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ISSN 1001-5256 (Print)
ISSN 2097-3497 (Online)
CN 22-1108/R
Volume 40 Issue 12
Dec.  2024
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Article Navigation >  Journal of Clinical Hepatology  > 2024  >  40(12): 2406-2414

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

DOI: 10.12449/JCH241210
  • 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

Research funding:

Beijing Key Project of Major Disease by Chinese Medicine and Western Medicine (2023BJSZDYNJBXTGG-017);

Beijing High-level Public Health Technical Personnel Construction Project (Discipline backbone-03-40);

Capital Health Development Scientific Research Project (2022-2-20213);

Capital Health Development Scientific Research Project (2022-1-2021)

More Information
  • Corresponding author: ZHAO Jingjie， zhaojj@ccmu.edu.cn （ORCID： 0000-0001-7763-1351）
  • Received Date: 2024-04-26
  • Accepted Date: 2024-06-19
  • Published Date: 2024-12-25
    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.

     

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