RESUMO
<p><b>OBJECTIVE</b>To evaluate the efficacy of Bufei Yishen Granule BFYSG) combined with Shufei Tie acupoint sticking therapy on quality of life of patients with stable chronic obstructive pulmonary disease (COPD).</p><p><b>METHODS</b>A multi-center, double-blinded, double-dummy and randomized controlled method was adopted in this trial. A total of 244 patients were randomly assigned to a trial group and a control group according to the random number, each with 122 patients; treatment allocation occurred when the participants met the inclusion criteria and signed the informed consent form. In the trial group, patients were treated with BFYSG combined with "Shufei Tie" acupoint sticking therapy and sustained-release theophylline dummy, and in the control group patients were treated with oral sustained-release theophylline and BFYSG dummy combined with "Shufei Tie" acupoint sticking therapy dummy. The therapeutic course for two groups was 4 months and the follow-up was 6 months. The frequency and duration of acute exacerbation calculated by adding up each frequency and duration of acute exacerbation in treatment and follow-up time respectively, the quality of life measured by the World Health Organization Quality of Life (WHOQOL)-BREF scale and adult COPD quality of life (COPD-QOL) scale were observed.</p><p><b>RESULTS</b>Among the 244 enrolled patients, 234 were screened for full analysis set (FAS); 221 were screened for per-protocol analysis set (PPS). After 4-month treatment and 6-month follow-up there were differences between the trial group and the control group in frequency of acute exacerbation (FAS: P=0.013; PPS: P=0.046); duration of acute exacerbation (FAS: P=0.005; PPS: P=0.006); scores of physiological, psychological and environment aspects of the WHOQOL-BREF questionnaire (FAS: P=0.002, P=0.006, P=0.000; PPS: P=0.00, P=0.001, P=0.000); scores of daily living ability, social activity, depression symptoms aspects of the COPD-QOL questionnaire (FAS: P=0.000, P=0.000, P=0.006; PPS: P=0.002, P=0.001, P=0.001).</p><p><b>CONCLUSION</b>BFYSG combined with acupoint sticking therapy could improve the quality of life of patients with stable COPD.</p>