Effectiveness of low dose Ethinylestradiol/Cyproterone Acetate, Ethinylestradiol/Desogestrel and metformin on hirsutism, hormonal and metabolic parameters of patients with polycystic ovary syndrome: A randomized, double-blind, placebo-controlled study

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 modifi ed Ferriman-Gallway Score (mFGS) were randomised to receive one of four drug combinations (arm A – EE/CPA, arm BEE/DES, arm CEE/CPA plus metformin, arm DEE/DES plus metformin). The outcomes assessed were body mass index (BMI), hirsutism (using mFGS) and health-related QOL (Polycystic Ovary Syndrome HealthRelated 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 signifi cant benefi t. Effectiveness of low dose Ethinylestradiol/Cyproterone Acetate, Ethinylestradiol/Desogestrel and metformin on hirsutism, hormonal and metabolic parameters of patients with polycystic ovary syndrome: A randomized, double-blind, placebo-controlled study Published: August 06, 2019 026 Introduction Polycystic ovary disease (PCOD) is a multisystem disease, and is the commonest endocrinological disease among women of the reproductive age group [1]. It is associated with biochemical and hormonal disturbances leading to adverse cosmetic, reproductive, metabolic, and psychological consequences [2]. A single community study conducted in Sri Lanka, showed that the prevalence of PCOD of a semi-urban population of women is 6.3% [3]. Health-related QOL is de ined as the functional effect of a clinical condition, and its treatments upon a patient, which is subjective and multidimensional, including physical function, psychological state, and social interactions. PCOD can impact the QOL of most women leading to psychosocial detriments. The psychological impact and the patients’ mental wellbeing are often-overlooked and inadequately managed in PCOD due to the lack of attention given to it [4]. The cosmetic impact and its associated psychological distress due to hirsutism and obesity, as well as the social tensions associated with infertility can be signi icant [5-7]. The psychological distress was high in women with hirsutism when compared to women without hirsutism according to some studies whereas others documented signi icant distress associated with obesity [7,8]. They often suffer from minor to major psychological problems such as, anxiety, body dissatisfaction, eating disorders, diminished sexual satisfaction, depression and lowered health-related QOL. Low self-esteem, decreased social activity and less romantic contentment were reported in women with PCOD [9,10]. The QOL may be objectively assessed by the use questionnaires such as Polycystic Ovary Syndrome Health-Related Quality of life Questionnaire (PCOSQ), 36-Item Short Form Health Survey (SF-36) and the Visual Analogue Scale (VAS) [11,12]. PCOSQ is a reliable instrument for measuring the health-related QOL in women with PCOD [13]. It has been used previously in clinical trials to assess the QOL following treatment [14]. It contains 26 items: emotions (eight items), hirsutism ( ive items), weight problems ( ive items), infertility problems (four items), and menstrual problems (four items) [15]. Each question in the PCOSQ is associated with a 7-point Likert scale in which seven represents optimal function and one represents the poorest function. VAS is a graded linear scale used to assess the patients’ QOL in relation to each of the affected problems such obesity, acne, emotion etc. A reduced total PCOSQ score in PCOD is associated with sexual dissatisfaction, depression, anxiety, aggression, infertility, weight dif iculties, menstrual irregularities and poor interpersonal functioning [16]. Hirsutism, acne and obesity have aesthetic implications. Infertility can lead to various social issues and marital problems particularly in South Asian communities. Most patients with PCOD have dif iculty in coming to terms with the disease [17]. Pharmacological treatment with hormonal therapy such as ethinyl oestradiol, desogestrel; antiandrogen therapy such as cyproterone acetate as well as metformin along with life style measures have been shown to have an impact on the improvement in obesity, menstruation, infertility, hirsutism and the emotional state of women with PCOD [5,18-20]. This in turn may contribute towards a better QOL. Thus, we hypothesise that optimal treatment may enhance the health related-QOL in women with PCOD.