Quality assessment of randomized controlled trials of compound traditional Chinese medicine prescriptions in treatment of nonalcoholic steatohepatitis in 2018—2023

Weiwei YAO; Ruimin JIAO; Kejia LIU; Shuai XU; Li LI; Hong YOU; Jingjie ZHAO

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Quality assessment of randomized controlled trials of compound traditional Chinese medicine prescriptions in treatment of nonalcoholic steatohepatitis in 2018—2023

VernacularTitle:2018—2023年中药复方治疗非酒精性脂肪性肝炎的随机对照试验质量评价
Author: Weiwei YAO ¹ ; Ruimin JIAO ¹ ; Kejia LIU ¹ ; Shuai XU ¹ ; Li LI ² ; Hong YOU ³ ; Jingjie ZHAO ¹
Author Information

1. Department of Traditional Chinese Medicine， Beijing Friendship Hospital， Capital Medical University， Beijing 100050， China
2. Department of Hepatology， Beijing Hospital of Traditional Chinese Medicine， Capital Medical University， Beijing 100050， China
3. Clinical Center for Integrated Traditional Chinese and Western Medicine Therapy for Metabolic Associated Fatty Liver Disease， Capital Medical University， Beijing 100050， China
Publication Type:Journal Article
Keywords: Non-alcoholic Fatty Liver Disease; Drugs， Chinese Herbal; Compounds; Randomized Controlled Trials as Topic
From: Journal of Clinical Hepatology 2024;40(12):2406-2414
CountryChina
Language:Chinese
Abstract: ObjectiveTo 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. MethodsDatabases 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. ResultsA 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. ConclusionA 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.