Djokic Gorica, Vojvodić Petar, Korcok Davor, Agic Anita, Rankovic Anica, Djordjevic Vladan, Vojvodic Aleksandra, Vlaskovic-Jovicevic Tatjana, Peric-Hajzler Zorica, Matovic Dusica, Vojvodic Jovana, Sijan Goran, Wollina Uwe, Tirant Michael, Thuong Nguyen Van, Fioranelli Massimo, Lotti Torello
Clinic for Mental Disorders "Dr. Laza Lazarevic", Belgrade, Serbia.
Abela Pharm, Belgrade, Serbia.
Open Access Maced J Med Sci. 2019 Aug 30;7(18):3101-3105. doi: 10.3889/oamjms.2019.771. eCollection 2019 Sep 30.
Insomnia means difficulty in falling asleep and/or stays asleep. Insomnia commonly leads to daytime sleepiness, lethargy, and a general feeling of being unwell. The most common treatment of insomnia includes GABAA receptor positive allosteric modulators or Melatonin agonists. Our study aimed to evaluate the efficacy of Magnesium- melatonin-vitamin B complex supplement in the treatment of insomnia. The study included 60 patients diagnosed with insomnia. The patients were randomly divided into study group (N = 30), and control group (N = 30), and study group was treated with Magnesium-melatonin-vitamin B complex (one dose contains 175 mg liposomal magnesium oxide, 10 mg Vit B6, 16 μg vit B12, melatonin 1 mg, Extrafolate-S 600 μg) once a day 1 hour before sleep, during the 3 months. The severity of insomnia symptoms was measured by self-reported Athens insomnia scale (AIS), with a cut-off score by Soldatos (AIS score ≥ 6). Mean AIS score at zero points was 14.93 ± 3.778 in the study group and 14.37 ± 4.081 in the control group (p = 0.476), indicating the compatibility of the groups, and both scores correspond to mild to moderate insomnia. Mean AIS score after 3 months of the Magnesium- melatonin- vitamin B complex supplementation was 10.50 ± 4.21 corresponding to mild insomnia, while median AIS score in the control group was 15.13 ± 3.76 which is referred to moderate insomnia, and difference among groups was significant (p = 0.000). Our founding's indicating that 3 months of the Magnesium- melatonin-vitamin B complex supplementation has a beneficial effect in the treatment of insomnia regardless of cause.
失眠是指入睡困难和/或难以维持睡眠。失眠通常会导致日间嗜睡、无精打采以及身体不适的总体感觉。失眠最常见的治疗方法包括GABAA受体正向变构调节剂或褪黑素激动剂。我们的研究旨在评估镁 - 褪黑素 - B族维生素复合物补充剂治疗失眠的疗效。该研究纳入了60名被诊断为失眠的患者。患者被随机分为研究组（N = 30）和对照组（N = 30），研究组在3个月内每天睡前1小时服用镁 - 褪黑素 - B族维生素复合物（一剂含有175毫克脂质体氧化镁、10毫克维生素B6、16微克维生素B12、1毫克褪黑素、600微克叶酸）。通过自我报告的雅典失眠量表（AIS）测量失眠症状的严重程度，Soldatos设定的临界值为（AIS评分≥6）。研究组零点时的平均AIS评分为14.93±3.778，对照组为1十四点三七±4.081（p = 0.476），表明两组具有可比性，且两个评分均对应轻度至中度失眠。补充镁 - 褪黑素 - B族维生素复合物3个月后的平均AIS评分为10.50±4.21，对应轻度失眠，而对照组的AIS中位数评分为15.13±三点七六，属于中度失眠，两组间差异有统计学意义（p = 0.000）。我们的研究结果表明，无论病因如何，补充3个月的镁 - 褪黑素 - B族维生素复合物对失眠治疗都有有益作用。
