Treatment of premenstrual syndrome by spironolactone: a double-blind, placebo-controlled study.

BACKGROUND: To reevaluate whether spironolactone, a steroid receptor antagonist, is effective in improving premenstrual syndrome (PMS) in a double-blind, placebo-controlled cross over study.

METHODS: Thirty-five women with PMS were given one tablet of 100 mg spironolactone or placebo daily from day 14 of the menstrual cycle until the first day of the following menstruation. Two pretreatment cycles were observed for diagnosis in each woman, followed by 6 treatment cycles with spironolactone and placebo applied in either the first or second 3 months. The assessment of symptoms and diagnosis of PMS were based on prospective daily self-ratings made by the women using a validated visual analogue scale.

RESULTS: The treatment with spironolactone was associated with an improvement in PMS symptoms compared to placebo as judged by significant decrease in negative mood symptom scores (p < 0.001) and somatic symptom scores (p < 0.001). Of the individual symptoms, spironolactone significantly improved irritability, depression, feeling of swelling, breast tenderness and food craving in comparison to placebo. A lasting effect of spironolactone was observed in women started with spironolactone after cross over to placebo.

CONCLUSIONS: Spironolactone appears to be an effective therapy for the negative mood changes and somatic symptoms in PMS.