单穴主治作用临床研究对照设置之我见

My Opinion on Control Design of Clinical Study on Indications of Single Acupoint

在临床研究中,常根据不同的研究目的选用不同的对照方法,对照组的选择是临床随机对照试验设计的关键环节之一。2003年国家中医药管理局设立的《中华人民共和国针灸穴典》专项研究进行了59项单穴主治作用的临床评价研究。从对照设置情况分析,该研究较为全面地涉及到了针灸临床研究常用的对照设置方法,在一定程度上为随后的研究起到了示范参考作用。但由于针灸过程是一种可见的治疗程序,对对照组设置和实施方法要求较高,要遵从盲法原则就不得不面对许多操作性的困难,这有待以后不断克服创新。

Various controls are commonly used in clinical studies according to different objectives.Application of controls is considered as a key part of a clinical randomized control trial.The project of Compendium of Acupoints of China was established in 2003 with funding from State Administration of Traditional Chinese Medicine of China.The indications of 59 acupoints were evaluated.The commonly used controls in acupuncture clinical studies were involved in this project,playing an exemplary role for future studies.However,as the process of acupuncture is a visible procedure of treatment,to implement a control experiment properly is difficult.Hence,if we want to comply with the principle of blind method,we would face many operational difficulties.It is necessary to develop the methodology continuously to overcome the difficulties in the future.