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.
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.
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.
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.