PMID- 37007028 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230404 IS - 1663-9812 (Print) IS - 1663-9812 (Electronic) IS - 1663-9812 (Linking) VI - 14 DP - 2023 TI - Effectiveness and safety of Qingfei Dayuan granules for treating influenza and upper respiratory tract infections manifested by the pulmonary heat-toxin syndrome: A multicenter, randomized, double-blind, placebo-controlled trial. PG - 1133560 LID - 10.3389/fphar.2023.1133560 [doi] LID - 1133560 AB - Background: Patients diagnosed with influenza and upper respiratory tract infections (URTIs) have similar clinical manifestations and biochemical indices and a low detection rate of viral pathogens, mixed infection with diverse respiratory viruses, and targeted antiviral treatment difficulty in the early stage. According to the treatment strategy of "homotherapy for heteropathy" in traditional Chinese medicine (TCM), different diseases with the same clinical symptoms can be treated with the same medicines. Qingfei Dayuan granules (QFDY), a type of Chinese herbal preparation included in the TCM Diagnosis and Treatment Protocol for COVID-19 of Hubei Province issued by the Health Commission of Hubei Province in 2021, are recommended for patients suffering from COVID-19 with symptoms of fever, cough, and fatigue, among others. Additionally, recent studies have shown that QFDY effectively alleviates fever, cough, and other clinical symptoms in patients with influenza and URTIs. Materials and methods: The study was designed as a multicenter, randomized, double-blind, placebo-controlled clinical trial for treatment for influenza and URTIs manifested by pulmonary heat-toxin syndrome (PHTS) with QFDY. A total of 220 eligible patients were enrolled from eight first-class hospitals in five cities of Hubei Province in China and randomly assigned to receive either 15 g of QFDY or a placebo three times a day for 5 days. The primary outcome was the complete fever relief time. Secondary outcomes included efficacy evaluation of TCM syndromes, scores of TCM syndromes, cure rate of each single symptom, incidence of comorbidities and progression to severe conditions, combined medications, and laboratory tests. Safety evaluations mainly involved adverse events (AEs) and changes in vital signs during the study. Results: Compared with the placebo group, the complete fever relief time was shorter in the QFDY group, 24 h (12.0, 48.0) in the full analysis set (FAS) and 24 h (12.0, 49.5) in the per-protocol set (PPS) (p 0.05). Meanwhile, no significant difference was found in the incidence of AEs and vital signs between the two groups (p > 0.05). Conclusion: The trial showed that QFDY was an effective and safe treatment modality for influenza and URTIs manifested by PHTS because it shortened the complete fever relief time, accelerated clinical recovery, and alleviated symptoms such as cough, a stuffy and running nose, and sneezing during the course of treatment. Clinical trial registration: https://www.chictr.org.cn/showproj.aspx?proj=131702, identifier ChiCTR2100049695. CI - Copyright (c) 2023 Li, Xie, Zhu, Yang, Wang, Yang, Li, Li, Yan, Wu, Zhao, Zhang, Yang, Guo, Li, Wang, Shi, Xiong, Xu, Kong, Cui, Yang and Ba. FAU - Li, Weinan AU - Li W AD - College of Traditional Chinese Medicine, Hubei University of Chinese Medicine, Wuhan, China. AD - Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China. AD - The Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan, China. AD - Hubei Provincial Academy of Traditional Chinese Medicine, Wuhan, China. FAU - Xie, Lihan AU - Xie L AD - Department of Nephrology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. FAU - Zhu, Xiaoyun AU - Zhu X AD - College of Traditional Chinese Medicine, Hubei University of Chinese Medicine, Wuhan, China. FAU - Yang, Yi AU - Yang Y AD - Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China. FAU - Wang, Linqun AU - Wang L AD - College of Traditional Chinese Medicine, Hubei University of Chinese Medicine, Wuhan, China. FAU - Yang, Min AU - Yang M AD - Department of Preventive Medicine, School of Basic Medicine, Hubei University of Chinese Medicine, Wuhan, China. FAU - Li, Hengfei AU - Li H AD - Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China. AD - The Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan, China. AD - Hubei Provincial Academy of Traditional Chinese Medicine, Wuhan, China. FAU - Li, Xucheng AU - Li X AD - Emergency Department, Wuhan Hospital of Traditional Chinese Medicine, Wuhan, China. FAU - Yan, Guangjun AU - Yan G AD - Jingzhou Hospital of Traditional Chinese Medicine, Jingzhou, China. FAU - Wu, Xiongfei AU - Wu X AD - Department of Infectious Diseases, People's Hospital of Hanchuan, Hanchuan, China. FAU - Zhao, Weijun AU - Zhao W AD - Respiratory Department, Yichang Hospital of Traditional Chinese Medicine, Yichang, China. FAU - Zhang, Jilong AU - Zhang J AD - Fever Clinic, Wuhan NO 1 Hospital, Wuhan, China. FAU - Yang, Gang AU - Yang G AD - Department of Respirology, Huangshi Hospital of Traditional Chinese Medicine, Huangshi, China. FAU - Guo, Yufei AU - Guo Y AD - Fever Outpatient Clinic, Hubei Provincial Hospital of Traditional Medicine and Western Medicine, Wuhan, China. FAU - Li, Chengyin AU - Li C AD - Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China. AD - The Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan, China. AD - Hubei Provincial Academy of Traditional Chinese Medicine, Wuhan, China. FAU - Wang, Rui AU - Wang R AD - College of Traditional Chinese Medicine, Hubei University of Chinese Medicine, Wuhan, China. FAU - Shi, Lijun AU - Shi L AD - Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China. AD - The Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan, China. AD - Hubei Provincial Academy of Traditional Chinese Medicine, Wuhan, China. FAU - Xiong, Zhili AU - Xiong Z AD - College of Traditional Chinese Medicine, Hubei University of Chinese Medicine, Wuhan, China. FAU - Xu, Puming AU - Xu P AD - College of Traditional Chinese Medicine, Hubei University of Chinese Medicine, Wuhan, China. FAU - Kong, Wenwen AU - Kong W AD - College of Traditional Chinese Medicine, Hubei University of Chinese Medicine, Wuhan, China. FAU - Cui, Mengdi AU - Cui M AD - College of Traditional Chinese Medicine, Hubei University of Chinese Medicine, Wuhan, China. FAU - Yang, Xi AU - Yang X AD - College of Traditional Chinese Medicine, Hubei University of Chinese Medicine, Wuhan, China. FAU - Ba, Yuanming AU - Ba Y AD - Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China. AD - The Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan, China. AD - Hubei Provincial Academy of Traditional Chinese Medicine, Wuhan, China. LA - eng PT - Journal Article DEP - 20230315 PL - Switzerland TA - Front Pharmacol JT - Frontiers in pharmacology JID - 101548923 PMC - PMC10050362 OTO - NOTNLM OT - Qingfei Dayuan granules OT - double-blind OT - influenza OT - multicenter OT - placebo-controlled OT - pulmonary heat-toxin syndrome OT - upper respiratory tract infections COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2023/04/04 06:00 MHDA- 2023/04/04 06:01 PMCR- 2023/03/15 CRDT- 2023/04/03 03:55 PHST- 2022/12/29 00:00 [received] PHST- 2023/02/28 00:00 [accepted] PHST- 2023/04/04 06:01 [medline] PHST- 2023/04/03 03:55 [entrez] PHST- 2023/04/04 06:00 [pubmed] PHST- 2023/03/15 00:00 [pmc-release] AID - 1133560 [pii] AID - 10.3389/fphar.2023.1133560 [doi] PST - epublish SO - Front Pharmacol. 2023 Mar 15;14:1133560. doi: 10.3389/fphar.2023.1133560. eCollection 2023.