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August 15, 2026Journal of Evidence-Based Medicine

Inadequate Reporting of Harms in RCTs of Chinese Herbal Medicine Formulas: A Systematic Survey of Leading Medical Journals

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Authors

RZRui ZhengXZXiaowei ZhangYJYinghui Jin

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Overview

Systematic survey reveals widespread deficiencies in adverse event reporting in Chinese herbal medicine trials, highlighting an urgent need for standardized safety frameworks.

Key Points

  • To evaluate harms reporting practices in placebo-controlled randomized clinical trials of Chinese herbal medicine formulas published in leading English and Chinese medical journals.
  • Systematic survey evaluating 96 placebo-controlled RCTs (49 from English Q1 journals and 47 from Chinese Tier-1 journals).
  • Two reviewers independently evaluated safety reporting practices against CONSORT Harms extension recommendations and formula-specific elements.
  • Only 19.8% (n = 19) of trials had a published protocol (p < 0.001 for English Q1 vs. Chinese Tier-1), and only one trial explicitly reported adherence to the CONSORT Harms extension.
  • Sixty-seven percent of studies (n = 64) omitted methods for assessing the relationship between harms and interventions, while 80% (n = 77) did not report statistical methods for harms analysis.
  • Tabular presentation of harms data was absent in 62% (n = 59) of the evaluated trials.

Cite This Study

Zheng et al. (2026) studied this question.

synapsesocial.com/papers/6a8019bb75c2e31742c85d06https://doi.org/10.1111/jebm.70174
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