Comparison of four different treatment regimes in hirsutism related to polycystic ovary syndrome.

Polycystic ovary syndrome is the most common endocrinological problem associated with hirsutism. The objective of this study was to compare four different treatment modalities for hirsutism related to this syndrome. Pelvic ultrasonography was performed on all patients who were referred to our Reproductive Endocrinology Outpatient Clinic because of complaints of hirsutism. After exclusion of hyperandrogenism caused by endocrine abnormalities other than polycystic ovary syndrome, 141 patients were included in the study. Patients were divided into four groups in regard to the drug chosen for treatment. Group 1 (n = 48) received low-dose combined oral contraceptive. Group 2 (n = 65) was treated with cyproterone acetate 100 mg daily for the first 10 days of a 21-day cycle with an oral contraceptive containing 2 mg cyproterone acetate, Group 3 (n = 12) with spironolactone (100-200 mg daily) and Group 4 (n = 16) with ketoconazole (400 mg daily). All patients were followed frequently with respect to side-effects, hirsutism scoring, and lipid and hormonal levels. All four drug regimens were effective in the treatment of hirsutism related to polycystic ovary syndrome, but the most effective seemed to be ketoconazole. The decrement level in hirsutism scoring was the largest in the ketoconazole group, followed by the cyproterone, oral contraceptive and spironolactone groups (34.6 +/- 2.2%, 20.1 +/- 2.7%, 18.1 +/- 2.7% and 12.8 +/- 3.7%, respectively, p < 0.05). Although high-density lipoprotein-cholesterol levels increased in all groups, this increment was smaller in Group 4 than in Groups 1 and 2 (5.1 +/- 2.8%, 34.1 +/- 5.5% and 29.1 +/- 4.9%, respectively, p < 0.05), but not statistically different from that in Group 3 (22.3 +/- 5.9%). The free testosterone levels decreased after treatment in all groups, but the decrement ratios did not differ significantly among groups, although the decrease in free testosterone levels with treatment seemed to be higher in the ketoconazole group than in Groups 1, 2 and 3 (57.0 +/- 2.5%, 22.7 +/- 10.2%, 26.7 +/- 6.5% and 9.5 +/- 19.9%, respectively). In conclusion, ketoconazole seems to be an excellent alternative to more-recognized therapies, but its effect on lipoprotein profile requires further study, because the hyperandrogenism, and the other problems related to hyperandrogenism besides hirsutism, should also be treated.

RCT Entities:   Population Interventions Outcomes