Source
McMaster University, St. Joseph's Hospital, Hamilton, Ontario, Canada.
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.