Melatonin does not reduce delirium severity in hospitalized older adults: Results of a randomized placebo‐controlled trial.
Background: Delirium is common in older inpatients, causing distress, cognitive decline, and death. Current therapies are unsatisfactory, limited by lack of efficacy and adverse effects. There is an urgent need for effective delirium treatment. Sleep wake cycle is disturbed in delirium; endogenous M...
| Publicado en: | Journal of the American Geriatrics Society Vol. 72; no. 6; pp. 1802 - 1810 |
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| Autores principales: | , , , , , , , |
| Formato: | Artículo |
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Wiley-Blackwell
Jun2024
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| Materias: | |
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ssf&AN=177946620&site=ehost-live header: @attributes: shortDbName: ssf uiTerm: 177946620 longDbName: Social Sciences Full Text (H.W. Wilson) uiTag: AN controlInfo: bkinfo: jinfo: jid: 00028614 20Q jtl: Journal of the American Geriatrics Society issn: 00028614 maglogo: Y pubinfo: dt: Jun2024 vid: 72 iid: 6 pid: 480 pub: Wiley-Blackwell artinfo: ui: 177946620 10.1111/jgs.18825 ppf: 1802 ppct: 8 formats: tig: atl: Melatonin does not reduce delirium severity in hospitalized older adults: Results of a randomized placebo‐controlled trial. aug: au: Lange, Peter W. Turbić, Alisa Soh, Cheng Hwee Clayton‐Chubb, Daniel Lim, Wen Kwang Conyers, Rachel Watson, Rosie Maier, Andrea B. affil: Department of Aged Care and Medicine, The Royal Melbourne Hospital, Melbourne Medical School, The University of Melbourne, Parkville Victoria,, Australia Department of Geriatrics and General Medicine, Werribee Mercy Hospital, Werribee Victoria,, Australia Bone and Fractures Research Program, Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne Victoria,, Australia Department of Gastroenterology, Alfred Health, Prahran Victoria,, Australia Department of Gastroenterology, Eastern Health, Box Hill Victoria,, Australia Department of Medicine, Central Clinical School, Monash University, Victoria,, Australia Department of Paediatrics, The University of Melbourne, Parkville Victoria,, Australia Heart Disease, Stem Cell Biology, Murdoch Children's Research Institute, Parkville Victoria,, Australia Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Parkville, Australia Department of Human Movement Sciences, @AgeAmsterdam, Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, The Netherlands Healthy Longevity Translational Research Program, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore Centre for Healthy Longevity, @AgeSingapore, National University Health System, Singapore, Singapore su: Placebos Blind experiment Randomized controlled trials Hospital care of older people Old age Controlled release preparations Data analysis Research funding Statistical sampling Severity of illness index Melatonin Oral drug administration Treatment effectiveness Tertiary care Descriptive statistics Mann Whitney U Test Delirium Statistics Internal medicine Comparative studies Length of stay in hospitals Sleep quality Sleep disorders Drug tolerance sug: subj: Placebos Blind experiment Randomized controlled trials Hospital care of older people Old age Marketing Research and Public Opinion Polling Specialty (except Psychiatric and Substance Abuse) Hospitals Controlled release preparations Data analysis Research funding Statistical sampling Severity of illness index Melatonin Oral drug administration Treatment effectiveness Tertiary care Descriptive statistics Mann Whitney U Test Delirium Statistics Internal medicine Comparative studies Length of stay in hospitals Sleep quality Sleep disorders Drug tolerance keyword: aged neurocognitive disorders delirium inpatients melatonin sepsis‐associated encephalopathy sleep wake disorders aged neurocognitive disorders delirium inpatients melatonin sepsis‐associated encephalopathy sleep wake disorders ab: Background: Delirium is common in older inpatients, causing distress, cognitive decline, and death. Current therapies are unsatisfactory, limited by lack of efficacy and adverse effects. There is an urgent need for effective delirium treatment. Sleep wake cycle is disturbed in delirium; endogenous Melatonin is perturbed, and exogenous Melatonin is a safe and effective medication for sleep disorders. This study aims to determine the effect of oral Melatonin 5 mg immediate release (IR) nightly for five nights on the severity of delirium in older (≥65 years) medical inpatients. Methods: This was a double‐blinded, randomized controlled trial in general internal medicine units of a tertiary teaching hospital. Older inpatients with Confusion Assessment Method positive, hyperactive or mixed delirium within 48 h of admission or onset of in‐hospital delirium were included. The primary outcome was change in delirium severity measured with the Memorial Delirium Assessment Scale (MDAS). A previous pilot trial showed 120 participants randomized 1:1 to Melatonin or Placebo would provide 90% power to demonstrate a 3‐point reduction in the MDAS. Results: One hundred and twenty participants were randomized, 61 to Melatonin 5 mg and 59 to Placebo. The medication was well tolerated. The mean MDAS improvement was 4.9 (SD 7.6) in the Melatonin group and 5.4 (SD 7.2) in the Placebo group, p‐value 0.42, a non‐significant difference. A post‐hoc analysis showed length of stay (LOS) was shorter in the intervention group (median 9 days [Interquartile Range (IQR) 4, 12] vs. Placebo group 10 [IQR 6, 16] p‐value = 0.033, Wilcoxon Rank Sum test). Conclusions: This trial does not support the hypothesis that Melatonin reduces the severity of delirium. This may be due to no effect of Melatonin, a smaller effect than anticipated, an effect not captured on a multidimensional delirium assessment scale, or a type II statistical error. Melatonin may improve LOS; this hypothesis should be studied. pubtype: Academic Journal doctype: Article src: R language: English refInfo: copyright: @attributes: flag: N holdings: @attributes: islocal: N |
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