Effects of Wenfei Guyuan umbilical moxibustion on patients with stable chronic obstructive pulmonary disease: A multicenter randomized controlled trial

IF 3.3 3区医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE

Complementary therapies in medicine Pub Date : 2025-05-22 DOI:10.1016/j.ctim.2025.103194

Qionghua Xiao , Yuanyuan Meng , Gaoming Wang , Minghang Wang , Yong Meng , Miao Zhou

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引用次数: 0

Abstract

Background

Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease. Its high disability rate, high mortality rate, and heavy economic burden have made it a major public health problem. Umbilical moxibustion has been reported to have therapeutic effects on COPD, but there is a lack of high-quality evidence-based studies on this intervention. Therefore, the purpose of this study is to evaluate the efficacy and safety of Wenfei Guyuan (WFGY) umbilical moxibustion in the treatment of COPD.

Methods

This was a multicenter, open-label, randomized controlled trial (RCT). A total of 220 participants were randomly assigned at a 1:1 ratio to the experimental group (WFGY umbilical moxibustion in combination with conventional drugs) and the control group (conventional drugs). Both groups received 13 weeks of treatment, followed by 26 weeks of follow-up. The primary outcome was the frequency of acute exacerbations, and the secondary outcomes were the 6-minute walk distance (6MWD), modified Medical Research Council dyspnea scale (mMRC) score, clinical symptoms and signs scores, and lung function tests. Statistical analysis was performed using SPSS software (version 25.0).

Results

A total of 220 participants were included in the study, and 215 participants completed the trial. There were significant time effects and group effects on the frequency of acute exacerbations (P < 0.001, P = 0.001), but no interaction effects (P = 0.406). Compared with the control group, the frequency of acute exacerbations in the experimental group was significantly reduced at 4 and 13 weeks of treatment and at 13 and 26 weeks of follow-up (P < 0.05). Among the secondary outcomes, there were significant time effects, group effects, and interaction effects on the 6MWD, mMRC scores, and clinical symptoms and signs scores (cough, expectoration, wheezing, chest tightness, shortness of breath, fatigue, cyanosis, and total scores) at different time points between the two groups (P < 0.05). FVC and FEV1 had no time effects, group effects, or interaction effects (P > 0.05). FEV1 % had group effects (P < 0.05) but no time effects or interaction effects (P > 0.05). The overall skin sensitization incidence in the experimental group was 3.74 %, which was slightly higher than the 0 % incidence in the control group, but no statistically significant difference was observed between the two groups (P > 0.05).

Conclusions

The experimental group demonstrated superior efficacy to the control group in reducing the frequency of acute exacerbations, enhancing exercise tolerance, reducing dyspnea severity, and improving quality of life. This intervention demonstrated effectiveness and safety in the treatment of stable COPD, providing a foundation for further research.

Trial registration

https://www.chictr.org.cn, ChiCTR2100049802. Registered on August 9, 2021.

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温肺固源脐灸对稳定期慢性阻塞性肺疾病患者的影响：一项多中心随机对照试验

慢性阻塞性肺疾病（COPD）是一种常见的慢性呼吸系统疾病。它的高致残率、高死亡率和沉重的经济负担使其成为一个主要的公共卫生问题。据报道，脐灸对慢性阻塞性肺病有治疗作用，但缺乏高质量的循证研究。因此，本研究的目的是评价温肺固源（WFGY）脐灸治疗慢性阻塞性肺病的疗效和安全性。方法采用多中心、开放标签、随机对照试验（RCT）。将220名受试者按1:1的比例随机分为实验组（WFGY脐灸联合常规药物）和对照组（常规药物）。两组均接受治疗13周，随访26周。主要终点是急性加重的频率，次要终点是6分钟步行距离（6MWD）、改良的医学研究委员会呼吸困难量表（mMRC）评分、临床症状和体征评分以及肺功能测试。采用SPSS软件（25.0版）进行统计学分析。结果共纳入研究220例，完成试验215例。急性发作频率存在显著的时间效应和组效应（P <； 0.001,P = 0.001），但无交互效应（P = 0.406）。与对照组比较，实验组在治疗第4周、13周及随访第13周、26周急性加重次数显著降低（P <； 0.05）。次要结局中，两组患者不同时间点的6MWD、mMRC评分及临床症状体征评分（咳嗽、咳痰、喘息、胸闷、呼吸短促、乏力、发绀、总分）均存在显著的时间效应、组效应和交互效应（P <； 0.05）。FVC和FEV1无时间效应、组效应和交互效应（P >； 0.05）。FEV1 %有组效应（P <； 0.05），无时间效应和交互效应（P >； 0.05）。试验组整体皮肤致敏率为3.74 %，略高于对照组的0 %，但两组间差异无统计学意义（P >； 0.05）。结论实验组在减少急性发作次数、提高运动耐量、减轻呼吸困难严重程度、改善生活质量等方面均优于对照组。该干预措施在稳定期COPD治疗中表现出有效性和安全性，为进一步研究提供了基础。试用注册https://www.chictr.org.cn, ChiCTR2100049802。注册日期：2021年8月9日

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来源期刊

Complementary therapies in medicine 医学-全科医学与补充医学

CiteScore

8.60

自引率

2.80%

发文量

101

审稿时长

112 days

期刊介绍： Complementary Therapies in Medicine is an international, peer-reviewed journal that has considerable appeal to anyone who seeks objective and critical information on complementary therapies or who wishes to deepen their understanding of these approaches. It will be of particular interest to healthcare practitioners including family practitioners, complementary therapists, nurses, and physiotherapists; to academics including social scientists and CAM researchers; to healthcare managers; and to patients. Complementary Therapies in Medicine aims to publish valid, relevant and rigorous research and serious discussion articles with the main purpose of improving healthcare.