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The Effect of Melatonin, Magnesium, and Zinc on Primary Insomnia in Long‐Term Care Facility Residents in Italy: A Double‐Blind, Placebo‐Controlled Clinical Trial
Author(s) -
Rondanelli Mariangela,
Opizzi Annalisa,
Monteferrario Francesca,
Antoniello Neldo,
Manni Raffaele,
Klersy Catherine
Publication year - 2011
Publication title -
journal of the american geriatrics society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.992
H-Index - 232
eISSN - 1532-5415
pISSN - 0002-8614
DOI - 10.1111/j.1532-5415.2010.03232.x
Subject(s) - medicine , pittsburgh sleep quality index , placebo , insomnia , epworth sleepiness scale , multivitamin , bedtime , melatonin , morning , physical therapy , randomized controlled trial , sleep onset , primary insomnia , sleep disorder , polysomnography , psychiatry , sleep quality , vitamin , apnea , alternative medicine , pathology
OBJECTIVES: To determine whether nightly administration of melatonin, magnesium, and zinc improves primary insomnia in long‐term care facility residents. DESIGN: Double‐blind, placebo‐controlled clinical trial. SETTING: One long‐term care facility in Pavia, Italy. PARTICIPANTS: Forty‐three participants with primary insomnia (22 in the supplemented group, 21 in the placebo group) aged 78.3±3.9. INTERVENTION: 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. MEASUREMENTS: 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. RESULTS: 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. CONCLUSION: 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.