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Systematic analysis of randomised controlled trials of Chinese herb medicine for non-alcoholic steatohepatitis (NASH): implications for future drug development and trial design
Xianwen Chen1; Junnan Shi1; Yunfeng Lai2; Yan Xue1; Carolina Oi Lam Ung1,3; Hao Hu1,3
Source PublicationChinese Medicine
ISSN1749-8546
2023-05-19
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.

KeywordClinical Trial Design Non-alcoholic Steatohepatitis Randomised Controlled Trial Traditional Chinese Medicine
Language英語English
DOI10.1186/s13020-023-00761-5
URLView the original
Volume18
Issue1
Pages58
WOS IDWOS:000991037400001
WOS SubjectIntegrative & Complementary Medicine ; Pharmacology & Pharmacy
WOS Research AreaIntegrative & Complementary Medicine ; Pharmacology & Pharmacy
Indexed BySCIE
Scopus ID2-s2.0-85160049915
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Document TypeReview article
CollectionFaculty of Health Sciences
Institute of Chinese Medical Sciences
THE STATE KEY LABORATORY OF QUALITY RESEARCH IN CHINESE MEDICINE (UNIVERSITY OF MACAU)
DEPARTMENT OF PUBLIC HEALTH AND MEDICINAL ADMINISTRATION
Corresponding AuthorCarolina Oi Lam Ung; Hao Hu
Affiliation1.State Key Laboratory of Quality Research in Chinese Medicine,Institute of Chinese Medical Sciences,University of Macau,Taipa,Macao
2.School of Public Health and Management,Guangzhou University of Chinese Medicine,Guangzhou,China
3.Department of Public Health and Medicinal Administration,Faculty of Health Sciences,University of Macau,Taipa,Macao
First Author AffilicationInstitute of Chinese Medical Sciences
Corresponding Author AffilicationInstitute of Chinese Medical Sciences;  Faculty of Health Sciences
Recommended Citation
GB/T 7714
Xianwen Chen,Junnan Shi,Yunfeng Lai,et al. Systematic analysis of randomised controlled trials of Chinese herb medicine for non-alcoholic steatohepatitis (NASH): implications for future drug development and trial design[J]. Chinese Medicine, 2023, 18(1), 58.
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