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Journal of Chinese Integrative Medicine ›› 2011, Vol. 9 ›› Issue (12): 1312-1318.doi: 10.3736/jcim20111206

• Study Protocol • Previous Articles     Next Articles

Bufei Yishen Granule combined with acupoint-sticking therapy in patients with stable chronic obstructive pulmonary disease: Study protocol of a multicenter, randomized, double-blind, active-controlled trial

Jian-sheng Li1,2(), Su-yun Li, Xue-qing Yu2, Yang Xie1   

  1. 1. Institute of Geriatrics, Henan University of Traditional Chinese Medicine, Zhengzhou 450008, Henan Province, China
    2. Department of Respiratory Diseases, the First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, Henan Province, China
  • Received:2011-08-20 Accepted:2011-08-30 Online:2011-12-20 Published:2011-12-15

Background: Chronic obstructive pulmonary disease (COPD) is a serious disease constituting a major threat to public health. Current popularity of traditional Chinese medicine (TCM) in treating COPD implies its potential advantage in improving symptoms, reducing the frequency of acute exacerbation and improving the patients' quality of life. This study is to evaluate the efficacy and safety of a comprehensive intervention, Bufei Yishen Granule combined with acupoint-sticking therapy, in patients with stable COPD.
Methods and design: A multicenter, double-blind, double-dummy and randomized controlled design will be adopted. A total of 244 cases meeting the inclusion criteria will be enrolled into this study with 122 cases in the trial group and 122 in the control group, respectively. Patients in the trial group will receive Bufei Yishen Granule combined with acupoint-sticking therapy and dummy sustained-release theophylline, while patients in the control group will receive sustained-release theophylline and dummy Bufei Yishen Granule combined with dummy acupoint-sticking therapy. The frequency and duration of acute exacerbation, lung function, clinical symptoms, six-minute walking distance, dyspnea grade and quality of life will be observed during a four-month treatment period and a further six-month follow-up.
Discussion: It is hypothesized that Bufei Yishen Granule combined with acupoint-sticking therapy will have beneficial effects in reducing the frequency and duration of acute exacerbation, ameliorating the symptoms, and improving the quality of life of patients with stable COPD. The results of this study will provide evidence for developing a TCM-based regimen for patients with COPD. 

Trial registration: ChiCTR-TRC-11001409.

Key words: pulmonary disease, chronic obstructive, traditional Chinese medicine therapy, acupoint sticking therapy, clinical trial, clinical protocols

Figure 1

Procedure of this study"

[1] Zhong N, Wang C, Yao W, Chen P, Kang J, Huang S, Chen B, Wang C, Ni D, Zhou Y, Liu S, Wang X, Wang D, Lu J, Zheng J, Ran P . Prevalence of chronic obstructive pulmonary disease in China: a large, population- based survey[J]. Am Respir Crit Care Med. 2007 ; 176(8):753-760.
doi: 10.1164/rccm.200612-1749OC
[2] Lin HH, Murray M, Cohen T, Colijn C, Ezzati M . Effects of smoking and solid-fuel use on COPD, lung cancer, and tuberculosis in China: a time-based, multiple risk factor, modelling study. Lancet. 2008; 372(9648):1473-1483.
doi: 10.1016/S0140-6736(08)61345-8
[3] Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Yates JC, Vestbo J; TORCH investigators. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease[J]. N Engl Med. 2007; 356(8):775-789.
doi: 10.1056/NEJMoa063070
[4] Li JS, Wang ZW, Yu XQ, Wang MH, Li SY . Clinical efficacy and safety of TCM for COPD at stable phase : a systematic review. Liaoning Zhong Yi Za Zhi. 2010; 37 (2) : 229-232. Chinese with abstract in English.
李建生, 王至婉, 余学庆, 王明航, 李素云 . 中药治疗慢性阻塞性肺疾病稳定期的系统评价.辽宁中医杂志. 2010; 37(2) : 229-232.
[5] Li JS, Wang ZW, Yu XQ, Wang MH, Li SY . Systemic evaluation of TCM for COPD in the acute stage of exacerbation. Tianjin Zhong Yi Yao. 2008; 25(5): 428-432. Chinese with abstract in English.
李建生, 王至婉, 余学庆, 王明航, 李素云 . 中药治疗 COPD急性加重期的系统评价.天津中医药. 2008; 25(5):428-432.
[6] Li SY, Zhou QW, Wang MH, Wang HF, Wu JZ . Effect of Bufei Yishen granule on pulmonary ventilation function and immunological function of patients with chronic obstructive pulmonary disease in remission phase : a randomized grouping and placebo controlled study. Zhongguo Lin Chuang Kang Fu. 2006; 10(7): 145-147. English with abstract in Chinese.
李素云, 周庆伟, 王明航, 王海峰, 吴纪珍 . 以补肺益肾法复方制剂调节慢性阻塞性肺疾病缓解期患者肺通气及免疫功能:随机分组安慰剂对照.中国临床康复. 2006; 10(7) : 145-147.
[7] Li SY, Li JS, Yu XQ, Zhou QW, Wang XY . Clinical observation of Shu-Fei Tie acupoint-sticking therapy in the treatment of patients with chronic obstructive pulmonary disease. Shannxi Zhong Yi. 2009 ; 30 (4): 391-392. Chinese.
李素云, 李建生, 余学庆, 周庆伟, 王湘雨 . 舒肺贴治疗慢性阻塞性肺疾病疗效观察.陕西中医. 2009; 30(4):391-392.
[8] Pauwels RA, Buist AS, Calverley PM, Jenkins CR, Hurd SS; GOLD Scientific Committee . Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary. Am J Respir Crit Care Med. 2001; 163(5):1256-1276.
doi: 10.1164/ajrccm.163.5.2101039
[9] COPD Group of Chinese Society of Respiratory Diseases. Guidelines for the diagnosis and treatment of chronic obstructive pulmonary disease ( 2007 revised edition). Zhonghua Jie He He Hu Xi Za Zhi. 2007 ; 30(1) : 8-17. Chinese.
中华医学会呼吸病学分会慢性阻塞性肺疾病学组. 慢性阻塞性肺疾病诊治指南( 2007年修订版).中华结核和呼吸杂志. 2007; 30(1):8-17.
[10] Wang ZW, Li JS, Yu XQ, Wang MH, Li SY . Symptom diagnosis criteria for chronic obstructive pulmonary diseases at stationary phase based on literature. Zhong Yi Yan Jiu. 2008; 21(8): 55-58. Chinese.
王至婉, 李建生, 余学庆, 王明航, 李素云 . 基于文献的慢性阻塞性肺疾病稳定期证候诊断标准研究.中医研究. 2008; 21(8) : 55-58.
[11] Zhou Y, Wang X, Zeng X, Qiu R, Xie J, Liu S, Zheng J, Zhong N, Ran P . Positive benefits of theophylline in a randomized, double-blind, parallel-group, placebo- controlled study of low-dose, slow-release theophylline in the treatment of COPD for 1 year. Respirology. 2006; 11(5) : 603-610.
doi: 10.1111/res.2006.11.issue-5
[12] Fletcher CM, Elmes PC, Fairbairn MB, Wood CH . The significance of respiratory symptoms and the diagnosis of chronic bronchitis in a working population. Br Med J. 1959; 2(5147):257-266.
doi: 10.1136/bmj.2.5147.257
[13] Mahler DA, Wells CK . Evaluation of clinical methods for rating dyspnea. Chest. 1988; 93(3):580-586.
doi: 10.1378/chest.93.3.580
[14] World Health Organization. The World Health Organization Quality of Life (WHOQOL)-BREF. Geneva: World Health Organization. 2004.
[15] Cai YY, Li ZZ, Fang ZJ . Evaluation of the quality of life of chronic obstructive pulmonary disease patients. Zhonghua Quan Ke Yi Shi Za Zhi. 2004; 3(4): 225-227. Chinese.
蔡映云, 李倬哲, 方宗君 . 慢性阻塞性肺疾病患者生存质量评估.中华全科医师杂志. 2004; 3(4):225-227.
[16] ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement : guidelines for the six-minute walk test[J]. Am Respir Crit Care Med. 2002; 166(1):111-117.
doi: 10.1164/ajrccm.166.1.at1102
[17] Zhang WJ, Zhang YP . Recent research progress in traditional Chinese medicine treatment of chronic obstructive pulmonary disease. Beijing Zhong Yi Yao Da Xue Xue Bao Zhong Yi Lin Chuang Ban. 2007 ; 14(5) : 39-41. Chinese.
doi: 10.3969/j.issn.1672-2205.2007.05.015
张文江, 张燕萍 . 中医药防治慢性阻塞性肺疾病研究近况. 北京中医药大学学报(中医临床版). 2007; 14(5):39-41.
doi: 10.3969/j.issn.1672-2205.2007.05.015
[18] Molfino NA, Zhang P . A meta-analysis on the efficacy of oral theophylline in patients with stable COPD[J]. Int Chron Obstruct Pulmon Dis. 2006; 1(3):261-266.
doi: 10.2147/copd.2006.1.3.261 pmid: 2707158
[19] Li JS, Wang MH, Li SY . Appraisal investigating progress of chronic obstructive pulmonary dyspnea. Henan Zhong Yi Xue Yuan Xue Bao. 2007 ; 22(2) : 79-82. Chinese.
doi: 10.3969/j.issn.1674-8999.2007.02.050
李建生, 王明航, 李素云 . 慢性阻塞性肺疾病呼吸困难的评估研究进展.河南中医学院学报. 2007; 22(2):79-82.
doi: 10.3969/j.issn.1674-8999.2007.02.050
[20] Montes de Oca M, Torres SH, Gonzalez Y, Romero E, Hernandez N, Talamo C . Changes in exercise tolerance, health related quality of life, and peripheral muscle characteristics of chronic obstructive pulmonary disease patients after 6 weeks’ training. Arch Bronconeumol. 2005; 41(8) : 413-418.
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