Dose finding is not efficacy testing: reconsidering improvement in hydrogen water trials for ME/CFS

Pramana Pramana; Melati Budi Srikandi

doi:10.1080/21641846.2026.2728908

September 8, 2026Fatigue Biomedicine Health & Behavior

Dose finding is not efficacy testing: reconsidering improvement in hydrogen water trials for ME/CFS

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Key Points

Clarify the methodological and statistical distinction between early pilot dose-finding designs and definitive efficacy evaluations in hydrogen-enriched water trials for ME/CFS.
Critically evaluated the trial design, endpoint interpretations, and statistical assumptions reported in a pilot randomized dose-comparison trial of hydrogen-enriched water for ME/CFS.
Assessed methodological risks of deriving treatment efficacy claims from exploratory dose-escalation protocols that lack sham or placebo controls.
Demonstrates that perceived symptom improvements in pilot dose-comparison studies cannot establish therapeutic efficacy without dedicated placebo-controlled testing.
Identifies that exploratory dose-finding protocols primarily evaluate safety, feasibility, and dosing parameters rather than valid clinical outcome responses.

Implication

Methodological critique reveals conflation of dose finding with efficacy in ME/CFS trials, highlighting the need for rigorous confirmatory testing.

Abstract

To the Editor,We read with interest Friedberg et al.’s August 2026 article, ‘Comparing different doses of hydrogen enriched water in a pilot randomized treatment trial in chronic fatigue syndrome.’...

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Cite This Study

Pramana et al. (2026) studied this question.

synapsesocial.com/papers/6aa27b2658559d80afc742f2 https://doi.org/10.1080/21641846.2026.2728908

View at Publisher

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Dose finding is not efficacy testing: reconsidering improvement in hydrogen water trials for ME/CFS

Key Points

Implication

Abstract

Discussion

Cite This Study

Dose finding is not efficacy testing: reconsidering improvement in hydrogen water trials for ME/CFS

Key Points

Implication

Abstract

Discussion

Cite This Study

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