Manheimer Eric, Cheng Ke, Linde Klaus, Lao Lixing, Yoo Junghee, Wieland Susan, van der Windt Daniëlle Awm, Berman Brian M, Bouter Lex M
Center for Integrative Medicine, University of Maryland School of Medicine, Kernan Hospital Mansion, 2200 Kernan Drive, Baltimore, Maryland, USA, 21207-6697.
Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD001977. doi: 10.1002/14651858.CD001977.pub2.
BACKGROUND: Peripheral joint osteoarthritis is a major cause of pain and functional limitation. Few treatments are safe and effective. OBJECTIVES: To assess the effects of acupuncture for treating peripheral joint osteoarthritis. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2008, Issue 1), MEDLINE, and EMBASE (both through December 2007), and scanned reference lists of articles. SELECTION CRITERIA: Randomized controlled trials (RCTs) comparing needle acupuncture with a sham, another active treatment, or a waiting list control group in people with osteoarthritis of the knee, hip, or hand. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We contacted study authors for additional information. We calculated standardized mean differences using the differences in improvements between groups. MAIN RESULTS: Sixteen trials involving 3498 people were included. Twelve of the RCTs included only people with OA of the knee, 3 only OA of the hip, and 1 a mix of people with OA of the hip and/or knee. In comparison with a sham control, acupuncture showed statistically significant, short-term improvements in osteoarthritis pain (standardized mean difference -0.28, 95% confidence interval -0.45 to -0.11; 0.9 point greater improvement than sham on 20 point scale; absolute percent change 4.59%; relative percent change 10.32%; 9 trials; 1835 participants) and function (-0.28, -0.46 to -0.09; 2.7 point greater improvement on 68 point scale; absolute percent change 3.97%; relative percent change 8.63%); however, these pooled short-term benefits did not meet our predefined thresholds for clinical relevance (i.e. 1.3 points for pain; 3.57 points for function) and there was substantial statistical heterogeneity. Additionally, restriction to sham-controlled trials using shams judged most likely to adequately blind participants to treatment assignment (which were also the same shams judged most likely to have physiological activity), reduced heterogeneity and resulted in pooled short-term benefits of acupuncture that were smaller and non-significant. In comparison with sham acupuncture at the six-month follow-up, acupuncture showed borderline statistically significant, clinically irrelevant improvements in osteoarthritis pain (-0.10, -0.21 to 0.01; 0.4 point greater improvement than sham on 20 point scale; absolute percent change 1.81%; relative percent change 4.06%; 4 trials;1399 participants) and function (-0.11, -0.22 to 0.00; 1.2 point greater improvement than sham on 68 point scale; absolute percent change 1.79%; relative percent change 3.89%). In a secondary analysis versus a waiting list control, acupuncture was associated with statistically significant, clinically relevant short-term improvements in osteoarthritis pain (-0.96, -1.19 to -0.72; 14.5 point greater improvement than sham on 100 point scale; absolute percent change 14.5%; relative percent change 29.14%; 4 trials; 884 participants) and function (-0.89, -1.18 to -0.60; 13.0 point greater improvement than sham on 100 point scale; absolute percent change 13.0%; relative percent change 25.21%). In the head-on comparisons of acupuncture with the 'supervised osteoarthritis education' and the 'physician consultation' control groups, acupuncture was associated with clinically relevant short- and long-term improvements in pain and function. In the head on comparisons of acupuncture with 'home exercises/advice leaflet' and 'supervised exercise', acupuncture was associated with similar treatment effects as the controls. Acupuncture as an adjuvant to an exercise based physiotherapy program did not result in any greater improvements than the exercise program alone. Information on safety was reported in only 8 trials and even in these trials there was limited reporting and heterogeneous methods. AUTHORS' CONCLUSIONS: Sham-controlled trials show statistically significant benefits; however, these benefits are small, do not meet our pre-defined thresholds for clinical relevance, and are probably due at least partially to placebo effects from incomplete blinding. Waiting list-controlled trials of acupuncture for peripheral joint osteoarthritis suggest statistically significant and clinically relevant benefits, much of which may be due to expectation or placebo effects.
背景:外周关节骨关节炎是疼痛和功能受限的主要原因。很少有治疗方法既安全又有效。 目的:评估针刺治疗外周关节骨关节炎的效果。 检索策略:我们检索了Cochrane对照试验中心注册库(《Cochrane图书馆》2008年第1期)、MEDLINE和EMBASE(均截至2007年12月),并查阅了文章的参考文献列表。 选择标准:将针刺与假针刺、另一种积极治疗或等待名单对照组进行比较的随机对照试验(RCT),研究对象为膝、髋或手部骨关节炎患者。 数据收集与分析:两位作者独立评估试验质量并提取数据。我们与研究作者联系以获取更多信息。我们使用组间改善差异计算标准化均数差。 主要结果:纳入了16项试验,涉及3498人。其中12项RCT仅纳入膝骨关节炎患者,3项仅纳入髋骨关节炎患者,1项纳入髋和/或膝骨关节炎患者的混合样本。与假对照相比,针刺在骨关节炎疼痛方面显示出具有统计学意义的短期改善(标准化均数差 -0.28,95%置信区间 -0.45至 -0.11;在20分制上比假针刺多改善0.9分;绝对百分比变化4.59%;相对百分比变化10.32%;9项试验;1835名参与者)和功能改善(-0.28,-0.46至 -0.09;在68分制上比假针刺多改善2.7分;绝对百分比变化3.97%;相对百分比变化8.63%);然而,这些汇总的短期益处未达到我们预先定义的临床相关性阈值(即疼痛1.3分;功能3.57分),并且存在显著的统计学异质性。此外,限制使用被认为最有可能使参与者充分对治疗分配不知情的假针刺进行假对照试验(这些假针刺也被认为最有可能具有生理活性),减少了异质性,并导致针刺的汇总短期益处更小且无统计学意义。在六个月的随访中与假针刺相比,针刺在骨关节炎疼痛方面显示出临界的统计学意义、临床无关紧要的改善(-0.10,-0.21至0.01;在20分制上比假针刺多改善0.4分;绝对百分比变化1.81%;相对百分比变化4.06%;4项试验;1399名参与者)和功能改善(-0.11,-0.22至0.00;在68分制上比假针刺多改善1.2分;绝对百分比变化1.79%;相对百分比变化3.89%)。在与等待名单对照组的二次分析中,针刺与骨关节炎疼痛方面具有统计学意义、临床相关的短期改善相关(-0.96,-1.19至 -0.72;在100分制上比假针刺多改善14.5分;绝对百分比变化14.5%;相对百分比变化29.14%;4项试验;884名参与者)和功能改善(-0.89,-1.18至 -0.60;在100分制上比假针刺多改善13.0分;绝对百分比变化13.0%;相对百分比变化25.21%)。在针刺与“监督性骨关节炎教育”和“医生咨询”对照组的直接比较中,针刺与疼痛和功能方面临床相关的短期和长期改善相关。在针刺与“家庭锻炼/建议手册”和“监督性锻炼”的直接比较中,针刺与对照组的治疗效果相似。针刺作为基于运动的物理治疗方案的辅助手段,与单独的运动方案相比没有带来更大的改善。仅8项试验报告了安全性信息,甚至在这些试验中报告也有限且方法各异。 作者结论:假对照试验显示出具有统计学意义的益处;然而,这些益处很小,未达到我们预先定义的临床相关性阈值,并且可能至少部分归因于不完全盲法导致的安慰剂效应。针对外周关节骨关节炎的针刺等待名单对照试验表明具有统计学意义和临床相关的益处,其中大部分可能归因于期望或安慰剂效应。
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