The efficacy of fluoxetine in improving physical symptoms associated with premenstrual dysphoric disorder

Abstract

OBJECTIVE: To determine the effectiveness of fluoxetine in alleviating physical symptoms of premenstrual dysphoric disorder. DESIGN: Randomised, double-blind, placebo controlled, parallel study. SETTING: Canadian University based outpatient clinics. Participants Four hundred and five subjects, of whom 320 with prospectively determined premenstrual dysphoric disorder were randomised. METHODS: Randomised women were assigned to fluoxetine 20 or 60 mg/day or placebo. Common physical symptoms associated with premenstrual dysphoric disorder including breast tenderness, bloating, and headache were evaluated by visual analog scales and the self-rated and observer premenstrual tension syndrome scales. OUTCOME MEASURES: Luteal phase change from mean baseline scores to mean treatment scores for all scales. RESULTS: Fluoxetine treatment was statistically superior to placebo, with no significant differences between the two fluoxetine dosages in their effects on physical symptoms. CONCLUSION: Daily fluoxetine treatment is superior to placebo in improving the most common physical symptoms associated with premenstrual dysphoric disorder.