title: Role of paroxetine in the management of hot flashes in gynecological cancer survivors: Results of the first randomized single-center controlled trial.
abstract: OBJECTIVE
  To examine the effects of paroxetine supplementation on hot flashes and sleep in gynecological cancer survivors.
  
  
  METHODS
  In a randomized, double-blind, placebo-controlled study, postmenopausal women with a prior history of stage 0-III gynecological cancer who had completed active cancer treatment (including hormonal therapy) were randomly assigned 1:1 to either 7.5mg oral paroxetine or placebo daily for 16weeks. Sleep and hot flashes were assessed at baseline, week 4 and week 16.
  
  
  RESULTS
  Eighty women (91%) completed the study. We found out a statistically significant difference in weekly reductions in VMS frequency and severity for paroxetine 7.5mg than for placebo on week 4 and 16. Regarding sleep characteristics, the analysis of data through week 16 reported a statistically significant reduction in the number of nighttime awakenings attributed to VMS among participants receiving paroxetine than among participants receiving placebo on baseline and weeks. The duration of sleep per night increased significantly more among participants receiving paroxetine than among those receiving placebo at all post baseline time points. No significant differences in sleep-onset latency were noted between the two treatment arms during the course of the study. Paroxetine was well-tolerated with a high level of compliance. In our cohort of patients, no serious adverse events have been reported.
  
  
  CONCLUSIONS
  This is the first randomized placebo-controlled study in gynecological cancer survivors that demonstrates that paroxetine significantly reduces hot flashes in weekly frequency and severity and the number of nighttime awakenings attributed to vasomotor symptoms, increasing sleep duration.
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy. Electronic address: 3452572851s.capriglione@unicampus.it.
authors.forename: Stella
authors.initials: S
authors.lastname: Capriglione
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Plotti
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Montera
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Luvero
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Lopez
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Scaletta
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: Aloisi
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy.
authors.forename: Giovan Battista
authors.initials: GB
authors.lastname: Serra
authors.affiliation: Department of Obstetrics and Gynaecology, Campus Bio-Medico University of Rome, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Angioli
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D005833:Genital Neoplasms, Female / Q000628:therapy*; D019584:Hot Flashes / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D017374:Paroxetine / Q000627:therapeutic use*; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D012890:Sleep; D012893:Sleep Wake Disorders / Q000209:etiology / Q000503:physiopathology*; D017741:Survivors; D016896:Treatment Outcome
chemical_list: D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors
keywords: Cancer survivors; Gynecological cancers; Hot flashes; Menopause; Non hormonal; Paroxetine