title: Efficacy of melatonin in the treatment of endometriosis: a phase II, randomized, double-blind, placebo-controlled trial.
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.
authors.affiliation: Laboratory of Pain & Neuromodulation at Hospital de Clínicas de Porto Alegre (HCPA)/Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.
authors.forename: André
authors.initials: A
authors.lastname: Schwertner
authors.forename: Claudia C
authors.initials: CC
authors.lastname: Conceição Dos Santos
authors.forename: Gislene Dalferth
authors.initials: GD
authors.lastname: Costa
authors.forename: Alícia
authors.initials: A
authors.lastname: Deitos
authors.forename: Andressa
authors.initials: A
authors.lastname: de Souza
authors.forename: Izabel Cristina Custodio
authors.initials: IC
authors.lastname: de Souza
authors.forename: Iraci L S
authors.initials: IL
authors.lastname: Torres
authors.forename: João Sabino L
authors.initials: JS
authors.lastname: da Cunha Filho
authors.forename: Wolnei
authors.initials: W
authors.lastname: Caumo
mesh_terms: D000293:Adolescent; D000328:Adult; D000700:Analgesics / Q000494:pharmacology / Q000627:therapeutic use; D004311:Double-Blind Method; D004412:Dysmenorrhea / Q000188:drug therapy*; D004715:Endometriosis / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008550:Melatonin / Q000494:pharmacology / Q000627:therapeutic use*; D008875:Middle Aged; D010049:Ovarian Diseases / Q000188:drug therapy*; D010147:Pain Measurement; D017699:Pelvic Pain / Q000188:drug therapy*; D012890:Sleep / Q000187:drug effects; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D008550:Melatonin