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

• Published in: PloS one 2014-08, Vol.9 (8), p.e103168
• Main Authors: Wang, Genfa, Liu, Baojun, Cao, Yuxue, Du, Yijie, Zhang, Hongying, Luo, Qingli, Li, Bei, Wu, Jinfeng, Lv, Yubao, Sun, Jing, Jin, Hualiang, Wei, Kai, Zhao, Zhengxiao, Kong, Lingwen, Zhou, Xianmei, Miao, Qing, Wang, Gang, Zhou, Qingwei, Dong, Jingcheng
• Format: Article
• Language: English
• Subjects: Acupuncture; Adult; Aged; Analysis; Care and treatment; Chinese medicine; Chronic obstructive lung disease; Chronic obstructive pulmonary disease; Clinical trials; Cytokines; Disease control; Double-Blind Method; Double-blind studies; Drugs, Chinese Herbal - administration & dosage; Drugs, Chinese Herbal - therapeutic use; Female; Granular materials; Herbal medicine; Humans; Hydrocortisone; Inflammation; Interleukin 10; Interleukin 17; Interleukin 6; Interleukin 8; Interleukin-10 - blood; Interleukin-17 - blood; Interleukin-6 - blood; Interleukin-8 - blood; Kinases; Lung diseases; Male; Medical services; Medicine and Health Sciences; Medicine, Chinese Traditional; Middle Aged; Obstructive lung disease; Patients; Pulmonary Disease, Chronic Obstructive - blood; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - pathology; Randomization; Research and Analysis Methods; Respiratory function; Respiratory Function Tests; Respiratory system agents; Safety; Systematic review; Transforming Growth Factor beta1 - blood; Transforming growth factor-b1; Tumor Necrosis Factor-alpha - blood; Tumor necrosis factor-α
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0103168

The study aims to evaluate the efficacy and safety of two Chinese herbal formulae for the treatment of stable COPD. 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. 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(P0.05) among three groups. BY granule and BF tablet were positively effective for the treatment of COPD, and the former performed better in general. Chinese Clinical Trial Register center ChiCTR-TRC-09000530.