# Efficacy and Safety of Hydrogen Therapy in Patients with Early-Stage Interstitial Lung Disease: A Single-Center, Randomized, Parallel-Group Controlled Trial.
> 早期間質性肺疾患患者における水素吸入療法の有効性と安全性：単施設無作為化並行群間対照試験


## Abstract

A prospective, single-center randomized controlled trial enrolled 87 patients with early-stage interstitial lung disease (ILD), randomly assigned 1:1 to hydrogen-rich water (HW) or N-acetylcysteine (NAC). The primary endpoints were changes in high-resolution computed tomography (HRCT) scores and composite physiologic index (CPI) from baseline to week 48. HRCT improvement was observed in 63.6% of the HW group versus 39.5% in the NAC group. The HW group demonstrated a statistically significant reduction in CPI and improvement in DCO-sb compared with NAC. Other pulmonary function parameters—FVC, FEV, FEV/FVC%, and TLC—did not differ significantly between groups. Adverse events occurred in 15.9% of HW patients and 23.3% of NAC patients, with no statistically significant difference (p=0.706). These findings suggest that molecular hydrogen may offer superior radiological and physiological outcomes relative to NAC in early-stage ILD, with a comparable safety profile.

### Mechanism

Molecular hydrogen is proposed to exert selective scavenging of reactive oxygen species and anti-inflammatory effects, thereby attenuating fibrotic progression in lung tissue and improving physiological indices such as CPI and DCO-sb.

## Bibliographic

- **Authors**: Tang C, Wang L, Chen Z, Yang J, Gao H, Guan C, et al.
- **Journal**: Ther Clin Risk Manag
- **Year**: 2023
- **PMID**: [38107500](https://pubmed.ncbi.nlm.nih.gov/38107500/)
- **DOI**: [10.2147/TCRM.S438044](https://doi.org/10.2147/TCRM.S438044)
- **PMC**: [PMC10723077](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10723077/)
- **Study type**: human randomized controlled trial
- **Delivery route**: hydrogen-rich water
- **Effect reported**: positive

## Delivery context

Hydrogen-rich water is a low-risk delivery route, but the achievable systemic hydrogen dose is bounded. For clinical applications, inhalation is the most efficient route; inhalation, however, carries explosion risk, and concentration matters (empirical LFL of 10% applies to inhalation environments; high-concentration devices are documented in the Consumer Affairs Agency accident database and are not recommended).

## Safety notes

Hydrogen-rich water is a low-risk delivery route, but the achievable systemic hydrogen dose is bounded. For clinical applications, inhalation is the most efficient route; inhalation, however, carries explosion risk, and concentration matters (empirical LFL of 10% applies to inhalation environments; high-concentration devices are documented in the Consumer Affairs Agency accident database and are not recommended).

See also:
- [Inhalation concentration and LFL / UFL](https://h2-papers.org/en/safety-notes/inhalation-concentration)
- [Consumer Affairs Agency accident cases](https://h2-papers.org/en/safety-notes/accident-cases)
- [Inhalation safety threshold lineage](https://h2-papers.org/en/safety-notes/lineage)

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> **Cite as**: H2 Papers — PMID 38107500. https://h2-papers.org/en/papers/38107500
> **Source**: PubMed PMID [38107500](https://pubmed.ncbi.nlm.nih.gov/38107500/)