カワジリ　スミヒロ   KAWAJIRI Sumihiro   河尻　澄宏    所属   医学部 医学科（附属東洋医学研究所）    職種   准教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	A randomized double-blind multi-center trial of hydrogen water for Parkinson's disease: protocol and baseline characteristics.
掲載誌名	正式名：BMC neurology 略　 称：BMC Neurol ISSNコード：14712377/14712377
掲載区分	国外
巻・号・頁	16,pp.66
著者・共著者	Yoritaka Asako, Abe Takashi, Ohtsuka Chigumi, Maeda Tetsuya, Hirayama Masaaki, Watanabe Hirohisa, Saiki Hidemoto, Oyama Genko, Fukae Jiro, Shimo Yasushi, Hatano Taku, Kawajiri Sumihiro, Okuma Yasuyuki, Machida Yutaka, Miwa Hideto, Suzuki Chikako, Kazama Asuka, Tomiyama Masahiko, Kihara Takeshi, Hirasawa Motoyuki, Shimura Hideki, Hattori Nobutaka
発行年月	2016/05
概要	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).
DOI	10.1186/s12883-016-0589-0
PMID	27176725