Melatonin on sleep in Parkinson's disease: A randomized double blind placebo controlled trial
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 107 participants or records.
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