Acupuncture for treating fibromyalgia

  • Review
  • Intervention

Authors

  • John C Deare,

    1. Compmed Health Institute, Southport, Queensland, Australia; and Traditional & Complementary Medicine Program, Health Innovations Research Institute, Discipline of Chinese Medicine, School of Health Sciences, RMIT University, Bundoora, Victoria, Australia
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  • Zhen Zheng,

    Corresponding author
    1. RMIT University, Traditional & Complementary Medicine Research Program, Health Innovations Research Institute and Discipline of Chinese Medicine, School of Health Sciences, Bundoora, Victoria, Australia
    • Zhen Zheng, Traditional & Complementary Medicine Research Program, Health Innovations Research Institute and Discipline of Chinese Medicine, School of Health Sciences, RMIT University, PO Box 71, Bundoora, Victoria, 3083, Australia. zhen.zheng@rmit.edu.au.

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  • Charlie CL Xue,

    1. RMIT University, Traditional & Complementary Medicine Research Program, Health Innovations Research Institute and Discipline of Chinese Medicine, School of Health Sciences, Bundoora, Victoria, Australia
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  • Jian Ping Liu,

    1. Beijing University of Chinese Medicine, Centre for Evidence-Based Chinese Medicine, Beijing, China
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  • Jingsheng Shang,

    1. Akupunktoren Bruno Aamo AS, Tromsoe, Norway
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  • Sean W Scott,

    1. Royal North Shore Hospital, Department of Emergency Medicine, St Leonards, New South Wales, Australia
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  • Geoff Littlejohn

    1. Monash Medical Centre, Department of Rheumatology, Clayton, VIC, Australia
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Abstract

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.

Résumé scientifique

L'acupuncture pour le traitement de la fibromyalgie

Contexte

Une personne sur cinq souffrant de fibromyalgie est traitée par acupuncture dans les deux ans suivant le diagnostic.

Objectifs

Examiner les bénéfices et l'innocuité de l'acupuncture pour la fibromyalgie.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans CENTRAL, PubMed, EMBASE, CINAHL, National Research Register, HSR Project and Current Contents, ainsi que dans les bases de données chinoises VIP et Wangfang jusqu'à janvier 2012, sans restriction de langue.

Critères de sélection

Des études randomisées et quasi-randomisées évaluant un type quelconque d'acupuncture invasive pour la fibromyalgie diagnostiquée selon les critères de l'ACR (American College of Rheumatology), et rendant compte d'un des principaux critères résultat : douleur, fonction physique, fatigue, sommeil, bien-être total, rigidité et événements indésirables.

Recueil et analyse des données

Deux paires d'auteurs ont sélectionné les essais, extrait les données et évalué le risque de biais. Les effets du traitement ont été rapportés, pour les résultats continus, sous forme de différence moyenne standardisée (DMS) avec intervalle de confiance (IC) à 95% à l'aide de différents outils de mesure (douleur, fonction physique, fatigue, sommeil, bien-être totale et rigidité), et sous forme de risque relatif (RR) avec IC à 95% pour les variables dichotomiques (événements indésirables). Nous avons regroupé les données à l'aide du modèle à effets aléatoires.

Résultats principaux

Neuf essais (soit 395 participants) ont été inclus. Toutes les études, sauf une, présentaient un faible risque de biais de sélection, cinq présentaient un risque de biais de notification sélective (favorisant un groupe de traitement), deux étaient sujettes à un biais d'attrition (en faveur de l'acupuncture), trois étaient sujettes à un biais de performance (en faveur de l'acupuncture) et une à un biais de détection (en faveur de l'acupuncture). Trois études avaient utilisé l'électro-acupuncture (EA), alors que les autres avaient utilisé l'acupuncture manuelle (AM) sans stimulation électrique. Toutes les études avaient utilisé la « formule acupuncture », sauf une qui avait utilisé des points de déclenchement.

Les résultats de faible qualité d'une étude (13 participants) montraient que, un mois après le traitement, l'EA avait amélioré les symptômes sans susciter d'événements indésirables. La douleur moyenne dans le groupe témoin sans traitement était de 70 points sur une échelle de 100 points, et l'EA avait réduit en moyenne la douleur de 22 points (intervalle de confiance (IC) à 95 % 4 à 41), soit 22% d'amélioration absolue. Le bien-être global dans le groupe témoin était de 66,5 points sur une échelle de 100 points et l'EA avait amélioré en moyenne le bien-être de 15 points (IC 95% 5 à 26 points). La rigidité dans le groupe de contrôle était de 4,8 points sur une échelle de 0 à 10 et l'EA avait réduit en moyenne la rigidité de 0,9 points (IC 95% 0,1 à 2 points ; réduction absolue de 9% ; IC 95% de 4% à 16%). La fatigue était de 4,5 points (échelle de 10 points) sans traitement et l'EA avait réduit en moyenne la fatigue de 1 point (IC 95% 0,22 à 2 points), réduction absolue de 11% (2% à 20%). Il n'y avait pas de différence dans la qualité du sommeil (DM 0,4 points ; IC 95% -1 à 0,21 points, échelle de 10 points). Il n'avait pas été rendu compte de la fonction physique.

Les résultats de qualité moyenne de six études (286 participants) indiquaient que l'acupuncture (EA ou AM) n'était pas meilleure que l'acupuncture factice, à l'exception d'une baisse de la rigidité à un mois. L'analyse en sous-groupes de deux études (104 participants) a mis en évidence des bénéfices de l'EA. La douleur moyenne avec le traitement factice était de 70 points, sur une échelle de 0 à 100, et l'EA avait réduit la douleur de 13% (5% à 22%) (DMS -0,63 ; IC 95% -1,02 à -0,23). Le bien-être global avec le traitement factice était de 5,2 points, sur une échelle de 10 points, et l'EA avait amélioré le bien-être : DMS 0,65 ; IC 95% 0,26 à 1,05 ; amélioration absolue de 11% (4% à 17%). L'EA améliorait le sommeil de 3 points, sur une échelle de 0 à 10, dans le groupe de traitement factice : DMS 0,40 (IC 95% 0,01 à 0,79) amélioration absolue de 8% (0,2% à 16%). Les résultats de mauvaise qualité d'une étude suggéraient que le groupe d'AM avait une moins bonne fonction physique : la fonction moyenne dans le groupe de traitement factice était de 28 points (échelle de 100 points) et le traitement avait dégradé en moyenne la fonction de 6 points (IC 95% -10,9 à -0,7). Les résultats de mauvaise qualité de trois essais (289 participants) ne laissent pas apparaitre de différence dans les événements indésirables entre l'acupuncture réelle (9%) et l'acupuncture factice (35%) : RR 0,44 (IC 95% 0,12 à 1,63).

Les résultats de qualité moyenne d'une étude (58 participants) montrent qu'en comparaison avec le seul traitement standard (antidépresseurs et exercice), le traitement d'appoint d'acupuncture avait réduit la douleur un mois après le traitement : La douleur moyenne était de 8 points, sur une échelle de 0 à 10, dans le groupe de traitement standard et l'acupuncture d'appoint avait réduit la douleur de 3 points (IC 95% -3,9 à -2,1), une réduction absolue de 30% (21% à 39%). Deux personnes traitées par acupuncture avaient fait état d'événements indésirables ; il n'y en avait eu aucun dans le groupe de contrôle (RR 3,57 ; IC 95% 0,18 à 71,21). Il n'était pas rendu compte du bien-être global, du sommeil, de la fatigue et de la rigidité. Les données sur la fonction physique n'étaient pas utilisables.

Les résultats de mauvaise qualité d'une étude (38 participants) montraient un avantage à court terme de l'acupuncture par rapport aux antidépresseurs dans le soulagement de la douleur : la douleur moyenne était de 29 points (échelle de 0 à 100) dans le groupe à antidépresseurs et l'acupuncture avait réduit la douleur de 17 points (IC 95% -24,1 à -10,5). Il n'avait pas été rendu compte d'autres critères de résultat ni des événements indésirables.

Les résultats de qualité moyenne d'une étude (41 participants) indiquaient qu'il n'y avait pas différence entre l'aiguilletage profond avec et sans deqi pour la douleur, la fatigue, la fonction ou les événements indésirables. Il n'avait pas été rendu compte d'autres critères de résultat.

Quatre études n'avaient rapporté aucune différence entre l'acupuncture et le contrôle ou d'autres traitements décrits, lors du suivi à six ou sept mois.

Aucun événement indésirable grave n'avait été signalé, mais il n'y avait pas eu suffisamment d'événements indésirables pour être certain quant aux risques.

Conclusions des auteurs

Il y a des preuves de niveau faible à modéré qu'en comparaison avec l'absence de traitement ou le traitement standard, l'acupuncture améliore la douleur et la rigidité chez les personnes atteintes de fibromyalgie. Il y a des preuves de niveau modéré que l'effet de l'acupuncture ne diffère pas de celui de l'acupuncture factice quant à la réduction de la douleur ou de la fatigue, ou à l'amélioration du sommeil ou du bien-être global. L'EA est probablement meilleure que l'AM pour la réduction de la douleur et de la rigidité, ainsi que pour l'amélioration du bien-être global, du sommeil et de la fatigue. L'effet dure jusqu'à un mois, mais ne subsiste pas au bout de six mois de suivi. L'AM n'améliore probablement pas la douleur ou le fonctionnement physique. L'acupuncture semble sûre. Les personnes atteintes de fibromyalgie peuvent envisager d'utiliser l'EA, seule ou conjointement à de l'exercice et des médicaments. La petite taille des effectifs, la rareté des études pour chaque comparaison et l'absence d'une acupuncture factice idéale affaiblissent le niveau des preuves et leurs implications cliniques. Il conviendra de mener des études à plus grande échelle.

초록

섬유근통의 침 치료

배경

섬유근통 환자 5명 중 1명은 진단 후 2년 이내에 침 치료를 받는다.

목적

섬유근통의 침 치료 효과와 안전성 평가

검색 전략

센트럴(CENTRAL), 펍메드(PubMed), 엠베이스(EMBASE), CINAHL, 국가연구등록(National Research Register), 의료 서비스 연구(HSR protect and current contents[p1]) 그리고 중국 데이터베이스 VIP 와 왕팡 등에서 2012년 1월까지 언어제한 없이 검색하였다. [p1]Health Service Research: 의료 서비스 연구

선정 기준

1) 미국 류마티스학회 (ACR) 기준에 따른섬유근통 환자에 대한 모든 유형의 자입형 침 치료를 적용한 연구 2) 무작위 또는 유사-무작위 대조 연구 3) 통증, 신체 기능, 피로, 수면, 전반적 안녕감, 강직, 이상반응 등 주요 평가항목 중 하나라도 측정한 연구 위 3가지를 모두 만족할 경우 선정 대상으로 하였다.

자료 수집 및 분석

저자들은 두 명씩 짝을 이루어 각각 임상시험 선택, 자료 추출, 비뚤림 위험 평가를 수행했다. 치료효과는 여러 항목 (통증, 신체기능, 피로, 수면, 전반적 안녕감과 강직) 의 연속형 결과에 대해 표준화된 평균값차이 (SMD) 와 95 % 신뢰구간 (CI) 을, 이분형 결과 (이상반응) 는 상대위험도 (RRs) 와 95% 신뢰구간을 사용하여 보고하였다. 무작위-효과 모형을 이용하여 치료 효과를 추산하였다.

주요 결과

임상연구 9개 (참여자 395명)를 분석하였다. 이 중 8개 연구에서는 선택 비뚤림 위험이 낮았다. 이외에는 선택적 보고 비뚤림 위험 (5개 연구, 침 또는 대조치료가 좋다는 결과 보고), 탈락 비뚤림 위험 (2개 연구, 침 치료가 좋다는 결과 보고), 수행 비뚤림 위험 (3개 연구, 침 치료가 좋다는 결과 보고), 평가 비뚤림 (1개 연구, 침 치료가 좋다는 결과 보고) 등이 있었다. 3개 연구에서 전침을 사용하였고, 나머지 5개 연구에서는 전기 자극 없는 수기 침을 사용하였다. 한 연구에서는 발통점에 자침하였고, 나머지 8개 연구에서는 미리 정해진 경혈 처방에 따라 침을놓았다.

한 연구 (참여자 13명) 에서는 전침 치료 한 달 후 이상반응 없이 증상 개선을 보였지만 근거의 질은 낮았다. 치료하지 않은 대조군의 통증은 평균 100점 만점에 70점 이었다; 전침은 평균 22점 (95% CI 4,41점) 통증을 감소키거나, 또는 22%의 절대적 개선을 보였다. 대조군의 전반적 안녕감은100점 만점에 66.5점 이었다; 전침은안녕감 지수를 평균 15점 (95% CI 5,26점) 향상시켰다. 대조군의 강직은 10점 중 4.8점 이었다. 전침은 강직 정도를 평균 0.9점 감소시켰다 (95% CI 0.1,2점 ; 절대 감소율 9%, 95% CI 4,16%). 피로는 치료하지 않은 대조군에서 4.5점 (10점 만점)이었다; 전침은 피로를 평균 1점 (95% CI 0.22,2점), 절대적 감소는 11% (95% CI 2,20%) 감소시켰다. 수면의 질 (평균차 0.4점, 95% CI –1,0.21점, 10 점 만점) 과 신체 기능에서는 치료군과 대조군의 차이가 없었다.

6개 연구 (참여자 286명) 에서, 침 (전침 또는 수기침) 치료는 치료 한 달 후 강직이 덜하다는 것 외에는 거짓 침 보다 더 나은 것이 없었으며, 이 근거의 질은 중간 정도였다. 두 연구 (참여자 104명) 의 하위 그룹 분석은 전침이 효과적일 가능성을 제기하였다. 거짓 침 치료 후 통증은 100점 만점에 평균 70 점 이었다; 전침은 통증을 13% (5, 22%) 감소시켰다 (SMD -0.63, 95% CI -1.02 to -0.23). 전반적 안녕감은 거짓 침 치료 후 10점 만점에 4.1점 이었으나 전침 후 결과가 더 좋았다 (SMD 0.65, 95% CI 0.26, 1.05; 절대 개선율 11%, 95% CI 4, 17%). (역주1) 전침은 수면의 질을 개선시켰다 (SMD 0.40, 95% CI 0.01, 0.79; 절대 개선율 8%, 95% CI 0.2, 16%; 거짓 침 군의 10점 만점 상 3점 대비). 근거의 질이 낮은 한 연구는, 수기 침 치료를 받은 군에서 신체 기능 지수가 더 낮았음을 보고하였다. 거짓 침 군의 평균 기능 점수는 100점 만점에 28점이었는데, 침 치료 군은 이보다 평균 6점 낮았다 (95% CI -10.9, -0.7). 낮은 수준의 근거를 제시한 세 개의 연구 (203명 참여자 는 진짜 침 (9%) 과 거짓 침 (35%) 간 이상 반응의 차이는 없다고 하였다 (RR 0.44; 95% CI 0.12,1.63). (역주2)

중간 질의 근거를 제시한 한 연구 (58명의 참가자) 는, 표준 치료 (항우울제와 운동) 에 침 치료를 추가하면 치료 후 1개월 시점 통증이 줄어들었음을 보고하였다. 표준 치료 군에서는 평균 통증이 10점 만점 상 8점인데, 침 치료 군에서는 이보다 3점 (95% CI -3.9, -2.1) 줄었으며 이는 30% 절대 감소에 해당한다 (21%, 39%). 침 치료군 중 두 명이 이상 반응을 보고하였고 대조군에서는 아무도 이상반응을 보고하지 않았다 (RR 3.57; 95% CI 0.18, 71.21). 전반적 안녕감, 수면, 피로, 강직, 신체 기능 등의 결과변수는 보고되지 않았다.

낮은 질의 근거를 제시한 한 연구 (38명의 참가자) 는, 침 치료가 항우울제 보다 단기적 통증 완화 효과가 크다고 보고하였다. 통증은 항우울제 투여 군에서 평균 29점(100점 만점) 이었으나 침 치료 군에서는 이보다17점 (95% CI –24.1, -10.5) 더 낮았다. 통증 외 다른 평가결과나 이상 반응은 보고되지 않았다.

중간 수준의 근거를 제시한 한 연구 (참가자 41명) 는 침을 깊이 놓은 후 득기 반응을 얻은 군과 득기 반응을 얻지 않은 군 간 통증, 피로, 신체 기능 또는 이상반응에서 차이가 없다고 하였다. 다른 평가결과는 보고되지 않았다.

네 개의 연구는 6~7개월 추적조사에서 침 치료군과 대조군 또는 다른 치료군 사이에 차이가 없었음을 보고하였다.

중대 이상반응은 보고되지 않았으나, 이상반응의 위험이 어느 정도인지 알기에는 불충분했다.

연구진 결론

치료하지 않거나 표준 치료만 한 것에 비해 침 치료가 섬유근통 환자의 통증과 강직을 개선시킨다는 낮음-중간 수준의근거가 있다. 통증 또는 피로 경감, 수면 또는 전반적 안녕감개선 측면에서 침의 효과는 거짓 침과 차이가 없다는 중간수준의 근거가있다. 전침은 통증과 강직 감소,전반적 안녕감, 수면, 피로의 개선면에서 수기 침보다 더 효과가 좋을 수도 있다. 효과가 한 달까지는 지속되었지만, 6 개월 후에는 유지되지 않았다. 수기 침은 통증이나 신체 기능을 개선시키지 못하는 것으로 보인다. 침 치료는 안전한 것으로 보인다. 섬유근통 환자들에게 전침 단독 적용 혹은 운동 및 투약에 부가적 적용을 고려해 볼 수 있다. 적은 표본 수, 치료군과 대조군 간 비교 유형별 자료의 부족, 거짓 침의 기술적 한계 등은 근거의 수준과 그 임상적 의의를 약화시킨다. 보다 큰 규모의 연구가 필요하다.

역주

[역주1] 영어원문에는 '5.2 point' 라고 되어 있으나 본문과 대조확인 결과 오류가 있어 수정사항을 반영하여 '4.1점' 으로 번역하였다. [역주2] 영어원문에는 '289 participants' 라고 되어 있으나 본문과 대조확인 결과 오류가 있어 수정사항을 반영하여 '203명 참여자' 로 번역하였다. [역주3] 이 리뷰는 강민정 님 (부산대학교 한의학전문대학원), 김건형 님 (부산대학교 한의학전문대학원) 이 번역하였습니다. 번역 내용과 관련한 문의점은 강민정(oriental1@nate.com) 님에게 연락 주십시오.

アブストラクト

線維筋痛症治療のための鍼治療

背景

線維筋痛症患者の5人に1人は、診断から2年以内に鍼治療を受けている。

目的

線維筋痛症のための鍼治療の効果と安全性の調査すること。

検索戦略

CENTRAL、PubMed、EMBASE、CINAHL、National Research Register、HSR Project and Current Contents、the Chinese databases VIP、Wangfang を言語制限無しで2012年1月分まで検索した。

選択基準

American College of Rheumatology (ACR)の基準に従って診断された線維筋痛症に対するあらゆるタイプの侵襲的鍼治療を評価し、疼痛、身体機能、疲労、睡眠、総合的な健康状態、こわばり、有害事象などのあらゆる主なアウトカムを報告したランダム化および準ランダム化試験。

データ収集と分析

2名の著者がペアで試験を選択し、データを抽出し、バイアスのリスクを評価した。治療効果は標準化平均差(SMD)で、異なった計測ツール(疼痛、身体機能、疲労、睡眠、総合的な健康状態、こわばり)を使った継続的アウトカムを95%の信頼区間(CI)で、二値アウトカム(有害事象)をリスク比(RR)および95%CIで報告した。変量効果モデルを使いデータをプールした。

主な結果

9件の試験(395例)を選択した。1件を除くすべての試験で選択バイアスのリスクは低かったが、5件に選択記録バイアス(いずれかの治療群)、2件に摩耗バイアス(鍼治療群)、3件にパフォーマンス・バイアス(鍼治療群)、1件に検出バイアス(鍼治療群)があった。3件の試験では、電気刺激を行わない手技による鍼治療(MA)、残り1件の試験では刺激と電気鍼治療(EA)を併用した。トリガーポイントを使った1件を除いて「鍼治療処方」を用いた。

1件(13例)で質の低いエビデンスがあり、治療1カ月の時点でEAによる症状改善が認められ、有害事象の発現がなかったこと示されてた。無治療対照群の平均疼痛は、100ポイントスケールで70であったが、EAにより平均22ポイント(95% 信頼区間 (CI) 4~41)疼痛が緩和、あるいは22%の絶対的改善を示した。対照群の総合的な健康状態は、100ポイントスケールで66.5ポイントであり、EAにより健康状態は平均15ポイント改善した(95% CI 5~26ポイント)。対照群のこわばりは、0~10ポイントの4.8ポイントで、EAにより平均0.9ポイント減少した(95% CI 0.1 ~2 ポイント; 絶対的減少 9%, 95% CI 4%~16%)。疲労は治療前4.5ポイント(10ポイントスケール)であったが、EAにより平均1ポイント減少し(95% CI 0.22~2 ポイント)、11%で絶対的減少(2%~20%)した。睡眠の質では差がなく(MD 0.4 ポイント, 95% CI -1~0.21ポイント, 10ポイントスケール)、身体機能は報告されなかった。

6件(286例)で中程度の質のエビデンスがあり、鍼治療(EAまたはMA)は治療1カ月の時点では、こわばりは減少したものの偽鍼治療ほど効果がないことがわかった。2件(104例)のサブグループ解析ではEAの利益が示された。偽治療の平均疼痛は0~100ポイントスケールで70ポイントであり、EAにより疼痛は13%(5%~22%)減少した(SMD -0.63, 95% CI -1.02~-0.23)。偽治療の総合的な健康状態は10ポイントスケールで5.2ポイントであり、EAにより改善した:SMD 0.65, 95% CI 0.26~1.05; 絶対的改善11% (4%~17%)。EAはまた、偽治療の睡眠を10ポイントスケールで3ポイントから改善した:SMD 0.40 (95% CI 0.01~0.79); 絶対的改善 8% (0.2%~16%)。 1件に質の低いエビデンスがあり、MA群は身体機能が悪化したことを示した。偽治療群での平均機能は28ポイント(100ポイントスケール)で、治療により平均6ポイント機能が悪化した(95% CI -10.9~-0.7)。3件(289例)に質の低いエビデンスがあり、治療群(9%)と偽治療群(35%)の有害事象には差がないことが示された; RR 0.44 (95% CI 0.12~1.63)。

1件(58例)で中程度の質のエビデンスがあり、標準治療と単独比較した場合(抗うつ剤および運動)治療1カ月の時点で併用鍼治療で疼痛の減少が見られた。平均疼痛は0~10ポイントスケールで治療群では8ポイントであり、治療により3ポイント減少した(95% CI -3.9~-2.1), 30% 絶対的減少(21%~39%)。鍼治療群の2例に有害事象の報告があった。対照群は0であった(RR 3.57; 95% CI 0.18~71.21)。総合的な健康状態、睡眠、疲労、こわばりは報告がなかった。身体機能データは無効であった。

1件(38例)に質の低いエビデンスがあり、抗うつ剤に対する鍼治療で疼痛緩和において短期的な利益が見られた。抗うつ剤群で平均疼痛は29ポイント(0~100ポイントスケール)であり、鍼治療群では17ポイント疼痛が減少した(95% CI -24.1~-10.5)。その他のアウトカムまたは有害事象は報告がなかった。

1件(41例)で中程度の質のエビデンスがあり、深部穿刺において得気の有無に関係なく、疼痛、疲労、機能、有害事象で差異は見られなかった。 その他のアウトカムは報告がなかった。

4件の試験で、6~7カ月のフォローアップで鍼治療群と対照群またはその他の治療群で差がないことがわかった。

重篤な有害事象は報告されなかったが、リスクを明確にする有害事象も十分ではなかった。

著者の結論

無治療、標準治療と比べて鍼治療では線維筋痛症患者における疼痛およびこわばりが改善するという低~中程度の質のエビデンスがある。疼痛、疲労の緩和または睡眠、総合的な健康状態の改善において、鍼治療の効果は偽鍼治療と差がない、という中程度のエビデンスがある。EAは疼痛、こわばりの緩和および総合的な健康状態、睡眠、疲労の改善に対して、MAより効果がある可能性がある。その効果は1カ月持続するが、6カ月のフォローアップまでは持続しない。MAが疼痛または身体機能を改善する可能性はない。鍼治療は安全であるように思われる。線維筋痛症の患者の治療にはEA単独または運動および薬物との併用が考えられる。症例数が小さいうえ、それぞれを比較した試験数が少なく、また理想的な偽鍼治療がないので臨床上の意義およびエビデンスのレベルは低い。より規模の大きい試験が必要である。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2016.1.2]
《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

Plain language summary

Acupuncture for fibromyalgia

This summary of a Cochrane review presents what we know from research about the effect of acupuncture on fibromyalgia.

The review shows that in people with fibromyalgia:

- acupuncture is probably better than non-acupuncture treatment in reducing pain and stiffness and improving overall well-being and fatigue;

- acupuncture with electrical stimulation is probably better than needling alone in reducing pain and stiffness, and improving overall well-being, sleep and fatigue;

- acupuncture without electrical stimulation probably does not reduce pain or improve fatigue, overall well-being or sleep; and

- acupuncture probably enhances the effect of drugs and exercise on pain.

What is fibromyalgia and what is acupuncture?

When you have fibromyalgia, you experience pain in many sites of your body, with a range of other symptoms including joint stiffness, sleep disturbance, fatigue and mood disorders, which affect the quality of life. There is no cure and few treatment options for fibromyalgia at present, so the treatments aim to relieve pain and improve your well-being and the ability to function.

Acupuncture is a form of Chinese medicine and uses fine needles to stimulate certain areas of the body, called acupuncture points. Acupuncture is commonly used by people to reduce various forms of pain. It works by reducing inflammation, stimulating the release of your body's own pain killer, that is endorphins, and calming your brain. It is safe with few, short-lasting side effects. If supported by the overall body of evidence, acupuncture will offer much needed effective symptom relief for fibromyalgia.

Best estimate of what happens to people with fibromyalgia who use acupuncture:

Comparing acupuncture with sham interventions

Pain (higher scores mean worse or more severe pain)

- People who had needle acupuncture with electrical stimulation rated their pain to be 13 points lower on a 100-point scale (absolute improvement) after six sessions of treatment.

- People who had fake acupuncture rated their pain to be 70 on a scale of 0 to 100 at the end of treatment.

- People who had needle acupuncture with electrical stimulation rated their pain to be 57.

Physical function (higher scores mean better function):

- People who used needle acupuncture without electrical stimulation rated their physical function to be six points lower (absolute deterioration).

- People who had fake treatment rated their physical function to be 28 on a scale of 0 to 100 at the end of treatment.

- People who had needle acupuncture without electrical stimulation rated their physical function to be 22.

- There are no data on needle acupuncture with electrical stimulation.

Global well-being rated by participants (higher scores mean better function):

- People who had needle acupuncture with electrical stimulation rated their well-being to be 11 points higher (absolute improvement).

- People who had fake treatment rated their well-being to be 41 on a scale of 0 to 100 at the end of treatment.

- People who had needle acupuncture with electrical stimulation rated their well-being to be 52.

Sleep (higher scores mean better sleep):

- People who used acupuncture rated their sleep to be eight points higher (absolute improvement).

- People who had fake treatment rated their sleep to be 30 on a scale of 0 to 100 at the end of treatment.

- People who had needle acupuncture with electrical stimulation rated their sleep to be 38.

Fatigue (higher scores mean more severe fatigue):

- People who had needle acupuncture with electrical stimulation rated their fatigue to be 15 points lower (absolute improvement).

- People who had fake treatment rated their fatigue to be 78 on a scale of 0 to 100.

- People who had needle acupuncture with electrical stimulation rated their fatigue to be 63.

Stiffness (higher scores mean more severe stiffness):

- People who had needle acupuncture with electrical stimulation rated their stiffness to be nine points lower (absolute improvement).

- People who had fake treatment rated their stiffness to be 66 on a scale of 0 to 100 at the end of treatment.

- People who had needle acupuncture with electrical stimulation rated their stiffness to be 57.

- Data on needle acupuncture without electrical acupuncture were not available.

Adverse effects:

- One in six people who had acupuncture reported adverse events.

- One in three people who had fake treatments reported adverse events.

- Overall, such events were minor and lasted less than one day.

Acupuncture as an adjunct therapy

Pain (higher scores mean more severe pain):

- People who had needle acupuncture in addition to a standard treatment of exercise and medication (antidepressants) rated their pain to be 30 points lower on a scale of 0 to 100 (absolute improvement) after 20 sessions of acupuncture.

- People who had standard therapy rated their pain to be 80 on a scale of 0 to 100 at the end of treatment.

- People who had additional acupuncture treatment rated their pain to be 50.

Acupuncture compared with antidepressants

Pain (higher scores mean more severe pain):

- People who had acupuncture rated their pain to be 17 points lower (absolute improvement) after 28 sessions of acupuncture.

- People who had antidepressants rated their pain to be 29 on a scale of 0 to 100 at the end of treatment.

- People who had acupuncture treatment rated their pain to be 12.

Comparing acupuncture with non-acupuncture (wait list)

- People who had needle acupuncture with electrical stimulation rated 23, 11 and 9 points lower on a 100-point scale for pain, fatigue and stiffness, respectively; and reported their global well-being to be 15 points better than those who did not have acupuncture.

Résumé simplifié

L'acupuncture pour le traitement de la fibromyalgie

Ce résumé d'une revue Cochrane présente l’état de nos connaissances découlant des recherches portant sur l'effet de l'acupuncture sur la fibromyalgie.

Cette revue démontre que chez les patients souffrant de fibromyalgie :

- l'acupuncture est probablement meilleure que le non traitement par acupuncture pour la réduction de la douleur et de la rigidité, et l'amélioration du bien-être général et de la fatigue ;

- l'acupuncture avec stimulation électrique est probablement meilleure que le seul aiguilletage pour la réduction de la douleur et de la rigidité, et l'amélioration du bien-être général, du sommeil et de la fatigue ;

- l'acupuncture sans stimulation électrique ne réduit probablement pas la douleur ni n'améliore la fatigue, le bien-être général ou le sommeil ; et

- l'acupuncture accroit probablement l'effet des médicaments et de l'exercice physique sur la douleur.

Définition de la fibromyalgie et de l'acupuncture

Lorsque vous souffrez de fibromyalgie, vous ressentez des douleurs en de nombreux endroits de votre corps, avec toute une gamme d'autres symptômes comme la raideur articulaire, les troubles du sommeil, la fatigue et les troubles de l'humeur, qui affectent la qualité de vie. Il n'existe à l'heure actuelle aucun remède et peu d'options de traitement pour la fibromyalgie, les traitements visent donc à soulager la douleur et à améliorer votre bien-être et votre capacité à fonctionner.

L'acupuncture est une forme de médecine chinoise qui utilise de fines aiguilles pour stimuler certaines zones du corps, appelées points d'acupuncture. L'acupuncture est couramment utilisée pour réduire diverses formes de douleur. Elle agit en réduisant l'inflammation, en stimulant la libération d'analgésiques par votre corps (les endorphines) et en calmant votre cerveau. Elle est sûre, avec quelques effets secondaires de courte durée. Si elle est étayée par l'ensemble des données disponibles, l'acupuncture pourra offrir le soulagement efficace tant attendu des symptômes de la fibromyalgie.

Meilleure estimation des conséquences liées à l'usage de l'acupuncture par les patients souffrant de fibromyalgie :

Comparaison de l'acupuncture avec des interventions factices

Douleur (des scores plus élevés signifient une douleur plus pénible ou plus accentuée)

- Les personnes ayant bénéficié de l'acupuncture à aiguilles avec stimulation électrique avaient attribué à leur douleur une note plus basse de 13 points, sur une échelle de 100 points, (amélioration absolue) après six séances de traitement.

- Les personnes à qui on avait fait de l'acupuncture factice avaient attribué à leur douleur une note de 70, sur une échelle de 0 à 100, à la fin du traitement.

- Les personnes ayant bénéficié de l'acupuncture à aiguilles avec stimulation électrique avaient attribué à leur douleur une note de 57.

Fonction physique (des scores plus élevés signifient une meilleure fonction) :

- Les personnes ayant utilisé l'acupuncture à aiguilles sans stimulation électrique avaient attribué à leur fonction physique une note plus basse de six points (détérioration absolue).

- Les personnes ayant reçu un traitement factice avaient attribué à leur fonction physique une note de 28, sur une échelle de 0 à 100, à la fin du traitement.

- Les personnes ayant bénéficié de l'acupuncture à aiguilles sans stimulation électrique avaient attribué à leur fonction physique une note de 22.

- Il n'y a pas de données sur l'acupuncture à aiguilles avec stimulation électrique.

Bien-être global estimé par les participants (des scores plus élevés signifient un plus grand bien-être) :

- Les personnes ayant bénéficié de l'acupuncture à aiguilles avec stimulation électrique avaient attribué à leur bien-être une note plus élevée de 11 points (amélioration absolue).

- Les personnes ayant reçu un traitement factice avaient attribué à leur bien-être une note de 41, sur une échelle de 0 à 100, à la fin du traitement.

- Les personnes ayant bénéficié de l'acupuncture à aiguilles avec stimulation électrique avaient attribué à leur bien-être une note de 52.

Sommeil (des scores plus élevés signifient un meilleur sommeil) :

- Les personnes ayant utilisé l'acupuncture avaient attribué à leur sommeil une note plus élevée de huit points (amélioration absolue).

- Les personnes ayant reçu un traitement factice avaient attribué à leur sommeil une note de 30, sur une échelle de 0 à 100, à la fin du traitement.

- Les personnes ayant bénéficié de l'acupuncture à aiguilles avec stimulation électrique avaient attribué à leur sommeil une note de 38.

Fatigue (des scores plus élevés signifient une fatigue plus sévère) :

- Les personnes ayant bénéficié de l'acupuncture à aiguilles avec stimulation électrique avaient attribué à leur fatigue une note plus basse de 15 points (amélioration absolue).

- Les personnes ayant reçu un traitement factice avaient attribué à leur fatigue une note de 78, sur une échelle de 0 à 100.

- Les personnes ayant bénéficié de l'acupuncture à aiguilles avec stimulation électrique avaient attribué à leur fatigue une note de 63.

Rigidité (des scores plus élevés signifient une rigidité plus sévère) :

- Les personnes ayant bénéficié de l'acupuncture à aiguilles avec stimulation électrique avaient attribué à leur rigidité une note plus basse de neuf points (amélioration absolue).

- Les personnes ayant reçu un traitement factice avaient attribué à leur rigidité une note de 66, sur une échelle de 0 à 100, à la fin du traitement.

- Les personnes ayant bénéficié de l'acupuncture à aiguilles avec stimulation électrique avaient attribué à leur rigidité une note de 57.

- Il n'y avait pas de données disponibles sur l'acupuncture à aiguilles sans acupuncture électrique.

Effets indésirables :

- Une personne sur six ayant reçu de l'acupuncture avait fait état d'événements indésirables.

- Une personne sur trois ayant reçu un traitement factice avait fait état d'événements indésirables.

- Dans l'ensemble, ces événements étaient mineurs et duraient moins d'une journée.

L'acupuncture comme traitement d'appoint

Douleur (des scores plus élevés signifient une douleur plus accentuée) :

- Les personnes ayant bénéficié de l'acupuncture à aiguilles en complément à un traitement standard d'exercices physiques et de médicaments (antidépresseurs) avaient attribué à leur douleur une note plus basse de 30 points, sur une échelle de 0 à 100, (amélioration absolue) après 20 séances d'acupuncture.

- Les personnes ayant reçu le traitement standard avaient attribué à leur douleur une note de 80, sur une échelle de 0 à 100, à la fin du traitement.

- Les personnes ayant bénéficié d'un traitement d'acupuncture complémentaire avaient attribué à leur douleur une note de 50.

Comparaison de l'acupuncture et des antidépresseurs

Douleur (des scores plus élevés signifient une douleur plus accentuée) :

- Les personnes ayant bénéficié de l'acupuncture avaient attribué à leur douleur une note plus basse de 17 points (amélioration absolue) après 28 séances d'acupuncture.

- Les personnes ayant reçu des antidépresseurs avaient attribué à leur douleur une note de 29, sur une échelle de 0 à 100, à la fin du traitement.

- Les personnes ayant bénéficié d'un traitement d'acupuncture avaient attribué à leur douleur une note de 12.

Comparaison de l'acupuncture à l'absence d'acupuncture (liste d'attente)

- Les personnes ayant bénéficié de l'acupuncture à aiguilles avec stimulation électrique avaient attribué des notes inférieures de 23, 11 et 9 points, sur une échelle de 100 points, à leur douleur, fatigue et rigidité, respectivement ; ils avaient aussi attribué à leur bien-être global 15 points de plus que ceux qui n'avaient pas eu d'acupuncture.

Notes de traduction

Traduit par: French Cochrane Centre 3rd June, 2013
Traduction financée par: Pour la France : Minist�re de la Sant�. Pour le Canada : Instituts de recherche en sant� du Canada, minist�re de la Sant� du Qu�bec, Fonds de recherche de Qu�bec-Sant� et Institut national d'excellence en sant� et en services sociaux.

쉬운 말 요약

섬유근통의 침 치료

이 코크란 리뷰 요약본은 섬유근통의 침 치료 효과에 대한 연구 결과를 제시한다.

연구 결과, 섬유근통 환자들에게

- 침 치료가 침 이외의 다른 치료에 비해 통증, 강직도 경감과 전반적 안녕감, 피로 호전 측면에서 아마도 더 좋은 효과를 나타내는 것으로 보인다;

전침은 전기 자극을 하지 않는 침 (수기 침) 에 비해 통증, 강직도 경감과 전반적 안녕감, 수면, 피로 호전 측면에서 아마도 더 좋은 효과를 나타내는 것으로 보인다.

전기 자극을 하지 않는 침은 통증 경감, 수면, 피로 호전 측면에서 아마도 효과가 없는 것으로 보인다.

침 치료는 통증 경감 측면에서 약물 및 운동의 효과를 아마도 향상시키는 것으로 보인다.

섬유근통이란? 침 치료란?

섬유근통 환자는 몸의 여러 곳에 통증을 느끼며, 관절 강직, 수면 장애, 피로감 및 기분 장애 등 삶의 질에 영향을 미치는 다양한 증상을 함께 경험한다. 완치란 없으며 현재 시점에서는 정립된 치료법도 거의 없어서, 섬유근통 환자의 치료는 통증 경감 및 안녕감과 기능 향상을 주 목적으로 한다.

침은 중의학 치료 중 하나로 정교한 침으로 신체의 특정부위, 즉 경혈을 자극한다. 대체로 침은 다양한 유형의 통증경감에 활용되고 있다. 침은 염증을 줄이고, 몸 속 자연 진통제인 엔돌핀 방출을 자극하며 두뇌를 진정시킨다. 침은 안전하며, 부작용은 거의 없거나 잠시 나타났다 사라진다. 근거가 제시된다면, 섬유근통 환자에게 꼭 필요한 효과적 증상 경감을 위해 침 치료가 사용될 수 있을 것이다.

섬유근통 환자의 침 치료 결과에 대한 최적의 추산:

거짓 침과 비교했을 때

통증 (점수가 높을수록 더 이상 심한 통증임)

- 6회 전침 치료를 한 사람들의 통증 점수는 100점 만점에 13점 더 낮았다. (절대적 개선)

- 거짓 침을 맞은 사람은 치료 후 통증이 100점 만점에 70점 이었다.

- 전침 치료를 받은 사람은 통증이 57점 이었다.

신체 기능 (점수가 높을수록 더 나은 기능을 의미):

- 전기 자극을 하지 않은 침 (수기 침) 치료를 받은 사람들은 신체기능 점수가 6점 더 낮았다. (절대 기준 상 악화)

- 거짓 침 치료 후 신체기능 점수는 100점 만점에 28점 이었다.

- 전기 자극 없는 침(수기 침)치료 후 점수는 22점 이었다.

- 전침에 대한 자료는 없었다.

참여자가 평가한 전반적 안녕감 (점수가 높을수록 더 나은 안녕감을 의미):

- 전침 치료를 받은 사람들의 안녕감 지수가 11점 높았다. (절대적 개선)

- 거짓 침 치료를 받은 사람들의 치료 후 안녕감 지수는 100점 만점에 41점 이었다.

- 전침 치료를 받은 사람들의 안녕감 지수는 52점 이었다.

수면 (점수가 높을 수록 더 나은 수면을 의미):

- 침 치료를 받은 사람들의 수면점수가 8점 더 높았다. (절대적 개선)

- 거짓 침 치료를 받은 사람들의 수면점수는 치료 후 100점 만점에 30점 이었다.

- 전침 치료를 받은 사람들의 수면점수는 38점 이었다.

피로 (점수가 높을수록 더 심한 피로를 의미):

- 전침 치료를 받은 사람들의 피로가 15점 더 낮았다. (절대적 개선)

- 거짓 침 치료를 받은 사람들의 피로는 100점 만점에 78점 이었다.

- 전침 치료를 받은 사람들의 피로는 63점 이었다.

강직도 (점수가 높을수록 더 심각한 강직을 의미):

- 전침 치료를 받은 사람들의 강직도가 9점 더 낮았다. (절대적 개선)

- 거짓 침 치료를 받은 사람들의 치료 후 강직도는 100점 만점에 66점 이었다.

- 전침 치료를 받은 사람들의 강직도는 57점 이었다.

- 전기 자극없는 침 (수기 침) 치료에 대한 자료는 없다.

이상반응:

- 침 치료를 받은 6명 중 한명이 이상 반응을 보고했다.

- 거짓 침 치료를 받은 3명 중 한명이 이상반응을 보고했다.

- 전반적으로, 이상반응은 경미하거나 하루를 못 가 사라졌다.

보조 요법으로서의 침

통증 (점수가 높을수록 통증이 심해짐을 의미):

- 운동과 약물 치료 (항우울제) 등의 표준 치료와 함께 침 치료를 받은 사람들은 20회 치료 후 통증이 100점 만점에 30점 더 낮았다. (절대적 개선)

- 표준 치료를 받은 사람들의 통증은 100점 만점에 80점 이었다.

- 추가로 침 치료를 받은 사람의 통증은 50점 이었다.

항우울제와 침 치료 비교

통증 (점수가 높을수록 통증이 심해짐을 의미):

- 28회 침 치료를 받은 사람들의 통증은 17점 더 낮아졌다. (절대적 개선)

- 항우울제를 복용한 사람들의 치료 후 통증 점수는 100점 만점에 29점이었다.

- 침 치료를 받은 사람들의 통증 점수는 12점 이었다.

침 치료를 하지 않은 군과 침 치료 군 비교

- 전침 치료를 받은 사람들은 100점 만점 상 통증 23점, 피로 11점, 강직도 9점이 낮았고 (호전), 전반적 안녕감은 침 치료를 받지 않은 군에 비해 15점 높았다 (호전).

역주

[역주1] 영어원문에는 '5.2 point' 라고 되어 있으나 본문과 대조확인 결과 오류가 있어 수정사항을 반영하여 '4.1점' 으로 번역하였다. [역주2] 영어원문에는 '289 participants' 라고 되어 있으나 본문과 대조확인 결과 오류가 있어 수정사항을 반영하여 '203명 참여자' 로 번역하였다. [역주3] 이 리뷰는 강민정 님 (부산대학교 한의학전문대학원), 김건형 님 (부산대학교 한의학전문대학원) 이 번역하였습니다. 번역 내용과 관련한 문의점은 강민정(oriental1@nate.com) 님에게 연락 주십시오.

平易な要約

線維筋痛症に対する鍼治療

本コクラン・レビュー要約は、線維筋痛症における鍼治療の効果について試験で得られたことを提示している。

本レビューは線維筋痛症患者における以下のことを明示している:

-鍼治療は疼痛およびこわばりの緩和や総合的な健康状態および疲労の改善において、無鍼治療より効果がある可能性がある

-電気刺激を伴う鍼治療は鍼単独治療より、疼痛およびこわばりの緩和や総合的な健康状態、睡眠および疲労の改善において効果がある可能性がある

-電気刺激を伴わない鍼治療が、疼痛を緩和したり、疲労、総合的な健康状態または睡眠を改善する可能性はない

-また鍼治療は、疼痛に対する薬物や運動の効果を強める可能性がある

線維筋痛症とは? 鍼治療とは?

線維筋痛症になると、関節のこわばり、睡眠障害、疲労、気分障害など の症状を伴い、身体の多くの部位に痛みを感じる。これらはQOLに 影響を及ぼすことになる。現在のところ治癒の見込みはなく、選択できる治療法もほとんどない。したがって治療目的は疼痛の緩和および 健康状態、機能力の改善である。

鍼治療は中医学の一種で、つぼと呼ばれる身体のある部位に細い針で 刺激を与える。鍼治療は普通、患者の様々な疼痛の緩和のために使われる。炎症を緩和し、身体がもともと持っている鎮痛剤(エンドルフ ィン)を分泌するのを刺激し、頭を鎮静化する働きがある。安全であり、短期間副作用がわずかにあるだけである。総合的なエビデンスで支持された場合、鍼治療は線維筋痛症の症状を効果的に緩和するものとして非常に必要とされるだろう。

鍼治療をした線維筋痛症患者に起こりうるものとして最も推測できる ものに以下のものがある:

偽介入と鍼治療の比較

疼痛(スコアが高いほど疼痛が重篤)

-電気刺激を伴う鍼治療の患者では、6回の治療後100ポイントスケール(絶対的改善)で疼痛評価が13ポイント低下した

-偽鍼治療の患者は、治療終了時0~100ポイントスケールで70ポイントであった

-電気刺激を伴う鍼治療の患者は、57ポイントであった

身体機能(スコアが高いほど良好)

-電気刺激の無い鍼治療の患者は、身体機能が6ポイント低下した(絶対的低下)

-偽治療の患者は、治療終了時身体機能が0~100ポイントスケールで28であった

-電気刺激の無い鍼治療の患者は、身体機能が22であった

-電気刺激を伴う鍼治療のデータは無い

患者による総合的な健康状態の評価(スコアが高いほど良好)

-電気刺激を伴う鍼治療の患者は、健康状態が11ポイント高かった(絶対的改善)

-偽治療の患者は治療終了時、健康状態が0~100ポイントスケールで41であった

-電気刺激を伴う鍼治療の患者は、健康状態が52であった

睡眠(スコアが高いほど良好)

-鍼治療の患者は、睡眠が8ポイント高かった(絶対的改善)

-偽治療の患者は治療終了時、睡眠が0~100ポイントスケールで30であった

-電気刺激を伴う鍼治療の患者は、睡眠が38であった

疲労(スコアが高いほど深刻)

-電気刺激を伴う鍼治療の患者は、疲労が15ポイント低かった(絶対的改善)

-偽治療の患者は疲労が0~100ポイントスケールで78であった

-電気刺激を伴う鍼治療の患者は、疲労が63であった

こわばり(スコアが高いほどこわばりが重篤)

-電気刺激を伴う鍼治療の患者は、こわばりが9ポイント低かった(絶対的改善)

-偽治療の患者は治療終了時、こわばりが0~100ポイントスケールで66であった

-電気刺激を伴う鍼治療の患者は、こわばりが57であった

-電気鍼治療でない鍼治療に関するデータは入手不可能であった

有害作用

-鍼治療群の6例中1例に有害事象が報告された

-偽治療群の3例中1例に有害事象が報告された

-総体的に有害事象は少なく、1日以内で消失した

併用療法としての鍼治療の効果

疼痛(スコアが高いほど深刻)

-薬物と運動の標準治療に鍼治療を付加した患者は、20回の鍼治療後0~100ポイントスケール(絶対的改善)で疼痛が30ポイント低下した

-標準治療の患者は治療終了時、0~100ポイントスケールで疼痛が80であった

-付加鍼治療の患者は疼痛が50であった

抗うつ剤と比較した鍼治療の効果

疼痛(スコアが高いほど深刻)

-鍼治療の患者は28回の治療後、疼痛が17ポイント(絶対的改善)低下した

-抗うつ剤の患者は治療終了時、0~100ポイントスケールで疼痛が29であった

-鍼治療の患者は疼痛が12であった

鍼治療と非鍼治療(待機者リスト)の比較

-電気刺激を伴う鍼治療をした患者は、0~100ポイントスケールで疼痛、疲労、こわばりがそれぞれ23、11、9ポイント低下した。また無鍼治療の患者より総合的な健康状態が、15ポイント良いと報告された

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2016.1.2]
《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

Summary of findings(Explanation)

Summary of findings for the main comparison. Acupuncture versus non-acupuncture for treating fibromyalgia
  1. *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
    AR: absolute risk; CI: confidence interval; EA: electroacupuncture; FIQ: Fibromyalgia Impact Questionnaire; MD : mean difference; NNT: number needed to treat; RR: risk ratio; VAS: visual analogue scale

    GRADE Working Group grades of evidence
    High quality: Further research is very unlikely to change our confidence in the estimate of effect.
    Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
    Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
    Very low quality: We are very uncertain about the estimate.

    1 Itoh 2010, no follow-up.

    2VAS (0 = no pain, 10 = worse pain ever).

    3FIQ (20-item questionnaire, higher scores indicate participant is more affected by fibromyalgia).

    4Intention-to-treat not used, single study with small sample size.

    5Small sample size.

Acupuncture versus non-acupuncture for treating fibromyalgia

Patient or population: patients with fibromyalgia

Settings: Japan1

Intervention: acupuncture versus non-acupuncture

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Non-acupunctureAcupuncture (EA)
Pain up to 1 month after treatment
VAS2

No treatment
69.8 points

Scale (0 to 100)

EA

47.4 points

(Lower score indicates less pain)

22.4 MD lower
(40.98 lower to 3.82 lower)

 13
(1 study)
⊕⊕⊝⊝
low4

AR % -22.40% (-40.98% to -3.82%)

RR % -30.19% (-55.23% to -5.15%)

NNT 4 (1 to 161)

Physical functionNot reported    Not reported

Global well-being up to 1 month after treatment

FIQ3

No treatment
66.5 points

Scale (0 to 100)

EA

51.1 points

(Lower score indicates better well-being)

15.4 MD lower
(25.62 lower to 5.18 lower)

 13
(1 study)
⊕⊕⊝⊝
low4

AR % -15.40% (-25.62% to -5.18%)

RR % -23.88% (-39.72% to -8.03%)

NNT 4 (1 to 52)

Sleep up to 1 month after treatment

Subset (rest) FIQ3

No treatment
4.0 points

Scale (0 to 10)

EA

3.6 points

(Lower score indicates better sleep)

0.4 MD lower
(1.01 lower to 0.21

higher)

 13
(1 study)
⊕⊕⊝⊝
low4

AR % -4.00% (-10.10% to 2.10%)

RR % -10.53% (-26.58% to 5.53%)

NNT N/A

Fatigue up to 1 month after treatment

Subset (fatigue) FIQ3

No treatment
4.5 points

Scale (0 to 10)

EA

3.4 points

(Lower score indicates less fatigue)

1.1 MD lower
(1.98 lower to 0.22 lower)

 13
(1 study)
⊕⊕⊝⊝
low4

AR % -11.00% (-19.80% to -2.20%)

RR % -26.19% (-47.14% to -5.24%)

NNT 4 (1 to 52)

Stiffness up to 1 month after treatment

Subset (stiffness) FIQ3

No treatment
4.8 points

Scale (0 to 10)

EA

3.9 points

(Lower score indicates less stiffness)

0.9 MD lower
(1.66 lower to 0.14 lower)

 13
(1 study)
⊕⊕⊝⊝
low4

AR % -9.00% (-16.60% to -1.40%)

RR % -21.95% (-40.49% to -3.41%)

NNT 3 (1 to 128)

Adverse events Not estimable13
(1 study)
low5No adverse events only withdrawals (3) due to non-improvement in condition

Summary of findings 2 Acupuncture versus placebo or sham acupuncture for treating fibromyalgia

Summary of findings 2. Acupuncture versus placebo or sham acupuncture for treating fibromyalgia
  1. 1USA: Assefi 2005; Harris 2005; Harris 2008; Harris 2009; Martin 2006; Switzerland: Deluze 1992. Follow-up only Assefi 2005 (3 and 6 months) and Martin 2006 (1 and 7 months).
    2Pain: Assefi 2005: VAS (10 cm, 0 = no pain, 10 = worse pain ever), Deluze 1992: VAS (1 to 100 mm, does say which is worse 1 or 100), Harris 2005: NRS (101 points, 0 to 100, 5-point increments, 0 = no pain, 100 = worse pain imaginable), Harris 2008 and Harris 2009 SF-MPQ (subset VAS), Martin 2006; MPI (generalised measure of pain, 61-item questionnaire, higher score means more pain). At up to 7 months follow-up ( Assefi 2005 and Martin 2006 ), pain: 2.4 points lower on a 100-point scale (SMD -0.12; 95% CI -0.52 to 0.28, P = 0.55).
    3 Harris 2005: SF-36 questionnaire (score 0 to 100 with higher scores indicating better function).
    4Global well-being: Assefi 2005: VAS (0 to 10, 0 = worse ever, 10=best ever), Deluze 1992: VAS (1 to 10, 10 = best), Martin 2006: FIQ (20-item questionnaire, higher scores indicate participant is more affected by fibromyalgia). At up to 7 months follow-up ( Assefi 2005 and Martin 2006 ), global well-being: 6.7 points lower on a 100-point scale (SMD -0.03; 95% CI -0.87 to 0.81, P = 0.94).
    5Sleep: Assefi 2005: VAS (0 to 10, 0 = worse ever,10 = best ever), Deluze 1992: VAS (1 to 10, 10 = best), Martin 2006: subset FIQ (rest). At up to 7 months follow-up ( Assefi 2005 and Martin 2006 ), sleep: 1.8 points lower on a 100-point scale (SMD -0.09; 95% CI -0.44 to 0.26, P = 0.62).
    6Fatigue: Assefi 2005: VAS (0 to 10, 0 = worse ever, 10 = best ever, Harris 2005: MFI (calculated using Reliability of Change Index, scores range from 4 to 20 with larger scores indicating more fatigue), Martin 2006: subset FIQ (fatigue). At up to 7 months follow-up ( Assefi 2005 and Martin 2006 ), fatigue: 1 point lower on a 100-point scale (SMD -0.04; 95% CI -0.52 to 0.59, P = 0.90).

    7Stiffness: Deluze 1992: morning stiffness (minutes), Martin 2006: subset FIQ (stiffness). At up to 7 months follow-up ( Martin 2006 ), fatigue: 3 points lower on a 100-point scale (95% CI -1.60 to 1.00, P = 0.65).

    8 Deluze 1992: intention-to-treat not used.
    9People who used acupuncture rated their physical function to be 4 points lower (absolute deterioration), small sample size.
    10Small sample size (however some studies reported no adverse events).

Acupuncture versus placebo or sham acupuncture for treating fibromyalgia
Patient or population: patients with fibromyalgia
Settings: USA, Switzerland1
Intervention: acupuncture versus placebo or sham acupuncture
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control (sham or placebo)Acupuncture (EA or MA or combined)
Pain up to 1 month after treatment
(VAS, NRS, SF-MPQ, MPI)2
Combined EA and MA
70 points
Scale (0 to 100), lower score means less pain)2

Combined EA and MA

0.14 SMD lower
(0.53 lower to 0.25 higher)

EA: 57 points

SMD -0.63 (-1.02 to -0.23)

 286
(6 studies)
⊕⊕⊕⊝
moderate 8

EA

AR %: -13% (-22% to -5%)

RR %: 22% (35% to 8%)

NNT 3 (2 to 9)

MA

AR % 0.28% (-0.34% to 0.90%)

RR % 4.00% (-4.86% to 12.86%)

NNT N/A

Physical function up to 1 month after treatment
(SF-36)3

MA

28 points
Scale (0 to 100)4

MA

22.2 points

(Higher score indicates
better physical function)

5.8 MD lower
(10.91 lower to 0.69 lower)

 56
(1 studies)
⊕⊕⊕⊝
moderate 9

AR % -5.80% (-10.91% to -0.69%)

RR % -15.21% (-28.61% to -1.81%)

NNT 4 (2 to 53)

Global well-being: rated by participants up to 1 month after treatment
(VAS, FIQ)4

Combined EA and MA

4.1 points
Scale (0 to 10)6

Combined EA and MA

0.29 SMD higher
(0.44 lower to 1.01 higher)

EA

SMD 0.65 higher (0.26 to 1.05)

(Higher score indicates better well-being)

 200
(3 studies)
⊕⊕⊕⊝
moderate 8

EA

AR % 11% (4% to 17%)

RR % 23% (9% to 38%

NNT 3 (2 to 9)

MA

AR % -8.00% (-17.20% to 1.20%)

RR % -20.00% (-43.00% to 3.00%

NNT N/A

Sleep up to 1 month after treatment
(VAS, subset FIQ (rest))5

Combined EA and MA
3.03 points:

Scale (0 to 10)8

Combined EA and MA

0.16 SMD higher
(0.29 lower to 0.61 higher)

EA
3.82 points

SMD 0.40 higher (0.01 to 0.79)

(Higher score indicates
better sleep)

 200
(3 studies)
⊕⊕⊕⊝
moderate 8

EA

AR % 8% (0.20% to 16%)

RR % 9% (0.21% to 17%)

NNT 5 (3 to 206)

MA

AR % -5.00% (-14.20% to 4.20%)

RR % -16.50% (-46.86% to 13.86%)

NNT N/A

Fatigue up to 1 month after treatment
(VAS, MFI, subset FIQ (fatigue))6

Combined EA and MA
7.77 points:

Scale (0 to 10)9

Combined EA and MA

0.1 SMD lower (0.81 lower to 0.61 higher)

(Lower score indicates
less fatigue)

EA

6.24 points

SMD -0.85 (-1.44 to -0.27)

 201
(3 studies)
⊕⊕⊕⊝
moderate 8

EA

AR % -15.30% (-25.92% to -4.86%)

RR % -20.13% (-34.11% to -6.39%

NNT 3 (2 to 8)

MA

AR % 4.34% (-1.34% to 10.1%)

RR % 5.59% (-1.72% to 13.11%)

NNT N/A

Stiffness up to 1 month after treatment
(Minutes, subset FIQ (stiffness))7

EA
6.6 points:

Scale (0 to 10)10

EA

5.7 points

(Lower score indicates
less stiffness)

0.45 SMD lower
(0.84 lower to 0.06 lower)

 104
(2 studies)
⊕⊕⊕⊝
moderate 8

AR % -9.00% (-16.80% to -1.20%)

RR % -13.24% (-24.71% to -1.76%)

NNT 5 (3 to 35)

Adverse events

Adverse events includes withdrawal and drop-outs that could be clearly identified as due to an adverse event

Study populationRR 0.44
(0.12 to 1.63)
289
(5 studies1)
⊕⊕⊕⊝
moderate 10

AR % 44.00% (12.00% to 163.00%)

RR % 56.00% (88.00% to 63.00%)

1/6 people who had acupuncture reported adverse events

1/3 people who had fake treatments reported adverse events

Overall, such events were minor and lasted less than 1 day

372 per 1000164 per 1000
(45 to 606)
Moderate
83 per 100037 per 1000
(10 to 135)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

AR: absolute risk; CI: confidence interval; EA: electro-acupuncture; FIQ: Fibromyalgia Impact Questionnaire; MA: manual acupuncture; MD: mean difference; MFI: Multidimensional Fatigue Inventory; MPI: Multidimensional Pain Inventory; NNT: number needed to treat; NRS: numerical pain rating scale; RR: risk ratio; SF-MPQ: Short-Form McGill Pain Questionnaire; SMD: standardised mean difference; VAS: visual analogue scale

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings 3 Acupuncture versus medication for treating fibromyalgia

Summary of findings 3. Acupuncture versus medication for treating fibromyalgia
  1. 1 Guo 2005, paper stated follow-up at 6 months but no data provided.

    2VAS (0 = no pain, 10 = worse pain ever).

    3Poorly reported paper (see 'Risk of bias' table).

Acupuncture versus medication for treating fibromyalgia
Patient or population: patients with fibromyalgia
Settings: China1
Intervention: acupuncture versus medication
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Medication (antidepressant)Acupuncture

Pain up to 1 month after treatment

VAS2

MA

28.8 points

Scale

(0 to 100)

MA

11.5 points

(Lower score indicates less pain)

17.3 MD lower
(24.13 lower to 10.47 lower)

 38
(1 study)
⊕⊕⊝⊝
low3

AR % -17.30% (-24.13% to -10.47%)

RR % -23.32% (-32.52% to -14.11%)

NNT 2 (lower 1, upper 3)

Physical function     Not reported
Global well-being: rated by participants     Not reported
Sleep     Not reported
Fatigue     Not reported
Stiffness     Not reported
Adverse eventsStudy populationNot estimable38
(1 study)
⊕⊕⊝⊝
low3
No details were reported about adverse events, however from the data it would appear there were no drop-outs or withdrawals
See commentSee comment
Moderate
0 per 10000 per 1000
(0 to 0)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
AR: Absolute risk; CI: Confidence interval; MA: Manual acupuncture; MD: mean difference; NNT: number needed to treat; RR: risk ratio; VAS: visual analogue scale
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings 4 Acupuncture as an adjunct therapy for treating fibromyalgia

Summary of findings 4. Acupuncture as an adjunct therapy for treating fibromyalgia
  1. 1 Targino 2008, follow-up 6, 12 and 24 months. At up to 7 months follow-up, pain: 5 points lower on a 100-point scale (95% CI -1.49 to 0.4, P = 0.32).
    2VAS (10 cm, 0 = no pain, 10 = worst pain experienced).
    3MOS SF-36 (Portuguese version, 8 multi-item scale measuring quality of life, higher values indicate better life).
    4No control and single study with small sample size.

Acupuncture as an adjunct therapy for treating fibromyalgia
Patient or population: patients with fibromyalgia
Settings: Brazil1
Intervention: acupuncture as an adjunct therapy
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Medication and exerciseAcupuncture plus medication and exercise

Pain up to 1 month after treatment

VAS2

MA

8 points

Scale (0 to 10)

MA

5 points

(Lower score indicates
less pain)

3.0 MD lower
(3.9 lower to 2.1 lower)

 58
(1 study)
⊕⊕⊕⊝
moderate 4

AR % -30.00% (-39.00% to -21.00%)

RR% -37.50% (-48.75% to -26.25%)

NNT 3 (lower 2, upper 10)

Physical function

MOS SF-363

     Confirmed data not available at time of publication
Global well-being: rated by participants     Not reported
Sleep     Not reported
Fatigue     Not reported
Stiffness     Not reported
Adverse eventsStudy populationRR 3.57
(0.18 to 71.21)
58
(1 study)
⊕⊕⊕⊝
moderate 4
2 adverse events in acupuncture group (hand oedema at LI4 site)
0 per 10002 per 1000
(0 to 0)
Moderate
0 per 10000 per 1000
(0 to 0)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
AR: absolute risk; CI: confidence interval; MA: manual acupuncture; NNT: number needed to treat; RR: risk ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Summary of findings 5 Deep invasive acupuncture stimulation versus non-stimulated acupuncture for treating fibromyalgia

Summary of findings 5. Deep invasive acupuncture stimulation versus non-stimulated acupuncture for treating fibromyalgia
  1. 1 Harris 2005 compared one type of acupuncture (needles placed in traditional site with manual stimulation) with another type (needles placed in traditional site without stimulation). No follow-up.
    2NRS rating scale (0 to 100 points, 5-point increments, 0 = no pain, 100 worse pain imaginable).

    3SF-36 questionnaire (score 0 to 100, with higher scores indicating better function).

    4MFI (calculated using Reliability of Change Index, scores range from 4 to 20 with larger scores indicating more fatigue).

    5Single study with small sample size.

Deep invasive acupuncture stimulation versus non-stimulated acupuncture for treating fibromyalgia
Patient or population: patients with fibromyalgia
Settings: USA1
Intervention: deep needling with stimulation versus deep needling without stimulation
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control acupuncture: deep needling without stimulationAcupuncture: deep needling with stimulation
Pain up to 1 month after treatment
NRS2

MA

53.9 points

Scale (0 to 100)

MA

54.2 points

(Lower score indicates less pain)

0.3 MD higher
(18.34 lower to 18.94 higher)

 41
(1 study)
⊕⊕⊕⊝
moderate 5

AR % 0.30% (-18.34% to 18.94%)

RR % 0.57% (-34.55% to 35.68%)

NNT N/A

Physical function up to 1 month after treatment
SF-363

MA

40.2 points

Scale (0 to 100)

MA

34.7 points

(Higher score indicates
better physical function)

5.5 MD higher
(11.43 lower to 0.43 higher)

 41
(1 study)
⊕⊕⊕⊝
moderate 5

AR % 5.50% (-11.43% to 0.43%)

RR % 14.63% (-30.40% to 1.14%)

NNT N/A

Global well-being: rated by participants     Not reported
Sleep     Not reported

Fatigue up to 1 month after treatment

MFI4

MA

14.6 points

Scale (0 to 20)

MA

15.7 points

(Lower score indicates less fatigue)

1.1 MD higher
(1.41 lower to 3.61 higher)

 41
(1 study)
⊕⊕⊕⊝
moderate 5

AR % 5.50% (-7.05% to 18.05%)

RR % 6.74% (-8.63% to 22.11%)

NNT N/A

Stiffness     Not reported
Adverse events     Contained in Table 2
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
AR: absolute risk; CI: confidence interval; MA: manual acupuncture; MD: mean difference; MFI: Multidimensional Fatigue Inventory; NNT: number needed to treat; NRS: numerical pain rating scale; RR: risk ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Background

Fibromyalgia is a musculoskeletal disorder characterised by widespread chronic pain and any number of co-morbidities, such as sleep disturbance, fatigue, stiffness, irritable bowel syndrome, headaches and mood disorders. It affects over 2% of the population and occurs predominantly in females (Wallace 2005). There was, until recently, no pharmacotherapy that effectively addressed all the symptoms associated with fibromyalgia (Lawson 2006). The United States of America's Food and Drug Administration (FDA) has approved 'Lyrica' (pregabalin), 'Savella' (milnacipran HCl) and 'Cymbalta' (duloxetine hydrochloride) (Boomershine 2009) for the treatment of fibromyalgia. In contrast, to date the European Medicines Agency has not approved any pharmacotherapy for the treatment of fibromyalgia (www.fibroaction.org), suggesting that the approved FDA drugs for fibromyalgia are not readily accessible by people globally. Non-drug therapies, such as cognitive behavioural therapy (CBT) and exercise, or a combination of the two approaches, are potentially beneficial for people with fibromyalgia (Nüesch 2012).

With respect to complementary and alternative medicine (CAM), acupuncture, a physical therapy of Traditional Chinese Medicine (TCM) that has been used to treat chronic pain for over two millennia in China, is promising for alleviating the symptoms associated with fibromyalgia (Bergman 2007). Among fibromyalgia sufferers, 91% had used CAM (Pioro-Boisset 1996) and one in five sufferers had sought acupuncture for treatment within two years of diagnosis (Bombardier 1996). In 1998, the National Institutes of Health Consensus Development Conference on Acupuncture stated that acupuncture may be used as an adjunct therapy for fibromyalgia (NIH 1998).

However, no therapy alone has been demonstrated to be universally superior to the others. Consequently, it was considered appropriate that when treating fibromyalgia a multidisciplinary approach be used (Arnold 2006). In the United States of America, approximately one million consumers use acupuncture annually (Burke 2006; Ezzo 2000). Furthermore, acupuncture is a relatively safe intervention (Vincent 2001) when compared with pharmacotherapies. Adverse events associated with acupuncture tend to be mild and short-lasting, such as lethargy and pain at the needling sites (MacPherson 2004).

The plausible mechanism of acupuncture analgesia is its effect on the central nervous system and consequent regulation of neurotransmitters and hormones. Acupuncture stimulates nerve fibres (e.g. A delta afferents), which in turn activate transmission neurons in the dorsal laminae of the spinal cord and further activate three levels of the endogenous pain modulation systems at the spinal cord, midbrain, thalamus and hypothalamus. The activation results in a cascade of pain-modulating endorphins, serotonin and noradrenaline, which contributes to analgesia (Cao 2002; Han 1997; Sims 1997).

Although the pathophysiology of fibromyalgia is not well understood, data suggest that ineffective descending inhibition of the central nervous system may cause an abnormal modulation of sensory inputs (such as mechanoreceptor inputs), resulting in pain (Price 2005). Acupuncture action enhances the function of the endogenous pain inhibition systems and therefore may be beneficial to people with fibromyalgia.

The World Health Organization (WHO) defines real acupuncture, in its broadest sense, as the insertion of needles into the human body surface for therapeutic purposes (WHO 2007). Throughout its history, different treatment styles of acupuncture have been developed in relation to needle size, depth of needling and duration of needle retention as well as deqi sensation. Deqi is the feeling of soreness, numbness, distension, heaviness or the electric shock sensation that occurs around a correctly placed and manipulated acupuncture needle (WHO 2007).

A number of different styles of acupuncture are presently in use, according to acupuncture point selection and stimulation modes. In clinical practice, the selection of acupuncture points for each patient is based on either a Chinese medicine diagnosis (individualised acupuncture treatment) or symptom alleviation (formula acupuncture treatment). Sometimes trigger points are also selected for needling and this may be described as dry needling. There is also micro-system acupuncture where needles are mainly inserted into defined points on an anatomical part of the body such as the head (scalp acupuncture), the ear (auricular acupuncture) or the hand (hand acupuncture). Needles can be deeply inserted into soft tissue and manipulated to elicit deqi (also known as traditional Chinese acupuncture) or superficially inserted into the skin without eliciting deqi (which may be described as Japanese acupuncture/meridian therapy).

Apart from, and in addition to, needles, acupuncture points or other points mentioned above can be stimulated using heat (such as moxibustion), with electrical current (known as electro-acupuncture), using mechanical pressure (acupressure) or using laser (laser acupuncture). Of all the forms of stimulation of acupuncture points, needling involving skin penetration (manual acupuncture) is the most commonly used method.

In 2007, a systematic review of acupuncture for fibromyalgia concluded that "acupuncture could not be recommended for fibromyalgia" (Mayhew 2007). However, it appears that this review neither searched for nor included studies from Chinese databases. In addition, new studies have been published. Therefore, there is a need to perform a thorough review to allow an up-to-date assessment of all available studies to determine the potential role of acupuncture in the management of fibromyalgia.

Objectives

The present review aims to determine whether real acupuncture is more beneficial in terms of pain reduction, function and well-being improvement than placebo and other treatments and is safe in people with fibromyalgia. We examined the following comparisons:

  1. Acupuncture versus no acupuncture (e.g. wait list)

  2. Acupuncture versus placebo or sham acupuncture

  3. Acupuncture versus standard/usual care (e.g. cognitive behavioural therapy (CBT) and/or exercise and/or pharmacotherapy)

  4. Acupuncture as an adjunct therapy to standard/usual care (evaluating additional effect)

  5. A particular style of acupuncture versus another (e.g. deep needling with stimulation versus deep needling without stimulation)

Methods

Criteria for considering studies for this review

Types of studies

We considered randomised and quasi-randomised controlled clinical studies of acupuncture for treating patients with fibromyalgia. Quasi-randomised studies are those that do not strictly adhere to methods of true randomisation, e.g. location by the order of admission or date of birth. Inclusion of studies was not restricted according to language, type of publication or presence of blinding. We excluded studies from which we could not extract reported clinical outcomes or data for analyses.

Types of participants

Criteria for inclusion were participants of either gender, aged 18 and over, with a diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) classification criteria for fibromyalgia (Wolfe 1990).

Types of interventions

Types of intervention were restricted to acupuncture that breaks the skin for therapeutic benefit (WHO 2002). Studies comparing different styles of acupuncture were also included. In addition, studies in which acupuncture was an adjunct therapy to other therapies (e.g. herbs, cupping, physiotherapy, exercise) were included, provided the control groups also received these therapies. Studies in which acupuncture points were stimulated with methods that did not break the skin, such as transcutaneous electrical nerve stimulation (TENS), infrared light, laser or digital pressure, were excluded. Acupuncture points refer to those points as defined in the Standard Acupuncture Nomenclature by the World Health Organization (WHO) (WHO 2002). Studies that used ashi acupuncture points (i.e. tender points) or trigger points were also to be included.

The control interventions included sham/fake/placebo acupuncture, other types of placebo control, non-acupuncture treatment, different styles of acupuncture or other treatment. An example of non-acupuncture treatment is a wait list. We considered standard care to be pharmacotherapy and/or exercise and/or CBT. When selecting studies that used sham/placebo acupuncture, we chose controls that did not intend to be an effective intervention, for example, needling on irrelevant acupuncture points, superficial needling or both. Other sham controls could have a disconnected electro-acupuncture stimulator, an inactive laser, mock TENS, infrared light or digital pressure. If there were sufficient studies, we planned to examine the differences between the various types of sham acupuncture (e.g. insertion verses non-insertion, deep needle verses shallow needle, on the acupuncture point versus off the acupuncture point). We excluded studies that did not provide adequate details of the control intervention.

Types of outcome measures

Included studies must have reported one or more of the following main clinical outcome measures related to pain, function and quality of life.

Main outcomes
  1. Pain (e.g. visual analogue scale (VAS), numerical pain rating scale (NRS), McGill Pain Questionnaire (SF-MPQ), Multidimensional Pain Inventory (MPI) or Regional Pain Scale score)

  2. Physical function (e.g. 36-Item Short-Form Health Survey (SF-36, Physical) or Health Assessment Questionnaire (HAQ))

  3. Global well-being as rated by participants (e.g. Fibromyalgia Impact Questionnaire (FIQ), VAS rated by participants)

  4. Sleep (e.g. VAS of intensity, numerical sleep scale 1 to 10)

  5. Fatigue (e.g. VAS, Multidimensional Fatigue Inventory (MFI))

  6. Morning stiffness (e.g. numerical scale)

  7. Adverse events: proportion of participants who experienced an adverse event and proportion who withdrew due to adverse events

Provided the studies had main outcomes, we also considered any of the following minor outcomes.

Minor outcomes
  1. Tenderness (e.g. number of tender points or pain threshold of tender points as measured with a dolorimeter)

  2. Mental well-being (e.g. SF-36 (mental), Hamilton Depression Rating Scale (HAMD))

  3. Analgesic use (e.g. diary)

  4. Changes in fibromyalgia symptoms (e.g. observer-rated change in fibromyalgia symptoms (including that rated by physicians))

  5. Overall well-being rated by the study care givers

In the 'Summary of findings' table, we included the main outcomes of pain, physical function, global well-being, sleep, fatigue, stiffness and total adverse events (Arnold 2011).

Search methods for identification of studies

We initially searched the following databases from their inception to April 2008 as per protocol. We updated the search in May 2010 and January 2012. Search terms used included 'fibromyalgia' and 'acupuncture' and their variations (Figure 1).

Figure 1.

A flow chart of study selection. ('English' refers to English databases and 'Chinese' refers to Chinese databases).

Additional studies

We handsearched the bibliographies of review articles, excluded studies and textbooks on acupuncture, pain and fibromyalgia for additional studies. We contacted authors of published studies in an attempt to locate any unpublished studies.

Data collection and analysis

Selection of studies

One author (JD) searched the English language databases, while another author (ZZ) searched the Chinese language databases. These two authors independently examined the abstracts of the potential studies and obtained the full-text articles for consideration based on our pre-defined inclusion and exclusion criteria. We checked all references in the retrieved full-text English, Chinese and foreign language studies. Three potential papers were translated by the Cochrane Centres in Germany (one) and Italy (two). Three native speakers of Russian, Dutch and Spanish examined one paper each in these languages for potential studies. Four authors (JD, SS, ZZ, CX) with two in each group examined the English and Chinese studies, respectively, for inclusion/exclusion. Two authors (JD and ZZ) assessed the Harris 2008, Itoh 2010 and Targino 2008 papers. There were no disagreements between each pair of review authors.

Data extraction

Two author pairs (English: JD, SS and Chinese: ZZ, JSS) independently extracted data for each included study using our standard data extraction sheet. JD and ZZ extracted the data from Harris 2008, Itoh 2010 and Targino 2008. Data extracted included study characteristics, items related to the 'Risk of bias' tool and adverse events for each arm of the studies. We also extracted effect measures from each trial, including mean and standard deviation for continuous outcomes at or within one month of the end of the treatment; and number of events and number of participants in each group for dichotomous outcomes at the end of the treatment.

Assessment of risk of bias in included studies

Two review author groups, with two authors in each (JD, SS and ZZ, JSS), individually assessed the methodological quality of the English and Chinese studies, respectively, and incorporated them into the 'Risk of bias' tables. Items included in the tables are adequate sequence generation, allocation concealment (selection bias), blinding of the participants (performance bias), blinding of the assessor (detection bias), incomplete outcome data and its impact on the effect of estimate (attrition bias), and selective reporting (reporting bias). Using the extracted information, two authors (JD, ZZ) assessed whether they met the guidelines by selecting one of three choices: 'Yes', 'No' or 'Unclear' and reported the details of each decision in the allocated section of the table. 

Assessment of the quality of the acupuncture treatments

To assess the quality of the acupuncture treatments, the two review author groups, all experienced clinical acupuncturists (minimum 10 years of experience each), used three instruments. We used the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) (MacPherson 2002) to extract the details of acupuncture intervention (Appendix 10), including acupuncture rationale, needling details, treatment regimen, co-interventions, practitioner background and control interventions, which are not addressed by other assessment tools. The purpose of STRICTA is to improve the reporting of interventions of controlled studies in acupuncture. This allows replication of the acupuncture treatment in other studies and clinical practice. As STRICTA does not offer a rating or scale to make a critical evaluation of the reporting, we further developed two rating systems to assess the adequacy of acupuncture treatment and confidence in the acupuncture diagnosis and treatment based on STRICTA data. Similar approaches have been used in other systematic reviews (Linde 2009; Scott 2006).

Adequacy of acupuncture treatment protocol

The rationale for examining the adequacy of treatment was to ensure that the study treatment protocol was comparable to routine clinical practice and the style of treatment was consistent with the techniques applied. For instance, a study claiming to be based on Chinese medicine but not eliciting deqi or only using a single needle would be considered inappropriate. Likewise, a treatment using appropriate Chinese medicine point selection but with only a single treatment would also be viewed as inadequate.

Assessment is based the on the following parts of the STRICTA table (Appendix 10).

  • Acupuncture style

  • Rationale for treatment/points used

  • Literature sources

  • Uni/bilateral

  • Number of needles inserted

  • Depth of insertion

  • Response elicited

  • Type of needle stimulation (electro/manual with or without tonification/dispersion etc.)

  • Needle retention time

  • Number of treatment sessions

  • Frequency of treatments

From the list above, the review authors were required to judge if the acupuncture treatment performed was suitable for the style of acupuncture stated in the rationale for treatment. The experienced acupuncturists (JD, ZZ, JSS, SS) on the team rated the studies as low, medium or high according to whether the acupuncture treatment protocol was adequate. If there was insufficient information, we marked the study as 'insufficient information'.

Confidence in the diagnosis and treatment delivery

The determination of confidence in the administration of the acupuncture treatments was based on whether the person making the diagnosis, delivering the treatment or both was trained to the industry standard in that style. For example, L.Ac (licensed acupuncturist) would indicate meeting the USA standard. We used information about practitioners' training and practice background from STRICTA (Appendix 10) and information about the trial procedure to assess the level of confidence. For instance, it would be inappropriate to have an acupuncturist trained in Japanese/meridian style, i.e. shallow needling on acupuncture points, to provide Chinese acupuncture. Equally, we did not consider it appropriate that acupuncturists who had no Chinese medicine differential diagnosis training to deliver Chinese medicine diagnosis and treatment, unless a well-explained protocol was in place or pre-trial training was given and competence of the trial acupuncturists was assessed prior to the commencement of the study. The review authors rated their confidence at three levels: low, medium or high.

Measures of treatment effect

We analysed the data according to the Cochrane guidelines. To examine the immediate effect, we used completed data at up to one month after the end of the treatment. This method has been used in other reviews (Vickers 2012). To examine the long-term effect, we extracted data collected up to seven months after the end of the treatment. We plotted outcomes from each study as point estimates with corresponding 95% confidence intervals (CI) expressed as mean differences (MD) for continuous outcomes using the same scale, such as a 0 to 100 VAS for the measurement of pain or standardised mean differences (SMD) for continuous outcomes that used different scales, such as VAS and NRS for pain. We reported the number of adverse events and the number of drop-outs due to adverse events using risk ratios (RR). We also analysed data at one and up to seven months after treatment.

When ranges of data were presented, we calculated the standard deviations (SD) as advised and checked by the statistician from the Cochrane Musculoskeletal Group (CMSG) according to the Cochrane guidelines. With studies using more than one control arm we combined them as per the Cochrane guidelines (Higgins 2011).

Dealing with missing data

We contacted the authors of the included/excluded articles to obtain further information. We received responses to queries from the authors of Assefi 2005 (via the last author of the article); Deluze 1992; Harris 2005; Harris 2008; Harris 2009; Itoh 2010; Martin 2006; Sprott 1998; Targino 2008.

Assessment of reporting biases and small sample biases

For studies published after 1 July 2005, we screened the Clinical Trial Register via the International Clinical Trials Registry Platform of the World Health Organization (http://www.who.int/ictrp/en/) and compared the outcome measures described in the registry with those reported in the publications to assess whether selective reporting of outcomes was present (outcome reporting bias).

As planned, we compared the fixed-effect estimate against the random-effects model to assess the possible presence of small sample bias in the published literature given that the random-effects estimate of the intervention is more beneficial than the fixed-effect estimate in the presence of small sample bias (Higgins 2011). We found no difference between the two analyses in any outcome measures except for pain under the comparison of acupuncture versus sham acupuncture. The result of the random-effects model was more conservative than the fixed-effect model. Thus, we reported only the results from random-effects model.

If there were sufficient studies (> 10 studies with the same outcome), we planned to assess for publication bias using a funnel plot (Sutton 2000). This was not conducted due to an insufficient number of trials.

Data synthesis

As recommended by the Cochrane Musculoskeletal Group editor, we used the random-effects model as the default for data synthesis.

Subgroup analyses and assessment of heterogeneity

When there were sufficient appropriate data, we planned subgroup analyses to assess the effect of different types of acupuncture: 1) manual acupuncture versus electro-acupuncture; 2) shallow needling versus deep needling; 3) different forms of sham/placebo acupuncture.

We used the I2 statistic to describe the percentage variability of effect estimates that were due to heterogeneity. If there was substantial statistical heterogeneity (I2 value of 50% or more) (Higgins 2011), we examined the characteristics of individual studies to determine possible causes.

Sensitivity analyses

We also planned to conduct sensitivity analyses to examine whether aspects of methodological quality influence the effect size. For example, did inadequate or unclear concealment of allocation or failure to blind outcome assessors change the overall effect estimate of our meta-analysis for pain?

'Summary of findings' tables

We presented the main outcomes (pain, physical function, global well-being (rated by participants), sleep, fatigue, stiffness and adverse events (Arnold 2011)) in 'Summary of findings' tables. The tables include an overall grading of the evidence using the GRADE approach of high, moderate, low and very low quality:

  • High quality: further research is very unlikely to change our confidence in the estimate of effect.

  • Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.

  • Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.

  • Very low quality: we are very uncertain about the estimate.

The 'Summary of findings' tables also contain the available data on the main outcomes as the calculations for statistically significant outcomes, and the number needed to treat (NNT) as recommended by The Cochrane Collaboration (Higgins 2011).

For continuous outcomes, we calculated the NNT using the Wells calculator software, available from the Cochrane Musculoskeletal Group editorial office (www.cochranemsk.org), which requires a minimal clinically important difference for input into the calculator. For pain we used a 1.5-point difference out of a 0 to 10 scale or 15 out of 0 to 100 scale as a minimal clinically important change. For global well-being, we used 14 out of 100 as a minimal clinically important change as recommended by Bennett 2009 for dealing with FIQ data. For sleep, fatigue, stiffness (Martin 2006) and physical function (Harris 2005), we used 13 out of 100 or 1.3 out of 10 as a minimal clinically important change (Bennett 2009). We calculated absolute change (benefit) from the mean difference or standard mean difference and expressed this as a per cent and in the original units, and calculated relative difference in the change from baseline as the absolute benefit divided by the baseline mean of the control group.

Results

Description of studies

Detailed data are summarised in the tables 'Characteristics of included studies' and 'Characteristics of excluded studies'.

Total studies located for this review

We conducted our initial search in 2008, updated it in May 2010 and then updated it again in January 2012. The search period ranged from the inception of the databases to the end of December 2011. The study selection process is illustrated in Figure 1. The search resulted in 439 studies from the English databases and 63 from Chinese databases. After removing duplicates and irrelevant papers, we identified 49 acupuncture trials for fibromyalgia, including 17 papers in English, 24 in Chinese, four in German, two in Italian, one in Spanish and one in Swedish.

Studies excluded from the review

We excluded 40 studies for the following reasons:

Studies included in the review

Nine RCTs and one quasi-RCT were included. Five studies were conducted in the United States of America (Assefi 2005 n = 96; Harris 2005 n = 56; Harris 2008 n = 10; Harris 2009 n = 20; Martin 2006 n = 49), one in Switzerland (Deluze 1992 n = 55), one in Brazil (Targino 2008 n = 58), one in Japan (Itoh 2010 n = 13) and one quasi-RCT in China (Guo 2005 n = 38). All studies were published in English except for one published in Chinese.

Participants

In total 395 participants were involved. The authors of the selected papers explained their inclusion and exclusion criteria well except for Guo 2005, which only reported inclusion without exclusion criteria. All studies used acupuncture-naive participants except for Targino 2008, while Guo 2005 did not report this. Targino 2008 admitted participants into their study if they had not received acupuncture in the last 12 months. All studies reported using ACR fibromyalgia criteria for the selection of participants. However, confirmation of the diagnosis before commencement of the studies was reported in only four studies (Assefi 2005; Itoh 2010; Martin 2006; Targino 2008). Assefi 2005 used a researcher trained in tender point examination, Itoh 2010 obtained participants direct from fibromyalgia specialists at hospitals, Martin 2006 used a rheumatologist and Targino 2008 used a physician. The other five studies did not report whether or not they performed a confirmation of diagnosis (Deluze 1992; Guo 2005; Harris 2005; Harris 2008; Harris 2009).

Sample size

All included studies clearly explained their sample size calculation except for Guo 2005, Harris 2008, Harris 2009 and Itoh 2010. The sample size ranged from four participants to 36 per arm.

Main outcomes

Main outcome measurement tools varied. Five studies (Assefi 2005; Deluze 1992; Guo 2005; Itoh 2010; Targino 2008) used a VAS for measuring pain. Other measurement tools for pain included Regional Pain Score (Deluze 1992), Numeric Rating Scale (Harris 2005), Multidisciplinary Pain Inventory (Martin 2006) and Short Form of the McGill Pain Questionnaire (Harris 2008; Harris 2009). Three studies measured quality of life (SF-36). Assefi 2005 used SF-36 including the Physical and Mental component, Harris 2005 the SF-36 Physical component, and Targino 2008 reported all eight domains of SF-36. Two studies measured function using the FIQ (Itoh 2010; Martin 2006), which is labelled as global well-being in the current review. Five studies did not include a follow-up phase after the end of the treatment (Deluze 1992; Harris 2005; Harris 2008; Harris 2009; Itoh 2010). The remaining four had follow-ups at different time points with Assefi 2005 at the 3rd and 6th months after the end of the treatment; Guo 2005 at the 6th month; Martin 2006 at the 1st and 7th months; and Targino 2008 at the 3rd, 6th, 12th and 24th months.

Withdrawal/drop-outs

All studies reported withdrawal, drop-outs or both except for Guo 2005, however the reported data indicated there were no drop-outs. The most common reason for withdrawal or drop-out was time constraint, followed by worsening of fibromyalgia symptoms and scheduling conflicts (e.g. appointments). The serious events for discontinuing participation were: one experienced heart attack from the acupuncture group (Assefi 2005); three hospitalisations with one from the acupuncture group and two from the control group; one ankle oedema from the acupuncture group (Deluze 1992), which was the only case that authors reported to be directly related to the acupuncture treatment (ankle oedema). The heart attack and the hospitalisation cases were not explained and connections with interventions were not established. The low drop-out rate may suggest the treatments were well tolerated by the participants.

Assessment of the quality of the acupuncture treatments

STRICTA

Reporting of the acupuncture treatments was generally adequate with the exception of Guo 2005 and Itoh 2010, being the poorest. Upon our request, some authors provided missing details via e-mails, however based on the published papers as they were, it would have been impossible to reproduce any of the studies accurately (Appendix 10).

Adequacy of acupuncture treatment protocol

Reporting of the rationale of the acupuncture treatment was insufficient, making it difficult for us to give a rating. Considering all 11 criteria, we rated the studies as 'medium' for all studies except for Guo 2005 and Itoh 2010, which we noted as 'insufficient data'. Six studies (Deluze 1992; Guo 2005; Harris 2005; Harris 2009; Itoh 2010; Martin 2006) actually stated the acupuncture style, while the rest did not report the style. Based on how they reported the acupuncture treatment, we inferred that it was 'formula acupuncture' (symptom alleviation), using a set of fixed acupuncture points.

None of the studies stated whether they had made a diagnosis according to Chinese medicine, except for Deluze 1992, but there was insufficient information to confirm this. Deluze 1992 stated that they individualised treatment and provided references to support their decision. However, the authors failed to report their Chinese medicine diagnosis.

The justification of acupuncture point selection deserved some attention. Only one study provided journal references for their decision on point selection and choice of electro-acupuncture (Deluze 1992). This study reported, however, only two mandatory acupuncture points without detailing the other eight optional points. Assefi 2005 commented that no gold standard existed for acupuncture point selection in the treatment of fibromyalgia, with the authors consulting three experienced acupuncturists in treating fibromyalgia for their point selection. Guo 2005 did not state what acupuncture points were used, instead naming the channels/meridians they used. They considered 'Back Shu' points along the Bladder meridian important to strengthen Liver, Spleen and Kidney when treating Bi-Syndrome, a Chinese medicine term for a series of rheumatic conditions, including fibromyalgia. Harris 2005 chose acupuncture points based on their "ability to relieve fibromyalgia symptoms in CM", however this was referenced to a textbook that does not specify Chinese medicine treatments for fibromyalgia. Harris 2008 and Harris 2009 referenced their 2005 trial for their acupuncture point selection. Itoh 2010 did not explain. Martin 2006 stated they used "strong regulatory points that commonly recur in acupuncture literature", yet provided neither reference nor stated the acupuncture points used on the back (published a small diagram of areas used). They also stated that their acupuncture point selection might not be optimal as judged by others, but did not provide the reason. Targino 2008 used "classical acupuncture points" and they referenced an acupuncture point location book that does not include fibromyalgia. The most commonly used point in all included studies was He Gu (LI4), followed by Zu San Li (ST36).

With the reporting of unilateral/bilateral needling details, Assefi 2005, Deluze 1992, Guo 2005 and Itoh 2010 did not state which side they inserted the needles on, while Martin 2006, Harris 2005 and Harris 2009 provided diagrams. Harris 2008 based the treatment on their 2005 trial. Except for Deluze 1992, Guo 2005 and Itoh 2010 the number of needles used was clearly stated. Reporting the depth of needle insertion was clear in all studies except for Guo 2005, which we thought was subcutaneous because the needling technique was "point to point threading" along the back meridian/channels. Reporting of elicitation of deqi was clear except for Assefi 2005, Guo 2005 and Itoh 2010; two stated "stimulation" without mentioning deqi (Assefi 2005; Itoh 2010) and the other did not report this (Guo 2005). The description of the type of needle stimulation/manipulation (e.g. lifting/thrusting/even etc.) was clear in only three studies (Harris 2005; Harris 2009; Itoh 2010). With the electro-acupuncture studies (Deluze 1992; Itoh 2010; Martin 2006) both reported Hz but not where the red/black clips went or what type of stimulation setting was used, such as 'continuous'. Needle gauge/length/manufacturer or material varied greatly and were not well reported by some.

Needle retention time ranged from 20 to 30 minutes. Four studies treated the participants for 30 minutes (Assefi 2005; Guo 2005; Harris 2005; Itoh 2010), two for 25 minutes (Harris 2008; Harris 2009) and two for 20 minutes (Martin 2006; Targino 2008). One did not report the needling duration (Deluze 1992). The median duration of acupuncture treatment sessions was four weeks (range 3 to 13). Two had six sessions (Deluze 1992; Martin 2006), with the remainder, nine (Harris 2008; Harris 2009), 10 (Itoh 2010), 18 (Harris 2005), 20 (Targino 2008), 24 (Assefi 2005) and 28 sessions (Guo 2005). Itoh 2010 was a cross-over study and we used data before cross-over for analysis; that is after five sessions of treatment. Frequency of treatments was similar in most studies, with twice weekly being the commonest (Assefi 2005; Deluze 1992; Martin 2006; Targino 2008). Two trials (Harris 2008; Harris 2009) had nine sessions over four weeks, another (Harris 2005) gave 18 sessions over 13 weeks, while one (Itoh 2010) delivered weekly and the remainder (Guo 2005) daily treatment. 

Confidence in the treatment delivery

We rated our confidence that acupuncture treatments were appropriately delivered by skilled practitioners as 'high' for Assefi 2005 and Harris 2005 and 'medium' for Targino 2008. The remaining studies (Deluze 1992; Guo 2005; Harris 2008; Harris 2009; Itoh 2010; Martin 2006) we noted as 'insufficient data'. 

Adverse events

Reporting of adverse events was inconsistent. Only two studies provided details of the number of events (Assefi 2005; Targino 2008). With the remaining studies, three did not report any (Harris 2005; Harris 2008; Harris 2009), which the author confirmed as nil. Two (Deluze 1992; Itoh 2010) cited them as withdrawals, one (Martin 2006) discussed them in the results without labelling them as adverse events and one (Guo 2005) did not report any.

None of the studies reported serious adverse events. The worst events that could directly be attributed to an acupuncture treatment were oedema of the left hand and ankle, despite a lack of evidence of a causal relationship (Targino 2008). Two cases of vasovagal symptoms reported by Martin 2006 were likely due to the posture of the participants. The author did not explain which treatment group the cases were in. In that study, all participants received acupuncture treatment seated without a back support for 20 minutes, which is not a common practice (participants are mostly in a prone or supine position), however it allowed the participants to be blinded. This type of adverse event could be prevented or reduced with correct posture as suggested by the author.

Subgroup analyses

We undertook subgroup analyses within the comparison of acupuncture versus placebo/sham acupuncture to compare electro- and manual acupuncture for the outcome of pain, fatigue, sleep and global well-being (rated by participants) as data were available for those outcome measures. We also undertook a subgroup analyses of studies using sham acupuncture without breaking the skin (Assefi 2005; Harris 2008; Harris 2009; Martin 2006) versus studies using breaking-skin sham interventions (Assefi 2005; Deluze 1992; Harris 2005). One arm of the control (simulating) in Assefi 2005 and the sham controls in Harris 2008 and Harris 2009 used a tooth pick in an acupuncture guide tube, which has been shown in other studies of back pain to be indistinguishable (Sherman 2002). Martin 2006 indented the skin with a blunt probe and placed over the area a small circular plaster rigged with an acupuncture needle that stuck out; they stated that preliminary trials showed volunteers could not tell the difference.

Publication bias

We did not perform the planned publication bias funnel plot analysis due to an insufficient number of selected studies (Sutton 2000).

Sensitivity analyses

We could not conduct planned sensitivity analyses due to a lack of trials with and without adequate concealment of allocation; or with and without blinded outcome assessor under one comparison. For instance, under the comparison of real and sham acupuncture, all six studies were at low risk of selection bias with adequate concealment of treatment allocation, using no treatment as the control, and at low risk of detection bias with outcome assessors being blinded (Assefi 2005; Deluze 1992; Harris 2005; Harris 2008; Harris 2009; Itoh 2010; Martin 2006). Two studies were at higher risk of selection bias with unclear or inadequate allocation concealment and had a high risk of detection bias with inadequate or unclear blinding of outcome assessor (Guo 2005; Targino 2008). They were, however, under different comparison categories and contained only one study in each. Itoh 2010 had a moderate risk of bias as a non-acupuncture treatment control was used.

Risk of bias in included studies

All studies were described as RCTs. Adequate sequence generation and allocation concealment were well described and adequate in all included studies except for Guo 2005, which used order of admission for randomisation (quasi-randomisation) and Martin 2006, which did not say how the sequence was generated. All studies used acupuncture-naive participants except for Guo 2005 (who did not report this) and Targino 2008 (patients had not had acupuncture in the last 12 months). Four studies tested for assessment of masking/blinding (Assefi 2005; Harris 2005; Harris 2009; Martin 2006) and found no difference between groups. Five studies blindfolded their participants (Assefi 2005; Harris 2005; Harris 2008; Harris 2009), while Martin 2006 blocked the vision of the participants. All used blinded assessors except for Guo 2005, which did not report this. All studies showed no missing data except for Deluze 1992 and Itoh 2010, which did not include participants who dropped out from the study in their data analysis, while Guo 2005 did not report this specifically. All reported numbers lost to follow-up except for Guo 2005, which did not report this but no participant was missing from the reported data. In terms of selective reporting, only Assefi 2005, Harris 2005 and Targino 2008 were registered with the International Clinical Trials Registry Platform of the World Health Organization and we found that the outcome measures reported were same as those included in the published protocols. Among the remainder, one did not know about it (Martin 2006), one did not need to report it as it was before the establishment of the Registry (Deluze 1992), whereas the others did not list this (Guo 2005; Harris 2008; Harris 2009; Itoh 2010) (Figure 2; Figure 3).

Figure 2.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Figure 3.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Effects of interventions

See: Summary of findings for the main comparison Acupuncture versus non-acupuncture for treating fibromyalgia; Summary of findings 2 Acupuncture versus placebo or sham acupuncture for treating fibromyalgia; Summary of findings 3 Acupuncture versus medication for treating fibromyalgia; Summary of findings 4 Acupuncture as an adjunct therapy for treating fibromyalgia; Summary of findings 5 Deep invasive acupuncture stimulation versus non-stimulated acupuncture for treating fibromyalgia

1) Real acupuncture versus non-acupuncture treatment

One study in this category (Itoh 2010) included 13 participants and compared electro-acupuncture plus trigger point acupuncture with no acupuncture treatment. This was a cross-over study, and we used data before cross-over for analysis, that is after five sessions of treatment at the end of week five of a 10-week treatment programme.

Main outcome measure 1: Pain

Pain severity was measured using a VAS (100 mm). It showed a statistically significant reduction in pain for those treated with real acupuncture compared with no acupuncture at the end of treatment (mean difference (MD) -22.40 points on a 100-point scale; 95% confidence interval (CI) -40.98 to -3.82, P = 0.02), favouring acupuncture (Analysis 1.1).

Main outcome measure 2: Global well-being; rated by participant

Global well-being was measured using the Fibromyalgia Impact Questionnaire (FIQ) 100-point scale. It showed a statistically significant group difference at the end of treatment (MD -15.40 points on a 100-point scale; 95% CI -25.62 to -5.18, P = 0.003), favouring acupuncture (Analysis 1.2).

Main outcome measure 3: Sleep

Sleep was measured using the subset 'rested' on the FIQ. It showed no statistically significant group difference at the end of treatment (MD -0.40 points on a 10-point scale; 95% CI -1.01 to 0.21, P = 0.20) (Analysis 1.3).

Main outcome measure 4: Fatigue

Fatigue was measured using the subset 'fatigue' on the FIQ. It showed a statistically significant group difference at the end of treatment (MD -1.10 points on a 10-point scale; 95% CI -1.98 to -0.22, P = 0.01), favouring acupuncture (Analysis 1.4).

Main outcome measure 5: Stiffness

Stiffness was measured using the subset 'stiffness' on the FIQ. It showed a statistically significant group difference at the end of treatment (MD -0.90 points on a 10-point scale; 95% CI -1.66 to -0.14, P = 0.02), favouring acupuncture (Analysis 1.5).

Main outcome measure 6: Adverse events

No adverse events were reported, only withdrawals and drop-outs. One patient from the acupuncture group and two from the control group left the study as their condition was not improving.

Minor outcome measure 1: Mental well-being

Mental well-being was measured using the subset 'depression' on the FIQ. It showed no statistically significant group difference at the end of treatment (MD -0.50 points on a 10-point scale; 95% CI -1.10 to 0.10, P = 0.10) (Analysis 1.7).

Long-term effect of acupuncture

There was no follow-up and long-term effect was not measured.

2) Real acupuncture versus placebo or sham acupuncture

Main outcome measure 1: Pain up to one month after treatment

Six studies totaling 286 participants were in this category (Assefi 2005; Deluze 1992; Harris 2005; Harris 2008; Harris 2009; Martin 2006). Measurement tools used included VAS (0 to 10 cm and 0 to 100 mm), numerical pain rating scale (NRS), Multidimensional Pain Inventory (MPI) and McGill Pain Questionnaire (SF-MPQ). Pooled analysis of the six studies showed no statistically significant difference between the groups in reducing pain (standardised mean difference (SMD) -0.14; 95% CI -0.53 to 0.25, P = 0.48; corresponding to a reduction of 2.8 points on a 100-point scale) (Analysis 2.1). Moderate heterogeneity was found (I2 = 54%, P = 0.05) and is likely due to the two forms of acupuncture, electro- and manual, employed in the different studies.

Pain subgroup analysis (electro- versus manual acupuncture)

Pooled subgroup analysis of two electro-acupuncture studies, including 104 participants (Deluze 1992; Martin 2006), indicated that real electro-acupuncture was statistically significantly better than sham electro-acupuncture in reducing pain (SMD -0.63; 95% CI -1.02 to -0.23, P = 0.002, about 13 points on a 100-point scale) (Analysis 2.1) up to one month after treatment, with low heterogeneity (I2 = 0%, P = 0.72). Subgroup analysis of four manual acupuncture studies, including 182 participants (Assefi 2005; Harris 2005; Harris 2008; Harris 2009) showed no group difference between real and sham manual acupuncture in reducing pain (SMD 0.14; 95% CI -0.17 to 0.45, P = 0.37, 2.8 points on a 100-point scale) (Analysis 2.1), with no heterogeneity (I2 = 0%, P = 0.57). There was a statistically significant subgroup difference between electro- and manual acupuncture (Chi2 = 8.94, P = 0.003).

Main outcome measure 2: Physical function (SF-36) up to one month after treatment

One study totaling 56 participants was in this category (Harris 2005). Physical function was measured with the SF-36. Analysis of the study indicated that sham manual acupuncture was superior to manual acupuncture in improving SF-36 physical function (MD -5.80 points on a 100-point scale; 95% CI -10.91 to -0.69, P = 0.03, Analysis 2.4).

Main outcome measure 3: Global well-being: rated by participants up to one month after treatment

Three studies totaling 200 participants were in this category (Assefi 2005; Deluze 1992; Martin 2006). Measurement tools included VAS and FIQ. Pooled analysis of the three studies showed no statistically significant difference between real and sham acupuncture (SMD 0.29; 95% CI -0.44 to 1.01, P = 0.44, 5.8 points on a 100-point scale) (Analysis 2.5), with high heterogeneity (I2 = 81%, P = 0.003). This is likely due to the two forms of acupuncture, electro- and manual, employed in the different studies.

Global well-being subgroup analysis (electro-acupuncture versus manual acupuncture)

Pooled subgroup analysis of two electro-acupuncture studies with 104 participants (Deluze 1992; Martin 2006) indicated that real electro-acupuncture was statistically significantly better than sham electro-acupuncture in reducing global well-being as rated by participants (SMD 0.65; 95% CI 0.26 to 1.05, P = 0.001, about 11 points on a 100-point scale) (Analysis 2.5), up to one month after treatment, with low heterogeneity (I2 = 0%, P = 0.99). Subgroup analysis of one manual acupuncture study of 96 participants (Assefi 2005) showed no difference between real and sham manual acupuncture (SMD -0.40; 95% CI -0.86 to 0.06, P = 0.09, about eight points worse on a 100-point scale) (Analysis 2.5). Subgroup comparison indicated that electro-acupuncture was statistically significantly better than manual acupuncture in improving global well-being as rated by participants up to one month after treatment (Chi2 = 11.49 , P = 0.0007).

Main outcome measure 4: Sleep up to one month after treatment

Three studies totaling 200 participants were in this category (Assefi 2005; Deluze 1992; Martin 2006). Sleep quality was measured with a VAS sleep scale and the subset 'rested' on the FIQ. Pooled analysis showed no statistically significant difference with real acupuncture when compared with sham interventions (SMD 0.16; 95% CI -0.29 to 0.61, P = 0.49, about 3.2 points on a 100-point scale) (Analysis 2.7), with moderate heterogeneity (I2 = 56%, P = 0.10).

Sleep subgroup analysis (electro-acupuncture versus manual acupuncture)

Pooled subgroup analysis of two electro-acupuncture studies with 104 participants (Deluze 1992; Martin 2006) indicated that real electro-acupuncture was statistically significantly better than sham electro-acupuncture in improving sleep quality (SMD 0.40; 95% CI 0.01 to 0.79, P = 0.05, about eight points on a 100-point scale) (Analysis 2.7) up to one month after treatment, with low heterogeneity (I2 = 0%, P = 0.74). Subgroup analysis of one manual acupuncture study with 96 participants (Assefi 2005) showed no difference between real and sham manual acupuncture in improving sleep (SMD -0.25; 95% CI -0.71 to 0.21, P = 0.29, five points worse on a 100-point scale) (Analysis 2.7). Subgroup comparison indicated that electro-acupuncture was statistically significantly better than manual acupuncture in improving sleep up to one month after treatment (Chi2 = 4.44 , P = 0.04).

Main outcome measure 5: Fatigue up to one month after treatment

Three studies totaling 201 participants were in this category (Assefi 2005; Harris 2005; Martin 2006). Fatigue was measured with a VAS, the Multidimensional Fatigue Inventory (MFI) and the subset 'fatigue' on the FIQ. Pooled analysis showed no statistically significant difference between real and sham acupuncture in reducing fatigue (SMD -0.10; 95% CI -0.81 to 0.61, P = 0.78, about 1.7 points on a 100-point scale, Analysis 2.9), with high heterogeneity (I2 = 82%, P = 0.004). This is likely due to the two forms of acupuncture, electro- and manual, being employed in the different studies.

Fatigue subgroup analysis (electro-acupuncture versus manual acupuncture)

Subgroup analysis of one electro-acupuncture study (Martin 2006) of 49 participants indicated that real electro-acupuncture was statistically significantly better than sham electro-acupuncture in reducing fatigue (SMD -0.85; 95% CI -1.44 to -0.27, P = 0.004, about 15.3 points on a 100-point scale) (Analysis 2.9) up to one month after treatment. Pooled subgroup analysis of two manual acupuncture studies (Assefi 2005; Harris 2005) with 152 participants showed no group difference between real and sham manual acupuncture in reducing fatigue (SMD 0.26; 95% CI -0.08 to 0.61, P = 0.13, about 4.3 points worse on a 100-point scale) (Analysis 2.9), with low heterogeneity (I2 = 0%, P = 0.39). Subgroup comparison indicated that electro-acupuncture was statistically significantly better than manual acupuncture in improving fatigue up to one month after treatment (Chi2= 10.31, P = 0.001).

Main outcome measure 6: Stiffness up to one month after treatment

Two studies totaling 104 participants using electro-acupuncture treatment (Deluze 1992; Martin 2006) were in this category. Stiffness was measured as minutes (Deluze 1992) and the subset 'stiffness' on the FIQ (Martin 2006). Pooled analysis showed that real electro-acupuncture was statistically significantly better than sham electro-acupuncture in improving stiffness (SMD -0.45; 95% CI -0.84 to -0.06, P = 0.02, nine points on a 100-point scale) (Analysis 2.11) up to one month after treatment, with low heterogeneity (I2 = 0%, P = 0.42).

Main outcome measure 7: Adverse events

There were no serious adverse events reported. Minor adverse events were reported in 11 out of 113 participants in the acupuncture groups and 58 out of 156 in the control groups (risk ratio (RR) 0.44; 95% CI 0.12 to 1.63, P = 0.22, Analysis 2.13), with moderate heterogeneity (I2 = 67%, P = 0.05). This could be due to the three sham groups in one study (Assefi 2005) reporting over 60% adverse events; this was much higher than the other studies, which were typically under 30%.

Minor outcome 1: Mental well-being up to one month after treatment

One study totaling 49 participants using electro-acupuncture was in this category (Martin 2006). Mental well-being was measured with the subset 'depression' of the FIQ. Analysis showed a statistically significantly better result with real electro-acupuncture when compared to sham electro-acupuncture in improving mental well-being (MD -1.70 points on a 10-point scale; 95% CI -3.13 to -0.27, P = 0.02) (Analysis 2.14), up to one month after treatment.

Minor outcome measure 2: Analgesic use (number of tablets) up to one month after treatment

One study with 55 participants using electro-acupuncture treatment (Deluze 1992) measured analgesic use by the number of tablets per week. There was no difference between real and sham electro-acupuncture (MD -3.20 tablets less per week; 95% CI -10.20 to 3.80, P = 0.37) (Analysis 2.16).

Minor outcome measure 3: Analgesic use (number of participants) up to one month after treatment

One study with 80 participants using manual acupuncture treatment (Assefi 2005) measured analgesic use by number of participants taking analgesics. There was no difference between real and sham manual acupuncture (RR 0.94; 95% CI 0.66 to 1.32, P = 0.71) (Analysis 2.17).

Minor outcome 4: Tenderness up to one month after treatment

One study with 55 participants using electro-acupuncture treatment (Deluze 1992) measured pressure pain threshold (kg/cm2). Electro-acupuncture was better than sham electro-acupuncture in enhancing pain thresholds (MD 0.80 kg/cm2 higher; 95% CI 0.02 to 1.58, P = 0.04) (Analysis 2.18), up to one month after treatment.

Minor outcome measure 5: Overall well-being: rated by care giver

One study with 55 participants using electro-acupuncture treatment (Deluze 1992) reported overall well-being rated by care givers. Analysis showed a statistically significantly better result with real electro-acupuncture when compared with sham electro-acupuncture (MD 2.00 points on a 10-point scale; 95% CI 0.81 to 3.19, P = 0.001) (Analysis 2.19), up to one month after treatment.

Long-term effects of acupuncture

Two studies (Assefi 2005; Martin 2006) measured long-term effects of acupuncture for up to seven months after the end of the treatment. There was no difference between real and sham acupuncture on any outcome measures, including pain (Analysis 2.2), global well-being (Analysis 2.6), sleep (Analysis 2.8), fatigue (Analysis 2.10), stiffness (Analysis 2.12) and mental well-being (Analysis 2.15). Subgroup comparison indicated that electro-acupuncture was not statistically significantly better than manual acupuncture at improving any of the outcomes at seven months after treatment.

Sham non-invasive (not breaking skin) acupuncture versus sham invasive (breaking skin) acupuncture

Four studies (Assefi 2005; Harris 2008; Harris 2009; Martin 2006) with 116 participants using non-invasive sham acupuncture were compared with three studies (Assefi 2005; Harris 2005; Deluze 1992) with 170 participants using invasive sham interventions. There was no statistically significant difference between the two subgroups on pain rating (Chi2 = 0.40, P = 0.53, Analysis 2.3).

3) Real acupuncture versus standard or usual care (medication)

One study in this category (Guo 2005) included 38 participants and compared manual acupuncture with Western medicine (amitriptyline).

Main outcome measure 1: Pain at up to one month after treatment

Pain severity was measured using a VAS. It showed a statistically significant group difference favouring acupuncture (MD -17.30 points on a 100-point scale; 95% CI -24.13 to -10.47, P < 0.00001) (Analysis 3.1).

Main outcome measure 2: Adverse events

No adverse events were reported, however all participants were included in the final analyses. No withdrawals or drop-outs were reported either.

Minor outcome measure 1: Number of tender points at up to one month after treatment

A statistically significant group difference was shown for number of tender points, favouring acupuncture (MD -4.00 number of tender points; 95% CI -6.73 to -1.27, P = 0.004) (Analysis 3.3).

Long-term effect of acupuncture at the sixth month after treatment

The authors stated there was follow-up at six months but no data were provided.

The poor reporting of the trial raises questions about its quality. For example, the authors claimed 'cure' of 12 fibromyalgia participants, with nine in the acupuncture group and three in the control, without a definition of what 'cure' was, except for saying "signs and symptoms free with no tender point" without further explanation as to which time point these were measured at.

4) Real acupuncture as an adjunct therapy

One study in this category (Targino 2008) with 58 participants compared manual acupuncture plus standard therapy, which included tricyclic antidepressants and exercise, with standard therapy alone.

Main outcome measure 1: Pain at up to one month after treatment

Pain severity was measured using a VAS. It showed a statistically significant group difference favouring acupuncture (MD -3.00 points on a 10-point scale; 95% CI -3.90 to -2.10, P < 0.00001) (Analysis 4.1).

Main outcome measure 2: Adverse events

There were no serious adverse events reported. No group difference in the number of minor adverse events was found (RR 3.57; 95% CI 0.18 to 71.21, P = 0.40) (Analysis 4.3).

Minor outcome measure 1: Tenderness - number of tender points below kg/cm2 up to one month after treatment

Tenderness was measured the number of tender points below the threshold. The results showed a statistically significant group difference favouring acupuncture (MD -4.50 number of tender points; 95% CI -6.20 to -2.80, P < 0.00001) (Analysis 4.4).

Minor outcome measure 2: Tenderness - mean pressure threshold by pressure algometry at end of treatment

Tenderness was measured with the mean pressure threshold (kg/cm2). The results showed a statistically significant group difference (MD 0.70 kg/cm2; 95% CI 0.41 to 0.99, P < 0.00001) (Analysis 4.6), favouring acupuncture.

Long-term effect of acupuncture (follow-up at six months)

At the six-month follow-up, the acupuncture as an adjunct therapy group continued to be better than the standard therapy alone group for tender points (MD -2.00 number of tender points; 95% CI -3.51 to -0.49, P = 0.009) (Analysis 4.5) and mean pressure pain threshold (MD 0.60 kg/cm2; 95% CI 0.26 to 0.94, P = 0.0005) (Analysis 4.7) but not pain (MD -0.50 points on a 10-point scale; 95% CI -1.49 to 0.49, P = 0.37) (Analysis 4.2).

5) A particular style of acupuncture versus another (deep invasive needling with stimulation (deqi) (T/S) versus deep invasive needling without stimulation (T/O))

Two different styles of acupuncture, deep needling using manual acupuncture on the point with stimulation to achieve deqi as in traditional Chinese acupuncture (T/S) versus deep needling on the point without stimulation (T/O), were compared in one study of 41 participants (Harris 2005).  

Main outcome measure 1:  Pain at the end of the treatment

Pain was measured using the NRS. It showed no statistically significant difference between the two interventions (MD 0.30 on a 10-point scale; 95% CI -18.34 to 18.94, P = 0.97) (Analysis 5.1).

Main outcome measure 2: Physical function (SF-36) at the end of the treatment

Physical function was measured using the SF-36 (physical). There was no group difference between the two interventions (MD -5.50 points on a 100-point scale; 95% CI -11.43 to 0.43, P = 0.07) (Analysis 5.2).

Main outcome measure 3: Fatigue at the end of the treatment

Fatigue was measured using the MFI. There was no group difference between the two interventions (MD 1.10 points on 20-point scale; 95% CI -1.41 to 3.61, P = 0.39) (Analysis 5.3).

Discussion

Summary of main findings

Out of 124 studies screened, we identified nine randomised controlled trials (RCTs) involving 395 participants. Most of the studies were excluded because of insufficient data. All selected studies used a fixed set of acupuncture points (formula acupuncture) with six using manual acupuncture and three electro-acupuncture.

When compared with the group not receiving acupuncture, the acupuncture treatment group improved in terms of pain, global well-being, fatigue and stiffness, but not sleep. We found no difference between real and sham acupuncture on any outcome measures except for stiffness and physical functioning. Stiffness was measured in two electro-acupuncture studies, which showed a moderate effect of electro-acupuncture over sham interventions. On the contrary, sham intervention produced better improvement in physical functioning. Subgroup analyses demonstrated that electro-acupuncture was consistently better than manual acupuncture in eliciting moderate benefits on pain, fatigue, sleep and global well-being as rated by participants.

Comparing acupuncture with standard pharmacotherapy (amitriptyline), the result of a single trial favoured acupuncture for pain and muscle tenderness. The quality of that paper was poor, affecting the validity of the result. One study examined acupuncture as an adjunct therapy to standard care comprising of a tricyclic antidepressant and exercise and found an additive effect of acupuncture for pain relief and reduction of muscle tenderness.

Measurement of treatment effects was within one month of the end of treatment. Many effects of acupuncture were short-lasting and not maintained at six to seven-month follow-ups. Adverse events reported were mild and no difference between real and sham acupuncture, or other control interventions, was found.

Overall, there is a low to moderate level of evidence indicating that formula acupuncture could be a safe option for fibromyalgia. There is a low to moderate level of evidence that acupuncture is better than non-acupuncture, Western medication and standard therapy in improving pain and stiffness for people with fibromyalgia. There is a moderate level of evidence that the effect of acupuncture does not differ from sham acupuncture in terms of reduction of pain, fatigue, improvement of sleep or global well-being. Subgroup analyses indicate that electro-acupuncture was consistently better than sham interventions. When considering acupuncture, electro-acupuncture could be an effective modality for short-term pain relief. We reached these gradings because of the small sample sizes in all included studies, although the risks of biases were low. None of the studies had more than 50 participants in any of the trial arms and there is a possibility of random errors due to small sample size. As a result, our findings warrant further research with an adequate sample size and long-term follow-up.

Quality of the evidence

With additional information provided by the authors, we were able to ascertain that the risk of bias of the included studies was acceptable in all studies except for three pragmatic trials (Guo 2005; Itoh 2010; Targino 2002). The other six studies (Assefi 2005; Deluze 1992; Harris 2005; Harris 2008; Harris 2009; Martin 2006) that compared acupuncture with sham controls included acupuncture-naive participants, adopted adequate randomisation procedures, blinded assessors, properly recorded drop-outs and five out of six studies used intention-to-treat analysis. Five studies also blinded participants (Assefi 2005; Harris 2005; Harris 2008; Harris 2009; Martin 2006), tested the blinding of participants (except for Harris 2008) and reported that the participants could not tell to which group they were allocated. We consider that the risk of bias is low in these six out of the nine included studies.

Acupuncture versus non-acupuncture

There is low-quality evidence based on one trial (electro-acupuncture, 13 participants) that acupuncture significantly reduced pain and stiffness and improved global well-being and fatigue when compared with the non-acupuncture group. We downgraded the quality of evidence because participant blinding was impossible, intention-to-treat analysis was not used and due to the small sample size. Adverse events were not reported. Three participants withdrew due to ineffective treatment (Summary of findings for the main comparison).

Acupuncture versus sham acupuncture

There is moderate-quality evidence based on data from six trials (289 participants) (combined manual and electro-acupuncture) that acupuncture did not significantly reduce pain compared with sham acupuncture, but subgroup analysis indicates that electro-acupuncture was significantly better than sham electro-acupuncture; whereas manual acupuncture showed no significant difference from sham manual acupuncture. Based on one manual acupuncture trial (56 participants), there is moderate-quality evidence that sham acupuncture improved physical function better than acupuncture, with the quality being downgraded due to inconsistency with other outcome measures. Global well-being has moderate-quality evidence based on three trials (203 participants, combined manual and electro-acupuncture) that acupuncture was not better than sham acupuncture, with subgroup analysis indicating that electro-acupuncture showed greater improvement than manual acupuncture did. Sleep had moderate-quality evidence with data from three trials (203 participants) that acupuncture (combined electro- and manual) did not significantly improve sleep time over sham acupuncture. However, subgroup analysis indicates that electro-acupuncture improved sleep quality significantly. We downgraded the quality of evidence for 'pain', 'global well-being' and 'sleep' due to one study (Deluze 1992) not using intention-to-treat analysis. There is high-quality evidence based on three trials (204 participants, combined manual and electro-acupuncture) that acupuncture did not significantly reduce fatigue, however subgroup analysis indicates that electro-acupuncture reduced fatigue significantly. Stiffness has moderate-quality evidence based on two trials (104 participants, electro-acupuncture only) that acupuncture significantly reduced stiffness compared with sham acupuncture and was downgraded due to one study (Deluze 1992) not using intention-to-treat analysis. Moderate-quality evidence from six trials (289 participants) showed no statistically significant difference between real and sham acupuncture in the number of adverse events associated with acupuncture. We downgraded the quality due to the small sample size within the studies. One in six people who had acupuncture reported adverse events, in contrast to one in three in the sham treatment groups. Such events were minor and lasted less than one day (Summary of findings 2).

Acupuncture versus medication

There is low-quality evidence based on one trial (38 participants, manual acupuncture only) that acupuncture significantly reduced pain when compared with medication. We downgraded the quality of evidence due to the poor reporting of the paper. No details about adverse events were reported. From the data it would appear that there were no drop-outs or withdrawals (Summary of findings 3).

Acupuncture as an adjunct therapy

There is moderate-quality evidence based on one trial (manual acupuncture, 58 participants) that acupuncture significantly reduced pain as an adjunct therapy to medication and exercise. We downgraded the quality of evidence due to the small sample size. There were two adverse events in the acupuncture group, which was not significantly different from the control group. We downgraded the evidence due to small sample size (Summary of findings 4).

Deep needling with stimulation versus deep needling without stimulation

There is moderate-quality evidence based on one trial (manual acupuncture, 41 participants) which showed that there was no significant difference between the two needling styles in the reduction of pain or improvement of their physical function. We downgraded the evidence due to small sample size (Summary of findings 5).

Comparison with other systematic reviews

Three meta-analyses of RCTs of acupuncture for the treatment of fibromyalgia have recently been published (Cao 2010; Langhorst 2010; Martin-Sanchez 2009) with conflicting conclusions. Cao 2010 considered that acupuncture could be a safe and effective therapy for treating fibromyalgia, while Martin-Sanchez 2009 and Langhorst 2010 concluded that acupuncture was neither effective nor could the effect be distinguished from bias.

In comparison, the present review has the following strengths: our search was comprehensive, including both English and Chinese databases; we adopted strict trial selection criteria based on the American College of Rheumatology (ACR) requirements; the adequacy of acupuncture protocol and treatment delivery were assessed by experts in the field; we contacted all authors to obtain additional data; we extracted data for multiple outcome measures and we limited acupuncture intervention to needling only. Laser acupuncture differs from manual or electro-acupuncture due to its mechanism and depth of stimulation. We selected studies using invasive needling acupuncture as the main or adjunct therapy. Consequently, all studies identified for inclusion in those three reviews have been either included in or excluded from our review. Martin-Sanchez 2009 only examined pain and did not include other outcome measures that are associated with fibromyalgia. Langhorst 2010 included most of the studies selected for this review. Langhorst 2010 found the reduction of pain to be significantly better in the real acupuncture group post-treatment (standardised mean difference (SMD) -0.25; 95% confidence interval (CI) -0.49 to -0.02, P = 0.04) and their effect size was smaller when compared with our data (SMD -0.42) due to inclusion of two studies that we excluded (Lautenschlager 1989; Sprott 1998) for not using ACR criteria or not reporting confirmable data, respectively. They also excluded one study which was included in our review (Harris 2008). Langhorst 2010 went on to conclude that "significant reduction of pain was only present in studies with risk of bias" because they considered three positive studies (Assefi 2005; Deluze 1992; Martin 2006) as having a high risk of bias. As indicated in Figure 3 and Figure 2, our data do not support this claim as explained above in the 'Quality of the evidence' section. We also included three other studies comparing acupuncture with non-acupuncture, medication and standard therapy.

Outcome measures for fibromyalgia

The top three core domains for outcome measures in any pain studies as recommended in IMMPACT are pain, function and emotion (Dworkin 2010). Furthermore, the 2010 ACR preliminary diagnostic criteria identified pain as well as a range of non-pain symptoms, for instance cognitive symptoms, headache and irritable bowel syndrome (Wolfe 2010). In all studies included in this review, the measurement tools for pain were adequate and validated. However, only four studies measured function or quality of life, two studies measured mental well-being, with one using the depression and anxiety sub-scales of the Fibromyalgia Impact Questionnaire (FIQ) and the other using the mental component of the SF-36. None measured cognition or somatic symptoms apart from sleep and fatigue. The FIQ, a condition-specific, validated function measure, was used only in two studies (Itoh 2010; Martin 2006). The FIQ has been in existence for 18 years and translated into eight languages (Bennett 2005). Targino 2008 explained they could not use the FIQ because the Brazilian version had not been validated at the time of the trial. The other two (Assefi 2005; Harris 2005) used the SF-36, which assesses quality of life but not function in fibromyalgia. The data from Assefi 2005 could not be used for the current review due to incorrect labelling of data in the published papers. To our knowledge, there is only one trial comparing the FIQ and the SF-36 in fibromyalgia and rheumatoid arthritis participants (Birtane 2006). The total score on the FIQ was moderately correlated with physical function, physical role and bodily pain on the SF-36, but not with other domains. Sub-scales of the FIQ were not correlated with relevant domains on the SF-36. For instance, bodily pain on the SF-36 was correlated with stiffness but not pain on the FIQ, and mental health on the SF-36 was correlated with anxiety but not depression on the FIQ. For this reason, we analysed data from the SF-36 and the FIQ separately, with the SF-36 measuring physical and mental function and the FIQ measuring overall well-being. We question the suitability of the SF-36 for measuring function in fibromyalgia participants. Physical function measured with the SF-36 physical domain was poorer in the acupuncture group than in the sham intervention group. The change was statistically, but not clinically, significant. We could not explain this finding. Given that the finding was from one trial, future studies with large sample sizes might impact on the direction of changes.

Fibromyalgia is characterised by widespread chronic pain as well as a range of non-pain symptoms and co-morbidities. A recent review indicates that when rating global improvement, fibromyalgia participants consider not only pain reduction, but also improvement in fatigue, functioning, mood and daily living (Hudson 2009). It is therefore important to assess a wide range of measures when examining the effect of any interventions for fibromyalgia. The FIQ consists of measures of pain, fatigue, sleep and physical and emotional functioning and is an ideal outcome measurement tool. OMERACT (Outcome Measures in Rheumatology) participants have agreed that pain, tenderness, fatigue, participant global rating or well-being, function and sleep are the core outcomes to be measured (Mease 2009). The FIQ measures most of these domains. In future studies, researchers should consider using the FIQ or include the assessment of the key co-morbidities and emotional and cognitive aspects of fibromyalgia. Such a design would help identify the specific effects of acupuncture on fibromyalgia.

Quality of acupuncture treatment

Overall, the treatment was adequate in terms of frequency (two to three sessions per week), number of treatments (six to 28 sessions) and length of each session of treatment (20 to 30 minutes). However, reporting of some details of the treatment, such as needling depth and unilateral or bilateral needling, were unavailable. It is important that both authors and journals adhere to the STRICTA guidelines for adequate reporting of acupuncture treatments.  

The major weakness of reporting of acupuncture treatments was a lack of rationale for the acupuncture treatment in all but one included trial (Deluze 1992), and justification of point selection was rarely provided, which could be due to a lack of standard Chinese medicine syndrome differential criteria for fibromyalgia. Acupuncture therapy in a clinical setting relies on the syndrome pattern differentiation for accurate point selection. None of the studies included offered a diagnosis or attempted a syndrome pattern differentiation for fibromyalgia according to Chinese medicine.

The current Western medicine diagnosis of fibromyalgia does not result in a single entity or homogenous group. Reliance on the two main criteria of chronic widespread pain and 11 out of 18 tender points according to the ACR diagnostic criteria has been criticised for not considering other important symptoms and co-morbidities (Mease 2005; Wilke 2009; Wolfe 2003). It was never intended for the ACR criteria to be used for clinical diagnosis but rather for research as a standardised definition of fibromyalgia, and there is no gold standard for fibromyalgia diagnosis (Katz 2005). To address this, Western medical research is being undertaken to examine the differentiation of fibromyalgia into subgroup/symptom clusters (Muller 2007; Schneider 2005; Wilson 2009). The 2010 ARC preliminary criteria (Wolfe 2010) are a positive step towards clinically orientated approaches.

Although fibromyalgia is not a diagnosis of Chinese medicine, the types of pain and co-morbidities associated with it may fit into the Chinese medicine diagnostic concept of Bi-Syndrome, documented 2500 years ago (Ni 1995). Dividing Bi-Syndrome into a number of patterns depends on the characteristics of pain, as well as the accompanying signs and symptoms, which allows syndrome pattern differentiation, leading to an individualised approach to treatment that is part of the clinical decision-making process within traditional/clinical acupuncture practice. However, the Chinese medicine diagnostic criteria for fibromyalgia are yet to be developed. This might explain why only formula acupuncture treatments were used in all included studies. It is common in modern Chinese medicine for a disease or condition in Western medicine to be given a set of differentiation diagnoses so that understanding of subgroups can be standardised to provide guidance for treatment. There is an urgent need for research into developing Chinese medicine syndrome differentiation diagnostic criteria.

Modes of acupuncture

The current data do not allow us to conclude the best acupuncture stimulation mode for the treatment of fibromyalgia. However, only one trial examined the two types of stimulation, and found deep needling with stimulation did not differ from deep needling without stimulation. That is to say deqi, one of the essences of acupuncture stimulation, might not play the expected role in the treatment of fibromyalgia. Subgroup analyses indicate that electro-acupuncture was consistently superior to manual acupuncture for a number of major outcome measures. However, no trial directly compared electro- with manual acupuncture. 

Sensitivity of the nervous system of fibromyalgia participants may influence the treatment outcome of different types of stimulation, however dose of treatment could be another explanation. A recent trial in healthy humans compared the effect of sham acupuncture with manual and electro-acupuncture on electrical pain thresholds (Zheng 2010). The researchers found that electro-acupuncture induced the best analgesia, followed by manual acupuncture, then the sham intervention. In electro-acupuncture, the stimulation was delivered constantly for 25 minutes, whereas in manual acupuncture the stimulation was about one minute and in sham acupuncture was close to zero. The treatments were similar to those in the selected studies for this review. That is, any difference between electro- and manual or manual with sham manual acupuncture could be due to the duration and strength of stimulation, or dose. This hypothesis will need to be tested in a trial examining all three modes of stimulation in the fibromyalgia population.

Challenges of sham acupuncture design in fibromyalgia studies

Sham acupuncture controls varied amongst the studies. We conducted a subgroup analysis comparing studies using invasive sham acupuncture with studies using a non-invasive method and found no subgroup difference. This comparison is, however, influenced by the small number of studies and mixed studies using electro- and manual acupuncture. Consequently, we could not draw a strong inference as to what the ideal sham control is. Sham controls were non-invasive (Assefi 2005 (one arm) and Harris 2008; Harris 2009; Martin 2006), invasive, off the point/channel (Assefi 2005 (one arm); Deluze 1992; Harris 2005 (two arms)) plus invasive on irrelevant point (Assefi 2005 (one arm)). The inert nature of these sham methods is debatable and no agreed standard for sham controls exists for acupuncture (Birch 2006). Penetrating the skin anywhere would appear to activate one of the commonly proposed mechanisms of acupuncture analgesia, i.e. diffuse noxious inhibitory control (Lewith 1983; Pomeranz 1988). Four of the included studies reported that their choice of sham might in fact be active (Assefi 2005; Harris 2005; Martin 2006; Targino 2008). Indeed, in a trial comparing muscle blood flow in fibromyalgia participants with that of healthy controls, the researchers found that in healthy controls only deep needle insertion into an acupuncture point increased blood flow, but in fibromyalgia participants both shallow and deep insertion were equally effective (Sandberg 2004). 

In a review, Lundeberg 2007 questioned whether sham acupuncture was a valid procedure for fibromyalgia participants due to their dysfunctional central nervous system (central sensitisation). As such, the nervous system may be responsive to the sub-pain threshold stimulus involved in any invasive sham acupuncture, subsequently activating the endogenous pain inhibition pathways (Mense 2003) that are usually activated by painful stimulation. Further clouding the issue is the result of a positron emission tomography (PET) trial of participants with fibromyalgia (Harris 2009). They found no difference between real manual acupuncture and non-invasive sham manual acupuncture in pain reduction. However, they identified significant group difference in brain activities. Morphine binding potential was increased in the real manual acupuncture group in the brain centres that modulated pain, whereas it was reduced or there was no change in the non-invasive sham manual acupuncture group. The results indicate that a non-invasive sham acupuncture technique may become active treatment in this population group, and its mechanism is likely due to non-opioid mediated pain modulation. This might also explain why there was no difference between deep needling with and without stimulation.

The placebo effect, including a range of components such as patient expectation, patient/therapist relationship and conditioning, has also been considered as one of the mechanisms explaining acupuncture analgesia (Finniss 2010). An analysis of data from four acupuncture trials totaling 864 participants concluded that there is a strong association between expectation and pain relief (Linde 2007). In a qualitative study, Kerr and colleagues (Kerr 2011) found that trial participants interpreted the sensation elicited by non-invasive placebo acupuncture needles as being meaningful and therapeutic. Those studies indicate that acupuncture is a complex intervention with multiple components. Indeed, some researchers challenge the usefulness of sham acupuncture controlled trials (Langevin 2011).

However, having some form of placebo is important in establishing the efficacy of a therapy. Future studies need to identify an adequate sham acupuncture intervention for fibromyalgia participants before studies are commenced. It is also important to conduct high-quality pragmatic trials to compare acupuncture with other proven therapies. In the current review, we found that acupuncture was superior to antidepressants and a combination of antidepressants and exercise for fibromyalgia, but the findings were from two studies with a small sample size.

Reporting of adverse events

We identified inconsistent reporting of adverse events in the included studies, with some studies reporting no adverse events (Harris 2005; Harris 2008) and others reporting 53% of participants experiencing them (Assefi 2005). So far, there is no uniform understanding of what constitutes an adverse event in acupuncture treatment or what should be recorded. For example, should 'pain at site of needling' be an adverse event, when for some techniques this is normal? Is being 'relaxed/tired' an adverse event or a typical indication of the therapeutic effect of acupuncture?

The discrepancy of reporting adverse events is also reflected by other published studies. For example, one clinic audit found that bleeding occurring in 53% cases and pain in 24% (White 2001), whereas another reported bleeding in 0.4% and pain in 1.2% of cases (MacPerson 2001). Although the former study audited treatments performed by medical or physiotherapy acupuncturists and the latter by traditional Chinese acupuncturists, the significant differences are likely due to reporting discrepancy and the definition of adverse events. Generally, acupuncture is considered safe. A consensus on how to report adverse events in acupuncture treatment is needed. 

Authors' conclusions

Implications for practice

Due to the weaknesses of the included studies, the implications for practice are limited. Overall, there is a low to moderate-quality level of evidence that formula acupuncture for the treatment of fibromyalgia is safe. There is a moderate level of evidence that acupuncture is not better than sham controls. Electro-acupuncture is found to be consistently better than sham interventions in improving pain, global well-being, sleep, stiffness and fatigue. The effect of acupuncture was not maintained at six to seven months after treatment. The same level of evidence supports acupuncture as an adjunct therapy to medication and exercise or acupuncture when compared with a medication and exercise control. When comparing acupuncture with medication or a wait list, there is low quality evidence in favour of acupuncture but this needs more rigorous and methodologically sound studies.

Evidence suggests that treatment sessions should be twice per week, over four weeks, with each session lasting for 25 minutes. Electro-acupuncture seems to provide a number of benefits for fibromyalgia participants. Practitioners should consider electro-acupuncture with 2 to 5 Hz electrical stimulation and acupuncture points could include ST36 and LI4. Optimal needling depth, point selection and needle stimulation are yet to be identified. 

Like any treatment for chronic pain, maintenance acupuncture treatment is likely to be required for long-term benefit for fibromyalgia. How frequent the treatment should be is unknown.

Implications for research

We recommend a number of ways in which to address the weaknesses identified in the included studies. To further test the usefulness of acupuncture in treating fibromyalgia, researchers need to develop Chinese medicine diagnostic and subgroup differentiation criteria. The suitability of any sham acupuncture needs to be tested in this population prior to any further studies. In regards to the safety profile, a clear definition of what adverse events are associated with acupuncture is needed. Future studies testing the efficacy of acupuncture should use an adequate sample size, apply electro-acupuncture and assess the long-term results. Use of a disease-specific tool, such as the Fibromyalgia Impact Questionnaire, and accurate reporting of treatment using the Standards for Reporting Interventions in Controlled studies of Acupuncture (STRICTA) guidelines would be desirable. Future studies also need to assess how often acupuncture should be delivered to maintain its long-term benefit and the cost-effectiveness of such a treatment plan.

Acknowledgements

We would like to thank Robin Christensen at CMSG for statistical support and advice; Anette Bluemie at the German Cochrane Centre, Lorenzo Moja at the Italian Cochrane Centre and Juan Molero at the School of Health Sciences, RMIT University, Australia, for translating potential papers; and the authors of Targino 2008, Harris 2007 (excluded), Harris 2008 and Itoh 2010 for providing papers and raw data directly to us.

Data and analyses

Download statistical data

Comparison 1. Acupuncture versus non-acupuncture treatment
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Pain up to 1 month after treatment113Mean Difference (IV, Random, 95% CI)-22.4 [-40.98, -3.82]
2 Global well-being: rated by participants up to 1 month after treatment113Mean Difference (IV, Random, 95% CI)-15.40 [-25.62, -5.18]
3 Sleep up to 1 month after treatment113Mean Difference (IV, Random, 95% CI)-0.40 [-1.01, 0.21]
4 Fatigue up to 1 month after treatment113Mean Difference (IV, Random, 95% CI)-1.1 [-1.98, -0.22]
5 Stiffness up to 1 month after treatment113Mean Difference (IV, Random, 95% CI)-0.90 [-1.66, -0.14]
6 Adverse events113Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]
7 Mental well-being up to 1 month after treatment113Mean Difference (IV, Random, 95% CI)-0.5 [-1.10, 0.10]
Analysis 1.1.

Comparison 1 Acupuncture versus non-acupuncture treatment, Outcome 1 Pain up to 1 month after treatment.

Analysis 1.2.

Comparison 1 Acupuncture versus non-acupuncture treatment, Outcome 2 Global well-being: rated by participants up to 1 month after treatment.

Analysis 1.3.

Comparison 1 Acupuncture versus non-acupuncture treatment, Outcome 3 Sleep up to 1 month after treatment.

Analysis 1.4.

Comparison 1 Acupuncture versus non-acupuncture treatment, Outcome 4 Fatigue up to 1 month after treatment.

Analysis 1.5.

Comparison 1 Acupuncture versus non-acupuncture treatment, Outcome 5 Stiffness up to 1 month after treatment.

Analysis 1.6.

Comparison 1 Acupuncture versus non-acupuncture treatment, Outcome 6 Adverse events.

Analysis 1.7.

Comparison 1 Acupuncture versus non-acupuncture treatment, Outcome 7 Mental well-being up to 1 month after treatment.

Comparison 2. Acupuncture versus placebo or sham acupuncture
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Pain (subgroup EA & MA) up to 1 month after treatment6286Std. Mean Difference (IV, Random, 95% CI)-0.14 [-0.53, 0.25]
1.1 Electro-acupuncture2104Std. Mean Difference (IV, Random, 95% CI)-0.63 [-1.02, -0.23]
1.2 Manual acupuncture4182Std. Mean Difference (IV, Random, 95% CI)0.14 [-0.17, 0.45]
2 Pain follow-up to 7 months after treatment (subgroup EA vs MA)2145Std. Mean Difference (IV, Random, 95% CI)-0.12 [-0.52, 0.28]
2.1 Electro-acupuncture149Std. Mean Difference (IV, Random, 95% CI)-0.37 [-0.93, 0.20]
2.2 Manual acupuncture196Std. Mean Difference (IV, Random, 95% CI)0.05 [-0.41, 0.51]
3 Pain: sham non-invasive acupuncture (not breaking skin) vs sham invasive acupuncture (breaking skin)6 Std. Mean Difference (IV, Random, 95% CI)Subtotals only
3.1 Sham breaking skin3170Std. Mean Difference (IV, Random, 95% CI)-0.21 [-0.57, 0.15]
3.2 Sham not breaking skin4116Std. Mean Difference (IV, Random, 95% CI)0.04 [-0.64, 0.71]
4 Physical function (SF-36)156Mean Difference (IV, Random, 95% CI)-5.80 [-10.91, -0.69]
5 Global well-being: rated by participants (subgroup EA vs MA) up to 1 month after treatment3200Std. Mean Difference (IV, Random, 95% CI)0.29 [-0.44, 1.01]
5.1 Electro-acupuncture2104Std. Mean Difference (IV, Random, 95% CI)0.65 [0.26, 1.05]
5.2 Manual acupuncture196Std. Mean Difference (IV, Random, 95% CI)-0.40 [-0.86, 0.06]
6 Global well-being follow-up to 7 months after treatment (subgroup EA & MA)2145Std. Mean Difference (IV, Random, 95% CI)-0.03 [-0.87, 0.81]
6.1 Electro-acupuncture149Std. Mean Difference (IV, Random, 95% CI)0.41 [-0.15, 0.98]
6.2 Manual acupuncture196Std. Mean Difference (IV, Random, 95% CI)-0.45 [-0.91, 0.01]
7 Sleep (subgroup EA & MA) up to 1 month after treatment3200Std. Mean Difference (IV, Random, 95% CI)0.16 [-0.29, 0.61]
7.1 Electro-acupuncture2104Std. Mean Difference (IV, Random, 95% CI)0.40 [0.01, 0.79]
7.2 Manual acupuncture196Std. Mean Difference (IV, Random, 95% CI)-0.25 [-0.71, 0.21]
8 Sleep follow-up to 7 months after treatment (subgroup EA & MA)2145Std. Mean Difference (IV, Random, 95% CI)-0.09 [-0.44, 0.26]
8.1 Electro-acupuncture149Std. Mean Difference (IV, Random, 95% CI)0.07 [-0.49, 0.63]
8.2 Manual acupuncture196Std. Mean Difference (IV, Random, 95% CI)-0.20 [-0.66, 0.26]
9 Fatigue (subgroup EA vs MA) up to 1 month after treatment3201Std. Mean Difference (IV, Random, 95% CI)-0.10 [-0.81, 0.61]
9.1 Electro-acupuncture149Std. Mean Difference (IV, Random, 95% CI)-0.85 [-1.44, -0.27]
9.2 Manual acupuncture2152Std. Mean Difference (IV, Random, 95% CI)0.26 [-0.08, 0.61]
10 Fatigue follow-up to 7 months after treatment (subgroup EA vs MA)2145Std. Mean Difference (IV, Random, 95% CI)0.04 [-0.52, 0.59]
10.1 Electro-acupuncture149Std. Mean Difference (IV, Random, 95% CI)-0.27 [-0.84, 0.29]
10.2 Manual acupuncture196Std. Mean Difference (IV, Random, 95% CI)0.30 [-0.16, 0.76]
11 Stiffness up to 1 month after treatment2104Std. Mean Difference (IV, Random, 95% CI)-0.45 [-0.84, -0.06]
12 Stiffness follow-up to 7 months after treatment149Mean Difference (IV, Random, 95% CI)-0.30 [-1.60, 1.00]
13 Adverse events6289Risk Ratio (M-H, Random, 95% CI)0.44 [0.12, 1.63]
14 Mental well-being up to 1 month after treatment149Mean Difference (IV, Random, 95% CI)-1.70 [-3.13, -0.27]
15 Mental well-being follow-up to 7 months149Mean Difference (IV, Random, 95% CI)-1.40 [-3.01, 0.21]
16 Analgesic use (number of tablets per week) up to 1 month after treatment155Mean Difference (IV, Random, 95% CI)-3.20 [-10.20, 3.80]
17 Analgesic use (number of participants taking analgesics up to 1 month after treatment)180Risk Ratio (M-H, Random, 95% CI)0.94 [0.66, 1.32]
18 Tenderness up to 1 month after treatment155Mean Difference (IV, Random, 95% CI)0.80 [0.02, 1.58]
18.1 Mean pressure pain threshold (kg/cm2)155Mean Difference (IV, Random, 95% CI)0.80 [0.02, 1.58]
19 Overall well-being: rated by care giver at end of treatment155Mean Difference (IV, Random, 95% CI)2.0 [0.81, 3.19]
Analysis 2.1.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 1 Pain (subgroup EA & MA) up to 1 month after treatment.

Analysis 2.2.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 2 Pain follow-up to 7 months after treatment (subgroup EA vs MA).

Analysis 2.3.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 3 Pain: sham non-invasive acupuncture (not breaking skin) vs sham invasive acupuncture (breaking skin).

Analysis 2.4.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 4 Physical function (SF-36).

Analysis 2.5.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 5 Global well-being: rated by participants (subgroup EA vs MA) up to 1 month after treatment.

Analysis 2.6.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 6 Global well-being follow-up to 7 months after treatment (subgroup EA & MA).

Analysis 2.7.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 7 Sleep (subgroup EA & MA) up to 1 month after treatment.

Analysis 2.8.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 8 Sleep follow-up to 7 months after treatment (subgroup EA & MA).

Analysis 2.9.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 9 Fatigue (subgroup EA vs MA) up to 1 month after treatment.

Analysis 2.10.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 10 Fatigue follow-up to 7 months after treatment (subgroup EA vs MA).

Analysis 2.11.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 11 Stiffness up to 1 month after treatment.

Analysis 2.12.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 12 Stiffness follow-up to 7 months after treatment.

Analysis 2.13.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 13 Adverse events.

Analysis 2.14.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 14 Mental well-being up to 1 month after treatment.

Analysis 2.15.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 15 Mental well-being follow-up to 7 months.

Analysis 2.16.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 16 Analgesic use (number of tablets per week) up to 1 month after treatment.

Analysis 2.17.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 17 Analgesic use (number of participants taking analgesics up to 1 month after treatment).

Analysis 2.18.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 18 Tenderness up to 1 month after treatment.

Analysis 2.19.

Comparison 2 Acupuncture versus placebo or sham acupuncture, Outcome 19 Overall well-being: rated by care giver at end of treatment.

Comparison 3. Acupuncture versus medication
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Pain up to 1 month after treatment138Mean Difference (IV, Random, 95% CI)-17.3 [-24.13, -10.47]
2 Adverse events138Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]
3 Tenderness up to 1 month after treatment138Mean Difference (IV, Random, 95% CI)-4.00 [-6.73, -1.27]
3.1 Number of tender points138Mean Difference (IV, Random, 95% CI)-4.00 [-6.73, -1.27]
Analysis 3.1.

Comparison 3 Acupuncture versus medication, Outcome 1 Pain up to 1 month after treatment.

Analysis 3.2.

Comparison 3 Acupuncture versus medication, Outcome 2 Adverse events.

Analysis 3.3.

Comparison 3 Acupuncture versus medication, Outcome 3 Tenderness up to 1 month after treatment.

Comparison 4. Acupuncture as an adjunct therapy
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Pain up to 1 month after treatment158Mean Difference (IV, Random, 95% CI)-3.0 [-3.90, -2.10]
2 Pain up to 7 months after treatment158Mean Difference (IV, Random, 95% CI)-0.5 [-1.49, 0.49]
3 Adverse events158Risk Ratio (M-H, Fixed, 95% CI)3.57 [0.18, 71.21]
4 Tenderness - number of tender points below kg/cm2 up to 1 month after treatment158Mean Difference (IV, Random, 95% CI)-4.5 [-6.20, -2.80]
5 Tenderness - number of tender points below kg/cm2 up to 7 month after treatment158Mean Difference (IV, Random, 95% CI)-2.0 [-3.51, -0.49]
6 Tenderness - mean pressure threshold by pressure algometry up to 1 month after treatment168Mean Difference (IV, Fixed, 95% CI)0.70 [0.41, 0.99]
7 Tenderness - mean pressure threshold by pressure algometry, follow up to 7 months after treatment158Mean Difference (IV, Random, 95% CI)0.60 [0.26, 0.94]
Analysis 4.1.

Comparison 4 Acupuncture as an adjunct therapy, Outcome 1 Pain up to 1 month after treatment.

Analysis 4.2.

Comparison 4 Acupuncture as an adjunct therapy, Outcome 2 Pain up to 7 months after treatment.

Analysis 4.3.

Comparison 4 Acupuncture as an adjunct therapy, Outcome 3 Adverse events.

Analysis 4.4.

Comparison 4 Acupuncture as an adjunct therapy, Outcome 4 Tenderness - number of tender points below kg/cm2 up to 1 month after treatment.

Analysis 4.5.

Comparison 4 Acupuncture as an adjunct therapy, Outcome 5 Tenderness - number of tender points below kg/cm2 up to 7 month after treatment.

Analysis 4.6.

Comparison 4 Acupuncture as an adjunct therapy, Outcome 6 Tenderness - mean pressure threshold by pressure algometry up to 1 month after treatment.

Analysis 4.7.

Comparison 4 Acupuncture as an adjunct therapy, Outcome 7 Tenderness - mean pressure threshold by pressure algometry, follow up to 7 months after treatment.

Comparison 5. Deep needling with stimulation (T/S) versus deep needling without stimulation (T/O)
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Pain up to 1 month after treatment1 Mean Difference (IV, Random, 95% CI)Subtotals only
1.1 NRS141Mean Difference (IV, Random, 95% CI)0.30 [-18.34, 18.94]
2 Physical function (SF-36) up to 1 month after treatment141Mean Difference (IV, Random, 95% CI)-5.50 [-11.43, 0.43]
3 Fatigue up to 1 month after treatment141Mean Difference (IV, Fixed, 95% CI)1.10 [-1.41, 3.61]
Analysis 5.1.

Comparison 5 Deep needling with stimulation (T/S) versus deep needling without stimulation (T/O), Outcome 1 Pain up to 1 month after treatment.

Analysis 5.2.

Comparison 5 Deep needling with stimulation (T/S) versus deep needling without stimulation (T/O), Outcome 2 Physical function (SF-36) up to 1 month after treatment.

Analysis 5.3.

Comparison 5 Deep needling with stimulation (T/S) versus deep needling without stimulation (T/O), Outcome 3 Fatigue up to 1 month after treatment.

Appendices

Appendix 1. Cochrane search strategy and results

(Updated search on 21 January 2012)

#1MeSH descriptor Fibromyalgia explode all trees494
#2(fibromyal*):ti,ab,kw790
#3(fibromyalgia syndrome):ti,ab,kw275
#4(chronic widespread pain):ti,ab,kw

52

 

#5(#1 OR #2 OR #3 OR #4)

817

 

#6(#5 AND ( randomised AND controlled AND trial ))

496

 

#7MeSH descriptor Acupuncture explode all trees127
#8MeSH descriptor Acupuncture Therapy explode all trees2470
#9(acupuncture point):ti,ab,kw1628
#10(body acupuncture):ti,ab,kw

242

 

#11MeSH descriptor Electroacupuncture explode all trees

381

 

#12(electro-acupuncture):ti,ab,kw

191

 

#13MeSH descriptor Acupuncture, Ear explode all trees91
#14(auricular acupuncture):ti,ab,kw166
#15(scalp acupuncture):ti,ab,kw160
#16(dry needling):ti,ab,kw71
#17(trigger point):ti,ab,kw

360

 

#18(acupoint injection):ti,ab,kw119
#19     (#7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14

3655

 

#20(#19 AND ( randomised AND controlled AND trial ))2770
#21(#6 AND #20)28

 

Appendix 2. MEDLINE search strategy and results

(Updated searched on  21 January 2012)

#22      #6 AND #21 Limits: Randomized Controlled Trial                                        15
#21      #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19 Limits: Randomized Controlled Trial   2190

#20      #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19

 

15315
#19      Search acupoint injection [tw]81
#18      trigger point [tw]520
#17      dry needling [tw] 84
#16      scalp acupuncture [tw] 110
#15      auricular acupuncture [tw] 201
#14      ear acupuncture [MeSH] 197
#13      electro-acupuncture [tw]518
#12      electro-acupuncture {MeSH]0
#11      electroacupuncture [MeSH] 2024
#10      body acupuncture [tw]102
#9         acupuncture point [MeSH]2962
#8         acupuncture therapy [MeSH] 14011
#7         acupuncture [MeSH] 14710
#6        #1 OR #2 OR #3 OR #4 Limits: Randomized Controlled Trial  397
#5        #1 OR #2 OR #3 OR #46753
#4        chronic widespread pain [tw] 305
#3         fibromyalgia syndrome [tw]1146
#2         fibromyal* [tw]  6664
#1         fibromyalgia [MeSH]  5234
#3         fibromyalgia syndrome [tw]   1146
#2         fibromyal* [tw] 6664
#1         fibromyalgia [MeSH]  5234

Appendix 3. EMBASE search strategy and results

(Updated search on 17 January 2012)

#1
(Acupuncture and fibromyalgia).mp. [mp=title, abstract, subject headings,
heading word, drug trade name, original title, device manufacturer, drug
manufacturer, device trade name, keyword]
401
#2
limit 1 to yr="2010 - 2012"
65

Appendix 4. CINAHL search strategy and results

(Via EBSCOhost updated search on 17 January 2012 then 28 March 2012)

1
TX Acupuncture AND TX Fibromyalgia 
535
2
limit 1 to yr="Jan 2010 – Dec 2011"
70

Appendix 5. Chongqing Weipu (VIP) search strategy and results

Search terms

Vip

 1989-2010

(tw=任意字段;abstract=文摘)

# 1 纤维肌痛 [tw]273
# 2 纤维肌痛 [abstract]212
# 3 纤维肌痛综合征 [tw]201
# 4 纤维肌痛综合征[abstract]158
# 5 RCT [abstract ]6443
# 6 随机对照试验[abstract]3504
# 7临床科研[tw]2620
# 8临床观察 [tw]172039
# 9 随机对照 [tw]15101
# 10 针刺[tw]42588
# 11 针灸[tw]67944
# 12 电针[tw]10444
# 13 耳针 [tw]1118
# 14 头针 [tw]1952
# 15 水针 [tw]2281
#1 or # 2 or #3 or #4 AND #5 or #6  or #7 or #8 or #9 AND  #10 or #11 or #12 or #13 or #14 or #1535

Appendix 6. Wanfang search strategy and results

Search terms

Wangfang

Inception to 2010

# 1 纤维肌痛 [tw]4109
# 2 纤维肌痛 [abstract]3090
# 3 纤维肌痛综合征 [tw]131
# 4 纤维肌痛综合征[abstract]146
# 5 RCT [abstract ]4977
# 6 随机对照试验[abstract]3686
# 7临床科研[tw]1696
# 8临床观察 [tw]141525
# 9 随机对照 [tw]16801
# 10 针刺[tw]37681
# 11 针灸[tw]52905
# 12 电针[tw]10225
# 13 耳针 [tw]807
# 14 头针 [tw]1731
# 15 水针 [tw]1481
#1 or # 2 or #3 or #4 AND #5 or #6  or #7 or #8 or #9 AND  #10 or #11 or #12 or #13 or #14 or #1528

Appendix 7. National Research Register search strategy and results

(Updated search on 21 January 2012)

You searched for fibromyalgia AND acupuncture

 "There are no results."

Appendix 8. HSRProj search strategy and results

(Updated search on 21 January 2012)

((fibromyalgia AND acupuncture) AND (randomised controlled trial))

0 result found 

Appendix 9. Current Contents search strategy and results

(via Web of Science updated search on 17 January 2012 then 28 March 2012)

1
Topic=(Acupuncture) AND Topic=(fibromyalgia)

Databases=ABES, SBS, CM, LS, PCES, ECT, AH, BC, EC Timespan=All Years

Lemmatization=On  

99

2
Topic=(Acupuncture) AND Topic=(fibromyalgia)

Refined by: Publication Years=( 2010 OR 2011 )

Databases=ABES, SBS, CM, LS, PCES, ECT, AH, BC, EC Timespan=All Years

Lemmatization=On 

22

Appendix 10. STRICTA

Detailed information of acupuncture treatment (modified STRICTA items)

Study ID

Assefi

2005

Deluze

1992

Guo

2005

Harris

2005

Harris

2008

Harris

2009

Itoh

2010

Martin

2006 

Targino

2008

Acupuncture styleManual acupuncture with formula pointsElectro-acupuncture with formula points

Manual

point-to-point threading acupuncture with formula points

Manual acupuncture with formula pointsManual acupuncture with formula pointsManual acupuncture with formula pointsElectro-acupuncture plus trigger point acupunctureElectro-acupuncture plus formula CM

Manual acupuncture with formula points

 

Rationale for treatment including 3 items: CM diagnosis/

point selection/      trial protocol

NR/NR/NRNR/individualised with 2 main points/points selection and EA was based on journal articles

NR/NR/NR Only mentioned "Standard treatment"

 

NR/points selected based on "ability to reduce symptoms of FM"/NRNR/points selected based on Harris 2005 study/NRNR/points selected based on Harris 2005 study/NRNR/NR/NRNR/points standardised formula "strong regulatory points"/NR 

NR/points

selected based on

"Classical"/based on clinical experience

Sources to justify rationaleClinical experience and discussion with 3 other acupuncturists

Textbook and journal articles

(referenced)

Classic literature and research papers

(not referenced)

Textbook

(referenced)

However this text does not specifically state those points are for fibromyalgia

Referenced to Harris 2005 paperReferenced to Harris 2005 paperNRNRReferenced to WHO standard nomenclature, but the reference is not related to fibromyalgia diagnosis or treatment
Points used in real acupuncture treatment

Alternating

between

LI11, SP9, CV12, ST25, KI7, TE5, Ex-HN-3 (Yin Tang) and

 KI7, BL17,

BL18, BL20, BL22, BL43, BL44

LI4, ST36 plus up to 6 other points which were not reported

 

Along GV meridian and the 2 lines of the Bladder meridian. Exact start and finish points not reportedUnilateral
Left LI11, ST36 SP6, GB34
Right LI4, LR3, plus GV20 and ear point shenmen
As per Harris 2005 studyAs per Harris 2005 studyPoints selected using trigger point therapy but does state apart from muscle groups what they wereBilateral LI4, ST36, LR2, SP6 PC6, HT7 plus 3 cervical and 4 lumber axial on BL channel but did not state actual points

Ex-HN-3 (Yin Tang)

LR3, LI4, PC6, GB34 and SP6

Uni/bilateralNot reported clearlyBilateralNRAs aboveAs per Harris 2005 study [MCIT1] As per Harris 2005 studyBilateralAs aboveAll bilateral except for Ex-HN-3
Number of needles inserted7-1410 (study used 5 pairs of electrodes)NR999

Real 10 for 10 wks

Non-acupuncture nil for 5 wks, then 5 after wk 5

18 first 3 tx

20 final 3 tx

11
Depths of insertion

"Standard depth"

(referenced to a textbook)

Real: 10 to 25 mm

Control: 3 to 4 mm

Subcutaneous

All groups had the same depth,

20 to 30 mm

Real 20 mm

Sham non-penetrating

Real 20 mm

Sham non-penetrating

EA 5 to 20 mm

Trigger point 10 to 20 mm

NR, But figure shows needling into muscles10 to 30 mm, perpendicular insertion for all points except when needling Ex-HN-3 which was obliquely inserted
Responses elicited"Stimulation" stated but not clear if deqi was elicited

Real: deqi elicited

Control: no deqi

NR

Deqi was elicited in 2 out of the 4 arms

 

Real: deqi was elicited on all points below the neckReal: deqi was elicited on all points below the neckDeqi on both EA and trigger pointNo deqi intendedDeqi was elicited
Type of needle stimulationManual

Electrical real: visible muscle twitch

10 mA - continuous Control: no muscle twitch setting similar to real group but weaker

 

Point-to-point

threading, even movement

Lifting and thrusting with even rotation (12 rotations at 180° clock and anticlockwiseManualManual

EA visible muscle twitch, 4 Hz, rectangular biphasic top

 

Trigger point "Sparrow pecking"

Electrical, 2 Hz, LI4 and ST36 plus 10 Hz (alternating cervical and lumber BL channel)Manual
Needle retention time30 minutesNR30 minutes20 minutes25 minutes25 minutes

EA 15 minutes

Trigger point 15 minutes

20 minutes20 minutes
Needle size/ length/type/ manufacturer

NR/34 to 40 mm/Chinese,

Japanese, Korean/NR

0.3 mm/25 mm/

Stainless steel/NR

0.35 mm/40 mm/NR/NR25 mm/38 mm/ Stainless steel/HBW Supply Inc

25 mm/50 mm/

Stainless steel/

Seirin

NR/NR/NR/NR

 

 0.2 mm/40 mm/stainless steel/Seirin

NR/NR/NR/NR

 

EA unit IC-1107+, ITO, Japan

25 mm/40 mm/NR/NR
Number of treatment sessions24 over 12 wks6 over 3 wks28 over 30 days with 14 for each course; a rest of 2 days in between courses 

18 over 13 wks Forced-titration paradigm (1 tx wkly 3 wks), (2 tx wkly 3 wks), (3 tx wkly 3 wks)

2 wk washout between each tx group 

9 over 4 wks9 over 4 wks

10 over 10 wks

(this was a cross-over study after 5 weeks. 1st 5 weeks tx was only on 1 arm with the other non-acupuncture)

6 over 3 wks20 over 3 months
Frequency of treatmentsTwice weeklyTwice weeklyDailyAs aboveTwice to 3 times weeklyTwice weeklyWeeklyEvery 2 to 4 days over 2 to 3 wksTwice weekly
Practitioner background: training, clinical experience, expertise in specific condition

8 acupuncturists

received standardised training in the different styles for the study. Trial acupuncturist had 15 years experience in treating fibromyalgia patients

NRAuthors from Chinese medicine university Point location determined by 2 licensed acupuncturists with 12 yrs experience in fibromyalgia  and 17 yrs experience in acupuncture.  95% of tx done by 1 acupuncturist1 acupuncturist trained at the Maryland Institute of Traditional Chinese Medicine with 6 years clinical acupuncture experience.  No expertise in a specific conditionNR

1 acupuncturist,

4 yrs acupuncture training and clinical experience of 3 or 10 yrs

2 acupuncturists but no details reported

1 acupuncturist

(physician) with 5 years clinical experience

Abbreviations used: CM: Chinese medicine; EA: electro-acupuncture; mm: millimetre; NR: not reported; tx: treatments; wk = weeks: wkly = weekly; yrs: years

What's new

Last assessed as up-to-date: 15 January 2012.

DateEventDescription
10 May 2008AmendedCMSG ID A019-R
13 April 2008AmendedConverted to new review format.

Contributions of authors

John C Deare (JD)

  • Topic conception, protocol development and revision

  • Systematic review study selection, methodology, adequacy of treatment, data extraction, data analysis and interpretation of findings

  • Co-author of the review

Zhen Zheng (ZZ)

  • Topic conception, protocol development review and revision

  • Systematic review study selection, methodology, adequacy of treatment, data extraction, data analysis and interpretation of findings

  • Co-author of the review

Charlie C Xue (CX)

  • Topic conception and methodological aspects

  • Protocol review

  • Systematic review dispute resolution for study selection, adequacy of treatment, and revision and review of final interpretations of findings

Jian Ping Liu (JPL)

  • Topic conception, methodological perspectives, data analysis

  • Protocol revision and review

  • Systematic review dispute resolution for methodological quality and final proof

Jingsheng Shang (JSS)

  • Topic conception

  • Protocol review proof

  • Systematic review final proof

Sean W Scott (SS)

  • Protocol review proof

  • Systematic review data extraction

  • Systematic review final proof

Geoff Littlejohn (GL)

  • Protocol review proof

  • Systematic review final proof

Declarations of interest

The authors plan to conduct an acupuncture clinical trial on fibromyalgia in the future. No other potential conflicts of interest have been noted.

Sources of support

Internal sources

  • Traditional & Complementary Medicine Program, Health Innovations Research Institute, Discipline of Chinese Medicine, School of Health Sciences, RMIT University, Australia.

  • Compmed Health Institute, Southport, Australia.

  • Centre for Clinical Research and Evaluation, Beijing University of Chinese Medicine, Beijing, China.

External sources

  • National Center for Complementary and Alternative Medicine (NCCAM, Number R24 AT001293), National Institutes of Health (NIH), USA.

    JD was supported by NCCAM grant. The contents of this systematic review are solely the responsibility of the authors and do not necessarily represent the official views of the NCCAM or the NIH.

  • National Health and Medical Research Council (NHMRC Project Grants 555411 and 555414), Australia.

    ZZ and CCLX were partially supported by the NHMRC grants. The contents of this systematic review are solely the responsibility of the authors and do not necessarily represent the official views of the NHMRC.

Differences between protocol and review

We updated the background and changed the order of importance of the main and minor outcomes, based on findings from reviews. In accordance with new Cochrane Collaboration guidelines, we have included in the review 'Risk of bias' and replaced the planned 'Clinical relevance tables' with the 'Summary of findings' tables. We did not conduct the searches of ACULARS, AcuBriefs, SIGLE or AMED as they could either not be accessed via RMIT University, it was a pay for service or the content of the databases was covered by our other searches.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Assefi 2005

Methods

Randomised: computer-generated blocked random allocation sequence with block size of 4. Researcher not involved in the study conducted randomisation (used academic research centre).

Blinding: participants blinded during treatment. Staff who collected and analysed the data were blinded to treatment group. Care givers were not blinded to group allocation.

Setting: individual private offices, does not state where these are

Was study aim clear: yes

Informed consent: verbal and written

Ethics approval: institutional review boards at participating institution

WHO clinical trial register: listed and outcomes as per listing

Intention-to-treat used: yes

Follow-up: 3 and 6 months

Participants

Total number of participants: 100 participants, mean duration of illness (years): directed acupuncture: 6 years SD 5; sham control groups: acupuncture for unrelated condition 5 years SD 3; sham needling 7 years SD 6; simulated acupuncture 7 years SD 4

2 male and 94 female

Mean age: directed acupuncture; 46 years SD 11; sham control groups: acupuncture for unrelated condition 46 years SD 11; sham needling 49 years SD 14; simulated acupuncture 48 years SD 10

Diagnosis: ACR

Acupuncture-naive participants: yes

Excluded: other pain conditions, contraindicated for acupuncture (bleeding disorders, severe needle phobia), pregnant or breastfeeding, use of narcotics, litigation and previous acupuncture treatments

Recruitment source: the Greater Seattle, Washington State metropolitan area using newspaper, television, university-affiliated hospitals, local fibromyalgia support groups and health care providers

Previous treatments: manual (physical, ergonometric, chiropractic, massage), mental health therapies (psychotherapy, cognitive behavioural therapy), dietary changes or other (nerve blocks, hypnosis or biofeedback)

Interventions

1) Real: directed acupuncture

Randomised to this group: 25 (analysed 25)

2) Control: acupuncture for unrelated condition, treating for irregular menses or early menses due to Blood Heat

Randomised to this group: 25 (analysed 25)

3) Control: sham needling, using body points not recognised as true acupuncture points

Randomised to this group 24 (1 did not complete baseline questionnaire) (analysed 24)

4) Control: simulated acupuncture; same acupuncture points as directed acupuncture but with toothpick inside a needle guide tube to mimic needle insertion/withdrawal

Randomised to this group 25 (analysed 25)

Minimum number of treatments needed: possible 24 treatments, required to attend 80% (19/24)

Co-interventions: maintain current use of pharmacological and non-pharmacological therapies through out the study

Acupuncturists: 8 US trained and licensed with median of 10 years experience (range 4 to 18 years)

See STRICTA table for treatment details (Appendix 10)

Outcomes

Primary outcomes:

1) Pain; visual analogue scale (VAS) (0 = no pain, 10 = worst ever)

2) Function: Short-Form 36 health survey, mean of 50 and standard deviation of 10, with higher scores indicating better functioning

Secondary outcomes:

3) Fatigue: VAS (0 = none, 10 = worst ever)

4) Sleep: VAS (0 = worst ever, 10 = best ever)

5) Over well-being: VAS (0 = worst ever, 10 = best ever)

Outcome measures primary and secondary: 1), 2), 3), 4), 5) taken at weeks 1, 4, 8, 12 and 3 and 6 months

6) Blinding: participants rated how certain they were that they had received directed acupuncture or stimulated acupuncture on a 7-point scale (1 = very sure, 7 = very uncertain) measured at 12 weeks

7) Acupuncturist: participants rated acupuncturist skill level (1 = high, 7 = low) and adverse events measured at weeks 1, 4, 8 and 12

8) Other co-interventions: medication use measured at week 1 and week 12

Outcome measure results:

"No significant differences were detected between the directed acupuncture and the pooled control group for any of the study outcomes".

For the blinding procedures, "32% believed they were receiving acupuncture specifically designed for FM"; no significant difference between the groups (P > 0.2). 4% believed they were receiving simulated acupuncture; no difference between the groups (P > 0.2).

Combined groups had no significant difference in the skill of the acupuncturist (P > 0.2). 77% rated their skill as high, 5% as medium, 17% did not know

84% in the directed group and 79% of the pooled sham groups completed the full course of treatment. On average 21/24 (P > 0.2).

Total medication use showed no significant difference between groups (P > 0.2). Most commonly used medications were ibuprofen, acetaminophen and naproxen.

Withdrawals/drop-outs: 4 in at the randomised stage, 10 at the allocated intervention stage, directed group 2, unrelated acupuncture treatment 2, sham acupuncture 2 and simulated acupuncture 4

Complications/adverse events: 89 participants reported adverse events. 37% reported discomfort at site of needle insertion or simulation of needles, 3% reported nausea, 0.3% felt faint. Participants in simulated acupuncture (39%) had less discomfort than directed acupuncture (61%), while unrelated acupuncture (70%) and sham acupuncture (64%) were similar to directed. Bruising was reported less in the simulated acupuncture group (10%), while directed acupuncture (52%) it was reported more, the unrelated treatments (74%) was the worse, with sham acupuncture (68%) being similar to the last 2 groups. 

Data extraction methods: data were extracted from the published paper. We selected the 'directed acupuncture' group as the real acupuncture treatment and we combined all the control arms as the sham acupuncture control as per the Cochrane Handbook and confirmed with the Cochrane editors. Mean data were measured from Figure 2 in the published data and SD was taken from baseline as this was not provided in the figure and was not published anywhere else. For the comparison of invasive and non-invasive sham controls we used the 'simulated acupuncture' as it was the same tool (Sherman 2002) as used in both the Harris 2008 and Harris 2009 studies. We could not extract data from the SF-36 graphs (Figure 3) as both graphs were labelled as SF-36 Physical Component.

Notes

Other info: 1 author was contacted by e-mail and confirmed intention-to-treat, however no further information was given about data or in response to other questions we had

Refunded costs to participants: not reported

Funding: NCCAM

Language: English

Publication: full paper

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated random number
Allocation concealment (selection bias)Low riskBlocked random allocation sequence with block size of 4 with an independent researcher advising the acupuncture clinic of treatment assignment
Incomplete outcome data (attrition bias)
All outcomes
Low riskData from 7 participants were not included in the analysis. However, the missing outcome data were balanced across the groups and less likely to have impacted on the outcome.
Selective reporting (reporting bias)Low riskAll outcomes reported, as per WHO clinical trials register
Blinding of participants and personnel (performance bias)
All outcomes
Low riskRestricted conversation during treatment, participants blindfolded and used acupuncture-naive participants. Care giver not blinded to group allocation. Participants tested for blinding could not detect which group they belonged to at the end of treatment.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskData collection staff and data analysts were blinded to treatment group

Deluze 1992

Methods

Randomised: electronic number generator, closed envelopes, numbered 1 to 70, prepared before study and opened in numerical order after recruitment

Blinding: participants and outcomes assessors were blinded. Care giver was NOT blinded to group allocation.

Setting: University Hospital, Geneva, Switzerland

Was study aim clear: yes

Informed consent: verbal and written

Ethics approval: Department of Medicine ethics committee

WHO clinical trial register: not listed as had not been established when study undertaken

Follow-up: none

Intention-to-treat used: not stated, but in the results section it states that the 15 participants that withdraw were not re-evaluated. Martin 2006 in their journal article stated that analysis used intention-to-treat, yet the review by Berman 1999 using intention-to-treat, found 42% had no benefit, 39% had satisfactory benefit, while 19% had an unexpectedly large benefit. In a recent review this detail was omitted by (Mayhew 2007). Assefi 2005 and Harris 2005 also did not mention this point in their discussion about other studies.

Participants

Total number of participants: 70 participants, mean duration of disease (years); real acupuncture = 14.4 years (3.7) (6.9 to 22.0), control = 6.9 years (1.3) (4.3 to 9.6)

16 male and 54 female (excess of men in the control group P = 0.015)

Mean age (years): real acupuncture = 46.8, control = 49

Diagnosis: ACR

Acupuncture-naive participants: yes

Excluded: severe concomitant disease, use of morphine-like drugs or anticoagulants, peripheral neuropathy, bleeding disorders, language difficulties and past use of acupuncture

Recruitment source: referred, but does not state where from

Previous treatments: not reported

Interventions

1) Real: electro-acupuncture (visible muscle contraction)

Randomised to this group: 36 (analysed 28)

2) Control: sham electroacupuncture, similar number of needles except off the acupuncture point by 20 mm and current used on electro-stimulator was weaker than the real group. No increase in electrical volume was applied once the threshold of perception had been reached.

Randomised to this group: 34 (analysed 27)

Co-interventions: individual treatments continued, physiotherapy, anti-inflammatory agents, tricyclic antidepressants and analgesics.

See STRICTA table for treatment details (Appendix 10).

Outcomes

Primary outcomes:

1) Pain; visual analogue scale (1 to 100 mm)

Secondary outcomes:

2) Pain threshold, measured by pressure gauge over the 18 tender points as defined by ACR, before and after treatment

3) Analgesic use, tablets. Initial measurements taken in the week before the evaluation took place

4) Regional pain score, body drawing in which 21 regions are indicated. Patient assesses their pain in each region on a scale of 1 to 5, with 5 being the worst.

5) Sleep quality scale (1 to 10), with 10 being the best

6) Morning stiffness, measured in minutes

7) Patient general state (1 to 10), measured by patient, with 10 being the best

8) Evaluating physician impression (1 to 10), measured by physician as to the patient's general state, with 10 being the best

Outcome measures taken before and after treatments completed

Outcome measure results:

Overall approximately 50% improved significantly, 25% had no change with the balance showing "unexpectedly large improvement, with almost complete disappearance of symptoms"; 1 in the control group was observed to have a similar result

Real group improved significantly in 5 out of the 8 areas except morning stiffness

Pain threshold improved by 70% in the real group as opposed to 4% in the control group

Withdrawals/drop-outs: real acupuncture = 8, control group = 7

Complications/adverse events: real electroacupuncture 6 (2 = increase in symptoms, 3 = unpleasantness of needle sensation, 1 = ankle oedema). Sham electroacupuncture 5 (4 = increase in symptoms, 1 = unpleasantness of needle sensation)

Data extraction method: data were extracted from the published paper using table 2 and ZZ converted the SE data to SD. We selected the 'VAS pain scale' rather than the 'regional pain score' as it was the most used measurement tool for pain.

Notes

Other info: e-mail contact was made with lead author who stated they were too busy to answer questions

Refunded costs to participants: not reported

Funding: not stated

Language: English

Publication: full paper

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskElectronic number generator
Allocation concealment (selection bias)Low riskClosed envelopes, numbered 1 to 70, prepared before study and opened in numerical order after recruitment
Incomplete outcome data (attrition bias)
All outcomes
High risk11 participants dropped out from the study, and their data were not included in the whole analysis. Number of participants dropped out from the study and reasons for drop-out were comparable in both groups (5/27; 6/28). As nearly 80% of those dropped out were due to increased symptoms, attrition bias is possible although this was comparable in both treatment groups.
Selective reporting (reporting bias)Low riskWHO clinical trials register was not established at time of publication
Blinding of participants and personnel (performance bias)
All outcomes
Low riskUsed acupuncture-naive participants, care giver not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low riskIndependent evaluator, unaware of group allocations

Guo 2005

Methods

Randomised: semi-randomised according to the order of admission

Blinding: patient/care giver were not  blinded. Whether assessors were blinded is not reported. 

Setting: in and outpatients of an affiliated hospital, Helongjiang, China

Was study aim clear: no

Informed consent: not reported

Ethics approval: not reported

WHO clinical trial register: not listed

Follow-up: 6 months

Intention-to-treat used: not reported

Participants

Total number of participants: 38 patients, mean duration of illness: acupuncture: 11 (2.3) months; control: 10 (3.6) months

7 male and 31 female; acupuncture group: M:F 3:16; control: M:F 4:15

Mean age: real acupuncture group = 50 (2.9) yrs (not sure if this is SD); control = 49 (3.4)

Diagnosis: ACR

Acupuncture-naive participants: not reported 

Excluded: not reported (did not mention if there were exclusion criteria)

Recruitment source: not reported.

Previous treatments: not reported

Interventions

1) Real: acupuncture group

Randomised to this group: 19 (analysed 19)

2) Control: Western medication group (amitriptyline, tricyclic antidepressant, start from 10 mg, increased by 10 mg every 10 days until 30 mg, dividing dose into 2 and taking them at 2 different times of the day, 30 days 1 course)

Randomised to this group: 19 (analysed 19)

Co-interventions: not reported

See STRICTA table for treatment details (Appendix 10)

Outcomes

Primary outcome:

1) Pain; visual analogue scale (VAS), did not specify either 1 to 10 or 0 to 100 range

Secondary outcome:

2) Number of tender points, did not specify details

Outcome measure results:

Symptoms and signs-free, no tender points; acupuncture 9; control: 3

Significantly improved: VAS and tender points both reduced by or over 50%; most symptoms and signs resolved; 5:2

Improved: VAS and tender points both reduced by 25% to 50%; some improvement in S/S; 4:8

No effect: VAS and tender points both reduced < 25%, no changes in S/S; 1:6 

Withdrawals/drop-outs: no reported but based on data there were none

Complications/adverse events: not reported

Data extraction method: data were extracted from published paper table 2

Notes

Other info: we could not contact the lead author to clarify missing information

Refunded costs to participants: not reported

Funding: not reported

Language: Chinese

Publication: full paper

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskRCT, but no other information
Allocation concealment (selection bias)High riskSemi-randomised according to the order of admission
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo drop-out reported. According to the data provided, all participants were included in the analysis.
Selective reporting (reporting bias)Unclear riskNot listed on WHO clinical trials register
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNot reported
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot reported

Harris 2005

Methods

Randomised: computer-generated random numbers in a 4-block design. Concealed in an opaque envelope and given to the acupuncturist 1 day before treatment. 

Blinding: participants blindfolded with a non-blinded research assistant present during the treatments to monitor and ensure treatment integrity. Outcome assessors were blinded to treatment allocation. Care givers knew the allocation groups and the hypothesis.

Setting: Georgetown University, Washington DC

Was study aim clear: yes

Informed consent: verbal and written

Ethics approval: Institutional Review Board

WHO clinical trial register: listed on site and outcomes as per listing

Follow-up: none

Intention-to-treat: yes

Participants

Total number of participants: 114 participants, mean duration of illness (years): T/S = 5.50 years (3.71), T/O = 5.26 years (4.83), N/S = 5.17 years (4.24), N/O = 5.77 years (4.10)

8 male and 106 female

Mean age: T/S 46.0 (10.1), T/O 44.5 (10.9), N/S 51.3 (10.0), N/O 48.1 (10.9)

Diagnosis: ACR

Acupuncture-naive participants: yes

Excluded: previous acupuncture treatments including sufficient knowledge that would prevent blinding, bleeding diathesis, autoimmune or inflammatory disease, daily narcotic analgesic use or a history of substance abuse, contraindication to use of acetaminophen or ibuprofen, in other clinical studies, pregnancy or lactation, receiving disability payment or litigation related to fibromyalgia

Recruitment source: the Washington DC metropolitan area using newspaper, periodicals and screened by telephone

Previous treatments: not reported

Interventions

1) Real: traditional acupuncture (T/S) with stimulation

Randomised to this group: 29

2) Control: traditional acupuncture (T/O) without stimulation

Randomised to this group: 30

3) Control: non-traditional acupuncture (N/S) with stimulation, needles at same depth and stimulation as T/S group. Needles were placed in sites not believed to effective in Traditional Chinese Medicine based acupuncture
Randomised to this group: 28

4) Control: non-traditional acupuncture (N/O) without stimulation, in non-traditional sites

Randomised to this group: 27

(Each group received treatment once per week for 3 weeks, then twice per week for 3 weeks, then 3 times per week for 3 weeks (total 18 treatments). Between each treatment, there was a 2-week washout period)

Minimum number of treatments needed: not reported

Co-interventions: participants were allowed to continue normal treatments including antidepressants. They were not allowed to make any changes during the trial and not to seek acupuncture outside of the trial.

See STRICTA table for treatment details (Appendix 10)

Outcomes

Primary outcomes:

1) Pain: numeric rating scale, 101-point, range from 0 to 100 points in 5-point increments, 0 = no pain to 100 = worst pain imaginable (assessed before and week 3, 4 to 5, 8, 9 to 10, 13, 14 to 15)

2) Function: Short-Form 36, score ranges from 0 to 100 with higher scores indicating better function (assessed before and week 4 to 5, 9 to 10, 14 to 15)

Secondary outcomes:

3) Fatigue: Multi-Dimensional Fatigue Inventory questionnaire, scores range from 4 to 20 with larger scores indicating more fatigue (assessed before and week 4 to 5, 9 to 10, 14 to 15)

4) Blinding: participants were asked in week 4 whether they could determine which treatment arm they were in (A = acupuncture, B = placebo and C = could not tell)

Outcome measure results:

"Clinically significant improvements in pain were observed in 25% to 35% of subjects".

"Blinding assessment indicated that participants remained blinded to treatment at week 4 (P = 0.259)".

Withdrawals/drop-outs: 38 (T/S = 7, T/O = 11, N/S = 8,  N/O = 12)

Complications/adverse events: not reported

Data extraction method: data were extracted from the published paper using Table 2. We selected T/S and N/O data to represent real and sham acupuncture. For comparing different acupuncture styles we choose T/S versus T/O.

Notes

Other info: contact was made with lead author who confirmed details of drop-outs and location of trial

Refunded costs to participants: not reported

Funding: NCCAM

Language: English

Publication: full paper

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated
Allocation concealment (selection bias)Low riskRandom numbers in a 4-block design. Concealed in an opaque envelope and given to the acupuncturist 1 day before treatment. 
Incomplete outcome data (attrition bias)
All outcomes
Low riskAll participants including those who dropped out from the study were included in the data analysis. The number of and reasons for drop-out were comparable among the groups.
Selective reporting (reporting bias)Low riskAll outcomes reported, as per WHO clinical trials register
Blinding of participants and personnel (performance bias)
All outcomes
Low riskUsed acupuncture-naive participants, other participants not present at clinic during treatment, blindfolded during treatment. Care giver not blinded. Non-blinded research assistant present during all treatments to ensure treatment integrity. Blinding of allocation groups was tested at week 3 with no significant differences noted.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAll evaluators blinded to treatment allocation

Harris 2008

Methods

Randomised: random number generator used (blocks of 4 with 2 acupuncture and 2 sham)

Blinding: participants blindfolded during treatments. All assessors were blinded to treatment assignments.

Setting: University of Michigan, USA

Was study aim clear: yes

Informed consent: written and informed

Follow-up: none, only for term of treatment

Ethics approval: University of Michigan Institutional Review Board

WHO clinical trial register: not listed and confirmed by author

Intention-to-treat: yes, all subjects completed trial

Participants

Total number of participants: 10 participants, duration of fibromyalgia for > 1 year

0 male (acupuncture and control) and 10 female

Mean age: both acupuncture and control combined mean 48 SD 15 years

Diagnosis: ACR 1990 criteria

Acupuncture-naive participants: yes

Excluded: as per Harris 2005 study

Recruitment source: fibromyalgia subject registry at the University of Michigan Chronic Pain and Fatigue Center

Previous treatments:

Interventions

1) Real: acupuncture

Randomised to this group: 6

2) Control: non skin-penetrating acupuncture (Sherman 2002)

Randomised to this group: 4

Minimum number of treatments needed: 9 out of 9

Co-intervention: none

See STRICTA table for treatment details (Appendix 10)

Outcomes

Primary outcomes:

1) Pain: VAS subset of Short-Form McGill Pain Questionnaire (SF-MPQ)

Assessments: at baseline and end of treatment

Outcome measure results: clinical pain improved from pre- to post-treatment according to SF-MPQ rating of the sensory dimensions of pain (mean difference in clinical pain rating 3.50 (SD 4.70); P = 0.043)

SF-MPQ sensory score baseline mean (SD) = 12.3 (4.35)

SF-MPQ sensory score end of treatment mean (SD) = 8.80 (5.61)

Withdrawals/drop-outs: no drop-outs

Complications/adverse events: no adverse events

Author stated "actually the primary outcome for this study was neuroimaging changes for TA and SA. Clinical pain was never a primary outcome, it was only used as a covariate".

Data extraction method: data for pain was provided by the author directly

Notes

Other info: part of an ongoing study; results for this study have not been published anywhere else. Missing details from the study were confirmed by the lead author via e-mail. They included details of randomisation, blinding, whether acupuncture-naive, score baseline/end of treatment/drop-outs and data. The lead author confirmed that this is not a subset of the Harris 2005 study.

Funding: US Department of Army grant and NIH/National Centre for Complementary and Alternative Medicine

Refunded costs to participants: not reported

Language: English

Publication: full paper 

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated
Allocation concealment (selection bias)Low riskRandom number generator used (blocks of 4, with 2 acupuncture and 2 sham)
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskNot listed on WHO clinical trials register
Blinding of participants and personnel (performance bias)
All outcomes
Low riskUsed acupuncture-naive participants, participants blindfolded, care giver was not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAll assessments were blinded

Harris 2009

Methods

Randomised: random number generator used (blocks of 4 with 2 acupuncture and 2 sham)

Blinding: participants blindfolded during treatments. All assessors were blinded to treatment assignments.

Setting: University of Michigan, USA

Was study aim clear: yes

Informed consent: written and informed

Follow-up: none, only for term of treatment

Ethics approval: University of Michigan Institutional Review Board

WHO clinical trial register: not listed and confirmed by author

Intention-to-treat: yes, all subjects completed trial

Participants

Total number of participants: 20 participants, duration of fibromyalgia > 1 year

0 male (acupuncture and control) and 20 female

Mean age: both acupuncture and control combined mean 44.3 SD 13.6 years

Diagnosis: ACR 1990 criteria

Acupuncture-naive participants: yes

Excluded: as per Harris 2005 study

Recruitment source: fibromyalgia subject registry at University of Michigan

Previous treatments: not reported

Interventions

1) Real: acupuncture (TA)

Randomised to this group: 10

 2) Control: non skin-penetrating acupuncture (SA) (Sherman 2002)

Randomised to this group: 10

Minimum number of treatments needed: 9 out of 9

Co-intervention: medication (agreed not to change)

See STRICTA table for treatment details (Appendix 10)

Outcomes

Primary outcomes:

1) Pain: McGill Pain Questionnaire (SF-MPQ)

Assessments: st baseline and end of treatment

Outcome measure results: "significant reductions in pain were observed for the entire cohort for the total score SF-MPQ"
Total: mean difference (SD) treatment - baseline: -3.45 (7.39); P = 0.05

SF-MPQ Sensory Score: mean (SD): -2.65 (5.98) P = 0.06

SF-MPQ Affective Score: mean (SD): -0.80 (2.25) P = 0.13

Both TA and SA resulted in clinically meaningful reductions in pain (SF-MPQ total score mean difference (SD): TA -4.00 (6.72); SA -2.90 (8.33)

2) Assessment of masking:

Participants had to guess which group they belonged to after the first PET scan. Overall the 2 distributions were not statistically different: Chi2 = 0.88, P = 0.65

Withdrawals/drop-outs: no drop-outs

Complications/adverse events: no adverse events

Author stated "actually the primary outcome for this study was neuroimaging changes for TA and SA. Clinical pain was never a primary outcome, it was only used as a covariate".

Data extraction method: data were provided by the author. The author noted that "actually in this manuscript (Harris 2009) we did not analyse real versus sham acupuncture groups. We combined both groups together in this analysis".

Notes

Other info: part of an ongoing study. Details of study were confirmed by the author via e-mail: drop-outs/adverse events and data. The author confirmed that this is not a subset study of Harris 2005.

Funding: US Department of Army grant and NIH/National Centre for Complementary and Alternative Medicine

Refunded costs to participants: not reported

Language: English

Publication: full paper

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated
Allocation concealment (selection bias)Low riskRandom number generator used (blocks of 4, with 2 acupuncture and 2 sham)
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data
Selective reporting (reporting bias)Unclear riskNot listed on WHO clinical trials register
Blinding of participants and personnel (performance bias)
All outcomes
Low riskUsed acupuncture-naive participants, participants blindfolded, care giver was not blinded. Participants had to guess which group they belonged to after first PET scan. Overall the 2 distributions were not statistically different.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAll assessments were blinded

Itoh 2010

Methods

Randomised: randomly assigned with a computerised randomisation program (SAMPSIZE V2.0, Blackwell Science Ltd, UK), permutated block randomisation to either group

Blinding: outcome assessors were blinded to treatment assignments

Setting: Acupuncture and Moxibustion Center, Meiji University of Integrative Medicine, Kyoto, Japan

Was study aim clear: yes

Informed consent: written and informed

Follow-up: none, only for term of treatment

Ethics approval: Ethics Committee of Meiji University of Integrative Medicine

WHO clinical trial register: not listed and confirmed by author

Intention-to-treat: no, analysis only of participants that completed study

Participants

Total number of participants: 13 participants, duration of fibromyalgia for Group A 3.9 (SD 8.4), Group B 4.4 (SD 2.3)

3 male and 13 female; does not state which group they were allocated to

Mean age: Group A 45.7 (15.2), Group B 47.3 (13.3) years

Diagnosis: ACR 1990 criteria

Acupuncture-naive participants: yes

Excluded: previous acupuncture, bleeding disorders, autoimmune or inflammatory diseases, participation in other trials, pregnancy or lactation, receiving disability payments or involved in litigation related to fibromyalgia

Recruitment source: fibromyalgia specialists at hospitals

Previous treatments: maintain current medication use

Interventions

1) Real: acupuncture (TA)

Group B, electro- and trigger point acupuncture

Randomised to this group: 7

 2) Control: Group A received 5 acupuncture sessions after 5 weeks of weekly or twice weekly clinical examinations only

Randomised to this group: 6

Minimum number of treatments needed: not reported

Co-intervention: medications using amitriptyline, SSRIs and SNRIs (agreed not to change)

See STRICTA table for treatment details (Appendix 10)

Outcomes

Primary outcomes:

1) Pain: VAS 19 cm scale with higher score indicating negative impact

2) Function: Fibromyalgia Impact questionnaire FIQ), 20 items covering physical functioning, work status, depression, anxiety, sleep (rest/morning tiredness), pain, stiffness, fatigue and well-being. Each scored 0 to 10. The higher the combined score the worse the condition is affecting the participant. Full details on scoring can be found in Burckhardt 1991.

Assessments: before start, week 5 and at end of treatments, week 10 

Outcome measure results: VAS, Group A remained unchanged until acupuncture treatment started, while Group B decreased by week 5. No differences between groups at baseline (P = 0.566), while at week 5, significant differences in VAS between groups (P = 0.022) and at week 10 no difference (P = 0.252).

FIQ, Group A remained unchanged until acupuncture treatment started, while Group B decreased by week 5. No differences between groups at baseline (P = 0.616), while at week 5 significant differences in FIQ between groups (P = 0.026) and at week 10 no difference (P = 0.86).

Withdrawals/drop-outs: Group A 2, Group B 1, both lost due to lack of response to treatment

Complications/adverse events: none reported 

Data extraction method: data were provided by the lead author directly

Notes

Other info: author was contacted by e-mail and provided data

Funding: not reported

Refunded costs to participants: not reported

Language: English

Publication: full paper

Results: see the comparisons

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated
Allocation concealment (selection bias)Low riskPermutated block randomisation to either group
Incomplete outcome data (attrition bias)
All outcomes
High riskIntention-to-treat not used, 3 drop-outs (1 acupuncture, 2 no treatment groups) due to lack of response to treatment, however drop-out rates were not significantly different between groups
Selective reporting (reporting bias)Unclear riskNot listed on WHO clinical trials register
Blinding of participants and personnel (performance bias)
All outcomes
High riskUsed acupuncture-naive participants, however participants at start of treatment would have known which group they belonged to due to study design; care giver was not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAll assessments performed by independent investigator not aware of treatment sequence or treatment received

Martin 2006

Methods

Randomised: immediately before first treatment. Opaque envelopes, labelled sequentially. Each contained a 3 x 5 index card, which was printed with the group assignment. Every 4 envelopes contained 2 control and 2 experimental assignments. This was done in blocks of 2 to prevent imbalances in treatment allocation. Envelopes were opened in order.

Blinding: participants seated in an arrangement that blocked their view to treatment. Outcome assessors blinded to group allocation. Care givers and participants maintained neutral conversion.

Setting: Mayo Fibromyalgia Treatment Program, Rochester, Minnesota, USA

Was study aim clear: yes

Informed consent: verbal and written

Ethics approval: Mayo Foundation Institutional Review Board

WHO clinical trial register: not listed and confirmed by author who stated they did not know about it

Follow-up: 1 and 7 months

Intention-to-treat: yes

Participants

Total number of participants: 50 patients, mean duration of illness (years): not reported

1 male (control group) and 49 female (real and control)

Mean age: acupuncture 47.9 SD 11.2 years, control 51.7 SD 14.1 years

Diagnosis: ACR

Acupuncture-naive participants: yes

Excluded: prior acupuncture experience, bleeding diathesis, had to be able to understand consent and to be able to fill out the questionnaires

Recruitment source: referrals to programme from physician after conservative management

Previous treatments: patients had received conservative management, but this was not described; "many had already used most of the basic treatments for fibromyalgia"

Interventions

1) Real: electroacupuncture, used a special table arrangement that did not allow the patient to see what was happening;

Randomised to this group: 25

2) Control: sham electroacupuncture, setting was same as real group, except needle was attached to plaster and did not break the skin;

Randomised to this group: 25

Minimum number of treatments needed: all patients completed at least 5 treatments

Co-interventions: 1.5 days of education, counselling and group discussion about symptom management (done before enrolment into study, 4-week wash-out period before start of treatments). No other co-interventions were reported.

See STRICTA table for treatment details (Appendix 10)

Outcomes

Primary outcomes:

1) Pain: Multidimensional Pain Inventory (MPI), 61-item questionnaire developed for chronic pain. Composed of 13 scales that measure different pain-related aspects. 4 of the questions that related to support from spouse or significant other were excluded, as it was not part of the standard treatment programme.

2) Function: Fibromyalgia Impact Questionnaire (FIQ), 20 items covering physical functioning, work status, depression, anxiety, sleep (rest/morning tiredness), pain, stiffness, fatigue and well-being. Each scored 0 to 10. The higher the combined score the worse the condition is affecting the patient. Full details on scoring can be found in the article by Burckhardt 1991.

Secondary outcomes:

3) Participants were asked their opinion regarding group assignment

Assessments: before start, immediately at end of treatment sessions and at 1 and 7 months

Outcome measure results:

FIQ showed significant improvement in the acupuncture group over control acupuncture during study period (P = 0.01), with the greatest difference at the 1 month (P = 0.007). Subscale analysis showed significant group effect for fatigue (P = 0.001) and anxiety (P = 0.003) at 1 month. Other sub-scales showed trends towards improvement but were not statistically significant.

MPI group effect showed significant improvement in pain at 1 month (P = 0.03) but effect was lost at the 7-month measure (P = 0.05).

Blinding of participants did not exceed chance

Withdrawals/drop-outs: 1 lost to follow-up

Complications/adverse events: many participants in both groups experienced feeling tired and/or relaxed after treatment. Mild bruising and soreness was common in acupuncture group. 2 patients experienced mild vasovagal symptoms (1 from each group). 1 patient experienced a pulmonary embolism (believed to be unrelated to the study). 

Data extraction method: data were extracted from published paper table 3 and we used data at the one month after treatment point as per our protocol

Notes

Other info: author was contacted by e-mail and confirmed allocation concealment, WHO listing and point locations

Funding: Mayo Foundation and Mayo Anaesthesia Clinical Research Unit

Refunded costs to participants: financial compensation provided for parking

Language: English

Publication: full paper

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskRandom sequence not reported
Allocation concealment (selection bias)Low riskImmediately before first treatment. Opaque envelopes, labelled sequentially. Each contained a 3 x 5 index card, which was printed with the group assignment. Every 4 envelopes contained 2 control and 2 experimental assignments. This was done in blocks of 4 to prevent imbalances in treatment allocation. Envelopes were opened in order.
Incomplete outcome data (attrition bias)
All outcomes
Low riskAll participants completed outcome measures at the end of treatment; 1 from the control group did not have data for 1 and 7-month follow-ups and was excluded from follow-up analysis. Given this was only 1 participant, this exclusion would have minimal impact on the outcome.
Selective reporting (reporting bias)Unclear riskNot listed on the WHO clinical trials register; author stated did not know about it
Blinding of participants and personnel (performance bias)
All outcomes
Low riskUsed acupuncture-naive participants, blinded to actual treatment by seated arrangement of protocol, restricted conversation during treatment and use of blinded study co-ordinator for questions. Care giver was not blinded. Group allocation was tested and ability of patients to determine treatment received did not exceed chance.
Blinding of outcome assessment (detection bias)
All outcomes
Low riskAll evaluations were obtained from participants by study co-ordinator who was blinded to group allocations

Targino 2008

  1. a

    ACR: American College of Rheumatology
    CMSG: Cochrane Musculoskeletal Group
    FIQ: Fibromyalgia Impact Questionnaire
    MPI: Multidimensional Pain Inventory
    NCCAM: National Centre for Complementary and Alternative Medicine
    NIH: National Institutes of Health
    N/O: non-traditional acupuncture without stimulation
    N/S: non-traditional acupuncture with stimulation
    PET: positron emission tomography
    RCT: randomised controlled trial
    SA: non skin-penetrating acupuncture
    SD: standard deviation
    SE: standard error
    SF-MPQ: Short-Form McGill Pain Questionnaire
    SNRI: serotonin–norepinephrine reuptake inhibitor
    S/S: symptoms/signs
    SSRI: selective serotonin re-uptake inhibitor
    STRICTA: Standards for Reporting Interventions in Controlled studies of Acupuncture
    TA: acupuncture (real)
    T/O: traditional acupuncture without stimulation
    T/S: traditional acupuncture with stimulation
    VAS: visual analogue scale
    WHO: World Health Organization

Methods

Randomised: using "a computer-generated random sequence of numbers provided by the Hospitals Informatics Departments. The randomization was conducted by one physician who was not involved with the inclusion or exclusion process."

Blinding: assessor blind - "participants rated their pain intensity using a VAS. Blinded evaluation of PPT18 and TePsN was carried out by a single physician (HHSK), while blind evaluation of quality of life was conducted by one psychologist (LPMS). Even though the participants knew which group they were in (either the acupuncture treatment group or the standard care group), they were instructed not to communicate this information to the outcome assessors."

Setting: not reported, but assume it was the Clinics Hospital

Was study aim clear: yes

Informed consent: written and informed consent

Follow-up: 3 months (after randomisation and at the end of the treatment), 6 months, 12 months and 24 months

Ethics approval: the ethics review committee of the Clinics Hospital

WHO clinical trial register: listed and outcomes as per listing

Intention-to-treat: yes, up to 12 months follow-up, but not at 24 months follow-up     

Participants

Total number of participants: 58 patients, mean duration of pain (months): acupuncture group 118.8 (117.3), control 93.0 (75.25). Did not describe what they meant by pain duration, whether it was fibromyalgia diagnosis or pain. Assume it refers to fibromyalgia.

Gender: 0 male (acupuncture and control) and 58 female

Mean age: acupuncture 52.09 SD 10.97 years, control 51.17 SD 11.20 years

Diagnosis: ACR: "ACR criteria were applied by one of the physicians (HHSK) to confirm the diagnosis prior to the enrolment to the study."

Inclusion: 20 to 70 yrs old, have to have had pain VAC > 4/10; using an antidepressants at an analgesic dose (12.5 to 75 mg/kg). Author did not specify the name of medication

Acupuncture-naive participants: no, patients who had acupuncture in the previous 12 months were excluded. Presumably, this is not an important item because sham acupuncture is not used.

Excluded: patients with "severe psychiatric disease, the presence of neurological deficits, cardiac disease or glaucoma, and treatment with acupuncture within one year prior to the start of the study."

Recruitment source: "were recruited by physicians from the Clinics Hospital in Sao Paulo. They included doctors practising in the Pain Clinic of the Department of Neurology, those in the Rheumatology Clinic and those in the Division of Physical Medicine of the Institute of Orthopedics and Traumatology."

Previous treatments: none reported except for current medication

Interventions

1) Real: acupuncture + standard care (12.5 to 75 mg of tricyclic antidepressants per day), individualised plus exercise, including "oral instruction to walk for 30 min twice a week at their own pace, to breathe deeply and to perform mental relaxation exercises for another 30 min. They were also told to perform twice-weekly stretching exercises involving the para-spinalis muscles, glutei, hamstrings, ankle plantar flexors and hip flexors." Patients in the acupuncture group always had their sessions performed by the same physician (RAT).

Randomised to this group: 34

2) Control: standard care, tricyclic antidepressant (individualised, ranging from 12.5 to 75 mg/day, most (84.5%) received 50 mg/day) plus exercise. Participants "were seen by a physician at the beginning of the study and during the follow-up visits. No additional visits were scheduled for the controls to compensate for the extra attention being received by patients in the acupuncture treatment group. Compliance with the use of either exercise or antidepressant drugs was based on participants reports during the outcome evaluation interviews."

Randomised to this group: 24

Compliance: 97.1% (33 participants) completed all 20 sessions, with one leaving after 17 sessions due to complete relief from pain

Minimum number of treatments needed: not reported

Co-intervention: not reported

See STRICTA table for treatment details (Appendix 10)

Outcomes

Primary outcomes:

1) Visual analogue scale (VAS) with 0 = no pain and 10 = worst pain experienced

2) Quality of life: SF-36 form. Portuguese version of MOS 36-item short-form health survey (8-items), higher scores indicate better quality of life.

Secondary outcomes:

3) Number of tender points below 4 kg/cm2 (TePsN). The lower the number, the less the severity of symptoms.

4) Mean pressure pain threshold value, over the 18 fibromyalgia points (PPT18). The higher the values the less severe the symptoms, measured with algometry (not sure if electronic or manual).

Assessments: at baseline, 3 months (after randomisation and at the end of the treatment), 6 months, 12 months and 24 months

Outcome measure results:

The 2 groups were comparable at baseline. Also mentioned in the discussion, the usage of medication was not different between the 2 groups.

VAS showed statistically significant improvement in the acupuncture group at 3 months (P < 0.001, however at 6, 12 and 24 months follow-up, it was not statistically different between the groups (P > 0.05)

SF-36 showed improvement in only 5 sub-scales of the acupuncture group at 3 months (PF, BP, VT, RE, MH). At 6 months the acupuncture group benefit was for only 1 sub-scale (GH) and at 12-month follow-up only 1 sub-scale showed improvement (RP).

TePsN and PPT18 showed improvement in the acupuncture group at 3 and 6 months

There was no statistical difference in the scores of the standard care group at any time (P > 0.05)

Withdrawals/drop-outs: at 24 months, 2 were lost to follow-up in the acupuncture group (follow-up rate 94.1%), 1 in the control group (follow-up rate 95.8%)

Complications/adverse events: 2 patients in the acupuncture group reported temporary oedema of the left hand at LI4. There were no reported incidences of discomfort, soreness, vasovagal symptoms, bruising or haematoma at time of treatment or the during the follow-up period of 24 months.

Data extraction method: data were extracted from the published paper using table 2 and medians/ranges were converted by the CMSG statistician. We could not use SF-36 data as there were no available data for converting median/range to mean. We were waiting for details from the author at the time of publication.

Notes

Other info: 1 author of our review was in contact with the study author who that advised she had a paper awaiting publication which she provided direct. This was outside of our search at the start of review and provided further data.

Funding: no funding provided

Refunded costs to participants: not reported

Language: English

Publication: full paper

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated random sequence of numbers
Allocation concealment (selection bias)High riskDid not use, as study objective was to evaluate the benefit of the addition of acupuncture to a standard course of tricyclic antidepressants and exercise
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo drop-out was reported during the treatment or in the first 12 months of follow-up. 3 participants were not contacted at the 24-month follow-up and their data were excluded from analysis at that time. This exclusion will not impact on the outcome at the end of treatment or 12-month follow-up. Furthermore, the number of drop-outs at 24 months was comparable between the 2 groups.
Selective reporting (reporting bias)Low riskAll outcomes reported as per WHO clinical trials register
Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants were restricted to those who not had acupuncture in the last 12 months; care giver was not blinded
Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessors were blinded and participants were told not to inform them of their group allocation

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
  1. a

    ACR: American College of Rheumatology
    FIQ: Fibromyalgia Impact Questionnaire
    RCT: randomised controlled trial
    SD: standard deviation

Cao 2003Article in Chinese. "Randomised" stated but methods not described. Excluded as study had an extra therapy (mobile cupping) in the acupuncture and Western medicine arm that was not included in the control arm of Western medicine (i.e. acupuncture + Western medicine + mobile cupping versus Western medicine).
Cassisi 1994Article in Italian. "Patients were randomly chosen and divided into three therapeutic groups." Translation by Italian Cochrane Centre confirms article same as Cassisi 1995 and is a case series.
Cassisi 1995Article in Italian. "Patients were randomly chosen and divided into three therapeutic groups." Translation by Italian Cochrane Centre confirms article is a case series. This study has been quoted in a number of reviews and articles as a RCT but this is incorrect. Contact with one of the authors: the data in this reprint are incorrect and they advise to use the 1994 article.
Chen 2009Article in Chinese; case series
Collazo Chao 2010Article in Spanish; not a RCT
Dai 2009Article in Chinese; case series
Feldman 2001Conference report. RCT. The publisher and conference organisers were contacted and could not provide details of the whereabouts of the authors. Internet searches were undertaken to try and locate either author without success.
Gong 2010Article in Chinese. Extra therapy not included in both arms (acupuncture + mind focus versus Western medicine).
Gou 2010Article in Chinese. Extra therapy not included in both arms (acupuncture + infrared lamp versus Western medicine).
Guan 2005Article in Chinese. Data unusable as responder only.
Guevara 2007Conference report. No primary clinical outcomes published.
Guo 2003Article in Chinese. Data unusable as responder only.
Guo 2005aArticle in Chinese. Data unusable as responder only (although number of tender points reported for baseline).
Harris 2006Secondary analysis of original article (Harris 2005)
Harris 2007Data were from before acupuncture treatment (cross-sectional study)
Harris 2007aConference report, RCT. Author was contacted and has advised awaiting full journal publication.
Harris 2007bConference report, RCT. Author was contacted and has advised awaiting full journal publication.
Jiang 2010Article in Chinese. Invalid control (acupuncture + cupping + Western medicine versus acupuncture + cupping versus+ Western medicine).
Lautenschlager 1989Article in German. ACR criteria not met.
Li 2005Article in Chinese. Data unusable as responder only.
Li 2005aArticle in Chinese. Data unusable as responder only.
Li 2006Article in Chinese. 'Randomised' stated but methods not described. Excluded as study had an extra therapy (mobile cupping) in the acupuncture and Western medicine arm that was not included in the control arm of Western medicine (acupuncture + Western medicine + mobile cupping versus Western medicine).
Li 2008Article in Chinese. Did not report any of our primary outcomes measures.
Li 2010Article in Chinese. Invalid control (acupuncture + moxa versus acupuncture + moxa + Western medicine).
Lui 2002Article in Chinese. Did not meet ACR criteria.
Sandberg 1999Swedish study. Not a RCT.
Sandberg 2004Comparison study. None of the review's primary outcome measures were used.
Sprott 1995Article in German. Conference report. Author asked that the 1998 study be considered, although this report had more data than the 1998 study.
Sprott 1998"Randomly subdivided into 3 groups". Data unusable as shows only 'mean' results.
Sprott 2000Article in German. Unsure how randomised. None of the review's primary outcome measures were used.
Sun 2008Article in Chinese; case series
Targino 2002RCT; no quantitative data for analyses
Uhlemann 2001Article in German. Randomised. Conference report. Author could not be contacted; no quantitative data for analysis.
Wang 2002Article in Chinese. Data unusable as no SD.
Wang 2004Article in Chinese. Data unusable as responder only.
Wei 2006Article in Chinese. Data unusable as responder only.
Wu 2003Article in Chinese. Data unusable as responder only.
Yao 2006Article in Chinese. Data unusable as responder only.
Zhang 2001Article in Chinese. Data unusable as responder only.
Zhou 2003Article in Chinese. Data unusable as responder only.

Characteristics of ongoing studies [ordered by study ID]

Vas 2011

  1. a

    ACR: American College of Rheumatology
    FIQ: Fibromyalgia Impact Questionnaire
    RCT: randomised controlled trial

Trial name or titleEffects of acupuncture on patients with fibromyalgia: study protocol of a multi-centre randomised controlled trial
MethodsRCT multi-centre study
Participants156 participants, aged over 17, ACR diagnosis
InterventionsTrue or sham acupuncture, 9 treatments, once per week
OutcomesFIQ, Hamilton rating scale for depression, medication use. Follow-up 6 and 12 months
Starting dateOctober 2010 to December 2013
Contact informationjorgef.vas.sspa@juntadeandalucia.es
Notes 

Ancillary