解释性与实用性随机对照试验在针刺临床研究中的选择与应用

Selection and application of explanatory and pragmatic randomized controlled trials in clinical research of acupuncture

针对针刺随机对照试验(RCT)中真假针刺疗效无差异的结论引发的争议,分析其原因之一是很多临床研究对RCT研究设计理解与研究结果解读的不恰当。本文从解释性RCT与实用性RCT的概念与涵盖范畴出发,从研究目的与试验环境、受试者选择、干预措施、对照措施及结局评价5个方面列举两种RCT在针刺领域的应用实例,为其在临床试验中的应用提供一定的思路。

In the view of the controversy that there is no efficacy difference between true and sham acupuncture in acupuncture randomized controlled trials(RCTs),it is analyzed that one of the reasons is that many clinical studies do not properly understand the design of RCT research and interpret the research results.Starting from the concept and coverage of explanatory RCT and pragmatic RCT,this study lists the application examples of two types of RCTs in the field of acupuncture from five aspects:research purpose and trial environment,subject selection,intervention measures,control measures and outcome evaluation,so as to provide some ideas for their application in clinical trials.