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.
RCT Entities:
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.
Authors: Ellen W Freeman; Katherine A Guthrie; Bette Caan; Barbara Sternfeld; Lee S Cohen; Hadine Joffe; Janet S Carpenter; Garnet L Anderson; Joseph C Larson; Kristine E Ensrud; Susan D Reed; Katherine M Newton; Sheryl Sherman; Mary D Sammel; Andrea Z LaCroix Journal: JAMA Date: 2011-01-19 Impact factor: 157.335