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Randomised trial, 2002

Does daily fluoxetine help PMDD?

Yes. Fluoxetine 20 mg improved mood and physical symptoms compared to placebo. The 10 mg dose showed some benefits but was not as strong. Both were well tolerated.

Strong study design 260 women with PMDD

What they did

260 women with PMDD went through screening and placebo periods, then were randomly assigned to fluoxetine 10 mg, 20 mg, or placebo daily. All medications started 14 days before the expected period and continued through the first day of bleeding, for 3 menstrual cycles. Women recorded symptoms daily using a computerized system.

What they found

Fluoxetine 20 mg significantly improved overall PMDD symptoms compared to placebo. The 10 mg dose did not clearly improve overall symptoms but did help with some mood symptoms. Only the 20 mg dose improved physical symptoms including breast tenderness, bloating, and joint or muscle pain. Both were well tolerated.

What it means for you

Fluoxetine 20 mg is effective for both mood and physical PMDD symptoms. This comes from a large, well-designed trial. Using fluoxetine only during the luteal phase (before the period) may reduce side effects compared to year-round dosing.

260

women studied

20 mg

most effective daily dose

3

menstrual cycles of treatment

About the study

Original title
Premenstrual Daily Fluoxetine for Premenstrual Dysphoric Disorder
Authors
Lee S. Cohen, Cherri M. Miner, Eileen Brown et al.
Journal
Obstetrics and Gynecology
Year
2002
Study design
Randomised trial
Participants
260
What was tested
Fluoxetine 10 mg or 20 mg daily during the luteal phase versus placebo

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