L. Cusan et al., COMPARISON OF FLUTAMIDE AND SPIRONOLACTONE IN THE TREATMENT OF HIRSUTISM - A RANDOMIZED CONTROLLED TRIAL, Fertility and sterility, 61(2), 1994, pp. 281-287
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.