Hirohisa Ono1, Yoji Nishijima2, Shigeo Ohta3, Masaki Sakamoto2, Kazunori Kinone2, Tohru Horikosi2, Mituyuki Tamaki4, Hirosi Takeshita2, Tomoko Futatuki2, Wataru Ohishi2, Taichi Ishiguro2, Saori Okamoto2, Shou Ishii2, Hiroko Takanami5. 1. Department of Neurosurgery, Nishijima Hospital, Numazu-city, Shizuoka-ken, Japan. Electronic address: hirohisa.ono@live.jp. 2. Department of Neurosurgery, Nishijima Hospital, Numazu-city, Shizuoka-ken, Japan. 3. Department of Biochemistry and Cell Biology, Graduate School of Medicine, Nippon Medical School, Kawasaki-city, Kanagawa-ken, Japan; Department of Neurology, Juntendo University Graduate School of Medicine, Tokyo, Japan. 4. Department of Neurology, Nishijima Hospital, Numazu-city, Shizuoka-ken, Japan. 5. Department of Laboratory, Nishijima Hospital, Numazu-city, Shizuoka-ken, Japan.
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 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.
RCT Entities:
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.
Keywords:
Barthel Index; Hydrogen gas; MRI; National Institute of Health Stroke Scale; acute cerebral infarction; neuroprotection; randomized controlled clinical study