Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable chronic obstructive pulmonary disease: a randomized, double-blind, double-dummy, active-controlled, 4-center study.

ETHNOPHARMACOLOGICAL RELEVANCE: Bu-Fei Yi-Shen granule combined with acupoint sticking therapy has been used in the patients with stable chronic obstructive pulmonary disease (COPD) as major traditional interventions for the treatment of the disease. AIM OF THE STUDY: The objective of this study was to evaluate the efficacy and safety of traditional Chinese herbal medicine, the Bu-Fei Yi-Shen granule combined with acupoint sticking therapy in patients with stable COPD. METHODS: A 4-center, double-blinded, double-dummy and randomized controlled method was conducted. 244 patients who were divided into the trial group (n=122, treated with Bu-Fei Yi-Shen granule combined with Shu-Fei Tie acupoint sticking therapy and oral placebo sustained-release theophylline) and the control group (n=122, treated with oral sustained-release theophylline and placebo Bu-Fei Yi-Shen granule combined with placebo Shu-Fei Tie acupoint sticking therapy). The frequency and duration of acute exacerbation, lung function, clinical symptoms, six-minute walking distance, dyspnea grade and quality of life were observed during the 4-month treatment period, and for a further 6 months follow-up. RESULTS: Two hundred and twenty one patients fully completed the study, intent-to-treat (ITT) population was 234 and per-protocol (PP) population was 221. After treatment for 4 months and follow-up for 6 months, there were differences between the experimental and control group in frequency of acute exacerbation (ITT: P=0.007, P=0.013; PP: P=0.045, P=0.046); duration of acute exacerbation (ITT: P=0.030, P=0.005; PP: P=0.048, P=0.006); scores of symptoms (ITT: P=0.000, P=0.000; PP: P=0.000, P=0.000); six-minute walking distance (ITT: P=0.002, P=0.001; PP: P=0.002, P=0.001); dyspnea grade (ITT: P=0.014, P=0.009; PP: P=0.018, P=0.012); physiological aspects (ITT: P=0.003, P=0.000; PP: P=0.001, P=0.000); psychological aspects (ITT: P=0.007, P=0.001; PP: P=0.001, P=0.000) and environment aspects (ITT: P=0.003, P=0.000; PP: P=0.001, P=0.000) of the WHOQOL-BREF questionnaire. There were no differences between the experimental and control group in FVC, FEV1 and FEV1% and adverse events. CONCLUSIONS: Bu-Fei Yi-Shen granule combined with acupoint sticking therapy showed beneficial effects for patients with stable COPD in the measured parameters over the 4-month treatment period and 6 months follow-up, with no relevant between-group differences in adverse events.