Effect of traditional Chinese medicine on outcomes in patients with mild/moderate chronic obstructive pulmonary disease: study protocol for a randomized placebo-controlled trial

Minghang Wang, Jiansheng Li, Suyun Li, Haifeng Wang, Xueqing Yu, Hailong Zhang, Minghang Wang, Jiansheng Li, Suyun Li, Haifeng Wang, Xueqing Yu, Hailong Zhang

Abstract

Background: Chronic obstructive pulmonary disease (COPD) has become a major public health problem worldwide because of its high and increasing prevalence, morbidity, and mortality. Little attention has been paid to earlier stages of COPD or before it has developed. Reportedly, TCM may have some advantages in relieving symptoms and reducing the incidence of COPD exacerbations. We postulate that patients with COPD will benefit from therapy with TCM treatment according to syndrome differentiation.

Methods and design: A prospective, multi-center, double-blinded and randomized controlled method will be used to test the therapeutic effects of TCM treatment according to syndrome differentiation. A total of 504 patients will be enrolled into this study with 252 in each treatment group. Patients will receive medication according to their assigned group. TCM for COPD will be administered twice daily over 52 weeks, and all patients will follow the treatment program for 52 weeks. The FEV(1) and exacerbations will be used as the primary outcome measures. The quality of life and the Modified Medical Research Council (MMRC) Dyspnea Scale, and the 6-min walk test (6MWD) will be used as the secondary outcome measures.

Discussion: We postulate that patients with COPD will benefit from therapy with TCM treatment according to syndrome differentiation.

Trial registration: This study is registered at ClinicalTrials.gov, NCT01486186.

References

    1. Sin DD, Stafinski T, Ng YC, Bell NR, Jacobs P. The impact of chronic obstructive pulmonary disease on work loss in the United States. Am J Respir Crit Care Med. 2002;165:704–707.
    1. Lopez AD, Shibuya K, Rao C. et al.Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J. 2006;27:397–412. doi: 10.1183/09031936.06.00025805.
    1. Buist AS, McBurnie MA, Vollmer WM. et al.International variation in the prevalence of COPD (the BOLD Study): a population-based prevalence study. Lancet. 2007;370:741–750. doi: 10.1016/S0140-6736(07)61377-4.
    1. Zhong N, Wang C, Yao W. et al.Prevalence of chronic obstructive pulmonary disease in China: a large, population-based survey. Am J Respir Crit Care Med. 2007;176:753–760. doi: 10.1164/rccm.200612-1749OC.
    1. Chan-Yeung M, Ait-Khaled N, White N, Ip MS, Tan WC. The burden and impact of COPD in Asia and Africa. Int J Tuberc Lung Dis. 2004;8:2–14.
    1. Scanlon PD, Connett JE, Waller LA, Altose MD, Bailey WC, Buist AS. Smoking cessation and lung function in mild-to-moderate chronic obstructive pulmonary disease. The Lung Health Study. Am J Respir Crit Care Med. 2000;161:381–390.
    1. Nonoyama ML, Brooks D, Guyatt GH, Goldstein RS. Effect of oxygen on health quality of life in patients with chronic obstructive pulmonary disease with transient exertional hypoxemia. Am J Respir Crit Care Med. 2007;176:343–349. doi: 10.1164/rccm.200702-308OC.
    1. Tashkin DP, Celli B, Senn S. et al.A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008;359:1543–1554. doi: 10.1056/NEJMoa0805800.
    1. Calverley PM, Anderson JA, Celli B. et al.Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007;356:775–789. doi: 10.1056/NEJMoa063070.
    1. Mao B, Li W, Liang WQ. Visceral syndrome differentiation in traditional Chinese medicine and the changes of nutrition status or blood gas analysis in patients with chronic obstructive pulmonary disease. Zhong Xi Yi Jie He Xue Bao. 2007;5:506–509. doi: 10.3736/jcim20070505.
    1. Pang HQ, Xiong XD. Treatment of respiratory failure in patients with chronic obstructive pulmonary disease with traditional Chinese medicine. Zhong Xi Yi Jie He Xue Bao. 2005;3:66–69. doi: 10.3736/jcim20050121.
    1. Moher D, Hopewell S, Schulz KF. et al.CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. doi: 10.1136/bmj.c869.
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152:726–732.
    1. Jones PW, Harding G, Berry P, Wiklund I, Chen WH. Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009;34:648–654. doi: 10.1183/09031936.00102509.
    1. Mahler DA, Mackowiak JI. Evaluation of the short-form 36-item questionnaire to measure health-related quality of life in patients with COPD. Chest. 1995;107:1585–1589. doi: 10.1378/chest.107.6.1585.
    1. Ludbrook J. Multiple inferences using confidence intervals. Clin Exp Pharmacol Physiol. 2000;27:212–215. doi: 10.1046/j.1440-1681.2000.03223.x.
    1. Li W, Mao B, Wang G. et al.Effect of Tanreqing injection on treatment of acute exacerbation of chronic obstructive pulmonary disease with Chinese medicine syndrome of retention of phlegm and heat in Fei. Chin J Integr Med. 2010;16:131–137. doi: 10.1007/s11655-010-0131-y.
    1. Li W, Mao B, Wang G. et al.A study of the mechanism of Qingre Huatan therapy in treatment of acute exacerbation of chronic obstructive pulmonary disease by improving airway inflammation and mucus hypersecretion. Zhong Xi Yi Jie He Xue Bao. 2008;6:799–805. doi: 10.3736/jcim20080806.
    1. Hong ML, Yang GZ, Chen WX, Gao LY, Cai SH, Dai SZ. Effect of Yufeining on induced sputum interleukin-8 in patients with chronic obstructive pulmonary disease at the stable phase. Chin J Integr Med. 2005;11:179–182. doi: 10.1007/BF02836500.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren