Abstract
BackgroundTraditional Chinese medicine (TCM) has been used to treat chronic obstructive pulmonary disease (COPD) for many years. This study aimed to evaluate the efficacy and safety of the comprehensive therapy based on the three common TCM patterns in stable COPD patients.MethodsA four-center, open-label randomized controlled method was conducted. A total of 352 patients were divided into the trial group (n = 176, treated with conventional Western medicine and Bu-Fei Jian-Pi granules, Bu-Fei Yi-Shen granules, and Yi-Qi Zi-Shen granules based on the TCM patterns respectively) and the control group (n = 176, treated with conventional Western medicine). The frequency and duration of acute exacerbation, lung function, clinical symptoms, 6-minute walking distance (6MWD), dyspnea scale and quality of life were observed during a 6-month treatment period and at a further 12-month follow-up.ResultsA total of 306 patients completed the study fully. The full analysis set (FAS) population was 350 and the per-protocol analysis set (PPS) population was 306. After the 6-month treatment and 12-month follow-up, there were significant differences between the trial and control group in the following: frequency of acute exacerbation (FAS: P = 0.000; PPS: P = 0.000); duration of acute exacerbation (FAS: P = 0.000; PPS: P = 0.001); FEV1 (FAS: P = 0.007; PPS: P = 0.008); symptoms (FAS: P = 0.001; PPS: P = 0.001); 6MWD (FAS: P = 0.045; PPS: P = 0.042); dyspnea scale (FAS: P = 0.002; PPS: P = 0.004); and physical domain (FAS: P = 0.000; PPS: P = 0.000), psychological domain (FAS: P = 0.008; PPS: P = 0.011), social domain (FAS: P = 0.001; PPS: P = 0.000) and environment domain (FAS: P = 0.015; PPS: P = 0.009) of the WHOQOL-BREF questionnaire. There were no differences between the trial and control group in FVC, FEV1% and adverse events.ConclusionsBased on the TCM patterns, Bu-Fei Jian-Pi granules, Bu-Fei Yi-Shen granules and Yi-Qi Zi-Shen granules have beneficial effects on measured outcomes in stable COPD patients over the 6-month treatment and 12-month follow-up, with no relevant between-group differences in adverse events.Trial RegistrationThis trial was registered at Chinese Clinical Trial Register Center, ChiCTR-TRC-11001406.
Highlights
Traditional Chinese medicine (TCM) has been used to treat chronic obstructive pulmonary disease (COPD) for many years
Traditional Chinese medicine pattern criteria The TCM pattern criteria of stable COPD were established by literature analysis, clinical investigation, expert counseling, scientific assessment and clinical application [9,12]
Inclusion criteria Patients were included in the study according to the following: (1) patients met the diagnostic criteria; (2) patients met the TCM pattern criteria of stable COPD (TCM diagnosis); (3) patients were stable and met the diagnosis of mild to severe COPD (Global Initiative for Chronic Obstructive Lung Disease, GOLD 1,2,3); (4) patients were aged between 40 to 80 years; (5) patients underwent a twoweek wash-out period prior to randomization; (6) patients had no experience in other interventional trials in the previous 1 month; and (7) patients should receive the treatment voluntarily and sign informed consent
Summary
Traditional Chinese medicine (TCM) has been used to treat chronic obstructive pulmonary disease (COPD) for many years. This study aimed to evaluate the efficacy and safety of the comprehensive therapy based on the three common TCM patterns in stable COPD patients. Chronic obstructive pulmonary disease (COPD) is a major public health problem throughout the world. The high prevalence, morbidity, mortality and economic burdens of COPD are increasing steadily. The projection for 2020 indicates that COPD will become the third leading cause of death worldwide [1]. Designing strategies and treatments for COPD is important. In light of evidence-based medicine, short-acting bronchodilators, long-acting bronchodilators, inhaled glucocorticosteroids, and low-dose, slow-release theophylline are the established interventions for treating COPD patients [3]. It is difficult to improve people’s symptoms without suffering too many side effects or adverse events [4]
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