国内针刺随机临床试验文献中对照类型的分析

目的:分析目前中国大陆医学期刊发表的针刺随机临床试验的对照设置,并采用临床流行病学的方法评价对照设置的合理性,为提高国内针刺临床试验的质量提供依据。方法:全面检索中国知网、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,纳入所有以针刺为试验措施的随机对照临床试验,采用EpiData建立的资料提取表提取对照等相关信息,并用SPSS 21对资料进行统计描述。结果:截止到2012年12月31日,共检索到国内中文期刊发表的针刺随机临床试验7 085篇。其中,2组平行设计针刺随机对照试验6 241篇:空白对照(51,0.7%)、安慰针刺对照(62,0.9%)、其他中医疗法对照(含针刺)(3 261,46.0%)、常规治疗对照(2 794,39.4%);另有844篇针刺随机对照试验采用2组以上对照设计。62篇采用安慰针刺对照的研究中,仅有19篇报告实施盲法。结论:国内中文期刊发表的针刺随机临床试验近半数采用中医疗法作为对照,由于设计不合理,难以回答针刺的临床疗效。建议明确研究目的的基础上采用肯定有效或肯定无效的措施作为对照。

Literature review on control interventions in randomized clinical trials on acupuncture published in mainland Chinese biomedical journals

Objective： To analyze the control interventions of randomized clinical trials （RCTs） of acupuncture published in mainland Chinese journals, and to evaluate the rationale of control design based on clinical epidemiology principle and give suggestions for future RCTs design of acupuncture. Methods：We searched four main Chinese electronic databases including China National Knowledge Infrastructure （CNKI）, Chinese Scientific Journal Database （VIP）, Wanfang Database （Wanfang）, and Sinomed for RCTs of acupuncture. Epidata was applied for data extraction,and SPSS 21 was used for statistical analysis. Results：A total of 7 085 RCTs were included by the end of 2012, among which, 6 241 RCTs had one control group including blank （0. 7% ）, placebo （0. 9% ）, Chinese medicine （46. 0% ）, and conventional medicine（ 39.4% ）. Besides ,844 RCTs of acupuncture had more than two control groups. Among those trials using placebo controls ,only 19 RCTs reported blinding. Conclusion： Almost half of RCTs of acupuncture published in Chinese journals used Chinese medicine as control intervention. However,it would be difficult to evaluate the efficacy of acupuncture due to inappropriate design for comparison. We suggest that RCTs of acupuncture in the future should design controls based on specific study aim.