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: > 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).