COMPARISON OF FLUTAMIDE AND SPIRONOLACTONE IN THE TREATMENT OF HIRSUTISM - A RANDOMIZED CONTROLLED TRIAL

Objective: To compare the clinical efficacy and safety of the pure ant iandrogen flutamide and the steroidal derivative spironolactone in the treatment of hirsutism in women. Design: Fifty-three premenopausal wo men suffering from moderate to severe hirsutism were randomized into t wo groups and received either flutamide or spironolactone in associati on with a triphasic oral contraceptive (OC) pill. Hirsutism, acne, seb orrhea, alopecia, and side effects were monitored monthly for a treatm ent period of 9 months and a follow-up after treatment period of 6 mon ths. Blood samples were taken at each visit for assessment of endocrin e, biochemical, and hematologic parameters. Results: After only 6 mont hs of therapy, flutamide caused a maximal reduction in the hirsutism s core to a Value within almost normal range; during the same period, sp ironolactone caused only a 30% reduction of the hirsutism score. Where as flutamide caused a dramatic (80%) decrease in total acne, seborrhea , and hair loss score after only 3 months of therapy, spironolactone c aused only a 50% reduction in acne and seborrhea, with no significant effect on the hair loss score. Four patients in the spironolactone gro up but only one in the flutamide group stopped the medication because of adverse side effects. Conclusion: The present data obtained in a ra ndomized prospective study clearly demonstrate that the pure antiandro gen flutamide is superior to spironolactone in the treatment of female hirsutism and its related androgen-dependent symptoms and signs in wo men.