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Randomised trial, 2001

Does fluoxetine help the physical symptoms of PMDD?

Fluoxetine taken daily was significantly better than placebo at improving physical symptoms like breast tenderness, bloating, and headache. Both 20 mg and 60 mg doses worked similarly.

Strong study design 320 women with PMDD from Canadian university clinics

What they did

In this double-blind placebo-controlled trial, 320 women with PMDD (out of 405 screened) were randomly assigned to fluoxetine 20 mg/day, fluoxetine 60 mg/day, or placebo. Physical symptoms including breast tenderness, bloating, and headache were measured throughout the trial.

What they found

Fluoxetine at either 20 mg/day or 60 mg/day was significantly better than placebo at improving physical symptoms including breast tenderness, bloating, and headache. There was no significant difference between the 20 mg and 60 mg doses in their effects on these symptoms.

What it means for you

Daily fluoxetine helps the physical symptoms of PMDD more than placebo. A lower dose (20 mg) may work as well as a higher dose (60 mg), which could mean lower doses might be preferable if they work. This is from a large randomized trial.

320

women with PMDD randomized

405

women screened

20-60 mg

fluoxetine doses tested

About the study

Original title
The efficacy of fluoxetine in improving physical symptoms associated with premenstrual dysphoric disorder
Authors
Steiner M, Romano SJ, Babcock S et al.
Journal
BJOG : an international journal of obstetrics and gynaecology
Year
2001
Study design
Randomised trial
What was tested
Fluoxetine 20 mg/day or 60 mg/day taken daily
Open access
Yes

Topics