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.