Progress in the design and quality control of placeboes for clinical trials of traditional Chinese medicine

作     者：Ning Guo Fei Wu Mei Wu Yuan Wang Qing Lang Xiao Lin Yi Feng Ning Guo;Fei Wu;Mei Wu;Yuan Wang;Qing Lang;Xiao Lin;Yi Feng

作者机构：College of Chinese Materia MedicaShanghai University of Traditional Chinese MedicineShanghai 201203China Engineering Research Center of Modern Preparation Technology of TCM of Ministry of EducationShanghai University of Traditional Chinese MedicineShanghai 201203China Department of Traditional Chinese MedicineBeicai Community Health Service Center of Pudong New DistrictShanghai 201204China 

出 版 物：《Journal of Integrative Medicine》 (结合医学学报（英文版）)

年 卷 期：2022年第20卷第3期

页      面：204-212页

核心收录：

学科分类：1006[医学-中西医结合] 1002[医学-临床医学] 10[医学] 100602[医学-中西医结合临床] 

基　　金：sponsored by Natural Science Foundation of Shanghai(18ZR1439800,18ZR1436600) Three-year Action Plan for the Development of Traditional Chinese Medicine of Shanghai Municipal Health Planning Commission(ZY(2018-2020)-CCCX2001-03) Xinglin Young Scholar Program of Shanghai University of Traditional Chinese Medicine(A1-U17205010416) the Clinical Research Fund of Shanghai Municipal Health Commission(201940296) Science and Technology Innovation Project in Traditional Chinese Medicine of Pudong New District(PDZY2021-0813)。 

主　　题：Traditional Chinese medicines Placebo Critical quality attributes Clinical trial Similarity 

摘      要：In recent years,new preparations of traditional Chinese medicines(TCMs)have been developed,increasing the need for their clinical trials.Using placeboes rather than control drugs is increasingly popular in clinical trials of TCMs,as the therapeutic effects of the tested TCMs can be more properly judged.The basic attributes of TCM placeboes include similarity,safety,applicability and controllability.In particular,it is necessary to have similarities in appearance,color,smell and taste between the tested TCMs and placeboes.This is quite difficult for some TCMs due to their distinctive smell and taste.On the other hand,according to the TCM theory on homology of medicine and food,many foods also have certain bioactivities,potentially further complicating the selection of materials for TCM placeboes.In this review,firstly,studies on the special smell and taste of TCMs were introduced.Then,the preparation quality evaluation processes for TCM placeboes were summarized and discussed,based on the relevant literature published in recent years and the research results from our own lab.This review will facilitate the further research and development of TCM placeboes.