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). Conclusion Treatment with paroxetine controlled-release may constitute an efficacious alternative for symptomatic perimenopausal and postmenopausal women after menopausal hormone discontinuation.