Fred Friedberg
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 placeb…
Inclusion Criteria: * Patients aged 18-65 of both sexes * considered physically capable and willing to perform the study tasks * Meet validated phone-screen eligibility for ME/CFS criteria * Participant has internet and computer Exclusion Criteria: * Cases of fatigue clearly attributable to self-report medical conditions such as untreated hypothyroidism, unstable diabetes mellitus, organ failure, chronic infections, and chronic inflammatory diseases, or AIDS. Kidney disease/renal failure is also an exclusion * Exclusionary psychiatric disorders include any psychosis, or alcohol/ substance a…
16 week intervention of magnesium pill without active ingredient of molecular hydrogen.
The 3 daily doses of molecular hydrogen scheduled for a 16 week intervention. This distinguishes it from the placebo comparator condition.
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