title: Effects of two Chinese herbal formulae for the treatment of moderate to severe stable chronic obstructive pulmonary disease: a multicenter, double-blind, randomized controlled trial.
abstract: OBJECTIVE
  The study aims to evaluate the efficacy and safety of two Chinese herbal formulae for the treatment of stable COPD.
  
  
  METHODS
  A multicenter, double-blind, double-dummy, and randomized controlled trial (RCT) was conducted. All groups were treated with additional conventional medicines. There were a 6-month treatment and a 12-month follow-up for 5 times. Primary outcomes included lung function test, exacerbation frequency, score of SGRQ. Second outcomes consisted of 6MWD, BODE index, psychological field score, inflammatory factors and cortisol.
  
  
  RESULTS
  A total of 331 patients were randomly divided into two active treatment groups (Bushen Yiqi (BY) granule group, n = 109; Bushen Fangchuan (BF) tablet group, n = 109) and a placebo group (n = 113). Finally 262 patients completed the study. BY granule & BF tablet increased the values of VC, FEV1 (%) and FEV1/FVC (%), compared with placebo. BY granule improved PEF. Both treatments reduced acute exacerbation frequency (P = 0.067), BODE index and psychological field score, while improved 6MWD. In terms of descent rang of SGRQ score, both treatments increased (P = 0.01). Both treatments decreased inflammatory cytokines, such as IL-8, and IL-17(P = 0.0219). BY granule obviously descended IL-17(P<0.05), IL-1β (P = 0.05), IL-6, compared with placebo. They improved the level of IL-10 and cortisol. BY granule raised cortisol (P = 0.07) and decreased TNF-α. Both treatments slightly descended TGF-β1. In terms of safety, subject compliance and drug combination, there were no differences (P>0.05) among three groups.
  
  
  CONCLUSIONS
  BY granule and BF tablet were positively effective for the treatment of COPD, and the former performed better in general.
  
  
  BACKGROUND
  Chinese Clinical Trial Register center ChiCTR-TRC-09000530.
authors.affiliation: Department of integrated traditional Chinese and western medicine, Huashan Hospital, Fudan University, Shanghai, PR China; Institute of integrated traditional Chinese and western medicine of Fudan University, Shanghai, PR China.
authors.forename: Genfa
authors.initials: G
authors.lastname: Wang
authors.affiliation: Department of integrated traditional Chinese and western medicine, Huashan Hospital, Fudan University, Shanghai, PR China; Institute of integrated traditional Chinese and western medicine of Fudan University, Shanghai, PR China.
authors.forename: Baojun
authors.initials: B
authors.lastname: Liu
authors.affiliation: Department of integrated traditional Chinese and western medicine, Huashan Hospital, Fudan University, Shanghai, PR China; Institute of integrated traditional Chinese and western medicine of Fudan University, Shanghai, PR China.
authors.forename: Yuxue
authors.initials: Y
authors.lastname: Cao
authors.affiliation: Department of integrated traditional Chinese and western medicine, Huashan Hospital, Fudan University, Shanghai, PR China; Institute of integrated traditional Chinese and western medicine of Fudan University, Shanghai, PR China.
authors.forename: Yijie
authors.initials: Y
authors.lastname: Du
authors.affiliation: Department of integrated traditional Chinese and western medicine, Huashan Hospital, Fudan University, Shanghai, PR China; Institute of integrated traditional Chinese and western medicine of Fudan University, Shanghai, PR China.
authors.forename: Hongying
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Department of integrated traditional Chinese and western medicine, Huashan Hospital, Fudan University, Shanghai, PR China; Institute of integrated traditional Chinese and western medicine of Fudan University, Shanghai, PR China.
authors.forename: Qingli
authors.initials: Q
authors.lastname: Luo
authors.affiliation: Department of integrated traditional Chinese and western medicine, Huashan Hospital, Fudan University, Shanghai, PR China; Institute of integrated traditional Chinese and western medicine of Fudan University, Shanghai, PR China.
authors.forename: Bei
authors.initials: B
authors.lastname: Li
authors.affiliation: Department of integrated traditional Chinese and western medicine, Huashan Hospital, Fudan University, Shanghai, PR China; Institute of integrated traditional Chinese and western medicine of Fudan University, Shanghai, PR China.
authors.forename: Jinfeng
authors.initials: J
authors.lastname: Wu
authors.affiliation: Department of integrated traditional Chinese and western medicine, Huashan Hospital, Fudan University, Shanghai, PR China; Institute of integrated traditional Chinese and western medicine of Fudan University, Shanghai, PR China.
authors.forename: Yubao
authors.initials: Y
authors.lastname: Lv
authors.affiliation: Department of integrated traditional Chinese and western medicine, Huashan Hospital, Fudan University, Shanghai, PR China; Institute of integrated traditional Chinese and western medicine of Fudan University, Shanghai, PR China.
authors.forename: Jing
authors.initials: J
authors.lastname: Sun
authors.affiliation: Department of integrated traditional Chinese and western medicine, Huashan Hospital, Fudan University, Shanghai, PR China; Institute of integrated traditional Chinese and western medicine of Fudan University, Shanghai, PR China.
authors.forename: Hualiang
authors.initials: H
authors.lastname: Jin
authors.affiliation: Department of integrated traditional Chinese and western medicine, Huashan Hospital, Fudan University, Shanghai, PR China; Institute of integrated traditional Chinese and western medicine of Fudan University, Shanghai, PR China.
authors.forename: Kai
authors.initials: K
authors.lastname: Wei
authors.affiliation: Department of integrated traditional Chinese and western medicine, Huashan Hospital, Fudan University, Shanghai, PR China; Institute of integrated traditional Chinese and western medicine of Fudan University, Shanghai, PR China.
authors.forename: Zhengxiao
authors.initials: Z
authors.lastname: Zhao
authors.affiliation: Department of integrated traditional Chinese and western medicine, Huashan Hospital, Fudan University, Shanghai, PR China; Institute of integrated traditional Chinese and western medicine of Fudan University, Shanghai, PR China.
authors.forename: Lingwen
authors.initials: L
authors.lastname: Kong
authors.affiliation: Respiratory Department, Jiangsu Province Hospital of TCM, Nanjing University of TCM, Nanjing, PR China.
authors.forename: Xianmei
authors.initials: X
authors.lastname: Zhou
authors.affiliation: Respiratory Department, Xiyuan Hospital CACMS, Beijing, PR China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Miao
authors.affiliation: Respiratory Department, West China Hospital, Sichuan University, Chengdu, PR China.
authors.forename: Gang
authors.initials: G
authors.lastname: Wang
authors.affiliation: Respiratory Department, the First Hospital Affiliated to Henan University of TCM, Zhengzhou, PR China.
authors.forename: Qingwei
authors.initials: Q
authors.lastname: Zhou
authors.affiliation: Department of integrated traditional Chinese and western medicine, Huashan Hospital, Fudan University, Shanghai, PR China; Institute of integrated traditional Chinese and western medicine of Fudan University, Shanghai, PR China.
authors.forename: Jingcheng
authors.initials: J
authors.lastname: Dong
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D016753:Interleukin-10 / Q000097:blood; D020381:Interleukin-17 / Q000097:blood; D015850:Interleukin-6 / Q000097:blood; D016209:Interleukin-8 / Q000097:blood; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D012129:Respiratory Function Tests; D053773:Transforming Growth Factor beta1 / Q000097:blood; D014409:Tumor Necrosis Factor-alpha / Q000097:blood
chemical_list: D004365:Drugs, Chinese Herbal; D020381:Interleukin-17; D015850:Interleukin-6; D016209:Interleukin-8; D053773:Transforming Growth Factor beta1; D014409:Tumor Necrosis Factor-alpha; D016753:Interleukin-10