Jiansheng Li,1,2,* Hailong Zhang,1,3,* Huanrong Ruan,3 Yimei Si,3 Zikai Sun,4 Hong Liu,5 Jihong Feng,6 Yanqing Wang,7 Lihua Li,8 Li Bai,9 Hui Sun10 1Co-Construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou, People’s Republic of China; 2Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou, People’s Republic of China; 3The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, People’s Republic of China; 4Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing, People’s Republic of China; 5The First Affiliated Hospital of Zhengzhou University, Zhengzhou, People’s Republic of China; 6The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, People’s Republic of China; 7Haici Hospital of Qingdao, Qingdao, People’s Republic of China; 8Zhengzhou People’s Hospital, Zhengzhou, People’s Republic of China; 9Shanxi Hospital of Integrated Traditional and Western Medicine, Taiyuan, People’s Republic of China; 10Nanyang City Center Hospital, Nanyang, People’s Republic of China*These authors contributed equally to this workCorrespondence: Jiansheng Li No. 156 Jinshui East Road, Zhengdong New District, Zhengzhou, Henan 450046, People’s Republic of ChinaTel +86 371 65676568Fax +86 371 65944307Email li_js8@163.comPurpose: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is an essential occurrence in COPD management and is the leading cause of morbidity and mortality. Chinese herbal medicine is widely used in the treatment of AECOPD, but high quality randomized controlled trials are limited. This study aimed to evaluate the efficacy and safety of Chinese herbal medicine as adjuvant therapy for patients with AECOPD.Methods: This was a randomized, double-blind, placebo-controlled study of 378 participants from eight centers in China. Participants were randomly assigned to receive 10 g of Chinese herbal medicine (according to the type of Traditional Chinese medicine syndrome: Sanhanhuayin, Qingrehuatan, or Zaoshihuatan granules) or placebo, two times per day, for 14 days, in addition to conventional medicine. Participants were followed up for 84 days after the treatment. The primary end point was the COPD assessment test (CAT) score. Secondary end points included the Modified British Medical Research Council (mMRC) questionnaire and the COPD patient-reported outcome scale (COPD-PRO). We also assessed treatment failure and treatment success rate, length of hospitalization, number of patients with acute exacerbations, number of patients readmitted due to AECOPD, and number of deaths and intubation.Results: The between-group difference in the change from baseline for CAT on day 14 (end of treatment) was − 2.11 (95% confidence interval [CI], − 3.198 to − 1.050; P< 0.001), exceeding the minimal clinically important difference. The mMRC and COPD-PRO scores were lower in the intervention group compared to the control group (between-group difference in the change from baseline, − 0.28; 95% CI, − 0.48 to − 0.08; P=0.007 and − 2.51; 95% CI, − 4.087 to − 0.929; P=0.002, respectively) on day 14. The intervention group had a significantly shorter duration of hospital stay than the control group (mean difference, − 1.21days; 95% CI, − 2.041 to − 0.419; P=0.003), significantly lower of number of exacerbations (risk ratio [RR], 0.60; 95% CI, 0.409 to 0.892; P=0.010), and significantly lower number of readmissions due to AECOPD (RR, 0.41; 95% CI, 0.193 to 0.865; P=0.015). Significant differences in the number of treatment failures or successes, deaths, and intubation were not observed. The difference in safety variables and adverse events between the two groups was not observed.Conclusion: Chinese herbal medicine appears to be safe and beneficial for AECOPD and can be considered a complementary treatment for patients with AECOPD.Keywords: acute exacerbations, chronic obstructive pulmonary disease, randomized controlled trial, Chinese herbal medicine
