Objective To determine the effectiveness of¯uoxetine 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 ®ve subjects, of whom 320 with prospectively determined premenstrual dysphoric disorder were randomised.Methods Randomised women were assigned to¯uoxetine 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.

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