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Volume 332:1529-1534 June 8, 1995 Number 23 Next

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ABSTRACT

Background Premenstrual dysphoria shares certain features with depression and anxiety states, which have been linked to serotonergic dysregulation. We evaluated the efficacy and safety of fluoxetine (which selectively inhibits the reuptake of serotonin) in the treatment of premenstrual dysphoria.

Methods The trial consisted of a single-blind, placebo washout period lasting two menstrual cycles, followed by a randomized, double-blind, placebo-controlled trial of fluoxetine at a dose of either 20 mg or 60 mg per day or placebo for six menstrual cycles. Healthy women meeting criteria for what was then called late-luteal-phase dysphoric disorder were recruited at seven university-affiliated women's health clinics in Canada. The primary outcome measure consisted of visual-analogue scales for tension, irritability, and dysphoria during the late luteal phase of each cycle.

Results Of 405 women enrolled in the placebo washout period, 313 subsequently entered the randomized phase of the study, which lasted six menstrual cycles, and 180 completed it. Fluoxetine at a dose of 20 or 60 mg per day was significantly superior to placebo in reducing symptoms of tension, irritability, and dysphoria, as measured by the visual-analogue scales (P<0.001). The women who received 60 mg of fluoxetine per day reported significantly more side effects than those who received 20 mg per day or placebo (P<0.001).

Conclusions Fluoxetine is useful in the treatment of premenstrual dysphoria. Treatment with fluoxetine at a dose of 20 mg per day reduces the potential for side effects while maximizing therapeutic efficacy.

Source Information

From the Departments of Psychiatry and Biomedical Sciences, St. Joseph's Hospital, McMaster University, Hamilton, Ont. (M.S.); the Department of Psychiatry, St. Mary's Hospital, McGill University, Montreal (S.S.); the Department of Psychiatry, St. Michael's Hospital, University of Toronto, Toronto (D. Stewart); the Department of Psychiatry, University Hospital, University of British Columbia, Vancouver (D.C.); the Department of Psychiatry, Montreal General Hospital, Concordia University, Montreal (C.B.); the Department of Obstetrics and Gynecology, Queen's University, Kingston, Ont. (R.R.); the Department of Psychiatry, University of Alberta Hospital, Edmonton (D.G.); and the Departments of Psychiatry and Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ont. (D. Streiner) — all in Canada.

Address reprint requests to Dr. Steiner at the Department of Psychiatry, St. Joseph's Hospital, 50 Charlton Ave. E., Hamilton, ON L8N 4A6, Canada.

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Fluoxetine for Premenstrual Dysphoria
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Extract | Full Text  
N Engl J Med 1995; 333:1152-1153, Oct 26, 1995. Correspondence

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