Paroxetine Versus Placebo for Women in Midlife After Hormone Therapy Discontinuation

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• 作者：Claudio N. Soares ; Hadine Joffe ; Adele C. Viguera ; Laura Petrillo ; Maya Rydzewski ; Revital Yehezkel ; Brittny Somley ; Lee S. Cohen
• 关键词：Depression ; Hormone therapy ; Hot flashes ; Hot flushes ; Menopause ; Paroxetine ; Perimenopause ; Sleep ; Vasomotor symptoms ; Women
• 刊名：The American Journal of Medicine
• 出版年：2008
• 出版时间：February 2008
• 年：2008
• 卷：121
• 期：2
• 页码：159-162.e1
• 全文大小：107 K

文摘

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.