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

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