Journal Article

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

Wei, Kai, Zhou, Qingwei, Zhao, Zhengxiao, Zhang, Hongying, Miao, Qing, Dong, Jingcheng, Wang, Genfa, Jin, Hualiang, Du, Yijie, Wang, Gang, Liu, Baojun, Kong, Lingwen, Zhou, Xianmei, Lv, Yubao, Cao, Yuxue, Li, Bei, Luo, Qingli, Sun, Jing, Wu, Jinfeng

2014

Overview

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(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. 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.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: 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 / Traditional Chinese medicine / Transforming Growth Factor beta1 - blood / Transforming growth factor-b1 / Tumor Necrosis Factor-alpha - blood / Tumor necrosis factor-α