Randomised trial, 1994
Does nefazodone help premenstrual syndrome?
Premenstrual symptoms improved significantly in both groups. Improvement appeared by week 4 at an average dose of 245 mg. However, this was an open-label study without a placebo control, so the true effect is uncertain.
What they did
47 women with PMS (23 without depression, 24 with depression) received open-label nefazodone starting at 100 mg and titrated up to 600 mg daily in two divided doses for 8 weeks, with optional continuation for up to 1 year.
What they found
Premenstrual symptoms improved significantly in both groups by the end of the first treated cycle (4 weeks). Average dose at improvement was 245 mg (range 100-400 mg). 47 of 54 patients completed 2 months of treatment with mean daily dose of 319 mg. Most common side effects were nausea and headache.
What it means for you
Nefazodone may help PMS and PMS that occurs with depression. Improvement occurred quickly at relatively modest doses. However, this was open-label without a placebo control, so we cannot separate medication effect from expectations and attention. The authors recommend a placebo-controlled study.
47
women who completed 2 months
245 mg
average effective dose
4 weeks
time to symptom improvement
About the study
- Original title
- Nefazodone in the treatment of premenstrual syndrome: a preliminary study
- Authors
- Freeman EW, Rickels K, Sondheimer SJ et al.
- Journal
- Journal of clinical psychopharmacology
- Year
- 1994
- Study design
- Randomised trial
- Participants
- 24
- What was tested
- Nefazodone 100-600 mg daily in two divided doses for 8 weeks
- Read the paper
- https://pubmed.ncbi.nlm.nih.gov/8027414/
Topics
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