Panacea Index Logo

Command Palette

Search for a command to run...

Effect of Melatonin on Sleep in the Perioperative Period after Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial.

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine
February 1, 2016
Michael Tvilling Madsen et al. (8 authors)
Journal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

To determine if 6 mg melatonin administered before bedtime perioperatively in breast cancer surgery patients improves sleep outcomes measured by actigraphy.

Results Summary

Melatonin significantly increased sleep efficiency and reduced wake after sleep onset postoperatively but had no effect on other objective sleep outcomes or subjective sleep quality measures (VAS and KSS). Overall, sleep outcomes remained within normal ranges, with no pathological disturbances reported.

Population

Breast cancer surgery patients.

Effective Dosage

6 mg approximately 60 minutes before bedtime.

Duration

From 3 nights preoperatively until at least one week postoperatively.

Interactions

None mentioned.

Extracted Claims (4)
InterventionDirectionEndpointPopulationDosageImpactClaim #
6 mg oral melatonin
increase
sleep efficiency
patients in breast cancer surgery
-
significantly increased
#1
6 mg oral melatonin
decrease
wake after sleep onset
patients in breast cancer surgery
-
reduced
#2
6 mg oral melatonin
no change
other objective sleep outcomes
patients in breast cancer surgery
-
had no effects
#3
6 mg oral melatonin
no change
subjective sleep quality (VAS and KSS)
patients in breast cancer surgery
-
had no effects
#4
Abstract

STUDY OBJECTIVES: To investigate whether administration of an oral dose of 6 mg melatonin before bedtime perioperatively in breast cancer surgery could change sleep outcomes measured by actigraphy. METHODS: This paper reports secondary outcomes from a double-blind, placebo-controlled, randomized clinical trial where patients received 6 mg melatonin (n = 27) or placebo (n = 21) approximately 60 minutes before bedtime 3 nights preoperatively until at least one week postoperatively. Participants were monitored in the entire period with actigraphy, and were instructed to complete visual analogue scale (VAS) for sleep, and the Karolinska Sleepiness Scale (KSS) each morning. RESULTS: Administration of 6 mg oral melatonin approximately 1 hour before bedtime resulted in significantly increased sleep efficiency and reduced wake after sleep onset for the entire 2-week postoperative period. No other significant differences for actigraphy determined sleep outcomes or subjective outcome parameters in the perioperative period were found between the groups. Overall, the patients sleep outcomes were within normal ranges and no participants had pathological sleep disturbances. CONCLUSIONS: Melatonin significantly changed sleep efficiency and wake after sleep onset after surgery, but had no effects on other objective sleep outcomes or on subjective sleep quality (VAS and KSS).

Medical Subject Headings (MeSH)
ActigraphyAdultAgedBreast NeoplasmsDouble-Blind MethodFemaleHumansHypnotics and SedativesMelatoninMiddle AgedPerioperative PeriodSleepVisual Analog Scale
Study Links
Quality Scores
Safety85
Efficacy70/10
Quality80/10
Citation Metrics
Total Citations46
Citations/Year5.1
Relative Citation Ratio2.20
NIH Percentile77.4%
Research Impact Scores
APT Score0.75
Weight Score1.98
Normalized Score0.78
Related Supplements