针刺临床研究中的盲法及其关键问题

Blinding Designs and Critical Issues in Acupuncture Clinical Trials

盲法是临床研究中控制测量偏倚的重要手段。作为一种复杂的侵入性干预措施,与药物相比,在盲法设计及实施方面针刺面临更大的困难和更高的破盲风险。本文对目前针刺临床研究中盲法进行了概述,并就目前存在的关键问题进行了总结分析,主要包括:假针刺设计及实施需进行规范、仍需研发合适的假针具、尚无解决针刺操作者盲法的有效方法、盲法评价未得到应有的重视、假针刺和盲法需规范化报告。研究者应针对上述关键问题和挑战开展深入研究,为提高和促进针刺临床研究质量提供方法学支撑。

Blinding is an important method to control the measure bias in clinical trials.As a complex and invasive intervention,acupuncture has more difficulty in blinding implementation compared to drugs and has a higher risk of unblinding breakage.This article provides an overview of the blinding in acupuncture clinical study and summarized the key aspects,including:there is no standard for the application and reporting of sham acupuncture design and blinding measures,appropriate sham acupuncture devices still need to be developed,currently there are no effective methods of operator blinding,blinding assessment has not been given due attention,sham acupuncture design should be standardized and reported.Researchers should conduct further studies to address critical questions and challenges to provide methodological support to improve and promote the quality of acupuncture clinical research.