Trial reportThe clinical respiratory journal2026
Efficacy and Safety of Lianhua Qingke Tablets in Children With Mycoplasma pneumoniae Pneumonia: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Clinical Trial.
Trial report in The clinical respiratory journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
20 authors.
Funding
Abstract
backgroundMycoplasma 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
designThis prospective, multicenter, randomized, double-blind, placebo-controlled trial adhered to the Declaration of Helsinki and was registered in the Chinese Clinical Trial Registry (ChiCTR2300078209).
methodsA 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.
resultsThe 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.
conclusionLHQK 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.
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