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Randomised trial, 1997

Does fluoxetine help premenstrual syndrome?

Yes, fluoxetine 20 mg daily was significantly better than placebo at relieving PMS symptoms. It did have some side effects: stomach problems, sleep problems, and sexual dysfunction in smaller numbers of women.

Moderate study design 35 women with PMS identified from 440 screened

What they did

Double-blind, placebo-controlled study. 440 women recorded their symptoms daily for 2 menstrual cycles. Only 35 met strict PMS criteria. Those 35 were randomly assigned to fluoxetine 20 mg daily or placebo for 3 menstrual cycles.

What they found

Fluoxetine was significantly superior to placebo at reducing PMS symptoms. Common side effects were gastrointestinal irritability (15%), insomnia (11%), and sexual dysfunction (8.5%).

What it means for you

Fluoxetine works for PMS, but many women who think they have PMS may not actually meet strict criteria when tracked carefully. The side effects are important to discuss with a doctor. Overall it was well-tolerated.

35

women with confirmed PMS

20 mg

daily dose

11%

experienced insomnia

About the study

Original title
Fluoxetine in the treatment of premenstrual syndrome
Authors
Ozeren S, Corakçi A, Yücesoy I et al.
Journal
European journal of obstetrics, gynecology, and reproductive biology
Year
1997
Study design
Randomised trial
Participants
440
What was tested
Fluoxetine 20 mg daily for 3 menstrual cycles

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