A multicenter, randomized, double-blind, double-simulated, positive drug parallel-controlled clinical trial to evaluate the efficacy and safety of Xiao'er Fengreqing oral liquid in the treatment of acute pharyngitis/tonsillitis in children.

BACKGROUND: Acute pharyngitis and tonsillitis are common in children. Xiao'er Fengreqing Oral Liquid (XFQOL) shows potential benefits in previous studies of pediatric acute upper respiratory tract infections and influenza, but high-quality clinical evidence for pediatric acute pharyngitis/tonsillitis remains limited. METHODS: This multicenter, block-randomized, double-blind, double-dummy, active-controlled trial enrolled 120 children from three tertiary hospitals. Participants were randomly assigned in a 1:1 ratio to receive either XFQOL plus Xiao'er Yanbian Granules (XYG) placebo (XFQOL group, n = 60) or XYG plus XFQOL placebo (control group, n = 60) for 5 days. Primary efficacy endpoints were the day-5 response and disappearance rates of sore throat, assessed using the Wong-Baker Faces Pain Rating Scale (WBS). Secondary endpoints included the time to WBS response and disappearance, the day-3 WBS response rate, and changes in traditional Chinese medicine (TCM) syndrome scores and individual symptoms and signs. Safety was assessed via adverse events and adverse drug reactions. RESULTS: A total of 120 participants were included in the Full Analysis Set. Baseline characteristics were comparable between the groups. Response rate for the WBS sore throat score after 5 days of treatment was 100% in both groups. The disappearance rate was 98.33% in the experimental group and 90% in the control group, with a hazard ratio and its 95% confidence interval (experimental group/control group) of 0.0833 (97.5% CI: 0.0008-0.1659). Non-inferiority testing demonstrated that the experimental group was not inferior to the control group. In addition, statistically significant intergroup differences were observed in TCM syndrome sore throat onset time and TCM syndrome sore throat disappearance time, no statistically significant differences were detected in any other indicators. No related adverse events were attributed to XFQOL. CONCLUSION: XFQOL is non-inferior to XYG for the 5-day sore throat disappearance rate in pediatric acute pharyngitis/tonsillitis. Secondary endpoint analyses suggest potential advantages in the speed of symptom relief, including a shorter time to sore throat disappearance and a higher 3-day response rate, while the effects on TCM syndrome total scores and most individual symptom/sign scores are comparable between groups. Furthermore, XFQOL demonstrates a favorable safety profile, with no treatment-related adverse events identified, suggesting its potential for clinical application. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, ITMCTR2024000569.