Systematic analysis of randomised controlled trials of Chinese herb medicine for non-alcoholic steatohepatitis (NASH): implications for future drug development and trial design

Bibliographic Details
Title: Systematic analysis of randomised controlled trials of Chinese herb medicine for non-alcoholic steatohepatitis (NASH): implications for future drug development and trial design
Authors: Xianwen Chen, Junnan Shi, Yunfeng Lai, Yan Xue, Carolina Oi Lam Ung, Hao Hu
Source: Chinese Medicine, Vol 18, Iss 1, Pp 1-22 (2023)
Publisher Information: BMC, 2023.
Publication Year: 2023
Collection: LCC:Other systems of medicine
Subject Terms: Non-alcoholic steatohepatitis, Traditional Chinese medicine, Randomised controlled trial, Clinical trial design, Other systems of medicine, RZ201-999
More Details: Abstract Background Non-alcoholic steatohepatitis (NASH) is a liver disease currently lacking an approved therapy, resulting in significant clinical demand. Traditional Chinese medicines (TCMs) have been commonly used to manage NASH. This study aimed to systematically analyse the randomised controlled trials (RCTs) using TCMs for NASH management. Methods A systematic literature review was performed by following PRISMA guidelines 2020 in six electronic databases: PubMed, Web of Science, Scopus, Embase, the Cochrane Library, and China National Knowledge Infrastructure, from inception until August 2022. RCTs using TCMs for NASH were included in the analysis, irrespective of language or blinding. Results 112 RCTs were included in this review, with 10,573 NASH participants. 108 RCTs were conducted in China, and 4 RCTs were in other countries. Herbal medicine decoction was the major dosage form used for treating NASH (82/112). 11 TCMs products have been approved for NASH treatment (8 in China, 2 in Iran, and 1 in Japan). Classic prescriptions, such as “Huang Lian Jie Du decoction”, “Yin Chen Hao decoction”, and “Yi Guan Jian” were used in some studies. The TCMs treatment of NASH involved the use of 199 different plants, with the top 5 herbs being Salviae Miltiorrhizae Radix Et Rhizoma, Alismatis Rhizoma, Bupleuri Radix, Poria, and Curcumae Radix. “Salviae Miltiorrhizae Radix Et Rhizoma + Bupleuri Radix/Alismatis Rhizoma” were the mostly common drug-pair in the herbs network analysis. Nowadays, “Bupleuri Radix/Alismatis Rhizoma + Atractylodis Macrocephalae Rhizoma” are increasingly applied in herbal formulas for NASH. Based on the PICOS principles, the included studies varied in terms of the population, intervention, comparator, outcomes, and study design. However, some studies reported unstandardised results and failed to report diagnostic standards, inclusion or exclusion criteria, or sufficient patient information. Conclusion Adopting Chinese classic prescriptions or drug-pair may provide a basis for developing new drugs of NASH management. Further research is needed to refine the clinical trial design and obtain more convincing evidence for using TCMs to treat NASH.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 1749-8546
Relation: https://doaj.org/toc/1749-8546
DOI: 10.1186/s13020-023-00761-5
Access URL: https://doaj.org/article/efdf0027035d4691a931073da5cb409d
Accession Number: edsdoj.fdf0027035d4691a931073da5cb409d
Database: Directory of Open Access Journals
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More Details
ISSN:17498546
DOI:10.1186/s13020-023-00761-5
Published in:Chinese Medicine
Language:English