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Randomised trial, 1994

Does nefazodone reduce symptoms of premenstrual syndrome?

Yes. Women taking nefazodone showed significant improvement in PMS symptoms within 4 weeks. However, this study did not use a placebo control group, so we cannot be certain the improvement was not due to expectancy.

Early or limited evidence 54 women with PMS (23 without depression, 24 with depression or dysthymia)

What they did

Two groups of women with PMS took nefazodone. The first group (N=23) had PMS without depression. The second group (N=24) had PMS with depression. They started at 100 mg daily and increased to up to 600 mg daily in two divided doses, for 8 weeks with optional continuation for up to 1 year.

What they found

Both groups improved significantly by 4 weeks at an average dose of 245 mg (range 100 to 400 mg). Of 54 women who started treatment, 47 completed 2 months at a mean dose of 319 mg daily. The most common side effects were nausea and headache, which were usually temporary.

What it means for you

Nefazodone may help PMS symptoms, but without a comparison to placebo, we cannot be sure the benefit was real. A controlled trial is needed to confirm these preliminary results.

47 of 54

Women completed 2 months

245 mg

Average dose at 4 weeks

319 mg

Mean daily dose at 2 months

About the study

Original title
Nefazodone in the Treatment of Premenstrual Syndrome
Authors
Ellen W. Freeman, Karl Rickels, Steven J. Sondheimer et al.
Journal
Journal of Clinical Psychopharmacology
Year
1994
Study design
Randomised trial
Participants
24
What was tested
Nefazodone at 100-600 mg daily in two divided doses

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