Efficacy and Safety of Lianhua Qingke Tablets in Children With Mycoplasma pneumoniae Pneumonia: A Randomized, Double‐Blind, Multicenter, Placebo‐Controlled Clinical Trial

BACKGROUND: Mycoplasma pneumoniae (MP) is a major cause of community-acquired pneumonia in children, with increasing macrolide resistance complicating treatment. Traditional Chinese Medicine (TCM) provides unique benefits for pediatric respiratory infections. PURPOSE: To evaluate the safety and efficacy of Lianhua Qingke (LHQK) tablets as adjunctive therapy in children with M. pneumoniae pneumonia (MPP). STUDY DESIGN: This prospective, multicenter, randomized, double-blind, placebo-controlled trial adhered to the Declaration of Helsinki and was registered in the Chinese Clinical Trial Registry (ChiCTR2300078209). METHODS: A total of 160 children aged 4-14 years with mild MPP were randomized 1:1 to receive conventional therapy plus LHQK or conventional therapy plus placebo for 7 days across 13 hospitals over 4 months. Efficacy analysis included 128 participants with centrally confirmed MP infection; safety analysis included all 160. Baseline characteristics were comparable (all p > 0.05), with 98.8% medication compliance in both groups (p > 0.05). The primary outcome was the major symptom resolution rate by Day 7. RESULTS: The LHQK group showed a significantly higher major symptom resolution rate (85.9% vs. 65.6%, p < 0.05), with a numerically shorter median time to resolution (4.5 vs. 5.0 days, p = 0.072). LHQK also significantly improved cough and expectoration relief rates (all p < 0.05). No differences were found in laboratory parameters. Adverse event incidence was lower with LHQK (2.5% vs. 8.8%, p > 0.05), with no serious events reported. CONCLUSION: LHQK is a safe and effective adjunctive TCM therapy for mild MPP in children, offering significant benefits in respiratory symptom alleviation and a favorable safety profile, with a trend toward shorter recovery time, providing a valuable treatment option amid rising antibiotic resistance.