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Efficacy of melatonin in the treatment of endometriosis: a phase II, randomized, double-blind, placebo-controlled trial.

Pain
June 1, 2013
André Schwertner et al. (9 authors)
Clinical Trial, Phase IIJournal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to investigate the effects of melatonin compared to placebo on endometriosis-associated chronic pelvic pain (EACPP), brain-derived neurotrophic factor (BDNF) levels, and sleep quality.

Results Summary

Melatonin significantly reduced daily pain scores by 39.80% and dysmenorrhea by 38.01%, improved sleep quality, reduced analgesic use by 80%, and lowered BDNF levels independently of pain effects. The study demonstrated melatonin's analgesic and anti-inflammatory properties in EACPP.

Population

Females aged 18-45 years with endometriosis-associated chronic pelvic pain.

Effective Dosage

10 mg melatonin daily.

Duration

8 weeks.

Interactions

None mentioned.

Extracted Claims (5)
InterventionDirectionEndpointPopulationDosageImpactClaim #
melatonin
decrease
daily pain scores
Forty females, aged 18 to 45 years
39.80%
reduced
#1
melatonin
decrease
dysmenorrhea
Forty females, aged 18 to 45 years
38.01%
reduced
#2
melatonin
increase
sleep quality
Forty females, aged 18 to 45 years
-
improved
#3
melatonin
decrease
risk of using an analgesic
Forty females, aged 18 to 45 years
80%
reduced the risk of using an analgesic
#4
melatonin
decrease
BNDF levels
Forty females, aged 18 to 45 years
-
reduced
#5
Abstract

Endometriosis-associated chronic pelvic pain (EACPP) presents with an intense inflammatory reaction. Melatonin has emerged as an important analgesic, antioxidant, and antiinflammatory agent. This trial investigates the effects of melatonin compared with a placebo on EACPP, brain-derived neurotrophic factor (BDNF) level, and sleep quality. Forty females, aged 18 to 45 years, were randomized into the placebo (n = 20) or melatonin (10 mg) (n = 20) treatment groups for a period of 8 weeks. There was a significant interaction (time vs group) regarding the main outcomes of the pain scores as indexed by the visual analogue scale on daily pain, dysmenorrhea, dysuria, and dyschezia (analysis of variance, P < 0.01 for all analyses). Post hoc analysis showed that compared with placebo, the treatment reduced daily pain scores by 39.80% (95% confidence interval [CI] 12.88-43.01%) and dysmenorrhea by 38.01% (95% CI 15.96-49.15%). Melatonin improved sleep quality, reduced the risk of using an analgesic by 80%, and reduced BNDF levels independently of its effect on pain. This study provides additional evidence regarding the analgesic effects of melatonin on EACPP and melatonin's ability to improve sleep quality. Additionally, the study revealed that melatonin modulates the secretion of BDNF and pain through distinct mechanisms.

Medical Subject Headings (MeSH)
AdolescentAdultAnalgesicsDouble-Blind MethodDysmenorrheaEndometriosisFemaleHumansMelatoninMiddle AgedOvarian DiseasesPain MeasurementPelvic PainSleepTreatment Outcome
Study Links
Quality Scores
SafetyNot Assessed
Efficacy85/10
Quality80/10
Citation Metrics
Total Citations98
Citations/Year8.2
Relative Citation Ratio4.05
NIH Percentile90.3%
Research Impact Scores
APT Score0.95
Weight Score1.71
Normalized Score0.70
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