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Randomised trial, 1995

Does fluoxetine help premenstrual dysphoria?

Yes. Fluoxetine at 20 mg or 60 mg per day significantly reduced tension, irritability, and dysphoria compared to placebo. The 20 mg dose had fewer side effects than the 60 mg dose.

Strong study design Healthy women with premenstrual dysphoria at Canadian university clinics

What they did

Double-blind, placebo-controlled trial. Women completed a 2-cycle placebo washout, then 6 cycles of fluoxetine at 20 mg or 60 mg per day or placebo. They rated their tension, irritability, and dysphoria daily using visual scales.

What they found

Fluoxetine at both doses significantly reduced tension, irritability, and dysphoria (P < 0.001). Women on 60 mg reported significantly more side effects than those on 20 mg or placebo (P < 0.001). Of 405 women enrolled, 313 entered the treatment phase and 180 completed it.

What it means for you

Fluoxetine at 20 mg per day is effective for premenstrual dysphoria and has fewer side effects than 60 mg. The study was done at Canadian university clinics, so results may vary in other populations.

405

Women enrolled in the study

180

Women who completed the study

20 or 60

Fluoxetine dose tested (mg per day)

About the study

Original title
Fluoxetine in the treatment of premenstrual dysphoria. Canadian Fluoxetine/Premenstrual Dysphoria Collaborative Study Group
Authors
Steiner M, Steinberg S, Stewart D et al.
Journal
The New England journal of medicine
Year
1995
Study design
Randomised trial
Participants
405
What was tested
Fluoxetine 20 mg or 60 mg per day

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