A randomized double-blind multi-center trial of hydrogen water for Parkinson's disease: protocol and baseline characteristics.
A randomized double-blind multi-center trial of hydrogen water for Parkinson's disease: protocol and baseline characteristics.
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DOI：
10.1186/s12883-016-0589-0
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发表时间：
2016-05-12
期刊：
影响因子：
2.6
通讯作者：
Hattori N
中科院分区：
文献类型：
--
作者：
Yoritaka A;Abe T;Ohtsuka C;Maeda T;Hirayama M;Watanabe H;Saiki H;Oyama G;Fukae J;Shimo Y;Hatano T;Kawajiri S;Okuma Y;Machida Y;Miwa H;Suzuki C;Kazama A;Tomiyama M;Kihara T;Hirasawa M;Shimura H;Hattori N
我们之前的随机双盲研究表明，饮用氢 (H2) 水 48 周可显着改善接受左旋多巴治疗的帕金森病 (PD) 患者的统一帕金森病评定量表 (UPDRS) 总分。我们旨在通过随机双盲安慰剂对照多中心试验来证实这一结果。将评估从基线到第 8、24、48 和 72 周以及第 8 周之后的 UPDRS 总分的变化。这种治疗对 PD 疗效的主要终点是 UPDRS 总评分从基线到第 72 周的变化。还将分析 UPDRS 第 II 部分、UPDRS 第 III 部分、每个 UPDRS 评分、PD 问卷 39 (PDQ-39) 和修改后的 Hoehn 和 Yahr 阶段在这些相同时间点的变化，以及由于需要额外的左旋多巴而导致方案完成或疾病进展的持续时间。还将检查不良事件和筛查实验室研究。氢水组的参与者将每天饮用 1000 毫升的氢气水，而安慰剂水组的参与者将饮用普通水。 178 名 PD 参与者（89 名女性，89 名男性；平均年龄：64.2 [SD 9.2] 岁，总 UPDRS：23.7 [11.8]，使用左旋多巴药物：154 名参与者，未使用左旋多巴药物：24 名参与者；每日左旋多巴剂量：344.1 [202.8] mg，总左旋多巴当量剂量： 592.0 [317.6] mg）在 14 家医院入组并进行随机分组。这项研究将证实氢气水是否可以改善帕金森病症状。 UMIN000010014（2013 年 2 月 13 日）
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 8th, 24th, 48th, and 72nd weeks, and after the 8th 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 72nd 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 (89 women, 89 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)