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Melatonin for the treatment of dementia (Review) Open Access


Author or creator
Jansen, S.L.
Forbes, D.
Duncan, V.
Morgan, D.G.
Malouf, R.
Additional contributors
Cognition disorders (drug therapy; etiology)
Randomized controlled trials as topic
Sleep initiation and maintenance disorders (drug therapy)
Melatonin (deficiency; therapeutic use)
Dementia (drug therapy; etiology)
Antioxidants (therapeutic use)
Type of item
Background There are a number of studies that suggest a relationship between decline of melatonin function and the symptoms of dementia. Objectives The review assessed the evidence of clinical effectiveness of melatonin in the treatment of symptoms of dementia. Relevant primary outcomes were cognition, mood, behaviour, functions of daily living, and safety of melatonin use and secondary outcomes were quality of life, morbidity, mortality and length of time to institutionalization and caregiver stress. Search methods The Specialized Register of the Cochrane Dementia and Cognitive Improvement Group (CDCIG), The Cochrane Library,MEDLINE, EMBASE, PsycINFO, CINAHL and LILACS were searched on 29 June 2009 using the terms: MELATONIN and N-ACETYL-5- METHOXYTRYPTAMINE. The CDCIG Specialized Register contains records from all major health care databases (The Cochrane Library, MEDLINE, EMBASE, PsycINFO, CINAHL, LILACS) as well as from many trials databases and grey literature sources. The search of June 2009 retrieved several studies for consideration by the authors. Selection criteria All relevant, randomized controlled trials in which orally administered melatonin in any dosage was compared with a control group for the effect on managing cognitive, behavioral (excluding sleep), and mood disturbances of people with dementia of any degree of severity. Data collection and analysis Two to three reviewers independently assessed the retrieved articles for relevance and risk of bias, and extracted data from the selected studies. Statistically significant differences in end-points or changes in outcomes frombaseline to end of treatment between themelatonin and control groups were examined. Each study was summarized using a measure of effect (e.g. mean difference) and meta-analyses were conducted when appropriate. Main results Five studies met the inclusion criteria. The pooled estimates of MMSE cognitive and ADAS-cognitive change scores from three of these studies revealed non-significant cognitive effects for melatonin treatment. In two of these studies, significant improvements in psychopathological behaviours (e.g., decreased mood symptoms of depression, anxiety and apathy and decreased behavior symptoms of hallucinations, delusions, agitation, irritability, and appetite disturbances), were found from meta-analysis of the change scores from the NPI (7 weeks, 2.5 mg melatonin), and ADAS non-cognitive (4 weeks, 3 mg melatonin) scales. Sensitivity analyses found similar results to those of the original meta-analyses, and thus, supported the effect estimates for non-significant cognitive outcomes. Individual study estimates for treatment effect of 2.5 mg melatonin at one year demonstrated a significant worsening of mood (e.g. decrease in positive affect) as measured by the Philadelphia Geriatric Centre Affect Rating Scale (positive). The remainder of the treatment effects for mood, behavior, and function of daily living were non-significant. There were no reported adverse effects associated with melatonin use. Authors’ conclusions The analyses did not support the use of melatonin for treatment of cognitive impairment associated with dementia. Meta-analysis of psychopathologic behavior scale scores suggested that melatonin may be effective in treating these dementia-related disturbances. P L A I N L A N G U A G E S U M M A R Y Melatonin treatment may be effective for the treatment of dementia-related behavior disturbances There are a number of studies that suggest a relationship between decline of melatonin function and the symptoms of dementia. Metaanalysis was conducted on data from three randomised, placebo controlled trials that were designed to evaluate melatonin for managing dementia-related cognitive changes; data also were pooled from two of these trials that evaluated melatonin for managing mood and behavioral disturbances. Significantly improved outcomes were found from the meta-analysis of psychopathologic behavior and mood scale scores. Melatonin treatment may be effective for the treatment of dementia-related psychopathologic behavior disturbances. No evidence was found to support the effectiveness of melatonin for the treatment of cognitive impairment.
Date created
License information
© 2006 The Cochrane Collaboration for John Wiley & Sons, Ltd. This version of this article is open access and can be downloaded and shared. The original author(s) and source must be cited.
Citation for previous publication
Jansen SL, Forbes D, Duncan V, Morgan DG, Malouf R. (2006). Melatonin for the treatment of dementia. Cochrane Database of Systematic Reviews, Issue 1, Art. No.: CD003802. DOI: 10.1002/14651858.CD003802.pub3.
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File title: Melatonin for the treatment of dementia
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