Randomized, double-blind, placebo-controlled superiority trial of the Yiqigubiao pill for the treatment of patients with chronic obstructive pulmonary disease at a stable stage

Li,Feng‑Sen; Zhang,Yan‑Li; Li,Zheng; Xu,Dan; Liao,Chun‑Yan; Ma,Huan; Gong,Li; Su,Jun; Sun,Qi; Xu,Qian; Gao,Zhen; Wang,Ling; Jing,Jing; Wang,Jing; Jiang,Min; Tian,Ge; Hasan,Bilal

doi:10.3892/etm.2016.3680

Randomized, double-blind, placebo-controlled superiority trial of the Yiqigubiao pill for the treatment of patients with chronic obstructive pulmonary disease at a stable stage

Authors:
- Feng‑Sen Li
- Yan‑Li Zhang
- Zheng Li
- Dan Xu
- Chun‑Yan Liao
- Huan Ma
- Li Gong
- Jun Su
- Qi Sun
- Qian Xu
- Zhen Gao
- Ling Wang
- Jing Jing
- Jing Wang
- Min Jiang
- Ge Tian
- Bilal Hasan
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Affiliations: Department of Integrated Pulmonology, Traditional Chinese Medicine Hospital Affiliated with Xinjiang Medical University, Ürümqi, Xinjiang 830000, P.R. China, National Clinical Research Base of Traditional Chinese Medicine, Traditional Chinese Medicine Hospital Affiliated with Xinjiang Medical University, Ürümqi, Xinjiang 830000, P.R. China, Department of Geriatric Medicine, Traditional Chinese Medicine Hospital Affiliated with Xinjiang Medical University, Ürümqi, Xinjiang 830000, P.R. China, Medical Research Design and Data Analysis Center, Traditional Chinese Medicine Hospital Affiliated with Xinjiang Medical University, Ürümqi, Xinjiang 830000, P.R. China, Xinjiang Laboratory of Respiratory Disease Research, Traditional Chinese Medicine Hospital Affiliated with Xinjiang Medical University, Ürümqi, Xinjiang 830000, P.R. China
Published online on: September 6, 2016 https://doi.org/10.3892/etm.2016.3680
Pages: 2477-2488

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Abstract

In traditional Chinese medicine (TCM), the Yiqigubiao pill is commonly used to enhance physical fitness. The current clinical trial was designed to evaluate the efficacy and safety of the Yiqigubiao pill as an adjuvant therapy for patients with stable chronic obstructive pulmonary disease (COPD). The current trial was a randomized, double‑blind, placebo‑controlled superiority trial. The participants were recruited from outpatients at the Traditional Chinese Medicine Hospital affiliated with Xinjiang Medical University (Ürümqi, China) between February and September 2012. All participants were patients with stable COPD that were randomized to the Yiqigubiao pill (YQGB; n=84) or placebo (Pb; n=87) groups. The occurrences of acute exacerbation (AE) of COPD during the trial were recorded. Lung function value assessments, scoring of life quality and exercise endurance, arterial blood gas analysis and serum inflammatory cytokines level determination were performed prior to and throughout the study. A total of 139 participants completed the intervention and 132 participants completed the study. The interval between the initial intervention and the first AECOPD was greater in the YQGB group compared with the Pb group (P<0.01). The incidence rate of AECOPD was lower in the YQGB group than in the Pb group (P<0.01). Subsequent to the intervention or at the end of the study, the 6‑min walking distance difference was longer in the YQGB group compared with the Pb group (P<0.01). The scores reflecting life quality decline became lower in the YQGB group (P<0.01). The serum levels of proinflammatory factors were downregulated to a greater extent in the YQGB group compared with the Pb group. Thus, the Yiqigubiao pill is an efficient and safe adjuvant therapy for the treatment of stable patients with COPD.

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