Trial characteristics and treatment effect estimates in randomized controlled trials of Chinese herbal medicine: A meta-epidemiological study.

Autor: Wang BH; Jockey Club School of Public Health and Primary Care, the Chinese University of Hong Kong, 999077, Hong Kong, China., Lin YL; Xiangya School of Public Health, Central South University, Changsha 410006, Hunan Province, China., Gao YY; Xiangya School of Public Health, Central South University, Changsha 410006, Hunan Province, China., Song JL; Xiangya School of Public Health, Central South University, Changsha 410006, Hunan Province, China., Qin L; Xiangya School of Public Health, Central South University, Changsha 410006, Hunan Province, China., Li LQ; Xiangya School of Public Health, Central South University, Changsha 410006, Hunan Province, China., Liu WQ; Xiangya School of Public Health, Central South University, Changsha 410006, Hunan Province, China., Zhong CCW; Jockey Club School of Public Health and Primary Care, the Chinese University of Hong Kong, 999077, Hong Kong, China., Jiang MY; School of Chinese Medicine, the Chinese University of Hong Kong, 999077, Hong Kong, China., Mao C; School of Public Health, Southern Medical University, Guangzhou 510080, Guangdong Province, China., Yang XB; State Key Laboratory of Dampness Syndrome of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, Guangdong Province, China; Chinese Medicine Syndrome Research Team, the Second Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou 510120, Guangdong Province, China; Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou 510120, Guangdong Province, China., Chung VCH; Jockey Club School of Public Health and Primary Care, the Chinese University of Hong Kong, 999077, Hong Kong, China; School of Chinese Medicine, the Chinese University of Hong Kong, 999077, Hong Kong, China., Wu IXY; Xiangya School of Public Health, Central South University, Changsha 410006, Hunan Province, China; Hunan Provincial Key Laboratory of Clinical Epidemiology, Central South University, Changsha 410006, Hunan Province, China. Electronic address: irenexywu@csu.edu.cn.
Jazyk: angličtina
Zdroj: Journal of integrative medicine [J Integr Med] 2024 May; Vol. 22 (3), pp. 223-234. Date of Electronic Publication: 2024 Apr 23.
DOI: 10.1016/j.joim.2024.04.003
Abstrakt: Background: Previously published meta-epidemiological studies focused on Western medicine have identified some trial characteristics that impact the treatment effect of randomized controlled trials (RCTs). Nevertheless, it remains unclear if similar associations exist in RCTs on Chinese herbal medicine (CHM). Further, Chinese medicine-related characteristics have not been explored yet.
Objective: To investigate trial characteristics related to treatment effect estimates on CHM RCTs.
Search Strategy: This meta-epidemiological study searched 5 databases for systematic reviews on CHM treatment published between January 2011 and July 2021.
Inclusion Criteria: An eligible systematic review should only include RCTs of CHM and conduct at least one meta-analysis.
Data Extraction and Analysis: Two reviewers independently conducted data extraction on general characteristics of systematic reviews, meta-analyses and included RCTs. They also assessed the risk of bias of RCTs using the Cochrane risk of bias tool. A two-step approach was used for data analyses. The ratio of odds ratios (ROR) and difference in standardized mean differences (dSMD) with 95% confidence interval (CI) were applied to present the difference in effect estimates for binary and continuous outcomes, respectively.
Results: Ninety-one systematic reviews, comprising 1338 RCTs were identified. For binary outcomes, RCTs incorporated with syndrome differentiation (ROR: 1.23; 95 % CI: [1.07, 1.39]), adopting Chinese medicine formula (ROR: 1.19; 95% CI: [1.03, 1.34]), with low risk of bias on incomplete outcome data (ROR: 1.29; 95% CI: [1.06, 1.52]) and selective outcome reporting (ROR: 1.12; 95% CI: [1.01, 1.24]), as well as a trial size ≥ 100 (ROR: 1.23; 95% CI: [1.04, 1.42]) preferred to show larger effect estimates. As for continuous outcomes, RCTs with Chinese medicine diagnostic criteria (dSMD: 0.23; 95% CI: [0.06, 0.41]), judged as high/unclear risk of bias on allocation concealment (dSMD: -0.70; 95% CI: [-0.99, -0.42]), with low risk of bias on incomplete outcome data (dSMD: 0.30; 95% CI: [0.18, 0.43]), conducted at a single center (dSMD: -0.33; 95% CI: [-0.61, -0.05]), not using intention-to-treat analysis (dSMD: -0.75; 95% CI: [-1.43, -0.07]), and without funding support (dSMD: -0.22; 95% CI: [-0.41, -0.02]) tended to show larger effect estimates.
Conclusion: This study provides empirical evidence for the development of a specific critical appraisal tool for risk of bias assessments on CHM RCTs. Please cite this article as: Wang BH, Lin YL, Gao YY, Song JL, Qin L, Li LQ, Liu WQ, Zhong CCW, Jiang MY, Mao C, Yang XB, Chung VCH, Wu IXY. Trial characteristics and treatment effect estimates in randomized controlled trials of Chinese herbal medicine: A meta-epidemiological study. J Integr Med. 2024; 22(3): 223-234.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 Shanghai Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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