今日の臨床サポート

線維筋痛症

著者: 松本美富士 地方独立行政法人 桑名市総合医療センター 膠原病リウマチ内科

監修: 上阪等 千葉西総合病院 膠原病リウマチセンター

著者校正/監修レビュー済:2020/10/07
参考ガイドライン:
  1. 日本線維筋痛症学会・AMED研究班:線維筋痛症診療ガイドライン2017
  1. Macfarlanw GK, Kronisch C, Dean LE, et al.:EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis 2017;76(2):318-328.

概要・推奨   

  1. 初回診断時には疾患受容のために、患者・家族教育を行う(推奨度1)。
  1. 不安、抑うつ気分、破局的思考が強い場合、抗うつ薬(デュロキセチン)の使用が推奨される(推奨度1)。
  1. 激痛、広範囲疼痛の場合、プレガバリン、トラマドールの単独ないし併用が推奨される(推奨度1)。
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が必要となり
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契
薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、
著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適用の査定において保険適用及び保険適用外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適用の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
松本美富士 : 特に申告事項無し[2021年]
監修:上阪等 : 特に申告事項無し[2021年]

改訂のポイント:
  1. 定期レビューを行い、以下の点について改訂を行った。
  1. COVID-19のパンデミックにおける線維筋痛症患者の対応
  1. プレガバリンの改良型薬剤であるミロガバリンの線維筋痛症への応用
  1. 線維筋痛症治療の保険適用薬剤間の効果の比較検討成績が蓄積

病態・疫学・診察

疾患(疫学・病態)のまとめ  
  1. 線維筋痛症(FM)は身体の広範な部位の慢性疼痛とこわばりを主症状とし、疲労・倦怠感、口腔乾燥、抑うつ気分、認知症状など多彩な身体、精神・神経症状などの随伴症状を呈する疾患である。
  1. 原因不明であるが、遺伝的要因も存在し、近年は精神科の疾患であるよりも、脳内神経炎症による中枢性の疼痛情報伝達系の異常であると考えられている[1][2][3]。誘因としては、脊椎外傷、手術、強い身体・精神的ストレスが誘因となることがあり、また他のリウマチ性疾患や膠原病、自己免疫疾患などに併存することもある。(表<図表>、表<図表>、表<図表>
  1. 線維筋痛症の日本での有病率は1.7%と欧米とほぼ同様であり比較的頻度の高い状態である。男性と女性の比率では女性の割合が高く(1:4.8)、中年以降(働き盛りの40~50歳代)の女性に好発するが、高齢者、小児例もある[4][5][6]。なお、日本における慢性疼痛の保有率が人口の約13%にみられるとの報告もあり、慢性疼痛の患者の中に一定の割合で線維筋痛症患者が含まれていると考えられている[7]
  1. 身体所見で広範な部位に圧痛やアロディニア(異痛症:通常は疼痛とならないような軽度の刺激で疼痛を感じること)を認める以外に一般的検査所見を含め異常を認めない。
  1. 治療としては、非ステロイド系抗炎症薬や副腎皮質ステロイド薬に効果がなく、抗うつ薬、神経障害性疼痛治療薬、弱オピオイド系鎮痛薬、認知行動療法、有酸素運動療法などが有効である。
 
線維筋痛症の臨床像

全身の疼痛以外に多彩な身体、精神・神経症状を大なり小なり伴う。身体所見には圧痛点の圧痛、アロディニア(異痛症)のみで、画像を含めた一般的臨床検査所見に異常がないことが特徴である。

出典

img1:  著者提供
 
 
問診・診察のポイント  
  1. 原因を問わない急性の限局性疼痛が持続し、3カ月以上持続する慢性疼痛となり、身体の広範な部位の慢性疼痛に至る時間経過(痛みの進化)を確認する。

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文献 

著者: Piercarlo Sarzi-Puttini, Fabiola Atzeni, Philip J Mease
雑誌名: Best Pract Res Clin Rheumatol. 2011 Apr;25(2):133-9. doi: 10.1016/j.berh.2011.04.001.
Abstract/Text Chronic pain can be classified as localised, regional or widespread, and its high prevalence in the general population seems to increase with age. The majority of cases present with musculoskeletal pain. The conditions associated with chronic widespread pain (CWP) are highly burdensome as their characteristic symptoms may include multifocal pain, fatigue, insomnia, memory difficulties and a higher rate of concomitant mood disorders. After many years of debate, it is still unclear whether CWP (central sensitisation) is an entirely explainable neurotransmitter-related process or is partially or totally due to individual cognitive experiences and evaluations. The two models (neurochemical and biopsychosocial) also affect our ability to find therapeutic answers.

Copyright © 2011 Elsevier Ltd. All rights reserved.
PMID 22094190  Best Pract Res Clin Rheumatol. 2011 Apr;25(2):133-9. do・・・
著者: Tobias Schmidt-Wilcke, Daniel J Clauw
雑誌名: Nat Rev Rheumatol. 2011 Jul 19;7(9):518-27. doi: 10.1038/nrrheum.2011.98. Epub 2011 Jul 19.
Abstract/Text Individuals with fibromyalgia generally experience chronic widespread pain, which can be accompanied by further symptoms including fatigue, sleep disturbances, cognitive dysfunction, anxiety and depressive episodes. As the recognition and diagnosis of fibromyalgia has improved, the availability of therapeutic options for patients has increased. Furthermore, research into the neurobiological mechanisms that contribute to the chronic pain and concomitant symptoms experienced by patients with fibromyalgia has advanced our understanding of this debilitating disorder. In this Review, we aim to provide an overview of existing pathophysiological concepts. The roles of biological and psychological stress, genetic factors, and pain and sensory processing in the pathophysiology of fibromyalgia and related conditions are discussed. In addition, pharmacological treatments, including monoamine modulators, calcium channel modulators and γ-aminobutyric acid modulators, as well as nonpharmacological treatment options are considered.

PMID 21769128  Nat Rev Rheumatol. 2011 Jul 19;7(9):518-27. doi: 10.103・・・
著者: Roland Staud
雑誌名: Rheum Dis Clin North Am. 2009 May;35(2):263-74. doi: 10.1016/j.rdc.2009.05.006.
Abstract/Text Many chronic pain syndromes are associated with hypersensitivity to painful stimuli and with reduced endogenous pain inhibition. These findings suggest that modulation of pain-related information may be linked to the onset or maintenance of chronic pain. The combination of heightened pain sensitivity and reduced pain inhibition seems to predispose individuals to greater risk for increased acute clinical pain. It is unknown whether such pain processing abnormalities may also place individuals at increased risk for chronic pain. Psychophysical methods can be used for the evaluation of pain sensitivity and pain inhibition. Long-term prospective studies that could yield insight into the role of heightened pain sensitivity and pain disinhibition for the development of chronic pain disorders like fibromyalgia in the general population are lacking, however.

PMID 19647141  Rheum Dis Clin North Am. 2009 May;35(2):263-74. doi: 10・・・
著者: Frederick Wolfe, Daniel J Clauw, Mary-Ann Fitzcharles, Don L Goldenberg, Robert S Katz, Philip Mease, Anthony S Russell, I Jon Russell, John B Winfield, Muhammad B Yunus
雑誌名: Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
Abstract/Text OBJECTIVE: To develop simple, practical criteria for clinical diagnosis of fibromyalgia that are suitable for use in primary and specialty care and that do not require a tender point examination, and to provide a severity scale for characteristic fibromyalgia symptoms.
METHODS: We performed a multicenter study of 829 previously diagnosed fibromyalgia patients and controls using physician physical and interview examinations, including a widespread pain index (WPI), a measure of the number of painful body regions. Random forest and recursive partitioning analyses were used to guide the development of a case definition of fibromyalgia, to develop criteria, and to construct a symptom severity (SS) scale.
RESULTS: Approximately 25% of fibromyalgia patients did not satisfy the American College of Rheumatology (ACR) 1990 classification criteria at the time of the study. The most important diagnostic variables were WPI and categorical scales for cognitive symptoms, unrefreshed sleep, fatigue, and number of somatic symptoms. The categorical scales were summed to create an SS scale. We combined the SS scale and the WPI to recommend a new case definition of fibromyalgia: (WPI > or =7 AND SS > or =5) OR (WPI 3-6 AND SS > or =9).
CONCLUSION: This simple clinical case definition of fibromyalgia correctly classifies 88.1% of cases classified by the ACR classification criteria, and does not require a physical or tender point examination. The SS scale enables assessment of fibromyalgia symptom severity in persons with current or previous fibromyalgia, and in those to whom the criteria have not been applied. It will be especially useful in the longitudinal evaluation of patients with marked symptom variability.

PMID 20461783  Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. do・・・
著者: Danyella de Melo Santos, Lais Verderame Lage, Eleonora Kehl Jabur, Helena Hideko Seguchi Kaziyama, Dan V Iosifescu, Mara Cristina Souza de Lucia, Renerio Fraguas
雑誌名: Clinics (Sao Paulo). 2011;66(6):973-8.
Abstract/Text INTRODUCTION: Personality traits have been associated with primary depression. However, it is not known whether this association takes place in the case of depression comorbid with fibromyalgia.
OBJECTIVE: The authors investigated the association between a current major depressive episode and temperament traits (e.g., harm avoidance).
METHOD: A sample of 69 adult female patients with fibromyalgia was assessed with the Temperament and Character Inventory. Psychiatric diagnoses were assessed with the Mini-International Neuropsychiatric Interview severity of depressive symptomatology with the Beck Depression Inventory, and anxiety symptomatology with the IDATE-state and pain intensity with a visual analog scale.
RESULTS: A current major depressive episode was diagnosed in 28 (40.5%) of the patients. They presented higher levels of harm avoidance and lower levels of cooperativeness and self-directedness compared with non-depressed patients, which is consistent with the Temperament and Character Inventory profile of subjects with primary depression. However, in contrast to previous results in primary depression, no association between a major depressive episode and self-transcendence was found.
CONCLUSIONS: The results highlight specific features of depression in fibromyalgia subjects and may prove important for enhancing the diagnosis and prognosis of depression in fibromyalgia patients.

PMID 21808861  Clinics (Sao Paulo). 2011;66(6):973-8.
著者: Chie Usui, Kotaro Hatta, Satoko Aratani, Naoko Yagishita, Kenya Nishioka, Teruhisa Kanazawa, Kenji Ito, Yoshihisa Yamano, Hiroyuki Nakamura, Toshihiro Nakajima, Kusuki Nishioka
雑誌名: Mod Rheumatol. 2012 Feb;22(1):40-4. doi: 10.1007/s10165-011-0462-3. Epub 2011 May 10.
Abstract/Text The aim of this study was to investigate the reliability and the validity of the Japanese version of the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia (ACR 2010-J), and its quantification scale, the Fibromyalgia Symptom Scale (FS-J). In this study, we divided patients with chronic pain without psychiatric disorders other than depression into two groups according to the 1990 ACR Diagnostic Criteria for Fibromyalgia, a fibromyalgia group and a non-fibromyalgia group (rheumatoid arthritis, osteoarthritis, and gout). Patients in both groups were assessed using the ACR 2010-J and FS-J. Seventy-seven of 94 (82%) patients in the fibromyalgia group met the ACR 2010-J, whereas 9% (4/43) of the non-fibromyalgia group did so, with a sensitivity of 82%, specificity of 91%, positive predictive value of 95%, negative predictive value of 70%, and positive likelihood ratio of 8.8. Mean total scores on the FS-J significantly differentiated the fibromyalgia from the non-fibromyalgia group. The scale had high inter-rater reliability and high internal consistency. With a cutoff score of 10, the positive likelihood ratio was 10.1. Our findings indicate that the ACR 2010-J and FS-J have high reliability and validity, and are useful for assessing fibromyalgia in Japanese populations with chronic pain. As regards the positive likelihood ratio, that of the FS-J might be suitable as a positive test.

PMID 21556970  Mod Rheumatol. 2012 Feb;22(1):40-4. doi: 10.1007/s10165・・・
著者: Frederick Wolfe, Daniel J Clauw, Mary-Ann Fitzcharles, Don L Goldenberg, Winfried Häuser, Robert S Katz, Philip Mease, Anthony S Russell, I Jon Russell, John B Winfield
雑誌名: J Rheumatol. 2011 Jun;38(6):1113-22. doi: 10.3899/jrheum.100594. Epub 2011 Feb 1.
Abstract/Text OBJECTIVE: To develop a fibromyalgia (FM) survey questionnaire for epidemiologic and clinical studies using a modification of the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia (ACR 2010). We also created a new FM symptom scale to further characterize FM severity.
METHODS: The ACR 2010 consists of 2 scales, the Widespread Pain Index (WPI) and the Symptom Severity (SS) scale. We modified these ACR 2010 criteria by eliminating the physician's estimate of the extent of somatic symptoms and substituting the sum of 3 specific self-reported symptoms. We also created a 0-31 FM Symptom scale (FS) by adding the WPI to the modified SS scale. We administered the questionnaire to 729 patients previously diagnosed with FM, 845 with osteoarthritis (OA) or with other noninflammatory rheumatic conditions, 439 with systemic lupus erythematosus (SLE), and 5210 with rheumatoid arthritis (RA).
RESULTS: The modified ACR 2010 criteria were satisfied by 60% with a prior diagnosis of FM, 21.1% with RA, 16.8% with OA, and 36.7% with SLE. The criteria properly identified diagnostic groups based on FM severity variables. An FS score ≥ 13 best separated criteria+ and criteria- patients, classifying 93.0% correctly, with a sensitivity of 96.6% and a specificity of 91.8% in the study population.
CONCLUSION: A modification to the ACR 2010 criteria will allow their use in epidemiologic and clinical studies without the requirement for an examiner. The criteria are simple to use and administer, but they are not to be used for self-diagnosis. The FS may have wide utility beyond the bounds of FM, including substitution for widespread pain in epidemiological studies.

PMID 21285161  J Rheumatol. 2011 Jun;38(6):1113-22. doi: 10.3899/jrheu・・・
著者: F Wolfe, H A Smythe, M B Yunus, R M Bennett, C Bombardier, D L Goldenberg, P Tugwell, S M Campbell, M Abeles, P Clark
雑誌名: Arthritis Rheum. 1990 Feb;33(2):160-72.
Abstract/Text To develop criteria for the classification of fibromyalgia, we studied 558 consecutive patients: 293 patients with fibromyalgia and 265 control patients. Interviews and examinations were performed by trained, blinded assessors. Control patients for the group with primary fibromyalgia were matched for age and sex, and limited to patients with disorders that could be confused with primary fibromyalgia. Control patients for the group with secondary-concomitant fibromyalgia were matched for age, sex, and concomitant rheumatic disorders. Widespread pain (axial plus upper and lower segment plus left- and right-sided pain) was found in 97.6% of all patients with fibromyalgia and in 69.1% of all control patients. The combination of widespread pain and mild or greater tenderness in greater than or equal to 11 of 18 tender point sites yielded a sensitivity of 88.4% and a specificity of 81.1%. Primary fibromyalgia patients and secondary-concomitant fibromyalgia patients did not differ statistically in any major study variable, and the criteria performed equally well in patients with and those without concomitant rheumatic conditions. The newly proposed criteria for the classification of fibromyalgia are 1) widespread pain in combination with 2) tenderness at 11 or more of the 18 specific tender point sites. No exclusions are made for the presence of concomitant radiographic or laboratory abnormalities. At the diagnostic or classification level, the distinction between primary fibromyalgia and secondary-concomitant fibromyalgia (as defined in the text) is abandoned.

PMID 2306288  Arthritis Rheum. 1990 Feb;33(2):160-72.
著者: M B Yunus, A T Masi
雑誌名: Arthritis Rheum. 1985 Feb;28(2):138-45.
Abstract/Text Primary fibromyalgia syndrome (PFS) is a common and characteristic rheumatologic condition manifested by diffuse musculoskeletal aches, pains, and stiffness frequently modulated by various factors, e.g., weather, physical activity, sleep quality, and anxiety/stress, and accompanied by discrete tender points at typical soft tissue sites. Although well-recognized in adults, this entity has not been reported separately in juveniles. This study documents PFS in 33 juveniles who presented at age 17 or younger and compares their findings with those in age- and sex-matched normal control subjects. As in adult PFS patients, associated non-musculoskeletal symptoms were common, including fatigue, poor sleep, anxiety/stress, headaches, and paresthesias. Physical examination revealed multiple tender points at characteristic soft tissue sites and no objective evidence of arthritis. Routine laboratory test results were normal or negative. Juvenile PFS is often misdiagnosed. Recognition of this common rheumatologic condition in juveniles is important in order to avoid unwarranted investigations and improper management.

PMID 3871615  Arthritis Rheum. 1985 Feb;28(2):138-45.
著者: Shumpei Yokota, Masako Kikuchi, Takako Miyamae
雑誌名: Pediatr Int. 2013 Aug;55(4):403-9. doi: 10.1111/ped.12155.
Abstract/Text Juvenile fibromyalgia (JFM) is a disease in which patients complain of acute and chronic severe pain, an overt primary cause for which cannot be found or surmised. Although patients with JFM mainly complain of systemic pain or allodynia in the medical interview and physical examination, the concept of the disease is the total sum of painful illness, chronic fatigue, hypothermia and many other autonomic symptoms and signs. Many issues are interacting including individual traits (personality, temperament, sensitivity, memory of pain; age: early adolescence), individual states (self-esteem, anxiety, developmental level), and external stressors (parent especially mother, school environment). JFM is diagnosed on the combination of disease history, physical examination to determine the 18 tender points and allodynia, pain from gently touching their hair, and negative results of blood tests (inflammatory markers, thyroid function, myogenic enzymes). The goals of treatment are the following: restoration of function and relief of pain. Psychological support is advocated. Although the exact number of patients with JFM is still to be elucidated, it seems to be growing because pediatric rheumatologists in Japan encounter children with a wide variety of musculoskeletal pains. This guideline describes how to diagnose JFM in children and how to treat them appropriately.

© 2013 The Authors. Pediatrics International © 2013 Japan Pediatric Society.
PMID 23758613  Pediatr Int. 2013 Aug;55(4):403-9. doi: 10.1111/ped.121・・・
著者: C S Burckhardt, S R Clark, R M Bennett
雑誌名: J Rheumatol. 1991 May;18(5):728-33.
Abstract/Text An instrument has been developed to assess the current health status of women with the fibromyalgia syndrome. The Fibromyalgia Impact Questionnaire (FIQ) is a brief 10-item, self-administered instrument that measures physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well being. We describe its development and validation. This initial assessment indicates that the FIQ has sufficient evidence of reliability and validity to warrant further testing in both research and clinical situations.

PMID 1865419  J Rheumatol. 1991 May;18(5):728-33.
著者: Kenichi Osada, Hiroshi Oka, Tatsuya Isomura, Ikuro Nakamura, Keiichiro Tominaga, Shinobu Takahashi, Ayako Kojima, Kusuki Nishioka
雑誌名: Int J Rheum Dis. 2011 Feb;14(1):74-80. doi: 10.1111/j.1756-185X.2010.01585.x.
Abstract/Text AIM: To perform a psychometric assessment of the Japanese version of the Fibromyalgia Impact Questionnaire (JFIQ).
METHODS: Data for the psychometric assessment were collected from Japanese fibromyalgia (FM) patients who visited a clinic. Analyses were performed to examine the reliability and validity of the JFIQ.
RESULTS: A total of 56 patients were included in the analysis. There was no remarkable floor or ceiling effect for the JFIQ item or total scores. In the analysis of reproducibility, the interclass correlation coefficients of each item score and total score ranged from 0.61 to 0.95. Cronbach's alpha coefficient was 0.92. For the concurrent validity, the total score and most of the item scores correlated to every domain of Short Form-36 or Beck Depression Inventory-II to a moderate or great extent. The results of the known-group comparisons indicated that the total score tended to increase with the increase in severity of FM and pain (P-values for trend < 0.05).
CONCLUSION: This psychometric assessment demonstrated good reliability and validity of the JFIQ for use with Japanese FM patients. In the future, we expect that this questionnaire will be used in clinical studies and medical practice, and will be beneficial in the development of new therapies as well as for the comprehensive evaluation of patients' conditions in Japan.

© 2011 The Authors. International Journal of Rheumatic Diseases © 2011 Asia Pacific League of Associations for Rheumatology and Blackwell Publishing Asia Pty Ltd.
PMID 21303485  Int J Rheum Dis. 2011 Feb;14(1):74-80. doi: 10.1111/j.1・・・
著者: Frederick Wolfe, Afton L Hassett, Brian Walitt, Kaleb Michaud
雑誌名: Arthritis Care Res (Hoboken). 2011 Jan;63(1):94-101. doi: 10.1002/acr.20301. Epub 2010 Jul 26.
Abstract/Text OBJECTIVE: To determine if mortality is increased among patients diagnosed as having fibromyalgia.
METHODS: We studied 8,186 fibromyalgia patients seen between 1974 and 2009 in 3 settings: all fibromyalgia patients in a clinical practice, patients participating in the US National Data Bank for Rheumatic Diseases (NDB), and patients invited to participate in the NDB who refused participation. Internal controls included 10,087 patients with osteoarthritis. Deaths were determined by multiple source communication, and all patients were also screened in the US National Death Index (NDI). We calculated standardized mortality ratios (SMRs) based on age- and sex-stratified US population data, after adjustment for NDI nonresponse.
RESULTS: There were 539 deaths, and the overall SMR was 0.90 (95% confidence interval [95% CI] 0.61-1.26). Among 1,665 clinic patients, the SMR was 0.92 (95% CI 0.81-1.05). Sensitivity analyses varying the rate of NDI nonidentification did not alter the nonassociation. Adjusted for age and sex, the hazard ratio for fibromyalgia compared with osteoarthritis was 1.05 (95% CI 0.94-1.17). The standardized mortality odds ratio (OR) compared with the US general population was increased for suicide (OR 3.31, 95% CI 2.15-5.11) and for accidental deaths (OR 1.45, 95% CI 1.02- 2.06), but not for malignancy.
CONCLUSION: Mortality does not appear to be increased in patients diagnosed with fibromyalgia, but the risk of death from suicide and accidents was increased.

Copyright © 2011 by the American College of Rheumatology.
PMID 20662040  Arthritis Care Res (Hoboken). 2011 Jan;63(1):94-101. do・・・
著者: Brian Walitt, Mary-Ann Fitzcharles, Afton L Hassett, Robert S Katz, Winfried Häuser, Frederick Wolfe
雑誌名: J Rheumatol. 2011 Oct;38(10):2238-46. doi: 10.3899/jrheum.110026. Epub 2011 Jul 15.
Abstract/Text OBJECTIVE: To describe the diagnosis status and outcome of patients diagnosed with fibromyalgia (FM) by US rheumatologists.
METHODS: We assessed 1555 patients with FM with detailed outcome questionnaires during 11,006 semiannual observations for up to 11 years. At entry, all patients satisfied American College of Rheumatology preliminary 2010 FM criteria modified for survey research. We determined diagnosis status, rates of improvement, responder subgroups, and standardized mean differences (effect sizes) between start and study completion scores of global well-being, pain, sleep problems, and health related quality of life. (QOL) RESULTS: The 5-year improvement rates were pain 0.4 (95% CI 0.2, 0.5), fatigue 0.4 (95% CI 0.2, 0.05), and global 0.0 (95% CI -0.1, 0.1). The standardized mean differences were patient global 0.03 (95% CI -0.02, 0.08), pain 0.22 (95% CI 0.16, 0.28), sleep problems 0.20 (95% CI 0.14, 0.25), physical component summary of the Short-form 36 (SF-36) 0.11 (95% CI -0.14, -0.07), and SF-36 mental component summary 0.03 (95% CI -0.07, 0.02). Patients switched between criteria-positive and criteria-negative states, with 716 patients (44.0%) failing to meet criteria at least once during 4228.5 patient-years (7448 observations). About 10% of patients had substantial improvement and about 15% had moderate improvement of pain. Overall, FM severity worsened in 35.9% and pain in 38.6%.
CONCLUSION: Although we found no average clinically meaningful improvement in symptom severity overall, 25% had at least moderate improvement of pain over time. The result that emerged from this longitudinal study was one of generally continuing high levels of self-reported symptoms and distress for most patients, but a slight trend toward improvement.

PMID 21765102  J Rheumatol. 2011 Oct;38(10):2238-46. doi: 10.3899/jrhe・・・
著者: Timothy R Deer, Dawood Sayed, Jason E Pope, Krishnan V Chakravarthy, Erika Petersen, Susan M Moeschler, Alaa Abd-Elsayed, Kasra Amirdelfan, Nagy Mekhail, ASPN COVID Workgroup
雑誌名: Anesth Analg. 2020 Aug;131(2):387-394. doi: 10.1213/ANE.0000000000005000.
Abstract/Text BACKGROUND: The current coronavirus disease 2019 (COVID-19) pandemic led to a significant disruption in the care of pain from chronic and subacute conditions. The impact of this cessation of pain treatment may have unintended consequences of increased pain, reduced function, increased reliance on opioid medications, and potential increased morbidity, due to the systemic impact of untreated disease burden. This may include decreased mobility, reduction in overall health status, and increase of opioid use with the associated risks.
METHODS: The article is the study of the American Society of Pain and Neuroscience (ASPN) COVID-19 task force to evaluate the policies set forth by federal, state, and local agencies to reduce or eliminate elective procedures for those patients with pain from spine, nerve, and joint disease. The impact of these decisions, which were needed to reduce the spread of the pandemic, led to a delay in care for many patients. We hence review an emergence plan to reinitiate this pain-related care. The goal is to outline a path to work with federal, state, and local authorities to combat the spread of the pandemic and minimize the deleterious impact of pain and suffering on our chronic pain patients.
RESULTS: The article sets forth a strategy for the interventional pain centers to reemerge from the current pandemic and to set a course for future events.
CONCLUSIONS: The COVID-19 pandemic represents an overwhelming challenge to interventional pain physicians and their patients. In addition to urgent actions needed for disease mitigation, the ASPN recommends a staged return to pain management professionals' workflow.

PMID 32452905  Anesth Analg. 2020 Aug;131(2):387-394. doi: 10.1213/ANE・・・
著者: Daniel J Clauw, Winfried Häuser, Steven P Cohen, Mary-Ann Fitzcharles
雑誌名: Pain. 2020 Aug;161(8):1694-1697. doi: 10.1097/j.pain.0000000000001950.
Abstract/Text
PMID 32701829  Pain. 2020 Aug;161(8):1694-1697. doi: 10.1097/j.pain.00・・・
著者: Chie Usui, Kotaro Hatta, Satoko Aratani, Naoko Yagishita, Kenya Nishioka, Teruhisa Kanazawa, Kenji Itoh, Yoshihisa Yamano, Hiroyuki Nakamura, Toshihiro Nakajima, Kusuki Nishioka
雑誌名: Mod Rheumatol. 2013 Sep;23(5):846-50. doi: 10.1007/s10165-012-0759-x. Epub 2012 Sep 24.
Abstract/Text PURPOSE: The aim of this study is to investigate the reliability and validity of the Japanese version of the modified American College of Rheumatology (ACR) Preliminary Diagnostic Criteria for Fibromyalgia (mACR 2010-J) and the Fibromyalgia Symptom Scale (mFS-J).
METHODS: According to the ACR 1990 classification criteria, patients with chronic pain were divided into the fibromyalgia group and nonfibromyalgia group (rheumatoid arthritis and osteoarthritis). Patients in both groups were assessed using mACR 2010-J and mFS-J.
RESULTS: 294 of 462 (64 %) patients in the fibromyalgia group met mACR 2010-J, whereas 4 % (9/231) of the nonfibromyalgia group did, with sensitivity of 64 %, specificity of 96 %, positive predictive value of 97 %, negative predictive value of 56 %, and positive likelihood ratio of 16.3. Mean total scores on mFS-J significantly differentiated the fibromyalgia from the nonfibromyalgia group. According to the value of the Youden index, the best cutoff score for the mFS-J was 9/10.
CONCLUSION: Our findings indicate that mACR 2010-J as a positive test and mFS-J as a quantification scale might be suitable for assessing fibromyalgia among Japanese chronic pain populations.

PMID 23001748  Mod Rheumatol. 2013 Sep;23(5):846-50. doi: 10.1007/s101・・・
著者: Christopher Eccleston, Fiona M Blyth, Blake F Dear, Emma A Fisher, Francis J Keefe, Mary E Lynch, Tonya M Palermo, M Carrington Reid, Amanda C de C Williams
雑誌名: Pain. 2020 May;161(5):889-893. doi: 10.1097/j.pain.0000000000001885.
Abstract/Text
PMID 32251203  Pain. 2020 May;161(5):889-893. doi: 10.1097/j.pain.0000・・・
著者: Domenico Merante
雑誌名: Curr Med Res Opin. 2020 Apr;36(4):661-666. doi: 10.1080/03007995.2020.1725744. Epub 2020 Feb 23.
Abstract/Text Aims: The main aim of this work was to identify and to share the lessons learned from the negative outcome of the mirogabalin ALDAY phase 3 clinical program in pain associated with fibromyalgia. These lessons are important to improve planning and design of future phase 3 programs in fibromyalgia.Methods: A systematic review from Cochrane Library, Medline, Embase, clinicaltrials.gov, pharmaceutical companies, and regulatory agencies' websites, was carried out starting from the development of gabapentin, the first α2δ ligand studied for the treatment of neuropathic pain and ending with the mirogabalin program.Results: Based on the outcome of the main fibromyalgia programs, several differences in design, primary endpoint choice, magnitude of placebo response, presence of an active comparator, and size of the entire clinical program were identified. This analysis focused on the negative primary results of the mirogabalin ALDAY program and found several contributing factors. Above all, the magnitude of placebo response and the unprecedented size of the program were identified. The number of study visits and procedures was also high and highly demanding on all subjects involved in ALDAY.Outcome: In terms of main lessons learned from ALDAY, the first was the need for a comprehensive patient-focused strategy to preliminarily identify the challenges of fibromyalgia based on patient perspective and study complexity. Second, there was a need for a harmonized, truly patient-centric, global regulatory guidance accepted by regulatory agencies. Third, ALDAY proved that a phase 2 proof of concept, dose ranging study is necessary before commencing any phase 3 program in fibromyalgia.

PMID 32027198  Curr Med Res Opin. 2020 Apr;36(4):661-666. doi: 10.1080・・・
著者: Ali Bidari, Ehsan Moazen-Zadeh, Banafsheh Ghavidel-Parsa, Shahrzad Rahmani, Sajjad Hosseini, Amir Hassankhani
雑誌名: Daru. 2019 Jun;27(1):149-158. doi: 10.1007/s40199-019-00257-4. Epub 2019 Mar 14.
Abstract/Text BACKGROUND: Duloxetine and pregabalin are among the most widely used medications in the treatment of patients with fibromyalgia syndrome (FM).
OBJECTIVES: To add to the very few lines of evidence that exist on the comparative safety and efficacy of these two medications.
METHODS: In this open-label randomized clinical trial, outpatient women, who were diagnosed with FM based on American College of Rheumatology 2010 criteria, and had an age range of 18-65 years old were assigned to either duloxetine 30-60 mg or pregabalin 75-150 mg per day for 4 weeks. Patients were excluded in cases of having used duloxetine, pregabalin, gabapentin, or antidepressants within 12 weeks prior to the study, having had a history of comorbid medical conditions that could provoke chronic pain, or having had comorbid neuropsychiatric disorders, except for major depressive/anxiety disorders. Primary outcomes were between-group differences in mean score changes from baseline to end point for Widespread Pain Index (WPI) and Beck Depression Inventory-II. Secondary outcomes were the same statistical estimates, but for Fibromyalgia Impact Questionnaire-Revised and 12-Item Short Form Survey. Descriptive statistics and independent samples t-test were the main methods of analysis. ( www.irct.ir ; IRCT2016030626935N1).
RESULTS: Among all the scales, only WPI scores improved with a statistically significant difference between the two treatment arms, favoring duloxetine (Mean difference in score change - 2.32, 95% CI, -4.46 to - 0.18; p = 0.034; Cohen's d 0.53 95% CI, 0.04 to 1.02). Drop out rate and cumulative incidence of nausea was significantly higher in the duloxetine arm compared to the pregabalin arm.
CONCLUSION: This study provides further evidence on higher efficacy of duloxetine compared to pregabalin for the treatment of pain in patients with fibromyalgia. Future comprehensive pragmatic clinical trials are warranted.

PMID 30877484  Daru. 2019 Jun;27(1):149-158. doi: 10.1007/s40199-019-0・・・
著者: Bill McCarberg, Robert L Barkin, Carolyn Zaleon
雑誌名: Am J Ther. 2012 May;19(3):211-27. doi: 10.1097/MJT.0b013e31822119b3.
Abstract/Text By the year 2030, it is projected that the US population over the age of 65 years will be 70 million (one-fifth of the US population). Pain of various etiologies initiates about 50% of yearly physician visits and is the most frequent reason for health care consultation in the United States identified commonly by the older patient. The negative impact on the patient coupled with less than optimal treatments often presented to the patient elicit patient and prescriber frustration with inadequate outcomes. This article is focused at pharmacotherapeutic selections to be utilized in a polymodal fashion for the older adult presenting with neuropathic pain. The pharmacotherapies are to be titrated in a patient-specific patient centered-patient focused-personalized pharmacotherapeutic care. The classes of agents discussed include antidepressants, mood stabilizers/antiseizure agents, opioids, anesthetics, and miscellaneous agents.

PMID 22198068  Am J Ther. 2012 May;19(3):211-27. doi: 10.1097/MJT.0b01・・・
著者: Elena Pita Calandre, Fernando Rico-Villademoros, Carmen María Rodríguez-López
雑誌名: Curr Rheumatol Rep. 2012 Dec;14(6):568-75. doi: 10.1007/s11926-012-0278-y.
Abstract/Text Fibromyalgia is a chronic pain disease whose clinical symptomatology also includes different symptom domains: fatigue, sleep disturbances, morning stiffness, dyscognition, and psychological distress. These associated symptoms usually vary in frequency and intensity from patient to patient. Because the efficacy of monotherapy is limited, more severely affected patients frequently require drug combinations. There is, however, scarce scientific information concerning the benefits and risks of such combinations. To date, only ten studies investigating the efficacy and tolerability of two-drug combinations have been published; some of these studies are old and/or studied drugs that are now known to be of little or no interest in fibromyalgia management. Thus, when polytherapy is considered, therapeutic decisions must be based on data from monotherapy trials and a sound knowledge of the pharmacological profile of each drug. Well-designed clinical trials exploring specific drug combinations selected on the basis of potential additive or synergistic effects should be performed.

PMID 22806139  Curr Rheumatol Rep. 2012 Dec;14(6):568-75. doi: 10.1007・・・
著者: Philip J Mease, Mildred V Farmer, Robert H Palmer, R Michael Gendreau, Joel M Trugman, Yong Wang
雑誌名: Ther Adv Musculoskelet Dis. 2013 Jun;5(3):113-26. doi: 10.1177/1759720X13483894.
Abstract/Text OBJECTIVE: To evaluate the safety, tolerability, and efficacy of adding milnacipran to pregabalin in patients with fibromyalgia who have experienced an incomplete response to pregabalin.
METHODS: In this randomized, multicenter, open-label study, patients received pregabalin 300 or 450 mg/day during a 4- to 12-week run-in period. Patients with weekly recall visual analog scale (VAS) pain score of at least 40 and up to 90, Patient Global Impression of Severity score of at least 4, and Patient Global Impression of Change (PGIC) score of at least 3 were classified as incomplete responders and randomized to continue pregabalin alone (n = 180) or receive milnacipran 100 mg/day added to pregabalin (n = 184). The primary efficacy parameter was responder status based on PGIC score of up to 2. The secondary efficacy parameter was change from randomization in weekly recall VAS pain score. Safety parameters included adverse events (AEs), vital signs, and clinical laboratory tests.
RESULTS: The percentage of PGIC responders was significantly higher with milnacipran added to pregabalin (46.4%) than with pregabalin alone (20.8%; p < 0.001). Mean improvement from randomization in weekly recall VAS pain scores was greater in patients receiving milnacipran added to pregabalin (-20.77) than in patients receiving pregabalin alone (-6.43; p < 0.001). During the run-in period, the most common treatment-emergent AEs with pregabalin were dizziness (22.8%), somnolence (17.3%), and fatigue (9.1%). During the randomized period, the most common treatment-emergent AEs with milnacipran added to pregabalin were nausea (12.5%), fatigue (10.3%), and constipation (9.8%).
CONCLUSIONS: In this exploratory, open-label study, adding milnacipran to pregabalin improved global status, pain, and other symptoms in patients with fibromyalgia with an incomplete response to pregabalin treatment.

PMID 23858335  Ther Adv Musculoskelet Dis. 2013 Jun;5(3):113-26. doi: ・・・
著者: D Goldenberg, M Mayskiy, C Mossey, R Ruthazer, C Schmid
雑誌名: Arthritis Rheum. 1996 Nov;39(11):1852-9.
Abstract/Text OBJECTIVE: To study the effect of fluoxetine (FL) and amitriptyline (AM), alone and in combination, in patients with fibromyalgia (FM).
METHODS: Nineteen patients with FM completed a randomized, double-blind crossover study, which consisted of 4 6-week trials of FL (20 mg), AM (25 mg), a combination of FL and AM, or placebo. Patients were evaluated on the first and last day of each trial period. Outcome measures included a tender point score, the Fibromyalgia Impact Questionnaire (FIQ), the Beck Depression Inventory (BDI) scale, and visual analog scales (VAS) for global well-being (1 completed by the physician and 1 by the patient), pain, sleep trouble, fatigue, and feeling refreshed upon awakening.
RESULTS: Both FL and AM were associated with significantly improved scores on the FIQ and on the VAS for pain, global well-being, and sleep disturbances. When combined, the 2 treatments worked better than either medication alone. Similar, but nonsignificant, improvement occurred in the BDI scale, the physician global VAS, and the VAS for fatigue and feeling refreshed upon awakening. Trends were less clear for the tender point score.
CONCLUSION: Both FL and AM are effective treatments for FM, and they work better in combination than either medication alone.

PMID 8912507  Arthritis Rheum. 1996 Nov;39(11):1852-9.
著者: T G Tzellos, K A Toulis, D G Goulis, G Papazisis, V A Zampeli, A Vakfari, D Kouvelas
雑誌名: J Clin Pharm Ther. 2010 Dec;35(6):639-56. doi: 10.1111/j.1365-2710.2009.01144.x.
Abstract/Text WHAT IS KNOWN AND OBJECTIVES: Fibromyalgia (FBM) is a common chronic pain disorder affecting up to 2% of the general population. Current treatment options are mostly symptom-based and limited both in efficacy and number. Two promising alternatives are gabapentin (GP) and pregabalin (PB). We aimed to estimate the efficacy and safety/tolerability of the two compounds in FBM through a systematic review and a meta-analysis of relevant randomized double-blind placebo-controlled (RCT) were performed.
DATA SOURCES, EXTRACTION AND ANALYSIS: A literature search was conducted through MEDLINE, EMBASE, Cochrane CENTRAL and the reference lists of relevant studies. Responders to treatment (>30% reduction in mean pain score) and dropouts due to lack of efficacy were used as primary outcome measures. Dropout rates and incidence of common adverse outcomes were also investigated. Four RCTs, reporting data on 2040 patients, were reviewed and three of them using PG were included in the meta-analysis.
RESULTS: Pregabalin at a dose of 600, 450 and 300 mg per day is effective in FBM compared to placebo (NNT: 7, upper 95% CI: 12, 450 mg). A number of adverse events (AE), such as dizziness, somnolence, dry mouth, weight gain, peripheral oedema, is consistently associated with treatment at any dose and could lead one out of four patients to quit treatment (NNH: 6, lower 95% CI: 4, 600 mg). Indirect comparison meta-analysis suggests that PB at a dose of 450 mg per day could result in more responders than at 300 mg, but this result needs to be interpreted with caution as there were no significant differences between 600 and 300 mg or between 600 and 450 mg. Data on GP is limited.
WHAT IS NEW AND CONCLUSIONS: The analysis indicates that PB at a dose of 450 mg per day is most likely effective in treating FBM, although AE are not negligible. Further evidence is necessary for more conclusive inferences.

© 2010 The Authors. JCPT © 2010 Blackwell Publishing Ltd.
PMID 21054455  J Clin Pharm Ther. 2010 Dec;35(6):639-56. doi: 10.1111/・・・
著者: Sebastian Straube, Sheena Derry, Robert A Moore, Henry J McQuay
雑誌名: Rheumatology (Oxford). 2010 Apr;49(4):706-15. doi: 10.1093/rheumatology/kep432. Epub 2010 Jan 7.
Abstract/Text OBJECTIVES: Meta-analysis of pregabalin trials in FM using company trial reports, which provide more detailed information about trials than published papers. FM is a common condition with a significant impact on quality of life.
METHODS: Reports of five high-quality randomized trials (3808 patients) of pregabalin in FM were obtained from Pfizer. Four trials (2754 patients) were of classical trial design and one was an enriched enrolment randomized withdrawal design. Outcomes for meta-analysis from the four trials with classical design were pooled in an intention-to-treat analysis.
RESULTS: Significant benefit of pregabalin over placebo was seen for a variety of outcomes including mean pain and sleep scores, the proportion of patients achieving at least 50% pain relief and most of the individual domains of short-form 36. Only a minority of patients achieve moderate or substantial pain relief. The proportions of patients with any adverse event, somnolence or dizziness were also significantly greater with pregabalin than with placebo. There was no difference with regard to serious adverse events. A dose-response relationship was apparent for at least 50% pain relief and for adverse event outcomes.
CONCLUSIONS: Pregabalin is effective in treating FM and is relatively safe. The size of therapeutic effect is similar to that with other recent interventions such as duloxetine and the combination of tramadol and paracetamol. Enriched enrolment randomized withdrawal design gives similar results to classical trial designs in FM.

PMID 20056767  Rheumatology (Oxford). 2010 Apr;49(4):706-15. doi: 10.1・・・
著者: R Andrew Moore, Philip J Wiffen, Sheena Derry, Henry J McQuay
雑誌名: Cochrane Database Syst Rev. 2011 Mar 16;(3):CD007938. doi: 10.1002/14651858.CD007938.pub2. Epub 2011 Mar 16.
Abstract/Text BACKGROUND: This review updates parts of two earlier Cochrane reviews investigating effects of gabapentin in chronic neuropathic pain (pain due to nerve damage). Antiepileptic drugs are used to manage pain, predominantly for chronic neuropathic pain, especially when the pain is lancinating or burning.
OBJECTIVES: To evaluate the analgesic effectiveness and adverse effects of gabapentin for chronic neuropathic pain management.
SEARCH STRATEGY: We identified randomised trials of gabapentin in acute, chronic or cancer pain from MEDLINE, EMBASE, and CENTRAL. We obtained clinical trial reports and synopses of published and unpublished studies from Internet sources. The date of the most recent search was January 2011.
SELECTION CRITERIA: Randomised, double-blind studies reporting the analgesic and adverse effects of gabapentin in neuropathic pain with assessment of pain intensity and/or pain relief, using validated scales. Participants were adults aged 18 and over.
DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data. We calculated numbers needed to treat to benefit (NNTs), concentrating on IMMPACT (Initiative on Methods, Measurement and Pain Assessment in Clinical Trials) definitions of at least moderate and substantial benefit, and to harm (NNH) for adverse effects and withdrawal. Meta-analysis was undertaken using a fixed-effect model.
MAIN RESULTS: Twenty-nine studies (3571 participants), studied gabapentin at daily doses of 1200 mg or more in 12 chronic pain conditions; 78% of participants were in studies of postherpetic neuralgia, painful diabetic neuropathy or mixed neuropathic pain. Using the IMMPACT definition of at least moderate benefit, gabapentin was superior to placebo in 14 studies with 2831 participants, 43% improving with gabapentin and 26% with placebo; the NNT was 5.8 (4.8 to 7.2). Using the IMMPACT definition of substantial benefit, gabapentin was superior to placebo in 13 studies with 2627 participants, 31% improving with gabapentin and 17% with placebo; the NNT was 6.8 (5.6 to 8.7). These estimates of efficacy are more conservative than those reported in a previous review. Data from few studies and participants were available for other painful conditions.Adverse events occurred significantly more often with gabapentin. Persons taking gabapentin can expect to have at least one adverse event (66%), withdraw because of an adverse event (12%), suffer dizziness (21%), somnolence (16%), peripheral oedema (8%), and gait disturbance (9%). Serious adverse events (4%) were no more common than with placebo.There were insufficient data for comparisons with other active treatments.
AUTHORS' CONCLUSIONS: Gabapentin provides pain relief of a high level in about a third of people who take if for painful neuropathic pain. Adverse events are frequent, but mostly tolerable. More conservative estimates of efficacy resulted from using better definitions of efficacy outcome at higher, clinically important, levels, combined with a considerable increase in the numbers of studies and participants available for analysis.

PMID 21412914  Cochrane Database Syst Rev. 2011 Mar 16;(3):CD007938. d・・・
著者: R Andrew Moore, Sheena Derry, Dominic Aldington, Peter Cole, Philip J Wiffen
雑誌名: Cochrane Database Syst Rev. 2012 Dec 12;12:CD008242. doi: 10.1002/14651858.CD008242.pub2. Epub 2012 Dec 12.
Abstract/Text BACKGROUND: Amitriptyline is a tricyclic antidepressant that is widely used to treat chronic neuropathic pain (pain due to nerve damage) and fibromyalgia, and is recommended in many guidelines. These types of pain can be treated with antidepressant drugs in doses below those at which the drugs act as antidepressants.
OBJECTIVES: To assess the analgesic efficacy of amitriptyline for chronic neuropathic pain and fibromyalgia.To assess the adverse events associated with the clinical use of amitriptyline for chronic neuropathic pain and fibromyalgia.
SEARCH METHODS: We searched CENTRAL, MEDLINE, and EMBASE to September 2012, together with reference lists of retrieved papers, previous systematic reviews, and other reviews; we also used our own handsearched database for older studies.
SELECTION CRITERIA: We included randomised, double-blind studies of at least four weeks' duration comparing amitriptyline with placebo or another active treatment in chronic neuropathic pain or fibromyalgia.
DATA COLLECTION AND ANALYSIS: We extracted efficacy and adverse event data, and two study authors examined issues of study quality independently. We performed analysis using two tiers of evidence. The first tier used data meeting current best standards, where studies reported the outcome of at least 50% pain intensity reduction over baseline (or its equivalent), without the use of last observation carried forward (LOCF) or other imputation method for dropouts, reported an intention-to-treat (ITT) analysis, lasted 8 to 12 weeks or longer, had a parallel-group design, and where there were at least 200 participants in the comparison. The second tier used data that failed to meet this standard and were therefore subject to potential bias.
MAIN RESULTS: Twenty-one studies (1437 participants) were included; they individually involved between 15 and 235 participants, only four involved over 100 participants, and the median study size was 44 participants. The median duration was six weeks. Ten studies had a cross-over design. Doses of amitriptyline were generally between 25 mg and 125 mg, and dose escalation was common.There was no top-tier evidence for amitriptyline in treating neuropathic pain or fibromyalgia.Second-tier evidence indicated no evidence of effect in cancer-related neuropathic pain or HIV-related neuropathic pain, but some evidence of effect in painful diabetic neuropathy (PDN), mixed neuropathic pain, and fibromyalgia. Combining the classic neuropathic pain conditions of PDN, postherpetic neuralgia (PHN) and post-stroke pain with fibromyalgia for second-tier evidence, in eight studies and 687 participants, there was a statistically significant benefit (risk ratio (RR) 2.3, 95% confidence interval (CI) 1.8 to 3.1) with a number needed to treat (NNT) of 4.6 (3.6 to 6.6). The analysis showed that even using this potentially biased data, only about 38% of participants benefited with amitriptyline and 16% with placebo; most participants did not get adequate pain relief. Potential benefits of amitriptyline were supported by a lower rate of lack of efficacy withdrawals; 8/153 (5%) withdrew because of lack of efficacy with amitriptyline and 14/119 (12%) with placebo.More participants experienced at least one adverse event; 64% of participants taking amitriptyline and 40% taking placebo. The RR was 1.5 (95% CI 1.4 to 1.7) and the number needed to treat to harm was 4.1 (95% CI 3.2 to 5.7). Adverse event and all-cause withdrawals were not different.
AUTHORS' CONCLUSIONS: Amitriptyline has been a first-line treatment for neuropathic pain for many years. The fact that there is no supportive unbiased evidence for a beneficial effect is disappointing, but has to be balanced against decades of successful treatment in many patients with neuropathic pain or fibromyalgia. There is no good evidence of a lack of effect; rather our concern should be of overestimation of treatment effect. Amitriptyline should continue to be used as part of the treatment of neuropathic pain or fibromyalgia, but only a minority of patients will achieve satisfactory pain relief. Limited information suggests that failure with one antidepressant does not mean failure with all.It is unlikely that any large randomised trials of amitriptyline will be conducted in specific neuropathic pain conditions or in fibromyalgia to prove efficacy.

PMID 23235657  Cochrane Database Syst Rev. 2012 Dec 12;12:CD008242. do・・・
著者: Winfried Häuser, Gerard Urrútia, Sera Tort, Nurcan Uçeyler, Brian Walitt
雑誌名: Cochrane Database Syst Rev. 2013 Jan 31;1:CD010292. doi: 10.1002/14651858.CD010292. Epub 2013 Jan 31.
Abstract/Text BACKGROUND: Fibromyalgia syndrome (FMS) is a clinically well-defined chronic condition of unknown etiology characterized by chronic widespread pain that often co-exists with sleep disturbances, cognitive dysfunction and fatigue. Patients often report high disability levels and poor quality of life (QOL). Drug therapy focuses on reducing key symptoms and improving quality of life.
OBJECTIVES: To assess the benefits and harms of serotonin and noradrenaline reuptake inhibitors (SNRIs) compared with placebo for treating FMS symptoms in adults.
SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), (The Cochrane Library 2012, Issue 9), MEDLINE (1966 to September 2012), EMBASE (1980 to September 2012), www.clinicalstudyresults.org (U.S.-marketed pharmaceuticals) (to September 2012) and www.clinicaltrials.gov (to September 2012) for published and ongoing trials and examined the reference lists of reviewed articles.
SELECTION CRITERIA: We selected randomized, controlled trials of any formulation of SNRIs against placebo for the treatment of FMS in adults.
DATA COLLECTION AND ANALYSIS: Two review authors independently extracted the data from the included studies, and assessed the risks of bias of the studies. Discrepancies were resolved by discussion.
MAIN RESULTS: Ten studies were included with a total of 6038 participants. Five studies investigated duloxetine against placebo, and five investigated milnacipran against placebo. A total of 3611 participants were included into duloxetine or milnacipran groups and 2427 participants into placebo groups. The studies had a low risk of bias in general. Duloxetine and milnacipran had a small incremental effect over placebo in reducing pain (standardized mean difference (SMD) -0.23; 95% confidence interval (CI) -0.29 to -0.18; 6.1% relative improvement). One-hundred and ninety-two participants per 1000 on placebo reported an at least 50% pain reduction compared to 280 per 1000 on SNRIs (Risk ratio (RR) 1.49, 95% CI 1.35 to 1.64; number needed to treat to benefit (NNTB) 11, 95% CI 9 to 15). Duloxetine and milnacipran did not reduce fatigue substantially (SMD -0.14; 95% CI -0.19 to -0.08; 2.5% relative improvement; NNTB 17, 95% CI 12 to 29), and did not improve QOL substantially (SMD -0.20; 95% CI -0.25 to -0.14; 4.6% relative improvement; NNTB 12, 95% CI 9 to 17) compared to placebo. There were no statistically significant differences between either duloxetine or milnacipran and placebo in reducing sleep problems (SMD -0.07; 95% CI -0.16 to 0.03; 2.5% relative improvement). One-hundred and seven participants per 1000 on placebo dropped out due to adverse events compared to 196 per 1000 on SNRIs. The dropout rate due to adverse events in the duloxetine and milnacipran groups was statistically significantly higher than in placebo groups (RR 1.83, 95% CI 1.53 to 2.18; number needed to treat to harm (NNTH) 11, 95% CI 9 to 13). There was no statistically significant difference in serious adverse events between either duloxetine or milnacipran and placebo (RR 0.78, 95% CI 0.55 to 1.12).
AUTHORS' CONCLUSIONS: The SNRIs duloxetine and milnacipran provided a small incremental benefit over placebo in reducing pain. The superiority of duloxetine and milnacipran over placebo in reducing fatigue and limitations of QOL was not substantial. Duloxetine and milnacipran were not superior to placebo in reducing sleep problems. The dropout rates due to adverse events were higher for duloxetine and milnacipran than for placebo. The most frequently reported symptoms leading to stopping medication were nausea, dry mouth, constipation, headache, somnolence/dizziness and insomnia. Rare complications of both drugs may include suicidality, liver damage, abnormal bleeding, elevated blood pressure and urinary hesitation.

PMID 23440848  Cochrane Database Syst Rev. 2013 Jan 31;1:CD010292. doi・・・
著者: Winfried Häuser, Frederick Wolfe, Thomas Tölle, Nurcan Uçeyler, Claudia Sommer
雑誌名: CNS Drugs. 2012 Apr 1;26(4):297-307. doi: 10.2165/11598970-000000000-00000.
Abstract/Text BACKGROUND: The role of antidepressants in the management of fibromyalgia syndrome (FMS) still needs to be determined.
OBJECTIVE: The objective of this study was to provide a quantitative analysis (meta-analysis) of the efficacy and harms of antidepressants in the management of adult FMS patients.
DATA SOURCES: The data sources used were the databases MEDLINE, SCOPUS and the Cochrane Central Register of Controlled Trials (until December 30, 2010), the reference lists of included articles, and the websites of the US National Institutes of Health (NIH) and the Pharmaceutical Research and Manufacturers of America (PhRMA).
STUDY SELECTION: Studies with a randomized controlled trial (RCT) design comparing any types of antidepressants with pharmacological placebo or head-to-head comparisons of different types of antidepressants in FMS patients were included. RCTs in which antidepressants were combined with any other defined treatment or antidepressants were tested against anything but drug placebo were excluded. Patients diagnosed with FMS according to predefined criteria of any age were included. To be included, studies had to assess at least one key domain of FMS (pain, sleep, fatigue, health-related quality of life [HRQOL]) as outcomes of efficacy and report total treatment discontinuation rates and/or dropout rates due to adverse events as outcomes for harms.
DATA EXTRACTION: Data were extracted according to protocols of previous systematic reviews on antidepressants in FMS. Methodology quality was assessed by the van Tulder score.
DATA SYNTHESIS: Standardized mean differences (SMD) were calculated for continuous outcomes by means and standard deviations and relative risks (RR) for 30% pain reduction and total dropout rate for comparisons of antidepressants with placebo. Examination of the combined results was performed by a random effects model. We used Cohen's categories to evaluate the magnitude of the effect size, calculated by SMD. Heterogeneity was tested by the I2 statistic. Thirty-five studies were included in the meta-analysis. The SMDs of serotonin noradrenaline (norepinephrine) reuptake inhibitors (SNRIs) on pain, sleep, fatigue, depression and HRQOL were significant. Based on Cohen's categories, the effect size on pain was small and the ones on sleep, fatigue, depression and HRQOL were not substantial. 1481/3528 (42.0%) patients with SNRIs and 737/2304 (32.0%) patients with placebo reported a 30% pain reduction (number needed to treat [NNT] 10.0; 95% CI 8.00, 13.4; I2 = 4%). The RR of dropouts due to adverse events was 1.83 (95% CI 1.53, 2.18; I2 = 33%). The SMDs of selective serotonin reuptake inhibitors (SSRIs) on pain, sleep, depression and HRQOL were significant. Based on Cohen's categories, the effect sizes on pain, depression and HRQOL were small and the one on sleep not substantial. 72/198 (36.4%) patients with SSRIs and 40/194 (20.6%) patients with placebo reported a 30% pain reduction (NNT 6.3; 95% CI 4.1, 14.1). The RR of dropouts due to adverse events was 1.60 (95% CI 0.84, 3.04; I2 = 0%). The SMDs of tricyclic antidepressants (TCAs) on pain, sleep, fatigue and HRQOL were significant. Based on Cohen's categories, the effect sizes on pain and sleep were moderate and the ones on fatigue and HRQOL were small. 140/290 (48.3%) patients with TCAs and 70/252 (27.8%) patients with placebo reported a 30% pain reduction (NNT 4.9; 95% CI 3.5, 8.0). The RR of dropouts due to adverse events was 0.84 (95% CI 0.46, 1.52; I2 = 0%).
CONCLUSIONS: The TCA amitriptyline and the SNRIs duloxetine and milnacipran are first-line options for the treatment of FMS patients. Physicians and patients should be realistic about the potential benefits of antidepressants in FMS. A small number of patients experience a substantial symptom relief with no or minor adverse effects. However, a remarkable number of patients dropout of therapy because of intolerable adverse effects or experience only a small relief of symptoms, which does not outweigh the adverse effects.

PMID 22452526  CNS Drugs. 2012 Apr 1;26(4):297-307. doi: 10.2165/11598・・・
著者: Suwimon Yeephu, Chuthamanee Suthisisang, Saithip Suttiruksa, Pradit Prateepavanich, Patchara Limampai, Irwin Jon Russell
雑誌名: Ann Pharmacother. 2013 Jul-Aug;47(7-8):921-32. doi: 10.1345/aph.1R725. Epub 2013 Jun 4.
Abstract/Text BACKGROUND: Data from an open-label trial suggest that mirtazapine might prove useful in treatment of fibromyalgia syndrome (FMS).
OBJECTIVE: To obtain preliminary efficacy data of mirtazapine for estimation of sample size requirements for a Phase 2 clinical trial in FMS.
METHODS: This 13-week randomized controlled trial compared the effects of mirtazapine 15 mg/day, mirtazapine 30 mg/day, and placebo in 40 patients with FMS. The primary outcomes were change in Pain Visual Analog Scale (PVAS) and proportion of pain responders (≥30% PVAS reduction). Secondary outcomes included scores from the Jenkins Sleep Scale (JSS), Patient Global Impression of Change (PGIC), Fibromyalgia Impact Questionnaire (FIQ), Hamilton Depression Rating Scale (HAM-D), Patient Global Assessment, and self-reported adverse events.
RESULTS: Significant within-group PVAS reductions from baseline were observed in all 3 groups, with the greatest improvement in the mirtazapine 30-mg group (p < 0.005); between-group difference was not significant. The proportion of pain responders did not meet significance criteria (66.67% for mirtazapine 30 mg, 50% for mirtazapine 15 mg, 41.67% for placebo). Significant within-group improvement in JSS scores was seen for mirtazapine 30 mg (p < 0.01) and mirtazapine 15 mg (p < 0.05). Between-group comparison achieved significance for JSS item 3, waking several times per night (p < 0.05). On the PGIC, 72.73% felt better with both mirtazapine dosages compared with 50% for placebo. Within-group FIQ responses indicated improvement in only mirtazapine-treated groups, whereas within-group improvement for HAM-D and Patient Global Assessment was observed in all groups. Based on our findings, the sample size requirement (80% power, 5% type I error) should be 83 per group to detect PVAS change difference between mirtazapine 30 mg and placebo. Common mirtazapine-related adverse events were increased appetite and weight gain.
CONCLUSIONS: Patients with FMS taking mirtazapine exhibited within-group significant improvement in most of the measured outcomes. Between-group analysis was predictably compromised by the small sample size. Mirtazapine was well tolerated. Further study with a larger sample size is likely to be useful.

PMID 23737510  Ann Pharmacother. 2013 Jul-Aug;47(7-8):921-32. doi: 10.・・・
著者: Neil S Roskell, Stephen M Beard, Yang Zhao, Trong Kim Le
雑誌名: Pain Pract. 2011 Nov-Dec;11(6):516-27. doi: 10.1111/j.1533-2500.2010.00441.x. Epub 2010 Dec 28.
Abstract/Text OBJECTIVE: This meta-analysis compared efficacy (pain response) of drugs that are licensed or commonly used in the treatment of fibromyalgia. A meta-analysis of safety measured via discontinuation because of adverse events was also performed.
METHODS: We conducted a meta-analysis of 21 clinical trials to estimate treatment differences vs. placebo, separately, for duloxetine, fluoxetine, gabapentin, milnacipran, pramipexole, pregabalin, either of two tricyclic antidepressants, and tramadol plus paracetamol. Indirect treatment comparisons using mixed treatment comparisons methodology were conducted for all pairwise comparisons. Pain response was analyzed as improvement of at least 30%, and separately of 50%, from baseline.
RESULTS: When compared with placebo, statistically significant pain responses (improvement of 30% and 50%) were observed for patients treated with duloxetine, milnacipran 200 mg/day, pregabalin 300 or 450 mg/day, and tramadol plus paracetamol. Treatment with fluoxetine, gabapentin, or milnacipran 100 mg/day resulted in significant findings for the 30% improvement in pain response. The meta-analysis showed a statistically increased risk of discontinuation because of adverse events for milnacipran 100 and 200 mg/day (both P < 0.001), and pregabalin 300 and 450 mg/day (P = 0.009 and P < 0.001, respectively). All other treatments, except fluoxetine, showed numerically increased risk over placebo for discontinuation because of adverse events. In the indirect comparisons, no pairwise comparison of active treatments reached statistical significance for either pain response end point.
CONCLUSION: All eight active treatments displayed evidence suggesting improvement over placebo in the treatment of pain in patients suffering from fibromyalgia. Indirect comparison of active treatments found no strong differences.

© 2011 RTI Health Solutions. Pain Practice © 2011 World Institute of Pain.
PMID 21199320  Pain Pract. 2011 Nov-Dec;11(6):516-27. doi: 10.1111/j.1・・・
著者: Mary-Ann Fitzcharles, Peter A Ste-Marie, Ann Gamsa, Mark A Ware, Yoram Shir
雑誌名: Am J Med. 2011 Oct;124(10):955-60. doi: 10.1016/j.amjmed.2011.05.031.
Abstract/Text BACKGROUND: As pain is the cardinal symptom of fibromyalgia, it is logical that treatments directed toward pain relief will be commonly used. Analgesic drug therapy remains the traditional treatment intervention for most chronic pain conditions, with a progressive increased use of opioids in the past 20 years. Concerns about efficacy, risk-benefit ratio, and possible long-term effects of chronic opioid therapy have been raised. There is limited information about opioid treatment in fibromyalgia, with all current guidelines discouraging opioid use.
METHODS: A chart review of all patients referred to a tertiary care pain center clinic with a referring diagnosis of fibromyalgia was conducted to evaluate use of opioid medications.
RESULTS: We have recorded opioid use by 32% of 457 patients referred to a multidisciplinary fibromyalgia clinic, with over two thirds using strong opioids. Opioid use was more commonly associated with lower education, unemployment, disability payments, current unstable psychiatric disorder, a history of substance abuse, and previous suicide attempts.
CONCLUSION: We have observed negative health and psychosocial status in patients using opioids and labeled as fibromyalgia. Prolonged use of opioids in fibromyalgia requires evaluation.

Copyright © 2011 Elsevier Inc. All rights reserved.
PMID 21962316  Am J Med. 2011 Oct;124(10):955-60. doi: 10.1016/j.amjme・・・
著者: Don L Goldenberg, Carol Burckhardt, Leslie Crofford
雑誌名: JAMA. 2004 Nov 17;292(19):2388-95. doi: 10.1001/jama.292.19.2388.
Abstract/Text CONTEXT: The optimal management of fibromyalgia syndrome (FMS) is unclear and comprehensive evidence-based guidelines have not been reported.
OBJECTIVE: To provide up-to-date evidence-based guidelines for the optimal treatment of FMS. DATA SOURCES, SELECTION, AND EXTRACTION: A search of all human trials (randomized controlled trials and meta-analyses of randomized controlled trials) of FMS was made using Cochrane Collaboration Reviews (1993-2004), MEDLINE (1966-2004), CINAHL (1982-2004), EMBASE (1988-2004), PubMed (1966-2004), Healthstar (1975-2000), Current Contents (2000-2004), Web of Science (1980-2004), PsychInfo (1887-2004), and Science Citation Indexes (1996-2004). The literature review was performed by an interdisciplinary panel, composed of 13 experts in various pain management disciplines, selected by the American Pain Society (APS), and supplemented by selected literature reviews by APS staff members and the Utah Drug Information Service. A total of 505 articles were reviewed.
DATA SYNTHESIS: There are major limitations to the FMS literature, with many treatment trials compromised by short duration and lack of masking. There are no medical therapies that have been specifically approved by the US Food and Drug Administration for management of FMS. Nonetheless, current evidence suggests efficacy of low-dose tricyclic antidepressants, cardiovascular exercise, cognitive behavioral therapy, and patient education. A number of other commonly used FMS therapies, such as trigger point injections, have not been adequately evaluated.
CONCLUSIONS: Despite the chronicity and complexity of FMS, there are pharmacological and nonpharmacological interventions available that have clinical benefit. Based on current evidence, a stepwise program emphasizing education, certain medications, exercise, cognitive therapy, or all 4 should be recommended.

PMID 15547167  JAMA. 2004 Nov 17;292(19):2388-95. doi: 10.1001/jama.29・・・
著者: Juan V Luciano, Nuria Martínez, Maria Teresa Peñarrubia-María, Rita Fernández-Vergel, Javier García-Campayo, Camino Verduras, María E Blanco, Mónica Jiménez, José M Ruiz, Yolanda López del Hoyo, Antoni Serrano-Blanco, FibroQoL Study Group
雑誌名: Clin J Pain. 2011 Jun;27(5):383-91. doi: 10.1097/AJP.0b013e31820b131c.
Abstract/Text OBJECTIVES: A recent meta-analysis concluded that multicomponent treatments are effective for some fibromyalgia (FM) symptoms. The objective of this study was to examine whether a psychoeducational intervention implemented in primary care is more effective than usual care for improving the functional status of patients with FM.
METHODS: This study was based on a randomized controlled trial. The 484 patients with FM included in a database of the Viladecans Hospital (Barcelona, Spain) were eligible for screening. Finally, 108 patients were randomly assigned to the intervention and 108 patients were assigned to usual care. The intervention comprised nine 2-hour sessions (5 sessions of education and 4 sessions of autogenic relaxation). The patients were assessed before and after the intervention with a battery of instruments (measuring sociodemographic data, medical comorbidities, functional status, trait anxiety, and social desirability).
RESULTS: The posttreatment drop-out rate was 9.7% (intervention: 6.5%; control: 13%). The intention-to-treat analyses showed significant differences between the groups at posttreatment: the intervention group improved in physical impairment, days not feeling well, pain, general fatigue, morning fatigue, stiffness, anxiety, and depression (medium effect size in most cases). The patients who responded to the intervention reported less trait anxiety at baseline than nonresponders. The absolute risk reduction with the intervention was 36.1% (95% confidence interval: 23.3-48.8) and the number needed to treat was 3 (95% confidence interval: 2.0-4.3).
DISCUSSION: A 2-month psychoeducational intervention improves the functional status of FM patients to a greater extent than usual care, at least in the short-term. The social desirability bias did not explain the reported outcomes. Trait anxiety was associated with response to treatment.

PMID 21317775  Clin J Pain. 2011 Jun;27(5):383-91. doi: 10.1097/AJP.0b・・・
著者: Sara Lera, Saúl M Gelman, María J López, Montse Abenoza, José Gabriel Zorrilla, Josefina Castro-Fornieles, Manel Salamero
雑誌名: J Psychosom Res. 2009 Nov;67(5):433-41. doi: 10.1016/j.jpsychores.2009.01.012. Epub 2009 Mar 6.
Abstract/Text 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.

PMID 19837206  J Psychosom Res. 2009 Nov;67(5):433-41. doi: 10.1016/j.・・・
著者: Daniel S Rooks, Shiva Gautam, Matthew Romeling, Martha L Cross, Diana Stratigakis, Brittany Evans, Don L Goldenberg, Maura D Iversen, Jeffrey N Katz
雑誌名: Arch Intern Med. 2007 Nov 12;167(20):2192-200. doi: 10.1001/archinte.167.20.2192.
Abstract/Text 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.

PMID 17998491  Arch Intern Med. 2007 Nov 12;167(20):2192-200. doi: 10.・・・
著者: Gwenda Hughes, Carlos Martinez, Eric Myon, Charles Taïeb, Simon Wessely
雑誌名: Arthritis Rheum. 2006 Jan;54(1):177-83. doi: 10.1002/art.21545.
Abstract/Text OBJECTIVE: To investigate the impact of a diagnosis of fibromyalgia (FM) in clinical practice on health care resource use in the UK.
METHODS: Rates of visits, prescriptions, referral, and diagnostic testing were estimated in patients who had been diagnosed as having FM between 1998 and March 2003 in UK primary care and compared with those in matched controls. Rates were calculated in 6-month intervals from 10 years before until 4 years after the FM diagnosis.
RESULTS: Patients (2260) were newly diagnosed as having FM; 81.3% were women. Their mean age was 49 years. FM patients had considerably higher rates of visits, prescriptions, and testing from at least 10 years prior to diagnosis compared with controls. By the time of diagnosis, FM patients had 25 visits and 11 prescriptions per year compared with 12 visits and 4.5 prescriptions per year in controls. Visit rates were highest for depression, followed by fatigue, chest pain, headache, and sleep disturbance. Following diagnosis, visits for most symptoms and health care use markers declined, but within 2-3 years, most visits rose to levels at or higher than those at diagnosis.
CONCLUSION: Primary care patients who had been diagnosed as having FM reported higher rates of illness and health care resource use for at least 10 years prior to their diagnosis, which suggests that illness behavior may play a role. Being diagnosed as having FM may help patients cope with some symptoms, but the diagnosis has a limited impact on health care resource use in the longer term, possibly because there is little effective treatment.

PMID 16385513  Arthritis Rheum. 2006 Jan;54(1):177-83. doi: 10.1002/ar・・・
著者: L Annemans, S Wessely, E Spaepen, K Caekelbergh, J P Caubère, K Le Lay, C Taïeb
雑誌名: Arthritis Rheum. 2008 Mar;58(3):895-902. doi: 10.1002/art.23265.
Abstract/Text OBJECTIVE: To evaluate the use and costs of medical resources before and after a diagnosis of fibromyalgia syndrome (FMS) in a large primary care population in the UK.
METHODS: We applied an existing data set for medical resource use among patients with a coded diagnosis of FMS. The observed quantities of 157 types of medical resource use before and after the diagnosis of FMS were multiplied by unit costs in order to calculate the cost of care (general practitioner [GP] visits, drugs, referrals, and diagnostics) within the National Health Service, excluding hospital costs. Costs before diagnosis were used in a trend analysis to predict later costs, assuming the diagnosis had never been made, and these predicted costs were compared with the observed costs after diagnosis.
RESULTS: Following a diagnosis of FMS, a decrease in costs as compared with the predicted trend was observed. In the 4 years after diagnosis, the average difference between the predicted and observed cost was pound66.21 per 6 months per patient. This suggests that making the diagnosis leads to savings and a decrease in resource use. The main effect was observed for tests and imaging ( pound24.02 per 6 months), followed by pharmaceuticals ( pound22.27), referrals ( pound15.56), and GP visits ( pound4.36).
CONCLUSION: Failure to diagnose a true case of FMS has its own costs, largely in excess GP visits, investigations, and prescriptions.

PMID 18311794  Arthritis Rheum. 2008 Mar;58(3):895-902. doi: 10.1002/a・・・
著者: Angela J Busch, Candice L Schachter, Tom J Overend, Paul M Peloso, Karen A R Barber
雑誌名: J Rheumatol. 2008 Jun;35(6):1130-44. Epub 2008 May 1.
Abstract/Text OBJECTIVE: Fibromyalgia (FM) is a syndrome expressed by chronic widespread pain often associated with reduced physical function. Exercise is a common recommendation in management of FM. We evaluated the effects of exercise training on global well-being, selected signs and symptoms, and physical function in individuals with FM.
METHODS: We searched Medline, Embase, CINAHL, SportDiscus, PubMed, PEDro, and the Cochrane Central Register for Controlled Trials to July 2005 and included randomized trials evaluating cardiorespiratory endurance, muscle strength, and flexibility. Methodological quality was assessed using the van Tulder and Jadad instruments. Training protocols were evaluated using American College of Sports Medicine (ACSM) guidelines. Clinical heterogeneity limited metaanalysis to 6 aerobic and 2 strength studies.
RESULTS: There were 2276 subjects across the 34 studies; 1264 subjects were assigned to exercise interventions. Metaanalysis of 6 studies provided moderate-quality evidence that aerobic-only exercise training at ACSM-recommended intensity levels has positive effects on global well-being (SMD 0.49, 95% CI 0.23-0.75) and physical function (SMD 0.66, 95% CI 0.41-0.92) and possibly on pain (SMD 0.65, 95% CI -0.09 to 1.39) and tender points (SMD 0.23, 95% CI -0.18 to 0.65). Strength and flexibility remain underevaluated; however, strength training may have a positive effect on FM symptoms.
CONCLUSION: Aerobic-only training has beneficial effects on physical function and some FM symptoms. Strength-only training may improve FM symptoms, but requires further study. Large, high-quality studies of exercise-only interventions that provide detailed information on exercise prescription and adherence are needed.

PMID 18464301  J Rheumatol. 2008 Jun;35(6):1130-44. Epub 2008 May 1.
著者: Ciğdem Bircan, Seide Alev Karasel, Berrin Akgün, Ozlem El, Serap Alper
雑誌名: Rheumatol Int. 2008 Apr;28(6):527-32. doi: 10.1007/s00296-007-0484-5. Epub 2007 Nov 3.
Abstract/Text The purpose of this study was to compare the effects of aerobic training with a muscle-strengthening program in patients with fibromyalgia. Thirty women with fibromyalgia were randomized to either an aerobic exercise (AE) program or a strengthening exercise (SE) program for 8 weeks. Outcome measures included the intensity of fibromyalgia-related symptoms, tender point count, fitness (6-min walk distance), hospital anxiety and depression (HAD) scale, and short-form health survey (SF-36). There were significant improvements in both groups regarding pain, sleep, fatigue, tender point count, and fitness after treatment. HAD-depression scores improved significantly in both groups while no significant change occurred in HAD-anxiety scores. Bodily pain subscale of SF-36 and physical component summary improved significantly in the AE group, whereas seven subscales of SF-36, physical component summary, and mental component summary improved significantly in the SE group. When the groups were compared after treatment, there were no significant differences in pain, sleep, fatigue, tender point count, fitness, HAD scores, and SF-36 scores. AE and SE are similarly effective at improving symptoms, tender point count, fitness, depression, and quality of life in fibromyalgia.

PMID 17982749  Rheumatol Int. 2008 Apr;28(6):527-32. doi: 10.1007/s002・・・
著者: Lucie Brosseau, George A Wells, Peter Tugwell, Mary Egan, Keith G Wilson, Claire-Jehanne Dubouloz, Lynn Casimiro, Vivian A Robinson, Jessie McGowan, Angela Busch, Stéphane Poitras, Harvey Moldofsky, Manfred Harth, Hillel M Finestone, Warren Nielson, Angela Haines-Wangda, Marion Russell-Doreleyers, Kim Lambert, Alison D Marshall, Line Veilleux, Ottawa Panel Members
雑誌名: Phys Ther. 2008 Jul;88(7):873-86. doi: 10.2522/ptj.20070115. Epub 2008 May 22.
Abstract/Text BACKGROUND AND PURPOSE: The objective of this study was to create guidelines for the use of strengthening exercises in the management of adult patients (>18 years of age) with fibromyalgia (FM), as defined by the 1990 American College of Rheumatology criteria.
METHODS: Following Cochrane Collaboration methods, the Ottawa Methods Group found and synthesized evidence from comparative controlled trials and formed the Ottawa Panel, with nominated experts from key stakeholder organizations. The Ottawa Panel then developed criteria for grading the recommendations based on experimental design (I for randomized controlled trials, II for nonrandomized studies) and strength of evidence (A, B, C+, C, D+, D, or D-). From the rigorous literature search, 5 randomized controlled trials were selected. Statistical analysis was based on Cochrane Collaboration methods. Continuous data were calculated with weighted mean differences between the intervention and control groups, and dichotomous data were analyzed with relative risks. Clinical improvement was calculated using absolute benefit and relative difference in change from baseline. Clinical significance was attained when an improvement of 15% relative to a control was found.
RESULTS: There were 5 positive recommendations: 2 grade A and 3 grade C+. All 5 were of clinical benefit.
DISCUSSION AND CONCLUSION: The Ottawa Panel recommends strengthening exercises for the management of fibromyalgia as a result of the emerging evidence (grades A, B, and C+, although most trials were rated low quality) shown in the literature.

PMID 18497302  Phys Ther. 2008 Jul;88(7):873-86. doi: 10.2522/ptj.2007・・・
著者: Narcís Gusi, Pablo Tomas-Carus
雑誌名: Arthritis Res Ther. 2008;10(1):R24. doi: 10.1186/ar2377. Epub 2008 Feb 22.
Abstract/Text INTRODUCTION: Physical therapy in warm water has been effective and highly recommended for persons with fibromyalgia, but its efficiency remains largely unknown. Should patients or health care managers invest in this therapy? The aim of the current study was to assess the cost-utility of adding an aquatic exercise programme to the usual care of women with fibromyalgia.
METHODS: Costs to the health care system and to society were considered in this study that included 33 participants, randomly assigned to the experimental group (n = 17) or a control group (n = 16). The intervention in the experimental group consisted of a 1-h, supervised, water-based exercise sessions, three times per week for 8 months. The main outcome measures were the health care costs and the number of quality-adjusted life-years (QALYs) using the time trade-off elicitation technique from the EuroQol EQ-5D instrument. Sensitivity analyses were performed for variations in staff salary, number of women attending sessions and time spent going to the pool. The cost effectiveness acceptability curves were created using a non-parametric bootstrap technique.
RESULTS: The mean incremental treatment costs exceeded those for usual care per patient by euro 517 for health care costs and euro 1,032 for societal costs. The mean incremental QALY associated with the intervention was 0.131 (95% CI: 0.011 to 0.290). Each QALY gained in association with the exercise programme cost an additional euro 3,947/QALY (95% CI: 1,782 to 47,000) for a health care perspective and euro 7,878/QALY (3,559 to 93,818) from a societal perspective. The curves showed a 95% probability that the addition of the water-based programme is a cost-effective strategy if the ceiling of inversion is euro 14,200/QALY from a health care perspective and euro 28,300/QALY from a societal perspective.
CONCLUSION: The addition of an aquatic exercise programme to the usual care regime for fibromyalgia in women is cost effective in terms of both health care costs and societal costs. However, the characteristics of facilities (distance from the patients' homes and number of patients that can be accommodated per session) are major determinants to consider before investing in such a programme.
TRIAL REGISTRATION: Current controlled trials ISRCTN53367487.

PMID 18294367  Arthritis Res Ther. 2008;10(1):R24. doi: 10.1186/ar2377・・・
著者: Pablo Tomas-Carus, Narcis Gusi, Arja Häkkinen, Keijo Häkkinen, Alejo Leal, Alfredo Ortega-Alonso
雑誌名: J Rehabil Med. 2008 Apr;40(4):248-52. doi: 10.2340/16501977-0168.
Abstract/Text 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.

PMID 18382819  J Rehabil Med. 2008 Apr;40(4):248-52. doi: 10.2340/1650・・・
著者: Angela J Busch, Sandra C Webber, Mary Brachaniec, Julia Bidonde, Vanina Dal Bello-Haas, Adrienne D Danyliw, Tom J Overend, Rachel S Richards, Anuradha Sawant, Candice L Schachter
雑誌名: Curr Pain Headache Rep. 2011 Oct;15(5):358-67. doi: 10.1007/s11916-011-0214-2.
Abstract/Text Fibromyalgia syndrome, a chronic condition typically characterized by widespread pain, nonrestorative sleep, fatigue, cognitive dysfunction, and other somatic symptoms, negatively impacts physical and emotional function and reduces quality of life. Exercise is commonly recommended in the management of people with fibromyalgia, and interest in examining exercise benefits for those with the syndrome has grown substantially over the past 25 years. Research supports aerobic and strength training to improve physical fitness and function, reduce fibromyalgia symptoms, and improve quality of life. However, other forms of exercise (e.g., tai chi, yoga, Nordic walking, vibration techniques) and lifestyle physical activity also have been investigated to determine their effects. This paper highlights findings from recent randomized controlled trials and reviews of exercise for people with fibromyalgia, and includes information regarding factors that influence response and adherence to exercise to assist clinicians with exercise and physical activity prescription decision-making to optimize health and well-being.

PMID 21725900  Curr Pain Headache Rep. 2011 Oct;15(5):358-67. doi: 10.・・・
著者: Anthony S Kaleth, James E Slaven, Dennis C Ang
雑誌名: Arthritis Care Res (Hoboken). 2014 Dec;66(12):1887-94. doi: 10.1002/acr.22398.
Abstract/Text OBJECTIVE: To examine the concurrent and predictive associations between the number of steps taken per day and clinical outcomes in patients with fibromyalgia (FM).
METHODS: A total of 199 adults with FM (mean age 46.1 years, 95% women) who were enrolled in a randomized clinical trial wore a hip-mounted accelerometer for 1 week and completed self-report measures of physical function (Fibromyalgia Impact Questionnaire-Physical Impairment [FIQ-PI], Short Form 36 [SF-36] health survey physical component score [PCS], pain intensity and interference (Brief Pain Inventory [BPI]), and depressive symptoms (Patient Health Questionnaire-8 [PHQ-8]) as part of their baseline and followup assessments. Associations of steps per day with self-report clinical measures were evaluated from baseline to week 12 using multivariate regression models adjusted for demographic and baseline covariates.
RESULTS: Study participants were primarily sedentary, averaging 4,019 ± 1,530 steps per day. Our findings demonstrate a linear relationship between the change in steps per day and improvement in health outcomes for FM. Incremental increases on the order of 1,000 steps per day were significantly associated with (and predictive of) improvements in FIQ-PI, SF-36 PCS, BPI pain interference, and PHQ-8 (all P < 0.05). Although higher step counts were associated with lower FIQ and BPI pain intensity scores, these were not statistically significant.
CONCLUSION: Step count is an easily obtained and understood objective measure of daily physical activity. An exercise prescription that includes recommendations to gradually accumulate at least 5,000 additional steps per day may result in clinically significant improvements in outcomes relevant to patients with FM. Future studies are needed to elucidate the dose-response relationship between steps per day and patient outcomes in FM.

Copyright © 2014 by the American College of Rheumatology.
PMID 25049001  Arthritis Care Res (Hoboken). 2014 Dec;66(12):1887-94. ・・・
著者: Borja Sañudo, Delfín Galiano, Luis Carrasco, Moisés de Hoyo, Joseph G McVeigh
雑誌名: J Rehabil Med. 2011 May;43(6):521-6. doi: 10.2340/16501977-0814.
Abstract/Text OBJECTIVE: To assess the impact of a long-term exercise programme vs usual care on perceived health status, functional capacity and depression in patients with fibromyalgia.
DESIGN: Randomized controlled trial.
SUBJECTS: Forty-two women with fibromyalgia were allocated randomly to 1 of 2 groups: an experimental group that carried out aerobic, strength and flexibility exercises for 24 weeks and a usual care control group.
METHODS: Health status and functional capacity were evaluated using the Fibromyalgia Impact Questionnaire and the Short Form Health Survey 36. Depression was evaluated with the Beck Depression Inventory.
RESULTS: Significant improvements were observed in health status and functional capacity for the exercise group over the control group. The magnitude of the effect size of these improvements, expressed as Cohen's d, was medium. The effect size (95% confidence interval) for the Fibromyalgia Impact Questionnaire was 0.58 (-14.12, -2.35), for the Short Form Health Survey 36. global score 0.54 (1.28, 14.52), and in the mental health domain of the Short Form Health Survey 36. 0.51 (1.20, 16.26). There was a large effect size in vitality. All the aforementioned improvements can be considered as clinically important changes.
CONCLUSION: Results confirm that a long-term combination of aerobic exercise, strengthening and flexibility improves psychological health status and health-related quality of life in patients with fibromyalgia.

PMID 21533333  J Rehabil Med. 2011 May;43(6):521-6. doi: 10.2340/16501・・・
著者: Borja Sañudo, Delfín Galiano, Luis Carrasco, Milisa Blagojevic, Moisés de Hoyo, John Saxton
雑誌名: Arch Phys Med Rehabil. 2010 Dec;91(12):1838-43. doi: 10.1016/j.apmr.2010.09.006.
Abstract/Text OBJECTIVE: To investigate the effects of supervised aerobic exercise (AE) and a combined program of supervised aerobic, muscle strengthening, and flexibility exercises (combined exercise [CE]) on important health outcomes in women with fibromyalgia syndrome (FMS).
DESIGN: Randomized controlled trial.
SETTING: Community-based supervised intervention.
PARTICIPANTS: Women (N=64) with a diagnosis of FMS according to the American College of Rheumatology criteria.
INTERVENTION: Participants were randomly allocated to 1 of 3 groups: supervised AE, supervised CE, or usual-care control. Exercise sessions were performed twice weekly (45-60min/session) for 24 weeks.
MAIN OUTCOME MEASURES: The primary outcome measure was the Fibromyalgia Impact Questionnaire (FIQ). Exploratory outcome measures were the 36-Item Short-Form Health Survey, Beck Depression Inventory (BDI), aerobic capacity (6-minute walk test), hand-grip strength, and range of motion in the shoulders and hips.
RESULTS: Compliance with both interventions was excellent, with women in the exercise groups attending more than 85% of sessions. A 14% to 15% improvement from baseline in total FIQ score was observed in the exercise groups (P≤.02) and was accompanied by decreases in BDI scores of 8.5 (P<.001) and 6.4 (P<.001) points in the AE and CE groups, respectively. Relative to nonexercising controls, CE evoked improvements in the SF-36 Physical Functioning (P=.003) and Bodily Pain (P=.003) domains and was more effective than AE for evoking improvements in the Vitality (P=.002) and Mental Health (P=.04) domains. Greater improvements also were observed in shoulder/hip range of motion and handgrip strength in the CE group.
CONCLUSION: Given the equivalent time commitment required for AE and CE, our results suggest that women with FMS can gain additional health benefits by engaging in a similar volume of CE.

Copyright © 2010 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
PMID 21112423  Arch Phys Med Rehabil. 2010 Dec;91(12):1838-43. doi: 10・・・
著者: Borja Sañudo, Luis Carrasco, Moisés de Hoyo, Joseph G McVeigh
雑誌名: Am J Phys Med Rehabil. 2012 Jul;91(7):561-9; quiz 570-3. doi: 10.1097/PHM.0b013e31824faa03.
Abstract/Text OBJECTIVE: This study aimed to evaluate the immediate effects of a 6-mo combined exercise program on quality-of-life, physical function, depression, and aerobic capacity in women with fibromyalgia syndrome and to determine the impact of repeated delivery of the intervention.
DESIGN: Forty-one women with fibromyalgia were randomly assigned to a training group (EG; n = 21) and a control group (CG; n = 20). Quality-of-life and physical function were assessed using the 36-item Short-Form Health Survey (SF-36) and the Fibromyalgia Impact Questionnaire, and depression was measured using the Beck Depression Inventory. Physical fitness was measured using the 6-min Walk Test. Outcomes were assessed at baseline and after each 6-mo intervention, which was delivered over 30 mos (6 mos of training and 6 mos of detraining).
RESULTS: After a 6-mo combined exercise program, there was a significant improvement in the Fibromyalgia Impact Questionnaire (P < 0.0005) for the training group over the control group. Repeated-measures analysis of variance across all time points demonstrated significant main effects for time for the Fibromyalgia Impact Questionnaire, SF-36, Beck Depression Inventory and the 6-min Walk Test, but there were no between-group interaction effects. For the EG, there were significant within-group changes in the Fibromyalgia Impact Questionnaire, SF-36, and Beck Depression Inventory at the final time point; however, there were no within-group changes for the control group. Improvement achieved for the training group were maintained during the detraining period.
CONCLUSIONS: A long-term exercise program can produce immediate improvements in key health domains in women with fibromyalgia. The benefits achieved with regular training can be maintained for 30 mos. The lack of difference between groups over time may be caused by attrition and consequent lack of power at the final time point.

PMID 22469880  Am J Phys Med Rehabil. 2012 Jul;91(7):561-9; quiz 570-3・・・
著者: Alison Hammond, Kaye Freeman
雑誌名: Clin Rehabil. 2006 Oct;20(10):835-46. doi: 10.1177/0269215506072173.
Abstract/Text 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.

PMID 17008336  Clin Rehabil. 2006 Oct;20(10):835-46. doi: 10.1177/0269・・・
著者: V Rucco, C Feruglio, F Genco, R Mosanghini
雑誌名: Riv Eur Sci Med Farmacol. 1995 Jan-Feb;17(1):41-50.
Abstract/Text The AA have conducted a controlled trial to determine the efficacy of two verbal techniques for muscular relaxation on 53 patients with fibromyalgia. The subjects were assigned at random to a autogenous training group (27 patients) or a analogic Erickson's techniques group (26 patients). The autogenous training showed the presence of various limits: (1) application limits (in which notable difficulties had to be faced to train the patients with fibromyalgia to practice the Autogenous training due to the revelation of "intrusive thoughts" or "abreactions", or because of the incapacity of the patients to practice the exercises at home without hearing the instructions of a therapist); (2) limits of efficacy (the state of optimum training needed many therapeutic sittings in order to be achieved and the improvements regarded nighttime sleep and morning rigidity, however, these improvements were less than those obtained with the analogic Erickson's techniques). The Erickson's techniques have showed, instead, many advantages: numerous patients continued the treatment until it was finished; only a small number of therapeutic sittings were necessary. There was an improvement of all the parameters examined, superior compared to the results obtained in the group of patients treated with autogenous training.

PMID 8545555  Riv Eur Sci Med Farmacol. 1995 Jan-Feb;17(1):41-50.
著者: Antoni Castel, Magdalena Pérez, José Sala, Anna Padrol, Maria Rull
雑誌名: Eur J Pain. 2007 May;11(4):463-8. doi: 10.1016/j.ejpain.2006.06.006. Epub 2006 Aug 4.
Abstract/Text The main aims of this experimental study are: (1) to compare the relative effects of analgesia suggestions and relaxation suggestions on clinical pain, and (2) to compare the relative effect of relaxation suggestions when they are presented as "hypnosis" and as "relaxation training". Forty-five patients with fibromyalgia were randomly assigned to one of the following experimental conditions: (a) hypnosis with relaxation suggestions; (b) hypnosis with analgesia suggestions; (c) relaxation. Before and after the experimental session, the pain intensity was measured using a visual analogue scale (VAS) and the sensory and affective dimensions were measured with the McGill Pain Questionnaire. The results showed: (1) that hypnosis followed by analgesia suggestions has a greater effect on the intensity of pain and on the sensory dimension of pain than hypnosis followed by relaxation suggestions; (2) that the effect of hypnosis followed by relaxation suggestions is not greater than relaxation. We discuss the implications of the study on our understanding of the importance of suggestions used in hypnosis and of the differences and similarities between hypnotic relaxation and relaxation training.

PMID 16889999  Eur J Pain. 2007 May;11(4):463-8. doi: 10.1016/j.ejpain・・・
著者: Hiroyoshi Ohta, Hiroshi Oka, Chie Usui, Masayuki Ohkura, Makoto Suzuki, Kusuki Nishioka
雑誌名: Arthritis Res Ther. 2012 Oct 12;14(5):R217. doi: 10.1186/ar4056. Epub 2012 Oct 12.
Abstract/Text INTRODUCTION: Fibromyalgia is a chronic disorder characterized by widespread pain and tenderness. Prior trials have demonstrated the efficacy of pregabalin for the relief of fibromyalgia symptoms, and it is approved for the treatment of fibromyalgia in the United States. However, prior to this study, there has not been a large-scale efficacy trial in patients with fibromyalgia in Japan.
METHODS: This randomized, double-blind, multicenter, placebo-controlled trial was conducted at 44 centers in Japan to assess the efficacy and safety of pregabalin for the symptomatic relief of pain in fibromyalgia patients. Patients aged ≥18 years who had met the criteria for fibromyalgia were randomized to receive either pregabalin, starting at 150 mg/day and increasing to a maintenance dose of 300 or 450 mg/day, or placebo, for 15 weeks. The primary efficacy endpoint was mean pain score at final assessment. Secondary endpoints included Patient Global Impression of Change (PGIC) together with measures of sleep, physical functioning and quality of life.
RESULTS: A total of 498 patients (89% female) were randomized to receive either pregabalin (n = 250) or placebo (n = 248). Pregabalin significantly reduced mean pain score at final assessment (difference in mean change from baseline, compared with placebo -0.44; P = 0.0046) and at every week during the study (P <0.025). Key secondary endpoints were also significantly improved with pregabalin treatment compared with placebo, including PGIC (percentage reporting symptoms "very much improved" or "much improved", 38.6% vs 26.7% with placebo; P = 0.0078); pain visual analog scale (difference in mean change from baseline, compared with placebo -6.19; P = 0.0013); Fibromyalgia Impact Questionnaire total score (-3.33; P = 0.0144); and quality of sleep score (-0.73; P <0.0001). Treatment was generally well tolerated, with somnolence and dizziness the most frequently reported adverse events.
CONCLUSIONS: This trial demonstrated that pregabalin, at doses of up to 450 mg/day, was effective for the symptomatic relief of pain in Japanese patients with fibromyalgia. Pregabalin also improved measures of sleep and functioning and was well tolerated. These data indicate that pregabalin is an effective treatment option for the relief of pain and sleep problems in Japanese patients with fibromyalgia.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT00830167.

PMID 23062189  Arthritis Res Ther. 2012 Oct 12;14(5):R217. doi: 10.118・・・
著者: Mari Viola-Saltzman, Nathaniel F Watson, Andy Bogart, Jack Goldberg, Dedra Buchwald
雑誌名: J Clin Sleep Med. 2010 Oct 15;6(5):423-7.
Abstract/Text STUDY OBJECTIVES: To investigate the prevalence of restless legs syndrome (RLS) in fibromyalgia (FM) and determine the presence and amount of sleep disruption in FM patients with RLS. RLS and FM have been associated in uncontrolled studies using a variety of RLS definitions. We explored this relationship using a cross-sectional study design.
METHODS: FM cases that met the American College of Rheumatology diagnostic criteria were recruited through an academic referral clinic and advertising. Pain- and fatigue-free controls were recruited from the Seattle metropolitan area. We enrolled 172 FM patients (mean age 50 years, 93% female) and 63 pain- and fatigue-free controls (mean age 41 years, 56% female). RLS was ascertained by a self-administered validated diagnostic interview.
RESULTS: The age- and gender-adjusted prevalence of RLS was higher in the FM group than the control group (33.0%; 95% CI: 25.9, 40.1 vs. 3.1%; 95% CI: 0.0, 7.4; p = 0.001). Likewise, the FM group was more likely to report RLS (OR = 11.7; 95% CI: 2.6, 53.0), even after adjusting for age and gender. The mean Pittsburgh Sleep Quality Index score was higher among FM patients with RLS than those without (11.8 vs. 9.9; p = 0.01) but subjective limb pain measures did not differ between these 2 groups.
CONCLUSIONS: There is a higher prevalence and odds of RLS in those with FM compared to controls. Clinicians should routinely query FM patients regarding RLS symptoms because treatment of RLS can potentially improve sleep and quality of life in these patients.

PMID 20957840  J Clin Sleep Med. 2010 Oct 15;6(5):423-7.
著者: Kathrin Bernardy, Nicole Füber, Volker Köllner, Winfried Häuser
雑誌名: J Rheumatol. 2010 Oct;37(10):1991-2005. doi: 10.3899/jrheum.100104. Epub 2010 Aug 3.
Abstract/Text OBJECTIVE: We performed the first systematic review with metaanalysis of the efficacy of cognitive-behavioral therapies (CBT) in fibromyalgia syndrome (FM).
METHODS: We screened Cochrane Library, Medline, PsychINFO, and Scopus (through June 2009) and the reference sections of original studies and systematic reviews for CBT in FM. Randomized controlled trials (RCT) comparing CBT to controls were analyzed. Primary outcomes were pain, sleep, fatigue, and health-related quality of life (HRQOL). Secondary outcomes were depressed mood, self-efficacy pain, and healthcare-seeking behavior. Effects were summarized using standardized mean differences (SMD).
RESULTS: A total of 14 out of 27 RCT with 910 subjects with a median treatment time of 27 hours (range 6-75) over a median of 9 weeks (range 5-15) were included. CBT reduced depressed mood (SMD -0.24, 95% CI -0.40, -0.08; p = 0.004) at posttreatment. Sensitivity analyses showed that the positive effect on depressed mood could not be distinguished from some risks of bias. There was no significant effect on pain, fatigue, sleep, and HRQOL at posttreatment and at followup. There was a significant effect on self-efficacy pain posttreatment (SMD 0.85, 95% CI 0.25, 1.46; p = 0.006) and at followup (SMD 0.90, 95% CI 0.14, 1.66; p = 0.02). Operant behavioral therapy significantly reduced the number of physician visits at followup (SMD -1.57, 95% CI -2.00, -1.14; p < 0.001).
CONCLUSION: CBT can be considered to improve coping with pain and to reduce depressed mood and healthcare-seeking behavior in FM.

PMID 20682676  J Rheumatol. 2010 Oct;37(10):1991-2005. doi: 10.3899/jr・・・
著者: Julia A Glombiewski, Alice T Sawyer, Jana Gutermann, Katharina Koenig, Winfried Rief, Stefan G Hofmann
雑誌名: Pain. 2010 Nov;151(2):280-95. doi: 10.1016/j.pain.2010.06.011. Epub 2010 Aug 19.
Abstract/Text The aims of the present analysis were to investigate the short- and long-term efficacies and treatment moderators of psychological interventions for fibromyalgia. A literature search using PubMed, PsychINFO, the Cochrane Library, and manual searches identified 23 eligible studies including 30 psychological treatment conditions and 1396 patients. Meta-analytic integration resulted in a significant but small effect size for short-term pain reduction (Hedges's g=0.37, 95% confidence interval (CI): 0.27-0.48) and a small-to-medium effect size for long-term pain reduction over an average follow-up phase of 7.4 months (Hedges's g=0.47, 95% CI: 0.3-0.65) for any psychological intervention. Psychological treatments also proved effective in reducing sleep problems (Hedges's g=0.46, 95% CI: 0.28-0.64), depression (Hedges's g=0.33, 95% CI: 0.20-0.45), functional status (Hedges's g=0.42, 95% CI: 0.25-0.58), and catastrophizing (Hedges's g=0.33, 95% CI: 0.17-0.49). These effects remained stable at follow-up. Moderator analyses revealed cognitive-behavioral treatment to be significantly better than other psychological treatments in short-term pain reduction (Hedges's g=0.60, 95% CI: 0.46-0.76). Higher treatment dose was associated with better outcome. Publication-bias analyses demonstrated that the effect sizes were robust. The results suggest that the effects of psychological treatments for fibromyalgia are relatively small but robust and comparable to those reported for other pain and drug treatments used for this disorder. Cognitive-behavioral therapy was associated with the greatest effect sizes.

Copyright © 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
PMID 20727679  Pain. 2010 Nov;151(2):280-95. doi: 10.1016/j.pain.2010.・・・
著者: Kati Thieme, Herta Flor, Dennis C Turk
雑誌名: Arthritis Res Ther. 2006;8(4):R121. doi: 10.1186/ar2010.
Abstract/Text The present study focused on the evaluation of the effects of operant behavioural (OBT) and cognitive behavioural (CBT) treatments for fibromyalgia syndrome (FMS). One hundred and twenty-five patients who fulfilled the American College of Rheumatology criteria for FMS were randomly assigned to OBT (n = 43), CBT (n = 42), or an attention-placebo (AP) treatment (n = 40) that consisted of discussions of FMS-related problems. Assessments of physical functioning, pain, affective distress, and cognitive and behavioural variables were performed pre-treatment and post-treatment as well as 6 and 12 months post-treatment. Patients receiving the OBT or CBT reported a significant reduction in pain intensity post-treatment (all Fs > 3.89, all Ps < 0.01). In addition, the CBT group reported statistically significant improvements in cognitive (all Fs > 7.95, all P < 0.01) and affective variables (all Fs > 2.99, all Ps < 0.02), and the OBT group demonstrated statistically significant improvements in physical functioning and behavioural variables (all Fs > 5.99, all Ps < 0.001) compared with AP. The AP group reported no significant improvement but actually deterioration in the outcome variables. The post-treatment effects for the OBT and CBT groups were maintained at both the 6- and 12-month follow-ups. These results suggest that both OBT and CBT are effective in treating patients with FMS with some differences in the outcome measures specifically targeted by the individual treatments compared with an unstructured discussion group. The AP group showed that unstructured discussion of FMS-related problems may be detrimental.

PMID 16859516  Arthritis Res Ther. 2006;8(4):R121. doi: 10.1186/ar2010・・・
著者: Chie Usui, Nagafumi Doi, Makiko Nishioka, Hiroyuki Komatsu, Ryoko Yamamoto, Taku Ohkubo, Takuya Ishizuka, Nobuto Shibata, Kotaro Hatta, Haruhiro Miyazaki, Kusuki Nishioka, Heii Arai
雑誌名: Pain. 2006 Apr;121(3):276-80. doi: 10.1016/j.pain.2005.12.025. Epub 2006 Feb 21.
Abstract/Text The pathophysiology of fibromyalgia remains unknown. Several reports have recently suggested the novel concept that fibromyalgia is due to the central nervous system becoming hyper-responsive to a peripheral stimulus. The effect of electroconvulsive therapy (ECT) as pain remedication in cases of fibromyalgia without major depressive disorder was studied in a prospective trial lasting three months. All of the patients taking part in the study fulfilled the American College of Rheumatology diagnostic criteria for fibromyalgia. Technetium-99m ethyl cysteinate dimer single photon emission computed tomography was used to assess regional cerebral blood flow (rCBF) before and after a course of ECT. Pain assessment in the patients was undertaken by use of the visual analog scale (VAS) and by evaluation of tender points (TPs). Beck's depression inventory (BDI) was further used to assess depressive mood change in the patients. Our study clearly demonstrated that pain was significantly less severe after ECT, as indicated by the VAS scale for pain and the evaluation of TPs. A further notable observation was that thalamic blood flow was also improved. We conclude that a course of ECT produced notable improvements in both intractable severe pain associated with fibromyalgia and also in terms of thalamic blood flow.

PMID 16495009  Pain. 2006 Apr;121(3):276-80. doi: 10.1016/j.pain.2005.・・・
著者: Martti J Huuhka, Maija L Haanpää, Esa V J Leinonen
雑誌名: Eur J Pain. 2004 Aug;8(4):371-6. doi: 10.1016/j.ejpain.2003.11.001.
Abstract/Text The effect of electroconvulsive therapy (ECT) on depression and other symptoms of fibromyalgia was studied in a prospective 3-month trial in 13 patients with fibromyalgia and concomitant depression. All the patients met the DSM-IV diagnostic criteria for Major Depressive Disorder and fulfilled the American College of Rheumatology diagnostic criteria for fibromyalgia. The Montgomery and Asberg Depression Rating Scale (MADRS) and the clinical global impression scale (CGI) were used to assess the severity of depression and the clinical change of the patients. The fibromyalgia impact questionnaire (FIQ) was used to evaluate the severity of the fibromyalgia symptoms. The intensity of pain was evaluated using a 6-point scale (0=no pain, 5=very severe pain), and tender point palpation. All assessments were performed at baseline and at follow-up visits, which took place one week, one month and three months after ECT. There was a significant improvement in depression after ECT according to MADRS. Using CGI, six patients were much or very much improved, while four patients were minimally improved and three patients had no change. There was significant improvement in four out of ten FIQ item scores, "feel good", "fatigue", "anxiety" and "depression". No significant change was found in the FIQ item scores "physical function", "pain", "stiffness" and "morning tiredness" or number of tender points and self-reported pain. We conclude that ECT is a safe and effective treatment for depression in fibromyalgia patients, but has no effect on the pain or other physical symptoms of these patients.

PMID 15207518  Eur J Pain. 2004 Aug;8(4):371-6. doi: 10.1016/j.ejpain.・・・
著者: A Passard, N Attal, R Benadhira, L Brasseur, G Saba, P Sichere, S Perrot, D Januel, D Bouhassira
雑誌名: Brain. 2007 Oct;130(Pt 10):2661-70. doi: 10.1093/brain/awm189. Epub 2007 Sep 14.
Abstract/Text 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.

PMID 17872930  Brain. 2007 Oct;130(Pt 10):2661-70. doi: 10.1093/brain/・・・
著者: E Baron Short, Jeffrey J Borckardt, Berry S Anderson, Heather Frohman, William Beam, Scott T Reeves, Mark S George
雑誌名: Pain. 2011 Nov;152(11):2477-84. doi: 10.1016/j.pain.2011.05.033. Epub 2011 Jul 20.
Abstract/Text Transcranial magnetic stimulation (TMS) of the prefrontal cortex can cause changes in acute pain perception. Several weeks of daily left prefrontal TMS has been shown to treat depression. We recruited 20 patients with fibromyalgia, defined by American College of Rheumatology criteria, and randomized them to receive 4000 pulses at 10 Hz TMS (n=10), or sham TMS (n=10) treatment for 10 sessions over 2 weeks along with their standard medications, which were fixed and stable for at least 4 weeks before starting sessions. Subjects recorded daily pain, mood, and activity. Blinded raters assessed pain, mood, functional status, and tender points weekly with the Brief Pain Inventory, Hamilton Depression Rating Scale, and Fibromyalgia Impact Questionnaire. No statistically significant differences between groups were observed. Patients who received active TMS had a mean 29% (statistically significant) reduction in pain symptoms in comparison to their baseline pain. Sham TMS participants had a 4% nonsignificant change in daily pain from their baseline pain. At 2 weeks after treatment, there was a significant improvement in depression symptoms in the active group compared to baseline. Pain reduction preceded antidepressant effects. TMS was well tolerated, with few side effects. Further studies that address study limitations are needed to determine whether daily prefrontal TMS may be an effective, durable, and clinically useful treatment for fibromyalgia symptoms.

Copyright © 2011 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
PMID 21764215  Pain. 2011 Nov;152(11):2477-84. doi: 10.1016/j.pain.201・・・
著者: Nicole M Marlow, Heather S Bonilha, E Baron Short
雑誌名: Pain Pract. 2013 Feb;13(2):131-45. doi: 10.1111/j.1533-2500.2012.00562.x. Epub 2012 May 28.
Abstract/Text OBJECTIVE:  To systematically review the literature to date applying repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) for patients with fibromyalgia syndrome (FMS).
METHOD:  Electronic bibliography databases screened included PubMed, Ovid MEDLINE, PsychINFO, CINAHL, and Cochrane Library. The keyword "fibromyalgia" was combined with ("transcranial" and "stimulation") or "TMS" or "tDCS" or "transcranial magnetic stimulation" or "transcranial direct current stimulation".
RESULTS:  Nine of 23 studies were included; brain stimulation sites comprised either the primary motor cortex (M1) or the dorsolateral prefrontal cortex (DLPFC). Five studies used rTMS (high-frequency-M1: 2, low-frequency-DLPFC: 2, high-frequency-DLPFC: 1), while 4 applied tDCS (anodal-M1: 1, anodal-M1/DLPFC: 3). Eight were double-blinded, randomized controlled trials. Most (80%) rTMS studies that measured pain reported significant decreases, while all (100%) tDCS studies with pain measures reported significant decreases. Greater longevity of significant pain reductions was observed for excitatory M1 rTMS/tDCS.
CONCLUSION:  Studies involving excitatory rTMS/tDCS at M1 showed analogous pain reductions as well as considerably fewer side effects compared to FDA apaproved FMS pharmaceuticals. The most commonly reported side effects were mild, including transient headaches and scalp discomforts at the stimulation site. Yearly use of rTMS/tDCS regimens appears costly ($11,740 to 14,507/year); however, analyses to apapropriately weigh these costs against clinical and quality of life benefits for patients with FMS are lacking. Consequently, rTMS/tDCS should be considered when treating patients with FMS, particularly those who are unable to find adequate symptom relief with other therapies. Further work into optimal stimulation parameters and standardized outcome measures is needed to clarify associated efficacy and effectiveness.

© 2012 The Authors. Pain Practice © 2012 World Institute of Pain.
PMID 22631436  Pain Pract. 2013 Feb;13(2):131-45. doi: 10.1111/j.1533-・・・
著者: Angela Valle, Suely Roizenblatt, Sueli Botte, Soroush Zaghi, Marcelo Riberto, Sergio Tufik, Paulo S Boggio, Felipe Fregni
雑誌名: J Pain Manag. 2009;2(3):353-361.
Abstract/Text Fibromyalgia has been recognized as a central pain disorder with evidence of neuroanatomic and neurophysiologic alterations. Previous studies with techniques of noninvasive brain stimulation--transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS)--have shown that these methods are associated with a significant alleviation of fibromyalgia-associated pain and sleep dysfunction. Here we sought to determine whether a longer treatment protocol involving 10 sessions of 2 mA, 20 min tDCS of the left primary motor (M1) or dorsolateral prefrontal cortex (DLPFC) could offer additional, more long-lasting clinical benefits in the management of pain from fibromyalgia. METHODS: Forty-one women with chronic, medically refractory fibromyalgia were randomized to receive 10 daily sessions of M1, DLPFC, or sham tDCS. RESULTS: Our results show that M1 and DLPFC stimulation both display improvements in pain scores (VAS) and quality of life (FIQ) at the end of the treatment protocol, but only M1 stimulation resulted in long-lasting clinical benefits as assessed at 30 and 60 days after the end of treatment. CONCLUSIONS: This study demonstrates the importance of the duration of the treatment period, suggesting that 10 daily sessions of tDCS result in more long lasting outcomes than only five sessions. Furthermore, this study supports the findings of a similarly designed rTMS trial as both induce pain reductions that are equally long-lasting.

PMID 21170277  J Pain Manag. 2009;2(3):353-361.
著者: Nassim P Assefi, Karen J Sherman, Clemma Jacobsen, Jack Goldberg, Wayne R Smith, Dedra Buchwald
雑誌名: Ann Intern Med. 2005 Jul 5;143(1):10-9.
Abstract/Text 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.

PMID 15998750  Ann Intern Med. 2005 Jul 5;143(1):10-9.
著者: Richard E Harris, Xiaoming Tian, David A Williams, Thomas X Tian, Thomas R Cupps, Frank Petzke, Kimberly H Groner, Pinaki Biswas, Richard H Gracely, Daniel J Clauw
雑誌名: J Altern Complement Med. 2005 Aug;11(4):663-71. doi: 10.1089/acm.2005.11.663.
Abstract/Text OBJECTIVES: The objective of this study was to investigate whether typical acupuncture methods such as needle placement, needle stimulation, and treatment frequency were important factors in fibromyalgia symptom improvement. DESIGN/SETTINGS/SUBJECTS: A single-site, single-blind, randomized trial of 114 participants diagnosed with fibromyalgia for at least 1 year was performed.
INTERVENTION: Participants were randomized to one of four treatment groups: (1) T/S needles placed in traditional sites with manual needle stimulation (n = 29): (2) T/0 traditional needle location without stimulation (n = 30); (3) N/S needles inserted in nontraditional locations that were not thought to be acupuncture sites, with stimulation (n = 28); and (4) N/0 nontraditional needle location without stimulation (n = 2 7). All groups received treatment once weekly, followed by twice weekly, and finally three times weekly, for a total of 18 treatments. Each increase in frequency was separated by a 2-week washout period.
OUTCOME MEASURES: Pain was assessed by a numerical rating scale, fatigue by the Multi-dimensional Fatigue Inventory, and physical function by the Short Form-36.
RESULTS: Overall pain improvement was noted with 25%-35% of subjects having a clinically significant decrease in pain; however this was not dependent upon "correct" needle stimulation (t = 1.03; p = 0.307) or location (t = 0.76; p = 0.450). An overall dose effect of treatment was observed, with three sessions weekly providing more analgesia than sessions once weekly (t = 2.10; p = 0.039). Among treatment responders, improvements in pain, fatigue, and physical function were highly codependent (all p < or = 0.002).
CONCLUSIONS: Although needle insertion led to analgesia and improvement in other somatic symptoms, correct needle location and stimulation were not crucial.

PMID 16131290  J Altern Complement Med. 2005 Aug;11(4):663-71. doi: 10・・・
著者: David P Martin, Christopher D Sletten, Brent A Williams, Ines H Berger
雑誌名: Mayo Clin Proc. 2006 Jun;81(6):749-57. doi: 10.4065/81.6.749.
Abstract/Text 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.

PMID 16770975  Mayo Clin Proc. 2006 Jun;81(6):749-57. doi: 10.4065/81.・・・
著者: C Deluze, L Bosia, A Zirbs, A Chantraine, T L Vischer
雑誌名: BMJ. 1992 Nov 21;305(6864):1249-52.
Abstract/Text OBJECTIVE: To determine the efficacy of electroacupuncture in patients with fibromyalgia, a syndrome of unknown origin causing diffuse musculoskeletal pain.
DESIGN: Three weeks' randomised study with blinded patients and evaluating physician.
SETTING: University divisions of physical medicine and rehabilitation and rheumatology, Geneva.
PATIENTS: 70 patients (54 women) referred to the division for fibromyalgia as defined by the American College of Rheumatology.
INTERVENTIONS: Patients were randomised to electroacupuncture (n = 36) or a sham procedure (n = 34) by means of an electronic numbers generator.
MAIN OUTCOME MEASURES: Pain threshold, number of analgesic tablets used, regional pain score, pain recorded on visual analogue scale, sleep quality, morning stiffness, and patient's and evaluating physician's appreciation.
RESULTS: Seven of the eight outcome parameters showed a significant improvement in the active treatment group whereas none were improved in the sham treatment group. Differences between the groups were significant for five of the eight outcome measures after treatment.
CONCLUSIONS: Electroacupuncture is effective in relieving symptoms of fibromyalgia. Its potential in long term management should now be studied.

PMID 1477566  BMJ. 1992 Nov 21;305(6864):1249-52.
著者: Huijuan Cao, Jianping Liu, George T Lewith
雑誌名: J Altern Complement Med. 2010 Apr;16(4):397-409. doi: 10.1089/acm.2009.0599.
Abstract/Text BACKGROUND: Traditional Chinese Medicine (TCM) is popular for treatment of fibromyalgia (FM) although there is a lack of comprehensive evaluation of current clinical evidence for TCM's therapeutic effect and safety.
OBJECTIVE: To review systematically the beneficial and harmful effects of TCM therapies for FM.
METHODS: We searched six English and Chinese electronic databases for randomized clinical trials (RCTs) on TCM for treatment of FM. Two authors extracted data and assessed the trial quality independently. RevMan 5 software was used for data analyses with an effect estimate presented as mean difference (MD) with a 95% confidence interval (CI).
RESULTS: Twenty-five RCTs were identified with 1516 participants for this review. Seven trials (28%) were evaluated as having a low risk of bias and the remaining trials were identified as being as unclear or having a high risk of bias. Overall, ten trials were eligible for the meta-analysis, and data from remaining 15 trials were synthesized qualitatively. Acupuncture reduced the number of tender points (MD, -3.21; 95% CI -4.23 to -2.11; p < 0.00001, I(2) = 0%), and pain scores compared with conventional medications (MD, -1.78; 95% CI, -2.24 to -1.32; p < 0.00001; I(2) = 0%). Acupuncture showed no significant effect, with a random-effect model, compared with sham acupuncture (MD, -0.55; 95% CI, -1.35-0.24; p = 0.17; I(2) = 69%), on pain reduction. A combination of acupuncture and cupping therapy was better than conventional medications for reducing pain (MD, -1.66; 95% CI, -2.14 to -1.19; p < 0.00001; I(2) = 0%), and for improving depression scores with related to FM (MD, -4.92; 95% CI, -6.49 to -3.34; p < 0.00001; I(2) = 32%). Other individual trials demonstrated positive effects of Chinese herbal medicine on pain reduction compared with conventional medications. There were no serious adverse effects reported that were related to TCM therapies in these trials.
CONCLUSIONS: TCM therapies appear to be effective for treating FM. However, further large, rigorously designed trials are warranted because of insufficient methodological rigor in the included trials.

PMID 20423209  J Altern Complement Med. 2010 Apr;16(4):397-409. doi: 1・・・
著者: Kakushi Matsushita, Akinori Masuda, Chuwa Tei
雑誌名: Intern Med. 2008;47(16):1473-6. Epub 2008 Aug 15.
Abstract/Text 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.

PMID 18703857  Intern Med. 2008;47(16):1473-6. Epub 2008 Aug 15.
著者: K A Azad, M N Alam, S A Haq, S Nahar, M A Chowdhury, S M Ali, A K Ullah
雑誌名: Bangladesh Med Res Counc Bull. 2000 Aug;26(2):41-7.
Abstract/Text Brain tryptophan is low in fibromyalgia. Intake of protein rich in large neutral amino acids is reported to lower brain tryptophan. This study was undertaken to assess whether any reduction of such proteins by exclusion of animal protein from the diet reduced pain and morbidity in fibromyalgia patients. It was an open, randomized controlled trial. 37 subjects with fibromyalgia were enrolled in the vegetarian diet and 41 in the amitriptyline groups. The outcome was assessed with the help of frequencies of fatigue, insomnia & non-restorative sleep, pain score on a 10-point VAS and tender point count. Fatigue, insomnia and non-restorative sleep were present in 41, 26 and 32 subjects before and in 3, 0 and 0 subjects respectively at six weeks of treatment in the amitriptyline group. The pain score and tender point count were 6.2 +/- 1.9 & 16.1 +/- 2.3 before and 2.3 +/- 1.3 & 6.4 +/- 3.0 after treatment. All these differences were significant (P < 0.001). In the vegetarian diet group, fatigue, insomnia and non-restorative sleep were present in 36, 24 and 27 subjects before and in 34, 29 and 29 subjects at six weeks of treatment. The pain score and tender point count were 5.7 +/- 1.8 and 15.7 +/- 2.4 before and 5.0 +/- 1.8 & 14.7 +/- 3.6 after treatment. All these differences were insignificant except that in the pain score. The decrease in the pain score, though significant, was much smaller than that in the amitriptyline group. So, it may be concluded that vegetarian diet is a poor option in the treatment of fibromyalgia.

PMID 11508070  Bangladesh Med Res Counc Bull. 2000 Aug;26(2):41-7.
著者: Andreas Michalsen, Chenying Li, Katharina Kaiser, Rainer Lüdtke, Larissa Meier, Rainer Stange, Christian Kessler
雑誌名: Evid Based Complement Alternat Med. 2013;2013:908610. doi: 10.1155/2013/908610. Epub 2013 Jan 23.
Abstract/Text Fibromyalgia poses a challenge for therapy. Recent guidelines suggest that fibromyalgia should be treated within a multidisciplinary therapy approach. No data are available that evaluated multimodal treatment strategies of Integrative Medicine (IM). We conducted a controlled, nonrandomized pilot study that compared two inpatient treatment strategies, an IM approach that included fasting therapy and a conventional rheumatology (CM) approach. IM used fasting cure and Mind-Body-Medicine as specific methods. Of 48 included consecutive patients, 28 were treated with IM, 20 with CM. Primary outcome was change in the Fibromyalgia Impact Questionnaire (FIQ) score after the 2-week hospital stay. Secondary outcomes included scores of pain, depression, anxiety, and well being. Assessments were repeated after 12 weeks. At 2 weeks, there were significant improvements in the FIQ (P < 0.014) and for most of secondary outcomes for the IM group compared to the CM group. The beneficial effects for the IM approach were reduced after 12 weeks and no longer statistically significant with the exception of anxiety. Findings indicate that a multimodal IM treatment with fasting therapy might be superior to CM in the short term and not inferior in the mid term. Longer-term studies are warranted to assess the clinical impact of integrative multimodal treatment in fibromyalgia.

PMID 23431352  Evid Based Complement Alternat Med. 2013;2013:908610. d・・・
著者: Eveline Nüesch, Winfried Häuser, Kathrin Bernardy, Jürgen Barth, Peter Jüni
雑誌名: Ann Rheum Dis. 2013 Jun;72(6):955-62. doi: 10.1136/annrheumdis-2011-201249. Epub 2012 Jun 27.
Abstract/Text OBJECTIVES: To synthesise the available evidence on pharmacological and non-pharmacological interventions recommended for fibromyalgia syndrome (FMS).
METHODS: Electronic databases including MEDLINE, PsycINFO, Scopus, the Cochrane Controlled Trials Registry and the Cochrane Library were searched for randomised controlled trials comparing any therapeutic approach as recommended in FMS guidelines (except complementary and alternative medicine) with control interventions in patients with FMS. Primary outcomes were pain and quality of life. Data extraction was done using standardised forms.
RESULTS: 102 trials in 14 982 patients and eight active interventions (tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin noradrenaline reuptake inhibitors (SNRIs), the gamma-amino butyric acid analogue pregabalin, aerobic exercise, balneotherapy, cognitive behavioural therapy (CBT), multicomponent therapy) were included. Most of the trials were small and hampered by methodological quality, introducing heterogeneity and inconsistency in the network. When restricted to large trials with ≥100 patients per group, heterogeneity was low and benefits for SNRIs and pregabalin compared with placebo were statistically significant, but small and not clinically relevant. For non-pharmacological interventions, only one large trial of CBT was available. In medium-sized trials with ≥50 patients per group, multicomponent therapy showed small to moderate benefits over placebo, followed by aerobic exercise and CBT.
CONCLUSIONS: Benefits of pharmacological treatments in FMS are of questionable clinical relevance and evidence for benefits of non-pharmacological interventions is limited. A combination of pregabalin or SNRIs as pharmacological interventions and multicomponent therapy, aerobic exercise and CBT as non-pharmacological interventions seems most promising for the management of FMS.

PMID 22739992  Ann Rheum Dis. 2013 Jun;72(6):955-62. doi: 10.1136/annr・・・
著者: Kathrin Bernardy, Petra Klose, Angela J Busch, Ernest H S Choy, Winfried Häuser
雑誌名: Cochrane Database Syst Rev. 2013 Sep 10;(9):CD009796. doi: 10.1002/14651858.CD009796.pub2. Epub 2013 Sep 10.
Abstract/Text BACKGROUND: Fibromyalgia (FM) is a clinically well-defined chronic condition of unknown aetiology characterized by chronic widespread pain that often co-exists with sleep disturbances, cognitive dysfunction and fatigue. Patients often report high disability levels and negative mood. Psychotherapies focus on reducing key symptoms, improving daily functioning, mood and sense of personal control over pain.
OBJECTIVES: To assess the benefits and harms of cognitive behavioural therapies (CBTs) for treating FM at end of treatment and at long-term (at least six months) follow-up.
SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 8), MEDLINE (1966 to 28 August 2013), PsycINFO (1966 to 28 August 2013) and SCOPUS (1980 to 28 August 2013). We searched http://www.clinicaltrials.gov (web site of the US National Institutes of Health) and the World Health Organization Clinical Trials Registry Platform (ICTRP) (http://www.who.int/ictrp/en/) for ongoing trials (last search 28 August,2013), and the reference lists of reviewed articles.
SELECTION CRITERIA: We selected randomised controlled trials of CBTs with children, adolescents and adults diagnosed with FM.
DATA COLLECTION AND ANALYSIS: The data of all included studies were extracted and the risks of bias of the studies were assessed independently by two review authors. Discrepancies were resolved by discussion.
MAIN RESULTS: Twenty-three studies with 24 study arms with CBTs were included. A total of 2031 patients were included; 1073 patients in CBT groups and 958 patients in control groups. Only two studies were without any risk of bias. The GRADE quality of evidence of the studies was low. CBTs were superior to controls in reducing pain at end of treatment by 0.5 points on a scale of 0 to 10 (standardised mean difference (SMD) - 0.29; 95% confidence interval (CI) -0.49 to -0.17) and by 0.6 points at long-term follow-up (median 6 months) (SMD -0.40; 95% CI -0.62 to -0.17); in reducing negative mood at end of treatment by 0.7 points on a scale of 0 to 10 (SMD - 0.33; 95% CI -0.49 to -0.17) and by 1.3 points at long-term follow-up (median 6 months) (SMD -0.43; 95% CI -0.75 to -0.11); and in reducing disability at end of treatment by 0.7 points on a scale of 0 to 10 (SMD - 0.30; 95% CI -0.51 to -0.08) and at long-term follow-up (median 6 months) by 1.2 points (SMD -0.52; 95% CI -0.86 to -0.18). There was no statistically significant difference in dropout rates for any reasons between CBTs and controls (risk ratio (RR) 0.94; 95% CI 0.65 to 1.35).
AUTHORS' CONCLUSIONS: CBTs provided a small incremental benefit over control interventions in reducing pain, negative mood and disability at the end of treatment and at long-term follow-up. The dropout rates due to any reason did not differ between CBTs and controls.

PMID 24018611  Cochrane Database Syst Rev. 2013 Sep 10;(9):CD009796. d・・・
著者: A J Busch, K A R Barber, T J Overend, P M J Peloso, C L Schachter
雑誌名: Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003786. doi: 10.1002/14651858.CD003786.pub2. Epub 2007 Oct 17.
Abstract/Text BACKGROUND: Fibromyalgia (FMS) is a syndrome expressed by chronic widespread body pain which leads to reduced physical function and frequent use of health care services. Exercise training is commonly recommended as a treatment. This is an update of a review published in Issue 2, 2002.
OBJECTIVES: The primary objective of this systematic review was to evaluate the effects of exercise training including cardiorespiratory (aerobic), muscle strengthening, and/or flexibility exercise on global well-being, selected signs and symptoms, and physical function in individuals with FMS.
SEARCH STRATEGY: We searched MEDLINE, EMBASE, CINAHL, SportDiscus, PubMed, PEDro, and the Cochrane Central Register for Controlled Trials (CENTRAL, Issue 3, 2005) up to and including July 2005. We also reviewed reference lists from reviews and meta-analyses of treatment studies.
SELECTION CRITERIA: Randomized trials focused on cardiorespiratory endurance, muscle strength and/or flexibility as treatment for FMS were selected.
DATA COLLECTION AND ANALYSIS: Two of four reviewers independently extracted data for each study. All discrepancies were rechecked and consensus achieved by discussion. Methodological quality was assessed by two instruments: the van Tulder and the Jadad methodological quality criteria. We used the American College of Sport Medicine (ACSM) guidelines to evaluate whether interventions had provided a training stimulus that would effect changes in physical fitness. Due to significant clinical heterogeneity among the studies we were only able to meta-analyze six aerobic-only studies and two strength-only studies.
MAIN RESULTS: There were a total of 2276 subjects across the 34 included studies; 1264 subjects were assigned to exercise interventions. The 34 studies comprised 47 interventions that included exercise. Effects of several disparate interventions on global well-being, selected signs and symptoms, and physical function in individuals with FMS were summarized using standardized mean differences (SMD). There is moderate quality evidence that aerobic-only exercise training at recommended intensity levels has positive effects global well-being (SMD 0.44, 95% confidence interval (CI 0.13 to 0.75) and physical function (SMD 0.68, 95% CI 0.41 to 0.95) and possibly on pain (SMD 0.94, 95% CI -0.15 to 2.03) and tender points (SMD 0.26, 95% CI -0.28 to 0.79). Strength and flexibility remain under-evaluated.
AUTHORS' CONCLUSIONS: There is 'gold' level evidence (www.cochranemsk.org) that supervised aerobic exercise training has beneficial effects on physical capacity and FMS symptoms. Strength training may also have benefits on some FMS symptoms. Further studies on muscle strengthening and flexibility are needed. Research on the long-term benefit of exercise for FMS is needed.

PMID 17943797  Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003786. d・・・
著者: Antonio Fraioli, Marcello Grassi, Gioacchino Mennuni, Andrea Geraci, Luisa Petraccia, Mario Fontana, Stefano Conte, Angelo Serio
雑誌名: Ann Ist Super Sanita. 2013;49(2):219-29. doi: DOI: 10.4415/ANN_13_02_13.
Abstract/Text BACKGROUND: Fibromyalgia is characterized by chronic widespread pain, tenderness at muscle and tendon insertions point when digital pressure is applied, sleep disorders, chronic fatigue, depressive episodes, anxiety, and other functional somatic syndromes.
OBJECTIVE: The aim of this study was to determine whether balneotherapy with mineral waters and mineral-water containing mud is effective in the management of fibromyalgia.
METHODS: We conducted a systematic review of the literature regarding spa therapy in the treatment of the fibromyalgia. We searched many databases for articles published between 2000 and 2012 and we selected 7 studies among 65 articles retrieved. A total of 142 patients received balneotherapy and 129 were controls.
CONCLUSION: Study data confirms that spa therapy could improve the symptoms of fibromyalgia including pain, depression and minor symptoms.

PMID 23771266  Ann Ist Super Sanita. 2013;49(2):219-29. doi: DOI: 10.4・・・
著者: John C Deare, Zhen Zheng, Charlie C L Xue, Jian Ping Liu, Jingsheng Shang, Sean W Scott, Geoff Littlejohn
雑誌名: Cochrane Database Syst Rev. 2013 May 31;5:CD007070. doi: 10.1002/14651858.CD007070.pub2. Epub 2013 May 31.
Abstract/Text BACKGROUND: One in five fibromyalgia sufferers use acupuncture treatment within two years of diagnosis.
OBJECTIVES: To examine the benefits and safety of acupuncture treatment for fibromyalgia.
SEARCH METHODS: We searched CENTRAL, PubMed, EMBASE, CINAHL, National Research Register, HSR Project and Current Contents, as well as the Chinese databases VIP and Wangfang to January 2012 with no language restrictions.
SELECTION CRITERIA: Randomised and quasi-randomised studies evaluating any type of invasive acupuncture for fibromyalgia diagnosed according to the American College of Rheumatology (ACR) criteria, and reporting any main outcome: pain, physical function, fatigue, sleep, total well-being, stiffness and adverse events.
DATA COLLECTION AND ANALYSIS: Two author pairs selected trials, extracted data and assessed risk of bias. Treatment effects were reported as standardised mean differences (SMD) and 95% confidence intervals (CI) for continuous outcomes using different measurement tools (pain, physical function, fatigue, sleep, total well-being and stiffness) and risk ratio (RR) and 95% CI for dichotomous outcomes (adverse events). We pooled data using the random-effects model.
MAIN RESULTS: Nine trials (395 participants) were included. All studies except one were at low risk of selection bias; five were at risk of selective reporting bias (favouring either treatment group); two were subject to attrition bias (favouring acupuncture); three were subject to performance bias (favouring acupuncture) and one to detection bias (favouring acupuncture). Three studies utilised electro-acupuncture (EA) with the remainder using manual acupuncture (MA) without electrical stimulation. All studies used 'formula acupuncture' except for one, which used trigger points.Low quality evidence from one study (13 participants) showed EA improved symptoms with no adverse events at one month following treatment. Mean pain in the non-treatment control group was 70 points on a 100 point scale; EA reduced pain by a mean of 22 points (95% confidence interval (CI) 4 to 41), or 22% absolute improvement. Control group global well-being was 66.5 points on a 100 point scale; EA improved well-being by a mean of 15 points (95% CI 5 to 26 points). Control group stiffness was 4.8 points on a 0 to 10 point; EA reduced stiffness by a mean of 0.9 points (95% CI 0.1 to 2 points; absolute reduction 9%, 95% CI 4% to 16%). Fatigue was 4.5 points (10 point scale) without treatment; EA reduced fatigue by a mean of 1 point (95% CI 0.22 to 2 points), absolute reduction 11% (2% to 20%). There was no difference in sleep quality (MD 0.4 points, 95% CI -1 to 0.21 points, 10 point scale), and physical function was not reported.Moderate quality evidence from six studies (286 participants) indicated that acupuncture (EA or MA) was no better than sham acupuncture, except for less stiffness at one month. Subgroup analysis of two studies (104 participants) indicated benefits of EA. Mean pain was 70 points on 0 to 100 point scale with sham treatment; EA reduced pain by 13% (5% to 22%); (SMD -0.63, 95% CI -1.02 to -0.23). Global well-being was 5.2 points on a 10 point scale with sham treatment; EA improved well-being: SMD 0.65, 95% CI 0.26 to 1.05; absolute improvement 11% (4% to 17%). EA improved sleep, from 3 points on a 0 to 10 point scale in the sham group: SMD 0.40 (95% CI 0.01 to 0.79); absolute improvement 8% (0.2% to 16%). Low-quality evidence from one study suggested that MA group resulted in poorer physical function: mean function in the sham group was 28 points (100 point scale); treatment worsened function by a mean of 6 points (95% CI -10.9 to -0.7). Low-quality evidence from three trials (289 participants) suggested no difference in adverse events between real (9%) and sham acupuncture (35%); RR 0.44 (95% CI 0.12 to 1.63).Moderate quality evidence from one study (58 participants) found that compared with standard therapy alone (antidepressants and exercise), adjunct acupuncture therapy reduced pain at one month after treatment: mean pain was 8 points on a 0 to 10 point scale in the standard therapy group; treatment reduced pain by 3 points (95% CI -3.9 to -2.1), an absolute reduction of 30% (21% to 39%). Two people treated with acupuncture reported adverse events; there were none in the control group (RR 3.57; 95% CI 0.18 to 71.21). Global well-being, sleep, fatigue and stiffness were not reported. Physical function data were not usable.Low quality evidence from one study (38 participants) showed a short-term benefit of acupuncture over antidepressants in pain relief: mean pain was 29 points (0 to 100 point scale) in the antidepressant group; acupuncture reduced pain by 17 points (95% CI -24.1 to -10.5). Other outcomes or adverse events were not reported.Moderate-quality evidence from one study (41 participants) indicated that deep needling with or without deqi did not differ in pain, fatigue, function or adverse events. Other outcomes were not reported.Four studies reported no differences between acupuncture and control or other treatments described at six to seven months follow-up.No serious adverse events were reported, but there were insufficient adverse events to be certain of the risks.
AUTHORS' CONCLUSIONS: There is low to moderate-level evidence that compared with no treatment and standard therapy, acupuncture improves pain and stiffness in people with fibromyalgia. There is moderate-level evidence that the effect of acupuncture does not differ from sham acupuncture in reducing pain or fatigue, or improving sleep or global well-being. EA is probably better than MA for pain and stiffness reduction and improvement of global well-being, sleep and fatigue. The effect lasts up to one month, but is not maintained at six months follow-up. MA probably does not improve pain or physical functioning. Acupuncture appears safe. People with fibromyalgia may consider using EA alone or with exercise and medication. The small sample size, scarcity of studies for each comparison, lack of an ideal sham acupuncture weaken the level of evidence and its clinical implications. Larger studies are warranted.

PMID 23728665  Cochrane Database Syst Rev. 2013 May 31;5:CD007070. doi・・・
著者: Mohammed Kamal Senna, Rehab Abd-El Raouf Sallam, Hala Salah Ashour, Mohammed Elarman
雑誌名: Clin Rheumatol. 2012 Nov;31(11):1591-7. doi: 10.1007/s10067-012-2053-x. Epub 2012 Sep 5.
Abstract/Text The aim of the study was to examine whether weight reduction can result in improvement of fibromyalgia impact questionnaire (FIQ) in the patients with fibromyalgia syndrome (FMS). This study was a randomized controlled trial. Obese patients with fibromyalgia were randomly assigned to 6-month dietary weight loss (n = 41) and no weight loss (n = 42) groups. Patients were assessed at baseline and at 6 months. The primary outcome measure was FIQ. Secondary measures included the tender point (TP) examination, Beck Depression Inventory-II, and Pittsburg Sleep Quality Index. Compared to the control group, patients who underwent weight reduction obtained significantly better FIQ (p = 0.007), lower mean TP count (p = 0.015), and lower mean TP pain rating in the lower body (p < 0.001). Patients who lost weight had less depression and better sleep quality than the controls. Patients who lost weight had significantly lower interleukin 6 and C-reactive protein levels than those in the control group (p = 0.034 and p = 0.007, respectively). Weight loss in obese patients with FMS leads to significant improvement in the quality of life as shown by the decrease in the FIQ score. Depression, sleep quality, and tender point count are also significantly improved by weight loss in obese patients with fibromyalgia. Our results suggest that weight reduction should be a part of fibromyalgia treatment.

PMID 22948223  Clin Rheumatol. 2012 Nov;31(11):1591-7. doi: 10.1007/s1・・・
著者: B Alvarez Lario, J L Alonso Valdivielso, J Alegre López, C Martel Soteres, J L Viejo Bañuelos, A Marañón Cabello
雑誌名: Am J Med. 1996 Jul;101(1):54-60.
Abstract/Text PURPOSE: Sleep alterations and muscular changes suggesting hypoxia have been reported in fibromyalgia syndrome (FS) pathophysiology. We tested the hypothesis that patients with FS show falls in the oxygen saturation of hemoglobin in arterial blood (SaO2%) during sleep.
PATIENTS AND METHODS: Overnight SaO2% was measured by digital pulse oximetry in 28 randomly selected women who met 1990 American College of Rheumatology criteria for the diagnosis of FS and 15 similar controls. Considering the results of pulse oximetry and in order to evaluate the possible presence of a sleep apnea syndrome (SAS) as the reason for the nocturnal desaturations, the Epworth Sleepiness Scale (ESS) was mailed to the patients and controls. Patients and controls who had a score higher than 10 on the ESS underwent a polysomnographic study.
RESULTS: Patients with FS showed lower overnight minimum SaO2% (86.8 +/- 1.3 versus 90.7 +/- 0.9 in controls, P < 0.05), greater number of desaturations (8.3 +/- 1.8 versus 2.7 +/- 0.8 in controls, P < 0.05) and more desaturations/hour (1.3 +/- versus 0.4 +/- 0.1 in controls, P < 0.05), more night minutes in SaO2% < 92% (56.3 +/- 12.9 versus 9.1 +/- 3.8 in controls, P < 0.01) and more minutes in SaO2% < 90% (14.7 +/- 3.7 versus 2.4 +/- 1.0 in controls, P < 0.05). There were no differences between patients with FS and controls in ESS scores. Five patients (19.2%) in the FS group and 2 (15.4%) in the control group had ESS scores higher than 10. One patient had 1 control subject showed on apnea-plus-hypopnea index higher than 5 (13 and 9, respectively) in polysomnographic study.
CONCLUSIONS: Patients with FS showed small overnight falls in SaO2% and spent more time during the night in SaO2% below 92% and 90% than did the control group. These alterations that, as a whole, are not due to the presence of an associated SAS could be important in FS musculoskeletal pathophysiology.

PMID 8686716  Am J Med. 1996 Jul;101(1):54-60.
著者: Omer Nuri Pamuk, Salim Dönmez, Necati Cakir
雑誌名: Rheumatol Int. 2009 Sep;29(11):1311-4. doi: 10.1007/s00296-009-0851-5. Epub 2009 Jan 20.
Abstract/Text 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.

PMID 19152091  Rheumatol Int. 2009 Sep;29(11):1311-4. doi: 10.1007/s00・・・

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