Effect of sequential treatment with TCM syndrome differentiation on acute exacerbation of chronic obstructive pulmonary disease and AECOPD risk window.

Objective: To evaluate the efficacy and safety of the comprehensive interventions based on three Traditional Chinese medicine (TCM) patterns therapy in acute exacerbations of chronic obstructive pulmonary disease (AECOPD) and AECOPD risk window.

Methods: A prospective, multi-center, single-blinded, double-dummy and randomized controlled clinical trial is being conducted to test the therapeutic effects of a sequential two stage treatment. A total of 364 patients were enrolled into this study with 182 in each treatment group (TCM and conventional). Patients received medication (or control) according to their assigned group. TCM treatment according to syndrome differentiation for AECOPD were administered twice daily to patients with AECOPD over 7-21days, followed by TCM for AECOPD risk window (RW) over 28days. All patients were followed up for 6 months. Exacerbations were used as the primary outcome measures. Forced expiratory volume in the first second (FEV) and the modified medical research council dyspnea (MMRC) scale, quality of life and mortality rate were used as secondary outcome measures.

Results: Of 364 randomized patients, 353 were included in the intention-to-treat analysis and 290 in the per-protocol analysis. In the TCM group, 16 patients (10.4%) reached the primary end point; 24 (17.7%) in the conventional group (RR 0.59, 95% CI 0.33-1.06; p=0.074). Among patients with a re-exacerbation, the median time to event was 107.5days (interquartile range [IQR], 39.5-129.0) in the TCM and 50days (IQR, 31-130.5) in the conventional group (P=0.011). After exacerbation therapy and a further 180-days follow-up, patients in the TCM group had significant improvements in dyspnea, as measured by MMRC (P=0.003), Patients in the TCM group also had improvements in health-related quality of life (P=0.002), as measured COPD Assessment Test (CAT). There was no difference between groups in death, and recovery of lung function. There were no differences between the TCM and conventional treatment group in adverse events.

Conclusions: In patients presenting to the respiratory department with acute exacerbations of COPD, TCM treatments with syndrome differentiation will have beneficial effects with regard to re-exacerbation, relieving symptoms, improving quality of life for COPD patients.