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

To evaluate harms reporting practices in placebo-controlled randomized clinical trials (RCTs) of Chinese herbal medicine (CHM) formulas published in Quartile 1 (Q1) English-language and Tier-1 Chinese journals.

This systematic survey evaluated harms reporting in CHM formula RCTs. We systematically identified eligible RCTs published in English-language journals Q1 (2024 Journal Citation Reports) and Chinese Tier-1 journals (2023 Traditional Chinese Medicine ranking). Two reviewers independently evaluated harms reporting using items derived from the CONSORT Extension for Harms (CONSORT Harms) recommendations and CHM formula-specific reporting elements.

Among 96 eligible RCTs (49 English Q1; 47 Chinese Tier-1), only 19.8% (n = 19) of trials had a published protocol, with a significantly higher proportion in English Q1 journals (p < 0.001). Only one trial explicitly reported adherence to the CONSORT Harms extension (2004 or 2022). Syndrome differentiation was significantly more frequent in Chinese Tier-1 journals than in English Q1 journals (76.6% vs. 38.8%, p < 0.001). Sixty-seven percent of studies (n = 64) did not report methods for assessing the relationship between harms and interventions, and 15.6% (n = 15) relied solely on clinical judgment. Eighty percent of studies (n = 77) did not report statistical methods for harms analysis. In the results section, 62% (n = 59) did not present harms data in tables.

Harms reporting in CHM formula RCTs remains inadequate. Routine adoption of the CONSORT Harms framework, together with CHM formula-specific harms reporting elements, is needed to improve transparency and facilitate the interpretation of harms data in CHM formula research.