The effective evaluation on symptoms and quality of life of chronic obstructive pulmonary disease patients treated by comprehensive therapy based on traditional Chinese medicine patterns

Abstract

Objective: To evaluate the efficacy of comprehensive interventions based on the three TCM patterns on symptoms and quality of life of COPD patients.

Design: An open-label, randomized, controlled trial.

Setting: Four hospitals in China.

Intervention: 352 patients were randomly divided into two groups. Patients in the trial group were given conventional Western medicine and Bu-Fei Jian-Pi granules, Bu-Fei Yi-Shen granules and Yi-Qi Zi-Shen granules respectively; patients in the control group were given conventional Western medicine. Data collection was performed at baseline, in the 3rd and 6th month during the treatment period, and the 12th month during the follow-up period.

Outcomes: Symptoms, including cough, sputum, pant, chest tightness, short of breath, lassitude, cyanosis and symptom total score; quality of life, measured by the WHOQOL-BREF questionnaire and adult COPD quality of life questionnaire (COPD-QOL).

Results: Of the 352 patients, 306 fully completed the study. After treatment and follow-up, there were significant differences between two groups in the following: cough, sputum, pant, chest tightness, shortness of breath, lassitude score and symptom total score (P<.05); physical, psychological, social and environment domain (P<.05) of the WHOQOL-BREF; daily living ability, social activity, depression symptoms and anxiety symptoms domain (P<.05) of the COPD-QOL. There were no differences between two groups in cyanosis and adverse events.

Conclusion: Based on the TCM patterns, Bu-Fei Jian-Pi granules, Bu-Fei Yi-Shen granules and Yi-Qi Zi-Shen granules have beneficial effects on symptoms and quality of life of COPD patients.

Keywords: Bu-Fei Jian-Pi granules; Bu-Fei Yi-Shen granules; COPD; Chronic obstructive pulmonary disease; FAS; FEV1; FEV1 percentage of predicted value; FEV1%; FVC; PPS; QOL; Quality of life; TCM; Tradition Chinese medicine pattern; Yi-Qi Zi-Shen granules; chronic obstructive pulmonary disease; forced expiratory volume in one second; forced vital capacity; full analysis set; per-protocol analysis set; quality of life; traditional Chinese medicine.