title: Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable chronic obstructive pulmonary disease: a randomized, double-blind, double-dummy, active-controlled, 4-center study.
abstract: BACKGROUND
  Bu-Fei Yi-Shen granule combined with acupoint sticking therapy has been used in the patients with stable chronic obstructive pulmonary disease (COPD) as major traditional interventions for the treatment of the disease.
  
  
  OBJECTIVE
  The objective of this study was to evaluate the efficacy and safety of traditional Chinese herbal medicine, the Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable COPD.
  
  
  METHODS
  A 4-center, double-blinded, double-dummy and randomized controlled method was conducted. 244 patients who were divided into the trial group (n=122, treated with Bu-Fei Yi-Shen granule combined with Shu-Fei Tie acupoint sticking therapy and oral placebo sustained-release theophylline) and the control group (n=122, treated with oral sustained-release theophylline and placebo Bu-Fei Yi-Shen granule combined with placebo Shu-Fei Tie acupoint sticking therapy). The frequency and duration of acute exacerbation, lung function, clinical symptoms, six-minute walking distance, dyspnea grade and quality of life were observed during the 4-month treatment period, and for a further 6 months follow-up.
  
  
  RESULTS
  Two hundred and twenty one patients fully completed the study, intent-to-treat (ITT) population was 234 and per-protocol (PP) population was 221. After treatment for 4 months and follow-up for 6 months, there were differences between the experimental and control group in frequency of acute exacerbation (ITT: P=0.007, P=0.013; PP: P=0.045, P=0.046); duration of acute exacerbation (ITT: P=0.030, P=0.005; PP: P=0.048, P=0.006); scores of symptoms (ITT: P=0.000, P=0.000; PP: P=0.000, P=0.000); six-minute walking distance (ITT: P=0.002, P=0.001; PP: P=0.002, P=0.001); dyspnea grade (ITT: P=0.014, P=0.009; PP: P=0.018, P=0.012); physiological aspects (ITT: P=0.003, P=0.000; PP: P=0.001, P=0.000); psychological aspects (ITT: P=0.007, P=0.001; PP: P=0.001, P=0.000) and environment aspects (ITT: P=0.003, P=0.000; PP: P=0.001, P=0.000) of the WHOQOL-BREF questionnaire. There were no differences between the experimental and control group in FVC, FEV1 and FEV1% and adverse events.
  
  
  CONCLUSIONS
  Bu-Fei Yi-Shen granule combined with acupoint sticking therapy showed beneficial effects for patients with stable COPD in the measured parameters over the 4-month treatment period and 6 months follow-up, with no relevant between-group differences in adverse events.
authors.affiliation: The Geriatric Department of Henan University of Traditional Chinese Medicine, Jinshui District, Zhengzhou, PR China. li_js8@163.com
authors.forename: Jian-Sheng
authors.initials: JS
authors.lastname: Li
authors.forename: Su-Yun
authors.initials: SY
authors.lastname: Li
authors.forename: Xue-Qing
authors.initials: XQ
authors.lastname: Yu
authors.forename: Yang
authors.initials: Y
authors.lastname: Xie
authors.forename: Ming-Hang
authors.initials: MH
authors.lastname: Wang
authors.forename: Ze-Geng
authors.initials: ZG
authors.lastname: Li
authors.forename: Nian-Zhi
authors.initials: NZ
authors.lastname: Zhang
authors.forename: Su-Ju
authors.initials: SJ
authors.lastname: Shao
authors.forename: Yi-Jie
authors.initials: YJ
authors.lastname: Zhang
authors.forename: Lin
authors.initials: L
authors.lastname: Zhu
authors.forename: Lian-Xiang
authors.initials: LX
authors.lastname: Guo
authors.forename: Yun-Ping
authors.initials: YP
authors.lastname: Bai
authors.forename: Yan-Fang
authors.initials: YF
authors.lastname: Wang
mesh_terms: D015669:Acupuncture Points; D015670:Acupuncture Therapy / Q000009:adverse effects; D000284:Administration, Oral; D000368:Aged; D001993:Bronchodilator Agents / Q000008:administration & dosage; D002681:China; D003131:Combined Modality Therapy; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D004417:Dyspnea / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D005080:Exercise Test; D017079:Exercise Tolerance / Q000187:drug effects; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D010946:Plants, Medicinal; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011788:Quality of Life; D019141:Respiratory System Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D013806:Theophylline / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome; D014797:Vital Capacity / Q000187:drug effects; D016138:Walking
chemical_list: D001993:Bronchodilator Agents; C574914:Bu-Fei-Yi-Shen; D003692:Delayed-Action Preparations; D004365:Drugs, Chinese Herbal; D019141:Respiratory System Agents; D013806:Theophylline