Hydrogen water and heart rate variability biofeedback as treatments for chronic fatigue syndrome: a pilot randomized trial

Background: Given the absence of restorative treatments for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), testing of alternative interventions may offer new options to help these debilitated individuals. Objective: To explore in an 8-week pilot randomized trial the potential benefit of two non-invasive treatments, hydrogen water (H2) and app-based heart rate variability biofeedback (HRV-BF), for the symptoms and functional limitations in ME/CFS. Methods: A three-arm, randomized, non-blinded design was adopted. Subjects were randomized to receive H2, HRV-BF or a combined condition of both treatments. The study was administered at a single site, Stony Brook University. Participants were recruited via online advertising and announcements on support group websites. 39 subjects participated in the study. All participant activities were completed in their homes. Intervention: Two daily treatments were self-administered by participants: 2–3 glasses of hydrogen-producing drinking water and/or heart rate variability biofeedback. Results: No significant post-intervention differences between the three groups were found. However, pre–post comparisons revealed significant improvements on the Fatigue Severity Scale (95% CI: [-0.66, -0.01]; p =.043) and the SF36 Physical Function subscale (95% CI: [5.19, 20.22]; p = 0.002) in the H2 group. For the single intervention conditions, compliance was higher for H2 treatment (94.6%) in comparison to HRV-BF (81.5%). Conclusion: The interventions of molecular hydrogen (H2) and app-based heart rhythm biofeedback (HRV-BF) did not yield improvements across conditions; however, pre–post improvements in physical function and fatigue in the H2 condition suggest that extended treatment may yield a more discernable benefit. Trial registration: ClinicalTrials.gov identifier: NCT05397626.