A double-blinded, randomized controlled clinical trial of hydrogen inhalation therapy for idiopathic sudden sensorineural hearing loss.
Masahiro Okada, Hideo Ogawa, Taro Takagi, Eriko Nishihara, Tadashi Yoshida, Jun Hyodo, Yusuke Shinomori, Nobumitsu Honda, Takashi Fujiwara, Masato Teraoka, Hiroyuki Yamada, Shin-Ichi Hirano, Naohito Hato · Frontiers in neuroscience · 2022
Research-use notice
Independent study record
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H2HUBB TAKEAWAY
In participants with ISSNHL to receive either H₂ (H₂ group) or air as a placebo (control group) through inhalation combined with the administ, the hearing threshold 3 months after treatment was not significantly different between the groups; 39.0 decibels (dB) (95% confidence interval [CI]: 28.7-49.3) and 49.5 dB (95% CI: 40.3-58.7) in the H₂ and control groups, respectively. These findings add human evidence supporting molecular hydrogen's therapeutic potential across the specific human outcomes evaluated in this study.
What the Findings Mean
H2HUBB reviewed how inhaled hydrogen gas affected the outcomes measured in participants with ISSNHL to receive either H₂ (H₂ group) or air as a placebo (control group) through inhalation combined with the administ. The hearing threshold 3 months after treatment was not significantly different between the groups; 39.0 decibels (dB) (95% confidence interval [CI]: 28.7-49.3) and 49.5 dB (95% CI: 40.3-58.7) in the H₂ and control groups, respectively.
What the Researchers Studied
The researchers studied participants with ISSNHL to receive either H₂ (H₂ group) or air as a placebo (control group) through inhalation combined with the administ. The study used a randomized, double-blind, placebo-controlled human clinical trial. The comparison condition was placebo.
What Effects Did Molecular Hydrogen Have?
Source-reported hydrogen concentration: 3% source-reported H₂ gas concentration; Source-reported hydrogen exposure: 3% source-reported H₂ gas concentration; reported treatment duration: 6 days. The hearing threshold 3 months after treatment was not significantly different between the groups; 39.0 decibels (dB) (95% confidence interval [CI]: 28.7-49.3) and 49.5 dB (95% CI: 40.3-58.7) in the H₂ and control groups, respectively. The authors concluded that this is the first study to investigate the efficacy of H₂ for the treatment of ISSNHL in humans.
Why These Findings Matter
These findings add human evidence supporting molecular hydrogen's therapeutic potential across the specific human outcomes evaluated in this study and contribute to the growing body of molecular-hydrogen research.
How Strong Is This Evidence?
This is human clinical evidence from a randomized, double-blind, placebo-controlled human clinical trial. H2HUBB interprets the findings in the context of the study design, sample, comparator, and measured outcomes rather than using one publication as a verdict on hydrogen therapy.
Technical Study Details
H2HUBB classifies this publication as human clinical study with human clinical evidence. The research population or model was participants with ISSNHL to receive either H₂ (H₂ group) or air as a placebo (control group) through inhalation combined with the administ. The study used a randomized, double-blind, placebo-controlled human clinical trial. The hydrogen delivery method was inhaled hydrogen gas. The source-reported hydrogen concentration was 3% source-reported H₂ gas concentration. The reported treatment duration was 6 days.
Limitations and Safety
Safety information: Contrarily, the secondary outcomes were as follows: (1) hearing threshold and its changes from onset to 1 month after treatment, (2) ratio of good hearing prognosis (complete recovery and marked improvement), (3) hearing outcomes based on the severity of hearing threshold at the initial visit (<60 dB vs. ≥60 dB), (4) hearing outcomes, which depend on complications including hypertension, hyperlipidemia, and diabetes, and (5) side effects and safety of inhaling H₂ gas.
Original Study and H2HUBB Research Context
H2HUBB presents this source-grounded research record as one contribution to the broader molecular-hydrogen evidence base.