Hydrogen Studies at ClinicalTrials.gov: The Dawn of a New Era?

Abstract

Hydrogen medicine has traveled a long and bumpy road. From the very first study published in 1975 in Science to a seminal paper from 2007 from Nature Medicine and many succeeding reports, molecular hydrogen (H2) has been affirmed as a beneficial agent in various pathologies yet still remains outside of conventional healthcare practice. A highly promising therapeutic, hydrogen appears to currently lack adequate effectiveness and safety evidence from well-controlled RCTs to meet the requirements of regulatory authorities to grant approval for clinical use. However, recent years have brought a notable upsurge in the number of clinical trials with hydrogen, thus suggesting a new compelling course in H2 appraisal. From ischemic stroke to bronchiectasis to solid tumors, hydrogen is currently being evaluated in 12 trials from the US, China, and other countries. The most frequently studied disease category based on the ICD-10 classification is the respiratory system (33.3%), followed by the nervous system (25.0%), and endocrine and/or metabolic system (16.7%). Inhalational hydrogen is being evaluated in 7 studies (58.3%) and oral sources of H2 are used in 4 studies (33.3%); 4 trials check out H2 coadministered with other therapeutics (e.g., oxygen, celsior). A duration of H2 treatment varies from 3 days to 1 year, with most studies administered hydrogen for 3 months. Endpoints include a myriad of patient- and clinician-reported outcomes, including laboratory assays and medical imaging. Of 12 trials, 9 (75.0%) are funded by governmental sources, 2 (16.7%) by private-for-profit entities and 1 trial (8.3%) by both.

Study details

Article type

Letter