本研究的亮点：采用随机、双盲、安慰剂对照，观察了氢气水对患者线粒体和炎症肌病（肌肉营养不良）的治疗效果。

分子氢气具有许多神奇的效应，超过30多种动物疾病模型中发现氢气具有治疗氧化应激相关疾病的作用。更重要的是，在临床研究中，人们发现氢气对人类二型糖尿病、血液透析、代谢综合征、肝癌放射治疗的损伤、脑干中风具有显著治疗效果。氢气治疗疾病的细胞学机制被认为是通过清除羟基自由基、过氧亚硝酸根这样具有强大氧化作用的自由基（不影响温和的过氧化氢等），而且氢气也可以影响细胞内信号系统。但是目前人们对氢气生物效应的分子细节仍不清楚（这里确实是一个非常令人值得期待的研究方向）。氢气是一个具有生物安全性的分子，人体内不停产生，到目前几乎没有任何明显不良作用被发现。因此氢气相关药物可能成为一类令人神往的临床应用药物。本文是第一个氢气医学领域的双盲随机对照研究。

先开展的开放性试验（试探性研究）中让进行性肌肉营养不良（进行性肌萎缩）患者每天饮1升富氢气水，连续12周。其中，4例患者为多发性肌炎-皮肌炎（似乎是自身免疫性疾病），5例患者为线粒体病。每四周检测18类血清学指标和尿的人8-异前列腺素F2a（8-isoprostane是可以说明氧化损伤程度的指标）。在随后的随机、双盲、安慰剂试验中，有10例DM(肌病)和12例线粒体病患者，给患者连续8周（怎么没有用12周）0.5升富氢水（为什么不是1升）或普通水（安慰剂），每4周检测18类血清指标。

研究结果：在该开放性研究（患者和医生了解治疗情况的研究）中，没有发现临床症状的加重或减轻。但是，发现氢气在肌肉病患者中乳糖/丙酮酸比例，餐后血糖，血清MMP3和血清甘油三脂具有显著影响。在双盲试验中，也没有发现明显的临床效果，但DM患者的乳糖/丙酮酸比例，和MM患者的血清MMP3仍明显改变，尽管没有统计学差异。没有在糖尿病患者中发现任何不良效应。

结论：氢气水MM患者的对线粒体功能和PM/DM患者的炎症反应过程具有治疗效果，但双盲试验中效果较差的原因可能是剂量比较小和观察时间比较短（为什么不增加剂量，延长观察时间？）。但也说明氢气的效果存在一个最低有效剂量（意思是说不能喝太少，至少要1升，有广告嫌疑），而且有剂量效应（更确认效果的可靠性）。

Research

Open-label trial and randomized, double-blind, placebo-controlled, crossover trial of hydrogen-enriched water for mitochondrial and inflammatory myopathies

Mikako Ito, Tohru Ibi, Ko Sahashi, Masatoshi Ichihara, Masafumi Ito and Kinji Ohno

For all author emails, please log on.

Medical Gas Research 2011, 1:24 doi:10.1186/2045-9912-1-24

Published: 3 October 2011

Abstract (provisional)

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.