Comparison of spironolactone, flutamide, and finasteride efficacy in the treatment of hirsutism: a randomized, double blind, placebo-controlled trial.

To compare objectively the efficacies of spironolactone (100 mg/day), flutamide (250 mg/day), and finasteride (5 mg/day) in the treatment of hirsutism, 40 hirsute women were randomly assigned to double blind treatments with 1 of these 3 drugs or placebo for 6 months. Before and at the end of treatment, hirsutism was quantitatively measured in each subject by determination, by computer-assisted light microscopy, of the largest diameter of 5 hairs plucked from the linea alba. These measurements were averaged to produce a mean hair shaft diameter. For each subject, baseline and posttreatment assessments were carried out at the same time by an investigator blinded to both time and type of therapy. In addition, a semi-quantitative clinical evaluation was carried out by a modification of the Ferriman-Gallwey (F-G) scoring method, performed by a single investigator. At baseline the 4 groups of women had similar hair diameters and F-G scores. After 6 months of therapy all groups of subjects given active drugs showed reductions of their hair diameters, without statistically significant differences among groups (mean change +/- SEM, -11.7+/-5.6%, -18.0+/-6.1%, and -12.6+/-6.7%, respectively, in the spironolactone, flutamide, and finasteride groups). F-G scores were also significantly reduced in women receiving antiandrogen drugs, again without differences among groups (mean change, -41.0+/-5.5%, -38.9+/-7.2%, and -31.6+/-3.7%, respectively). No significant changes from baseline values were recorded by either hair diameter (-1.4+/-5.2%) or F-G score (+5.4+/-3.7%) assessment in the placebo group. In conclusion, spironolactone, flutamide, and finasteride are all effective in the treatment of hirsutism. After a 6-month course of therapy, the clinical efficacies of these drugs, at least at the doses used, are similar.

RCT Entities:   Population Interventions Outcomes