title: A randomized double-blind multi-center trial of hydrogen water for Parkinson's disease: protocol and baseline characteristics.
abstract: 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.
  
  
  
  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.
  
  
  
  This study will confirm whether H2 water can improve PD symptoms.
  
  
  
  UMIN000010014 (February, 13, 2013).
authors.affiliation: Department of Neurology, Juntendo University Koshigaya Hospital, Fukuroyama 560, Koshigayashi, Saitama, 343-0032, Japan. ayori@juntendo.ac.jp.|Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan. ayori@juntendo.ac.jp.
authors.forename: Asako
authors.initials: A
authors.lastname: Yoritaka
authors.affiliation: Department of Neurology, Abe Neurological Clinic, Iwate, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Abe
authors.affiliation: Department of Neurology and Gerontology, Iwate Medical University, Iwate, Japan.
authors.forename: Chigumi
authors.initials: C
authors.lastname: Ohtsuka
authors.affiliation: Department of Neurology, Research Institute for Brain and Blood Vessels-Akita Hospital, Akita, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Maeda
authors.affiliation: Department of Pathophysiological Laboratory Sciences, Nagoya University Graduate School of Medicine, Aichi, Japan.
authors.forename: Masaaki
authors.initials: M
authors.lastname: Hirayama
authors.affiliation: Brain and Mind Research Center, Nagoya University Graduate School of Medicine, Aichi, Japan.
authors.forename: Hirohisa
authors.initials: H
authors.lastname: Watanabe
authors.affiliation: Department of Neurology, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.
authors.forename: Hidemoto
authors.initials: H
authors.lastname: Saiki
authors.affiliation: Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan.
authors.forename: Genko
authors.initials: G
authors.lastname: Oyama
authors.affiliation: Department of Neurology, Fukuoka University, Fukuoka, Japan.
authors.forename: Jiro
authors.initials: J
authors.lastname: Fukae
authors.affiliation: Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Shimo
authors.affiliation: Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan.
authors.forename: Taku
authors.initials: T
authors.lastname: Hatano
authors.affiliation: Department of Neurology, Juntendo University Shizuoka Hospital, Shizuoka, Japan.
authors.forename: Sumihiro
authors.initials: S
authors.lastname: Kawajiri
authors.affiliation: Department of Neurology, Juntendo University Shizuoka Hospital, Shizuoka, Japan.
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Okuma
authors.affiliation: Department of Neurology, Juntendo University Nerima Hospital, Tokyo, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Machida
authors.affiliation: Department of Neurology, Juntendo University Nerima Hospital, Tokyo, Japan.
authors.forename: Hideto
authors.initials: H
authors.lastname: Miwa
authors.affiliation: Department of Diagnostic Radiology, Department of Molecular Medicine and Surgery, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden.
authors.forename: Chikako
authors.initials: C
authors.lastname: Suzuki
authors.affiliation: Nozomi Hospital, Saitama, Japan.
authors.forename: Asuka
authors.initials: A
authors.lastname: Kazama
authors.affiliation: Department of Neurology, Aomori Prefectural Central Hospital, Aomori, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Tomiyama
authors.affiliation: Department of Neurology, Rakuwakai Otowa Rehabilitation Hospital, Kyoto, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kihara
authors.affiliation: Department of Neurology, Tokyo Rinkai Hospital, Tokyo, Japan.
authors.forename: Motoyuki
authors.initials: M
authors.lastname: Hirasawa
authors.affiliation: Department of Neurology, Juntendo University Urayasu Hospital, Chiba, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Shimura
authors.affiliation: Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan.
authors.forename: Nobutaka
authors.initials: N
authors.lastname: Hattori
mesh_terms: D000368:Aged; D000978:Antiparkinson Agents / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006859:Hydrogen / Q000627:therapeutic use*; D007980:Levodopa / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D014867:Water
chemical_list: D000978:Antiparkinson Agents; D014867:Water; D007980:Levodopa; D006859:Hydrogen
keywords: Hydrogen; Parkinson’s disease; oxidative stress; randomized double-blind placebo-controlled multicenter trial