Outcomes reported in randomized controlled trials of traditional Chinese medicine for chronic pharyngitis: a scoping review.

PURPOSE: Evidence synthesis of traditional Chinese medicine (TCM) interventions for chronic pharyngitis is hindered by substantial variation in the outcomes selected and reported across clinical trials. This scoping review aimed to systematically map the outcomes reported in randomized controlled trials (RCTs) and to characterize patterns and gaps in outcome reporting. The findings were intended to provide an empirical basis for the subsequent development of a core outcome set (COS) for chronic pharyngitis.

METHODS

A systematic literature search was conducted to identify RCTs evaluating TCM interventions in patients with chronic pharyngitis. For each eligible trial, study characteristics, reported outcomes, and assessment time points were charted using a structured approach. The identified outcomes were classified into predefined outcome domains and summarized using descriptive and narrative synthesis.

RESULTS

A total of 320 eligible RCTs were included, from which 1,204 individual outcomes were identified and classified into seven domains. Considerable variation was observed in outcome selection, with most individual outcomes reported in relatively few trials. Clinical symptoms and signs were the most frequently assessed outcomes, whereas health-related quality of life, economic outcomes, and long-term outcomes were rarely evaluated. Overall, outcome assessment was predominantly focused on short-term treatment effects, while adverse events, patient-reported outcomes, and extended follow-up remained insufficiently represented. Notably, none of the 69 trials reporting adverse reactions clearly specified the time points at which these outcomes were assessed.

CONCLUSION

Substantial heterogeneity in outcome selection, measurement, and reporting limits the comparability of RCTs evaluating TCM interventions for chronic pharyngitis and complicates evidence synthesis. By systematically characterizing current outcome practices and identifying important reporting gaps, this review provides an empirical foundation for the development of a COS for chronic pharyngitis. Adoption of a COS could promote greater consistency in outcome selection, measurement, and reporting, thereby improving the comparability, transparency, and clinical relevance of future trials.