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首页> 外文期刊>Medical Gas Research >Open-label trial and randomized, double-blind, placebo-controlled, crossover trial of hydrogen-enriched water for mitochondrial and inflammatory myopathies
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Open-label trial and randomized, double-blind, placebo-controlled, crossover trial of hydrogen-enriched water for mitochondrial and inflammatory myopathies

机译：富氢水用于线粒体和炎症性肌病的开放标签试验和随机，双盲，安慰剂对照，交叉试验

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Background Molecular hydrogen has prominent effects on more than 30 animal models especially of oxidative stress-mediated diseases and inflammatory diseases. In addition, hydrogen effects on humans have been reported in diabetes mellitus type 2, hemodialysis, metabolic syndrome, radiotherapy for liver cancer, and brain stem infarction. Hydrogen effects are ascribed to specific radical-scavenging activities that eliminate hydroxyl radical and peroxynitrite, and also to signal-modulating activities, but the detailed molecular mechanisms still remain elusive. Hydrogen is a safe molecule that is largely produced by intestinal bacteria in rodents and humans, and no adverse effects have been documented. Methods We performed open-label trial of drinking 1.0 liter per day of hydrogen-enriched water for 12 weeks in five patients with progressive muscular dystrophy (PMD), four patients with polymyositis/dermatomyositis (PM/DM), and five patients with mitochondrial myopathies (MM), and measured 18 serum parameters as well as urinary 8-isoprostane every 4 weeks. We next conducted randomized, double-blind, placebo-controlled, crossover trial of 0.5 liter per day of hydrogen-enriched water or placebo water for 8 weeks in 10 patients with DM and 12 patients with MM, and measured 18 serum parameters every 4 weeks. Results In the open-label trial, no objective improvement or worsening of clinical symptoms was observed. We, however, observed significant effects in lactate-to-pyruvate ratios in PMD and MM, fasting blood glucose in PMD, serum matrix metalloproteinase-3 (MMP3) in PM/DM, and serum triglycerides in PM/DM. In the double-blind trial, no objective clinical effects were observed, but a significant improvement was detected in lactate in MM. Lactate-to-pyruvate ratios in MM and MMP3 in DM also exhibited favorable responses but without statistical significance. No adverse effect was observed in either trial except for hypoglycemic episodes in an insulin-treated MELAS patient, which subsided by reducing the insulin dose. Conclusions Hydrogen-enriched water improves mitochondrial dysfunction in MM and inflammatory processes in PM/DM. Less prominent effects with the double-blind trial compared to the open-label trial were likely due to a lower amount of administered hydrogen and a shorter observation period, which implies a threshold effect or a dose-response effect of hydrogen.
机译：背景技术分子氢对30多种动物模型具有显著作用，尤其是在氧化应激介导的疾病和炎性疾病方面。此外，在2型糖尿病，血液透析，代谢综合症，肝癌放疗和脑干梗塞中也有氢对人类的影响。氢效应归因于消除羟基自由基和过氧亚硝酸盐的特定自由基清除活性，也归因于信号调节活性，但是详细的分子机理仍然难以捉摸。氢是一种安全的分子，主要由啮齿动物和人类的肠道细菌产生，并且没有不良反应的记录。方法我们对5例进行性肌营养不良（PMD），4例多发性肌炎/皮肌炎（PM / DM）和5例线粒体肌病患者进行了开放标签试验，每天饮用1.0升富氢水12周。 （MM），并每4周测量18个血清参数以及尿中的8-异前列腺素。接下来，我们对10例DM患者和12例MM患者进行了随机，双盲，安慰剂对照的交叉试验，每天0.5升的富氢水或安慰剂水进行8周，并每4周测量18个血清参数。结果在开放标签试验中，未观察到客观症状改善或临床症状恶化。但是，我们观察到PMD和MM中乳酸与丙酮酸的比例，PMD中的空腹血糖，PM / DM中的血清基质金属蛋白酶3（MMP3）和PM / DM中的血清甘油三酯具有显着影响。在双盲试验中，未观察到客观的临床效果，但在MM中发现乳酸有明显改善。 DM中MM和MMP3中的乳酸对丙酮酸的比率也显示出良好的反应，但无统计学意义。在任一试验中均未观察到不良反应，只是在接受胰岛素治疗的MELAS患者中出现了低血糖发作，这可通过减少胰岛素剂量来缓解。结论富氢水可改善MM的线粒体功能障碍和PM / DM的炎症过程。与开放标签试验相比，双盲试验的显着效果较差，这可能是由于施用的氢气量较少且观察期较短，这意味着氢气的阈值效应或剂量反应效应。

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