Efficacy and safety of Lianhua Qingwen versus oseltamivir in children with influenza: a multicenter, randomized, double-blind, positive parallel-controlled study

CONTEXT High-quality evidence on Lianhua Qingwen (LHQW) for treating influenza in children remains limited. OBJECTIVE To evaluate the efficacy and safety of LHQW in children aged 3-14 years with influenza, compared with oseltamivir. MATERIALS AND METHODS In this multicenter, randomized, double-blind, positive parallel-controlled trial, participants were randomly assigned (1:1) to receive either LHQW + oseltamivir placebo or oseltamivir + LHQW placebo. The primary outcome was clinical recovery time. Secondary outcomes included time to defervescence, symptom scores on the Canadian Acute Respiratory Illness and Flu Scale, the incidence of complications and severe/critical influenza, and the improvement rates for individual influenza symptoms. Safety outcomes were assessed based on adverse events. RESULTS A total of 520 participants were randomized (260 per group). Baseline characteristics were comparable. Median clinical recovery time was 5 days in both groups, with similar clinical recovery rates (71.5% vs. 71.2%; HR: 1.04, 95% CI: 0.84-1.29; one-sided p < 0.025). Median time to defervescence was shorter with LHQW (24 h vs. 30 h, p < 0.05). LHQW showed higher improvement rates for cough (56.9% vs. 45.5%) and sore throat (90.9% vs. 74.2%) (both p < 0.05). No severe or critical influenza occurred in the LHQW group. Adverse events incidence was similar between groups (p > 0.05). DISCUSSION LHQW may offer a safe and effective alternative to oseltamivir for pediatric influenza, with particular benefits for defervescence, cough, and sore throat. CONCLUSIONS LHQW was non-inferior to oseltamivir in clinical recovery time and resulted in faster defervescence and greater improvement in cough and sore throat, with comparable safety. CLINICAL TRIAL REGISTRATION NUMBER ChiCTR1900028390 (Chinese Clinical Trial Registry, Dec. 20, 2019).