二仙汤治疗绝经前后诸证随机对照试验质量评价

Design Quality Evaluation in Randomized Controlled Clinical Trials of Er Xian Decoction of Menopausal Disorders

目的客观评价以二仙汤为基本方治疗绝经前后诸证随机对照试验的报告质量。方法收集国内主要学术论文数据库中使用二仙汤治疗绝经前后诸证随机对照试验,参考"临床随机试验Consort对照表2010"和ICH-GCP制定质量评价表,从对纳入研究的试验条件准备、试验理论依据、试验操作设计、试验结果记录等方面对其进行质量评价。结果共评价符合本研究条件的报告40篇,发现对二仙汤治疗绝经前后诸证的随机对照试验在伦理学设计、预试验和样本含量估计、脱落和退出标准、随机方法、盲法原则、干预措施标准化、安全性评价等方面存在明显的问题,在研究中心、疗效评价标准、统计学方法的运用等方面存在一些不足。结论二仙汤治疗绝经前后诸证随机对照试验质量有待提高,临床研究者应参考常用的临床试验指导标准提高研究质量。

Objective To evaluate the design quality of randomized controlled clinical trials of Er Xian Decoction of Menopausal Disorders. Methods Collect academic paper of randomized controlled trials in the domestic main scientific paper database. Refer to randomized control trials Consort comparison table for the 2010 edition and the quality evaluation table of traditional Chinese medicine randomized controlled trials published by ICH-GCP. The quality evaluation shall be conducted on the test conditions, test theory, test operation, test result, etc, refer to randomized control trials Consort comparison table for the 2010 edition and the quality evaluation table of traditional Chinese medicine randomized controlled trials published by ICH-GCP.Results It is found by evaluating the quality of 40 reports eligible for this study that there are obvious problems in ethical design, pre-experiments, sample capacity valuation, fall off and exit criteria, safety evaluation, and some shortcomings in research institutions, curative effect evaluation criteria, statistical methods application of Er Xian Decoction used to treat postmenopausal syndrome. Conclusion The quality of randomized controlled clinical trials of Er Xian Decoction of Menopausal Disorders need to be improved, therefore, the clinical researchers should refer to the common guidelines for clinical trials to improve the quality of research.