Li Jiansheng, Xie Yang, Wang Yanjun, Wu Lei, Yu Xuefeng, Bai Li, Shao Suju, Zhou Miao, Zhang Mingli, Yu Xueqing, Han Weihong, Li Xuanlin, Chen Tao
Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, No.156 Jin-shui East Road, Zhengzhou, Henan 450046, China; Henan International Joint Laboratory of Evidence-based Evaluation for Respiratory Diseases, Henan Province Clinical Research Center for Respiratory Diseases, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan Province, China.
Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, No.19 Ren-min Road, Zhengzhou, Henan 450000, China; Henan International Joint Laboratory of Evidence-based Evaluation for Respiratory Diseases, Henan Province Clinical Research Center for Respiratory Diseases, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan Province, China.
Complement Ther Med. 2025 May;89:103146. doi: 10.1016/j.ctim.2025.103146. Epub 2025 Feb 14.
Chronic obstructive pulmonary disease (COPD) is a common and frequently occurring disease that seriously endangers health, causing a heavy economic burden on patients and society. Acupuncture has been reported to have a therapeutic effect on patients with chronic obstructive pulmonary disease (COPD). However, compared with medications, it is difficult to identify a superior therapy. Therefore, the aim of this study was to evaluate the efficacy and safety of acupuncture, conventional drug and acupuncture plus conventional drug in the treatment of COPD.
This was a multicenter, open-label randomized controlled trial (RCT) through a central randomization system. A total of 150 COPD patients were randomly assigned at a 1:1:1 ratio to the acupuncture group, conventional drug group or acupuncture plus conventional drug group for 12 weeks of treatment, followed by 12 weeks of untreated follow-up. The primary outcomes included the six-minute walk distance (6MWD) and St. George's Respiratory Questionnaire (SGRQ), and the secondary outcomes included the modified Medical Research Council dyspnea scale (mMRC), acute exacerbation, lung function, and quality of life (COPD assessment test). Statistical analysis was conducted via SPSS software (version 26.0).
A total of 150 patients were included in the study, and 143 patients completed the trial. There were time effects, group effects and interaction effects in the three groups (P < 0.05). Compared with that in the conventional drug group, the 6MWD in the acupuncture plus conventional drug group increased significantly at 4, 8, and 12 weeks of treatment and at 12 weeks of follow-up. The difference was statistically significant (P < 0.05). The symptom scores, motor scores, impact scores and total SGRQ scores at different time points in the three groups tended to change with time, with a time effect (P < 0.05), and there was no group or interaction effect (P > 0.05). Among the secondary outcomes, there were time effects on the number of acute exacerbations, forced expiratory volume in one second (FEV1) and forced expiratory volume in one second/forced vital capacity (FEV1/FVC) at different time points in the three groups (P < 0.05). mMRC had time and group effects (P < 0.05). CAT had time effects, group effects and interaction effects (P < 0.05).
Compared with the acupuncture group and the conventional drug group, the acupuncture plus conventional drug group was better at improving exercise ability, improving quality of life, and reducing dyspnea. It is safe and effective for the treatment of chronic obstructive pulmonary disease in the stable period, which can provide a reference for further related research.
ClinicalTrials.gov, NCT03169504. Registered on 30 May 2017.
慢性阻塞性肺疾病（COPD）是一种常见且多发病，严重危害健康，给患者和社会带来沉重经济负担。据报道，针灸对慢性阻塞性肺疾病（COPD）患者有治疗作用。然而，与药物相比，难以确定哪种治疗方法更优。因此，本研究旨在评估针灸、传统药物以及针灸联合传统药物治疗COPD的疗效和安全性。
这是一项通过中央随机系统进行的多中心、开放标签随机对照试验（RCT）。共150例COPD患者按1:1:1比例随机分为针灸组、传统药物组或针灸联合传统药物组，进行12周治疗，随后进行12周未治疗随访。主要结局指标包括六分钟步行距离（6MWD）和圣乔治呼吸问卷（SGRQ），次要结局指标包括改良医学研究理事会呼吸困难量表（mMRC）、急性加重、肺功能和生活质量（COPD评估测试）。通过SPSS软件（版本26.0）进行统计分析。
本研究共纳入150例患者，143例患者完成试验。三组存在时间效应、组间效应和交互效应（P<0.05）。与传统药物组相比，针灸联合传统药物组在治疗第4、8、12周及随访12周时6MWD显著增加。差异有统计学意义（P<0.05）。三组不同时间点的症状评分、运动评分、影响评分和SGRQ总分随时间变化，存在时间效应（P<0.05），但无组间效应或交互效应（P>0.05）。在次要结局指标中，三组不同时间点的急性加重次数、一秒用力呼气容积（FEV1）和一秒用力呼气容积/用力肺活量（FEV1/FVC）存在时间效应（P<0.05）。mMRC有时间和组间效应（P<0.05）。COPD评估测试（CAT）有时间效应、组间效应和交互效应（P<0.05）。
与针灸组和传统药物组相比，针灸联合传统药物组在改善运动能力、提高生活质量和减轻呼吸困难方面效果更佳。对稳定期慢性阻塞性肺疾病的治疗安全有效，可为进一步相关研究提供参考。
ClinicalTrials.gov，NCT03169504。于2017年5月30日注册。
