Bufei Yishen Granule combined with acupoint-sticking therapy in patients with stable chronic obstructive pulmonary disease: study protocol of a multicenter, randomized, double-blind, active-controlled trial

Abstract

Chronic obstructive pulmonary disease (COPD) is a serious disease constituting a major threat to public health. Current popularity of traditional Chinese medicine (TCM) in treating COPD implies its potential advantage in improving symptoms, reducing the frequency of acute exacerbation and improving the patients' quality of life. This study is to evaluate the efficacy and safety of a comprehensive intervention, Bufei Yishen Granule combined with acupoint-sticking therapy, in patients with stable COPD. A multicenter, double-blind, double-dummy and randomized controlled design will be adopted. A total of 244 cases meeting the inclusion criteria will be enrolled into this study with 122 cases in the trial group and 122 in the control group, respectively. Patients in the trial group will receive Bufei Yishen Granule combined with acupoint-sticking therapy and dummy sustained-release theophylline, while patients in the control group will receive sustained-release theophylline and dummy Bufei Yishen Granule combined with dummy acupoint-sticking therapy. The frequency and duration of acute exacerbation, lung function, clinical symptoms, six-minute walking distance, dyspnea grade and quality of life will be observed during a four-month treatment period and a further six-month follow-up. It is hypothesized that Bufei Yishen Granule combined with acupoint-sticking therapy will have beneficial effects in reducing the frequency and duration of acute exacerbation, ameliorating the symptoms, and improving the quality of life of patients with stable COPD. The results of this study will provide evidence for developing a TCM-based regimen for patients with COPD. ChiCTR-TRC-11001409.