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

Hirohisa Ono, MD; Yoji Nishijima, MD; Shigeo Ohta, PhD; Masaki Sakamoto, MD; Kazunori Kinone, MD; Tohru Horikosi, MD; Mituyuki Tamaki, MD; Hirosi Takeshita, MD; Tomoko Futatuki, MD; Wataru Ohishi, MD; Taichi Ishiguro, MD; Saori Okamoto, MD; Shou Ishii, MD; Hiroko Takanami, BA

doi:10.1016/j.jstrokecerebrovasdis.2017.06.012

Clinical TrialHighlighted✓ Verified by MHI

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

Hirohisa Ono, MD, Yoji Nishijima, MD, Shigeo Ohta, PhD, Masaki Sakamoto, MD, Kazunori Kinone, MD, Tohru Horikosi, MD, Mituyuki Tamaki, MD, Hirosi Takeshita, MD, Tomoko Futatuki, MD, Wataru Ohishi, MD, Taichi Ishiguro, MD, Saori Okamoto, MD, Shou Ishii, MD, Hiroko Takanami, BA

Journal of Stroke and Cerebrovascular Diseases · 2017 · 26(11) · 2587–2594

MHID-7349011PMID: 28669654 DOI: 10.1016/j.jstrokecerebrovasdis.2017.06.012

View PDF

Abstract

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 con- trolled 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.

Study details

Article type: Original Research
Disease / injury model: Acute cerebral infarction (ischemic stroke)
Duration: 14 days
Dose-dependent effect: No
Outcome: Positive
Findings: Hydrogen gas inhalation (3% H2, 1 hour twice daily for 7 days) in patients with acute cerebral infarction was safe and led to significant improvements in MRI signal intensity (indicating less severe infarction), NIHSS scores (stroke severity), and Barthel Index (physical therapy/ADL) compared to conventional therapy. No significant adverse effects were observed, and oxygen saturation improved in the H2 group.

Classification

Research Topics: Health & Wellness / Prevention Hydrogen Therapy Mechanistic-Direct Neurological Disorders
Study Type: Clinical Trial
Study Design: Randomized
Organs & Tissues: Brain
Physiological Systems: Nervous
Biomarkers: Barthel Index (BI)Blood chemistry (liver, kidney, pancreas, cardiac enzymes, electrolytes, blood counts)MRI relative signal intensity (RSI)NIHSS score Oxygen Saturation (SpO2)
Methods of Administration: Inhalation
Countries: Japan
Also: Highlighted ArticlesDrug/Therapy/Supplement ComparedPharmacokinetics DiscussedH2 Safety Discussed