Treatment of children with acute upper respiratory tract infection (wind-heat pattern) with Yin Hu Gan Mao San: a prospective real-world cohort study

Background Yin Hu Gan Mao San (YHGMS) is a traditional Chinese herbal preparation derived from Yin Qiao San, used for topical application to treat wind-heat colds. This study aims to evaluate the clinical efficacy and safety of YHGMS in children with acute upper respiratory tract infection (AURTI) of wind-heat pattern. Methods This prospective, real-world cohort study enrolled 999 children with AURTI from 23 hospitals from May 2022 to June 2023. Participants were naturally divided into an exposed group (n = 671) that received YHGMS and a non-exposed group (n = 328) that did not receive YHGMS or any other traditional Chinese medicine. Propensity score matching was used to balance baseline characteristics. Primary outcomes included clinical recovery rate and time to recovery. Secondary outcomes included time to normal temperature, symptom resolution rates, and safety profile. Results After propensity score matching, the YHGMS group demonstrated significantly higher recovery rates on day 3 (52.64% vs . 36.09%), day 5 (81.00% vs . 68.81%), and day 7 (94.72% vs . 87.64%) (all P < 0.0001). Median recovery time (3.0 vs . 4.0 days) and time to normal temperature (1.0 vs . 2.0 days) were significantly shorter in the YHGMS group (both P < 0.0001). Resolution rates of individual symptoms were consistently higher in the YHGMS group. The incidence of adverse reactions was low (1.51%), comprising only mild, self-limiting local skin reactions. Conclusion YHGMS was associated with faster clinical recovery and symptom resolution in children with AURTI (wind-heat pattern), without significant safety concerns. As monotherapy, YHGMS showed better outcomes than chemical medicine alone; in combination, it also accelerated resolution of clinical symptoms and recovery.