Efficacy and safety of hydrogen gas versus standard therapy in Chinese patients with cerebral infarction: A pilot study

Purpose: To evaluate the efficacy and safety of hydrogen (H-2) gas versus standard therapy in Chinese patients with acute cerebral infarction (ACI) Method: Chinese patients with ACI who had National Institutes of Health stroke scale (NIHSS) scores of 2 - 6 were enrolled and randomized to receive hydrogen gas through inhalation route or standard therapy. Hydrogen gas (3 %) was administered twice daily for 1 hour each over a period of 2 weeks using a facial mask (non-rebreathing). Standard treatment included edaravone 30 mg (iv every 12 h + antiplatelet drugs for 2 weeks. Efficacy endpoints were change in vital signs, change in NIHSS scores from baseline, change in magnetic resonance imaging (MRI) signal intensity, and improvement in rehabilitation index. Safety was also assessed. Results: Data for 200 patients were analyzed. Patients treated with H-2 gas had significantly greater improvement in NIHSS score than patients treated with standard therapy. This indicates that the neurological improvement was significantly greater in patients treated with H-2 gas than those that received standard therapy for all the days tested (p < 0.05). The onset of NIHSS score reduction was faster in patients treated with H-2 gas when compared to standard therapy. Furthermore, H-2 gas demonstrated significant improvement in MRI signal Intensity score, which indicates that H-2 gas was effective in recovery of infraction site. Conclusion: The findings of this study show that H-2 gas administered via the inhalation route is effective and safe in Chinese patients with acute cerebral infarction, and is therefore, superior to standard therapy.