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

Abstract

Purpose

Chronic obstructive pulmonary disease (COPD) is a disease characterized by frequent acute exacerbations (AEs), especially in severe and very severe cases. We aimed to evaluate the efficacy and safety of Bu-fei Yi-shen granules (BYGs) for COPD.

Patients and Methods

We conducted a multicenter, randomized, double-blinded, placebo-controlled trial of 348 COPD patients with GOLD 3–4 COPD. The patients were randomly assigned into experimental or control groups in a 1:1 ratio. Patients in the experimental group were prescribed BYG, while those in the control group were administered a placebo, orally, twice daily, with 5 days on and 2 days off per week for 52 weeks. The outcomes included AEs, pulmonary function, clinical signs and symptoms, dyspnea scores (mMRC), quality of life scores, and a 6-minute walk test (6MWT).

Results

A total of 280 patients completed the trial, including 135 patients in the experimental group and 145 in the control group. Compared to the control group, significant differences were observed in frequencies of AEs (mean difference: −0.35; 95% CI: −0.61, −0.10; P = 0.006) and AE-related hospitalizations (−0.18; 95% CI: −0.36, −0.01; P = 0.04), 6MWD (40.93 m; 95% CI: 32.03, 49.83; P < 0.001), mMRC (−0.57; 95% CI: −0.76, −0.37; P < 0.001), total symptoms (−2.18; 95% CI: −2.84, −1.53; P < 0.001), SF-36 (11.60; 95% CI: 8.23, 14.97; P < 0.001), and mCOPD-PRO (−0.45; 95% CI: −0.57, −0.33; P < 0.001) after treatment. However, there were no significant differences in mortality, pulmonary function, and mESQ-PRO scores (P > 0.05). No obvious adverse events were observed.

Conclusion

BYG, as compared to a placebo, could significantly reduce the frequencies of AEs and AE-related hospitalizations for GOLD 3–4 COPD patients. Clinical symptoms, treatment satisfaction, quality of life, and exercise capacity improved. There was no significant improvement in mortality and pulmonary function.

Keywords:

• chronic obstructive pulmonary disease
• traditional Chinese medicine
• efficacy
• safety
• RCT

Abbreviations

6MWD, 6-min walk distance; ANOVA, Analysis of Variance; CAT, COPD assessment test; COPD, chronic obstructive pulmonary disease; GOLD, global initiative for chronic obstructive lung disease; mCOPD-PRO, modified patient-reported outcome scale for COPD; mESQ-COPD, modified efficacy satisfaction questionnaire for COPD; mMRC, Modified Medical Research Council; PPS, Per Protocol Set; TCM, traditional Chinese Medicine.

Data Sharing Statement

The raw data for this study could be available from corresponding author under request only for researches, and cannot be disseminated.

Ethics Approval and Informed Consent

The trial protocol (version 2019.04.25.1.0.3.0) was approved by the Institution Ethics Committee of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine (No. 2019HL-010). The study obtained informed consent and handwritten informed consent forms from each participant before trial. The study was conducted in strict accordance with the reviewed protocol and adhered to the tenets of the Declaration of Helsinki.

Consent for Publication

All authors have read the manuscript and agree to publish.

Disclosure

The authors report no conflicts of interest in this work.

Additional information

Funding

This study has been supported by the National Key Research & Development Program of China (grant number: 2018YFC1704800, 2018YFC1704802). All the participant experts are appreciated for their diligence in this study.