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

IF 4.2 2区医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE

Journal of Integrative Medicine-Jim Pub Date : 2024-09-01 DOI:10.1016/j.joim.2024.07.003

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引用次数: 0

Abstract

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.

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清热化痰方治疗慢性阻塞性肺疾病急性加重期的疗效和安全性：多中心、随机、双盲、安慰剂对照试验

背景慢性阻塞性肺疾病（COPD）是一种常见的呼吸系统疾病，中医药可有效治疗该病。据报道，中药配方清热化痰汤能有效缓解慢性阻塞性肺疾病患者的临床症状。然而，目前尚缺乏多中心、随机、双盲、对照临床试验记录该方剂在治疗慢性阻塞性肺疾病急性加重期（AECOPD）中的临床疗效和安全性。本研究评估了清热化痰方在治疗慢性阻塞性肺疾病急性加重期中的疗效和安全性，从而提供高质量的临床证据。这项多中心、随机、双盲、安慰剂对照试验共纳入了276名AECOPD患者，并按1:1的比例随机分为治疗组和对照组。治疗组和对照组患者在接受西药治疗的同时，服用清瘟化毒颗粒或模拟清瘟化毒颗粒，每天两次，共14天。主要结果测量主要结果是症状稳定所需时间。次要结果包括抗生素使用时间、临床症状和体征评分、中医综合征评分、呼吸困难评分和生活质量（QOL）评分。同时，在整个试验过程中，通过尿液和粪便常规检查、心电图、肝功能和肾功能检查以及不良事件观察来评估配方的安全性。在治疗的第 6、9、12 和 14 天，两组的临床症状和体征评分均有所下降，尤其是治疗组（P < 0.01）。在治疗的第 9、12 和 14 天，两组的中医综合征评分均有所下降（P < 0.01），其中治疗组的下降更为显著。治疗结束后 3 个月，治疗组的临床症状和体征评分及中医证候评分仍低于对照组（P < 0.01）。在治疗的第 6、9、12 和 14 天，两组患者的呼吸困难和 QOL 评分明显降低（分别为 P < 0.05 和 P < 0.01），尤其是治疗组。治疗结束 3 个月后，治疗组的呼吸困难和 QOL 评分低于对照组（P <0.01）。结论清热化痰方能有效缩短 AECOPD 病程和抗生素使用时间，显著缓解 AECOPD 患者的临床症状，提高 QOL，且安全性良好。这些结果表明，该配方可作为 AECOPD 患者的辅助治疗：该方案已在中国临床试验注册中心注册（ChiCTR1900026576）：Zhu HZ, Li CY, Liu LJ, Tong JB, Lan ZH, Tian SG, Li Q, Tong XL, Wu JF, Zhu ZG, Li SY, Li JS.清瘟化浊方治疗慢性阻塞性肺疾病急性加重期的有效性和安全性：多中心、随机、双盲、安慰剂对照试验。J Integr Med.2024; 22(5):561-569.

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来源期刊

Journal of Integrative Medicine-Jim Medicine-Complementary and Alternative Medicine

CiteScore

9.20

自引率

4.20%

发文量

3319

期刊介绍： The predecessor of JIM is the Journal of Chinese Integrative Medicine (Zhong Xi Yi Jie He Xue Bao). With this new, English-language publication, we are committed to make JIM an international platform for publishing high-quality papers on complementary and alternative medicine (CAM) and an open forum in which the different professions and international scholarly communities can exchange views, share research and their clinical experience, discuss CAM education, and confer about issues and problems in our various disciplines and in CAM as a whole in order to promote integrative medicine. JIM is indexed/abstracted in: MEDLINE/PubMed, ScienceDirect, Emerging Sources Citation Index (ESCI), Scopus, Embase, Chemical Abstracts (CA), CAB Abstracts, EBSCO, WPRIM, JST China, Chinese Science Citation Database (CSCD), and China National Knowledge Infrastructure (CNKI). JIM Editorial Office uses ThomsonReuters ScholarOne Manuscripts as submitting and review system (submission link: http://mc03.manuscriptcentral.com/jcim-en). JIM is published bimonthly. Manuscripts submitted to JIM should be written in English. Article types include but are not limited to randomized controlled and pragmatic trials, translational and patient-centered effectiveness outcome studies, case series and reports, clinical trial protocols, preclinical and basic science studies, systematic reviews and meta-analyses, papers on methodology and CAM history or education, conference proceedings, editorials, commentaries, short communications, book reviews, and letters to the editor. Our purpose is to publish a prestigious international journal for studies in integrative medicine. To achieve this aim, we seek to publish high-quality papers on any aspects of integrative medicine, such as acupuncture and traditional Chinese medicine, Ayurveda medicine, herbal medicine, homeopathy, nutrition, chiropractic, mind-body medicine, taichi, qigong, meditation, and any other modalities of CAM; our commitment to international scope ensures that research and progress from all regions of the world are widely covered. These ensure that articles published in JIM have the maximum exposure to the international scholarly community. JIM can help its authors let their papers reach the widest possible range of readers, and let all those who share an interest in their research field be concerned with their study.