Fibromyalgia: Washington

Mease PJ, Seymour K. · Seattle Rheumatology Associates, Swedish Medical Center, Seattle, WA 98104, USA. · Curr Pain Headache Rep. · Pubmed #18973731 No free full text.

Abstract: Fibromyalgia (FM) is a disorder characterized by chronic widespread pain, tenderness, and associated symptoms such as fatigue, sleep disturbance, mood disorder, and cognitive dysfunction. Research on the pathophysiology of FM has focused on dysregulation of sensory processing in the central nervous system, as well as genetic and sociobiologic background factors. Abnormalities include excessive pronociceptive input and deficiency of modulatory signaling via noradrenergic and serotonergic pathways. Effective pharmacotherapy of FM includes medications that inhibit pronociceptive input and augment modulatory signaling. Several other dysregulated pathways may be involved and be potential targets for therapeutic intervention. This article reviews positive results of recent monotherapy trials of several norepinephrine and serotonin reuptake inhibitors. Although there has been little assessment of combination therapy in FM, this review outlines the basis for rational treatment using this approach (in order to most effectively treat multiple symptom domains). Controlled monotherapy trials of medications currently being approved for FM demonstrate significant effect on pain, patient global impression of change, and function. Trials are currently being developed to assess the potential additive or synergistic effects of combined central pharmacotherapy and to assess the safety and tolerability of this approach.

Holman AJ. · Pacific Rheumatology Research, Renton, WA 98055, USA. · Curr Pain Headache Rep. · Pubmed #18973730 No free full text.

Abstract: A flurry of recent randomized, placebo-controlled trials assessing dissimilar pharmacotherapeutic treatment options for fibromyalgia (FM) have been presented in the past few years. This review evaluates these trials in light of recent pathophysiological concepts germane to FM, including mood disorders, autonomic dysregulation, altered sleep stage architecture, and the diagnostic tender point controversy. Studies with gabapentin, pregabalin, duloxetine, milnacipran, sodium oxybate, and pramipexole for treatment of FM are discussed.

Pall ML, Bedient SA. · School of Molecular Biosciences, Washington State University, Pullman, Washington 99164-4234, USA. · Int Tinnitus J. · Pubmed #18229788 No free full text.

Abstract: Peripheral tinnitus is a good candidate for inclusion under the NO/ONOO cycle etiological mechanism, fitting each of the five principles of this mechanism. Cases of tinnitus are initiated by at least 11 short-term stressors increasing nitric oxide or other cycle mechanisms. Such cycle elements as N-methyl-D-aspartate activity; oxidative stress; nitric oxide; peroxynitrite; vanilloid activity; NF-kappaB activity; and intracellular calcium levels are all reported to be elevated in tinnitus. Tinnitus is comorbid with some putative NO/ONOO- cycle diseases. Most important, multiple agents that down-regulate NO/ONOO- cycle biochemistry are reported to be helpful in the treatment of tinnitus and related diseases. Previous studies suggested that NO/ONOO cycle diseases may be best treated with complex combinations of agents predicted to lower NO/ONOO- cycle biochemistry, and such combinations may be helpful in tinnitus treatment. Other inner-ear-related defects, such as acute or progressive hearing loss, vertigo, and dizziness, may also be NO/ONOO cycle diseases.

Mease P. · Seattle Rheumatology Associates, Washington 98104, USA. · J Rheumatol Suppl. · Pubmed #16078356 No free full text.

Abstract: Fibromyalgia syndrome (FM) is a common chronic pain condition that affects at least 2% of the adult population in the USA and other regions in the world where FM is studied. Prevalence rates in some regions have not been ascertained and may be influenced by differences in cultural norms regarding the definition and attribution of chronic pain states. Chronic, widespread pain is the defining feature of FM, but patients may also exhibit a range of other symptoms, including sleep disturbance, fatigue, irritable bowel syndrome, headache, and mood disorders. Although the etiology of FM is not completely understood, the syndrome is thought to arise from influencing factors such as stress, medical illness, and a variety of pain conditions in some, but not all patients, in conjunction with a variety of neurotransmitter and neuroendocrine disturbances. These include reduced levels of biogenic amines, increased concentrations of excitatory neurotransmitters, including substance P, and dysregulation of the hypothalamic-pituitary-adrenal axis. A unifying hypothesis is that FM results from sensitization of the central nervous system. Establishing diagnosis and evaluating effects of therapy in patients with FM may be difficult because of the multifaceted nature of the syndrome and overlap with other chronically painful conditions. Diagnostic criteria, originally developed for research purposes, have aided our understanding of this patient population in both research and clinical settings, but need further refinement as our knowledge about chronic widespread pain evolves. Outcome measures, borrowed from clinical research in pain, rheumatology, neurology, and psychiatry, are able to distinguish treatment response in specific symptom domains. Further work is necessary to validate these measures in FM. In addition, work is under way to develop composite response criteria, intended to address the multidimensional nature of this syndrome. A range of medical treatments, including antidepressants, opioids, nonsteroidal antiinflammatory drugs, sedatives, muscle relaxants, and antiepileptics, have been used to treat FM. Nonpharmaceutical treatment modalities, including exercise, physical therapy, massage, acupuncture, and cognitive behavioral therapy, can be helpful. Few of these approaches have been demonstrated to have clear-cut benefits in randomized controlled trials. However, there is now increased interest as more effective treatments are developed and our ability to accurately measure effect of treatment has improved. The multifaceted nature of FM suggests that multimodal individualized treatment programs may be necessary to achieve optimal outcomes in patients with this syndrome.

Turk DC. · Department of Anesthesiology, University of Washington, Seattle, WA 98195, USA. · Clin J Pain. · Pubmed #15599131 No free full text.

Abstract: A large and diverse number of treatments have been shown to be effective in reducing pain and other symptoms for a minority but statistically significant number of patients in different chronic pain syndromes. The means by which such different treatments achieve similar outcomes is not well understood. In this paper, the importance of considering patient heterogeneity for those who may be diagnosed with the same medical syndrome is discussed. The author suggests that the lack of satisfactory treatment outcomes for the treatments of chronic pain syndromes may be accounted for by the patient homogeneity myth--the assumption that all patients with the same medical diagnosis are similar on all important variables. The importance of subdividing (splitting) patients into meaningful groups is described. Studies presenting data on the identification of patient subgroups based on psychosocial and behavioral characteristics and the reliability and validity of this approach are presented. Some initial attempts to demonstrate the potential for matching treatments to patient subgroups are described.

Thieme K. · Department of Anesthesiology, University of Washington, Seattle, 1959NE Pacific Street, Washington 98195-6540, USA. · Orthopade. · Pubmed #15138685 No free full text.

Abstract: This contribution presents the psychosocial, psychopathological, psycho- and elektrophysiological as well as endocrine results in the aetiopathogenesis of fibromyalgia syndrome (FMS). Three subgroups could be differentiated based on psychosocial learning processes. They differ in pain intensity and interference, affective distress, activity and spouse responses. They influence pain behavior and CNS activity in the sense of operant conditioning. The relationship between dysregulated pain modulation in the CNS and endocrine dysregulation of the HPA-axis, which seems to be relevant for the autonome hyporeaction of muscle and blood pressure, are discussed. The "dynamic processing model for FMS" is presented.

Richardson RD, Engel CC. · VA Puget Sound Healthcare System, Seattle, WA, USA. · Neurologist. · Pubmed #14720312 No free full text.

Abstract: BACKGROUND: Medically unexplained physical symptoms (MUPS) and related syndromes are common in medical care and the general population, are associated with extensive morbidity, and have a large impact on functioning. Much of medical practice emphasizes specific pharmacological and surgical intervention for discrete disease states. Medical science, with its emphasis on identifying etiologically meaningful diseases comprised of homogeneous groups of patients, has split MUPS into a number of diagnostic entities or syndromes, each with its own hypothesized pathogenesis. However, research suggests these syndromes may be more similar than different, sharing extensive phenomenological overlap and similar risk factors, treatments, associated morbidities, and prognoses. Examples of syndromes consisting of MUPS include chronic fatigue syndrome, fibromyalgia, multiple chemical sensitivities, somatoform disorders, and 'Gulf War Syndrome.' REVIEW SUMMARY: This paper is a narrative review of the increasing body of evidence suggesting that MUPS and related syndromes are common, disabling, and costly. It emphasizes that MUPS occur along a continuum of symptom count, severity, and duration and may be divided into acute, subacute (or recurrent), and chronic types. Predisposing, precipitating, and perpetuating factors influence the natural history of MUPS. CONCLUSIONS: Effective symptom management involves collaborative doctor-patient approaches for identification of problems based on a combination of medical importance and patient readiness to initiate behavioral change, negotiated treatment goals and outcomes, gradual physical activation and exercise prescription. Additionally, efforts should be made to teach and support active rather than passive coping with the symptoms.

Holdcraft LC, Assefi N, Buchwald D. · Department of Psychiatry and Behavioral Sciences, Harborview Medical Center, University of Washington School of Medicine, Box 359797, 325 Ninth Ave, Seattle, WA 98104-2499, USA. · Best Pract Res Clin Rheumatol. · Pubmed #12849718 No free full text.

Abstract: Complementary and alternative medicine (CAM) has gained increasing popularity, particularly among individuals with fibromyalgia syndrome (FMS) for which traditional medicine has generally been ineffective. A systematic review of randomized controlled trials (RCTs) and non-RCTs on CAM studies for FMS was conducted to evaluate the empirical evidence for their effectiveness. Few RCTs achieved high scores on the CONSORT, a standardized evaluation of the quality of methodology reporting. Acupuncture, some herbal and nutritional supplements (magnesium, SAMe) and massage therapy have the best evidence for effectiveness with FMS. Other CAM therapies have either been evaluated in only one RCT with positive results (Chlorella, biofeedback, relaxation), in multiple RCTs with mixed results (magnet therapies), or have positive results from studies with methodological flaws (homeopathy, botanical oils, balneotherapy, anthocyanidins, dietary modifications). Lastly, other CAM therapies have neither well-designed studies nor positive results and are not currently recommended for FMS treatment (chiropractic care).

Aaron LA, Buchwald D. · Department of Oral Medicine, University of Washington, 1959 NE Pacific Street, B316, P.O. Box 356370, Seattle, WA 98195-6370, USA. · Best Pract Res Clin Rheumatol. · Pubmed #12849712 No free full text.

Abstract: This chapter reviews our current knowledge on the presence of overlapping syndromes in one form of chronic diffuse pain, fibromyalgia. Patients with fibromyalgia often present with signs and symptoms of other unexplained clinical conditions, including chronic fatigue syndrome, irritable bowel syndrome, temporomandibular disorders, and multiple chemical sensitivities. The high prevalence, impact on function and opportunities for treatment underscore the need for clinicians and researchers to screen routinely for co-morbid unexplained clinical conditions among persons with fibromyalgia. We, therefore, describe a simple approach to screening for such conditions in accordance with published criteria. Interventions should directly address both fibromyalgia symptoms and co-morbid unexplained clinical conditions, as well as the multiple factors that propagate pain, fatigue and limitations in function.

Turk DC, Monarch ES, Williams AD. · Department of Anesthesiology, Box 356540, University of Washington, Seattle, WA 98195, USA. · Rheum Dis Clin North Am. · Pubmed #12122915 No free full text.

Abstract: Symptoms of FMS are extremely distressing, and currently there is no cure or any treatment capable of substantially reducing all symptoms for all patients. Rehabilitation goals include improving emotional functioning, physical functioning, and quality of life. In light of these goals, psychological screening is an essential component of any comprehensive FMS evaluation. In many cases, the high levels of emotional distress, disability, and reduced quality of life noted in these patients warrants a more thorough psychological evaluation [11]. A comprehensive psychological evaluation is complex, involves exploration of a broad range of areas, and should be administered by an experienced health psychologist. The primary objective of this evaluation is to delineate emotional, cognitive, and behavioral factors involved in persistent pain, suffering, and disability, with an emphasis on the prescription of appropriate interventions for altering maladaptive patterns. The results of the psychological evaluation involve a synthesis of information and should assist in developing a list of behavioral problems that contribute to the maintenance and exacerbation of [table: see text] suffering and disability. Information obtained should facilitate treatment planning, specifically the matching of treatment components to the needs of individual patients.

Parcell S. · American Institute for Biosocial and Medical Research (AIBMR), Tacoma, WA, USA. · Altern Med Rev. · Pubmed #11896744 links to  free full text

Abstract: Because the role of elemental sulfur in human nutrition has not been studied extensively, it is the purpose of this article to emphasize the importance of this element in humans and discuss the therapeutic applications of sulfur compounds in medicine. Sulfur is the sixth most abundant macromineral in breast milk and the third most abundant mineral based on percentage of total body weight. The sulfur-containing amino acids (SAAs) are methionine, cysteine, cystine, homocysteine, homocystine, and taurine. Dietary SAA analysis and protein supplementation may be indicated for vegan athletes, children, or patients with HIV, because of an increased risk for SAA deficiency in these groups. Methylsulfonylmethane (MSM), a volatile component in the sulfur cycle, is another source of sulfur found in the human diet. Increases in serum sulfate may explain some of the therapeutic effects of MSM, DMSO, and glucosamine sulfate. Organic sulfur, as SAAs, can be used to increase synthesis of S-adenosylmethionine (SAMe), glutathione (GSH), taurine, and N-acetylcysteine (NAC). MSM may be effective for the treatment of allergy, pain syndromes, athletic injuries, and bladder disorders. Other sulfur compounds such as SAMe, dimethylsulfoxide (DMSO), taurine, glucosamine or chondroitin sulfate, and reduced glutathione may also have clinical applications in the treatment of a number of conditions such as depression, fibromyalgia, arthritis, interstitial cystitis, athletic injuries, congestive heart failure, diabetes, cancer, and AIDS. Dosages, mechanisms of action, and rationales for use are discussed. The low toxicological profiles of these sulfur compounds, combined with promising therapeutic effects, warrant continued human clinical trails.

Aaron LA, Buchwald D. · Department of Medicine, Division of Internal Medicine, Harborview Medical Center, 325 Ninth Avenue, Box 359780, Seattle, WA 98104, USA. · Ann Intern Med. · Pubmed #11346323 No free full text.

Abstract: PURPOSE: Unexplained clinical conditions share features, including symptoms (fatigue, pain), disability out of proportion to physical examination findings, inconsistent demonstration of laboratory abnormalities, and an association with "stress" and psychosocial factors. This literature review examines the nature and extent of the overlap among these unexplained clinical conditions and the limitations of previous research. DATA SOURCES: English-language articles were identified by a search of the MEDLINE database from 1966 to January 2001 by using individual syndromes and their hallmark symptoms as search terms. STUDY SELECTION: Studies that assessed patients with at least one unexplained clinical condition and that included information on symptoms, overlap with other unexplained clinical conditions, or physiologic markers. Conditions examined were the chronic fatigue syndrome, fibromyalgia, the irritable bowel syndrome, multiple chemical sensitivity, temporomandibular disorder, tension headache, interstitial cystitis, and the postconcussion syndrome. DATA EXTRACTION: Information on authorship, patient and control groups, eligibility criteria, case definitions, study methods, and major findings. DATA SYNTHESIS: Many similarities were apparent in case definition and symptoms, and the proportion of patients with one unexplained clinical condition meeting criteria for a second unexplained condition was striking. Tender points on physical examination and decreased pain threshold and tolerance were the most frequent and consistent objective findings. A major shortcoming of all proposed explanatory models is their inability to account for the occurrence of unexplained clinical conditions in many affected patients. CONCLUSIONS: Overlap between unexplained clinical conditions is substantial. Most studies are limited by methodologic problems, such as case definition and the selection and recruitment of case-patients and controls.

Aaron LA, Buchwald D. · Department of Medicine, Harborview Medical Center, 325 Ninth Avenue, Box 359780, Seattle, WA 98104, USA. · Curr Rheumatol Rep. · Pubmed #11286667 No free full text.

Abstract: Several unexplained clinical conditions frequently coexist with fibromyalgia; these include chronic fatigue syndrome, irritable bowel syndrome, temporomandibular disorder, tension and migraine headaches, and others. However, only recently have studies directly compared the physiological parameters of these conditions (eg, fibromyalgia vs irritable bowel syndrome) to elucidate underlying pathogenic mechanisms. This review summarizes data from comparative studies and discusses their implications for future research.

Sherry DD. · Department of Pediatric Rheumatology, Children's Hospital and Regional Medical Center, Rheumatology CH-73, 4800 Sand Point Way, NE, Seattle, WA 98105, USA. · Curr Rheumatol Rep. · Pubmed #11123080 No free full text.

Abstract: The pediatric rheumatologist cares for children who may have a wide variety of causes of musculoskeletal pain. These include such diverse conditions as arthritis, low-back pain, hypermobility, metabolic bone pain, and amplified pain syndromes such as complex regional pain syndrome and fibromyalgia. This review examines the recent literature on these and other conditions causing musculoskeletal pain in children and adolescents. Overall, headway is being made, but differentiating soma from psyche remains a problem. This is perhaps due to the marked and unique effect pain brings to each of us. Children are different from adults in causes, presentations, and outcome. Vigilance in history, physical examination, and judicious use of laboratory investigations are usually sufficient in establishing a diagnosis, as well as an appreciation for the variety of presentations each condition can manifest.

Turk DC, Okifuji A. · Department of Anesthesiology, Box 356540, University of Washington, Seattle, WA 98195, USA. · Curr Rheumatol Rep. · Pubmed #11123047 No free full text.

Abstract: Chronic diffuse pain and hyperalgesia are two cardinal features of pain in fibromyalgia syndrome (FMS). Advancement in understanding the pathophysiology and treatment efficacy often depends on pain that is defined and measured. Pain is a subjective phenomenon that we can measure only by indirect methods. In this article, we provide methodological guidelines for pain assessment and review recent developments in understanding pain mechanisms and evaluating treatments in FMS. Finally, we demonstrate the heterogeneity of the FMS population and suggest the need for matching treatments to patient characteristics in order to improve clinical outcomes.

Gardner GC. · Division of Rheumatology, Box 356428, University of Washington, Seattle, WA 98195, USA. · Curr Rev Pain. · Pubmed #10953277 No free full text.

Abstract: The concept that fibromyalgia may follow trauma is currently an area of intense debate within the medical field and is driven to a large extent by social and legal issues. This article questions whether the current literature supports the notion that trauma may cause fibromyalgia and explores the relative contribution of biology and psychology in the development of and sense of disability from fibromyalgia.

Mease PJ, Russell IJ, Arnold LM, Florian H, Young JP, Martin SA, Sharma U. · Seattle Rheumatology Associates, Seattle, Washington 98104, USA. · J Rheumatol. · Pubmed #18278830 No free full text.

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.

Assefi NP, Sherman KJ, Jacobsen C, Goldberg J, Smith WR, Buchwald D. · The Group Health Cooperative Center for Health Studies, and University of Washington, Seattle, Washington, USA. · Ann Intern Med. · Pubmed #15998750 links to  free full text

Abstract: BACKGROUND: Fibromyalgia is a common chronic pain condition for which patients frequently use acupuncture. OBJECTIVE: To determine whether acupuncture relieves pain in fibromyalgia. DESIGN: Randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. SETTING: Private acupuncture offices in the greater Seattle, Washington, metropolitan area. PATIENTS: 100 adults with fibromyalgia. INTERVENTION: Twice-weekly treatment for 12 weeks with an acupuncture program that was specifically designed to treat fibromyalgia, or 1 of 3 sham acupuncture treatments: acupuncture for an unrelated condition, needle insertion at nonacupoint locations, or noninsertive simulated acupuncture. MEASUREMENTS: The primary outcome was subjective pain as measured by a 10-cm visual analogue scale ranging from 0 (no pain) to 10 (worst pain ever). Measurements were obtained at baseline; 1, 4, 8, and 12 weeks of treatment; and 3 and 6 months after completion of treatment. Participant blinding and adverse effects were ascertained by self-report. The primary outcomes were evaluated by pooling the 3 sham-control groups and comparing them with the group that received acupuncture to treat fibromyalgia. RESULTS: The mean subjective pain rating among patients who received acupuncture for fibromyalgia did not differ from that in the pooled sham acupuncture group (mean between-group difference, 0.5 cm [95% CI, -0.3 cm to 1.2 cm]). Participant blinding was adequate throughout the trial, and no serious adverse effects were noted. LIMITATIONS: A prescription of acupuncture at fixed points may differ from acupuncture administered in clinical settings, in which therapy is individualized and often combined with herbal supplementation and other adjunctive measures. A usual-care comparison group was not studied. CONCLUSION: Acupuncture was no better than sham acupuncture at relieving pain in fibromyalgia.

Landis CA, Lentz MJ, Tsuji J, Buchwald D, Shaver JL. · Department of Biobehavioral Nursing and Health Systems, University of Washington, Seattle, WA 98195-7266, USA. · Brain Behav Immun. · Pubmed #15157947 No free full text.

Abstract: In women with fibromyalgia (FM), central nervous system (CNS) dysfunction in pain, mood, and sleep processes could be associated with changes in immune system indicators. The primary purpose of this study was to compare pain, psychological variables, subjective and objective sleep quality, lymphocyte phenotypes and activation markers, and natural killer activity (NKA) in midlife women with and without FM. A secondary purpose was to explore relationships among these variables in a step-wise regression. Subjects had pain pressure tender points assessed, completed a psychiatric interview and questionnaires (Beck Depression Inventory, SCL-90, Profile of Mood States, subjective sleep), and underwent polysomnograhic assessment for two consecutive nights. Lymphocyte phenotypes, activation markers, and NKA were assessed from blood drawn the morning after sleep laboratory night 2. Compared to controls, women with FM had lower pain thresholds, more psychological distress, higher depression scores, and reduced subjective and objective sleep quality. They also had fewer NK cells (p <.009) and more NK cells that expressed the IL-2 receptor (p <.04), but these differences were not statistically significant after correction for multiple comparisons. NKA was not statistically significantly lower in the women with FM compared to controls. In a multiple regression of age, tender point threshold, depression, psychological distress, and sleep efficiency, only the effect of group was significant (F = 5.479, p <.03) on NKA. In conclusion, we found little evidence to support the hypothesis that pain, mood, and sleep symptoms are associated with changes in the enumeration of peripheral lymphocytes or function in FM.

Lentz MJ, Landis CA, Rothermel J, Shaver JL. · Department of Biobehavioral Nursing and Health Systems, University of Washington, Seattle 98195-7266, USA. · J Rheumatol. · Pubmed #10405949 No free full text.

Abstract: OBJECTIVE: To determine whether disrupted slow wave sleep (SWS) would evoke musculoskeletal pain, fatigue, and an alpha electroencephalograph (EEG) sleep pattern. We selectively deprived 12 healthy, middle aged, sedentary women without muscle discomfort of SWS for 3 consecutive nights. Effects were assessed for the following measures: polysomnographic sleep, musculoskeletal tender point pain threshold, skinfold tenderness, reactive hyperemia (inflammatory flare response), somatic symptoms, and mood state. METHODS: Sleep was recorded and scored using standard methods. On selective SWS deprivation (SWSD) nights, when delta waves (indicative of SWS) were detected on EEG, a computer generated tone (maximum 85 decibels) was delivered until delta waves disappeared. Musculoskeletal tender points were measured by dolorimetry; skinfold tenderness was assessed by skin roll procedure; and reactive hyperemia was assessed with a cotton swab test. Subjects completed questionnaires on bodily feelings, symptoms, and mood. RESULTS: On each SWSD night, SWS was decreased significantly with minimal alterations in total sleep time, sleep efficiency, and other sleep stages. Subjects showed a 24% decrease in musculoskeletal pain threshold after the third SWSD night. They also reported increased discomfort, tiredness, fatigue, and reduced vigor. The flare response (area of vasodilatation) in skin was greater than baseline after the first, and again, after the third SWSD night. However, the automated program for SWSD did not evoke an alpha EEG sleep pattern. CONCLUSION: Disrupting SWS, without reducing total sleep or sleep efficiency, for several consecutive nights is associated with decreased pain threshold, increased discomfort, fatigue, and the inflammatory flare response in skin. These results suggest that disrupted sleep is probably an important factor in the pathophysiology of symptoms in fibromyalgia.

Wilson HD, Robinson JP, Turk DC. · University of Washington, Seattle, WA, USA. · Arthritis Rheum. · Pubmed #19333980 No free full text.

Abstract: OBJECTIVE: People with fibromyalgia (FM) report a number of physical, cognitive, and psychological symptoms. The purpose of the current study was to determine whether people with FM differed based on the type and severity of symptoms, and if so, whether subgroups differ with respect to health care utilization, functional ability, and work status. METHODS: Symptom, health care utilization, work, and physical data were available for 2,182 female responders to an Internet survey. Factor analysis was conducted on the physical and cognitive/psychological symptoms, and resulting factor scores were utilized in a cluster analysis to identify subgroups based on symptoms. Cluster groups were compared on a set of variables (e.g., health care utilization, coping). RESULTS: Factor analyses resulted in 3 symptom factor scores: musculoskeletal, non-musculoskeletal, and cognitive/psychological symptoms. The optimal cluster solution to the cluster analysis revealed 4 clusters. Group 1 was high on all 3 symptom domains, group 2 was moderate on the 2 physical symptom domains and high on cognitive/psychological symptoms, group 3 was moderate on the 2 physical symptom domains and low on cognitive/psychological symptoms, and group 4 was low on all symptom domains. The more symptomatic groups reported the greatest amount of health care utilization and difficulty in coping with symptoms. CONCLUSION: The FM population is heterogeneous with regard to symptom reporting. Additional research is needed to better understand differential symptom experience among people with FM. Clarification of these differences may increase understanding of the mechanisms involved in FM and provide guidance for treatment decisions.

Mease PJ, Clauw DJ, Gendreau RM, Rao SG, Kranzler J, Chen W, Palmer RH. · Seattle Rheumatology Associates, 1101 Madison Street, Suite 1000, Seattle, WA 98104, USA. · J Rheumatol. · Pubmed #19132781 No free full text.

Abstract: OBJECTIVE: To evaluate the safety and efficacy of milnacipran, a dual norepinephrine and serotonin reuptake inhibitor, in the treatment of fibromyalgia (FM). METHODS: A 27-week, randomized, double-blind, multicenter study compared milnacipran 100 and 200 mg/day with placebo in the treatment of 888 patients with FM. Two composite responder definitions were used to classify each patient's individual response to therapy. "FM responders" concurrently satisfied response criteria for improvements in pain (visual analog scale 24-h morning recall), patient global impression of change (PGIC), and physical functioning (SF-36 Physical Component Summary); while "FM pain responders" concurrently satisfied response criteria for improvements in pain and PGIC. RESULTS: At the primary endpoint, after 3-month stable dose treatment, a significantly higher percentage of milnacipran-treated patients met criteria as FM responders versus placebo (milnacipran 200 mg/day, p = 0.017; milnacipran 100 mg/day, p = 0.028). A significantly higher percentage of patients treated with milnacipran 200 mg/day also met criteria as FM pain responders versus placebo (p = 0.032). Significant pain reductions were observed after Week 1 with both milnacipran doses. At 15 weeks, milnacipran 200 mg/day led to significant improvements over placebo in pain (realtime, daily and weekly recall; all measures, p < 0.05), PGIC (p < 0.001), fatigue (p = 0.016), cognition (p = 0.025), and multiple SF-36 domains. Milnacipran was safe and well tolerated by the majority of patients during 27 weeks of treatment; nausea and headache were the most common adverse events. CONCLUSION: Milnacipran is safe and effective for the treatment of multiple symptoms of FM.

Assefi N, Bogart A, Goldberg J, Buchwald D. · Department of Medicine, University of Washington, Seattle, WA, USA. · J Altern Complement Med. · Pubmed #18991519 No free full text.

Abstract: OBJECTIVE: Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. DESIGN: This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. SETTING/LOCATION: The study setting was private medical offices in the Seattle, Washington metropolitan area. SUBJECTS: The subjects were comprised 100 adults with fibromyalgia. INTERVENTION: Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). OUTCOME MEASURES: The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by self-report. Improvement between groups was examined in an intention-to-treat analysis. RESULTS: Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. CONCLUSION: Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms.

Mease PJ, Arnold LM, Crofford LJ, Williams DA, Russell IJ, Humphrey L, Abetz L, Martin SA. · Seattle Rheumatology Associates, Seattle, Washington 98104, USA. · Arthritis Rheum. · Pubmed #18576290 links to  free full text

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.

Mease P, Arnold LM, Bennett R, Boonen A, Buskila D, Carville S, Chappell A, Choy E, Clauw D, Dadabhoy D, Gendreau M, Goldenberg D, Littlejohn G, Martin S, Perera P, Russell IJ, Simon L, Spaeth M, Williams D, Crofford L. · Seattle Rhumatology Associates, Seattle, WA 98104, USA. · J Rheumatol. · Pubmed #17552068 No free full text.

Abstract: The fibromyalgia syndrome (FM) workshop at OMERACT 8 continued the work initiated in the first FM workshop at OMERACT 7 in 2004. The principal objectives were to work toward consensus on core domains for assessment in FM studies, evaluate the performance quality of outcome measures used in a review of recent trials in FM, and discuss the research agenda of the FM working group. An initiative to include the patient perspective on identification and prioritization of domains, consisting of focus groups and a patient Delphi exercise, was completed prior to OMERACT 8. Patient-identified domains were, for the most part, similar to those identified by clinician-investigators in terms of symptoms and relative importance. However, patients identified certain domains, such as stiffness, that were not included by physicians, and emphasized the importance of domains such as dyscognition and impaired motivation. Many of the principal domains agreed upon by the clinician-investigators, patients, and OMERACT participants, including pain, fatigue, sleep, mood, and global measures, have been used in clinical trials and performed well when viewed through the OMERACT filter. The research agenda items reviewed and approved for continued study included development of objective "biomarkers" in FM, development of a responder index for FM, and coordination with the WHO's International Classification of Functioning Disability and Health (ICF) Research Branch and the US National Institutes of Health's Patient Reported Outcome Measures Information System network (PROMIS) to develop improved measures of function, quality of life, and participation. The OMERACT process has provided a framework for identification of key domains to be assessed and a path toward validation and standardization of outcome measures for clinical trials in FM.