There is a lack of effective therapies for stroke patients; its treatment is even more difficult considering the unexpected onset of the disease. In the last decade, melatonin has emerged as a promising neuroprotective agent which is able to cross the blood-brain-barrier (BBB) and with a low toxicity profile. The aim of this systematic review was to summarize and critically review clinical and pre-clinical evidence related to melatonin's effectiveness as a stroke treatment. Together with a comparative dose extrapolation with those used in the selected randomized controlled trials (RCTs), and based on these data to discuss whether the administered doses correlate with those advisable in human patients. To address this purpose, we performed a systematic review of the available literature. A total of 529 records were screened with the selecting of six full articles containing RCTs that met the inclusion/exclusion criteria. The evidence drawn from these six reports was analyzed to identify remaining gaps, treatment efficacy, and to suggest future directions. The primary outcome reported was the reduction of the oxidative response; the secondary outcome was the increase of the survival rate of the patients in the intervention groups. Calculations derived from animal studies revealed that the translational doses to humans were substantially higher than those employed in the RCTs. The findings of this systematic review revealed that there are insufficient RCTs to prove melatonin's value in stroke patients. Nevertheless, the evidence is promising, and further clinical research may support the benefits of melatonin in stroke patients, if the adequate dose is administered.

中文翻译：

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褪黑素在中风患者中的功效；剂量问题？系统的审查。

对于中风患者缺乏有效的治疗方法。考虑到疾病的意外发作，其治疗甚至更加困难。在过去的十年中，褪黑激素已经成为一种有前途的神经保护剂，它能够穿过血脑屏障（BBB）并且毒性低。这项系统评价的目的是总结和严格审查与褪黑素作为中风治疗有效性有关的临床和临床前证据。并与所选随机对照试验（RCT）中使用的剂量进行比较剂量外推，并基于这些数据来讨论给药剂量是否与人类患者建议的剂量相关。为了达到这个目的，我们对现有文献进行了系统的回顾。通过选择六篇包含符合纳入/排除标准的RCT的全文，筛选了总共529条记录。分析了从这六份报告中得出的证据，以找出剩余的差距，治疗效果并提出未来的方向。报道的主要结果是氧化反应的减少。次要结果是干预组患者生存率的提高。来自动物研究的计算表明，对人的翻译剂量大大高于RCT中使用的剂量。这项系统评价的结果表明，尚无足够的RCT来证明脑卒中患者褪黑激素的价值。不过，证据是有希望的，进一步的临床研究可能支持褪黑激素在中风患者中的益处，