Bu-Fei Yi-Shen Granules Reduce Acute Exacerbations in Patients with GOLD 3-4 COPD: A Randomized Controlled Trial

Area of Science:

• Respiratory Medicine
• Pharmacology
• Clinical Trials

Background:

• Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disease characterized by frequent acute exacerbations (AEs), particularly in severe stages.
• Management of severe COPD (GOLD 3-4) often involves addressing AEs to improve patient outcomes and quality of life.

Purpose of the Study:

• To evaluate the efficacy and safety of Bu-fei Yi-shen granules (BYGs) in managing patients with severe to very severe COPD.
• To assess the impact of BYGs on acute exacerbations, pulmonary function, clinical symptoms, and quality of life.

Main Methods:

• A multicenter, randomized, double-blinded, placebo-controlled trial was conducted involving 348 patients with GOLD 3-4 COPD.
• Participants received either BYG or a placebo orally, twice daily (5 days on, 2 days off) for 52 weeks.
• Outcomes measured included AEs, pulmonary function, mMRC dyspnea scores, 6-minute walk test (6MWT), quality of life (SF-36), and COPD-specific PROs.

Main Results:

• A total of 280 patients completed the study.
• BYG significantly reduced the frequency of AEs and AE-related hospitalizations compared to placebo (P=0.006 and P=0.04, respectively).
• Significant improvements were observed in 6MWD (40.93 m), mMRC scores (-0.57), total symptoms (-2.18), SF-36 scores (11.60), and mCOPD-PRO (-0.45) in the BYG group.

Conclusions:

• Bu-fei Yi-shen granules (BYGs) demonstrate significant efficacy in reducing acute exacerbations and hospitalizations for patients with GOLD 3-4 COPD.
• BYGs improve clinical symptoms, quality of life, and exercise capacity in severe COPD patients.
• No significant improvements in mortality or pulmonary function were noted, and no obvious adverse events were observed.