Objective To determine the effectiveness of fluoxetine in alleviating physi
cal 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 pla
cebo. Common physical symptoms associated with premenstrual dysphoric disor
der including breast tenderness, bloating, and headache were evaluated by v
isual analog scales and the self-rated and observer premenstrual tension sy
Outcome measures Luteal phase change from mean baseline scores to mean trea
tment scores for all scales.
Results Fluoxetine treatment was statistically superior to placebo, with no
significant differences between the two fluoxetine dosages in their effect
s on physical symptoms.
Conclusion Daily fluoxetine treatment is superior to placebo in improving t
he most common physical symptoms associated with premenstrual dysphoric dis