Open Fred Friedberg (University of Stonybrook) Hydrogen Rich Water; Heart rate variability biofeedback in CFS

Needs a blinded placebo option I think for each intervention.

 

I think there's a new ethical approval for this study:
https://clinicaltrials.gov/ct2/show/NCT05397626
Collaborator: Natural Wellness Now Health Products
Responsible Party: Fred Friedberg, Stony Brook University

The aim of this 10-week pilot study is to explore the potential benefit of two recently developed non-invasive interventions, heart rate variability biofeedback (HRV-BF) and over the counter (OTC) supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Symptom measures and heart monitoring information will be generated by this study. Given the lack of effective treatments in this illness, these two non-invasive home-based treatments may help patients feel and function better.

Participants will be randomized to one of the three study condition, HRV-BF alone, hydrogen water alone or combined HRV-BF and hydrogen water. All interventions are home-based with no in person visits. All communications with participants will be via virtual call, phone call, email and land mail.

Estimated enrolment: 39 participants

This clinical study involves three active intervention groups: group 1 receiving heart rhythm biofeedback alone, group receiving hydrogen water alone, and group 3 receiving both heart rhythm biofeedback and hydrogen water.

Masking: Single (Outcomes Assessor)
Masking treatment: Each participant fill out online outcome forms that involve no interaction with the principal investigator or study staff, thus avoiding any staff-specific influence on online outcome forms.

Primary Outcome Measures :

1. Fatigue Severity Scale [ Time Frame: 8 weeks ]
   self-report measure of fatigue impact on functioning.Minimum value=1; Maximum value=7; Range: 1.00-7.00. High scores indicate more sever fatigue and a worse outcome.

Secondary Outcome Measures :

1. Short Form-36 Physical Function Subscale [ Time Frame: 8 weeks ]
   Self-report measure of physical functioning. The short-form 36 physical function subscale is composed of ten items encompassing a hierarchical range of difficulties. Each item is scores on the basis of the limitations perceived by surveyed individuals. Item scores (1, 2, or 3) are summed to obtain a total score, which can then be scaled relative to its range. Higher scores indicate higher physical function.
   
   
2. Depression, Anxiety and Stress Scale [ Time Frame: 8 weeks ]
   Self-report measure if depression, anxiety and stress symptoms. This 21 item stress measure contains three 7-item subscales: anxiety, depression and stress. Domain scores are calculated by summing all items in a domain and multiplying by two.
   
   
3. Brief Resilience Scale [ Time Frame: 8 weeks ]
   This 6 item self-report scale focuses on how quickly an individuals bounces back and physically and emotionally exhausting events. 5 answer choices range from strongly disagree to strongly agree. Higher scores indicate higher resilience.

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There is no control, it's open label, outcomes are subjective
Recruitment ensures that people who are biased to thinking the treatment might work are selected.
Numbers of participants are small (11 per treatment recruited)
The design of treatment A; treatment B; treatment A+B helps give the supplement an extra chance of being successful


In short, the trial design is rubbish. It almost certainly will produce a favourable outcome for Natural Wellness Now Health Products. I am interested to know how Friedberg benefits from this research. Fred Friedberg is the president of IACFS/ME and yet he's actively contributing to the poor quality of ME/CFS research.

To repeat from the last paper I saw Friedberg was involved in:

I don't think we should be accepting this. @hope123, @Keith Geraghty
I also think Solve MECFS have a responsibility here -- they need to do some due diligence before they advertise studies.