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Non-randomised trial, 1993

Does fluoxetine (an antidepressant) help severe PMS?

In this uncontrolled trial, 10 women taking fluoxetine had moderate to marked symptom relief, and 7 maintained relief after stopping. Without a control group, we cannot be sure the improvement was from the drug.

Early or limited evidence 11 women with severe PMS (from 38 women initially evaluated)

What they did

Open trial (no control group) of fluoxetine 20 mg daily in 11 women with severe PMS lasting more than 5 to 6 days per month. Ten women continued treatment for 3 to 20 months.

What they found

Ten women continued fluoxetine with moderate to marked symptom relief and no major side effects. When nine women stopped treatment, seven had lasting symptom relief and two returned for another cycle of fluoxetine with relief.

What it means for you

Fluoxetine may help severe PMS symptoms, but this study had no control group or comparison to know if improvement was from the drug or natural resolution. A controlled trial is needed.

11

women in trial

10

women who continued treatment

7

women with lasting relief after stopping

About the study

Original title
Open trial of fluoxetine therapy for premenstrual syndrome
Authors
Elks ML
Journal
Southern medical journal
Year
1993
Study design
Non-randomised trial
Participants
38
What was tested
Fluoxetine 20 mg daily (one woman received 40 mg daily)

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