Bian Li-Qun, Li Bao-Shuang, Li Zhen-Hua, Wang Feng-Yun, Wen Yan-Dong, Tang Xu-Dong
Department of Gastroenterology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
Chin J Integr Med. 2017 Aug;23(8):631-634. doi: 10.1007/s11655-016-2538-6. Epub 2016 Dec 29.
Chinese medicine (CM) decoction placebo is one of the key factors restricting the placebo-controlled clinical trial of CM. In this article, based on the analysis of the diffificulties in preparing CM placebo, the production requirements for placebo were put forward. Moreover, in accordance with clinical practices, a production method and evaluation process of CM decoction placebo was proposed, to provide a reference for clinical research.
中药汤剂安慰剂是制约中药安慰剂对照临床试验的关键因素之一。本文在分析中药安慰剂制备难点的基础上,提出了安慰剂的制备要求。此外,结合临床实际,提出了中药汤剂安慰剂的制备方法及评价流程,为临床研究提供参考。