Paroxetine is an effective treatment for hot flashes: results from a prospective randomized clinical trial.
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.
Stearns
Vered
V
Lombardi Comprehensive Cancer Center at Georgetown University, Washington, DC, USA. vstearn1@jhmi.edu
Slack
Rebecca
R
Greep
Nancy
N
Henry-Tilman
Ronda
R
Osborne
Michael
M
Bunnell
Craig
C
Ullmer
Lynda
L
Gallagher
Ann
A
Cullen
Jennifer
J
Gehan
Edmund
E
Hayes
Daniel F
DF
Isaacs
Claudine
C
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*
D017374:Paroxetine; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors