Objective: To compare the clinical efficacy and safety of the combination of Diane 35 (2 mg of cyproterone acetate, and 35 microg of ethinyl estradiol) plus finasteride (5 mg), and Diane 35 alone in the treatment of hirsutism.
Design: Prospective randomized clinical study.
Setting: Outpatients in Erciyes University Medical School.
Patient(s): Forty women with hirsutism were selected.
Intervention(s): For 1 year, group 1 patients (n = 20) were treated with Diane 35 alone (2 mg of cyproterone acetate and 35 microg of ethinyl estradiol) daily on days 5 to 25 of the menstrual cycle and group 2 patients (n = 20) with Diane 35 plus finasteride (5 mg daily).
Main outcome measure(s): Hirsutism was graded at 6-month intervals using the Ferriman-Gallwey method. The basal hormone levels of total and free testosterone (T), androstenedione, DHEAS, and sex-hormone-binding globulin (SHBG) were measured by radioimmunoassay before the study. Total T, free T, SHBG, and DHEAS were also measured at 6-month intervals for 1 year. Multiscreen blood chemistry and side effects were evaluated during the treatment.
Result(s): Thirty-four patients completed the 12-month study period. A significant decrease in the hirsutism score as compared to baseline was observed after 12 months with both Diane 35 treatment (mean +/- SD, 15.62 +/- 4.89 vs. 9.75 +/- 3.97) and Diane 35 plus finasteride treatment (16.27 +/- 6.90 vs. 8.38 +/- 4.44). The percentage decreases in the hirsutism score (mean percent +/- SD) were 30.26 +/- 14.56 vs. 34.70 +/- 11.60 at 6 months, 38.09 +/- 11.46 vs. 48.14 +/- 14.27 at 12 months in the Diane 35 and the Diane 35 plus finasteride groups, respectively. The percentage reduction in the hirsutism score in the Diane 35 plus finasteride group at 12 months was greater than in the Diane 35 group (P <.05).
Conclusion(s): The percentage decrease in the hirsutism score at 12 months was higher in the Diane 35 plus finasteride group than in the Diane 35 group. We believe that Diane 35 plus finasteride is an effective and safe combination for the treatment of hirsutism.