F Keleştimur1, Y Sahin. 1. Department of Endocrinology, Erciyes University, Faculty of Medicine, Kayseri, Turkey.
Abstract
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 aloneand 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.
RCT Entities:
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.