Treating PMDD with an Oral Contraceptive
Abstract & Commentary
By Frank W. Ling, MD, Clinical Professor, Dept. of Obstetrics and Gynecology, Vanderbilt University School of Medicine, Nashville, is Associate Editor for OB/GYN Clinical Alert.
Dr. Ling reports no financial relationship to this field of study.
Synopsis: Drospirenone and ethinyl estradiol was superior to placebo in the treatment of premenstrual dysphoric disorder.
Source: Pearlstein TB, et al. Treatment of premenstrual dysphoric disorder with a new drospirenone-containing oral contraceptive formulation. Contraception. 2005;72:414-421.
In a multi-center, double-blind, placebo-controlled crossover study, drospirenone 3 mg plus ethinyl estradiol 20 micrograms was administered for 24 days per month to patients with premenstrual dysphoric disorder (PMDD) according to criteria established in the Diagnostic and Statistical Manual IV. Of the 511 patients screened, 64 were randomized with 25 completing the study. Each patient received the study drug or placebo for 3 cycles, then after a wash-out cycle, received the opposite treatment for 3 months. Response was measured using the Daily Record of Severity of Problems. Mood improvement of 51% was in seen in drug-treated patients compared to 31% in the placebo group. After crossover, there was a 34% improvement in mood compared to a 17% deterioration in the placebo group. Not only was there improvement in mood, but physical symptoms of breast pain, swelling, bloating, headache, and muscle pain also responded to treatment.
Commentary
So here's the latest verse in a long song that has many verses. Previously, oral contraceptives were used for premenstrual syndrome, a/k/a PMS with little success. Well-designed studies demonstrated efficacy no better than placebo for properly selected patients. Even though the logic of ovulation suppression seemed to imply that oral contraceptives should work, the data told us otherwise. With the use of drospirenone as the progestin, more promising results are apparent. It is an analog of spironolactone, an aldosterone antagonist with diuretic activity which can lessen breast pain, bloating, irritability and depression. The results certainly warrant consideration by the busy clinician looking for a first-line treatment in a condition that is relatively common, affecting up to 10% of women. Be prepared . . . if your pharmaceutical representative has not already talked about this with you regarding its approval by the FDA for this indication, he/she certainly will soon.
Having said that, I certainly don't want this to sound like a commercial. I really do believe that this is a good option, particularly for a patient who needs contraception in addition to treatment for PMS/PMDD. Getting both mood and physical symptom relief is a nice start, plus getting birth control on top of that is a bonus.
However, here are some other considerations:
- We still do not truly understand the underlying physiology of this condition. As best as we know, it's still normal hormone levels triggering abnormal or excessive physical response, particularly as it relates to serotonin and moods.
- The selective serotonin reuptake inhibitors (SSRI) such as fluoxetine, sertraline, etc are still a viable option for treatment, administered either all month or during the luteal phase only.
- Short of pharmacologic intervention, other approaches have also shown some efficacy, such as Tums E-X, chasteberry root, magnesium, and pyridoxine (Vitamin B-6).
- There is no evidence that this low-dose oral contraceptive is better than the SSRIs.
- As a consumer of the scientific literature, you shouldn't be turned off because the study was sponsored by the pill manufacturer. The study design was appropriate and the investigators are well-known in the field.
- Also, don't be upset that only 25 patients of the original 511 patients screened completed the trial. Having done research in the field, I can assure you that this drop-out rate is typical for this clinical arena.
- The best way to diagnose the condition is still prospective calendar charting. This was done in the study and, ideally, can be what you do in your practice.
As usual, there is a take-home message for our articles. In this case, you've got another option for PMS/PMDD that can significantly improve your patient's quality of life. It won't work for everyone, but it's a better choice than other oral contraceptives currently on the market that do not contain drospirenone.
In a multi-center, double-blind, placebo-controlled crossover study, drospirenone 3 mg plus ethinyl estradiol 20 micrograms was administered for 24 days per month to patients with premenstrual dysphoric disorder (PMDD) according to criteria established in the Diagnostic and Statistical Manual IV.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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