Quality assessment of randomized controlled trials of compound traditional Chinese medicine prescriptions in treatment of nonalcoholic steatohepatitis in 2018—2023
Journal Title: Journal of Clinical Hepatology - Year 2024, Vol 40, Issue 12
Abstract
[Objective] To assess the quality of randomized controlled trials (RCTs) of compound traditional Chinese medicine (TCM) prescriptions in the treatment of nonalcoholic steatohepatitis (NASH), and to provide recommendations for standardizing the design and reporting of RCTs in this field. [Methods] Databases such as PubMed, Web of Science, Embase, the Cochrane Library, CNKI, VIP, and Wanfang Data were searched for RCTs of compound TCM prescriptions in the treatment of NASH published from January 1, 2018 to December 31, 2023, and the articles were screened and assessed based on the Cochrane risk-of-bias assessment tool (RoB 2), the unified standard for clinical trial reporting (CONSORT 2010), and CONSORT-CHM Formulas 2017 for compound TCM prescriptions. [Results] A total of 45 articles were finally included, and most of these studies were rated as high-risk bias by RoB 2.0. The analysis based on the CONSORT control checklist showed a relatively low reporting rate for most of the key items regarding the quality of RCT studies. [Conclusion] A relatively large risk of bias is observed in the clinical studies on compound TCM prescriptions in the treatment of NASH published in the past six years, which may lead to the poor quality of reporting and evidence. It is suggested that the top-level design of clinical studies should be taken seriously in addition to investigating the advantages of TCM, so as to improve the quality of clinical studies.
Authors and Affiliations
Weiwei YAO, Ruimin JIAO, Kejia LIU, Shuai XU, Li LI, Hong YOU, Jingjie ZHAO
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