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Effects of fluoxetine and melatonin on mood, sleep quality and body mass index in postmenopausal women.

Journal of physiology and pharmacology : an official journal of the Polish Physiological Society
October 1, 2015
C Chojnacki et al. (6 authors)
Comparative StudyJournal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate the efficacy of melatonin combined with fluoxetine in treating mood, sleep, and appetite disorders in postmenopausal women.

Results Summary

The study found that melatonin combined with fluoxetine significantly reduced insomnia severity and BMI, while also showing comparable reductions in anxiety and depression to fluoxetine alone. The melatonin group showed greater improvements in sleep and weight management compared to the placebo group.

Population

Overweight postmenopausal women aged 54-65 with increased appetite (n=64).

Effective Dosage

5 mg melatonin in the evening, daily.

Duration

24 weeks.

Interactions

None mentioned.

Extracted Claims (7)
InterventionDirectionEndpointPopulationDosageImpactClaim #
fluoxetine (20 mg in the morning) and placebo (in the evening)
decrease
level of anxiety and depression
overweight postmenopausal women, aged 54 - 65 years, with increased appetite
statistically significant reduction
comparable and statistically significant reduction
#1
fluoxetine (20 mg in the morning) and melatonin (5 mg in the evening)
decrease
level of anxiety and depression
overweight postmenopausal women, aged 54 - 65 years, with increased appetite
statistically significant reduction
comparable and statistically significant reduction
#2
fluoxetine (20 mg in the morning) and placebo (in the evening)
decrease
insomnia severity index (ISI)
overweight postmenopausal women, aged 54 - 65 years, with increased appetite
from 14.9 ± 2.5 points to 10.9 ± 1.9 points
decreased
#3
fluoxetine (20 mg in the morning) and melatonin (5 mg in the evening)
decrease
insomnia severity index (ISI)
overweight postmenopausal women, aged 54 - 65 years, with increased appetite
from 15.8 ± 2.4 points to 7.7 ± 1.5 points
decreased
#4
fluoxetine (20 mg in the morning) and placebo (in the evening)
no change
body mass index (BMI)
overweight postmenopausal women, aged 54 - 65 years, with increased appetite
no reduction
no reduction
#5
fluoxetine (20 mg in the morning) and melatonin (5 mg in the evening)
decrease
body mass index (BMI)
overweight postmenopausal women, aged 54 - 65 years, with increased appetite
from 30.9 ± 3.1 to 26.3 ± 3.2
decreased
#6
combined administration of fluoxetine and melatonin
decrease
mood, sleep and appetite disorders
postmenopausal women
-
was useful option to treat
#7
Abstract

Frequent mood and sleep disorders and increased appetite leading to obesity are observed in postmenopausal women. Due to the limitations of hormone replacement therapy the researchers look for other treatment regimes. The aim of the study was to evaluate the efficacy of fluoxetine and melatonin in the treatment of these disorders. The study included 64 overweight postmenopausal women, aged 54 - 65 years, with increased appetite. They were randomly assigned in 2 groups. In group I (n = 30) fluoxetine (20 mg in the morning) and placebo (in the evening) were administered for 24 weeks. Group II (n = 34) received fluoxetine (20 mg in the morning) and melatonin (5 mg in the evening) in the same period of time. Hamilton anxiety rating scale (HARS), Beck depression scale (BDI), the insomnia severity index (ISI) and body mass index (BMI) were used to assess the health status and the treatment efficacy. After 24 weeks, comparable and statistically significant reduction in the level of anxiety and depression was obtained in both groups. In group I, the ISI decreased from 14.9 ± 2.5 points to 10.9 ± 1.9 points (P < 0.05) and in group II from 15.8 ± 2.4 points to 7.7 ± 1.5 points (P < 0.001). In group I no reduction in BMI was achieved whereas in group II this index decreased from 30.9 ± 3.1 to 26.3 ± 3.2 (P < 0.05). We conclude that combined administration of fluoxetine and melatonin was useful option to treat mood, sleep and appetite disorders in postmenopausal women.

Medical Subject Headings (MeSH)
AffectAgedAnxietyAppetiteBody Mass IndexDepressionDouble-Blind MethodDrug Therapy, CombinationFemaleFluoxetineHumansMelatoninMiddle AgedOverweightPostmenopausePsychiatric Status Rating ScalesSelective Serotonin Reuptake InhibitorsSleepTreatment Outcome
Study Links
PubMed ID26579572
Quality Scores
SafetyNot Assessed
Efficacy85/10
Quality75/10
Citation Metrics
Total Citations38
Citations/Year3.8
Relative Citation Ratio1.75
NIH Percentile70.2%
Research Impact Scores
APT Score0.75
Weight Score1.75
Normalized Score0.69
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