Design, Conduct, and Analysis of Randomized Clinical Trials of Chinese Herbal Medicine

How are randomized clinical trials (RCTs) of Chinese herbal medicine (CHM) currently designed, conducted, and analyzed, and are there any differences between RCTs published in English and Chinese? This cross-sectional study of 400 CHM RCTs published from 1992 to 2024 identified critical methodological limitations, including unclear study hypothesis, inadequate protocol, failure to register the trial, inadequate allocation concealment, lack of a specified primary outcome and sample size estimation, suboptimal handling of missing participant data, and unsatisfactory conduct of sensitivity analysis or subgroup analysis. The design, conduct, and analysis of CHM RCTs improved over time, and were superior for RCTs published in English-language journals and in English-language journals with higher impact. These findings highlight the urgent need for government authorities, universities, and research institutions to take the initiative in improving the planning and conduct of CHM RCTs, as well as for clinicians and methodologists to collaborate in developing standardized methodological guidelines for such RCTs.

Corresponding Authors: Xin Sun, PhD (sunxin@wchscu.cn), and Ling Li, PhD (liling@wchscu.cn), NHC Key Laboratory of Clinical Epidemiology and Evidence-based Medicine Center, West China Hospital, Sichuan University, 37 Guo Xue Xiang, Chengdu 610041, Sichuan, China.

Link to the article in your story

We encourage you to link out to this article in your story using the link below. It includes an access token that will give free access to the article for your readers up to one year after publication. (The link will be live after the article publishes and embargo is lifted.)

Please see the article for additional information, including full author list, author contributions and affiliations, conflict of interest and financial disclosures, and funding and support.

Need more information? Contact us.