Effectiveness of ethinyl oestradiol /cyproterone acetate and ethinyl oestradiol/ desogestrel with or without low-dose metformin on perceived health-related quality of life in hirsute women with polycystic ovary disease: A randomised, double-blind, placebo-controlled study
Published on: 6th August, 2019
Background: Polycystic ovary disease (PCOD) is an endocrine disorder. It leads to menstrual disturbances, infertility, obesity and dermatological manifestations such as hirsutism and acne which leads to impaired health-related quality of life (QOL).
Aims: To evaluate the perceived health related QOL in patients with PCOD treated with ethinyl oestradiol (35µg)/cyproterone acetate (2 mg) (EE/CPA) and ethinyl oestradiol (20 µg)/ desogestrel (0.15mg) (EE/DES) alone and in combination with low-dose metformin.
Methods: A total of 117 patients with PCOD diagnosed according to Rotterdam Consensus Criteria 2003 with a hirsutism score of 8 or more according to modified Ferriman-Gallway Score (mFGS) were randomised to receive one of four drug combinations (arm A – EE/CPA, arm B- EE/DES, arm C- EE/CPA plus metformin, arm D- EE/DES plus metformin). The outcomes assessed were body mass index (BMI), hirsutism (using mFGS) and health-related QOL (Polycystic Ovary Syndrome Health- Related quality of life Questionnaire (PCOSQ) and a Visual Analog Scale (VAS) score) at baseline and 12 months after treatment.
Results: PCOSQ score in relation to the hirsutism, emotions, menstruation, obesity, infertility and VAS score in relation to hirsutism and obesity had improved at the end of 12 months (p< 0.001) in all treatment arms. There was no difference between treatment arms in all measured outcomes at baseline and at the end of 12 months.
Conclusion: Treatment with EE/CPA and EE/DES is associated with an improvement in perceived QOL in patients with PCOD. The addition of low-dose metformin did not have a significant benefit.
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