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

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.

Keywords: Yiqigubiao pill; chronic obstructive pulmonary disease; randomized controlled trial; stable stage; traditional Chinese medicine.

Figure 1.

Flow chart displaying the participation throughout the study process. YQGB, Yiqigubiao pill; Pb, placebo.

Figure 2.

Lung function and life quality score throughout the 6-month study. Lung function, 6MWD and CAT score were measured prior to the study (month 0) and throughout the study (once per month). (A) Lung function parameters FEV1/FVC, FEV1% and %FVC. Mean differences between each time point and month 0 were calculated. (B) 6MWD and CAT score. Average differencea between the result at each time point and month 0 are peesented. YQGB, Yiqigubiao pill; Pb, placebo; FEV1, forced expiratory volume in 1 sec; FVC, forced vital capacity; 6MWD, 6-min walking distance; CAT, chronic obstructive pulmonary disease assessment test.