中医药随机对照试验中盲法的应用与评价

Application and Evaluation of Blind Method in Randomize Controlled Trials of Chinese Medicine

目的分析中医药随机对照试验(RCT)中盲法的应用现状,并对盲法的设计与报告进行评价。方法系统检索中国知网、中国科技期刊数据库、中国生物医学文献数据库、万方数据库,纳入所有中药治疗肠易激综合征和针刺治疗失眠的RCT。参考Cochrane协作网系统评价员手册5.0.2版中关于研究入选的方法,由两名研究者根据纳入标准独立进行文献筛选,并按照资料提取表进行文献资料提取,采用SPSS17.0对资料进行统计描述。结果共获得1 041篇,包括864篇中药治疗肠易激综合征的RCT和177篇针刺治疗失眠的RCT,其中有32篇RCT使用盲法,总应用率为3.1%。中药治疗肠易激综合征的RCT中有24篇应用了盲法(应用率为2.8%);应用盲法的RCT中4篇(16.7%)报告了施盲对象,3篇(12.5%)报告了盲法实施细节。针刺治疗失眠的RCT中有8篇应用了盲法(应用率为4.5%);应用盲法的RCT中2篇(25.0%)报告了施盲对象,无一报告盲法的实施细节。结论以两个中医药治疗的代表性疾病为例,中医药RCT盲法应用率很低,且报告不够完整,导致试验设计的质量低下。

Objective To analyze the current application of blind method and evaluate the design of ＇ blinding＇ in randomize controlled trials （RCTs） of Chinese medicine. Methods All RCTs on Chinese herbal medicine for irritable bowel syndrome （IBS） and acupuncture for insomnia in China National Knowledge Internet, VIP database, Chinese Biomedical Literature Database and Wanfang database were searched. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0. 2 was used. The literature was screened and the data was extracted by two researchers independently according to the inclusion criteria. The data was analyzed with SPSS17.0. Results A total of 1041 RCTs were included with 863 RCTs on Chinese herbal medicine for IBS and 177 RCTs on acupuncture for insomnia. The blind method was used in 32 （3.1%） RCTs. There were 4 （16.7%） RCTs reported the blinded objects and 3 （ 12. 5% ） RCTs reported the detailed implementation program in 24 （2.8%） RCTs on Chinese herbal medicine for IBS that used blind method. There were 2 （25%） RCTs reported the blinded objects and no RCTs reported the detailed implementation program in 8 （4.5%） RCTs on acupuncture for insomnia that used blind method. Conclusion The research reflects that the application rate of blind method in TCM RCTs is very low, the report is incomplete and the quality of trial design is low.