Bu-Fei Yi-Shen Granules Reduce Acute Exacerbations in Patients with GOLD 3–4 COPD: A Randomized Controlled Trial

Abstract

Xue-Qing Yu,1,2,* Jia-Qi Di,2,* Wei Zhang,3 Geng-Shu Wei,4 Zhan-Ping Ma,5 Lei Wu,6 Xue-Feng Yu,7 Hui-Zhi Zhu,8 Miao Zhou,9 Cui-Ling Feng,10 Ji-Hong Feng,11 Ping Fan,12 Jian-Sheng Li,1,2 Jian-Ya Yang1 1Department of Respiratory Disease, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan Province, 450000, People’s Republic of China; 2Co-Construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou, Henan, 450046, People’s Republic of China; 3Department of Respiratory Disease, Shanghai Shuguang Hospital, Shanghai University of Chinese Medicine, Shanghai, 200000, People’s Republic of China; 4Department of Respiratory Disease, the Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi Province, 712000, People’s Republic of China; 5Department of Respiratory Disease, Shaanxi Province Hospital of Traditional Chinese Medicine, Xi’an, Shaanxi Province, 710000, People’s Republic of China; 6Department of Respiratory Disease, Hebei Province Hospital of Traditional Chinese Medicine, Shijiazhuang, Hebei, 050000, People’s Republic of China; 7Department of Respiratory Disease, the Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning Province, 110000, People’s Republic of China; 8Department of Respiratory Disease, the First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui Province, 230000, People’s Republic of China; 9Department of Respiratory Disease, the Third Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan Province, 450000, People’s Republic of China; 10Department of Traditional Chinese Medicine, People’s Hospital Affiliated to Peking University, Beijing, 100000, People’s Republic of China; 11Department of Respiratory Disease, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300000, People’s Republic of China; 12Department of Respiratory Disease, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong Province, 510000, People’s Republic of China*These authors contributed equally to this workCorrespondence: Jian-Sheng Li, Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou, Henan, 450046, People’s Republic of China, Tel [phone], Email [email protected]: Chronic obstructive pulmonary disease (COPD) is a disease characterized by frequent acute exacerbations (AEs), especially in severe and very severe cases. We aimed to evaluate the efficacy and safety of Bu-fei Yi-shen granules (BYGs) for COPD.Patients and Methods: We conducted a multicenter, randomized, double-blinded, placebo-controlled trial of 348 COPD patients with GOLD 3– 4 COPD. The patients were randomly assigned into experimental or control groups in a 1:1 ratio. Patients in the experimental group were prescribed BYG, while those in the control group were administered a placebo, orally, twice daily, with 5 days on and 2 days off per week for 52 weeks. The outcomes included AEs, pulmonary function, clinical signs and symptoms, dyspnea scores (mMRC), quality of life scores, and a 6-minute walk test (6MWT).Results: A total of 280 patients completed the trial, including 135 patients in the experimental group and 145 in the control group. Compared to the control group, significant differences were observed in frequencies of AEs (mean difference: − 0.35; 95% CI: − 0.61, − 0.10; P = 0.006) and AE-related hospitalizations (− 0.18; 95% CI: − 0.36, − 0.01; P = 0.04), 6MWD (40.93 m; 95% CI: 32.03, 49.83; P

Keywords

• chronic obstructive pulmonary disease
• traditional chinese medicine
• efficacy
• safety
• rct