A randomized controlled double-blind study on the brain protection of infantile patients with epileptic spasm syndrome through atomized inhalation of hydrogen-oxygen gas
Chen C, He W, Chen J, Shi XY, Yang G, Wang J, Wang YY, Hu PL, Han F, Meng Y, Zou LP. · Frontiers in Neurology. 2026;17:1781738.
What kind of evidence is this?
Human
Single-center prospective randomized double-blind controlled trial
Other neurological conditions
Inhaled H₂
Not reported in this record.
Not reported in this record.
Methods at a glance
Children with infantile epileptic spasms syndrome treated at the Chinese PLA General Hospital from November 2021 to November 2023; guardians provided written informed consent.
60 children were initially enrolled; seven discontinued for personal reasons or poor adherence, and 53 completed treatment and were included in the efficacy analysis: oxyhydrogen n=27 and medical-air control n=26.
Four 1-hour inhalation sessions daily for 14 days; only short-term efficacy and safety were assessed.
In addition to standard IESS treatment, children inhaled the test mixture through a face mask for 1 hour, four times daily, for 14 consecutive days.
Brown's gas / oxyhydrogen — co-generated H₂ and O₂, not H₂ alone.
AMS-H-03 generator manufactured by Shanghai Huimei Medical Technology Co., Ltd.; 66.6% H₂ and 33.3% O₂ at a reported total flow of 3 L/min. The percentages total 99.9% because the article reports rounded values.
Approximately 1,998 mL/min H₂, calculated from the reported 3,000 mL/min total flow × 66.6%; the article does not report a separately measured H₂ flow.
33.3% O₂; approximately 999 mL/min O₂, calculated from 3,000 mL/min × 33.3%. The 0.1% rounding remainder is unresolved in the source.
Medical air delivered through a visually and operationally matched device at the same 3 L/min flow, with standard IESS treatment in both groups.
Outcomes and reported result
Spasm-frequency reduction and response rate, EEG hypsarrhythmia disappearance, Kramer and BASED scores, abnormal IL-6 rate, respiratory infection and adverse reactions including myocardial-enzyme elevation, gastrointestinal dysfunction and abnormal liver function.
No significant between-group difference was found for spasm reduction (p=0.705), treatment response (p=0.950), EEG hypsarrhythmia disappearance (p=0.576), Kramer score (p=0.140), BASED score (p=0.168) or abnormal IL-6 rate (p=0.081). Overall adverse-reaction incidence was reported as comparable and no serious adverse events occurred, but elevated myocardial enzymes (28.3% vs 10.9%), gastrointestinal dysfunction (43.5% vs 23.9%) and abnormal liver function (8.7% vs 0%) were reported more often in the oxyhydrogen group, all p<0.05.
The complete open-access article, randomization and blinding, participant flow, co-intervention, gas device, composition and total flow, efficacy outcomes including null results, safety findings, limitations, funding, trial registration and conflict statement were checked.
A reported association, difference or mechanism is not automatically a clinical benefit. Null findings, outcome type, study design and precision all matter.
Cautions and applicability
Small single-center trial with limited statistical power, seven post-enrollment discontinuations, fixed intervention parameters, 14-day exposure, no long-term neurodevelopmental follow-up and limited mechanistic assessment. The safety percentages reported in the article appear to use denominators larger than the stated randomized groups; Hydrogenology preserves the published values and flags this internal inconsistency rather than recalculating them. The National Key Research and Development Program of China funded the work; authors declared no commercial or financial conflicts.
Short-term adjunctive oxyhydrogen exposure in children already receiving standard IESS treatment; it did not show added efficacy and does not establish long-term safety.
Not reported in this record.
Not reported in this record.
Not reported in this record.
No single-study GRADE certainty rating is assigned. Certainty is assessed by important outcome across a complete eligible evidence set, not by attaching a final grade to one source.
Sources and record status
PMID: 41908285 · DOI: 10.3389/fneur.2026.1781738
Open-access Frontiers article and PubMed Central copy.
Complete Frontiers/PubMed Central article and PubMed metadata; full-text extraction checked 9 August 2026.
2026-08-10