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Randomised trial, 2005

Does a low-dose birth control pill with drospirenone help PMDD?

Yes, the pill reduced symptoms significantly more than placebo. On average, 8 women need to take it for 1 to experience major improvement (50% symptom reduction).

Strong study design 450 women with premenstrual dysphoric disorder

What they did

450 women with PMDD were randomly assigned to take either a birth control pill with drospirenone 3 mg and ethinyl estradiol 20 mcg (24 days active pills, 4 days inactive) or placebo. Symptoms were charted daily for 3 treatment cycles after 2 run-in cycles.

What they found

Total symptom scores decreased 37.49 with the pill versus 29.99 with placebo. Mood improved 19.2 versus 15.3. Physical symptoms improved 10.7 versus 8.6. Behavioral symptoms improved 7.7 versus 6.2. About 48% of pill users had at least 50% symptom improvement versus 36% with placebo. Number needed to treat was 8.

What it means for you

The pill works better than placebo for PMDD, though benefits are modest. The number needed to treat of 8 means 8 women need treatment for 1 to see major improvement. This is a large, high-quality trial.

450

women randomized

48%

pill users improved, versus 36% placebo

8

number needed to treat

About the study

Original title
Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder
Authors
Yonkers KA, Brown C, Pearlstein TB et al.
Journal
Obstetrics and gynecology
Year
2005
Study design
Randomised trial
Participants
450
What was tested
Drospirenone 3 mg with ethinyl estradiol 20 mcg (24/4 regimen) versus placebo

Topics