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BMC Neurol. 2016 May 12;16:66. doi: 10.1186/s12883-016-0589-0.

A randomized double-blind multi-center trial of hydrogen water for Parkinson's disease: protocol and baseline characteristics.

Author information

1
Department of Neurology, Juntendo University Koshigaya Hospital, Fukuroyama 560, Koshigayashi, Saitama, 343-0032, Japan. ayori@juntendo.ac.jp.
2
Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan. ayori@juntendo.ac.jp.
3
Department of Neurology, Abe Neurological Clinic, Iwate, Japan.
4
Department of Neurology and Gerontology, Iwate Medical University, Iwate, Japan.
5
Department of Neurology, Research Institute for Brain and Blood Vessels-Akita Hospital, Akita, Japan.
6
Department of Pathophysiological Laboratory Sciences, Nagoya University Graduate School of Medicine, Aichi, Japan.
7
Brain and Mind Research Center, Nagoya University Graduate School of Medicine, Aichi, Japan.
8
Department of Neurology, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.
9
Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan.
10
Department of Neurology, Fukuoka University, Fukuoka, Japan.
11
Department of Neurology, Juntendo University Shizuoka Hospital, Shizuoka, Japan.
12
Department of Neurology, Juntendo University Nerima Hospital, Tokyo, Japan.
13
Department of Diagnostic Radiology, Department of Molecular Medicine and Surgery, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden.
14
Nozomi Hospital, Saitama, Japan.
15
Department of Neurology, Aomori Prefectural Central Hospital, Aomori, Japan.
16
Department of Neurology, Rakuwakai Otowa Rehabilitation Hospital, Kyoto, Japan.
17
Department of Neurology, Tokyo Rinkai Hospital, Tokyo, Japan.
18
Department of Neurology, Juntendo University Urayasu Hospital, Chiba, Japan.

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).

KEYWORDS:

Hydrogen; Parkinson’s disease; oxidative stress; randomized double-blind placebo-controlled multicenter trial

PMID:
27176725
PMCID:
PMC4865993
DOI:
10.1186/s12883-016-0589-0
[Indexed for MEDLINE]
Free PMC Article

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