From the FDA Drug Label
Two multicenter, double-blind, randomized, placebo-controlled studies were conducted to evaluate the effectiveness of drospirenone and ethinyl estradiol tablets in treating the symptoms of PMDD. Women aged 18–42 who met DSM-IV criteria for PMDD, confirmed by prospective daily ratings of their symptoms, were enrolled Both studies measured the treatment effect of drospirenone and ethinyl estradiol tablets using the Daily Record of Severity of Problems scale, a patient-rated instrument that assesses the symptoms that constitute the DSM-IV diagnostic criteria In both trials, women who received drospirenone and ethinyl estradiol tablets had statistically significantly greater improvement in their Daily Record of Severity of Problems scores. In the primary study, the average decrease (improvement) from baseline was 37.5 points in women taking drospirenone and ethinyl estradiol tablets, compared to 30.0 points in women taking placebo.
Drospirenone and ethinyl estradiol tablets are effective in treating the symptoms of Premenstrual Dysphoric Disorder (PMDD).
- The studies showed a statistically significant improvement in symptoms in women taking drospirenone and ethinyl estradiol tablets compared to those taking placebo.
- The average decrease in symptoms was 37.5 points in the treatment group, compared to 30.0 points in the placebo group.
- The medication can be used to treat PMDD in women who have already decided to use oral contraceptives for birth control and have been diagnosed with PMDD by their healthcare provider 1.
From the Research
Selective serotonin reuptake inhibitors (SSRIs) are the first-line treatment for premenstrual dysphoric disorder (PMDD), and they are probably more effective when taken continuously compared to luteal phase administration. The treatment of PMDD typically involves a combination of medication, lifestyle changes, and psychological support. SSRIs like fluoxetine, sertraline, or escitalopram can be taken either continuously or just during the luteal phase (2 weeks before menstruation) 2.
Medication Treatment
- SSRIs are the primary medication treatment for PMDD, with fluoxetine, sertraline, and escitalopram being commonly used options 2.
- Hormonal treatments, such as combined oral contraceptives containing drospirenone, can also be effective in regulating hormonal fluctuations 3.
- For symptom management, NSAIDs like ibuprofen can help with physical symptoms, while calcium and vitamin B6 supplements may provide modest benefits 3.
Lifestyle Modifications
- Regular exercise, stress management techniques like meditation, adequate sleep, and reducing caffeine, alcohol, and salt intake are crucial lifestyle modifications for managing PMDD symptoms 3.
- Cognitive behavioral therapy (CBT) has shown effectiveness for the psychological aspects of PMDD 3.
Adverse Effects
- The adverse effects associated with SSRIs include nausea, insomnia, sexual dysfunction or decreased libido, fatigue or sedation, dizziness or vertigo, tremor, somnolence and decreased concentration, sweating, dry mouth, asthenia or decreased energy, diarrhea, and constipation 2.
- The certainty of the evidence for these adverse effects is moderate, with the main weakness being poor reporting of study methodology 2.
Recommendation
The most effective treatment for PMDD is probably continuous SSRI administration, as it has been shown to be more effective than luteal phase administration in reducing premenstrual symptoms 2. However, the decision to use continuous or luteal phase administration should be made on a case-by-case basis, taking into account the individual patient's needs and preferences.