Comparison of the clinical efficacy of flutamide and spironolactone plus ethinyloestradiol/cyproterone acetate in the treatment of hirsutism: A randomised controlled study

Introduction: Hirsutism is commonly a consequence of ovarian androgen over-production. Polycystic ovary syndrome (PCOS) or peripheral hypersensitivity to normal androgen circulating levels (idiopathic hirsutism) can be the underlying cause. Several drugs with anti-androgenic properties, such as cyproterone acetate (CPA), spironolactone and flutamide have been used to treat hirsutism, but the efficacy of these drugs has yet to be fully elucidated. The objective of this study was to compare the effectiveness of flutamide, and spironolactone plus a combination tablet of 2 mg CPA/35 μg ethinyloestradiol (EE) in the treatment of hirsutism. Methods: A prospective randomised clinical study was conducted in a tertiary care hospital setting. Twenty-nine women with hirsutism as a consequence of PCOS or idiopathic hirsutism were randomly assigned to receive 250 mg/day flutamide alone or 100 mg/day spironolactone plus a combination tablet of 2 mg CPA/35 μg EE, for 6 months. Patients’ hormonal and lipid profiles were evaluated. Hirsutism was graded according to the modified Ferriman-Gallwey (mF-G) score, and side effects were monitored. Results: A significant decrease in mF-G scores was observed in the flutamide (from 11.2±3.3 to 7.6±4.0) and spironolactone plus CPA/EE (from 9.9±1.9 to 7.1±2.0) groups. However, there was no statistically significant difference between the two groups. After flutamide therapy, total cholesterol levels decreased significantly but no significant change was observed in any other lipid parameters or in the patients’ hormone profiles. After spironolactone plus CPA/EE therapy, levels of luteinising hormone, total testosterone and free testosterone significantly decreased and triglyceride levels increased. No patients were found to have abnormal liver function test results. Conclusion: Flutamide and spironolactone plus CPA/EE are effective drugs in the treatment of hirsutism.