title: Paroxetine is an effective treatment for hot flashes: results from a prospective randomized clinical trial.
abstract: OBJECTIVE
  In an open-label trial we have previously demonstrated that paroxetine reduces hot flashes. We initiated a stratified, randomized, double-blind, cross-over, placebo-controlled trial to investigate the efficacy of paroxetine 10 mg and 20 mg compared to placebo in reducing hot flash frequency and composite score. A secondary objective was to evaluate quality of life (QOL) parameters.
  
  
  METHODS
  Women who suffered at least two hot flashes a day for 1 month or longer were eligible. Women were randomly assigned to 4 weeks of paroxetine 10 mg or 20 mg followed by placebo for 4 weeks, or placebo for 4 weeks followed by paroxetine 10 mg or 20 mg for 4 weeks. Participants completed baseline daily hot flash diaries for one week prior to the start of the study and throughout the study, and QOL questionnaires at baseline, week 5 and week 9.
  
  
  RESULTS
  279 women were screened, and 151 were randomly assigned. Paroxetine 10 mg reduced hot flash frequency and composite score by 40.6% and 45.6%, respectively, compared to 13.7% and 13.7% for placebo (P = .0006 and P = .0008, respectively). Paroxetine 20 mg reduced hot flash frequency and composite score by 51.7% and 56.1%, respectively, compared with 26.6% and 28.8% for placebo (P = .002 and P = .004, respectively). Efficacy was similar between the two doses, but women were less likely to discontinue low-dose paroxetine. Paroxetine 10 mg was associated with a significant improvement in sleep compared with placebo (P = .01).
  
  
  CONCLUSIONS
  Paroxetine is an effective treatment for hot flashes in women with or without a prior breast cancer.
authors.affiliation: Lombardi Comprehensive Cancer Center at Georgetown University, Washington, DC, USA. vstearn1@jhmi.edu
authors.forename: Vered
authors.initials: V
authors.lastname: Stearns
authors.forename: Rebecca
authors.initials: R
authors.lastname: Slack
authors.forename: Nancy
authors.initials: N
authors.lastname: Greep
authors.forename: Ronda
authors.initials: R
authors.lastname: Henry-Tilman
authors.forename: Michael
authors.initials: M
authors.lastname: Osborne
authors.forename: Craig
authors.initials: C
authors.lastname: Bunnell
authors.forename: Lynda
authors.initials: L
authors.lastname: Ullmer
authors.forename: Ann
authors.initials: A
authors.lastname: Gallagher
authors.forename: Jennifer
authors.initials: J
authors.lastname: Cullen
authors.forename: Edmund
authors.initials: E
authors.lastname: Gehan
authors.forename: Daniel F
authors.initials: DF
authors.lastname: Hayes
authors.forename: Claudine
authors.initials: C
authors.lastname: Isaacs
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000188:drug therapy*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D008875:Middle Aged; D017374:Paroxetine / Q000627:therapeutic use*; D010349:Patient Compliance; D010919:Placebos; D011788:Quality of Life; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*
chemical_list: D017374:Paroxetine; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors