中医药随机对照临床试验安慰剂选择的探讨

Discussion about the placebo choice of quality control in randomized controlled trial clinical study of traditional Chinese medicine

随机对照试验研究是医学科研的金标准。临床试验方案中安慰剂对照的合理选择及严格的质量控制,是保证临床试验质量的关键之一。中医药临床研究中安慰剂对照选择问题是制约中医药临床研究的难点之一;特别是中药汤剂安慰剂对照选择是中药新药开发的瓶颈。本课题组对中医药安慰剂汤剂的选择中作了一些探索,以求严格控制中医药临床试验的质量,提供可靠的循证医学证据。

Randomized controlled trial （RCT） clinical study is recognized as the gold standard of clinical study, and the most desirable approach to evaluate the effect of medicine and security. Optimum placebo choice and strict management are the key importances for the quality of clinical trials. Placebo choice in clinical study of TCM is one of the difficulties in stricting its sustaining development, particularly in traditional Chinese medicine decoction. This research group has explored the implementation of placebo choice in clinical study, to provide a reliable proof for the evidence based medicine.