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

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

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Antiparkinson Agents / therapeutic use
  • Double-Blind Method
  • Female
  • Humans
  • Hydrogen / therapeutic use*
  • Levodopa / therapeutic use
  • Male
  • Middle Aged
  • Parkinson Disease / drug therapy*
  • Water*

Substances

  • Antiparkinson Agents
  • Water
  • Levodopa
  • Hydrogen