Paroxetine versus placebo for women in midlife after hormone therapy discontinuation.
OBJECTIVE
Concerns about hormone therapy have led many menopausal women to discontinue hormone treatment. This study examines the efficacy of paroxetine controlled-release versus placebo for the treatment of women with vasomotor symptoms after discontinuing hormone therapy.


METHODS
Sixty-four perimenopausal and postmenopausal women without depression or anxiety but reporting vasomotor symptoms after hormone discontinuation entered a 1-week, single-blind, placebo lead-in phase, followed by a 6-week, flexible-dose, double-blind phase with paroxetine controlled-release (12.5-25 mg/d) or placebo. The primary outcome measure was a change in vasomotor symptoms. Other measures included changes in depressive symptoms and overall functioning.


RESULTS
Fifty subjects (paroxetine controlled-release, n=27; placebo, n=23) completed the study. At study entry, subjects had an average of 17 hot flushes per week, had used hormones for more than 5 years (median=66 months, interquartile range=18-120 months), and had discontinued treatment for less than 1 year (median=5 months, interquartile range=2-10 months) before study enrollment. Paroxetine controlled-release was more efficacious than placebo for the alleviation of vasomotor symptoms (mean reduction of 6.1 vs 2.8 hot flashes per week, respectively; P=.03). Depressive symptoms also improved with paroxetine (mean reduction of 3.6 points vs 0.4 points in Montgomery-Asberg Depression Rating Scale total scores; P=.01).


CONCLUSIONS
Treatment with paroxetine controlled-release may constitute an efficacious alternative for symptomatic perimenopausal and postmenopausal women after menopausal hormone discontinuation.
Soares
Claudio N
CN
Perinatal and Reproductive Psychiatry Program, Massachusetts General Hospital, Boston, USA. csoares@mcmaster.ca
Joffe
Hadine
H
Viguera
Adele C
AC
Petrillo
Laura
L
Rydzewski
Maya
M
Yehezkel
Revital
R
Somley
Brittny
B
Cohen
Lee S
LS
D000328:Adult; D003863:Depression / Q000150:complications / Q000188:drug therapy; D004311:Double-Blind Method; D015914:Estrogen Replacement Therapy; D005260:Female; D019584:Hot Flashes / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D017374:Paroxetine / Q000627:therapeutic use*; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D016037:Single-Blind Method; D016896:Treatment Outcome
D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors