随机对照试验研究中各种假针刺的评价

目的:在随机对照试验(Randomized Controlled Trials,RCTs)研究中,不同的假针刺方法广泛地用于评价针刺对某种病症除安慰效应外是否具有内在的治疗作用.为使试验结果可信和更有可比性,有必要对假针刺方法做个统一的规范.方法:回顾了最近14年高质量的针刺RCT研究,评价其中的各种假针刺方法的恰当与否.结果:根据进针部位、破皮方式、所用仪器的不同,这些假针刺方法主要可以分为5类.结论:最常用的假针刺方法有穴位旁开针刺、远部非穴部位针刺和不破皮假针刺3种,其中远部非经非穴部位针刺可能是比较理想的假针刺对照.另外,对照的设立应结合考虑RCT研究的目的和设计,如非劣效性、等效性、优效性试验.

Assessments of different kinds of sham acupuncture applied in randomized controlled trials

Objective： Different kinds of sham acupuncture are widely applied in randomized controlled trials （RCTs） to explore whether acupuncture has intrinsic therapeutic effects beyond the placebo effects for certain indication. To make conclusions of trials more comparable and convincing, it is of great necessity to unify the sham acupuncture procedure. Methods： RCTs of acupuncture with high quality in the recent 14 years were reviewed, and the appropriateness of the sham acupuncture procedures was assessed. Results： The sham acupuncture procedures were mainly classified into five kinds according to their administered sites, penetrating, and intervention apparatus. Conclusion： Among the sham acupuncture procedures, needling near the selected acupoints, needling at a distant non-acupoints, and non-penetrating sham acupuncture are most commonly used. Sham acupuncture performed at distant site belongs to non-meridian and non-acupoint may be an ideal control for the study of the intrinsic therapeutic effects of acupuncture. Besides, the selection of controls must focus on the design and aim of RCTs, such as non-inferiority, equivalence and superiority trials.