Hydrogen Gas Inhalation Treatment in Acute Cerebral Infarction: A Randomized Controlled Clinical Study on Safety and Neuroprotection

https://doi.org/10.1016/j.jstrokecerebrovasdis.2017.06.012 Get rights and content
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Background

Molecular hydrogen (H2) acts as a therapeutic antioxidant. Inhalation of H2 gas (1-4%) was effective for the improvement of cerebral infarction in multiple animal experiments. Thus, for actual applications, a randomized controlled clinical study is desired to evaluate the effects of inhalation of H2 gas. Here, we evaluate the H2 treatment on acute cerebral infarction.

Methods

Through this randomized controlled clinical study, we assessed the safety and effectiveness of H2 treatment in patients with cerebral infarction in an acute stage with mild- to moderate-severity National Institute of Health Stroke Scale (NIHSS) scores (NIHSS = 2-6). We enrolled 50 patients (25 each in the H2 group and the control group) with a therapeutic time window of 6 to 24 hours. The H2 group inhaled 3% H2 gas (1 hour twice a day), and the control group received conventional intravenous medications for the initial 7 days. The evaluations included daily vital signs, NIHSS scores, physical therapy indices, weekly blood chemistry, and brain magnetic resonance imaging (MRI) scans over the 2-week study period.

Results

The H2 group showed no significant adverse effects with improvements in oxygen saturation. The following significant effects were found: the relative signal intensity of MRI, which indicated the severity of the infarction site, NIHSS scores for clinically quantifying stroke severity, and physical therapy evaluation, as judged by the Barthel Index.

Conclusions

H2 treatment was safe and effective in patients with acute cerebral infarction. These results suggested a potential for widespread and general application of H2 gas.

Key Words

Hydrogen gas
acute cerebral infarction
randomized controlled clinical study
neuroprotection
National Institute of Health Stroke Scale
MRI
Barthel Index

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Grant support: Hydrogen Heath Medical Laboratory Co., Ltd. (Tokyo, Japan) provided financial supported for this study. The sponsors of the study had no role in the study design, data collection, data analysis, data interpretation, writing of the report, or the decision to submit the paper for publication.

Conflict of interest: S. Ohta is a patentee on a medical use of hydrogen gas. He did not contribute to the registration of the patients, data collection, and interpretation. The other authors declare no conflicts of interest.