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

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doi:10.1016/j.joim.2024.04.003

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

Betty H Wang^a, Ya-li Lin^b, Yin-yan Gao^b, Jin-lu Song^b, Lang Qin^b, Ling-qi Li^b, Wen-qi Liu^b, Claire CW Zhong^a, Mary Y Jiang^c, Chen Mao^d, Xiao-bo Yang^e,f,g, Vincent CH Chung^a,c, Irene XY Wu^b,h

a. Jockey Club School of Public Health and Primary Care, the Chinese University of Hong Kong, Hong Kong 999077, China
b. Xiangya School of Public Health, Central South University, Changsha 410006, Hunan Province, China
c. School of Chinese Medicine, the Chinese University of Hong Kong, Hong Kong 999077, China
d. School of Public Health, Southern Medical University, Guangzhou 510080, Guangdong Province, China
e. State Key Laboratory of Dampness Syndrome of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, Guangdong Province, China
f. Chinese Medicine Syndrome Research Team, the Second Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou 510120, Guangdong Province, China
g. Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou 510120, Guangdong Province, China
h. Hunan Provincial Key Laboratory of Clinical Epidemiology, Central South University, Changsha 410006, Hunan Province, China

Received:2023-07-06 Accepted:2024-03-26 Published:2024-04-27
Contact: Irene XY Wu E-mail:irenexywu@csu.edu.cn

Abstract

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 method 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.

Key words: Chinese herbal medicine, Randomized controlled trial, Risk of bias, Meta-epidemiological study, Effect estimates

Betty H Wang, Ya-li Lin, Yin-yan Gao, Jin-lu Song, Lang Qin, Ling-qi Li, Wen-qi Liu, Claire CW Zhong, Mary Y Jiang, Chen Mao, Xiao-bo Yang, Vincent CH Chung, Irene XY Wu. Trial characteristics and treatment effect estimates in randomized controlled trials of Chinese herbal medicine: A meta-epidemiological study. Journal of Integrative Medicine; Epub ahead of print.

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URL: http://www.jcimjournal.com/EN/10.1016/j.joim.2024.04.003

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