ABSTRACT
To compare the efficacy and safety of Diane 35 plus spironolactone and Diane 35 plus finasteride in the treatment of hirsutism and acne. A prospective randomized clinical trial was conducted on 120 Indian women with hirsutism. Group I patients were heated with Diane 35 plus spironolactone 100 mg daily and group II patients with Diane 35 plus finasteride 5 mg daily for 12 months. Hirsutism and acne score were graded every 3 months, for 18 months. The basal gonadotropins levels and androgens level were measured before the study. Statistical analysis was done by Students t-test and repeated measure analysis followed by post hoc comparison. Reduction in hirsutism and acne scores assessed every 3 months was significant [p<0.001] and similar between the two groups, indicating that if treatment was prolonged for over 12 months, reduction scores would have been better. A significant decrease in the hirsutism score of 55.3% +/- 17.2 and 59.4% +/- 17.5 was observed after 12 months in groups I and II respectively. Total reduction in hirsutism and acne scores of both groups was similar [P>0.05]. Diane 35 plus spironolactone and Diane 35 plus finasteride are equally effective and safe in the treatment of hirsutism and acne. For belier outcomes, it is recommended that the treatment period be over 12 months