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Open Access Research article

Effects of comprehensive therapy based on traditional Chinese medicine patterns in stable chronic obstructive pulmonary disease: a four-center, open-label, randomized, controlled study

Su-yun Li1, Jian-sheng Li12*, Ming-hang Wang1, Yang Xie2, Xue-qing Yu1, Zi-kai Sun3, Li-jun Ma4, Wei Zhang5, Hai-long Zhang2, Fan Cao2 and Ying-chao Pan2

Author affiliations

1 Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, No. 19 Renmin Road, Zhengzhou, PR China

2 The Geriatric Department, Henan University of Traditional Chinese Medicine, No. 1 Jinshui Road, Zhengzhou, PR China

3 Department of Respiratory Diseases, Jiangsu Provincial Hospital of Traditional Chinese Medicine, No. 155 Hanzhong Road, Nanjing, PR China

4 Department of Respiratory Diseases, Henan Provincial People’s Hospital, No. 5 Weiwu Road, Zhengzhou, PR China

5 Department of Respiratory Diseases, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, No. 42 Wenhua West Road, Jinan, PR China

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Citation and License

BMC Complementary and Alternative Medicine 2012, 12:197  doi:10.1186/1472-6882-12-197

Published: 29 October 2012

Abstract

Background

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.

Methods

A 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.

Results

A 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.

Conclusions

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 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 Registration

This trial was registered at Chinese Clinical Trial Register Center, ChiCTR-TRC-11001406.

Keywords:
Chronic obstructive pulmonary disease; Traditional Chinese medicine pattern; Clinical trial; Bu-Fei Jian-Pi granules; Bu-Fei Yi-Shen granules; Yi-Qi Zi-Shen granules