title: Effect of sequential treatment with TCM syndrome differentiation on acute exacerbation of chronic obstructive pulmonary disease and AECOPD risk window.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of the comprehensive interventions based on three Traditional Chinese medicine (TCM) patterns therapy in acute exacerbations of chronic obstructive pulmonary disease (AECOPD) and AECOPD risk window.
  
  
  METHODS
  A prospective, multi-center, single-blinded, double-dummy and randomized controlled clinical trial is being conducted to test the therapeutic effects of a sequential two stage treatment. A total of 364 patients were enrolled into this study with 182 in each treatment group (TCM and conventional). Patients received medication (or control) according to their assigned group. TCM treatment according to syndrome differentiation for AECOPD were administered twice daily to patients with AECOPD over 7-21days, followed by TCM for AECOPD risk window (RW) over 28days. All patients were followed up for 6 months. Exacerbations were used as the primary outcome measures. Forced expiratory volume in the first second (FEV1) and the modified medical research council dyspnea (MMRC) scale, quality of life and mortality rate were used as secondary outcome measures.
  
  
  RESULTS
  Of 364 randomized patients, 353 were included in the intention-to-treat analysis and 290 in the per-protocol analysis. In the TCM group, 16 patients (10.4%) reached the primary end point; 24 (17.7%) in the conventional group (RR 0.59, 95% CI 0.33-1.06; p=0.074). Among patients with a re-exacerbation, the median time to event was 107.5days (interquartile range [IQR], 39.5-129.0) in the TCM and 50days (IQR, 31-130.5) in the conventional group (P=0.011). After exacerbation therapy and a further 180-days follow-up, patients in the TCM group had significant improvements in dyspnea, as measured by MMRC (P=0.003), Patients in the TCM group also had improvements in health-related quality of life (P=0.002), as measured COPD Assessment Test (CAT). There was no difference between groups in death, and recovery of lung function. There were no differences between the TCM and conventional treatment group in adverse events.
  
  
  CONCLUSIONS
  In patients presenting to the respiratory department with acute exacerbations of COPD, TCM treatments with syndrome differentiation will have beneficial effects with regard to re-exacerbation, relieving symptoms, improving quality of life for COPD patients.
authors.affiliation: Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, Henan Province, PR China; Institute of Geriatrics, Henan University of Traditional Chinese Medicine, Zhengzhou 450008, Henan Province, PR China. Electronic address: li_js8@163.com.
authors.forename: Li
authors.initials: L
authors.lastname: Jiansheng
authors.affiliation: Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, Henan Province, PR China.
authors.forename: Wang
authors.initials: W
authors.lastname: Haifeng
authors.affiliation: Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, Henan Province, PR China.
authors.forename: Li
authors.initials: L
authors.lastname: Suyun
authors.affiliation: Institute of Geriatrics, Henan University of Traditional Chinese Medicine, Zhengzhou 450008, Henan Province, PR China.
authors.forename: Zhang
authors.initials: Z
authors.lastname: Hailong
authors.affiliation: Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, Henan Province, PR China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Xueqing
authors.affiliation: TCM hospital of Xinjiang Uygur Autonomous Region, Urumqi 830000, Xinjiang Uygur Autonomous Region, PR China.
authors.forename: Zhang
authors.initials: Z
authors.lastname: Xiaoyun
authors.affiliation: Sichuan Province Traditional Chinese Medicine Hospital, Chengdu 610072, Sichuan Province, PR China.
authors.forename: Li
authors.initials: L
authors.lastname: Fengsen
authors.affiliation: Jiangsu province Hospital of Traditional Chinese Medicine, Nanjing 210029, Jiangsu Province, PR China.
authors.forename: Zhou
authors.initials: Z
authors.lastname: Xianmei
authors.affiliation: Jiangsu province Hospital of Traditional Chinese Medicine, Nanjing 210029, Jiangsu Province, PR China.
authors.forename: Sun
authors.initials: S
authors.lastname: Zikai
authors.affiliation: The First Affiliated Hospital of Henan University of Science & Technology, Luoyang 471000, Henan Province, PR China.
authors.forename: Mao
authors.initials: M
authors.lastname: Yimin
authors.affiliation: Henan Provincial peoples Hospital, Zhengzhou 450000, Henan Province, PR China.
authors.forename: Ma
authors.initials: M
authors.lastname: Lijun
authors.affiliation: Henan University Huaihe Hospital, Kaifeng 475000, Henan Province, PR China.
authors.forename: Zhang
authors.initials: Z
authors.lastname: Yijie
authors.affiliation: The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, Henan Province, PR China.
authors.forename: Zhang
authors.initials: Z
authors.lastname: Guojun
authors.affiliation: Henan Provincial chest hospital. Zhengzhou 450008, Henan Province, PR China.
authors.forename: Tang
authors.initials: T
authors.lastname: Bingxiang
mesh_terms: D000368:Aged; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008516:Medicine, Chinese Traditional / Q000379:methods; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D012306:Risk; D016037:Single-Blind Method
chemical_list: D004365:Drugs, Chinese Herbal
keywords: Chronic obstructive pulmonary disease; Clinical trial; Exacerbation; Tradition Chinese medicine