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Non-randomised trial, 1997

Is fluoxetine an effective long-term treatment for PMDD, and what happens when women stop taking it?

Fluoxetine significantly improved PMDD symptoms in all 20 women after 6 months, and improvement persisted in those who continued treatment. However, symptoms returned in most women who stopped the medication.

Early or limited evidence 20 women with PMDD, 9 also with major depression and 11 with PMDD only

What they did

20 women with PMDD took fluoxetine 20 mg daily for 6 months. Nine women continued taking it until 18 months and 11 stopped after 6 months. Researchers assessed symptom severity monthly during the first 6 months and again at 18 months using multiple rating scales.

What they found

All 20 women completed 6 months of treatment with good tolerance. At 6 months, significant improvements were seen on all symptom scales: depression scores dropped from 22.4 to 5.3, anxiety scores dropped from 23.8 to 8.7, and another symptom score dropped from 36.4 to 18. Women who continued treatment maintained improvements at 18 months. Women who stopped treatment showed worsening symptoms by 18 months. The most common side effects were decreased libido, stomach complaints, nervousness, and insomnia, though these were mild.

What it means for you

Fluoxetine is an effective and well-tolerated short-term and long-term treatment for PMDD, but symptoms tend to return when women stop taking it. The main limitation is that this was a small uncontrolled study with no placebo control group.

20

women treated

6 months

initial treatment duration

22.4 to 5.3

depression score improvement at 6 months

About the study

Original title
[Premenstrual dysphoric disorder: long-term treatment with fluoxetine and discontinuation]
Authors
de la Gándara Martín JJ
Journal
Actas luso-espanolas de neurologia, psiquiatria y ciencias afines
Year
1997
Study design
Non-randomised trial
Participants
20
What was tested
Fluoxetine 20 mg per day

Topics