A randomized placebo-controlled trial evaluating the effect of melatonin on sleep quality in patients with mild–moderate dementia

Morales-Delgado, Rocio; Cámara-Lemarroy, Carlos R.; Salinas-Martínez, Ricardo; Gámez-Treviño, Daniel; Arredondo-Jaime, Alicia; Hernández-Maldonado, Edgar; Guajardo-Álvarez, Guillermo

doi:10.1007/s41999-018-0068-9

Cited by 10 publications

(8 citation statements)

References 27 publications

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“…Melatonin is a physiological indole amine that modulates circadian rhythms. Melatonin slightly improves sleep onset and sleep duration although the evidence remains inconclusive [72][73][74]. However, there are concerns about product quality and efficacy which may vary depending on the preparation [64].…”

Section: Alternatives For Benzodiazepines and Z-drugsmentioning

confidence: 99%

Therapeutic dilemmas with benzodiazepines and Z-drugs: insomnia and anxiety disorders versus increased fall risk: a clinical review

et al. 2022

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Purpose The aim of this clinical review was to summarise the existing knowledge on fall risk associated with benzodiazepines (BZDs) and Z-drugs in older people with focus on appropriate prescribing, including deprescribing. Methods We conducted a literature search in June 2021 in PubMed and Embase with citation and reference checking. Personal reference libraries and international websites were also used. Keywords for the searches included “benzodiazepines”, “Z-drugs”, “falls”, “deprescribing”, “fall-risk-increasing-drugs”, “inappropriate prescribing”, “older people” and matching synonyms. We discuss use of BZDs and Z-drugs, potential fall-related adverse reactions, alternatives for and deprescribing of BZDs and Z-drugs in older persons. Results BZDs and Z-drugs differ in fall-related adverse effect profile. They contribute to fall risk through orthostatic hypotension, dizziness and/or imbalance, sedation, muscular weakness, ataxia, etc. Fall incidents contribute significantly to mortality and morbidity. Therefore, there is a need for appropriate prescribing and use of BZDs and Z-drugs in older people. In practice, this means pertaining to a strict indication, strongly consider to non-pharmacological alternatives, limit use to the lowest dose and the shortest duration possible. Judicious deprescribing should be considered and encouraged as well. Practical resources, tools and algorithms are available to guide and assist clinicians in deprescribing BZDs and Z-drugs. Conclusions Prescribing BZDs and Z-drugs should be done in a well-considered way in fall-prone older people. A good overview and insight in the fall-related adverse effects of these drugs, as well as the availability of different strategies to increase the appropriate use, including deprescribing initiatives, can assist clinicians in clinical decision-making.

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Section: Alternatives For Benzodiazepines and Z-drugsmentioning

confidence: 99%

Therapeutic dilemmas with benzodiazepines and Z-drugs: insomnia and anxiety disorders versus increased fall risk: a clinical review

et al. 2022

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“…Of the 456 full-text studies first reviewed, 437 were excluded for the following reasons: ( 1 ) depression was not assessed quantitatively ( n = 97); ( 2 ) melatonin was not given to participants ( n = 194); ( 3 ) lack of placebo control ( n = 24); ( 4 ) melatonin was not solely used ( n = 36); ( 5 ) studies were not RCTs or randomized crossover trials ( n = 53); ( 6 ) no data were available ( n = 7); ( 7 ) study protocols ( n = 23); ( 8 ) publications in a language other than English ( n = 3). Consequently, 19 studies were included in the meta-analysis, among which 15 were RCTs ( 14 – 16 , 19 – 22 , 24 – 31 ) and four were randomized crossover trials ( 32 – 35 ).…”

Section: Resultsmentioning

confidence: 99%

The Therapeutic Effect of Exogenous Melatonin on Depressive Symptoms: A Systematic Review and Meta-Analysis

Tao

et al. 2022

Front. Psychiatry

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BackgroundDepression-related mortality and morbidity pose growing public health burdens worldwide. Although the therapeutic effect of exogenous melatonin on depression has been investigated, findings remain inconsistent. We conducted this systematic review and meta-analysis to clarify the effectiveness of melatonin in the treatment of depression, including primary and secondary depression symptoms.MethodsWe searched the online databases of PubMed, EMBASE, and the Cochrane Library for original studies published up to May 2021. We used STATA 14.0 software to synthesize the results of included studies. To evaluate the effectiveness of melatonin, we calculated the standardized mean differences (SMDs) and 95% confidence intervals (CIs) of depression scores between the melatonin and placebo groups.ResultsOur literature search returned 754 publications, among which 19 studies with 1,178 patients (715 women, 463 men; mean age: 56.77 years) met inclusion criteria. Melatonin dosages ranged from 2 to 25 mg per day; treatment durations were between 10 days and 3.5 years. Our synthesized results showed that melatonin was not found significantly beneficial for alleviating depressive symptoms (SMD = −0.17, 95% CI = [−0.38, 0.05]). Subgroup analysis demonstrated that the decrease in depression scores measured with the Beck Depression Inventory (BDI) was significant (SMD = −0.52, 95% CI = [−0.73, −0.31]).ConclusionsThere is very limited evidence for effects of melatonin on depression.

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“…Similar dose-dependent effects of exogenous melatonin on cognition could also be found in the previous RCTs. Specifically, significant beneficial effects on MMSE were found in patients with dementia receiving medium-dose melatonin supplementation [ 15 - 17 ] but not those receiving high-dose melatonin supplementation [ 18 , 175 ]. Furthermore, according to the previous RCT [ 3 ], low-dose melatonin in medium- to long-term but not short-term use could ameliorate cognitive decline along with the aging process [ 3 ].…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, according to the previous RCT [ 3 ], low-dose melatonin in medium- to long-term but not short-term use could ameliorate cognitive decline along with the aging process [ 3 ]. Therefore, based on the current NMA and previous RCTs [ 3 , 15 - 18 , 175 ], we hypothesize that the potential beneficial effects of exogenous melatonin on cognition might be restricted to a specific dosage for medium-term use, which might have a therapeutic window of low-dose (less than or equal to 3 mg/day) and medium-term use (at least 6 months but less than 1 year), but not a medium- or high-dose and short-term use.…”

Section: Discussionmentioning

confidence: 99%

The Dose and Duration-dependent Association between Melatonin Treatment and Overall Cognition in Alzheimer’s Dementia: A Network Meta- Analysis of Randomized Placebo-Controlled Trials

Tseng

Zeng

Chen

et al. 2022

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Background: While Alzheimer’s dementia (AD) has a prevalence as high as 3-32% and is associated with cognitive dysfunction and the risk of institutionalization, no efficacious and acceptable treatments can modify the course of cognitive decline in AD. Potential benefits of exogenous melatonin on cognition have been divergent across trials. Objective: The current network meta-analysis (NMA) was conducted under frequentist model to evaluate the potential benefits of exogenous melatonin supplementation on overall cognitive function in participants with AD in comparison with other FDA-approved medications (donepezil, galantamine, rivastigmine, memantine, and Namzaric). Methods: The primary outcome was the changes of the cognitive function [measured by mini-mental state examination (MMSE)] after treatment in patients with Alzheimer’s dementia. The secondary outcomes were change in the quality of life, behavioral disturbance, and acceptability (i.e. drop-out due to any reason and rate of any adverse event reported). Results: The current NMA of 50 randomized placebo-controlled trials (RCTs) revealed that the medium-term low-dose melatonin was associated with the highest post-treatment MMSE (mean difference = 1.48 in MMSE score, 95% confidence intervals [95% CIs] = 0.51 to 2.46) and quality of life (standardized mean difference = -0.64, 95% CIs = -1.13 to -0.15) among all of the investigated medications in the participants with AD. Finally, all of the investigated exogenous melatonin supplements were associated with similar acceptability as was the placebo. Conclusions: The current NMA provides evidence for the potential benefits of exogenous melatonin supplementation, especially medium-term low-dose melatonin, in participants with AD.

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A randomized placebo-controlled trial evaluating the effect of melatonin on sleep quality in patients with mild–moderate dementia

Cited by 10 publications

References 27 publications

Therapeutic dilemmas with benzodiazepines and Z-drugs: insomnia and anxiety disorders versus increased fall risk: a clinical review

Therapeutic dilemmas with benzodiazepines and Z-drugs: insomnia and anxiety disorders versus increased fall risk: a clinical review

The Therapeutic Effect of Exogenous Melatonin on Depressive Symptoms: A Systematic Review and Meta-Analysis

The Dose and Duration-dependent Association between Melatonin Treatment and Overall Cognition in Alzheimer’s Dementia: A Network Meta- Analysis of Randomized Placebo-Controlled Trials

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