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

Objective 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. Methods 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. Results 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. Conclusions 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.