Problems and strategies in clinical trials of traditional Chinese medicine / 中国中西医结合杂志

ABSTRACT

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.