欢迎访问中国中西医结合杂志！

Author Name	Affiliation
LI Ting-qian	四川大学华西医院中西医结合科成都610041
WANG Gang	四川大学华西医院中西医结合科成都610041
WANG Lei	四川大学华西医院中西医结合科成都610041

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中文摘要:

针对中医药临床试验中存在的问题,包括随机方法、随机隐藏、组间均衡性、盲法、疗效评价指标、不良反应观察、统计方法及发表偏倚等的现状与对策进行探讨。建议采用国际推荐的CONSORT声明以提高中医药临床随机对照试验的设计与报告质量,并对以人作为受试对象,应根据伦理学的基本原则,在临床研究中进行伦理审查和签署知情同意书,以保证受试者的权益。

英文摘要:

To explore the problems and the strategies in clinical trials of traditional Chinese medicine (TCM), including the method and concealment of randomizing, equipoise of baseline, blindness and outcome measures, adverse reaction observation, statistical method and publication bias. The consolidated standard of reporting trials (CONSORT) is recommended to be applied in order to improve the quality of design and report of randomized controlled trials (RCTs) of TCM, and in case of human is taken as the subject of trial, according to the fundamental ethical principle, the clinical trial design should be censored by institutional review board (IRB), and the informed consent should be signed to protect the rights and interests of the trial participator.

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