针刺随机对照试验常见安慰组设置

Establishment of Common Placebo Groups in Randomized Controlled Trials of Acupuncture

目的现阶段很多研究者质疑针灸疗效是否等同于安慰剂效应,因此我们希望在针灸RCT中找到客观,且无特异性作用的安慰组设计方案,为证明针灸特异性疗效不同于安慰剂效应的临床试验设计提供帮助。方法检索Pub Med、Science Direct、Medline、Web of Science数据库近5年针灸临床随机对照试验的文献,根据严格的纳入排除标准,筛选出205篇,提取每篇文献的安慰组设计方案,设盲情况,安慰组与试验组、空白组(基线)结果差异,总结常用安慰组设计方案。结果针对于不同的针刺类型共总结出19种设盲成功率较高的常见安慰组设计方案,安慰组与试验组疗效具有明显差异性的文献数量占76.6%,安慰组与空白组(基线)有差异的文献占9.6%。结论现阶段常用的安慰针设计方案可以证明针刺特异性的存在,但安慰针也会产生一定的针刺作用。

Objective Many researchers now suspect that the therapeutic effect of acupuncture is equal to that of placebo.Therefore,we hope to find objective and nonspecific placebo group designs in acupuncture RCTs to provide help for clinical trial designs,which can prove that the specific therapeutic effect of acupuncture is different from that of placebo.Method PubMed,ScienceDirect,Medline and Web of Scienc were searched for recent 5 years’literature about randomized controlled trials of clinical acupuncture.Two hundred and five articles were sifted out according to strict inclusion and exclusion criteria.The placebo group design,the blind method and the difference in the result between the placebo group and the experiment or blank(baseline)group were extracted in every article to summarize common placebo group designs.Result To summarize according to different types of acupuncture,there were 19 kinds of common placebo group designs with a higher success rate of blinding.The literature with a significant difference in the therapeutic effect between the placebo and experiment groups accounted for 76.6%.The literature with a significant difference between the placebo and blank(baseline)groups accounted for 9.6%.Conclusion Placebo acupuncture designs often used at present can prove the existence of acupuncture specificity,but placebo acupuncture can also produce some effect of acupuncture.