A Randomized, Double-Blinded, Placebo-Controlled Study of the Use of Traditional Chinese Medicine for Treating Patients With Mild/Moderate Chronic Obstructive Pulmonary Disease

Aim

Chronic obstructive pulmonary disease (COPD) is a critical disease, with lung function closely linked to disease severity. This study aimed to evaluate the clinical efficacy of treatments for stable COPD in patients with pulmonary function Grades I and II.

Patients and Methods

We conducted a multicenter, randomized, double-blind, placebo-controlled trial (registration number: NCT01486186). A total of 502 patients were randomly assigned to an experimental group (n = 251, treated with Bufei, Bufei Jianpi, and Bufei Yishen granules based on traditional Chinese medicine [TCM] syndromes) and a control group (n = 251, treated with a Chinese medicine-based placebo). Acute exacerbations (AEs), lung function, clinical symptoms, 6-min walking distance (6MWD), and dyspnea were assessed over 12 months of treatment and 12 months of follow-up.

Results

A total of 432 patients, including 214 and 218 patients in the experimental and control groups, respectively, completed the trial. The early treatment group had fewer AEs (p < 0.05), better clinical symptom scores (p < 0.05), longer 6MWD (p < 0.05), and better Modified Medical Research Council (mMRC) scores than the control group (p < 0.05). No significant differences were found in forced vital capacity (FVC) and forced expiratory volume in first second (FEV1%) between the two groups, but there was a significant difference in FEV1 and the annual rate of FEV1 decline between the groups over 2 years (p < 0.05).

Conclusion

Treatment with TCM for stable COPD significantly reduced AEs, increased the 6MWD, and alleviated dyspnea in patients with pulmonary function Grades I and II. FEV1 was improved, and the slower FEV1 decline indicates a potential benefit in mitigating disease progression.