有关痛证研究中安慰针刺对照设置的思考

Thoughts on the Comfort Acupuncture Setting in the Pain Syndrome Clinical Research

针刺作为一种中医外治的干预手段,对多种疾病有效,特别在治疗痛证方面有着独到优势,其效果也被越来越多的试验所证实;但国际上也出现了一些大样本安慰针刺对照试验,显示针刺效应与安慰针刺效应差异无统计学意义。临床对照试验中安慰针刺的设置合理性是影响针刺研究水平的关键,也是临床试验的难点。此文分析安慰针刺效应的相关机制及使用现状,提出在进行安慰针刺设置时应综合考虑特定治疗作用最小化、受试者期望值一致化的因素,使针刺的特异治疗效应被国际认可。

As an intervention means of external therapy of traditional Chinese medicine,acupuncture is effective for a variety of dis-eases,especially in the treatment of pain syndrome.Its curative effect has been confirmed by more and more experiments.However,there are also some large sample comfort acupuncture control trials in the world,which show that there is no significant difference be-tween acupuncture effect and comfort acupuncture effect.The rationality of comfort acupuncture in clinical controlled trials is not only the key to the level of acupuncture research,but also the difficulty of clinical trials.This paper analyzed the relevant mechanism and application status of comfort acupuncture effect,and put forward that the factors of minimizing the specific therapeutic effect and unify-ing the expectations of the subjects should be considered comprehensively when setting up comfort acupuncture,so as to make the therapeutic effect of acupuncture recognized internationally.