Comparison of Diane 35 and Diane 35 plus spironolactone in the treatment of hirsutism.

OBJECTIVE

To compare the clinical efficacy and safety of Diane 35 (cyproterone acetate [2] mg and ethinyl estradiol [35 microg]) plus spironolactone [100 mg] combination and Diane 35 alone in the treatment of hirsutism.

DESIGN

Prospective clinical study.

SETTING

Outpatients in Erciyes University Medical School.

PATIENT(S): Fifty women with hirsutism.

INTERVENTION(S): Group I patients (n = 22) were treated with Diane 35 alone and group II patients (n = 28) with Diane 35 plus spironolactone [100 mg].

MAIN OUTCOME MEASURE(S): The basal hormone levels total and free T, androstenedione, DHEAS, sex hormone-binding globulin (SHBG), and prolactin (PRL) were measured by RIA before the study. Free T, SHBG, and DHEAS were also measured at 6-month intervals for 12 months. Hirsutism was graded at 6-month intervals.

RESULT(S): The basal hormone levels were similar between the groups. Hirsutism score significantly decreased at the end of the therapy in both groups. The reduction in hirsutism score in group II at 12 months was greater than in group I. But the scores before the treatment, at 6 and 12 months were similar between the groups.

CONCLUSION(S): Although the actual hirsutism score and free T concentration are not significantly different between the two groups at 12 months, percentage change in the hirsutism score at 12 months was higher in the Diane 35 plus spironolactone group. Therefore, the addition of spironolactone to Diane 35 may have a synergistic effect on hirsutism score.