Hydrogen IV Therapy Safe for Stroke Patients in Clinical Trial
- Authors
- Kimihiro Nagatani, Hiroshi Nawashiro, Satoru Takeuchi, Satoshi Tomura, Naoki Otani, Hideo Osada, Kojiro Wada, Hiroshi Katoh, Nobusuke Tsuzuki, Kentaro Mori
- Journal
- Medical Gas Research
- Year
- 2013
- DOI
- 10.1186/2045-9912-3-13
- Study Type
- Human
- Outcome
- Positive
- Peer Reviewed
- Yes
- Country
- Japan
- Health Condition
- Acute Ischemic Stroke
- Body System
- Nervous System
TL;DR
A pilot study suggests that intravenous hydrogen therapy is safe for stroke patients, even when used with a common stroke medication.
Key Finding
Intravenous hydrogen-enriched fluid was well-tolerated in 38 acute stroke patients, with only minor complications in 5.3% and no serious adverse events, even when combined with clot-busting medication.
Summary
This pilot study tested whether giving patients with acute ischemic stroke (a type of stroke caused by a blood clot) an intravenous solution enriched with hydrogen gas was safe. Thirty-eight stroke patients received the hydrogen-enriched fluid along with standard treatments. Only 2 patients experienced minor side effects (diarrhea and heart failure), and no serious complications or concerning lab or heart changes were observed. Patients' stroke severity scores improved over the 90-day follow-up period.
Practical Takeaway
This small, early-stage human study suggests that hydrogen therapy may be safe as an add-on treatment for acute stroke, but it was not designed to prove whether hydrogen actually helps patients recover better. Much larger, controlled studies would be needed to determine whether hydrogen provides real therapeutic benefit beyond standard stroke care.
Abstract
Most of the results regarding hydrogen (H2) therapy for acute cerebral ischemia are derived from in vitro studies and animal experiments, with only a few obtained from human trials with a limited number of subjects. Thus, there is a paucity of information regarding both the beneficial therapeutic effects as well as the side effects of H2 on acute cerebral ischemia in humans. We designed a pilot study to investigate single dose intravenous H2-administration in combination with edaravone, aiming to provide an initial estimate of the possible risks and benefits in select patients presenting with acute ischemic stroke. An open-label, prospective, non-randomized study of intravenous H2-administration was performed in 38 patients hospitalized for acute ischemic stroke. All patients received an H2-enriched intravenous solution in addition to edaravone immediately after the diagnosis of acute ischemic stroke. Acute stroke patients within 3 h of onset received intravenous tissue plasminogen activator (t-PA) (0.6 mg/kg) treatment, and patients receiving t-PA had to commence the administration of the H2-enriched intravenous solution and edaravone before or at the same time as the t-PA was infused. Complications were observed in 2 patients (5.3%), which consisted of diarrhea in 1 patient (2.6%) and cardiac failure in 1 patient (2.6%). No deterioration in laboratory tests, urinary tests, ECG, or chest X-ray radiograms occurred in any patient in this study. In all patients, the mean National Institutes of Health Stroke Scale (NIHSS) scores at baseline, and 7, 30, and 90 d after admission were 8.2 +/- 7.5, 5.6 +/- 7.1, 4.9 +/- 6.5, and 4.5 +/- 6.3, respectively. The early recanalization was identified in 4 of 11 patients (36.4%) who received intravenous t-PA administration. Hemorrhagic transformation was observed in 2 patients (18.2%). None of the patients in this study that were treated with t-PA developed symptomatic intracranial hemorrhage. Data from the current study indicate that an H2-enriched intravenous solution is safe for patients with acute cerebral infarction, including patients treated with t-PA.