Efficacy and safety of Qingfei Huatan formula in the treatment of acute exacerbation of chronic obstructive pulmonary disease: A multi-centre, randomised, double-blind, placebo-controlled trial.

Autor: Zhu HZ; Department of Respiratory Medicine, the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei 230031, Anhui Province, China., Li CY; Graduate School, Anhui University of Traditional Chinese Medicine, Hefei 230012, Anhui Province, China., Liu LJ; Department of Respiratory Medicine, Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang 330006, Jiangxi Province, China., Tong JB; Department of Respiratory Medicine, the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei 230031, Anhui Province, China., Lan ZH; Department of Respiratory Medicine, Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang 330006, Jiangxi Province, China., Tian SG; Department of Respiratory Diseases, the First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, Henan Province, China., Li Q; Department of Pulmonary Diseases, Taihe Hospital of Traditional Chinese Medicine Affiliated to Anhui University of Traditional Chinese Medicine, Fuyang 236600, Anhui Province, China., Tong XL; Department of Respiratory Medicine, the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei 230031, Anhui Province, China., Wu JF; Department of Respiratory and Critical Care Medicine, Jiangxi Province Hospital of Integrated Chinese and Western Medicine, Nanchang 330002, Jiangxi Province, China., Zhu ZG; Department of Respiratory Medicine, the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China., Li SY; Department of Respiratory Diseases, the First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, Henan Province, China. Electronic address: lisuyun2000@126.com., Li JS; Collaborative Innovation Center for Respiratory Disease Diagnosis and Treatment and Chinese Medicine Development of Henan Province, Zhengzhou 450046, Henan Province, China. Electronic address: li_js8@163.com.
Jazyk: angličtina
Zdroj: Journal of integrative medicine [J Integr Med] 2024 Sep; Vol. 22 (5), pp. 561-569. Date of Electronic Publication: 2024 Jul 09.
DOI: 10.1016/j.joim.2024.07.003
Abstrakt: Background: Chronic obstructive pulmonary disease (COPD), a common respiratory disease, can be effectively treated by traditional Chinese medicine (TCM). Qingfei Huatan, a TCM formula, has been reported to effectively alleviate the clinical symptoms of COPD patients. However, there is a lack of multi-centre, randomised, double-blind, controlled clinical trials documenting the clinical efficacy and safety of this formula in the treatment of acute exacerbation of COPD (AECOPD).
Objective: This study evaluated the efficacy and safety of Qingfei Huatan formula in the treatment of AECOPD, thereby providing high-quality clinical evidence.
Design, Setting, Participants and Interventions: A total of 276 patients with AECOPD were included in this multi-centre, randomised, double-blind, placebo-controlled trial and were randomised into treatment and control groups at a ratio of 1:1. Patients in the treatment and control groups took Qingfei Huatan granules or simulated Qingfei Huatan granules twice a day, for 14 days, in addition to Western medicine treatment. All patients were followed up for 3 months.
Main Outcome Measures: The primary outcome was time taken to symptom stabilisation. The secondary outcomes included duration of antibiotic use, clinical symptom and sign score, TCM syndrome score, dyspnoea score, and quality of life (QOL) score. Meanwhile, the safety of the formula was assessed through routine urine and stool tests, electrocardiograms, liver and kidney function tests, and the observation of adverse events throughout the trial.
Results: The time taken for effective stabilisation (P < 0.05) and obvious stabilisation (P < 0.01), and the duration of antibiotic use (P < 0.05) were significantly shorter in the treatment group than in the control group. On days 6, 9, 12 and 14 of treatment, clinical symptom and sign score decreased in both groups, particularly in the treatment group (P < 0.01). On days 9, 12 and 14 of treatment, the TCM syndrome scores of both groups were reduced (P < 0.01), with more significant reductions in the treatment group. At 3 months after the end of treatment, the treatment group continued to have lower clinical symptom and sign score and TCM syndrome score than the control group (P < 0.01). On days 6, 9, 12 and 14 of treatment, dyspnoea and QOL scores were markedly reduced in the two groups (P < 0.05 and P < 0.01, respectively), especially in the treatment group. At 3 months after the end of treatment, dyspnoea and QOL scores were lower in the treatment group than those in the control group (P < 0.01). No serious adverse events were observed in either group.
Conclusion: The Qingfei Huatan formula can effectively shorten the duration of AECOPD and antibiotic use, significantly relieve clinical symptoms, and increase QOL for AECOPD patients, with a favourable safety profile. These results suggest that this formula can be used as a complementary treatment for AECOPD patients.
Trial Registration: The protocol was registered at the Chinese Clinical Trial Registry (ChiCTR1900026576). Please cite this article as: Zhu HZ, Li CY, Liu LJ, Tong JB, Lan ZH, Tian SG, Li Q, Tong XL, Wu JF, Zhu ZG, Li SY, Li JS. Efficacy and safety of Qingfei Huatan formula in the treatment of acute exacerbation of chronic obstructive pulmonary disease: A multi-centre, randomised, double-blind, placebo-controlled trial. J Integr Med. 2024; 22(5): 561-569.
(Copyright © 2024 Shanghai Yueyang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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