Ezeh and colleagues conducted a retrospective analysis to evaluate the effectiveness of long-term combination suppressive therapy on hirsutism, acne, and menstrual disturbances in patients with PCOS and to identify the elements that could predict therapeutic response.
Details of the study
This chart review examined data from 200 nondiabetic patients with PCOS who presented between October 1987 and June 2002. PCOS diagnosis was based on the National Institutes of Health (NIH) 1990 criteria. During the initial visit, patients underwent a detailed medical history and physical exam, including a modified Ferriman-Gallwey hirsutism score and hormonal evaluation.
Treatment regimens. Patients were treated with suppressive therapy that consisted of an oral contraceptive (OC) (35 µg ethinyl estradiol plus 1 mg ethynodiol diacetate), an antiandrogen (spironolactone 200 mg/day), or a combination of these drugs. They were followed every 4 to 12 months (mean follow-up time, 34.2 months; range, 6–155 months), and subjective therapy response was assessed from medical records and by improvements in hirsutism scores.
Study findings. The 138 patients treated with combination suppressive therapy reported higher rates of subjective improvement in hirsutism compared with patients treated with other regimens (89.9% vs 72.0%, P<.0001). They also had a significant objective reduction in their modified Ferriman-Gallwey hirsutism score (6.0 vs 3.2; P = .0001). The combination therapy was superior to either regimen alone; the response to therapy for symptom resolution took at least 6 months and continued for up to 60 months of combination suppressive therapy.
Adding electrolysis treatment to the combination regimen resulted in improved patient satisfaction, but the differences were not significant. Patients’ satisfaction with the therapeutic response could be predicted from their pretreatment hirsutism scores or circulating sex hormone–binding globulin levels.
Study strengths and weaknesses
The study’s major strengths are the large number of patients included, the uniformity of criteria for diagnosis, and the prolonged follow-up. This is one of the few studies to report the impact of therapy on health-related quality of life in patients with PCOS and to assess response to therapy with use of objective measures, such as changes in the modified Ferriman-Gallwey score.
However, the criteria used to diagnose PCOS—the NIH 1990 criteria—currently are used less commonly than the Rotterdam 2003 criteria, and they are less inclusive for the diagnosis of PCOS.
The OC pill formulation used in this study contained the progestogen ethynodiol diacetate, which is not used routinely in modern clinical practice. In addition, the majority of patients were non-Hispanic white, which limits extrapolating these findings to other races and ethnicities.
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This retrospective study offers Level II evidence confirming the superiority of a combined OC plus spironolactone (compared with either agent alone) in the treatment of hirsutism in women with PCOS. In addition, this study emphasizes the importance of using combination suppressive therapy for at least 6 months to see a clinical response. Electrolysis may be helpful to patients especially during the initial 6 months of suppressive treatment. Finally, spironolactone alone could be reserved for cases in which OCs are contraindicated in women not interested in becoming pregnant.
In our practice, we treat patients with hirsutism using OC pills containing the progestogen levonorgestrel plus spironolactone at a lower dose of 100 mg/day, since patients treated with higher spironolactone doses report irregular bleeding and fatigue.
--ELIE HOBEIKA, MD, AND BERT SCOCCIA, MD