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 antiandrogen flutamide and the steroidal derivative spironolactone in the treatment of hirsutism in women.


METHODS
Fifty-three premenopausal women suffering from moderate to severe hirsutism were randomized into two groups and received either flutamide or spironolactone in association with a triphasic oral contraceptive (OC) pill. Hirsutism, acne, seborrhea, alopecia, and side effects were monitored monthly for a treatment period of 9 months and a follow-up after treatment period of 6 months. Blood samples were taken at each visit for assessment of endocrine, biochemical, and hematologic parameters.


RESULTS
After only 6 months of therapy, flutamide caused a maximal reduction in the hirsutism score to a value within almost normal range; during the same period, spironolactone caused only a 30% reduction of the hirsutism score. Whereas flutamide caused a dramatic (80%) decrease in total acne, seborrhea, and hair loss score after only 3 months of therapy, spironolactone caused only a 50% reduction in acne and seborrhea, with no significant effect on the hair loss score. Four patients in the spironolactone group but only one in the flutamide group stopped the medication because of adverse side effects.


CONCLUSIONS
The present data obtained in a randomized prospective study clearly demonstrate that the pure antiandrogen flutamide is superior to spironolactone in the treatment of female hirsutism and its related androgen-dependent symptoms and signs in women.
Cusan
L
L
Medical Research Council Group in Molecular Endocrinology, Centre Hospitalier, Université Laval Research Center, Québec, Canada.
Dupont
A
A
Gomez
J L
JL
Tremblay
R R
RR
Labrie
F
F
D000328:Adult; D003687:Dehydroepiandrosterone / Q000031:analogs & derivatives / Q000097:blood; D019314:Dehydroepiandrosterone Sulfate; D004958:Estradiol / Q000097:blood; D005260:Female; D005485:Flutamide / Q000009:adverse effects / Q000627:therapeutic use*; D005640:Follicle Stimulating Hormone / Q000097:blood; D006628:Hirsutism / Q000188:drug therapy*; D006801:Humans; D007986:Luteinizing Hormone / Q000097:blood; D017697:Premenopause; D011374:Progesterone / Q000097:blood; D013148:Spironolactone / Q000009:adverse effects / Q000627:therapeutic use; D013739:Testosterone / Q000097:blood
D013148:Spironolactone; D013739:Testosterone; D003687:Dehydroepiandrosterone; D011374:Progesterone; D004958:Estradiol; D019314:Dehydroepiandrosterone Sulfate; D005485:Flutamide; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone