2016 · Yoritaka et al. — A randomized double-blind multi-center trial of hydrogen water for Parkinson's disease: protocol and baseline characteristics.
Super-Abstract
This publication reports the protocol and baseline characteristics of a large multi-center RCT (n=178, 14 hospitals) designed to confirm whether 1000 mL/day of H₂ water can improve Parkinson's disease symptoms, as suggested by a prior smaller study. The primary endpoint is the change in total UPDRS score over 72 weeks. (BMC Neurology, 2016.)
Commentary
This paper is a protocol paper, not a results paper. It does not report clinical outcomes — instead, it lays out the design of a confirmatory multi-center RCT intended to replicate a previous positive single-center study by the same group (where H₂ water improved UPDRS scores over 48 weeks in levodopa-treated PD patients). The strength of this paper is its methodological rigor: randomized, double-blind, placebo-controlled, multi-center (14 hospitals), with a long follow-up of 72 weeks and well-defined primary and secondary endpoints. The baseline characteristics of 178 enrolled participants are described. The actual results of this trial need to be sought in subsequent publications. For a website reporting on human H₂ research, this paper is best positioned as evidence of rigorous scientific investigation — not as a demonstration of efficacy.
Key quotes
- „Our previous randomized double-blind study showed that drinking hydrogen (H2) water for 48 weeks significantly improved the total Unified Parkinson's Disease Rating Scale (UPDRS) score of Parkinson's disease (PD) patients treated with levodopa.“ — the study this trial aims to confirm — prior positive result in smaller cohort
- „The primary endpoint of the efficacy of this treatment in PD is the change in the total UPDRS score from baseline to the 72nd week.“ — long-term endpoint: 72-week observation — unusual rigor for H₂ research
- „One-hundred-and-seventy-eight participants with PD were enrolled in 14 hospitals and were randomized.“ — scale: 178 patients across 14 hospitals — largest H₂ water trial in Parkinson's disease
Our assessment
This is a protocol/baseline paper, not an efficacy report. Its value lies in demonstrating that the H₂-Parkinson hypothesis has been taken seriously enough to design a large, methodologically rigorous confirmatory trial. Important: the results of this trial are not contained in this paper — readers should seek the subsequent outcome publication. The prior smaller study was positive; whether this larger confirmatory trial replicates that result is the key open question.
Study design
- Type: Protocol paper + baseline characteristics of a randomized double-blind placebo-controlled multi-center trial · n: 178 enrolled (88 women, 90 men; mean age 64.2 years) · H₂ delivery: 1000 mL/day H₂ water vs. placebo water
- Primary endpoint: Change in total UPDRS score from baseline to week 72
- Status: Protocol publication — results not reported in this paper; 14 hospitals, UMIN000010014
Abstract
BACKGROUND: Our previous randomized double-blind study showed that drinking hydrogen (H2) water for 48 weeks significantly improved the total Unified Parkinson's Disease Rating Scale (UPDRS) score of Parkinson's disease (PD) patients treated with levodopa. We aim to confirm this result using a randomized double-blind placebo-controlled multi-center trial. METHODS: Changes in the total UPDRS scores from baseline to the 8(th), 24(th), 48(th), and 72(nd) weeks, and after the 8(th) week, will be evaluated. The primary endpoint of the efficacy of this treatment in PD is the change in the total UPDRS score from baseline to the 72(nd) week. The changes in UPDRS part II, UPDRS part III, each UPDRS score, PD Questionnaire-39 (PDQ-39), and the modified Hoehn and Yahr stage at these same time-points, as well as the duration until the protocol is finished because additional levodopa is required or until the disease progresses, will also be analyzed. Adverse events and screening laboratory studies will also be examined. Participants in the hydrogen water group will drink 1000 mL/day of H2 water, and those in the placebo water group will drink normal water. One-hundred-and-seventy-eight participants with PD (88 women, 90 men; mean age: 64.2 [SD 9.2] years, total UPDRS: 23.7 [11.8], with levodopa medication: 154 participants, without levodopa medication: 24 participants; daily levodopa dose: 344.1 [202.8] mg, total levodopa equivalent dose: 592.0 [317.6] mg) were enrolled in 14 hospitals and were randomized. DISCUSSION: This study will confirm whether H2 water can improve PD symptoms. TRIAL REGISTRATION: UMIN000010014 (February, 13, 2013).
Source & links
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