care. This article discusses the advantages and limitations of a selection of both newly developed and well-established and validated distress screening instruments that underlines the continuing challenge of assessing FM

     (12)    Salaffi F, Sarzi-Puttini P, Girolimetti R, Atzeni F, Gasparini S, Grassi W. Health-related quality of life in fibromyalgia patients: a comparison with rheumatoid arthritis patients and the general population using the SF-36 health survey. Clin Exp Rheumatol 2009; 27(5 Suppl 56):S67-S74.
Abstract: OBJECTIVES: To compare health-related quality of life (HRQL) in fibromyalgia (FM) patients with that of patients with rheumatoid arthritis (RA) and the general population, and investigate if the factors are associated with the greater impact of FM. METHODS: This cross-sectional study involved 380 patients with FM, 693 patients with RA and 1579 healthy controls. HRQL was evaluated using the Medical Outcome Study Short-Form 36 (SF-36), and the measures included disease-related characteristics, demographic variables and comorbidities. S-scores were calculated for comparisons with the norm, and multivariate analyses were used to assess the relationships between HRQL and clinical and demographic variables. RESULTS: In comparison with the general population, the FM patients showed significant impairment in relation to all of the eight scales of the SF-36 (p<0.0001), as well as the physical and mental component summary scores (PCS and MCS) (p<0.0001). The mean PCS and MCS of the FM patients were 38.5 (SD=6.9) and 32.8 (SD=10.9), whereas those of the RA patients were 33.5 (SD=6.4) (p<0.01) and 40.2 (SD=11.9) (p<0.001). The dimensions typically affected by FM were vitality (s-score -1.61), mental health (s-score -1.46) and general health (s-score-1.47), whereas physical functioning (s-score-1.63) and role limitations due to physical function (s -score -0.94) were more impaired in the RA patients; the bodily pain scores were similar in the two groups. The PCS was lower than the MCS in the RA patients (s-scores -1.80 vs. -0.62), but the two scores were similar in the FM patients (s-scores -1.20 vs. -1.08). Multiple regression models showed that the physical component of the SF-36 was associated with widespread pain (the SAPS score) (p<0.0001), educational level (p=0.0017), and the body mass index (p=0.007), and the mental component was associated with the widespread pain (p=0.0005), sleep abnormalities (p=0.0033), physical function (p=0.015), fatigue (p=0.029), gender (p=0.014) and a low educational level (p=0.0007). CONCLUSION: Patients with FM see the disease as having a worse health than RA patients and the general population, especially in terms of mental health

     (13)    Sanudo B, Galiano D. Using cardiovascular parameters and symptom severity to prescribe physical activity in women with fibromyalgia. Clin Exp Rheumatol 2009; 27(5 Suppl 56):S62-S66.
Abstract: OBJECTIVES: This study has two main aims, firstly to define subgroups of women affected by fibromyalgia syndrome (FMS) based on symptoms and secondly to determine cardiovascular parameters in treadmill exercises in order to prescribe physical activity. METHODS: Thirty-two women (age= 53.26+/-6.61 yr) were assigned to two different groups based on their functional capacity and symptoms as measured by the Fibromyalgia Impact Questionnaire and pain. Subjects were submitted twice to a maximum treadmill incremental test until participants achieved volitional exhaustion (VO2max). Expired respiratory gases, ventilator parameters and heart rate (HR) were measured continuously through exercise, and rate perceived exertion (RPE) was assessed once a minute during the test. RESULTS: Peak VO2 values for the moderately affected group (Group 1) were significantly different from those of severely affected group (Group 2) (26.2+/-2.1 ml x kg(-1) x min(-1) (Group 1) and 22.1+/-2.5 ml x kg(-1) x min(-1) (Group 2)). Additionally taking into account VO2 at ventilatory threshold (VO2VT), significant differences between groups were found in both tests. Some notable differences in all parameters evaluated were also found. CONCLUSION: This study has demonstrated that the aerobic capacity of patients with FMS was different according to how severely affected they were by the condition; therefore, physical activity of the same intensity should not be prescribed for both groups. According to these results, health professionals could prescribe physical activity with confidence to this patient group

     (14)    Dell'Osso L, Bazzichi L, Consoli G, Carmassi C, Carlini M, Massimetti E et al. Manic spectrum symptoms are correlated to the severity of pain and the health-related quality of life in patients with fibromyalgia. Clin Exp Rheumatol 2009; 27(5 Suppl 56):S57-S61.
Abstract: OBJECTIVES: We aimed at investigating the impact of lifetime manic spectrum symptoms on the severity of pain and the health-related quality of life (HRQoL) in patients with fibromyalgia (FM). METHODS: One hundred and sixty-seven patients with FM, assessed according to the ACR criteria, were consecutively enrolled. Psychiatric diagnoses were carried out following the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV-TR). The severity of pain and the HRQoL of FM patients was measured by means of the Fibromyalgia Impact Questionnaire (FIQ) and the Medical Outcomes Study Short Form-36 Health Survey (MOS SF-36); the mood spectrum symptomatology by means of the Mood Spectrum-Self Report (MOODS-SR). RESULTS: A high rate of lifetime manic symptoms was detected and resulted as related to the Pain Visual Analogic Scale ("pain VAS") of the FIQ and the FIQ total scores as well as to the "bodily pain", and to the physical and mental component summary scores of the MOS SF-36, both in the whole sample (n=167) and in FM patients without bipolar disorder (n=160). CONCLUSION: Our results highlight the need to pay more attention to manic spectrum symptoms and features in FM patients, because of their relationship with the severity of pain and with a worse HRQoL

     (15)    Rasmussen LB, Mikkelsen K, Haugen M, Pripp AH, Forre OT. Treatment of fibromyalgia at the Maharishi Ayurveda Health Centre in Norway. A six-month follow-up study. Clin Exp Rheumatol 2009; 27(5 Suppl 56):S46-S50.
Abstract: BACKGROUND: Treatments offered at the Maharishi Ayurveda Health Centre in Norway are based on Maharishi Vedic medicine, which is also known as Maharishi Ayurveda. It is a consciousness based revival of the ancient Ayurvedic medicine tradition in India and is established by Maharishi Mahesh Yogi, the founder of the Transcendental Meditation (TM) technique. OBJECTIVE: To conduct a pilot study of the effect of the treatment program at the Health Centre on fibromyalgia patients. METHODS: Thirty-one women with diagnosed fibromyalgia received an individually designed Maharishi Vedic physiological purification therapy. All subjects received personal advice on diet based on Ayurvedic principles, including a novel approach to food into-lerance, and daily routines. In addition they were offered instruction in TM (for stress and pain management and personal development) (four subjects started), and recommended Ayurvedic herbal food products for home treatment. MAIN OUTCOME MEASURES: A modified Fibromyalgia Impact Questionnaire included a visual analogue scale for each of the seven outcomes: working ability, generalised pain, tiredness, stiffness, tiredness on arising, anxiety and depression. Pre-treatment scores were compared with scores at six-month follow-up for levels of statistical significance. RESULTS: Twenty-eight subjects (90%) completed the follow-up. The outcome measures were reduced by 25 to 46% by the study's endpoint: working ability (p<0.002), pain (p<0.001), tiredness (p<0.001), morning tiredness (p<0.001), stiffness (p<0.005), anxiety (p<0.136), and depression (p<0.001). A group of five excellent responders including all four participants who started to practise TM, had almost no symptoms by the endpoint. Compared to the non-meditating control group the TM-subgroup showed statistically significant improvements for all outcome measures except depression. CONCLUSIONS: In this pilot study fibromyalgia patients undergoing treatment at Maharishi Ayurveda Health Centre in Norway showed significant improvements six months post treatment. Because fibromyalgia is considered a treatment-resistant condition, these encouraging results warrant further research

     (16)    Calandre EP, Rodriguez-Claro ML, Rico-Villademoros F, Vilchez JS, Hidalgo J, Delgado-Rodriguez A. Effects of pool-based exercise in fibromyalgia symptomatology and sleep quality: a prospective randomised comparison between stretching and Ai Chi. Clin Exp Rheumatol 2009; 27(5 Suppl 56):S21-S28.
Abstract: OBJECTIVE: To evaluate the effectiveness and tolerability of two pool-based physical therapies, stretching and Ai Chi, in fibromyalgia symptomatology and sleep quality. METHODS: Eighty-one patients, randomly assigned to stretching (n=39) or Ai Chi (n=42), received 18 physiotherapy sessions and were evaluated at baseline, at treatment termination, and after 4 and 12 weeks of follow-up. Main outcome measures were the Fibromyalgia Impact Questionnaire (FIQ) and the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures included the Beck Depression Inventory (BDI), the State and Trait Anxiety Inventory (STAI), and the SF-12 Health Survey (SF-12). Data analysis was done with repeated measures ANOVA and effect size estimation. RESULTS: No differences were found between groups but significant reduction in the FIQ and the PSQI scores were observed in Ai Chi but not in stretching group, with larger effect sizes and longer effect duration on sleep measures. BDI scores decreased in stretching but not in Ai Chi group with small effect sizes. Trait-anxiety scores decreased in both groups also with small effect sizes. The mental component summary of the SF-12 increased only in stretching group with effect sizes moderate to large. CONCLUSIONS: Although no global differences were found between groups, Ai Chi significantly improved fibromyalgia symptomatology and sleep quality, whereas stretching only improved subjects' psychological well-being

     (17)    Rico-Villademoros F, Hidalgo J, Morillas-Arques P, Vilchez JS, Delgado-Rodriguez A, Calandre EP. An open-label study of levopromazine (methotrimeprazine) as an add-on therapy in fibromyalgia management. Clin Exp Rheumatol 2009; 27(5 Suppl 56):S16-S20.
Abstract: OBJECTIVES: To assess the potential efficacy and tolerability of levopromazine(methotrimeprazine) in the treatment of fibromyalgia. METHODS: Unicentre, open-label study conducted in thirty-five outpatients, aged 18 years or older, who met the ACR criteria for fibromyalgia and had not satisfactorily responded to previous fibromyalgia treatment. Levopromazine, flexibly dosed (12.5-100 mg/d), was added to the outpatients' original treatment regimens for 12 weeks. The primary outcome measure was the mean change from baseline to endpoint in the Fibromyalgia Impact Questionnaire (FIQ) total score in the intent-to-treat sample. Secondary outcomes included the Clinical Global Impression (CGI) of Severity scale, Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory, State-Trait Anxiety Inventory, 12-Item Short Form Health Survey, and individual items of the FIQ. RESULTS: The mean FIQ total score did not decrease significantly at the study endpoint (63.37 SD 11.32 vs. 61.19 SD 9.32, p=0.73). Pain intensity, as evaluated by the Visual Analogue Scale, remained unchanged at study endpoint (8.5 SD 1.6 vs. 8.2 SD 1.2, p=0.49). A statistically significant reduction was observed in the PSQI score (15.65 SD 3.33 vs. 12.23 SD 3.79, p<0.001, effect size: 1.03) and the CGI-severity score (4.71 SD 0.64 vs. 4.03 SD 1.01, p<0.002, effect size: 1.06). No significant or relevant changes were seen in the remaining fibromyalgia symptoms, psychopathological scales or quality-of-life. The drug was well tolerated. CONCLUSIONS: Despite its efficacy in improving sleep quality, levopromazine does not appear to be a useful alternative treatment for fibromyalgia

     (18)    Le GM, Mainguy Y, Le LK, Nadjar A, Allain D, Galissie M. Linguistic validation of six patient-reported outcomes instruments into 12 languages for patients with fibromyalgia. Joint Bone Spine 2010; 77(2):165-70.
Abstract: CONTEXT: The multidimensional nature of the fibromyalgia syndrome means that different instruments need to be used to assess the patients' perception of this constellation of physical and psychological symptoms and their impact on their daily lives. Six questionnaires (Multidimensional Fatigue Inventory MFI, Fibromyalgia Impact Questionnaire FIQ, Multiple Ability Self-report Questionnaire MASQ, State-Trait Anxiety Inventory STAI, Beck Depression Inventory-II BDI-II and Patient Global Impression of Change PGIC) were linguistically validated into 12 languages. METHODS: The standardized cross-cultural adaptation process includes the following steps: forward translation, backward translation, and review of the version by a clinician and comprehension tests on subjects in the target country. RESULTS: Regardless of the instruments and dimensions studied, the same translation and cultural adaptation issues arose: (1) an issue that is strictly related to translation, for example, the word "things" was translated as "something"; (2) literal translation is possible but culturally irrelevant, for example the expression "to walk several blocks", which is a completely abstract concept in Europe, was translated as "to walk for more than one kilometre"; (3) the translation needed to be reformulated or the tense needed to be changed for idiomatic reasons. For example, the present perfect does not exist in German and so the present simple was used in the first version. The imperfect was eventually used with adverbs such as "lately". CONCLUSIONS: Linguistic adaptation was completed according to a recognized and rigorous method allowing for the wide-scale use of these patient-reported outcomes instruments in international studies

     (19)    Cho KI, Lee JH, Lee HG, Kim SM, Kim TI. Assessment of myocardial function in patients with fibromyalgia and the relationship to chronic emotional and physical stress. Korean Circ J 2010; 40(2):74-80.
Abstract: BACKGROUND AND OBJECTIVES: An association between emotional or physical stressful triggers and adverse cardiovascular events, such as death and myocardial infarction, has been recognized for many years. The clinical features of transient left apical ballooning syndrome have been clearly described, but the effect of chronic stress on the myocardium is unknown. Our objective was to assess left ventricular (LV) function in patients with fibromyalgia (FM) with chronic emotional and physical stress. SUBJECTS AND METHODS: We investigated 30 consecutive postmenopausal women (mean age, 48+/-8 years) satisfying the criteria for FM with atypical chest pain and 20 age-matched healthy controls by means of standard and 2-dimensional strain (2DS) echocardiography. Patients with hypertension, coronary heart disease, or diabetes were excluded. Global and segmental longitudinal deformation parameters of LV function from 3 apical views were analyzed, and patients underwent a manual tender point survey for the number of tender points and tender point counts, and completed the Fibromyalgia Impact Questionnaire (FIQ), which was comprised of physical and feel scores, the Brief Fatigue Inventory (BFI), and the Beck Depression Inventory (BDI). RESULTS: Both global and segmental longitudinal LV strains were significantly reduced in FM patients with high FIQ scores (>50) compared to FM patients with low FIQ scores (-18.98% vs. -22.72%). Various emotional and physical stress indexes were significantly correlated with global LV strain. CONCLUSION: Global and segmental LV strains were negatively associated with fatigue, tender point count, and FIQ score. However, there was no significant association between depression and LV strain. This study demonstrated that chronic emotional or physical stress in FM patients might reduce myocardial longitudinal deformation

     (20)    Choy E, Richards S, Bowrin K, Watson P, Lloyd A, Sadosky A et al. Cost effectiveness of pregabalin in the treatment of fibromyalgia from a UK perspective. Curr Med Res Opin 2010; 26(4):965-75.
Abstract: BACKGROUND: Fibromyalgia is a chronic condition associated with widespread pain, sleep disturbance and disability. Disease related costs are high and effective treatment options few. OBJECTIVES: To evaluate the cost effectiveness of pregabalin in the treatment of fibromyalgia. METHODS: A decision-analytic model was developed comparing pregabalin 300 mg or 450 mg against placebo, duloxetine 60 mg or 120 mg, gabapentin, tramadol and amitriptyline. After a 12 week treatment phase patients who responded to treatment entered an ongoing treatment phase using a Markov model in which patients maintained response, lost response or dropped out. The base case considered patients with severe fibromyalgia defined as a Fibromyalgia Impact Questionnaire score of >or=59 and a pain score of >or=6.5 at baseline. Response rates for pregabalin and placebo were taken from three randomised trials, and a 1 year open-label extension study was used for long-term parameters. Response was defined as a >or=30% improvement over baseline in pain score and a patient global impression of change rating of much improved or very much improved. Relative rates of response for other comparators over placebo were extracted from a systematic review of published randomised controlled studies. The primary effectiveness endpoint was Quality Adjusted Life Years (QALYs). Utilities gained over baseline were estimated by applying the SF-6D utility algorithm to SF-36 data collected in the pregabalin trials. Resource use associated with fibromyalgia management was estimated from published studies and costs were estimated from the UK NHS perspective at 2008 prices. Costs and QALYs were discounted at 3.5%. Non-parametric bootstrapping analysis was used to generate confidence intervals. RESULTS: In the base case, pregabalin 300 mg and 450 mg increased cost per patient by pound601 (95% CI: 532, 669) and pound653 (587, 727) and improved QALYs per patient by 0.03 (-0.03, 0.06) and 0.03 (-0.04, 0.08) respectively compared to placebo. The cost per QALY gained (CQG) was pound23,166 and pound22,533. In the base case population CQG for pregabalin 450 mg against duloxetine 60 mg and 120 mg was pound19,224 and pound14,096, against gabapentin pound35,737, against tramadol pound98,072, and was dominated by amitriptyline. Sensitivity analysis found the cost effectiveness of pregabalin to be most sensitive to drug price and response rates. Limitations of the analysis include different definitions of response used and lack of subgroup data reported in the published studies synthesised, and limited data on long-term effect of therapies in fibromyalgia. Although the analysis was based on the best available evidence, the comparisons against amitriptyline and tramadol rely on old studies that were not designed to meet current quality criteria. CONCLUSION: This model found pregabalin 300 mg and 450 mg to be cost effective compared with placebo and, within the limits of available evidence, against duloxetine using standard UK criteria in patients with fibromyalgia experiencing severe pain

     (21)    Branco JC, Zachrisson O, Perrot S, Mainguy Y. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia. J Rheumatol 2010; 37(4):851-9.
Abstract: OBJECTIVE: This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population. METHODS: Outpatients diagnosed with FM according to 1990 American College of Rheumatology criteria (N = 884) were randomized to placebo (n = 449) or milnacipran 200 mg/day (n = 435) for 17 weeks (4-week dose escalation, 12-week stable dose, 9-day down-titration), followed by a 2-week posttreatment period. The primary efficacy criterion was a 2-measure composite responder analysis requiring patients to achieve simultaneous improvements in pain (>or= 30% improvement from baseline in visual analog scale, 24-hour morning recall) and a rating of "very much" or "much" improved on the Patient Global Impression of Change scale. If responder analysis was positive, Fibromyalgia Impact Questionnaire (FIQ) was included as an additional key primary efficacy measure. RESULTS: At the end of the stable dose period (Week 16), milnacipran 200 mg/day showed significant improvements from baseline relative to placebo in the 2-measure composite responder criteria (p = 0.0003) and FIQ total score (p = 0.015). Significant improvements were also observed in multiple secondary efficacy endpoints, including Short-Form 36 Health Survey (SF-36) Physical Component Summary (p = 0.025), SF-36 Mental Component Summary (p = 0.007), Multidimensional Fatigue Inventory (p = 0.006), and Multiple Ability Self-Report Questionnaire (p = 0.041). Milnacipran was safe and well tolerated; nausea, hyperhidrosis, and headache were the most common adverse events. CONCLUSION: Milnacipran is an effective and safe treatment for pain and other predominant symptoms of FM. Registered as trial no. NCT00436033

     (22)    Kim JS, Lee SS, Kim TJ, Park YW. Serum hyaluronic acid levels do not explain morning stiffness in patients with fibromyalgia. Clin Rheumatol 2010; 29(5):535-9.
Abstract: To investigate the serum levels of hyaluronic acid (HA) in Korean female patients with fibromyalgia (FM) and correlate these levels with variables of disease severity including morning stiffness, we measured HA serum levels in 69 FM patients, 72 rheumatoid arthritis (RA) patients, and 71 healthy controls by enzyme-linked binding protein assay. The serum levels of HA in FM patients did not differ from those in the age-matched controls, whereas HA levels were significantly higher in RA patients than in FM patients and controls (both P < 0.001). With a cut-off value of 75 ng/mL, the prevalence of seropositivity was higher in RA patients (59.7%) than in FM patients (26.1%) or controls (14.1%; both P < 0.001). There were no differences in seropositivity between FM patients and controls, or between FM patients with severe symptoms and those with mild symptoms. The HA levels in FM patients were significantly correlated with age, age at diagnosis, age at symptom development, disease duration, symptom duration, and level of education. There were no correlations between HA levels and morning stiffness, tender point counts and scores, or Fibromyalgia Impact Questionnaire, State-Trait Anxiety Inventory, and Beck Depression Inventory scores. In our patients, the serum HA levels were not increased and did not reflect disease severity. These results suggest that serum HA is not a useful laboratory marker for diagnosis and assessment of FM

     (23)    Oh TH, Stueve MH, Hoskin TL, Luedtke CA, Vincent A, Moder KG et al. Brief interdisciplinary treatment program for fibromyalgia: six to twelve months outcome. Am J Phys Med Rehabil 2010; 89(2):115-24.
Abstract: OBJECTIVE: To evaluate the impact and long-term benefit of a brief 1(1/2)-day fibromyalgia treatment program. DESIGN: We assessed 6-12-mo outcome of 521 participants who underwent a 1(1/2)-day interdisciplinary fibromyalgia treatment program in a tertiary medical center. We administered three self-reported instruments: the Fibromyalgia Impact Questionnaire, the Short Form-36 Health Status Questionnaire, and a satisfaction survey, at baseline, and 6-12 mos after completing the fibromyalgia treatment program. The difference in the Fibromyalgia Impact Questionnaire and Short Form-36 scores before and after the fibromyalgia treatment program was the main outcome measure. RESULTS: Compared with baseline, the Fibromyalgia Impact Questionnaire total score was decreased by a mean (SD) of 7.2 (17.7) points at follow-up (P < 0.001). All Fibromyalgia Impact Questionnaire subscales improved significantly at follow-up (all P < 0.001), except depression score (P = 0.67). The Short Form-36 scores improved significantly in all areas at follow-up (all P < 0.001), except general health perception (P = 0.58) and role emotional (P = 0.13). CONCLUSIONS: A brief 1(1/2)-day fibromyalgia treatment program improves symptoms and quality of life in patients with fibromyalgia for 6-12 mos. Further clinical investigations are needed to compare this fibromyalgia treatment program with other programs and interventions

     (24)    Vallejo MA, Rivera J, Esteve-Vives J. Development of a self-reporting tool to obtain a combined index of severity of fibromyalgia (ICAF). Health Qual Life Outcomes 2010; 8(1):2.
Abstract: BACKGROUND: Fibromyalgia is a syndrome with heterogeneous symptoms. The evaluation in the clinical setting usually fails to cover the complexity of the syndrome. This study aims to determine how different aspects of fibromyalgia are inter-related when measured by means of a self-reporting tool. The objective is to develop a more complete evaluation model adjusted to the complexity and multi-dimensional nature of the syndrome. METHODS: Application was made of the Fibromyalgia Impact Questionnaire, the Hospital Anxiety and Depression Scale, the Brief Pain Inventory, the Fatigue Assessment Scale, the Health Assessment Questionnaire, the General Health Questionnaire (GHQ-28), the Chronic Pain Coping Inventory, the Arthritis Self-efficacy Scale and the Sleep Quality Scale. An assessment was made, on the basis of clinical interviews, case histories and specific tests, of the patient sociodemographic data, comorbidity, physical exploration and other clinical indexes. An exploratory factor analysis was made, with comparisons of the clinical index scores in extreme groups of patients. RESULTS: The ICAF composed of 59 items was obtained, offering four factors that explain 64% of the variance, and referred to as Emotional Factor (33.7%), Physical-Activity (15%), Active Coping (9%) and Passive Coping (6.3%). A t-test between the extreme scores of these factors in the 301 patients revealed statistically significant differences in occupational status, medically unexplained syndromes, number of tender points, the six-minutes walk test, comorbidity and health care costs. CONCLUSIONS: This study offers a tool allowing more complete and rapid evaluation of patients with fibromyalgia. The test intrinsically evaluates the emotional aspects: anxiety and depression, and their impact upon social aspects. It also evaluates patient functional capacity, fatigue, sleep quality, pain, and the way in which the patient copes with the disease. This is achieved by means of a self-assessment questionnaire based on elements from well known tests

     (25)    Distler O, Eich W, Dokoupilova E, Dvorak Z, Fleck M, Gaubitz M et al. Evaluation of the efficacy and safety of terguride in patients with fibromyalgia syndrome: results of a twelve-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum 2010; 62(1):291-300.
Abstract: OBJECTIVE: To assess the efficacy and safety of terguride, a partial dopamine agonist, in patients with fibromyalgia syndrome (FMS). METHODS: In a 12-week, multicenter, double-blind, placebo-controlled, parallel-group study, 99 patients were randomized at a ratio of 2 to 1 to receive terguride or placebo. Over 21 days, the dosage was titrated to a maximum daily dose of 3 mg of terguride or placebo, and this fixed dosage was continued over 9 weeks. The primary efficacy variable was the intensity of pain (100-mm visual analog scale). Secondary efficacy variables included the Fibromyalgia Impact Questionnaire (FIQ) score, the tender point score (TPS), and the Hamilton Depression Scale (HDS) score. During the study, patients were evaluated for the presence of cervical spine stenosis by magnetic resonance imaging (MRI). RESULTS: No significant differences in the change in pain intensity, FIQ score, TPS, or HDS score between baseline and 12 weeks were observed in the terguride group as compared with the placebo group. Cervical spine stenosis was detected in 22% of the patients. Only patients with cervical spine stenosis responded to terguride treatment. FIQ scores improved significantly (per-protocol analysis), and pain intensity, the TPS score, and the HDS score showed a trend toward improvement in the terguride group as compared with the placebo group. Terguride treatment was safe. Only those adverse events already known to be side effects of terguride were observed. Premature termination of the study in patients receiving terguride (26%) occurred predominantly during up-titration and in the absence of comedication for treatment of nausea. CONCLUSION: Terguride treatment did not improve pain, the FIQ score, the TPS, or the HDS score in the total study population. However, a subgroup of patients with cervical spine stenosis seemed to benefit from terguride treatment

     (26)    Chwieduk CM, McCormack PL. Milnacipran: in fibromyalgia. Drugs 2010; 70(1):99-108.
Abstract: Milnacipran is an orally administered selective serotonin and norepinephrine (noradrenaline) reuptake inhibitor indicated for the management of fibromyalgia in adults. In adults, milnacipran was generally effective in the treatment of fibromyalgia in four well designed trials of 3 or 6 months' duration. Composite responder rates for the treatment of fibromyalgia and fibromyalgia pain (co-primary efficacy variables) were generally higher with milnacipran 100 or 200 mg/day (in two divided doses) than with placebo after 12 weeks of fixed-dose treatment. In one study, the composite responder rate for fibromyalgia pain (co-primary efficacy variable) was also higher with milnacipran 200 mg/day than with placebo after 24 weeks of fixed-dose treatment. Furthermore, the benefits of milnacipran therapy were sustained in a 6-month extension of an initial double-blind trial. Improvements from baseline in mean 24-hour recall pain scores, mean weekly recall pain scores, Patient Global Impression of Change scores and in several items of the Fibromyalgia Impact Questionnaire were observed in patients receiving continuous milnacipran for up to 12 months, as well as in patients who switched from placebo to milnacipran therapy at the start of the extension phase. Milnacipran was generally well tolerated in adults with fibromyalgia, with most adverse events being mild to moderate in severity. Nausea was the most common adverse event reported in milnacipran recipients

     (27)    Goldenberg DL, Clauw DJ, Palmer RH, Mease P, Chen W, Gendreau RM. Durability of therapeutic response to milnacipran treatment for fibromyalgia. Results of a randomized, double-blind, monotherapy 6-month extension study. Pain Med 2010; 11(2):180-94.
Abstract: OBJECTIVE: To evaluate the durability of improvement and long-term efficacy of milnacipran treatment in fibromyalgia, to assess efficacy in patients re-randomized from placebo to milnacipran, and to collect additional information on the tolerability and efficacy of long-term treatment with milnacipran. DESIGN: A total of 449 patients who successfully completed a 6-month lead-in study enrolled in this 6-month extension study (87.7% of eligible subjects). Patients initially receiving milnacipran 200 mg/day during the lead-in study were maintained at 200 mg/day (n = 209); patients initially assigned to placebo or milnacipran 100 mg/day were re-randomized (1:4) to either 100 mg/day (n = 48) or 200 mg/day (n = 192) of milnacipran for an additional 6 months of treatment. Efficacy assessments included visual analog scale pain ratings, Fibromyalgia Impact Questionnaire (FIQ) total score, and Patient Global Impression of Change (PGIC). RESULTS: Patients continuing on milnacipran demonstrated a sustained reduction in pain over the full 12-month period. Additional beneficial effects were also maintained, as indicated by the PGIC and FIQ. Patients initially assigned to either placebo or milnacipran 100 mg/day in the lead-in study and subsequently re-randomized to milnacipran 200 mg/day in the extension study experienced further improvements in their mean pain scores, FIQ total scores, and PGIC ratings at 1 year. Milnacipran treatment was generally well tolerated. The most commonly reported newly emergent adverse event was nausea. CONCLUSIONS: In addition to confirming that milnacipran safely and effectively improves the multiple symptoms of fibromyalgia, these data indicate that milnacipran provides 1-year durable efficacy in this patient population

     (28)    Cherry BJ, Weiss J, Barakat BK, Rutledge DN, Jones CJ. Physical performance as a predictor of attention and processing speed in fibromyalgia. Arch Phys Med Rehabil 2009; 90(12):2066-73.
Abstract: Cherry BJ, Weiss J, Barakat BK, Rutledge DN, Jones CJ. Physical performance as a predictor of attention and processing speed in fibromyalgia. OBJECTIVE: To explore the associations between physical (both self-report and objective measures) and cognitive function for persons with fibromyalgia (FM). DESIGN: Correlational study. SETTING: An exercise testing laboratory in southern California. PARTICIPANTS: Community-residing and functionally independent (not wheelchair-bound) adults meeting the American College of Rheumatology 1990 criteria for FM (N=51) with a mean age of 54 years and no history of stroke. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Composite Physical Function Scale, Fibromyalgia Impact Questionnaire, adapted Trail Making Test parts A (TMT-A) and B (TMT-B), Digit Symbol Substitution Test, a composite index of TMT-A, TMT-B, and Digit Symbol Substitution Test combined, and physical performance assessments. RESULTS: Hierarchical regression analyses indicated that better objective physical performance predicted increased cognitive function for TMT-A and the composite cognitive score after controlling for age and symptom burden. That is, as the physical performance level decreased, cognitive performance levels decreased. CONCLUSIONS: Findings suggest that research is needed to determine whether patterns of physical activity participation, through their effects on physical fitness and performance, can enhance cognitive performance in persons with FM. Physiologic changes in specific brain regions in FM (eg, hippocampus, neural pain regions) suggest that further research is also warranted in determining specific relationships between biomarkers and cognitive performance in persons with FM

     (29)    Altan L, Korkmaz N, Bingol U, Gunay B. Effect of pilates training on people with fibromyalgia syndrome: a pilot study. Arch Phys Med Rehabil 2009; 90(12):1983-8.
Abstract: Altan L, Korkmaz N, Bingol U, Gunay B. Effect of Pilates training on people with fibromyalgia syndrome: a pilot study. OBJECTIVE: To investigate the effects of Pilates on pain, functional status, and quality of life in fibromyalgia, which is known to be a chronic musculoskeletal disorder. DESIGN: Randomized, prospective, controlled, and single-blind trial. SETTING: Physical medicine and rehabilitation department. PARTICIPANTS: Women (N=50) who had a diagnosis of fibromyalgia syndrome (FMS) according to the American College of Rheumatology criteria. INTERVENTION: The participants were randomly assigned into 2 groups. In group 1, a Pilates exercise program of 1 hour was given by a certified trainer to 25 participants 3 times a week for 12 weeks. In group 2, which was designed as the control group, 25 participants were given a home exercise (relaxation/stretching) program. In both groups, pre- (week 0) and posttreatment (week 12 and week 24) evaluation was performed by one of the authors, who was blind to the group allocation. MAIN OUTCOME MEASURES: Primary outcome measures were pain (visual analog scale) and Fibromyalgia Impact Questionnaire (FIQ). Exploratory outcome measures were number of tender points, algometric score, chair test, and Nottingham Health Profile. RESULTS: Twenty-five Pilates exercise and 24 relaxation/stretching exercise participants completed the study. In group 1, significant improvement was observed in both pain and FIQ at week 12 but only in FIQ at 24 weeks. In group 2, no significant improvement was obtained in pain and FIQ at week 12 and week 24. Comparison of the 2 groups showed significantly superior improvement in pain and FIQ in group 1 at week 12 but no difference between the 2 groups at week 24. CONCLUSIONS: We suggest Pilates as an effective and safe method for people with FMS. Our study is the first clinical study designed to investigate the role of the Pilates method in FMS treatment. We believe that further research with more participants and longer follow-up periods could help assess the therapeutic value of this popular physical exercise method

     (30)    Arnold LM, Clauw DJ, Wohlreich MM, Wang F, Ahl J, Gaynor PJ et al. Efficacy of duloxetine in patients with fibromyalgia: pooled analysis of 4 placebo-controlled clinical trials. Prim Care Companion J Clin Psychiatry 2009; 11(5):237-44.
Abstract: OBJECTIVE: To investigate the efficacy of duloxetine in the treatment of pain and improvement in functional impairment and quality of life in patients with fibromyalgia from a pooled analysis of 4 placebo-controlled, double-blind, randomized trials. METHOD: Patients were eligible for inclusion in the studies if they were at least 18 years of age, met criteria for fibromyalgia as defined by the American College of Rheumatology, and had specified minimum pain severity scores. Across all studies, 797 patients received duloxetine 60-120 mg/d and 535 patients received placebo. Pain was assessed by the Brief Pain Inventory (BPI) 24-hour average pain severity score; other efficacy measures included the Clinical Global Impressions-Severity of Illness scale (CGI-S), Patient Global Impressions-Improvement scale (PGI-I), 17-item Hamilton Depression Rating Scale (HDRS-17), Fibromyalgia Impact Questionnaire (FIQ) total score, BPI pain interference items, Sheehan Disability Scale (SDS), and Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) mental and physical components. Changes from baseline to endpoint (last observation carried forward) for most of the above efficacy measures were analyzed using an analysis-of-covariance model. RESULTS: After 12 weeks of treatment, pain was significantly reduced in patients treated with duloxetine (P < .001) compared with placebo. In addition, duloxetine was superior to placebo in improving CGI-S (P < .001); PGI-I (P < .001); FIQ total (P < .001); HDRS-17 total (P = .003); SDS global functioning (P < .001), work/school (P = .018), and family life (P < .001); SF-36 mental (P < .001) and physical (P = .026) component; and BPI pain interference (P < .001) scores. Treatment-by-subgroup interactions were not significant for sex (P = .320), age (P = .362), or race (P = .180). CONCLUSIONS: This pooled analysis provides evidence that 12 weeks of treatment with duloxetine 60-120 mg/d effectively improves fibromyalgia symptoms and may offer benefits beyond pain relief

     (31)    van KS, Kraaimaat FW, van LW, van Riel PL, Evers AW. A patient's perspective on multidisciplinary treatment gain for fibromyalgia: an indicator for pre-post treatment effects? Arthritis Rheum 2009; 61(12):1626-32.
Abstract: OBJECTIVE: Increasing attention is devoted to the patient's perspective in clinical research and practice. However, the relationship between the patient's view on treatment progress and standardized pre-post changes in health outcomes is not well understood. The objective of this study was to investigate whether the patient's perception of treatment gain converges with pre-post treatment effects of a multidisciplinary treatment as assessed by standardized self-report measures. METHODS: During a tailored multidisciplinary treatment for fibromyalgia, validated self-report questionnaires were assessed at baseline and posttreatment on the outcome measures of pain, functional disability, fatigue, anxiety, and negative mood. In addition, the participants were asked to fill in a questionnaire at the end of the treatment assessing the patient's perception of improvement on core outcomes, as well as satisfaction and usefulness of the treatment. RESULTS: Moderate to relatively high correlations were found between the patient's perception of improvement and pre-post changes on the physical outcomes, in contrast to small or nonsignificant correlations for psychological outcomes. In addition, satisfaction and usefulness were significantly related to pre-post changes on physical outcomes, but no relationship was found with respect to psychological outcomes. CONCLUSION: Results suggest that the patient's perception of treatment gain and pre-post changes in outcomes during treatment assess different aspects of the patient's treatment progress, particularly with regard to psychological functioning. Future research on clinical improvements should consider the patient's perception of treatment gain as an independent and clinically relevant outcome, in addition to standardized trial data of pre-post assessments of health outcomes

     (32)    Sutbeyaz ST, Sezer N, Koseoglu F, Kibar S. Low-frequency pulsed electromagnetic field therapy in fibromyalgia: a randomized, double-blind, sham-controlled clinical study. Clin J Pain 2009; 25(8):722-8.
Abstract: OBJECTIVE: To evaluate the clinical effectiveness of low-frequency pulsed electromagnetic field (PEMF) therapy for women with fibromyalgia (FM). METHODS: Fifty-six women with FM, aged 18 to 60 years, were randomly assigned to either PEMF or sham therapy. Both the PEMF group (n=28) and the sham group (n=28) participated in therapy, 30 minutes per session, twice a day for 3 weeks. Treatment outcomes were assessed by the fibromyalgia Impact questionnaire (FIQ), visual analog scale (VAS), patient global assessment of response to therapy, Beck Depression Inventory (BDI), and Short-Form 36 health survey (SF-36), after treatment (at 4 wk) and follow-up (at 12 wk). RESULTS: The PEMF group showed significant improvements in FIQ, VAS pain, BDI score, and SF-36 scale in all domains at the end of therapy. These improvements in FIQ, VAS pain, and SF-36 pain score during follow-up. The sham group also showed improvement were maintained on all outcome measures except total FIQ scores after treatment. At 12 weeks follow-up, only improvements in the BDI and SF-36 scores were present in the sham group. CONCLUSION: Low-frequency PEMF therapy might improve function, pain, fatigue, and global status in FM patients

     (33)    Joshi MN, Joshi R, Jain AP. Effect of amitriptyline vs. physiotherapy in management of fibromyalgia syndrome: What predicts a clinical benefit? J Postgrad Med 2009; 55(3):185-9.
Abstract: CONTEXT: Fibromyalgia is a chronic disabling condition, and physicians treat it using a number of different treatment modalities. It is not known if one or more of such modalities are better than the others. We compared the efficacy of physiotherapy and amitriptyline in disability reduction in patients of fibromyalgia syndrome in a rural tertiary care hospital in Central India. DESIGN: Open-label alternate patient treatment allocation. MATERIALS AND METHODS: A six-month follow-up was done to assess the benefit of amitriptyline and physiotherapy for disability reduction in patients with fibromyalgia syndrome. Primary outcome measure was improvement in fibromyalgia impact questionnaire (FIQ) score. Statistical Analysis Used : Predictors of benefit were determined using multivariate logistic regression. RESULTS: A total of 175 outpatients were assigned to either amitriptyline (n=87) or structured physiotherapy (n=88) treatments. There was a significant but similar (P=0.82) improvement in disability in both groups. High FIQ score at baseline and low socioeconomic status scores were significant predictors of benefit. CONCLUSIONS: Therapy with amitriptyline or physiotherapy is equally effective in improving outcome in patients of fibromyalgia over a period of six months

     (34)    Lange M, Krohn-Grimberghe B, Petermann F. [Fibromyalgia: influence of depressive symptoms on the outcome after rehabilitation]. Rehabilitation (Stuttg) 2009; 48(5):298-305.
Abstract: BACKGROUND: For the therapy of fibromyalgia a multimodal therapy with patient education is recommended. It integrates pain management and stress management as well as cognitive restructuring. It will be examined whether depressiveness has an influence on rehabilitation outcome immediately after inpatient rehabilitation. METHODS: Various questionnaires, i. e. the Hospital Anxiety and Depression Scale (HADS-D), German Pain Questionnaire (DSF), Cognitive, Behavioural Coping and Psychological Strains Through Chronic Pain questionnaire (FESV), German version of the Pain Anxiety Symptom Scale (PASS-D) and the Patient questionnaire IRES-24, were distributed to 102 fibromyalgia patients in the framework of a pre post design. The scores of patients with and without depressiveness (HADS-D cut-off >or=11) were compared by analysis of variance at two treatment points. RESULTS AND CONCLUSIONS: Immediately after therapy, a general improvement was found regarding depressiveness and pain (strong effect size) as well as regarding pain-related anxiety (medium effect sizes). Only "countertraded activity" of coping with pain did not show any improvement. The "rehabilitation status" improved significantly whereas, in contrast, the "physical health" aspect did not improve. A significant increase was found on the "pain" scale. Additionally, depressive symptoms had a strong impact on the aspects "physical health", "subjective health" and on "rehabilitation status". In particular, patients with fibromyalgia and depressiveness showed poorer outcomes regarding these aspects than patients with fibromyalgia without depressiveness. A multimodal therapy with patient education can have a positive impact on the outcome of rehabilitation

     (35)    Vazquez-Rivera S, Gonzalez-Blanch C, Rodriguez-Moya L, Moron D, Gonzalez-Vives S, Carrasco JL. Brief cognitive-behavioral therapy with fibromyalgia patients in routine care. Compr Psychiatry 2009; 50(6):517-25.
Abstract: OBJECTIVE: The purpose of the present study was to evaluate the effectiveness of a brief cognitive-behavioral therapy (CBT) group intervention for fibromyalgia syndrome in routine care. METHOD: Thirty-four female outpatients who participated in a 5- to 6-week group CBT program were assessed for depression (Beck Depression Inventory), anxiety (State-Trait Anxiety Inventory), coping strategies (Coping Questionnaire for Chronic Pain), physical functioning (Fibromyalgia Impact Questionnaire), and somatization (Health Attitude Survey) at 3 time points (baseline, pretreatment, and posttreatment) using a pre-post, quasi-experimental design. RESULTS: Twenty-three female outpatients (68% of the initial sample) for which data were available in all 3 time points were included in the analyses. No changes were found during the waiting period. During the treatment period, there were significant reductions in depression (P = .001) and anxiety (P = .006) symptoms and an increased use of distraction skills (P < .001). The analysis of rate of change showed a significant correlation between anxiety and depression (P = .004), but not between these variables and the use of distraction as a coping strategy. CONCLUSION: Brief group CBT is effective in reducing emotional distress in female patients with long-standing fibromyalgia syndrome in the context of routine care. Attention-distraction skills appear to be amenable to change by means of brief CBT, but further research is needed to clarify their contribution to short-term clinical improvement

     (36)    Lera S, Gelman SM, Lopez MJ, Abenoza M, Zorrilla JG, Castro-Fornieles J et al. Multidisciplinary treatment of fibromyalgia: does cognitive behavior therapy increase the response to treatment? J Psychosom Res 2009; 67(5):433-41.
Abstract: OBJECTIVE: Multidisciplinary treatments (MTs) are usually recommended for reducing fibromyalgia (FM) symptoms and include physical exercise, drug management, education, and cognitive behavior therapy (CBT). However, there is no evidence that CBT adds efficacy to the other therapeutic components. This randomized controlled trial analyzed the response of FM patients to two MTs, with and without CBT, according to the presence of concurrent symptoms. METHODS: Eighty-three women with FM were randomly assigned to MT or combined MT and CBT. The MT included medical intervention, physical training, education, and discussion of the syndrome. The CBT focused on coping with stress, modifying lifestyles, and changing pain behaviors. Demographic and clinical data, information regarding tender points, and questionnaire responses about functional capability [Fibromyalgia Impact Questionnaire (FIQ)], health status [36-item Short Form Health Survey (SF-36)], and mental health [Symptom Checklist-90-Revised (SCL-90-R)] were obtained at the beginning, at the end of the 15-week treatment, and at 6-month follow-up. Subgroups are identified in relation to treatment response. RESULTS: Sixty-six women (80%) completed treatment. Although the variance of the total sample had changed at posttreatment (F=2.67, P=.031), there was no significant effect for the TimexTreatment interaction (F=1.65, P=.16). Univariate tests detected a significant fall in the FIQ score. The subgroup of patients with fatigue showed a better response with MT+CBT than with MT. At 6-month follow-up, the statistical differences had been maintained. Intention-to-treat analysis ratified these results. CONCLUSIONS: MT improves functional capability and reduces symptom impact. CBT increases mildly the effect of MT in patients with fatigue

     (37)    Hudson JI, Arnold LM, Bradley LA, Choy EH, Mease PJ, Wang F et al. What makes patients with fibromyalgia feel better? Correlations between Patient Global Impression of Improvement and changes in clinical symptoms and function: a pooled analysis of 4 randomized placebo-controlled trials of duloxetine. J Rheumatol 2009; 36(11):2517-22.
Abstract: OBJECTIVE: To investigate the relationship between changes in clinical rating scale items and endpoint Patient Global Impression of Improvement (PGI-I). METHODS: Data were pooled from 4 randomized, double-blind, placebo-controlled studies of duloxetine in patients with fibromyalgia (FM). Variables included in the analyses were those that assessed symptoms in FM domains of pain, fatigue, sleep, cognitive difficulties, emotional well-being, physical function, and impact on daily living. The association of endpoint PGI-I with changes from baseline in individual variables was assessed using Pearson product-moment correlations (r). Stepwise linear regression was used to identify those variables for which changes from baseline were statistically significant independent predictors of the endpoint PGI-I ratings. RESULTS: Changes in pain variables and interference of symptoms with the ability to work were highly correlated (r >or= 0.5 or r <or= -0.5) with endpoint PGI-I. Moderate correlation with endpoint PGI-I (0.30 <or= r < 0.5 or -0.5 < r <or= -0.30) included changes in variables that assessed physical functioning, depression, anxiety, fatigue, and several variables related to impact on daily living. Independent predictor variables of endpoint PGI-I identified by stepwise linear regression included assessments for pain, physical function, vitality, anxiety, social function, and tender point thresholds. CONCLUSION: In addition to pain reduction, what makes patients with FM feel better may include improvement in fatigue, physical functioning, mood, and impact on daily living. An assessment of these domains may be important in clinical trials of FM and in the management of patients with FM

     (38)    Ablin JN, Odes L, Neumann L, Buskila D. The Hebrew version of the FibroFatigue scale: validation of a questionnaire for assessment of fibromyalgia and chronic fatigue syndrome. Rheumatol Int 2009.
Abstract: The objective of this study is to validate a translated Hebrew version of the FibroFatigue Scale (FFS). The Hebrew version of the FFS was administered to 100 patients fulfilling ACR criteria for classification of FM together with the validated Hebrew version of the Fibromyalgia Impact Questionnaire (FIQ), the validated Hebrew version of the Short Form-36 (SF-36) and a Visual Analogue Scale (VAS) measurement of pain, anxiety, depression, morning stiffness and global well being. 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. Mean duration of symptoms was 10.7 years, and mean age of participants was 53.5 years. Test-retest reliability was between 0.46 and 0.85 for the various FFS items. Internal consistency was 0.89 for the overall FFS. Significant correlations were obtained between the FFS items and the SF-36. These results support the reliability and validity of the data obtained with the Hebrew version of the FSS for detecting and measuring symptom severity in Hebrew speaking patients with FM

     (39)    Mannerkorpi K, Nordeman L, Ericsson A, Arndorw M. Pool exercise for patients with fibromyalgia or chronic widespread pain: a randomized controlled trial and subgroup analyses. J Rehabil Med 2009; 41(9):751-60.
Abstract: OBJECTIVE: To evaluate the effects of pool exercise in patients with fibromyalgia and chronic widespread pain and to determine characteristics influencing the effects of treatment. METHODS: A total of 134 women with fibromyalgia and 32 with chronic widespread pain were randomized to a 20-session pool exercise and a 6-session education programme or to a control group undertaking the same education programme. The primary outcomes were the Fibromyalgia Impact Questionnaire (FIQ) total score and the 6-minute walk test (6MWT). FIQ Pain and other health variables were included. RESULTS: The FIQ total (p = 0.04) improved in the intervention group, with an effect size of 0.32. Patients who had participated in at least 60% of the exercise sessions improved in the FIQ total (effect size 0.44), the 6MWT (effect size 0.43) and FIQ Pain (effect size 0.69) compared with controls (p < 0.05). Long-term follow-up revealed lasting, but small, improvement (effect size < 0.29) in the 6MWT among the active participants (p < 0.05). Analyses within the subgroups showed that patients with milder stress, pain or depression improved most by treatment on the FIQ total (effect size > 0.50, p < 0.05) compared with controls. CONCLUSION: The exercise-education programme showed significant, but small, improvement in health status in patients with fibromyalgia and chronic widespread pain, compared with education only. Patients with milder symptoms improved most with this treatment

     (40)    Bidari A, Ghavidel-Parsa B, Ghalehbaghi B. Reliability of ACR criteria over time to differentiate classic fibromyalgia from nonspecific widespread pain syndrome: a 6-month prospective cohort study. Mod Rheumatol 2009; 19(6):663-9.
Abstract: American College of Rheumatology (ACR) 1990 criteria, initially introduced to classify fibromyalgia (FM) syndrome, has gained popularity in research and clinical grounds for diagnostic purposes. The objectives of this study were designed to assess the consistency of ACR criteria against the time in classifying FM. This was a prospective cohort study performed in a multidisciplinary pain clinic from October 2002 to June 2005. Patients who were clinically suspected of having FM and had a normal screening laboratory evaluation were scheduled for dolorimetry. Those found to have 6 or more tender points were considered eligible and labeled as either classic or atypical FM if they did or did not, respectively, fulfil ACR criteria. The 2 groups were assessed using the Fibromyalgia Impact Questionnaire (FIQ) and compared using baseline characteristics. We reassessed dolorimetric exam and FIQ 6 months later. Of 91 patients who participated in this study,70 completed the follow-up. Of them, 34 (49%) patients were identified as atypical, and 36 (51%) were labeled as classic FM. At first visit, the classic FM group had higher scores on sleep quality, stiffness, anxiety, depression, and total FIQ score (p\0.05) but not for other variables. At 6 months, there was no significant difference between the 2 groups in all measured variables. Labeling shift from classic to atypical FM and vice versa occurred at a rate of 36.1 and 32.4%, respectively. This study showed the ACR 1990 criteria was not able to consistently classify affected patients with FM syndrome within a group of patients having nonspecific body pain and multiple tender points over 6 months of follow-up

     (41)    Karsdorp PA, Vlaeyen JW. Active avoidance but not activity pacing is associated with disability in fibromyalgia. Pain 2009; 147(1-3):29-35.
Abstract: Activity pacing has been suggested as a behavioural strategy that may protect patients with fibromyalgia (FM) against activity dysregulation and disability. The aim of the present study was to empirically test whether the construct of activity pacing is distinct from other behavioural strategies assessed with the Chronic Pain Coping Inventory (CPCI), such as guarding, resting, asking for assistance, relaxation, task persistence, exercise/stretch, seeking social support, and coping self-statements. The second objective was to test whether pacing was associated with physical disability when controlling for pain catastrophizing, pain severity and the other behavioural strategies as measured with CPCI. A random sample of patients with FM (N=409) completed the CPCI, the Pain Catastrophizing Scale (PCS), the Physical Index of the Fibromyalgia Impact Questionnaire (FIQ-PH) and the Pain Disability Index (PDI). The results demonstrated that the Dutch version of the CPCI including the pacing subscale has adequate internal consistency and construct validity. Moreover, guarding and asking for assistance, but not pacing, were associated with disability. These findings are in line with fear-avoidance models and suggest that specifically active avoidance behaviours are detrimental in FM. The authors recommend developing cognitive-behavioural and exposure-based interventions and challenge the idea that pacing as an intervention is essential in pain self-management programs

     (42)    Salaffi F, Sarzi-Puttini P, Girolimetti R, Gasparini S, Atzeni F, Grassi W. Development and validation of the self-administered Fibromyalgia Assessment Status: a disease-specific composite measure for evaluating treatment effect. Arthritis Res Ther 2009; 11(4):R125.
Abstract: INTRODUCTION: The Fibromyalgia Impact Questionnaire (FIQ) is a composite disease-specific measure validated for fibromyalgia (FM), but it is rarely used in clinical practice. The objective was to develop and analyse the psychometric properties of a new composite disease-specific index (Fibromyalgia Assessment Status, FAS), a simple self-administered index that combines a patient's assessment of fatigue, sleep disturbances and pain evaluated on the basis of the 16 non-articular sites listed on the Self-Assessment Pain Scale (SAPS) in a single measure (range 0 to 10). METHODS: The FAS index was constructed using a traditional development strategy, and its psychometric properties were tested in 226 FM patients (209 women, 17 men); whose disease-related characteristics were assessed by means of an 11-numbered circular numerical rating scale (NRS) for pain, fatigue, sleep disturbances and general health (GH), the tender point score (TPS), the SAPS, the FIQ, and the SF-36. A group of 226 rheumatoid arthritis (RA) patients was used for comparative purposes. Of the 179 FM patients who entered the follow-up study, 152 completed the three-month period and were included in the responsiveness analyses. One hundred and fifty-four patients repeated the FAS questionnaire after an interval of one week, and its test/re-test reliability was calculated. Responsiveness was evaluated on the basis of effect size and the standardised response mean. RESULTS: The FAS index fulfilled the established criteria for validity, reliability and responsiveness. Factor analysis showed that SAPS and fatigue contributed most, and respectively explained 47.4% and 31.2% of the variance; sleep explained 21.3%. Testing for internal consistency showed that Cronbach's alpha was 0.781, thus indicating a high level of reliability. As expected, closer significant correlations were found when FAS was compared with total FIQ (rho = 0.347; P < 0.0001) and the FIQ subscales, particularly job ability, tiredness, fatigue and pain (all P < 0.0001), but the correlation between FAS and the mental component summary scale score (MCS) of the SF-36 (rho = -0.531; P < 0.0001) was particularly interesting. Test/re-test reliability was satisfactory. The FAS showed the greatest effect size. The magnitude of the responsiveness measures was statistically different between FAS (0.889) and the FIQ (0.781) (P = 0.038), and between the SF-36 MCS (0.434) and the SF-36 physical component summary scale score (PCS) (0.321) (P < 0.01). CONCLUSIONS: The self-administered FAS is a reliable, valid and responsive disease-specific composite measure for assessing treatment effect in patients with FM

     (43)    Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther 2009; 11(4):R120.
Abstract: INTRODUCTION: The Fibromyalgia Impact Questionnaire (FIQ) is a commonly used instrument in the evaluation of fibromyalgia (FM) patients. Over the last 18 years, since the publication of the original FIQ, several deficiencies have become apparent and the cumbersome scoring algorithm has been a barrier to widespread clinical use. The aim of this paper is to describe and validate a revised version of the FIQ: the FIQR. METHODS: The FIQR was developed in response to known deficiencies of the FIQ with the help of a patient focus group. The FIQR has the same 3 domains as the FIQ (that is, function, overall impact and symptoms). It differs from the FIQ in having modified function questions and the inclusion of questions on memory, tenderness, balance and environmental sensitivity. All questions are graded on a 0-10 numeric scale. The FIQR was administered online and the results were compared to the same patient's online responses to the 36-Item Short Form Health Survey (SF-36) and the original FIQ. RESULTS: The FIQR was completed online by 202 FM patients, 51 rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE) patients (31 RA and 20 SLE), 11 patients with major depressive disorder (MDD) and 213 healthy controls (HC). The mean total FIQR score was 56.6 +/- 19.9 compared to a total FIQ score of 60.6 +/- 17.8 (P < 0.03). The total scores of the FIQR and FIQ were closely correlated (r = 0.88, P < 0.001). Each of the 3 domains of the FIQR correlated well with the 3 related FIQ domains (r = 0.69 to 0.88, P < 0.01). The FIQR showed good correlation with comparable domains in the SF-36, with a multiple regression analysis showing that the three FIQR domain scores predicted the 8 SF-36 subscale scores. The FIQR had good discriminant ability between FM and the 3 other groups; total FIQR scores were HC (12.1 +/- 11.6), RA/SLE (28.6 +/- 21.2) and MDD (17.3 +/- 11.8). The patient completion time was 1.3 minutes; scoring took about 1 minute. CONCLUSIONS: The FIQR is an updated version of the FIQ that has good psychometric properties, can be completed in less than 2 minutes and is easy to score. It has scoring characteristics comparable to the original FIQ, making it possible to compare past FIQ results with future FIQR results

     (44)    Williams DA, Schilling S. Advances in the assessment of fibromyalgia. Rheum Dis Clin North Am 2009; 35(2):339-57.
Abstract: Fibromyalgia (FM) has historically been considered a chronic pain condition. Recent clinical studies, however, reveal that while pain may be the cardinal symptom of FM, there are many other symptoms and consequences of having FM that have an impact on the lives of individuals with this condition. As such, an area of intense clinical research has focused upon improving approaches to assessment for FM. This article provides an overview of how the art of assessing FM has evolved over time, current methods of assessment, the value of patients' perspectives in assessment, and emerging advancements representing the future of for FM

     (45)    Glattacker M, Opitz U, Jackel WH. Illness representations in women with fibromyalgia. Br J Health Psychol 2010; 15(Pt 2):367-87.
Abstract: OBJECTIVE: In the US population, the prevalence of fibromyalgia is about 3.4% in women. For those who are affected, fibromyalgia is associated with significant limitations relating to quality of life, activity, and participation. Furthermore, fibromyalgia leads to serious socio-economic costs. The objective of the present paper is to describe the cognitive illness representations of women with fibromyalgia and to analyse their relationship to rehabilitation outcomes. METHODS: The outcome was measured using the SF-36 and fibromyalgia impact questionnaire. The illness perceptions were assessed using the Illness Perception Questionnaire - revised. The prediction of outcome was done using hierarchical multiple regression analyses. RESULTS: N=245 patients are included in the sample. The patients attribute a multitude of symptoms to fibromyalgia and name numerous triggering factors. Illness representations are correlated with the illness impact at the beginning of rehabilitation and predict the outcome after the end of rehabilitation. CONCLUSION: The fact that illness representations turn out to be predictors of outcome, even when the baseline health status is statistically controlled, highlights the relevance of the illness representations of patients with fibromyalgia. Therefore, effective and efficient methods should be developed for integrating patient's illness beliefs into the management of the illness as early as possible

     (46)    Martin S, Chandran A, Zografos L, Zlateva G. Evaluation of the impact of fibromyalgia on patients' sleep and the content validity of two sleep scales. Health Qual Life Outcomes 2009; 7:64.
Abstract: BACKGROUND: Disturbed sleep is commonly reported in fibromyalgia (FM). Both the Sleep Quality Numeric Rating Scale (NRS) and the Medical Outcomes Study Sleep Scale (MOS-Sleep) have demonstrated positive psychometric properties in patients with FM. However, these assessments were developed prior to the current recommendation to include patient input during the concept elicitation or item generation phases. Therefore, the objective of this study was to evaluate the impact of FM on participants, including their sleep, and to test the content validity of these two sleep measures in FM patients. METHODS: Qualitative interviews were conducted in Raleigh, North Carolina and Detroit, Michigan with 20 adults who reported a physician diagnosis of FM. Sixteen participants were female, 13 were white, and the average age was 50 years. Two researchers conducted all interviews using a structured guide. RESULTS: Participants consistently reported that FM had a debilitating impact on their lives and their sleep, particularly getting to sleep and staying asleep. Participants responded positively to the Sleep Quality NRS as an assessment of their sleep. The majority of participants stated that they would not change the response numbering or wording of the item's anchors. Participants also responded positively to the 24-hour recall period of the Sleep Quality NRS. Participants found the 12-item MOS-Sleep to be appropriate and relevant; 19 participants indicated the measure captured all of their sleep-related symptoms. However, areas for potential modification were identified, such as the need to separate the item regarding awakening short of breath and awakening with a headache into two separate questions. Participants also questioned the relevance of the snoring and awakening short of breath items to FM. Half of participants expressed a preference for a daily rather than a weekly recall period. CONCLUSION: This study demonstrates the significant impact that FM has on patients' lives, particularly sleep. While patients with FM were not part of the development of the generic sleep assessments that were evaluated, this study provides evidence of their content validity, supporting their use in FM studies. Modifications to the MOS-Sleep may improve the psychometric properties and relevance to patients with FM

     (47)    Pena M, Garcia RJ, Olalla JM, Llanos EV, de Miguel AG, Cordero XF. Impact of the most frequent chronic health conditions on the quality of life among people aged >15 years in Madrid. Eur J Public Health 2010; 20(1):78-84.
Abstract: BACKGROUND: This study sought to ascertain to what degree health-related quality of life (HRQL) in the City of Madrid was affected by each of the most frequent chronic health conditions, and the specific quality-of-life (QL) domains on which such health conditions had the greatest impact, taking co-morbidity and socio-demographic variables into account. METHODS: A descriptive, analytical, cross-sectional study was conducted covering 7341 subjects aged >or=16 years in the City of Madrid. Data were collected on self-reported diagnosed morbidity, including hypertension, hypercholesterolaemia, varicose veins, diabetes, chronic asthma/bronchitis, myocardial infarction/angina pectoris, stomach problems, allergy, arthrosis/arthritis or rheumatism, depression/anxiety, cataracts, cerebrovascular accidents (CVACs), chronic constipation, osteoporosis and Alzheimer's disease or dementia. HRQL was measured using the COOP/WONCA questionnaire. The effects of diagnosis, age, social class, gender and the co-morbidity were analysed using a multivariate analysis of covariance (ANCOVA). RESULTS: The chronic health conditions that registered the worst overall mean scores on the COOP/WONCA questionnaire were Alzheimer's disease or dementia, Parkinson's disease, fibromyalgia, CVACs and depression, with scores of over 26 points in all cases. After the introduction of socio-demographic variables in the model, the highest values of Snedecor's F-test corresponds to depression (F = 461.63), 'arthrosis/arthritis or rheumatism' (F = 175.41), Alzheimer's disease or dementia (F = 65.70), gastric disorders (F = 65.17), cancer (F = 43.08) and CVACs (F = 41.65). CONCLUSIONS: Depression and 'arthrosis/arthritis or rheumatism' are the two chronic health conditions, which have the greatest impact on HRQL in Madrid's citizens, therefore is mandatory to propose and implement public health strategies that would reduce the prevalence and morbidity of such disorders

     (48)    Slatkowsky-Christensen B, Mowinckel P, Kvien TK. Health status and perception of pain: a comparative study between female patients with hand osteoarthritis and rheumatoid arthritis. Scand J Rheumatol 2009; 38(5):342-8.
Abstract: OBJECTIVE: Osteoarthritis (OA) is the most frequent rheumatic joint disease and its occurrence is growing due to prolonged life expectancy and an increasing number of elderly individuals in the population. The main objective of this study was to compare the burden of disease, assessed by measures of pain and health-related quality of life (HRQoL), between female patients with hand osteoarthritis (HOA) and rheumatoid arthritis (RA). METHODS: One hundred and ninety female HOA patients were compared with 194 female RA patients of the same age. HRQoL was measured with the Arthritis Impact Measurement 2 Scale (Aims2), the 36-item Short-Form Health Survey (SF-36) and its preference-based single index measure SF-6D, the Health Assessment Questionnaire (HAQ), the modified HAQ (MHAQ), self-efficacy scales, and visual analogue scales (VAS) for pain and fatigue. We also compared levels of fibromyalgia (FM)-like symptoms (headache, muscle pain, numbness, and concentration problems). Scores were compared by a multivariate analysis of covariance (ANCOVA), adjusted for age, number of comorbidities, and years of education. Sime's procedure was used to adjust for multiple testing. RESULTS: RA patients had significantly lower levels of physical functioning compared to HOA patients, whereas pain measured on the Arthritis Impact Measurement Scale 2 (AIMS2) was significantly worse in HOA as compared with RA. The HOA patients also had worse scores for FM-like symptoms. SF-6D utility scores in HOA and RA were similar (0.63 and 0.64, respectively). CONCLUSIONS: The overall impact of the disease on HRQoL was similar between RA and HOA patients, based on the SF-6D scores. Physical function was worse in RA patients, but HOA patients reported worse scores in pain measures and FM-like symptoms

     (49)    Vargas-Alarcon G, Fragoso JM, Cruz-Robles D, Vargas A, Martinez A, Lao-Villadoniga JI et al. Association of adrenergic receptor gene polymorphisms with different fibromyalgia syndrome domains. Arthritis Rheum 2009; 60(7):2169-73.
Abstract: OBJECTIVE: Fibromyalgia (FM) patients have signs of relentless sympathetic hyperactivity associated with hyporeactivity to stress. Adrenergic receptors (ARs) are parts of the sympathetic nervous system that are fundamental for maintenance of homeostasis. We undertook this study to correlate alpha-AR and beta-AR gene polymorphisms with the presence of FM and with different domains of the FM syndrome as measured by the Fibromyalgia Impact Questionnaire (FIQ). METHODS: We studied 78 Mexican FM patients and 48 age-matched controls as well as 78 Spanish FM patients and 71 controls. All subjects studied were women. Single-nucleotide polymorphisms (SNPs) of alpha(1A)-AR (rs574584, rs1383914, rs1048101, and rs573542), beta(2)-AR (rs1042713 and rs1042714), and beta(3)-AR (rs4994) were analyzed by 5' exonuclease TaqMan polymerase chain reaction. Polymorphic haplotypes were constructed after linkage disequilibrium analysis. RESULTS: The beta(2)-AR AC haplotype was a risk factor for the presence of FM. This haplotype had an increased frequency in Mexican patients compared with Mexican controls (42.1% versus 30.5%; P = 0.04). Similarly, 50.4% of Spanish patients had this haplotype compared with 40.0% of Spanish controls (P = 0.05). In Spanish patients, the alpha(1A)-AR SNP rs1383914 was associated with the presence of FM (P = 0.01), and the alpha(1A)-AR SNP rs1048101 was linked with FIQ disability (P = 0.02). Mexican patients with the rs574584 GG genotype presented the highest FIQ score compared with Mexican patients with other genotypes (P = 0.01), and in Mexicans SNP rs574584 was associated with FIQ morning stiffness (P = 0.04) and with FIQ tiredness upon awakening (P = 0.02). CONCLUSION: AR gene polymorphisms are related to the risk of developing FM and are also linked to different domains of the FM syndrome

     (50)    Yoshikawa GT, Heymann RE, Helfenstein M, Jr., Pollak DF. A comparison of quality of life, demographic and clinical characteristics of Brazilian men with fibromyalgia syndrome with male patients with depression. Rheumatol Int 2010; 30(4):473-8.
Abstract: The primary aim of this study was to assess the quality of life (Qol) in men with fibromyalgia (FM) as compared to the Qol of depressive patients, using the SF-36 questionnaire. The secondary objectives were as follows: to describe demographic and clinical characteristics of male patients with FM; to evaluate basal levels of dehydroepiandrosterone sulfate (DHEAS) and total testosterone in both groups; and to investigate the relationship among pain, tender points, anxiety, and depression in these patients. Fifty men with FM and 20 depressed males, matched by age and body mass index entered the study. All participants answered the SF-36, the Beck Depression Inventory and the State-Trait Anxiety Inventory questionnaire. Radioimmunoassay was used to determine serum concentration of DHEAS and total testosterone. Patients and controls had similar demographic characteristics. The scores were significantly lower in all domains of the SF-36 in patients with FM as compared with the depressive controls. No significant differences were observed among patient and control in the mean concentration of either DHEAS or total testosterone. Male patients with FM experience worse Qol than depressive men. Depression was influential on mental health, whereas FM impacted on both physical and mental health

     (51)    Amital D, Herskovitz C, Fostick L, Silberman A, Doron Y, Zohar J et al. The premenstrual syndrome and fibromyalgia--similarities and common features. Clin Rev Allergy Immunol 2010; 38(2-3):107-15.
Abstract: The aim of the study was to assess the clinical similarities and common features of fibromyalgia syndrome (FM) and premenstrual dysphoric syndrome (PMDD). Thirty young patients who met the diagnostic criteria for PMDD were included in the study and compared to 26 women belonging to the medical staff of a general psychiatry department. All enrollees were interviewed and examined by a skilled physician. They completed the following nine survey items: demographic information, clinical health assessment questionnaire, fibromyalgia impact questionnaire, sleep and fatigue questionnaires, Sheehan disability scales, SF-36 assessment for quality of life, visual analog scale for pain, Mini International Neuropsychiatric Interview (MINI) questionnaire (assessment of coexistent psychiatric conditions), and the premenstrual severity scale. Additionally, each individual underwent a physical examination measuring the classical tender points and was asked to describe the distribution and continuum of her pain or tenderness. The PMDD group scored significantly higher in the measures pain and tenderness as well as in severity of premenstrual symptoms compared to the control group. Five patients in the PMDD group and none in the control group had FM. Quality of life measured by the SF-36 was higher in the control group than in the PMDD group and correlated with the degree of tenderness reported. Psychiatric comorbidity was significantly more common in the PMDD group, affecting 16 of the 30 PMDD patients compared to only three of the 26 control patients. In this study, patients with PMDD were found to have higher levels of tenderness, higher psychiatric comorbidity, greater level of physical disabilities, and a lower quality of life. These parameters were highly correlated with a lower pain threshold

     (52)    Shuster J, McCormack J, Pillai RR, Toplak ME. Understanding the psychosocial profile of women with fibromyalgia syndrome. Pain Res Manag 2009; 14(3):239-45.
Abstract: Fibromyalgia syndrome (FMS) is a disease with a complex etiology characterized by symptoms of widespread pain and fatigue. FMS is more common in women. Both depression and anxiety have been found to be independently associated with the severity of pain in symptoms of FMS. The goal of the present study was to examine the psychosocial profile of women with FMS and to see how the attributions, perceived social support and cognitive biases of women with FMS are related to internalizing ratings of depression and anxiety. The current study included a sample of women with FMS from a local support group and a control group to examine how women with FMS differed from controls with respect to psychosocial variables, and to determine the relationship between these variables. Women with FMS reported a higher external locus of control, lower levels of adaptive cognitive bias, less perceived family support and lower mood than controls. Correlations between these variables were examined within the FMS group, and it was found that an external locus of control was significantly associated with higher ratings of anxiety and depressed mood. These results suggest that beliefs about locus of control and perceived family support of women with FMS may importantly impact their health outcomes, and that treatments related to locus of control and advocating for family support may considerably improve the quality of life of patients with FMS

     (53)    Arnold LM, Hudson JI, Wang F, Wohlreich MM, Prakash A, Kajdasz DK et al. Comparisons of the efficacy and safety of duloxetine for the treatment of fibromyalgia in patients with versus without major depressive disorder. Clin J Pain 2009; 25(6):461-8.
Abstract: OBJECTIVES: To investigate whether comorbid major depressive disorder (MDD) influenced the efficacy and safety of duloxetine in treating fibromyalgia (FM). METHODS: This was a post-hoc analysis using pooled data from 4 double-blind, placebo-controlled studies of patients with American College of Rheumatology-defined primary FM with or without MDD. Patients were randomized to duloxetine [60 or 120 mg/d (N=797)] or placebo (N=535) for approximately 3 months. Efficacy measures included the Brief Pain Inventory average pain score, 17-item Hamilton Depression Rating Scale, Fibromyalgia Impact Questionnaire, and Patient's/Clinician's Global Impressions of Improvement/Severity scales. RESULTS: At baseline, 26% of patients met diagnostic criteria for MDD. At endpoint (3 mo or last observation), duloxetine showed significantly (P<0.05) greater improvement versus placebo on the Brief Pain Inventory, Fibromyalgia Impact Questionnaire, Patient's Global Impressions of Improvement scale, and Clinician's Global Impressions of Severity scale in patients with and without comorbid MDD. The effect of duloxetine on these efficacy measures was consistent across FM patients with or without MDD (P>0.1 for treatment-by-strata interaction). On the 17-item Hamilton Depression Rating Scale, duloxetine showed significantly (P<0.05) greater improvement versus placebo in patients with comorbid MDD. The safety profile of duloxetine versus placebo with respect to serious adverse events and discontinuation owing to adverse events was similar for FM patients with versus without MDD (P>0.1 treatment-by-strata interaction). DISCUSSION: Duloxetine was effective in reducing pain and other symptoms in FM patients with and without MDD and demonstrated a similar safety profile for both groups

     (54)    Cimen OB, Cimen MY, Yapici Y, Camdeviren H. Arginase, NOS activities, and clinical features in fibromyalgia patients. Pain Med 2009; 10(5):813-8.
Abstract: OBJECTIVES: Fibromyalgia (FM) is a form of nonarticular rheumatism characterized by chronic widespread musculoskeletal aching and tender points. The aim of the present study was to investigate the effect of arginase and nitric oxide synthase (NOS) enzyme activities in FM with respect to their importance in pathogenesis, and the relationship with FM-related clinical parameters. METHODS: After obtaining informed consent, 25 female FM patients were compared with 23 healthy female controls. NOS and arginase enzyme activities were measured spectrophometrically in sera. Tender points were examined using the protocol described by Wolfe et al. The health status of patients was assessed by Fibromyalgia Impact Questionnaire. Musculoskeletal pain was scored according to visual analog scale. Health Assessment Questionnaire, Beck depression and Beck anxiety scales, and dyspnea scores were administered to analyze functional, psychiatric, and respiratory status of the patients. RESULTS: We found that NOS activity was significantly higher whereas arginase activity was lower in patients with FM. In the correlation analysis, NOS levels showed statistically significant positive correlation with chest pain and dyspnea parameters. NOS enzyme activities were higher in subjects with positive history of migraine, pain, and morning stiffness. On the other hand, arginase levels were lower in subjects with positive history of irritable bowel syndrome and morning stiffness. CONCLUSION: Animal experiments have suggested that nitric oxide (NO) is an important transmitter in pain pathways. It can also stimulate cyclooxygenase activity. We observed increased NOS activity and reduced arginase activity in FM patients, which may be due to increased cyclooxygenase enzyme activity and oxidant/antioxidant imbalance. In conclusion, we think that future studies concerning clinical control of pain with selective NOS inhibitors are needed in order to determine new therapeutic approaches and the exact pathophysiologic mechanisms in FM patients

     (55)    Assumpcao A, Cavalcante AB, Capela CE, Sauer JF, Chalot SD, Pereira CA et al. Prevalence of fibromyalgia in a low socioeconomic status population. BMC Musculoskelet Disord 2009; 10:64.
Abstract: BACKGROUND: The aim of this study was to estimate the prevalence of fibromyalgia, as well as to assess the major symptoms of this syndrome in an adult, low socioeconomic status population assisted by the primary health care system in a city in Brazil. METHODS: We cross-sectionally sampled individuals assisted by the public primary health care system (n = 768, 35-60 years old). Participants were interviewed by phone and screened about pain. They were then invited to be clinically assessed (304 accepted). Pain was estimated using a Visual Analogue Scale (VAS). Fibromyalgia was assessed using the Fibromyalgia Impact Questionnaire (FIQ), as well as screening for tender points using dolorimetry. Statistical analyses included Bayesian Statistics and the Kruskal-Wallis Anova test (significance level = 5%). RESULTS: From the phone-interview screening, we divided participants (n = 768) in three groups: No Pain (NP) (n = 185); Regional Pain (RP) (n = 388) and Widespread Pain (WP) (n = 106). Among those participating in the clinical assessments, (304 subjects), the prevalence of fibromyalgia was 4.4% (95% confidence interval [2.6%; 6.3%]). Symptoms of pain (VAS and FIQ), feeling well, job ability, fatigue, morning tiredness, stiffness, anxiety and depression were statically different among the groups. In multivariate analyses we found that individuals with FM and WP had significantly higher impairment than those with RP and NP. FM and WP were similarly disabling. Similarly, RP was no significantly different than NP. CONCLUSION: Fibromyalgia is prevalent in the low socioeconomic status population assisted by the public primary health care system. Prevalence was similar to other studies (4.4%) in a more diverse socioeconomic population. Individuals with FM and WP have significant impact in their well being

     (56)    Henriksen M, Lund H, Christensen R, Jespersen A, Dreyer L, Bennett RM et al. Relationships between the fibromyalgia impact questionnaire, tender point count, and muscle strength in female patients with fibromyalgia: a cohort study. Arthritis Rheum 2009; 61(6):732-9.
Abstract: OBJECTIVE: To test the hypothesis that fibromyalgia (FM) patients with reduced lower extremity strength are more symptomatic and tender than FM patients with normal muscle strength. METHODS: A total of 840 FM patients and 122 healthy subjects were evaluated between 1998 and 2005. All of the patients completed version 1 of the Fibromyalgia Impact Questionnaire (FIQ) and were assessed for tender points and knee muscle strength. All subjects underwent bilateral isokinetic knee muscle strength testing in flexion and extension. Normative knee muscle strength values were calculated from the healthy subjects, and the FM cohort was divided in 2 groups: 1) patients with normal muscle strength and 2) patients with low muscle strength (2 SDs below normal). The clinical characteristics of these 2 groups were compared. RESULTS: Significantly reduced knee muscle strength was found in 52% of the patients. There were no clinically significant differences between patients with low versus normal muscle strength. There were no clinically significant correlations between total FIQ score, tender point count, and muscle strength. Only 4.6% of the FIQ scores and 5.1% of the tender point counts were explained by muscle strength. CONCLUSION: Significantly reduced knee muscle strength was found in more than half of the patients. Patients with subnormal muscle strength were not more symptomatic or tender than patients with normal muscle strength. There were no clinically significant correlations between FIQ, tender point count, and muscle strength; therefore, reduced knee muscle strength appears to be a common objective abnormality in FM that is independent of measurements of disease activity. The implication of this finding in regard to the clinical assessment of FM needs further study

     (57)    Reitblat T, Zamir D, Polishchuck I, Novochatko G, Malnick S, Kalichman L. Patients treated by tegaserod for irritable bowel syndrome with constipation showed significant improvement in fibromyalgia symptoms. A pilot study. Clin Rheumatol 2009; 28(9):1079-82.
Abstract: The symptoms of irritable bowel syndrome (IBS) are commonly seen in fibromyalgia (FM) patients. This study aimed to evaluate the effect of 5-hydroxytryptamin-4 receptor partial agonist (tegaserod) on the symptoms of FM among the patients who receive the medicine because of IBS. Forty-one female patients with IBS and constipation, which were subjects to tegaserod treatment, were examined by rheumatologist and 14 were found to suffer from FM. The fibromyalgia impact questionnaire (FIQ) and clinical examination were done before tegaserod treatment and 1 month after. The IBS status, the total FIQ score, the number of tender points and pain in tender points were lowered significantly after the treatment (p < 0.001 for all variables). The results of this pilot study provide the preliminary evidence that FM patients can benefit from treatment by 5-hydroxytryptamin-4 receptor partial agonist. Additional studies are needed to support this conclusion

     (58)    Giske L, Bautz-Holter E, Sandvik L, Roe C. Relationship between pain and neuropathic symptoms in chronic musculoskeletal pain. Pain Med 2009; 10(5):910-7.
Abstract: OBJECTIVE: The present study aimed to assess neuropathic symptoms, their stability over time and relationship to pain intensity, pain distribution, and emotional distress in patients with musculoskeletal disorders. DESIGN: This is a prospective study. SETTING: The study was done at the Department of Physical Medicine and Rehabilitation at Ulleval University Hospital. PATIENTS: Eighty-six subjects between 18 years and 70 years with chronic musculoskeletal pain participated. Forty-nine subjects had widespread pain and 39 subjects fulfilled the American College of Rheumatology (ACR) criteria for fibromyalgia. OUTCOME MEASURES: McGill pain drawing, pain intensity (visual analog scales), emotional distress (Hopkins Symptom Checklist v 25), and fibromyalgia impact questionnaire were the recorded predictors, and neuropathic symptoms (Leeds assessment of neuropathic symptoms and signs-LANSS) were the main outcome variable which was assessed over 4 months. RESULTS: The mean LANSS score was 6.7 (standard deviation 5.6). Thirteen percent of the subjects had a score of 12 or more. Self-reported LANSS symptoms did not change over the 4 months follow-up, and the reliability of measurements as evaluated by intraclass correlation coefficient was 0.78. In a backward multiple regression analysis, the presence of fibromyalgia diagnosis and emotional distress remained the final predictors for neuropathic symptoms. CONCLUSIONS: Our study demonstrates that neuropathic symptoms are prominent features of chronic musculoskeletal pain and are stable over time. These symptoms were closely related to emotional distress and to the diagnosis of fibromyalgia. The results lend support to the theory that neuropathic symptoms represent an underlying sensitization

     (59)    Pae CU, Masand PS, Marks DM, Krulewicz S, Peindl K, Mannelli P et al. History of depressive and/or anxiety disorders as a predictor of treatment response: a post hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release in patients with fibromyalgia. Prog Neuropsychopharmacol Biol Psychiatry 2009; 33(6):996-1002.
Abstract: BACKGROUND: Despite of a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited but antidepressants are commonly prescribed to treat fibromyalgia in clinical practice. We investigated whether a history of depressive and/or anxiety disorders was associated with response to paroxetine controlled release (CR) in the treatment of fibromyalgia. METHODS: One hundred sixteen (116) fibromyalgia subjects were randomized to receive paroxetine CR or placebo for 12 weeks. The primary outcome was treatment response defined as >or=25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. In multivariate logistic regression, we determined if a history of depression and/or anxiety disorders was an independent predictor of response to paroxetine CR. RESULTS: In logistic regression, the history of depression and/or anxiety did not predict treatment response as measured by >or=25% reduction in Fibromyalgia Impact Questionnaire (FIQ) score (OR=0.66, 95% CI=.29-1.49, Wald=0.97, p=0.32), while the drug status (paroxetine CR) was significantly associated with treatment response (OR=2.57, CI=1.2-5.61, Wald=5.5, p=0.02). CONCLUSION: A significant proportion of patients with fibromyalgia had a history of anxiety and or depressive disorders. However response to treatment of fibromyalgia symptoms with paroxetine CR was not associated with a history of depressive and/or anxiety disorders. Our findings need to be confirmed in more adequately-powered and well-designed subsequent studies

     (60)    Kroese M, Schulpen G, Bessems M, Nijhuis F, Severens J, Landewe R. The feasibility and efficacy of a multidisciplinary intervention with aftercare meetings for fibromyalgia. Clin Rheumatol 2009; 28(8):923-9.
Abstract: The objective of this study is to examine the feasibility and long-term results of a 12-week multidisciplinary part-time daycare intervention with five aftercare meetings in fibromyalgia (FM) patients. One hundred and five patients diagnosed with FM started with a multidisciplinary intervention and were assessed for feasibility, functional status (Fibromyalgia Impact Questionnaire [FIQ]), and quality of life (EuroQol-5D [EQ-5D]) until 9 months after completion. The program consisted of sociotherapy, physiotherapy, psychotherapy, and creative arts therapy. Drop-out rate was 4.8%. The attendance rate of 100 patients who completed the 12-week program and five aftercare meetings was high (97.4%), just like patient and therapist satisfaction (8.2 on a 10 points scale). After the 12-week program, statistically significant improvement was seen in both FIQ and EQ-5D. This improvement was maintained after 9 months of follow-up. On average, moderate improvements were observed. Our 12-week multidisciplinary part-time daycare intervention with five aftercare meetings for FM patients is feasible and it is indicated that it can lead to sustained improvement in functional status and quality of life

     (61)    Garcia-Campayo J, Serrano-Blanco A, Rodero B, Magallon R, Alda M, Andres E et al. Effectiveness of the psychological and pharmacological treatment of catastrophization in patients with fibromyalgia: a randomized controlled trial. Trials 2009; 10:24.
Abstract: BACKGROUND: Fibromyalgia is a prevalent and disabling disorder characterized by widespread pain and other symptoms such as insomnia, fatigue or depression. Catastrophization is considered a key clinical symptom in fibromyalgia; however, there are no studies on the pharmacological or psychological treatment of catastrophizing. The general aim of this study is to assess the effectiveness of cognitive-behaviour therapy and recommended pharmacological treatment for fibromyalgia (pregabalin, with duloxetine added where there is a comorbid depression), compared with usual treatment at primary care level. METHOD/DESIGN: DESIGN: A multi-centre, randomized controlled trial involving three groups: the control group, consisting of usual treatment at primary care level, and two intervention groups, one consisting of cognitive-behaviour therapy, and the other consisting of the recommended pharmacological treatment for fibromyalgia. SETTING: 29 primary care health centres in the city of Zaragoza, Spain. SAMPLE: 180 patients, aged 18-65 years, able to understand and read Spanish, who fulfil criteria for primary fibromyalgia, with no previous psychological treatment, and no pharmacological treatment or their acceptance to discontinue it two weeks before the onset of the study. INTERVENTION: Psychological treatment is based on the manualized protocol developed by Prof. Escobar et al, from the University of New Jersey, for the treatment of somatoform disorders, which has been adapted by our group for the treatment of fibromyalgia. It includes 10 weekly sessions of cognitive-behaviour therapy. Pharmacological therapy consists of the recommended pharmacological treatment for fibromyalgia: pregabalin (300-600 mg/day), with duloxetine (60-120 mg/day) added where there is a comorbid depression). MEASUREMENTS: The following socio-demographic data will be collected: sex, age, marital status, education, occupation and social class. The diagnosis of psychiatric disorders will be made with the Structured Polyvalent Psychiatric Interview. Other instruments to be administered are the Pain Catastrophizing Scale, the Hamilton tests for Anxiety and for Depression, the Fibromyalgia Impact Questionnaire (FIQ), the EuroQuol-5 domains (EQ-5D), and the use of health and social services (CSRI). Assessments will be carried out at baseline, 1, 3, and 6 months. MAIN VARIABLE: Pain catastrophizing. ANALYSIS: The analysis will be per intent to treat. We will use the general linear models of the SPSS version 15 statistical package, to analyse the effect of the treatment on the result variable (pain catastrophizing). DISCUSSION: It is necessary to assess the effectiveness of pharmacological and psychological treatments for pain catastrophizing in fibromyalgia. This randomized clinical trial will determine whether both treatments are effective for this important prognostic variable in patients with fibromyalgia. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10804772

     (62)    Kiyak EK. A new nonpharmacological method in fibromyalgia: the use of wool. J Altern Complement Med 2009; 15(4):399-405.
Abstract: OBJECTIVES: The aim was to assess the effect of wool use in patients with fibromyalgia. BACKGROUND: Various studies concerning the treatment of patients with fibromyalgia using nonpharmacological methods have been carried out. There are, however, no reports on the use of wool clothing and bedding in treating these patients. DESIGN AND METHODS: The study employed two-group, experimental design. A total of 50 patients with fibromyalgia, based on the criteria of the American College of Rheumatology, were selected for the study. They were distributed equally into two groups: a control group and a treatment group. The 25 patients in each group were randomly selected and the compositions of the two groups were statistically identical. The patients in the treatment group wore woolen underwear (which covered the body from the shoulders to the thighs) and used woolen bedding such as woolen bed liner, woolen quilt and pillow during the experimental period of 6 weeks. All patients were assessed at the beginning the trial (pre-test) and the end of 6th (post-test) week. Data were collected using the visual analogue scale (0-10), tender points count, and Fibromyalgia Impact Questionnaire. RESULTS: Patients in the treatment group reported significant improvements in their conditions including a reduction in pain levels, tender point counts, and all scores of the Fibromyalgia Impact Questionnaire (p <or= 0.001). CONCLUSIONS: The use of woolen underwear and woolen bedding were effective in reducing the symptoms of patients suffering from fibromyalgia. The use of wool is recommended as a means of treatment for alleviating the pain of fibromyalgia. RELEVANCE TO CLINICAL PRACTICE: Nurses provide professional support to patients with fibromyalgia. They select suitable clothes and sleeping materials for their patients with this object in mind: to keep their patients warm and to protect them from the cold

     (63)    Pae CU, Masand PS, Marks DM, Krulewicz S, Han C, Peindl K et al. History of early abuse as a predictor of treatment response in patients with fibromyalgia: a post-hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release. World J Biol Psychiatry 2009; 10(4 Pt 2):435-41.
Abstract: OBJECTIVES: We conducted a post-hoc analysis to determine whether a history of physical or sexual abuse was associated with response to treatment in a double-blind, randomized, placebo-controlled trial of paroxetine controlled release (CR) in fibromyalgia. METHODS: A randomized, double-blind, placebo-controlled trial of paroxetine controlled release (CR) (dose 12.5-62.5 mg/day) was conducted in patients with fibromyalgia for 12 weeks. A total of 112 subjects provided complete information on childhood history of abuse that was recorded using the Sexual and Physical Abuse Questionnaire and randomized to treatments. Outcome evaluations in the abuse subgroup were identical to those in the entire sample. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), and the Perceived Stress Scale (PSS). Fibromylagia symptom severity was determined using the Fibromyalgia Impact Questionnaire (FIQ) and the Visual Analogue Scale for Pain (VAS). The primary outcome was treatment response defined as > or = 25% reduction in the FIQ-total score. Secondary outcomes include changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively) and SF-36. RESULTS: The rate of childhood physical and/or sexual abuse was 52.7% (n=59). The baseline characteristics (health status, perceived stress, symptom severity) were not associated with abuse history. In logistic regression, the history of abuse did not predict treatment response as measured by > or = 25% reduction in FIQ-total score (OR = 1.16, 95% CI = 1.18-1.60, P = 0.35), while the drug status (paroxetine CR) was significantly associated with treatment response (OR = 2.51, 95% CI = 1.12-5.64, P = 0.02). Abuse history did not predict CGI-I (P = 0.32) or CGI-S (P = 0.74) improvements during treatment. After 12 weeks of treatment, subjects with sexual abuse history showed significantly lower mean change in health status (SF-36) than those without sexual abuse history (P = 0.04). CONCLUSIONS: Although, a significant proportion of patients with fibromyalgia reported a history of abuse, it does not appear to have any significant clinical correlates at baseline. History of abuse did not predict response to treatment in patients with fibromyalgia participating in a controlled trial of paroxetine controlled release. Prospective, well-designed studies are needed to confirm whether selective serotonin uptake inhibitors are effective in patients with fibromyalgia irrespective of their abuse history

     (64)    Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol 2009; 36(6):1304-11.
Abstract: OBJECTIVE: The Fibromyalgia Impact Questionnaire (FIQ) is a disease-specific composite instrument that measures the effect of problems experienced by patients with fibromyalgia (FM). Utilization of the FIQ in measuring changes due to interventions in FM requires derivation of a clinically meaningful change for that instrument. Analyses were conducted to estimate the minimal clinically important difference (MCID), and to propose FIQ severity categories. METHODS: Data from 3 similarly designed, 3-month placebo-controlled, clinical treatment trials of pregabalin 300, 450, and 600 mg/day in patients with FM were modeled to estimate the change in the mean FIQ total and stiffness items corresponding to each category on the Patient Global Impression of Change. FIQ severity categories were modeled and determined using established pain severity cutpoints as an anchor. RESULTS: A total of 2228 patients, mean age 49 years, 93% women, with a mean baseline FIQ total score of 62 were treated in the 3 studies. Estimated MCID on a given measure were similar across the studies. In a pooled analysis the estimated MCID (95% confidence interval) was 14% (13; 15) and for FIQ stiffness it was 13% (12; 14). In the severity analysis a FIQ total score from 0 to <39 was found to represent a mild effect, >or= 39 to <59 a moderate effect, and >or=59 to 100 a severe effect. CONCLUSION: The analysis indicates that a 14% change in the FIQ total score is clinically relevant, and results of these analyses should enhance the clinical utility of the FIQ in research and practice

     (65)    Bazzichi L, Dini M, Rossi A, Corbianco S, De FF, Giacomelli C et al. Muscle modifications in fibromyalgic patients revealed by surface electromyography (SEMG) analysis. BMC Musculoskelet Disord 2009; 10:36.
Abstract: BACKGROUND: Several studies have been carried out in order to investigate surface electromyography (SEMG) response on fibromyalgic (FM) patients. Some studies failed to demonstrate differences between FM patients and healthy individuals while others found differences in SEMG parameters. Different muscular region have been analyzed in FM patients and heterogeneity is also produced because of the different ways in which the SEMG technique is used. The aims of this study were to evaluate muscle modifications by SEMG analysis in FM women with respect to a sample of healthy controls and to investigate the relationships between SEMG parameters and the clinical aspects of the disease. METHODS: SEMG was recorded in 100 FM women (48.10 +/- 11.96 yr) and in 50 healthy women (48.60 +/- 11.18 yr), from the tibialis anterior and the distal part of vastus medialis muscle during isometric contraction. Initial values and rate of change of median spectral frequency (MDF) and conduction velocity (CV) of the SEMG signal were calculated.The clinical parameters "Fibromyalgia Impact Questionnaire", pain, tender points, tiredness were evaluated and the relationships between these data and the SEMG results were also studied. For the statistical analysis Mann-Whitney test, chi-square test and Spearman correlation were used. RESULTS: MDF absolute values and the so-called Fatigue Index (FI) were significantly lower (p < 0.001) in both muscles studied in FM patients (MDF: 93.2 microV; FI: 1.10, 0.89) with respect to healthy controls (MDF: 138.2 microV; FI: 2.41, 1.66) and a smaller reduction in the percentage values of MDF was observed in FM patients vs controls (22% vs 38%). A significant correlation was found between the SEMG parameter decrement of normalized median frequency (MNF) (%) and seriousness of FM (evaluated by means of tender points). CONCLUSION: We have found some interesting muscle modifications in FM patients with respect to healthy controls, regarding MDF, CV and FI values which resulted significantly lower in FM. Patients might have a different fiber recruitment or a possible atrophy of type II fibers suggesting that they are not able to reach muscle relaxation

     (66)    Arvold DS, Odean MJ, Dornfeld MP, Regal RR, Arvold JG, Karwoski GC et al. Correlation of symptoms with vitamin D deficiency and symptom response to cholecalciferol treatment: a randomized controlled trial. Endocr Pract 2009; 15(3):203-12.
Abstract: OBJECTIVE: To examine the association of symptoms with vitamin D deficiency and symptom response to cholecalciferol treatment in a randomized, double-blind, placebo-controlled trial. METHODS: Adult primary care patients in Duluth, Minnesota, were screened for vitamin D deficiency in February 2007. Participants completed questionnaires pertaining to a variety of symptoms, vitamin D intake, and selected medical conditions. Patients with mild to moderate vitamin D deficiency (25-hydroxyvitamin D [25(OH)D], 10-25 ng/mL) participated in a randomized controlled trial (RCT) of vitamin D replacement and its effect on symptoms. Participants were randomly assigned to receive 50 000 units of cholecalciferol (vitamin D3) weekly or placebo for 8 weeks. Patients with severe vitamin D deficiency (25[OH]D <10 ng/mL) were treated in an unblinded fashion, and symptoms were reevaluated post treatment. RESULTS: A total of 610 patients underwent initial screening, and 100 patients with mild to moderate vitamin D deficiency participated in the RCT. Thirty-eight severely deficient patients were treated in an unblinded fashion. On initial screening, 46.2% of participants were deficient in vitamin D. Self-reported vitamin D supplementation, milk intake, celiac disease, gastric bypass, and chronic pancreatitis were predictive of vitamin D status. Severely deficient participants reported increased musculoskeletal symptoms, depression (including seasonal), and higher (worse) scores on a fibromyalgia assessment questionnaire. In the RCT, the treated group showed significant improvement in fibromyalgia assessment scores (P = 0.03), whereas the placebo-treated participants did not. Severely deficient patients did not show symptom improvement over the 8-week trial period or when followed up 1 year later. CONCLUSIONS: Compared with participants in the placebo group, patients in the treatment group showed mild short-term improvement in the overall fibromyalgia impact score, but did not show significant improvement in most musculoskeletal symptoms or in activities of daily living

     (67)    Relton C, Smith C, Raw J, Walters C, Adebajo AO, Thomas KJ et al. Healthcare provided by a homeopath as an adjunct to usual care for Fibromyalgia (FMS): results of a pilot Randomised Controlled Trial. Homeopathy 2009; 98(2):77-82.
Abstract: OBJECTIVES: To assess the feasibility of a Randomised Controlled Trial (RCT) design of usual care compared with usual care plus adjunctive care by a homeopath for patients with Fibromyalgia syndrome (FMS). METHODS: In a pragmatic parallel group RCT design, adults with a diagnosis of FMS (ACR criteria) were randomly allocated to usual care or usual care plus adjunctive care by a homeopath. Adjunctive care consisted of five in depth interviews and individualised homeopathic medicines. The primary outcome measure was the difference in Fibromyalgia Impact Questionnaire (FIQ) total score at 22 weeks. RESULTS: 47 patients were recruited. Drop out rate in the usual care group was higher than the homeopath care group (8/24 vs 3/23). Adjusted for baseline, there was a significantly greater mean reduction in the FIQ total score (function) in the homeopath care group than the usual care group (-7.62 vs 3.63). There were significantly greater reductions in the homeopath care group in the McGill pain score, FIQ fatigue and tiredness upon waking scores. We found a small effect on pain score (0.21, 95% CI -1.42 to 1.84); but a large effect on function (0.81, 95% CI -8.17 to 9.79). There were no reported adverse events. CONCLUSIONS: Given the acceptability of the treatment and the clinically relevant effect on function, there is a need for a definitive study to assess the clinical and cost effectiveness of adjunctive healthcare by a homeopath for patients with FMS

     (68)    Solano C, Martinez A, Becerril L, Vargas A, Figueroa J, Navarro C et al. Autonomic dysfunction in fibromyalgia assessed by the Composite Autonomic Symptoms Scale (COMPASS). J Clin Rheumatol 2009; 15(4):172-6.
Abstract: BACKGROUND: It has been suggested that autonomic nervous system dysfunction may explain all of fibromyalgia (FM) multisystem features. Such proposal is based mostly on the results of diverse heart rate variability analyses. The Composite Autonomic Symptom Scale (COMPASS) is a different validated method to recognize dysautonomia. OBJECTIVES: The main objective of our study was to investigate symptoms of autonomic dysfunction in FM patients by means of COMPASS. A secondary objective was to define whether there is a correlation between COMPASS and Fibromyalgia Impact Questionnaire (FIQ) scores in FM patients. METHODS: Design, analytical cross-sectional study. Our study population included 3 different groups of women: 30 patients with FM, 30 patients with rheumatoid arthritis, and 30 women who considered themselves healthy. All participants filled out COMPASS and FIQ questionnaires. RESULTS: FM patients had significantly higher values in all COMPASS domains. COMPASS total score (54.6 +/- 20.9; mean +/- standard deviation) clearly differentiated FM patients from the other 2 groups (21.6 +/- 16.5 and 9.5 +/- 10.2, respectively). P < 0.0001. The majority of FM patients gave affirmative answers to questions related to orthostatic, digestive, sleep, sudomotor, or mucosal dysfunction. There was a significant correlation between COMPASS and FIQ scores (Spearman r = 0.5, P < 0.005). CONCLUSIONS: Patients with FM have multiple nonpain symptoms related to different expressions of autonomic dysfunction. There is a correlation between a questionnaire that measures FM severity (FIQ) and an autonomic dysfunction questionnaire (COMPASS). Such correlation suggests that autonomic dysfunction is inherent to FM

     (69)    Boomershine CS, Crofford LJ. A symptom-based approach to pharmacologic management of fibromyalgia. Nat Rev Rheumatol 2009; 5(4):191-9.
Abstract: Fibromyalgia is a prevalent disorder that is characterized by widespread pain along with numerous other symptoms, including fatigue, poor sleep, mood disorders, and stiffness. Previous guidelines for the management of fibromyalgia recommended an approach that integrates pharmacologic and nonpharmacologic therapies selected according to the symptoms experienced by individual patients. However, they offered no recommendations for a system of patient assessment that would provide a basis for individualized treatment selection. We present a simple, rapid and easily remembered system for symptom quantitation and pharmacologic management of fibromyalgia that combines visual analogue scale symptom scores from a modified form of the disease-neutral Fibromyalgia Impact Questionnaire, with a review of medications that can be used to treat the individual symptoms. This symptom-based approach is amenable to caring for patients with fibromyalgia in a busy clinical practice

     (70)    Smith AK, Togeiro SM, Tufik S, Roizenblatt S. Disturbed sleep and musculoskeletal pain in the bed partner of patients with obstructive sleep apnea. Sleep Med 2009; 10(8):904-12.
Abstract: BACKGROUND: Obstructive sleep apnea (OSA) has been recognized as a distressing experience to the female partner, but a causal association remains controversial. Furthermore, a growing body of evidence supports a relationship of distress and sleep disruptions with musculoskeletal pain, also prevalent in middle-aged women. To test the hypothesis that sharing a bed with an OSA man may contribute to manifestations of distress and impaired sleep, we conducted a case-control study of 17 OSA wives and 17 wives of healthy sleepers. METHODS: Clinical outcome variables were scores of the Fibromyalgia Impact Questionnaire (FIQ) and visual analog scales (VAS), tender point (TP) count and algometric index. Sleep outcome parameters were VAS scores for sleep quality and polysomnographic (PSG) parameters. Secondary outcomes were VAS scores for distress and marital relationship and coping strategies adopted by OSA wives. Clinical assessment and PSG scoring were conducted blindly. RESULTS: After controlling for age and menopausal status, OSA wives exhibited lower sleep quality and higher distress scores than controls (p<0.05, all). Increase in pain threshold (TP count and algometric index) and in FIQ score were also observed, and in their PSG, there was an increase in awaken period and stage 1 amount during sleep, as well as in alpha power during slow wave sleep (p<0.05, all). These sleep parameters had substantial correlation with tiredness and poor sleep quality and were moderately correlated to pain assessments and distress scores. CONCLUSION: Thus, independently of age and menopausal status of the group, wives of OSA patients exhibited an increase in pain threshold, distress and impaired sleep in comparison to controls

     (71)    Eyigor S, Karapolat H, Korkmaz OK, Eyigor C, Durmaz B, Uslu R et al. The frequency of fibromyalgia syndrome and quality of life in hospitalized cancer patients. Eur J Cancer Care (Engl ) 2009; 18(2):195-201.
Abstract: To explore the frequency of fibromyalgia syndrome (FMS) among hospitalized cancer patients and address the relationships between pain, fatigue and quality of life with regard to the extent of pain, a cross-sectional and descriptive study was carried out in the Oncology Supportive Care Unit on 122 hospitalized cancer patients. Pain, sleep, disease impact (Fibromyalgia Impact Questionnaire), fatigue (Brief Fatigue Inventory), quality of life (Short Form 36 and European Organization for Research on Treatment of Cancer questionnaires Quality of Life-C30) were gathered using standardized measures. Thirteen of the hospitalized cancer patients (10.7%) included in the study were diagnosed with FMS. There were no statistically significant differences among three pain groups with respect to demographic characteristics (P > 0.05). There were significant differences among groups with regard to the presence of metastasis, fatigue, sleep disorder, pain, Brief Fatigue Inventory, Fibromyalgia Impact Questionnaire, most of subscores of Short Form 36 and European Organization for Research on Treatment of Cancer questionnaires Quality of Life-C30 scores (P < 0.05). In the present study, we have calculated the frequency of FMS among patients admitted to the oncology hospital in addition to establishing the relationships between pain, fatigue and quality of life with regard to the extent of pain. We believe that the descriptive data presented in this study would be helpful in future studies and therapeutic approaches

     (72)    Stutts LA, Robinson ME, McCulloch RC, Banou E, Waxenberg LB, Gremillion HA et al. Patient-centered outcome criteria for successful treatment of facial pain and fibromyalgia. J Orofac Pain 2009; 23(1):47-53.
Abstract: AIMS: To define treatment success from the facial pain and fibromyalgia pain patient perspective across four domains (pain, fatigue, emotional distress, interference with daily activities) through the use of the Patient-Centered Outcomes (PCO) Questionnaire. METHODS: Participants included 53 facial pain (46 women, seven men) and 52 fibromyalgia (49 women, three men) patients who completed the PCO Questionnaire. The PCO assesses four relevant domains of chronic pain: pain, fatigue, distress, and interference in daily activities. Participants rated their usual levels, expected levels, levels they considered successful improvements, and how important improvements were in each of the four domains following treatment. Repeated-measures analyses of variance were performed to determine whether differences existed across domains and across pain groups. RESULTS: Both groups of participants defined treatment success as a substantial decrease in their pain, fatigue, distress, and interference ratings (all approximately 60%). Fibromyalgia participants reported high levels of pain (mean = 7.08, SD = 2.04), fatigue (mean = 7.82, SD = 1.71), distress (mean = 6.35, SD = 2.46), and interference (mean = 7.35, SD = 2.21). Facial pain participants' ratings of these domains were significantly lower for pain (mean = 5.62, SD = 2.38), fatigue (mean = 5.28, SD = 2.64), distress (mean = 4.34, SD = 2.78), and interference (mean = 4.10, SD = 3.06). CONCLUSION: These results demonstrate the high expectations of individuals with facial pain and fibromyalgia regarding treatment of their symptoms. Health care providers should incorporate these expectations into their treatment plans and discuss realistic treatment goals with their pain patients

     (73)    Hincapie-Zapata ME, Suarez-Escudero JC, Pineda-Tamayo R, Anaya JM. [Quality of life in multiple sclerosis and other chronic autoimmune and non-autoimmune diseases]. Rev Neurol 2009; 48(5):225-30.
Abstract: INTRODUCTION: Diseases that involve the nervous system and the musculoskeletal system are particularly likely to produce different limitations and deficits, and to affect the individual conception of quality of life. AIM: To determine the impact on quality of life generated by chronic autoimmune diseases like multiple sclerosis (MS), rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), Sjogren's syndrome (SS), ankylosing spondylitis (AS) and chronic musculotendinous diseases like osteoarthritis (OA) and fibromyalgia (FM), using the Short Form 36-item (SF-36) health questionnaire. PATIENTS AND METHODS: A descriptive cross-sectional study was conducted between January 2004 and June 2006 and included 509 individuals, of whom 56 had MS, 36 SS, 24 AS, 200 RA, 65 SLE, 54 OA and 74 FM. Guided interviews were conducted to evaluate each sphere of the SF-36 health questionnaire. The statistical analysis was performed using the general lineal model, with means differences according to each diagnosis. RESULTS: Compared to patients with RA, those with MS showed significant differences in the physical functioning and social functioning dimensions. The lowest score was recorded in those with FM, except in physical functioning, where MS had the lowest mean. No differences were found in the mean scores on general conception of the state of health in each condition analysed. CONCLUSIONS: Different neurological functions deteriorate progressively in MS, which has repercussions on the musculoskeletal system; this leads to a poorer quality of life, mainly in the physical and social functions. The disability generated is not only defined by deficit but also by the degrees of functional limitation within the context of personal health. Quality of life thus becomes a global biopsychosocial phenomenon

     (74)    Schafranski MD, Malucelli T, Machado F, Takeshi H, Kaiber F, Schmidt C et al. Intravenous lidocaine for fibromyalgia syndrome: an open trial. Clin Rheumatol 2009; 28(7):853-5.
Abstract: Fibromyalgia is a disorder characterized by chronic widespread pain. In this study, we investigated the effect of intravenous infusions of lidocaine in pain and quality of life of patients with fibromyalgia. Twenty-three consecutive patients were included in the study, which consisted on five sequential intravenous 2% lidocaine infusions with rising dosages (2-5 mg/kg, days 1-5). Fibromyalgia Impact Questionnaire (FIQ), Health Assessment Questionnaire, and a visual analog scale (VAS) for pain were applied before the first lidocaine infusion, immediately after the fifth infusion and 30 days after the fifth infusion. A significant improvement was observed in the FIQ scores after the fifth infusion (73.52 +/- 16.56 vs 63.29 +/- 21.21, p = 0.02), which was maintained after 30 days (73.52 +/- 16.56 vs 63.85 +/- 24.59, p = 0.04). Similar results were seen concerning the VAS: 8.19 +/- 1.76 vs 6.84 +/- 2.44, p = 0.01 and 8.19 +/- 1.76 vs 7.17 +/- 2.35, p = 0.05, respectively. Intravenous lidocaine infusions are safe and effective in the management of fibromyalgia

     (75)    Ali A, Njike VY, Northrup V, Sabina AB, Williams AL, Liberti LS et al. Intravenous micronutrient therapy (Myers' Cocktail) for fibromyalgia: a placebo-controlled pilot study. J Altern Complement Med 2009; 15(3):247-57.
Abstract: OBJECTIVES: Intravenous micronutrient therapy (IVMT), and specifically the Myers' Cocktail, is a popular approach for treating fibromyalgia syndrome (FMS) among complementary and alternative medicine practitioners, but its efficacy is uncertain. This trial assessed the feasibility, safety, and provided insights into the efficacy of this therapy. DESIGN: This was a randomized, double-blind, placebo-controlled pilot study. LOCATIONS: The study locations were an academic research center, teaching hospital, and affiliated Integrative Medicine Center in Derby, CT. SUBJECTS: The subjects were 34 adults with American College of Rheumatology (ACR)-defined FMS. INTERVENTION: Subjects were randomly assigned either to treatment (weekly infusions of IVMT) or to placebo (weekly infusions of lactated Ringer's solution) for 8 weeks. OUTCOME MEASURES: Primary outcome was change in the Tender Point Index, assessed 8 and 12 weeks after initiation. Secondary measures included a Visual Analog Scale to assess global pain, and validated measures of physical function (Fibromyalgia Impact Questionnaire), mood (Beck Depression Index), and quality of life (Health Status Questionnaire 2.0). RESULTS: Clinically significant improvements were noted (of a magnitude similar to other effective interventions). However, in part because of the high placebo response and the small sample size, no statistically significant differences were seen between groups, in any outcome measure, at 8 and 16 weeks. Statistically significant within-group differences were seen in both the intervention and placebo groups, demonstrating a treatment effect for both IVMT and placebo. At 8 weeks, the IVMT group experienced significantly improved tender points, pain, depression, and quality of life directly following treatment (all p < or = 0.02), while the placebo group experienced significantly improved tender points only (p < or = 0.05). The treatment effects of IVMT persisted at 4 weeks postintervention for tender points, pain, and quality of life, while placebo effects persisted only for tender points. A single minor adverse event was noted in one subject in the intervention group. CONCLUSIONS: This first controlled pilot study established the safety and feasibility of treating FMS with IVMT. Most subjects experienced relief as compared to baseline, but no statistically significant differences were seen between IVMT and placebo. The efficacy of IVMT for fibromyalgia, relative to placebo, is as yet uncertain

     (76)    Panton LB, Figueroa A, Kingsley JD, Hornbuckle L, Wilson J, St JN et al. Effects of resistance training and chiropractic treatment in women with fibromyalgia. J Altern Complement Med 2009; 15(3):321-8.
Abstract: OBJECTIVE: The objective of this study was to evaluate resistance training (RES) and RES combined with chiropractic treatment (RES-C) on fibromyalgia (FM) impact and functionality in women with FM. DESIGN: The design of the study was a randomized control trial. SETTING: Testing and training were completed at the university and chiropractic treatment was completed at chiropractic clinics. PARTICIPANTS: Participants (48 +/- 9 years; mean +/- standard deviation) were randomly assigned to RES (n = 10) or RES-C (n = 11). INTERVENTION: Both groups completed 16 weeks of RES consisting of 10 exercises performed two times per week. RES-C received RES plus chiropractic treatment two times per week. OUTCOME MEASURES: Strength was assessed using one repetition maximum for the chest press and leg extension. FM impact was measured using the FM impact questionnaire, myalgic score, and the number of active tender points. Functionality was assessed using the 10-item Continuous Scale Physical Functional Performance test. Analyses of variance with repeated measures compared groups before and after the intervention. RESULTS: Six (6) participants discontinued the study: 5 from RES and 1 from RES-C. Adherence to training was significantly higher in RES-C (92.0 +/- 7.5%) than in RES (82.8 +/- 7.5%). Both groups increased (p < or = 0.05) upper and lower body strength. There were similar improvements in FM impact in both groups. There were no group interactions for the functionality measures. Both groups improved in the strength domains; however, only RES-C significantly improved in the pre- to postfunctional domains of flexibility, balance and coordination, and endurance. CONCLUSIONS: In women with FM, resistance training improves strength, FM impact, and strength domains of functionality. The addition of chiropractic treatment improved adherence and dropout rates to the resistance training and facilitated greater improvements in the domains of functionality

     (77)    Ekici G, Bakar Y, Akbayrak T, Yuksel I. Comparison of manual lymph drainage therapy and connective tissue massage in women with fibromyalgia: a randomized controlled trial. J Manipulative Physiol Ther 2009; 32(2):127-33.
Abstract: OBJECTIVE: This study analyzed and compared the effects of manual lymph drainage therapy (MLDT) and connective tissue massage (CTM) in women with primary fibromyalgia (PFM). METHODS: The study design was a randomized controlled trial. Fifty women with PFM completed the study. The patients were divided randomly into 2 groups. Whereas 25 of them received MLDT, the other 25 underwent CTM. The treatment program was carried out 5 times a week for 3 weeks in each group. Pain was evaluated by a visual analogue scale and algometry. The Fibromyalgia Impact Questionnaire (FIQ) and Nottingham Health Profile were used to describe health status and health-related quality of life (HRQoL). Wilcoxon signed rank test and Mann-Whitney U test were used to analyze the data. RESULTS: In both groups, significant improvements were found regarding pain intensity, pain pressure threshold, and HRQoL (P < .05). However, the scores of FIQ-7 (P = .006), FIQ-9 (P = .006), and FIQ-total (P = .010) were significantly lower in the MLDT group than they were in the CTM group at the end of treatment. CONCLUSIONS: For this particular group of patients, both MLDT and CTM appear to yield improvements in terms of pain, health status, and HRQoL. The results indicate that these manual therapy techniques might be used in the treatment of PFM. However, MLDT was found to be more effective than CTM according to some subitems of FIQ (morning tiredness and anxiety) and FIQ total score. Manual lymph drainage therapy might be preferred; however, further long-term follow-up studies are needed

     (78)    Okifuji A, Bradshaw DH, Olson C. Evaluating obesity in fibromyalgia: neuroendocrine biomarkers, symptoms, and functions. Clin Rheumatol 2009; 28(4):475-8.
Abstract: The aim of this study was to investigate the associations between obesity and fibromyalgia syndrome (FMS). This study was conducted at the University of Utah Pain Management and Research Center, Salt Lake City, Utah. Thirty-eight FMS patients were included in this study. Neuroendocrine indices (catecholamines, cortisol, C-reactive protein [CRP], and interleukin-6), symptom measures (Fibromyalgia Impact Questionnaire), sleep indices (Actigraph), and physical functioning (treadmill testing) were measured. Body mass index (BMI) provided the primary indicator of obesity. Approximately 50% of the patients were obese and an additional 21% were overweight. Strong positive associations were found between BMI and levels of IL-6 (r=0.52) and epinephrine (r=0.54), and somewhat weaker associations with cortisol (r=0.32) and CRP (r=0.37). BMI was also related to maximal heart rate (r=0.33) and inversely related to distance walked (r= -0.41). BMI was associated with disturbed sleep: total sleep time (r= -0.56) and sleep efficiency (r= -0.44). No associations between self-reported symptoms and BMI were found. This study provides preliminary evidence suggesting that obesity plays a role in FMS-related dysfunction

     (79)    de TM, Sardaro M, Serpino C, Costantini F, Vecchio E, Prudenzano MP et al. Fibromyalgia comorbidity in primary headaches. Cephalalgia 2009; 29(4):453-64.
Abstract: Fibromyalgia syndrome (FMS) is a chronic pain condition of unknown aetiology characterized by diffuse pain and tenderness at tender points. The aim of the study was to assess the prevalence and clinical features of FMS in the different forms of primary headaches, in a tertiary headache centre. Primary headache patients (n = 217) were selected and submitted to the Total Tenderness Score, anxiety and depression scales, Migraine Disability Assessment, allodynia questionnaire, Short Form 36 Health Survey and the Medical Outcomes Study-Sleep Scale. In patients with FMS, the Multidimensional Assessment of Fatigue, the Pain Visual Analog Scale, the Manual Tender Point Survey and the Fibromyalgia Impact Questionnaire were employed. FMS was present in 36.4% of patients and prevailed significantly in tension-type headache and in patients with higher headache frequency. Headache frequency, pericranial muscle tenderness, anxiety and sleep inadequacy were especially associated with FMS comorbidity. In the FMS patients, fatigue and pain at tender points were significantly correlated with headache frequency. FMS seems increasingly prevalent with increased headache frequency, for the facilitation of central sensitization phenomena favoured by anxiety and sleep disturbances

     (80)    Pamuk ON, Donmez S, Cakir N. Increased frequencies of hysterectomy and early menopause in fibromyalgia patients: a comparative study. Clin Rheumatol 2009; 28(5):561-4.
Abstract: The objective was to determine the relationship between symptoms of fibromyalgia (FM) and early menopause and hysterectomy. We included 115 postmenopausal patients with FM (mean age 54.6 +/- 7.6) and 67 rheumatoid arthritis (RA) patients (mean age 55.5 +/- 9) into our study. All patients were questioned about the severity of their symptoms of FM, anxiety, and depression by using a visual analog scale and FM impact questionnaire. Patients' history of menopause and hysterectomy were recorded. Menopause (<or=45 years) was accepted to be early. The frequencies of early menopause (38.3% vs. 13.4%, p = 0.001) and hysterectomy (16.5% vs. 6%, p = 0.039) in FM patients were significantly higher than in RA patients. While chronic widespread pain and other FM-related symptoms started after menopause in 58.3% of FM patients, the disease started after menopause in 64.2% of RA patients (p > 0.05). FM-related symptoms started in 30 patients (26.1%) with FM with menopause or within the first postmenopausal year. When the clinical features of FM patients whose symptoms started within the first menopausal year were compared to other FM patients; it was observed that the frequency of early menopause was higher in the former group (p = 0.048). Duke anxiety and depression score was higher in patients with hysterectomy whose FM symptoms started within the first year of post-hysterectomy than other FM patients (9.1 +/- 2.7 vs. 6.7 +/- 2.7, p = 0.022). Early menopause and hysterectomy may be one of the factors contributing to the development of FM

     (81)    Heredia Jimenez JM, Aparicio Garcia-Molina VA, Porres Foulquie JM, Delgado FM, Soto Hermoso VM. Spatial-temporal parameters of gait in women with fibromyalgia. Clin Rheumatol 2009; 28(5):595-8.
Abstract: The aim of the present study was to determine if there are differences in such parameters among patients affected by fibromyalgia (FM) and healthy subjects and whether the degree of affectation by FM can decrease the gait parameters. We studied 55 women with FM and 44 controls. Gait analysis was performed using an instrumented walkway for measurement of the kinematic parameters of gait (GAITRite system), and patients completed a Spanish version of Fibromyalgia Impact Questionnaire (FIQ). Significant differences (p < 0.001) between FM and control groups were found in velocity, stride length, cadence, single support ratio, double support ratio, stance phase ratio, and swing phase ratio. There were significant inverse correlations between FIQ and velocity, stride length, swing phase, and single support, whereas significant direct correlations were found with stance phase and double support. Gait parameters of women affected by FM were severely impaired when compared to those of healthy women. Different factors such as lack of physical activity, bradikinesia, overweight, fatigue, and pain together with a lower isometric force in the legs can be responsible for the alterations in gait and poorer life quality of women with FM

     (82)    Weingarten TN, Podduturu VR, Hooten WM, Thompson JM, Luedtke CA, Oh TH. Impact of tobacco use in patients presenting to a multidisciplinary outpatient treatment program for fibromyalgia. Clin J Pain 2009; 25(1):39-43.
Abstract: OBJECTIVES: This study examined the relationship between the severity of fibromyalgia symptoms and current tobacco use in patients evaluated at a specialized fibromyalgia treatment program. METHODS: Demographic and clinical data from 984 consecutive patients evaluated at the Mayo Clinic Fibromyalgia Treatment Program including the Fibromyalgia Impact Questionnaire (FIQ) were prospectively collected and stored in an electronic medical record and an electronic database. Univariate analyses were performed comparing tobacco users and nonusers. A post-hoc analysis of covariance was conducted for tobacco use, using group differences of confounding clinical and demographic variables. A P value < or = 0.05 was accepted as the level of significance. RESULTS: One hundred and forty-five patients were identified as tobacco users (14.7%). Tobacco use was associated with greater pain intensity as measured by pain scales and the pain component of the FIQ. Tobacco users had a greater FIQ composite score 70.0(15.1) versus 61.8(16.8), P<0.001. By univariate analysis, tobacco users had higher scores on all the FIQ components and fewer good days and more days of work missed per week. Tobacco use was associated with several confounding clinical and demographic variables including lower education, higher unemployment, not being married or widowed, and history of abuse. After adjusting for these confounding variables, tobacco users continued to have greater pain intensity, a higher total and component FIQ scores except for fatigue. Smoking was not associated with a higher number of tender points. DISCUSSION: Current tobacco use was associated with more severe fibromyalgia symptoms in patients presenting to a specialized fibromyalgia treatment program

     (83)    Pamuk ON, Donmez S, Cakir N. The frequency of smoking in fibromyalgia patients and its association with symptoms. Rheumatol Int 2009; 29(11):1311-4.
Abstract: The objective of the study was to determine the frequency of smoking in fibromyalgia (FM) and rheumatoid arthritis (RA) patients and investigate its association with the symptoms of FM. We included age-matched 302 FM (289 F, 13 M), and 115 (105 F, 10 M) RA patients. All patients were questioned about smoking and the severity of their chronic widespread pain (CWP) and symptoms of FM by using a visual analog scale (VAS, 0-10) and FM impact questionnaire. In addition, patients were asked questions about depression and anxiety. The frequency of smoking in FM patients (77 subjects, 25.5%) tended to be higher than in RA patients (19 subjects, 16.5%) (P = 0.05). When the features of smoker FM patients were compared to others, it was observed that the frequencies of subjects with an education duration >9 years (P < 0.001) and subjects with an history of psychiatric therapy (P = 0.01) and alcohol consumption (P = 0.013) were higher. The mean age of FM patients with smoking (P = 0.002) was lower; the duration of FM (P = 0.024) was shorter; and the scores of CWP severity (P = 0.05), unrestorative sleepiness (P = 0.017), paresthesia (P = 0.038) and anxiety-depression (P = 0.007) were higher. An important proportion of FM patients, nearly one-fourth, were re-smokers. Smoker FM patients had higher education level, and the severity of their FM-related symptoms like CWP and their anxiety-depression scores were higher

     (84)    Almansa C, Rey E, Sanchez RG, Sanchez AA, Diaz-Rubio M. Prevalence of functional gastrointestinal disorders in patients with fibromyalgia and the role of psychologic distress. Clin Gastroenterol Hepatol 2009; 7(4):438-45.
Abstract: BACKGROUND & AIMS: Fibromyalgia is a rheumatologic disorder associated with somatic and psychologic conditions. Although fibromyalgia is associated with irritable bowel syndrome, its relationship with other functional gastrointestinal disorders (FGID) is unclear. We evaluated the prevalence of FGID in patients with fibromyalgia and the role of psychologic factors in this relationship. METHODS: From a Spanish population, 100 patients with fibromyalgia and 100 matched controls completed the Rome II Integrative Questionnaire to assess the prevalence of FGID and the Symptom Checklist-90 Revised (SCL-90R) to evaluate psychologic distress. Patients completed the Fibromyalgia Impact Questionnaire to evaluate the overall impact of fibromyalgia and controls filled out the Chronic Widespread Pain Questionnaire to detect potential cases of fibromyalgia. RESULTS: Ninety-three percent of the total study population was female, with a mean age of 50 years. We identified 6 cases of widespread pain among controls. The average Fibromyalgia Impact Questionnaire score for patients was 67.28 +/- 14.25. All gastrointestinal symptoms except for vomiting were more frequent in patients. Ninety-eight percent of patients with fibromyalgia had at least one FGID, compared with only 39% of controls. Fibromyalgia was correlated most highly with irritable bowel syndrome. Patients presented with significantly higher scores of psychologic distress than controls, especially those with fecal incontinence. CONCLUSIONS: There is a prevalence of FGID in patients with fibromyalgia and a wider distribution of such symptoms along the gastrointestinal tract compared with controls. We propose that an increased degree of psychologic distress in these patients predisposes them to FGID, especially significant for anorectal syndromes

     (85)    Jones KD, Horak FB, Winters-Stone K, Irvine JM, Bennett RM. Fibromyalgia is associated with impaired balance and falls. J Clin Rheumatol 2009; 15(1):16-21.
Abstract: BACKGROUND/OBJECTIVE: The purpose of this study was to determine whether fibromyalgia (FM) patients differ from matched healthy controls in clinical tests of balance ability and fall frequency. METHODS: Thirty-four FM patients and 32 age-matched controls were administered the Balance Evaluation-Systems Test (BESTest), rated their balance confidence with the Activities-Specific Balance Confidence (ABC) Scale, and reported the number of falls in the last 6 months. The Fibromyalgia Impact Questionnaire was used to assess FM severity. RESULTS: FM patients had significantly impaired balance in all components of the BESTest compared with controls. They also scored more poorly on balance confidence. Overall FM severity (Fibromyalgia Impact Questionnaire) correlated significantly with the BESTest and the ABC scale. The BESTest and ABC correlated significantly with 6 commonly reported FM symptoms (excluding pain). FM patients reported a total of 37 falls over the last 6-months compared with 6 falls in healthy controls. CONCLUSION: FM is associated with balance problems and increased fall frequency. Patients were aware of their balance problems. These results suggest that FM may affect peripheral and/or central mechanisms of postural control. Further objective study is needed to identify the relative contributions of various neural and musculoskeletal and other impairments to postural stability in FM to provide clinicians with methods to maximize postural stability and help fall prevention

     (86)    McParland JL, Knussen C. Just world beliefs moderate the relationship of pain intensity and disability with psychological distress in chronic pain support group members. Eur J Pain 2010; 14(1):71-6.
Abstract: The impact of pain beliefs on coping and adjustment is well established. However, less is known about how beliefs unrelated to pain might impact upon this experience. In particular, just world beliefs could impact upon and be influenced by chronic pain, given that pain is not experienced in a vacuum but instead is experienced in a social context where justice issues are potentially salient. The focus of this study was the ability of personal and general just world beliefs to moderate the relationships psychological distress held with pain intensity and disability in chronic pain. The sample (N=95) was recruited from members of arthritis and fibromyalgia support groups to investigate these social beliefs in a controlled community pain context. A cross-sectional, questionnaire design was adopted. The personal just world belief was endorsed significantly more than the general just world belief, and endorsement of the personal just world belief was negatively correlated with pain intensity, disability and psychological distress, while the general just world belief was unrelated to these variables. When interaction terms relating to personal and general just world beliefs were entered simultaneously into regression analyses, the personal just world belief did not predict psychological distress. However, pain intensity positively predicted psychological distress at low but not high levels of the general just world belief, while disability predicted psychological distress at low and high levels of this belief. This suggests that a strong general just world belief has implications for psychological well-being in chronic pain, and as such this belief may occupy a potential coping function in this context

     (87)    Russell IJ, Perkins AT, Michalek JE. Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis Rheum 2009; 60(1):299-309.
Abstract: OBJECTIVE: To evaluate the safety and efficacy of sodium oxybate for management of the symptoms of fibromyalgia syndrome (FMS). METHODS: Patients with FMS (according to the American College of Rheumatology 1990 criteria) were randomized, after discontinuing their prestudy medications for FMS, to receive 4.5 gm or 6 gm of sodium oxybate or matching placebo once per night for 8 weeks. The primary outcome variable (POV) was a composite score for changes from baseline in 3 coprimary self-report measures: patient's pain rating (in daily electronic diaries) on a visual analog scale (PVAS), the Fibromyalgia Impact Questionnaire (FIQ) score, and the Patient Global Impression of Change (PGI-C). A beneficial response rate for the POV composite score was defined as >or=20% improvement in the PVAS and FIQ scores plus a rating of "much better" or "very much better" on the PGI-C. Secondary measures included subjective sleep outcomes (on the Jenkins Scale for Sleep) and quality-of-life measures. The analyses were based on an intent-to-treat (ITT) population. RESULTS: The ITT population included 188 patients with FMS, 78% of whom completed the trial. Significant benefit was observed with both dosages of sodium oxybate, according to changes in the POV and subjective sleep quality. Improvements in the PVAS score were significantly correlated with sleep outcomes. Sodium oxybate was well tolerated overall; dose-related nausea (<or=28% of patients) and dizziness (<or=18% of patients) tended to resolve with continued therapy. CONCLUSION: Sodium oxybate therapy was well tolerated and significantly improved the symptoms of FMS. Further study of sodium oxybate as a novel therapeutic option for FMS is warranted

     (88)    Chappell AS, Bradley LA, Wiltse C, Detke MJ, D'Souza DN, Spaeth M. A six-month double-blind, placebo-controlled, randomized clinical trial of duloxetine for the treatment of fibromyalgia. Int J Gen Med 2009; 1:91-102.
Abstract: OBJECTIVE: Assess the efficacy of duloxetine 60/120 mg (N = 162) once daily compared with placebo (N = 168) in the treatment of patients with fibromyalgia, during six months of treatment. METHODS: This was a phase-III, randomized, double-blind, placebo-controlled, parallel-group study assessing the efficacy and safety of duloxetine. RESULTS: There were no significant differences between treatment groups on the co-primary efficacy outcome measures, change in the Brief Pain Inventory (BPI) average pain severity from baseline to endpoint (P = 0.053) and the Patient's Global Impressions of Improvement (PGI-I) at endpoint (P = 0.073). Duloxetine-treated patients improved significantly more than placebo-treated patients on the Fibromyalgia Impact Questionnaire pain score, BPI least pain score and average interference score, Clinical Global Impressions of Severity scale, area under the curve of pain relief, Multidimensional Fatigue Inventory mental fatigue dimension, Beck Depression Inventory-II total score, and 36-item Short Form Health Survey mental component summary and mental health score. Nausea was the most common treatment-emergent adverse event in the duloxetine group. Overall discontinuation rates were similar between groups. CONCLUSIONS: Although duloxetine 60/120 mg/day failed to demonstrate significant improvement over placebo on the co-primary outcome measures, in this supportive study, duloxetine demonstrated significant improvement compared with placebo on numerous secondary measures

     (89)    Chung CP, Titova D, Oeser A, Randels M, Avalos I, Milne GL et al. Oxidative stress in fibromyalgia and its relationship to symptoms. Clin Rheumatol 2009; 28(4):435-8.
Abstract: Oxidative stress is thought to play a role in the pathogenesis of fibromyalgia. We examined the hypothesis that oxidative stress was increased in patients with fibromyalgia and related to the severity of symptoms. Urinary F(2)-isoprostane excretion was measured in 48 patients with fibromyalgia and compared to those of 96 control subjects. In patients, we examined the association between oxidative stress and symptoms. Patients with fibromyalgia were significantly more symptomatic than control subjects, but urinary F(2)-isoprostane excretion did not differ significantly (2.3+/-1.9 vs. 2.8+/-2.2 ng/mg creatinine, p=0.16). In patients with fibromyalgia, F(2)-isoprostane excretion was associated with fatigue visual analog scale (rho=0.30, p=0.04) but not with pain, quality of life, functional capacity, depression, number of tender points, or overall impact of fibromyalgia. Oxidative stress is not increased in patients with fibromyalgia, but as was previously found in patients with systemic lupus erythematosus, oxidative stress was associated with fatigue

     (90)    Altomonte L, Atzeni F, Leardini G, Marsico A, Gorla R, Casale R et al. Fibromyalgia syndrome: preventive, social and economic aspects. Reumatismo 2008; 60 Suppl 1:70-8.
Abstract: There many open questions concerning the concept of primary prevention in FM. Diagnostic or classification criteria are not universally accepted, and this leads to difficulties in establishing the onset and duration of the disease. In the case of FM, primary prevention may consist of the immediate care of acute pain or treatment for affective disturbances as we do not have any specific laboratory or instrumental tests to determine risk factors of the disease. The goal of secondary prevention is early detection of the disease when patients are largely asymptomatic and intervention improves outcome. Screening allows for identification of an unrecognized disease or risk factor, which, for potential FM patients, includes analysis of tender points, Fibromyalgia Impact Questionnaire (FIQ), pain location and intensity, and fatigue and sleep complaints. Tertiary prevention inhibits further deterioration or reduces complications after the disease has developed. In FM the aim of treatment is to decrease pain and increase function via multimodal therapeutic strategies, which, in most cases, includes pharmacological and non-pharmacological interventions. Patients with FM are high consumers of health care services, and FM is associated with significant productivity-related costs. The degree of disability and the number of comorbidities are strongly associated with costs. An earlier diagnosis of FM can reduce referral costs and investigations, thus, leading to a net savings for the health care sector. However, every social assessment is closely related to the socio-economic level of the general population and to the legislation of the country in which the FM patient resides

     (91)    Munguia-Izquierdo D, Legaz-Arrese A. Assessment of the effects of aquatic therapy on global symptomatology in patients with fibromyalgia syndrome: a randomized controlled trial. Arch Phys Med Rehabil 2008; 89(12):2250-7.
Abstract: OBJECTIVES: To evaluate the effects of a 16-week exercise therapy in a chest-high pool of warm water through applicable tests in the clinical practice on the global symptomatology of women with fibromyalgia (FM) and to determine exercise adherence levels. DESIGN: A randomized controlled trial. SETTING: Testing and training were completed at the university. PARTICIPANTS: Middle-aged women with FM (n=60) and healthy women (n=25). INTERVENTION: A 16-week aquatic training program, including strength training, aerobic training, and relaxation exercises. MAIN OUTCOME MEASURES: Tender point count (syringe calibrated), health status (Fibromyalgia Impact Questionnaire); sleep quality (Pittsburgh Sleep Quality Index); physical (endurance strength to low loads tests), psychologic (State Anxiety Inventory), and cognitive function (Paced Auditory Serial Addition Task); and adherence 12 months after the completion of the study. RESULTS: For all the measurements, the patients showed significant deficiencies compared with the healthy subjects. Efficacy analysis (n=29) and intent-to-treat analysis (n=34) of the exercise therapy was effective in decreasing the tender point count and improving sleep quality, cognitive function, and physical function. Anxiety remained unchanged during the follow-up. The exercise group had a significant improvement of health status, not associated exclusively with the exercise intervention. There were no changes in the control group. Twenty-three patients in the exercise group were exercising regularly 12 months after completing the program. CONCLUSIONS: An exercise therapy 3 times a week for 16 weeks in a warm pool could improve most of the symptoms of FM and cause a high adherence to exercise in unfit women with heightened FM symptomatology. The therapeutic intervention's effects can be assessed through applicable tests in the clinical practice

     (92)    Nicholl BI, Macfarlane GJ, Davies KA, Morriss R, Dickens C, McBeth J. Premorbid psychosocial factors are associated with poor health-related quality of life in subjects with new onset of chronic widespread pain - results from the EPIFUND study. Pain 2009; 141(1-2):119-26.
Abstract: Chronic widespread pain (CWP) is associated with poor health-related quality of life (HRQoL). It is unclear whether pain itself is the cause of poor HRQoL or other factors play a role. We hypothesised that new onset of CWP was associated with poor physical and mental HRQoL but that psychosocial risk markers for CWP onset would explain this relationship. A prospective population-based survey measured pain and psychosocial status at baseline. Subjects free of CWP at baseline were followed up 15 months later, when pain status, threatening life events and HRQoL (SF-12) were assessed. The risk associated with the new onset of CWP and reporting poor SF12-MCS and SF12-PCS was quantified using multinomial logistic regression (relative risk ratios (RRRs) with 95% confidence intervals (95% CI)), adjusted for age and gender. 3000 subjects (77%) free of CWP at baseline participated at follow-up. 2650 subjects (88%) provided full SF-12 and pain data and formed the cohort for this analysis. 9.4% of subjects (n=248) reported new CWP. New CWP was associated with an increased risk of having the poorest SF12-MCS (RRR=2.3; 95% CI 1.6-3.2) and SF12-PCS (RRR=8.0; 95% CI 5.4-11.8) scores. After adjusting for baseline psychosocial status, the relationship between CWP onset and SF12-MCS was attenuated (RRR=1.2; 95% CI 0.8-1.8), although the association with SF12-PCS remained (RRR=4.8% CI 3.1-7.47). New onset of CWP is associated with poor mental and physical HRQoL. However, the relationship with mental HRQoL is explained by psychosocial risk markers

     (93)    Wahner-Roedler DL, Thompson JM, Luedtke CA, King SM, Cha SS, Elkin PL et al. Dietary Soy Supplement on Fibromyalgia Symptoms: A Randomized, Double-blind, Placebo-controlled, Early Phase Trial. Evid Based Complement Alternat Med 2008.
Abstract: Most patients with fibromyalgia use complementary and alternative medicine (CAM). Properly designed controlled trials are necessary to assess the effectiveness of these practices. This study was a randomized, double-blind, placebo-controlled, early phase trial. Fifty patients seen at a fibromyalgia outpatient treatment program were randomly assigned to a daily soy or placebo (casein) shake. Outcome measures were scores of the Fibromyalgia Impact Questionnaire (FIQ) and the Center for Epidemiologic Studies Depression Scale (CES-D) at baseline and after 6 weeks of intervention. Analysis was with standard statistics based on the null hypothesis, and separation test for early phase CAM comparative trials. Twenty-eight patients completed the study. Use of standard statistics with intent-to-treat analysis showed that total FIQ scores decreased by 14% in the soy group (P = 0.02) and by 18% in the placebo group (P<0.001). The difference in change in scores between the groups was not significant (P = 0.16). With the same analysis, CES-D scores decreased in the soy group by 16% (P = 0.004) and in the placebo group by 15% (P = 0.05). The change in scores was similar in the groups (P = 0.83). Results of statistical analysis using the separation test and intent-to-treat analysis revealed no benefit of soy compared with placebo. Shakes that contain soy and shakes that contain casein, when combined with a multidisciplinary fibromyalgia treatment program, provide a decrease in fibromyalgia symptoms. Separation between the effects of soy and casein (control) shakes did not favor the intervention. Therefore, large-sample studies using soy for patients with fibromyalgia are probably not indicated

     (94)    Alentorn-Geli E, Padilla J, Moras G, Lazaro HC, Fernandez-Sola J. Six weeks of whole-body vibration exercise improves pain and fatigue in women with fibromyalgia. J Altern Complement Med 2008; 14(8):975-81.
Abstract: OBJECTIVE: The aim of this study was to investigate the effectiveness of a 6-week traditional exercise program with supplementary whole-body vibration (WBV) in improving health status, physical functioning, and main symptoms of fibromyalgia (FM) in women with FM. METHODS: Thirty-six (36) women with FM (mean +/- standard error of the mean age 55.97 +/- 1.55) were randomized into 3 treatment groups: exercise and vibration (EVG), exercise (EG), and control (CG). Exercise therapy, consisting of aerobic activities, stretching, and relaxation techniques, was performed twice a week (90 min/day). Following each exercise session, the EVG underwent a protocol with WBV, whereas the EG performed the same protocol without vibratory stimulus. The Fibromyalgia Impact Questionnaire (FIQ) was administered at baseline and 6 weeks following the initiation of the treatments. Estimates of pain, fatigue, stiffness, and depression were also reported using the visual analogue scale. RESULTS: A significant 3 x 2 (group x time)-repeated measures analysis of variance interaction was found for pain (p = 0.018) and fatigue (p = 0.002) but not for FIQ (p = 0.069), stiffness (p = 0.142), or depression (p = 0.654). Pain and fatigue scores were significantly reduced from baseline in the EVG, but not in the EG or CG. In addition, the EVG showed significantly lower pain and fatigue scores at week 6 compared to the CG, whereas no significant differences were found between the EG and CG (p > 0.05). CONCLUSION: Results suggest that a 6-week traditional exercise program with supplementary WBV safely reduces pain and fatigue, whereas exercise alone fails to induce improvements

     (95)    van Wilgen CP, van Ittersum MW, Kaptein AA, van WM. Illness perceptions in patients with fibromyalgia and their relationship to quality of life and catastrophizing. Arthritis Rheum 2008; 58(11):3618-26.
Abstract: OBJECTIVE: In the last decade, illness perceptions have been identified as important in the treatment of fibromyalgia (FM). The aim of the present study was to examine illness perceptions and use of the revised Illness Perception Questionnaire in patients with FM (IPQ-R-FM) and their relationship to quality of life and catastrophizing. METHODS: A domain with specific causal attributions related to FM was added to the IPQ-R-FM. The psychometric properties of the IPQ-R-FM dimensions and attribution scales were examined. The causal domain, in which patients describe the most important perceived causes for their FM, was analyzed. To analyze the relationship with quality of life and catastrophizing, the Fibromyalgia Impact Questionnaire and the Pain Catastrophizing Scale were used. RESULTS: Fifty-one outpatients completed the questionnaires on 2 occasions, 3 weeks apart. FM was considered to be chronic and to have serious consequences; patients perceived little personal control and did not expect medical treatment to be effective. The psychometric properties of the IPQ-R-FM were found to be adequate. Patients most frequently attributed the causes of FM to an external somatic source (58%). Quality of life was related to experiencing more consequences attributable to FM. Catastrophizing was related to a limited understanding of the symptoms of FM, the more cyclical nature of FM, and an emotional representation. CONCLUSION: The IPQ-R-FM is a useful tool to assess illness perceptions in patients with FM. Illness perceptions are related to quality of life and catastrophizing; therefore, it seems important to assess and integrate illness perceptions into the management of patients with FM

     (96)    Guedj E, Cammilleri S, Niboyet J, Dupont P, Vidal E, Dropinski JP et al. Clinical correlate of brain SPECT perfusion abnormalities in fibromyalgia. J Nucl Med 2008; 49(11):1798-803.
Abstract: The purpose of this study was to investigate the specific clinical correlate of brain SPECT perfusion abnormalities reported in fibromyalgia. METHODS: We performed a whole-brain voxel-based correlation analysis involving regional cerebral blood flow and various parameters related to pain (Visual Analog Scale, Tubingen Pain Behavior Scale, and Questionnaire Douleur de Saint-Antoine Scale), disability (Fibromyalgia Impact Questionnaire [FIQ]), and anxiety and depression status (Hospital Anxiety and Depression scale) in 20 patients with fibromyalgia (P voxel < 0.005). Ten healthy control women were also included, in order to determine areas of significant hypo- and hyperperfusions in patients. RESULTS: FIQ total score was positively correlated with bilateral parietal perfusion, including postcentral cortex. These clusters of correlation were included in the areas of significant hyperperfusion. FIQ total score was also negatively correlated with perfusion of a left anterior temporal cluster, included in the areas of significant hypoperfusions. No other clinical correlation was observed with regional cerebral blood flow. CONCLUSION: These results show that brain perfusion abnormalities in patients with fibromyalgia are correlated with the clinical severity of the disease

     (97)    Sendur OF, Turan Y, Tastaban E, Yenisey C, Serter M. Serum antioxidants and nitric oxide levels in fibromyalgia: a controlled study. Rheumatol Int 2009; 29(6):629-33.
Abstract: We proposed to assess antioxidant status and nitric oxide in fibromyalgia (FM) patients in comparison to healthy controls. Additionally, the association between the serum antioxidant levels and clinical findings in FM patients was also investigated. Thirty-seven FM patients and 37 healthy controls were enrolled in this study. Severity of fatigue and pain were determined by Visual Analogue Scale. Functional capacity in daily living activities was evaluated by fibromyalgia impact questionnaire. Serum NO, catalase and glutathione were measured. Serum glutathione and catalase levels were significantly lower in FM patients than controls. However, no significant difference was seen in serum NO levels between the two groups. A significant correlation was evident between serum NO level and pain. Additionally, the correlation between glutathione level and morning stiffness was found to be significant. These findings support other studies, we assume that these two antioxidants might have impact on the pathogenesis of FM disease

     (98)    Ryan S, Hill J, Thwaites C, Dawes P. Assessing the effect of fibromyalgia on patients' sexual activity. Nurs Stand 2008; 23(2):35-41.
Abstract: AIMS: The primary aim of this study was to investigate whether a questionnaire developed for patients with rheumatoid arthritis (RA) could also be used with patients who have fibromyalgia. A secondary aim was to assess the impact of fibromyalgia on sexuality. METHOD: In the first of two phases the face and content validity of a sexuality questionnaire already being used in patients with RA were assessed in a qualitative, audio-taped, interview study of five patients with fibromyalgia. The second phase consisted of a self-report questionnaire distributed to 60 patients with fibromyalgia. FINDINGS: The interview data confirmed that the content of the RA sexuality questionnaire was relevant to patients with fibromyalgia. A total of 43 (72%) questionnaires were returned and, of these, 41 (95%) were usable. Patients reported that fibromyalgia had altered their sexual relationship. They cited pain, stiffness, fatigue, reduced sexual drive and the impact of drug therapy as the main reasons. CONCLUSION: The symptoms associated with fibromyalgia had a negative effect on sexual enjoyment. The questionnaire appears to be useful in addressing sexuality in patients with fibromyalgia

     (99)    de Souza JB, Goffaux P, Julien N, Potvin S, Charest J, Marchand S. Fibromyalgia subgroups: profiling distinct subgroups using the Fibromyalgia Impact Questionnaire. A preliminary study. Rheumatol Int 2009; 29(5):509-15.
Abstract: The main goal of this project was to identify the presence of fibromyalgia (FM) subgroups using a simple and frequently used clinical tool, the Fibromyalgia Impact Questionnaire (FIQ). A total of 61 women diagnosed with FM participated in this study. FM subgroups were created by applying a hierarchical cluster analysis on selected items of the FIQ (pain, fatigue, morning tiredness, stiffness, anxiety and depressive symptoms). We also tested for group differences on experimental pain, psychosocial functioning and demographic characteristics. Two cluster profiles best fit our data. FM-Type I was characterized by the lowest levels of anxiety, depressive and morning tiredness symptoms, while FM-Type II was characterized by elevated levels of pain, fatigue, morning tiredness, stiffness, anxiety and depressive symptoms. Both FM subgroups showed hyperalgesic responses to experimental pain. These results suggest that pain and stiffness are universal symptoms of the disorder but that psychological distress is a feature present only in some patients

   (100)    Orellana C, Casado E, Masip M, Galisteo C, Gratacos J, Larrosa M. Sexual dysfunction in fibromyalgia patients. Clin Exp Rheumatol 2008; 26(4):663-6.
Abstract: OBJECTIVE: To investigate the prevalence of sexual dysfunction in female patients with fibromyalgia (FM), the impact of FM on sexual activity and the factors associated with sexual dysfunction in these patients. METHODS: Thirty-one consecutive women with FM were enrolled; two groups of 20 aged-matched healthy women and 26 patients with rheumatoid arthritis (RA) were used as controls. Demographic features were recorded in all patients. A cross-sectional analysis of pain (100-mm VAS scale), anxiety and depression (as determined by the STAI and Beck Depression Inventory scales, respectively) was performed. Sexual function was assessed by the Changes in Sexual Functioning Questionnaire (CSFQ). RESULTS: FM and RA patients showed a significantly higher rate of sexual dysfunction compared to healthy controls. Sexual dysfunction was more frequent among FM patients (97%) than in RA patients (84%) but without statistical differences. A univariate analysis showed that age (p=0.0002), marital (p=0.036) and work status (p=0.048), pain intensity (p=0.007), level of anxiety (p=0.002), level of depression (p=0.0005), were significantly associated with sexual dysfunction in FM. However, only the intensity of depression was associated with the sexual dysfunction in patients with FM in the multivariate analysis (p=0.012). CONCLUSIONS: Sexual function was very frequently and severely affected in patients with FM and this impairment appeared to be particularly associated with the degree of depression. The recognition of this dysfunction and its inclusion for the multidisciplinary management of FM may contribute to improve quality of life of these patients

   (101)    Wood PB, Ledbetter CR, Glabus MF, Broadwell LK, Patterson JC. Hippocampal metabolite abnormalities in fibromyalgia: correlation with clinical features. J Pain 2009; 10(1):47-52.
Abstract: Although the pathology of fibromyalgia is poorly understood, a growing body of evidence suggests involvement of the central nervous system. The hippocampus is a brain center that is sensitive to the effects of stress exposure and has been demonstrated to be affected in a variety of disorders whose onset, like fibromyalgia, are associated with stressful experience. We therefore interrogated the bilateral hippocampus of 16 female fibromyalgia patients in comparison to 8 age- and gender-matched healthy control subjects using single voxel proton magnetic resonance spectroscopy. Our results demonstrate a significant reduction in the ratio of N-acetylaspartate to creatine (NAA/Cr) in fibromyalgia patients versus matched control subjects specifically in the right temporal lobe from a voxel centered on the right hippocampus (patient vs control, mean +/- standard deviation: 1.20 +/- 0.13 vs 1.34 +/- 0.10, P = .03). Moreover, correlation analysis demonstrated a significant negative correlation between patient scores on the Fibromyalgia Impact Questionnaire and NAA/Cr ratio within the right hippocampus (Spearman rank correlation, rho = -0.681, P = .018). Our results indicate that fibromyalgia is associated with brain metabolite abnormalities within the right hippocampus that correlate with patient symptoms. PERSPECTIVE: We have demonstrated an abnormality in hippocampal brain metabolites in premenopausal female fibromyalgia patients with no psychiatric comorbidity. A significant negative correlation between patient subjective experience of symptoms and a reduced NAA/Cr ratio suggests a role for hippocampal pathology in fibromyalgia

   (102)    Ablin JN, Beilinson N, Aloush V, Elkayam O, Finkelstein A. Association between fibromyalgia and coronary heart disease and coronary catheterization. Clin Cardiol 2009; 32(6):E7-11.
Abstract: BACKGROUND: Fibromyalgia (FM) has been associated with physical and emotional trauma including invasive medical procedures. Both FM and ischemic heart disease have been linked with depression. The purpose of this study was to retrospectively investigate the frequency of FM symptoms and physical findings among patients undergoing coronary catheterization. METHODS: Consecutive patients who underwent coronary angiography during the previous 6 mo were recruited. Patients with major depression, bi-polar disorder, schizophrenia, or malignancy were excluded. Patients underwent dolorimetry for tender-point assessment and completed the fibromyalgia impact questionnaire (FIQ). Group A included patients with significant coronary pathology (n = 43), group B included patients with normal coronary arteries (n = 50), and group C included patients with normal controls (n = 51). A cardiological score incorporated the number of coronary arteries with significant pathology and left ventricular function. Chi-square or Fisher's exact test was used for categorical data and a one-way analysis of variance for continuous variables; a multivariate linear regression was performed to compare groups. RESULTS: Significantly increased levels of tenderness were discovered among patients with coronary pathology compared with healthy controls. Significantly increased levels of depression were also found, as well as higher scores on the FIQ scale. On multivariate analysis, a positive correlation was demonstrated between tenderness/FIQ scores and a composite cardiological score. CONCLUSION: Coronary angiography is associated with a significantly increased frequency of pain, tenderness, and depression after 6 mo, apparent in both patients undergoing coronary procedures and patients with normal coronaries. This association may impact the outcome of patients with significant coronary disease

   (103)    Matsushita K, Masuda A, Tei C. Efficacy of Waon therapy for fibromyalgia. Intern Med 2008; 47(16):1473-6.
Abstract: OBJECTIVE: Fibromyalgia syndrome (FMS) is a chronic syndrome characterized by widespread pain with tenderness in specific areas. We examined the applicability of Waon therapy (soothing warmth therapy) as a new method of pain treatment in patients with FMS. METHODS: Thirteen female FMS patients (mean age, 45.2+/-15.5 years old; range, 25-75) who fulfilled the criteria of the American College of Rheumatology participated in this study. Patients received Waon therapy once per day for 2 or 5 days/week. The patients were placed in the supine or sitting position in a far infrared-ray dry sauna maintained at an even temperature of 60 degrees C for 15 minutes, and then transferred to a room maintained at 26-27 degrees C where they were covered with a blanket from the neck down to keep them warm for 30 minutes. Reductions in subjective pain and symptoms were determined using the pain visual analog scale (VAS) and fibromyalgia impact questionnaire (FIQ). RESULTS: All patients experienced a significant reduction in pain by about half after the first session of Waon therapy (11-70%), and the effect of Waon therapy became stable (20-78%) after 10 treatments. Pain VAS and FIQ symptom scores were significantly (p<0.01) decreased after Waon therapy and remained low throughout the observation period. CONCLUSION: Waon therapy is effective for the treatment of fibromyalgia syndrome

   (104)    Thompson EA, Mathie RT, Baitson ES, Barron SJ, Berkovitz SR, Brands M et al. Towards standard setting for patient-reported outcomes in the NHS homeopathic hospitals. Homeopathy 2008; 97(3):114-21.
Abstract: INTRODUCTION: We report findings from a pilot data collection study within a programme of quality assurance, improvement and development across all five homeopathic hospitals in the UK National Health Service (NHS). AIMS: (1) To pilot the collection of clinical data in the homeopathic hospital outpatient setting, recording patient-reported outcome since first appointment; (2) to sample the range of medical complaints that secondary-care doctors treat using homeopathy, and thus identify the nature and complexity of complaints most frequently treated nationally; (3) to present a cross section of outcome scores by appointment number, including that for the most frequently treated medical complaints; (4) to explore approaches to standard setting for homeopathic practice outcome in patients treated at the homeopathic hospitals. METHODS: A total of 51 medical practitioners took part in data collection over a 4-week period. Consecutive patient appointments were recorded under the headings: (1) date of first appointment in the current series; (2) appointment number; (3) age of patient; (4) sex of patient; (5) main medical complaint being treated; (6) whether other main medical complaint(s); (7) patient-reported change in health, using Outcome Related to Impact on Daily Living (ORIDL) and its derivative, the ORIDL Profile Score (ORIDL-PS; range, -4 to +4, where a score <or=-2 or >or=+2 indicates an effect on the quality of a patient's daily life); (8) receipt of other complementary medicine for their main medical complaint. RESULTS: The distribution of patient age was bimodal: main peak, 49 years; secondary peak, 6 years. Male:female ratio was 1:3.5. Data were recorded on a total of 1797 individual patients: 195 first appointments, 1602 follow-ups (FUs). Size of clinical service and proportion of patients who attended more than six visits varied between hospitals. A total of 235 different medical complaints were reported. The 30 most commonly treated complaints were (in decreasing order of frequency): eczema; chronic fatigue syndrome (CFS); menopausal disorder; osteoarthritis; depression; breast cancer; rheumatoid arthritis; asthma; anxiety; irritable bowel syndrome; multiple sclerosis; psoriasis; allergy (unspecified); fibromyalgia; migraine; premenstrual syndrome; chronic rhinitis; headache; vitiligo; seasonal allergic rhinitis; chronic intractable pain; insomnia; ulcerative colitis; acne; psoriatic arthropathy; urticaria; ovarian cancer; attention-deficit hyperactivity disorder (ADHD); epilepsy; sinusitis. The proportion of patients with important co-morbidity was higher in those seen after visit 6 (56.9%) compared with those seen up to and including that point (40.7%; P<0.001). The proportion of FU patients reporting ORIDL-PS>or=+2 (improvement affecting daily living) increased overall with appointment number: 34.5% of patients at visit 2 and 59.3% of patients at visit 6, for example. Amongst the four most frequently treated complaints, the proportion of patients that reported ORIDL-PS>or=+2 at visit numbers greater than 6 varied between 59.3% (CFS) and 73.3% (menopausal disorder). CONCLUSIONS: We have successfully piloted a process of national clinical data collection using patient-reported outcome in homeopathic hospital outpatients, identifying a wide range and complexity of medical complaints treated in that setting. After a series of homeopathy appointments, a high proportion of patients, often representing "effectiveness gaps" for conventional medical treatment, reported improvement in health affecting their daily living. These pilot findings are informing our developing programme of standard setting for homeopathic care in the hospital outpatient context

   (105)    van Uden-Kraan CF, Drossaert CH, Taal E, Seydel ER, van de Laar MA. Self-reported differences in empowerment between lurkers and posters in online patient support groups. J Med Internet Res 2008; 10(2):e18.
Abstract: BACKGROUND: Patients who visit online support groups benefit in various ways. Results of our earlier study indicated that participation in online support groups had a profound effect on the participants' feelings of "being empowered." However, most studies of online patient support groups have focused on the members of these groups who actively contribute by sending postings (posters). Thus far, little is known about the impact for "lurkers" (ie, those who do not actively participate by sending postings). OBJECTIVE: In the present study, we explored if lurkers in online patient support groups profit to the same extent as posters do. METHODS: We searched the Internet with the search engine Google to identify all Dutch online support groups for patients with breast cancer, fibromyalgia, and arthritis. Invitations to complete an online survey were sent out by the owners of 19 groups. In the online questionnaire, we asked questions about demographic and health characteristics, use of and satisfaction with the online support group, empowering processes, and empowering outcomes. The online questionnaire was completed by 528 individuals, of which 109 (21%) identified themselves as lurkers. RESULTS: Lurkers (mean age 47 years) were slightly older than active participants (mean age 43 years, P = .002), had a shorter disease history (time since diagnosis 3.7 years vs 5.4 years, P = .001), and reported lower mental well-being (SF 12 subscore 37.7 vs 40.5, P = .004). No significant differences were found in other demographic variables. Posters indicated visiting the online support groups significantly more often for social reasons, such as curiosity about how other members were doing, to enjoy themselves, as a part of their daily routine (all P < .001), and because other members expected them to be there (P = .003). Lurkers and posters did not differ in their information-related reasons for visiting the online support group. Lurkers were significantly less satisfied with the online support group compared to posters (P < .001). With regard to empowering processes such as "exchanging information" and "finding recognition," lurkers scored significantly lower than posters. However, lurkers did not differ significantly from posters with regard to most empowering outcomes, such as "being better informed," "feeling more confident in the relationship with their physician," "improved acceptance of the disease," "feeling more confident about the treatment," "enhanced self-esteem," and "increased optimism and control." The exception was "enhanced social well-being," which scored significantly lower for lurkers compared to posters (P < .001). CONCLUSION: Our study revealed that participation in an online support group had the same profound effect on lurkers' self-reported feelings of being empowered in several areas as it had on posters. Apparently, reading in itself is sufficient to profit from participation in an online patient support group

   (106)    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

   (107)    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

   (108)    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; 9(9):792-805.
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

   (109)    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

   (110)    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; 28(11):1117-21.
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 (microg/dL) and serum zinc (microg/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

   (111)    Emad Y, Ragab Y, Zeinhom F, El-Khouly G, Abou-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

   (112)    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; 22(5):575.
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

   (113)    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

   (114)    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

   (115)    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; 27(9):1103-8.
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

   (116)    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

   (117)    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

   (118)    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

   (119)    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

   (120)    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

   (121)    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

   (122)    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

   (123)    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

   (124)    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

   (125)    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

   (126)    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

   (127)    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

   (128)    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

   (129)    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

   (130)    Nieddu ME, Menza L, Baldi F, Frediani B, Marcolongo R. [Efficacy of Cellfood's therapy (deutrosulfazyme) in fibromyalgia]. Reumatismo 2007; 59(4):316-21.
Abstract: OBJECTIVE: To assess the efficacy of Cellfood'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 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 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's therapy improve fibromyalgia symptoms and health-related quality of life

   (131)    Ribel-Madsen S, Christgau S, Gronemann ST, Bartels EM, Danneskiold-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

   (132)    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.
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)

   (133)    Ayan C, Martin V, Alonso-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

   (134)    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

   (135)    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

   (136)    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

   (137)    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

   (138)    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

   (139)    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

   (140)    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

   (141)    Alvarez-Nemegyei J, Negreros-Castillo A, Nuno-Gutierrez BL, Alvarez-Berzunza J, Alcocer-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

   (142)    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

   (143)    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

   (144)    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

   (145)    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

   (146)    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

   (147)    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

   (148)    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

   (149)    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

   (150)    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

   (151)    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

   (152)    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

   (153)    Carville SF, Arendt-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

   (154)    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

   (155)    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

   (156)    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

   (157)    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

   (158)    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

   (159)    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

   (160)    Brand K, Littlejohn G, Kristjanson L, Wisniewski S, Hassard T. The fibromyalgia bladder index. Clin Rheumatol 2007; 26(12):2097-103.
Abstract: The aim of this study was to determine whether an existing outcome measure, the Interstitial Cystitis Symptom and Problem Index (ICSI/ICPI), is a valid, reliable, and clinically relevant instrument to assess the sensory urinary symptoms in women with fibromyalgia syndrome (FM). Ninety women with American College of Rheumatology 90 FM and who had at least two sensory bladder symptoms participated in the study. All underwent urological screening to exclude lower urinary tract pathology. All participants completed the following: ICSI/ICPI, Fibromyalgia Impact Questionnaire (FIQ), Medical Outcome Study Short Form 36, King's Health Questionnaire (KHQ), and Vulval Symptom Assessment Scale. Assessment was made for internal consistency reliability, test-retest reliability, and concurrent validity. Factor analysis was used to assess the internal structure of the scale. Factor analysis displayed two separate components of symptom and problem combinations as distinct from the original ICSI/ICPI developed for the interstitial cystitis population. The eight items of the index configured differently and formed two subscales of a newly developed Fibromyalgia Bladder Index. The two subscales of this index include the Bladder Urgency and Pain Subscale and the Bladder Frequency and Nocturia Subscale. This index has high internal consistency reliability (Cronbach's alpha coefficient of 0.81), test-retest reliability showing intraclass correlation of 0.85, and high concurrent validity through correlations between the Fibromyalgia Bladder Index and the KHQ (0.735, p = 0.000) and the FIQ (0.433, p = 0.000). This more specific configuration of the ICSI/ICPI better reflects FM bladder symptomatology. The Fibromyalgia Bladder Index is a validated FM-specific instrument that captures information about the sensory bladder symptoms and their impact in this fibromyalgia population. This instrument should allow for better understanding and management of this important fibromyalgia-associated problem

   (161)    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

   (162)    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

   (163)    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

   (164)    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

   (165)    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

   (166)    Bennett RM, Jones J, Turk DC, Russell IJ, Matallana L. An internet survey of 2,596 people with fibromyalgia. BMC Musculoskelet Disord 2007; 8:27.
Abstract: BACKGROUND: This study explored the feasibility of using an Internet survey of people with fibromyalgia (FM), with a view to providing information on demographics, sources of information, symptoms, functionality, perceived aggravating factors, perceived triggering events, health care utilization, management strategies, and medication use. METHODS: A survey questionnaire was developed by the National Fibromyalgia Association (NFA) in conjunction with a task force of "experts in the field". The questionnaire underwent several rounds of testing to improve its face validity, content validity, clarity and readability before it was mounted on the internet. The questionnaire consisted of 121 items and is available online at the website of the National Fibromyalgia Association. RESULTS: The questionnaire was completed by 2,569 people. Most were from the United States, with at least one respondent from each of the 50 states. Respondents were predominantly middle-aged Caucasian females, most of whom had FM symptoms for > or = 4 years. The most common problems were morning stiffness, fatigue, nonrestorative sleep, pain, concentration, and memory. Aggravating factors included: emotional distress, weather changes, insomnia, and strenuous activity. Respondents rated the most effective management modalities as rest, heat, pain medications, antidepressants, and hypnotics. The most commonly used medications were: acetaminophen, ibuprofen, naproxen, cyclobenzaprine, amitriptyline, and aspirin. The medications perceived to be the most effective were: hydrocodone preparations, aprazolam, oxycodone preparations, zolpidem, cyclobenzaprine, and clonazepam. CONCLUSION: This survey provides a snap-shot of FM at the end of 2005, as reported by a self-selected population of people. This descriptive data has a heuristic function, in that it identifies several issues for further research, such as the prescribing habits of FM health care providers, the role of emotional precipitants, the impact of obesity, the significance of low back pain and the nature of FM related stiffness

   (167)    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

   (168)    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

   (169)    Jespersen A, Dreyer L, Kendall S, Graven-Nielsen T, Arendt-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

   (170)    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

   (171)    Vargas A, Vargas A, Hernandez-Paz R, Sanchez-Huerta JM, Romero-Ramirez R, Amezcua-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

   (172)    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

   (173)    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

   (174)    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

   (175)    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

   (176)    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

   (177)    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

   (178)    Berglund B, Nordstrom G. Symptoms and functional health status of individuals with Ehlers-Danlos syndrome (EDS). J Clin Rheumatol 2001; 7(5):308-14.
Abstract: Ehlers-Danlos syndrome (EDS) is an inherited connective tissue disorder that can have a substantial impact on daily life. The aims of this study were to describe the symptoms reported in a group of individuals with EDS and to investigate the impact on functional health status by means of the Sickness Impact Profile (SIP). Seventy-seven individuals, members of the Swedish EDS Association, completed 2 mailed questionnaires. The most frequent symptoms were related to activity, e.g., joint problems (75%), to pain (71%), and to skin/tissue (52%). Pain was reported by 37 individuals (48%) as their most severe symptom. The SIP results showed an overall mean score of 13.0 (females 13.9, males 5.6), compared with a Swedish reference group with a SIP score 1.3. Women with EDS reported a better functional health status than females with rheumatoid arthritis (overall SIP score 13.9 versus 21.4). In comparison with women with fibromyalgia, the EDS females rated their functional health status as worse on the physical dimension (p <0.05) and the subscale home management (p <0.05), and as better on the subscale work (p <0.05). Impact of EDS on the individual's daily life needs to be acknowledged, assessed, and evaluated in healthcare

   (179)    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

   (180)    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

   (181)    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

   (182)    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

   (183)    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

   (184)    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

   (185)    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.
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

   (186)    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

   (187)    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

   (188)    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

   (189)    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

   (190)    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

   (191)    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

   (192)    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

   (193)    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

   (194)    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

   (195)    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

   (196)    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

   (197)    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

   (198)    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

   (199)    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

   (200)    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

   (201)    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

   (202)    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

   (203)    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

   (204)    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

   (205)    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

   (206)    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

   (207)    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

   (208)    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

   (209)    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

   (210)    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

   (211)    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

   (212)    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

   (213)    Brautbar A, Elstein D, Pines B, Krienen N, Hemmer J, Buskila D et al. Fibromyalgia and Gaucher's disease. QJM 2006; 99(2):103-7.
Abstract: BACKGROUND: Patients with symptomatic Gaucher's disease sometimes have non-specific symptoms (such as general malaise with widespread musculoskeletal pains) that respond poorly to enzyme replacement treatment. These may indicate fibromyalgia syndrome; if so, other therapeutic options might be more appropriate. AIM: To identify patients with Gaucher's disease for whom fibromyalgia-specific therapy may be therapeutic. DESIGN: Questionnaire-based survey. METHODS: Adult patients (n = 109) with non-neuronopathic Gaucher's disease and adult healthy controls (n = 108) completed health-related questionnaires including the Fibromyalgia Impact Questionnaire, and underwent testing with a dolorimeter to ascertain sensitivity at 22 tender points. RESULTS: Six patients, but no controls, met the criteria for fibromyalgia. Patients with fibromyalgia had a significantly greater incidence of co-morbidities (p = 0.014) relative to other patients with Gaucher's disease; four suffered from bone involvement and were receiving enzyme therapy, but two were untreated. DISCUSSION: The presence of fibromyalgia-specific trigger points may result from multiple aetiologies, or may be an independently-sorting predisposition. Our findings cannot distinguish between these possibilities, but if fibromyalgia were the cause, enzyme replacement therapy would be expensive and inappropriate

   (214)    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

   (215)    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

   (216)    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

   (217)    Lukaczer D, Darland G, Tripp M, Liska D, Lerman RH, Schiltz B et al. A pilot trial evaluating Meta050, a proprietary combination of reduced iso-alpha acids, rosemary extract and oleanolic acid in patients with arthritis and fibromyalgia. Phytother Res 2005; 19(10):864-9.
Abstract: The aim of this open-label, 8-week observational trial was to investigate the efficacy of Meta050 (a proprietary, standardized combination of reduced iso-alpha-acids from hops, rosemary extract and oleanolic acid) on pain in patients with rheumatic disease. Osteoarthritis, rheumatoid arthritis and fibromyalgia patients were given 440 mg Meta050 three times a day for 4 weeks, which was changed to 880 mg twice a day for the subsequent 4 weeks in the majority of patients. Pain and condition-specific symptoms were assessed using a standard visual analog scale (VAS), an abridged arthritis impact measurement scale (AIMS2) and the fibromyalgia impact questionnaire. Fifty-four subjects with rheumatic disease completed the trial. Following treatment, a statistically significant decrease in pain of 50% and 40% was observed in arthritis subjects using the VAS (p < 0.0001; Wilcoxon-ranked sums) and AIMS2 (p < 0.0001), respectively. Fibromyalgia subject scores did not significantly improve. A decreasing trend of C-reactive protein, a marker for inflammation, was also observed in those subjects who presented with elevated C-reactive protein. No serious side effects were observed. These observations suggest that Meta050 at a dosage of 440 mg three times a day has a beneficial effect on pain in arthritis subjects

   (218)    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

   (219)    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 d