Controlled Trial of Hydrogen Water as a Treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Overview

This is a 16-week controlled treatment trial of an over-the -counter supplement, hydrogen water, for individuals with ME/CFS patients. An active treatment condition will be compared to a placebo-control condition. The study will also seek confirmation of heart rate variability (HRV) as a biomarker, that is, as a predictor of improvement vs. non-improvement to be assessed at treatment termination. The HRV biomarker hypothesis is based on a finding that High Frequency HRV (cardio-parasympathetic measure) biologically separated improvers and non-improvers in my previous ME/CFS observational study.

The purpose of this pilot randomized controlled trial is (1) to more definitively test for the efficacy of hydrogen water as a treatment for chronic fatigue syndrome (CFS) and (2) identify and confirm a cardio-autonomic biomarker for improvement in chronic fatigue syndrome. Treatment of chronic fatigue syndrome will start with a 10-day graduated dosing schedule followed by a standard daily dose of hydrogen water (a magnesium-based OTC supplement) over 16 weeks. We expect the active treatment condition to show significant improvements in fatigue and physical function in comparison to the placebo control condition. The treatment outcomes will also be examined for the presence of two subgroups: improvers and non-improvers. These subgroups will be delineated by heart rate variability (HRV), a biological measure of health and well-being. Higher HRV will predict improvement and lower HRV will predict non-improvement (no change or worsening). This would be the first biomarker of improvement found in chronic fatigue syndrome. If treatment is successful, subjects will experience a reduction in fatigue and an increase in physical function. Thus, the study may advance potentially an effective intervention for individuals with CFS and further the understanding of the biology of favorable treatment outcomes, i.e., improved HRV status.