Bufei Huoxue capsules enhance lung function in pneumoconiosis: a multicenter, randomized clinical trial

To clarify the efficacy and safety of Bufei Huoxue (BFHX) capsules for the treatment of pneumoconiosis.

This multicenter, double-blind, randomized, placebo-controlled trial enrolled patients with pneum-oconiosis from five centers between June 2020 and June 2023. Participants were randomized 1∶1 to receive oral BFHX capsules or matched placebo (4 capsules, thrice daily) for 24 weeks. The primary endpoint was the change from baseline in forced vital capacity percent predicted (FVC%) at 24 weeks. Secondary outcomes included changes in forced expiratory volume in 1 s percent predicted (FEV₁%), 6-min walk test (6MWT) distance, COPD assessment test (CAT) score, Modified British Medical Research Council (mMRC) dyspnea scale score, and serum biomarkers at weeks 8 and 24. Safety was assessed through adverse events and laboratory analyses. Efficacy was evaluated in both the full analysis set (FAS) and per-protocol set (PPS), with blinding maintained throughout the trial.

In total, 162 patients were included in the study. For the primary outcome, the change from baseline in FVC% at 24 weeks was significantly greater in BFHX group than placebo group [BFHX-placebo least squares (LS): 5.65 ± 2.01, 95% confidence interval (CI) (1.68, 9.62), P = 0.0056]. A significant difference of FVC% was also observed at week 8 [BFHX-placebo LS: 3.50 ± 1.72, 95% CI(0.11, 6.90), P = 0.0434]. Significant improvements in secondary outcomes were also observed at week 24, including FEV₁% [BFHX-placebo LS: 5.33 ± 2.51, 95% CI(0.37, 10.3), P = 0.0352], 6MWT distance [BFHX-placebo LS: 22.7 ± 8.76, 95% CI(5.40, 40.1), P = 0.0105], CAT score [BFHX-placebo LS: －2.14 ± 0.85, 95% CI(－3.82, －0.46), P = 0.0130], and mMRC score [BFHX-placebo LS: －0.34 ± 0.10, 95% CI(－0.54, －0.13), P = 0.0014]. The mMRC score also showed improvement at week 8 [BFHX-placebo LS: －0.25 ± 0.11, 95% CI(－0.47, －0.02), P = 0.0308]. Results were consistent in both the per-protocol and full analysis sets. No significant between-group differences were observed in laboratory safety parameters, inflammatory markers, or coagulation profiles (all P > 0.05). The overall safety profile was similar between the two groups.

BFHX capsules improved lung function, exercise tolerance, and respiratory symptoms in patients with pneumoconiosis. Therefore, this treatment can be safely and effectively used in patients with pneumoconiosis.