Section of Human Nutrition and Dietetics, Department of Applied Health Sciences, Faculty of Medicine, Azienda di Servizi alla Persona di Pavia, University of Pavia, Pavia, Italy.
J Am Geriatr Soc. 2011 Jan;59(1):82-90. doi: 10.1111/j.1532-5415.2010.03232.x.
To determine whether nightly administration of melatonin, magnesium, and zinc improves primary insomnia in long-term care facility residents.
Double-blind, placebo-controlled clinical trial.
One long-term care facility in Pavia, Italy.
Forty-three participants with primary insomnia (22 in the supplemented group, 21 in the placebo group) aged 78.3 ± 3.9.
Participants took a food supplement (5 mg melatonin, 225 mg magnesium, and 11.25 mg zinc, mixed with 100 g of pear pulp) or placebo (100 g pear pulp) every day for 8 weeks, 1 hour before bedtime.
The primary goal was to evaluate sleep quality using the Pittsburgh Sleep Quality Index. The Epworth Sleepiness Scale, the Leeds Sleep Evaluation Questionnaire (LSEQ), the Short Insomnia Questionnaire (SDQ), and a validated quality-of-life instrument (Medical Outcomes Study 36-item Short Form Survey (SF-36)) were administered as secondary end points. Total sleep time was evaluated using a wearable armband-shaped sensor. All measures were performed at baseline and after 60 days.
The food supplement resulted in considerably better overall PSQI scores than placebo (difference between groups in change from baseline PSQI score=6.8; 95% confidence interval=5.4-8.3, P<.001). Moreover, the significant improvements in all four domains of the LSEQ (ease of getting to sleep, P<.001; quality of sleep, P<.001; hangover on awakening from sleep, P=.005; alertness and behavioral integrity the following morning, P=.001), in SDQ score (P<.001), in total sleep time (P<.001), and in SF-36 physical score (P=.006) suggest that treatment had a beneficial effect on the restorative value of sleep.
The administration of nightly melatonin, magnesium, and zinc appears to improve the quality of sleep and the quality of life in long-term care facility residents with primary insomnia.
确定在长期护理机构居民中，每晚给予褪黑素、镁和锌是否能改善原发性失眠。
双盲、安慰剂对照临床试验。
意大利帕维亚的一家长期护理机构。
43 名原发性失眠患者（补充组 22 名，安慰剂组 21 名），年龄 78.3±3.9 岁。
参与者每天睡前 1 小时服用补充剂（5mg 褪黑素、225mg 镁和 11.25mg 锌，混合在 100g 梨果肉中）或安慰剂（100g 梨果肉），持续 8 周。
主要目标是使用匹兹堡睡眠质量指数评估睡眠质量。还使用了 Epworth 嗜睡量表、利兹睡眠评估问卷（LSEQ）、简短失眠问卷（SDQ）和经过验证的生活质量工具（医疗结果研究 36 项简短形式调查（SF-36））作为次要终点。总睡眠时间使用可穿戴臂带式传感器进行评估。所有措施均在基线和 60 天后进行。
补充剂的整体 PSQI 评分明显优于安慰剂（组间 PSQI 评分变化差值=6.8；95%置信区间=5.4-8.3，P<.001）。此外，LSEQ 的所有四个领域（入睡容易度、睡眠质量、睡眠后醒来的残留、次日清晨的警觉性和行为完整性）、SDQ 评分（P<.001）、总睡眠时间（P<.001）和 SF-36 生理评分（P<.001）均有显著改善，表明治疗对睡眠的恢复价值有有益影响。
每晚给予褪黑素、镁和锌可改善长期护理机构原发性失眠患者的睡眠质量和生活质量。
