• Am. J. Med. · Feb 2008

    Controlled Clinical Trial

    Paroxetine versus placebo for women in midlife after hormone therapy discontinuation.

    • Claudio N Soares, Hadine Joffe, Adele C Viguera, Laura Petrillo, Maya Rydzewski, Revital Yehezkel, Brittny Somley, and Lee S Cohen.
    • Perinatal and Reproductive Psychiatry Program, Massachusetts General Hospital, Boston, USA. csoares@mcmaster.ca
    • Am. J. Med. 2008 Feb 1; 121 (2): 159162.e1159-162.e1.

    ObjectiveConcerns 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.MethodsSixty-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.ResultsFifty 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).ConclusionTreatment with paroxetine controlled-release may constitute an efficacious alternative for symptomatic perimenopausal and postmenopausal women after menopausal hormone discontinuation.

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