Efficacy and Safety of Lianhua Qingke Tablets in Children With Mycoplasma pneumoniae Pneumonia: A Randomized, Double‐Blind, Multicenter, Placebo‐Controlled Clinical Trial
He Wang, Haiwei Dou, Guangying Chen, Yanmin Wei, Hua Li, Shuqiong Xu, Rongzhen Kang, Shanhong Liu, Long Zhang, Nan Li, Hongli Sun, Chi Wang, Jie Zhao, Jirong Yi, Wentao Song, Hongrong Li, Rong Ma, Kunling Shen, Deli Xin, Wenjie QiABSTRACT
Background
Purpose
To evaluate the safety and efficacy of Lianhua Qingke (LHQK) tablets as adjunctive therapy in children with
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.