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Melatonin on sleep in Parkinson's disease: A randomized double blind placebo controlled trial.

Sleep medicine
December 1, 2024
Ramkumar Sugumaran et al. (6 authors)
Journal ArticleRandomized Controlled TrialHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine the effect of melatonin on sleep quality and daytime sleepiness in patients with Idiopathic Parkinson's Disease (IPD) using subjective and objective assessments.

Results Summary

Melatonin significantly improved sleep quality (PSQI), reduced daytime sleepiness (ESS), and enhanced non-motor symptoms (NMSS) and quality of life (PDQ 39) compared to placebo, with minimal side effects. Polysomnography also showed improvements in sleep latency and total sleep time.

Population

IPD patients (young, short disease duration, high anticholinergic use, modest levodopa equivalent dose).

Effective Dosage

3 mg melatonin daily.

Duration

8 weeks.

Interactions

None mentioned.

Extracted Claims (10)
InterventionDirectionEndpointPopulationDosageImpactClaim #
melatonin (3 mg)
decrease
Pittsburgh Sleep Quality Index (PSQI) score
IPD patients
mean change of 1.87 (95% CI: 1.5-2.1; p = 0.001)
favoring melatonin
#1
melatonin (3 mg)
decrease
Epworth Sleepiness Scale (ESS) score
IPD patients
mean change of 1.25 (95% CI: 0.80-1.71; p = 0.001)
favoring melatonin
#2
melatonin (3 mg)
decrease
Non-Motor Symptoms Scale (NMSS)
IPD patients
mean difference of 6.11 (95% CI 5.27-6.92; p = 0.001)
favoring melatonin
#3
melatonin (3 mg)
decrease
Parkinson's Disease Questionnaire (PDQ 39)
IPD patients
mean difference of 8.12 (95% CI 6.97-9.50; p = 0.001)
favoring melatonin
#4
melatonin (3 mg)
decrease
Polysomnography (PSG) parameters - sleep latency
IPD patients
mean difference of 8.36 (95% CI 4.38-12.34; p = 0.001)
favoring melatonin
#5
melatonin (3 mg)
increase
Polysomnography (PSG) parameters - total sleep time
IPD patients
mean difference of 14.51 (95% CI 5.00-24.41; p = 0.005)
favoring melatonin
#6
melatonin (3 mg)
no change
side effects
IPD patients
minimal
side effects attributable to melatonin were minimal
#7
melatonin (3 mg)
decrease
sleep problems
PD patients
-
is an effective and safe treatment option
#8
melatonin (3 mg)
decrease
non-motor symptoms
PD patients
-
beneficial effects on sleep quality are associated with improved
#9
melatonin (3 mg)
increase
quality of life
PD patients
-
beneficial effects on sleep quality are associated with improved
#10
Abstract

BACKGROUND: Sleep disturbances are one of the most common non-motor symptoms in Idiopathic Parkinson's Disease (IPD) patients. However, the effect of melatonin on sleep problems in Parkinson's disease patients is unclear. AIMS AND OBJECTIVES: To study the effect of melatonin on sleep in IPD patients through subjective and objective assessment. METHODS: Between August 2023 to February 2024, we conducted a randomized, double-blind, placebo-controlled trial on IPD patients. We randomized eligible subjects to melatonin (3 mg) (n = 43) or placebo (n = 43) for 8 weeks. The primary endpoint was sleep quality assessed through the Pittsburgh sleep quality index and daytime sleepiness using Epworth sleepiness scale. Secondary endpoints were polysomnographic sleep parameters, quality of life, motor and non-motor symptoms. Assessments were done at baseline and at the end of 8 weeks. RESULTS: We screened 107 IPD patients and 86 patients were included in the study. Seventy three patients (melatonin, 35 and placebo, 38) completed the study. The mean change in Pittsburgh Sleep Quality Index (PSQI) score between the two groups was 1.87 (95 % CI: 1.5-2.1; p = 0.001) and Epworth Sleepiness Scale (ESS) score was 1.25 (95 % CI: 0.80-1.71; p = 0.001) favoring melatonin. The mean difference between the two groups for Non-Motor Symptoms Scale (NMSS) was 6.11 (95 % CI 5.27-6.92; p = 0.001), Parkinson's Disease Questionnaire (PDQ 39) 8.12 (95 % CI 6.97-9.50; p = 0.001) & Polysomnography (PSG) parameters [sleep latency 8.36 (95 % CI 4.38-12.34; p = 0.001) and total sleep time 14.51 (95 % CI 5.00-24.41; p = 0.005)] favoring melatonin. Side effects attributable to melatonin were minimal. CONCLUSION: Melatonin is an effective and safe treatment option for sleep problems in PD patients, and beneficial effects on sleep quality are associated with improved non-motor symptoms and quality of life. We need to emphasize the fact that though we had statistically significant changes in our outcomes, it is not clear whether such changes would have real-life impact (meaningfulness) that would be relevant to licensing authorities or management as patients in our study are young, have short disease duration, have high use of anticholinergics and on modest levodopa equivalent dose. So, we are doubtful if this could be generalized to the typical PD population who are older, have longer disease duration and are on potentially sedating medications or not.

Medical Subject Headings (MeSH)
HumansMelatoninParkinson DiseaseDouble-Blind MethodMaleFemaleAgedPolysomnographyQuality of LifeSleep Wake DisordersMiddle AgedSleep Quality
Study Links
Quality Scores
Safety85
Efficacy75/10
Quality80/10
Citation Metrics
Total Citations5
Citations/Year5.0
Relative Citation Ratio2.26
Research Impact Scores
APT Score0.50
Weight Score2.87
Normalized Score0.80
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