Randomised trial, 1993
Does fluoxetine help severe PMS symptoms?
Yes. Fluoxetine significantly improved severe PMS symptoms in 15 of 16 women who completed the trial, with 8 showing almost complete remission of symptoms. Most side effects were temporary.
What they did
RCT with 21 women with severe PMS diagnosed with late luteal phase dysphoric disorder. They had a double-blind crossover trial of 20 mg fluoxetine daily versus placebo. After 3 months of baseline observation, they received 3 months each of fluoxetine and placebo in random order. Symptoms were rated daily, with monthly assessment forms and psychiatric interviews.
What they found
Fluoxetine produced marked improvement in 15 of 16 women completing the trial, with 8 showing virtually complete remission of PMS symptoms. Fluoxetine's benefit applied to emotional, physical and behavioral symptoms and was superior to placebo whether it came first or second. Three women withdrew due to adverse effects, and 10 of 16 completing the trial reported at least one adverse effect. Compared with placebo, fluoxetine produced more insomnia, sweating, gastrointestinal disturbance, and menstrual disturbance, though these were usually transient. Plasma levels of fluoxetine were not reliably associated with efficacy or side effects.
What it means for you
Fluoxetine appears highly effective for severe PMS with good tolerability. Temporary side effects like insomnia are common but often go away. The study had a small sample (16 women completed) and only tested one dose (20 mg daily).
21
women enrolled
15 of 16
who showed marked improvement on fluoxetine
20 mg
daily fluoxetine dose
About the study
- Original title
- Fluoxetine's spectrum of action in premenstrual syndrome
- Authors
- Menkes DB, Taghavi E, Mason PA et al.
- Journal
- International clinical psychopharmacology
- Year
- 1993
- Study design
- Randomised trial
- Participants
- 16
- What was tested
- 20 mg fluoxetine daily vs placebo
- Read the paper
- doi.org/10.1097/00004850-199300820-00003
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