Fuzheng Huayu tablets for treating pulmonary fibrosis in post-COVID-19 patients: a multicenter, randomized, double-blind, placebo-controlled trial.

Summary

In a 24‑week multicenter double‑blind RCT (n=142), FZHY increased HRCT‑assessed fibrosis regression (71.2% vs 49.2%, p=0.01), improved early FEV1/FVC (week 8), reduced pulmonary inflammation, and yielded a greater 6‑min walk distance gain, with no drug‑related adverse events. Symptom and QoL measures did not differ.

Key Findings

• Fibrosis regression at 24 weeks: 71.2% (FZHY) vs 49.2% (placebo); p=0.01.
• Higher FEV1/FVC at week 8 in FZHY (87.7±7.2%) vs placebo (82.7±6.9%); p=0.018.
• Greater 6‑min walk distance increase at week 4: 41.4±64.1 m vs 21.8±50.3 m; p=0.05.
• Pulmonary inflammation regression higher with FZHY (83.8% vs 68.8%; p=0.04).
• No drug‑related adverse events; symptom and QoL outcomes showed no significant between‑group differences.

Clinical Implications

FZHY, alongside rehabilitation and vitamin C, may be considered as an adjunct in post‑COVID fibrosis pending replication and broader spirometric confirmation; monitoring should include HRCT and standardized function tests.

Limitations

• Spirometry data were limited; clinical symptom and QoL improvements were not significant.
• Single‑country context; need independent replication and longer follow‑up with hard clinical endpoints.

Future Directions

Larger international RCTs with comprehensive lung function, antifibrotic comparators, and long‑term outcomes (exacerbations, hospitalization, mortality) to define positioning of FZHY.