Clinical evidence mapping for 54 types of oral Chinese patent medicines used in adult bronchial asthma: predominantly as add-on therapy and partially as monotherapy.

ETHNOPHARMACOLOGICAL RELEVANCE: Oral Chinese patent medicines (CPMs), derived from traditional Chinese medicine (TCM), are commonly utilized in China for adult bronchial asthma (BA); however, the scope and quality of clinical evidence supporting their efficacy remain unclear. AIM OF THE REVIEW: To construct an evidence map of clinical research on 54 oral CPMs for adult BA, focusing on their use as add-on therapy with partial monotherapy evidence also captured, to identify research gaps, and inform future study design and evidence-based practice. MATERIALS AND METHODS: Nine databases were explored from inception until January 5, 2026. The study included interventional studies, observational studies, systematic reviews, and guidelines/expert consensus on adult BA. The trial interventions consisted of oral CPMs used alone or combined with conventional Western medications. Two researchers conducted independent screenings of the literature and gathered data. We used tools such as RoB 2.0, ROBINS-I, NOS, AMSTAR-2, and AGREE II to assess the methodological quality of the included studies. RESULTS: A total of 192 publications (159 RCTs, 15 non-RCTs, 8 observational studies, 7 systematic reviews, 3 guidelines/consensuses) covering 54 CPMs were included. Studies on Bailing Capsules/Tablets accounted for the largest proportion, at 10.4%. 56.0% of the studies did not provide information on the staging of BA in adults, and 78.0% did not provide information on TCM syndrome patterns. In 96.7% of the studies, the intervention involved the combined use of CPMs and Western medicines. Clinical efficacy and pulmonary function tests were the most commonly used outcome measures, while TCM syndrome scores, quality of life, and pharmacoeconomic indicators were used less frequently. The overall methodological quality of all study types was rated as poor. CONCLUSION: This evidence map includes a total of 192 studies and 54 types of oral CPMs, demonstrating extensive research activity in this field. However, the quality of the evidence is severely limited by factors such as poor methodological design, insufficient reporting of BA staging and TCM syndrome patterns, overreliance on add-on therapy designs, and a lack of TCM-specific outcome measures. Given the generally low methodological quality, the reported therapeutic benefits should be interpreted as suggestive evidence of add-on therapy rather than definitive conclusions regarding the efficacy of TCM syndrome-differentiation-based treatment. Future studies should employ rigorously designed placebo-controlled add-on trials, incorporate TCM syndrome-type and staging criteria, establish a core set of outcome measures that includes TCM-specific indicators, and strengthen pharmacoeconomic evaluations.