Deare John C, Zheng Zhen, Xue Charlie C L, Liu Jian Ping, Shang Jingsheng, Scott Sean W, Littlejohn Geoff
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, 3083.
Cochrane Database Syst Rev. 2013 May 31;2013(5):CD007070. doi: 10.1002/14651858.CD007070.pub2.
One in five fibromyalgia sufferers use acupuncture treatment within two years of diagnosis.
To examine the benefits and safety of acupuncture treatment for fibromyalgia.
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.
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.
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.
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.
五分之一的纤维肌痛患者在确诊后的两年内会接受针灸治疗。
研究针灸治疗纤维肌痛的疗效和安全性。
检索截至2012年1月的Cochrane系统评价数据库（CENTRAL）、美国国立医学图书馆医学期刊数据库（PubMed）、荷兰医学文摘数据库（EMBASE）、护理学与健康照护领域数据库（CINAHL）、国家研究注册库、卫生服务研究项目数据库和期刊目次数据库，以及中文数据库维普和万方，检索无语言限制。
根据美国风湿病学会（ACR）标准诊断为纤维肌痛的患者，接受任何类型侵入性针灸治疗的随机和半随机研究，并报告任何主要结局：疼痛、身体功能、疲劳、睡眠、总体健康、僵硬和不良事件。
由两对作者选择试验、提取数据并评估偏倚风险。治疗效果以标准化均数差（SMD）和95%置信区间（CI）表示连续结局（使用不同测量工具测量的疼痛、身体功能、疲劳、睡眠、总体健康和僵硬），以风险比（RR）和95%CI表示二分结局（不良事件）。采用随机效应模型合并数据。
纳入9项试验（395名参与者）。除1项研究外，所有研究的选择偏倚风险均较低；5项研究存在选择性报告偏倚（倾向于任何一个治疗组）；2项研究存在失访偏倚（倾向于针灸组）；3项研究存在实施偏倚（倾向于针灸组），1项研究存在检测偏倚（倾向于针灸组）。3项研究采用电针（EA），其余研究采用无电刺激的手针（MA）。除1项研究使用触发点外，所有研究均采用“配方针灸”。1项研究（13名参与者）的低质量证据表明，电针治疗后1个月症状改善，无不良事件。非治疗对照组的平均疼痛评分为100分制中的70分；电针使疼痛平均降低22分（95%置信区间（CI）4至41），或绝对改善22%。对照组的总体健康评分为100分制中的66.5分；电针使总体健康平均改善15分（95%CI 5至26分）。对照组的僵硬评分为0至10分制中的4.8分；电针使僵硬平均降低0.9分（95%CI 0.1至2分；绝对降低9%，95%CI 4%至16%）。未治疗时疲劳评分为4.5分（10分制）；电针使疲劳平均降低1分（95%CI 0.22至2分），绝对降低11%（2%至20%）。睡眠质量无差异（MD 0.4分，95%CI -1至0.21分，10分制），未报告身体功能情况。6项研究（286名参与者）的中等质量证据表明，针灸（电针或手针）并不比假针灸更好，除了1个月时僵硬程度较低。2项研究（104名参与者）的亚组分析表明电针有疗效。假治疗组的平均疼痛评分为0至100分制中的70分；电针使疼痛降低13%（5%至22%）；（SMD -0.63，9%CI -1.02至-0.23）。假治疗组的总体健康评分为10分制中的5.2分；电针改善了总体健康：SMD 0.65，95%CI 0.这是一个未完成的句子，请提供完整文本，以便我进行准确翻译。105；绝对改善11%（4%至17%）。电针改善了睡眠，假治疗组的睡眠评分为0至10分制中的3分：SMD 0.40（95%CI 0.01至0.79）；绝对改善8%（0.2%至16%）。1项研究的低质量证据表明，手针组导致身体功能较差：假治疗组的平均功能评分为100分制中的28分；治疗使功能平均恶化6分（95%CI -10.9至-0.7）。3项试验（289名参与者）的低质量证据表明，真针灸（9%）和假针灸（35%）的不良事件无差异；RR 0.44（95%CI 0.12至1.63）。1项研究（58名参与者）的中等质量证据发现，与单独标准治疗（抗抑郁药和运动）相比，辅助针灸治疗在治疗后1个月时减轻了疼痛：标准治疗组的平均疼痛评分为0至10分制中的8分；治疗使疼痛降低3分（95%CI -3.9至-2.1），绝对降低30%（21%至39%）。2名接受针灸治疗的患者报告了不良事件；对照组无不良事件（RR 3.57；95%CI 0.18至71.21）。未报告总体健康、睡眠、疲劳和僵硬情况。身体功能数据不可用。1项研究（38名参与者）的低质量证据表明，针灸在缓解疼痛方面比抗抑郁药有短期优势：抗抑郁药组的平均疼痛评分为29分（0至100分制）；针灸使疼痛降低17分（95%CI -24.1至-10.5）。未报告其他结局或不良事件。1项研究（41名参与者）的中等质量证据表明，有或无得气的深刺在疼痛、疲劳、功能或不良事件方面无差异。未报告其他结局。4项研究报告了针灸与对照组或其他治疗在6至7个月随访时无差异。未报告严重不良事件，但不良事件数量不足，无法确定风险。
有低到中等质量的证据表明，与不治疗和标准治疗相比，针灸可改善纤维肌痛患者的疼痛和僵硬。有中等质量的证据表明，针灸在减轻疼痛或疲劳以及改善睡眠或总体健康方面与假针灸效果无差异。电针在减轻疼痛和僵硬以及改善总体健康、睡眠和疲劳方面可能比手针更好。这种效果可持续长达1个月，但在6个月随访时未维持。手针可能无法改善疼痛或身体功能。针灸似乎是安全的。纤维肌痛患者可考虑单独使用电针或与运动和药物联合使用。样本量小、每项比较的研究稀缺以及缺乏理想的假针灸削弱了证据水平及其临床意义。需要开展更大规模的研究。
