Open-label trial and randomized, double-blind, placebo-controlled, crossover trial of hydrogen-enriched water for mitochondrial and inflammatory myopathies
Ito M et al. · Med Gas Res. 2011;1:24.
Study at a glance
Human
People with progressive muscular dystrophy, inflammatory myopathy or mitochondrial myopathy
Open-label: 1.0 L/day for 12 weeks; crossover: 0.5 L/day H₂ water or placebo for 8 weeks each with a 4-week washout · Approximately 0.5 ppm dissolved H₂, about 31% saturation.
12 weeks open-label; two 8-week crossover periods separated by 4 weeks
Neither trial found objective clinical improvement or worsening. The crossover trial found a lactate difference in mitochondrial myopathy; L/P ratio and MMP3 were not significant. One insulin-treated MELAS patient had hypoglycemia that resolved after insulin reduction.
Very small heterogeneous samples, one uncontrolled study and one short crossover trial with multiple laboratory outcomes. The absence of objective clinical improvement is retained.
What kind of evidence is this?
Human
Open-label trial followed by a randomized double-blind placebo-controlled crossover trial
Musculoskeletal and pain research
H₂-rich water
Information not yet classified
Some editorial classification fields are still pending. The source-reported outcomes and result are shown below; Hydrogenology does not infer a positive or negative signal from prose automatically.
Methods
People with progressive muscular dystrophy, inflammatory myopathy or mitochondrial myopathy
Open-label: 14 participants; crossover: 22 participants, with six people participating in both trials
12 weeks open-label; two 8-week crossover periods separated by 4 weeks
Open-label: 1.0 L/day for 12 weeks; crossover: 0.5 L/day H₂ water or placebo for 8 weeks each with a 4-week washout
H₂ dissolved in drinking water — H₂ only, not Brown’s gas and not inhalation.
Approximately 0.5 ppm dissolved H₂, about 31% saturation.
Baseline observation in the open-label study and placebo water in the crossover trial
Outcomes and reported result
Clinical symptoms, serum lactate, lactate/pyruvate ratio, MMP3 and multiple serum and urinary markers
Neither trial found objective clinical improvement or worsening. The crossover trial found a lactate difference in mitochondrial myopathy; L/P ratio and MMP3 were not significant. One insulin-treated MELAS patient had hypoglycemia that resolved after insulin reduction.
Protocols, concentration, positive and null results and adverse events checked in the open-access full text.
A reported association, difference or mechanism is not automatically a clinical benefit.
Limitations and applicability
Very small heterogeneous samples, one uncontrolled study and one short crossover trial with multiple laboratory outcomes. The absence of objective clinical improvement is retained.
People with the specified mitochondrial or inflammatory muscle diseases; not general fatigue or sports recovery.
No single-study GRADE certainty rating is assigned. Read how records and evidence assessments are prepared.
Sources and record status
PMID: 22146674 · DOI: 10.1186/2045-9912-1-24
Open-access full text is available through PMC.
Open-access PMC full text and PubMed record.
10 August 2026
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