Efficacy and safety of Lianhua Qingwen versus oseltamivir in children with influenza: a multicenter, randomized, double-blind, positive parallel-controlled study
12 affiliations
- 1Department of Respiratory, Beijing Children’s Hospital, China National Clinical Research Center for Respiratory Disease, National Center for Children’s Health, Capital Medical University, Beijing, China
- 2National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China
- 3Luohe Hospital of Traditional Chinese Medicine, Luohe, China
- 4Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang, China
- 5Shandong University of Traditional Chinese Medicine Affiliated Hospital, Jinan, China
- 6Sanmenxia Central Hospital, Sanmenxia, China
- 7Hebei Provincial Traditional Chinese Medicine Hospital, Shijiazhuang, China
- 8The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, China
- 9State Key Laboratory for Innovation and Transformation of Luobing Theory, Shijiazhuang, China
- 10Hebei Academy of Integrated Traditional Chinese and Western Medicine, Shijiazhuang, China
- 11Hebei Yiling Hospital, Shijiazhuang, China
- 12Respiratory Department, Shenzhen Children’s Hospital, Shenzhen, China
Abstract
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)
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BibTeX
@article{xue2026efficacy,
title = {{Efficacy and safety of Lianhua Qingwen versus oseltamivir in children with influenza: a multicenter, randomized, double-blind, positive parallel-controlled study}},
author = {Fengxia Xue and Jialin Li and Siyuan Hu and Chengliang Zhong and Ziwei Feng and Zhu Chen and Baoqing Zhang and Chunying Ma and Shaoyi Geng and Xianqing Ren and Zhenhua Jia and Baoping Xu and Kunling Shen and Rong Ma},
journal = {Pharmaceutical Biology},
year = {2026},
month = oct,
doi = {10.1080/13880209.2026.2753284},
url = {https://doi.org/10.1080/13880209.2026.2753284},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Efficacy and safety of Lianhua Qingwen versus oseltamivir in children with influenza: a multicenter, randomized, double-blind, positive parallel-controlled study
AU - Fengxia Xue
AU - Jialin Li
AU - Siyuan Hu
AU - Chengliang Zhong
AU - Ziwei Feng
AU - Zhu Chen
AU - Baoqing Zhang
AU - Chunying Ma
AU - Shaoyi Geng
AU - Xianqing Ren
AU - Zhenhua Jia
AU - Baoping Xu
AU - Kunling Shen
AU - Rong Ma
PY - 2026
DA - 2026/10/27
JO - Pharmaceutical Biology
DO - 10.1080/13880209.2026.2753284
UR - https://doi.org/10.1080/13880209.2026.2753284
AB - 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)
SN - 1388-0209
SN - 1744-5116
ER -