# Open-label trial and randomized, double-blind, placebo-controlled, crossover trial of hydrogen-enriched water for mitochondrial and inflammatory myopathies.
> 水素富化水の筋ジストロフィー・炎症性筋疾患・ミトコンドリア筋疾患に対するオープンラベル試験および二重盲検プラセボ対照クロスオーバー試験


## Abstract

An open-label trial administered 1.0 liter per day of hydrogen-enriched water for 12 weeks to five patients with progressive muscular dystrophy (PMD), four with polymyositis/dermatomyositis (PM/DM), and five with mitochondrial myopathies (MM). Significant changes were found in lactate-to-pyruvate ratios in PMD and MM, fasting blood glucose in PMD, serum MMP3 in PM/DM, and serum triglycerides in PM/DM. A subsequent randomized, double-blind, placebo-controlled crossover trial using 0.5 liter per day for 8 weeks in 10 DM and 12 MM patients revealed a statistically significant reduction in lactate levels in MM, with favorable but non-significant trends in lactate-to-pyruvate ratios and MMP3. One insulin-dependent MELAS patient experienced hypoglycemic episodes that resolved after insulin dose reduction. The authors suggest that the attenuated effects in the double-blind phase may reflect a dose-response or threshold relationship.

### Mechanism

H2 is proposed to selectively scavenge hydroxyl radicals and peroxynitrite while also modulating intracellular signaling, thereby reducing mitochondrial dysfunction and inflammatory processes in affected muscle tissue.

## Bibliographic

- **Authors**: Ibi T, Sahashi K, Ichihara M, Ito M, Ohno K
- **Journal**: Med Gas Res
- **Year**: 2011 (2011-10-03)
- **PMID**: [22146674](https://pubmed.ncbi.nlm.nih.gov/22146674/)
- **DOI**: [10.1186/2045-9912-1-24](https://doi.org/10.1186/2045-9912-1-24)
- **PMC**: [PMC3231939](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3231939/)
- **Study type**: human randomized controlled trial
- **Delivery route**: hydrogen-rich water
- **Effect reported**: mixed

## 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 22146674. https://h2-papers.org/en/papers/22146674
> **Source**: PubMed PMID [22146674](https://pubmed.ncbi.nlm.nih.gov/22146674/)