A randomized, controlled trial comparing the metformin, oral contraceptive pills and their combination in patients with polycystic ovarian syndrome

Abstract

Background:Polycystic ovarian syndrome (PCOS) is a condition characterized by insulin resistance (IR) and hormonal dysfunction. We conducted a randomized, controlled trial comparing the effects of metformin, oral contraceptive pills (OCP) and their combination in PCOS.Materials and Methods:We randomized 90 newly diagnosed PCOS (age 18–40 year, symptom duration >6 months) patients into three groups (Group 1–Metformin, Group 2–OCP, and Group 3– Metformin + OCP) in this prospective study. We excluded patients with past use of insulin sensitizers and hormone therapy. We evaluated for the hyperandrogenism (acne, acanthosis, hirsutism, and hormone panel), IR by homeostasis model assessment (HOMA-IR), inflammation (high-sensitivity C-reactive protein, fibrinogen, and ferritin), and body composition (% fat, android/gynoid ratio) markers at baseline and 6 months after therapy. The data were analyzed using appropriate statistical methods and P < 0.05 was considered statistically significant.Results:The study population had a mean age 23.2 ± 4.4 years and body mass index of 28.4 ± 6.1 kg/m2. The improvement in the clinical parameters was similar in all the groups. The combination therapy showed a better response in reducing inflammatory markers, IR, and body composition than either of the groups using a single drug. Metformin alone has resulted in a minor reduction of the androgens. None of the patients developed significant adverse effect to the given therapy.Conclusion:PCOS is managed with either metformin or OCP in many patients. The combination improves the hyperandrogenism, body composition, and reduces the inflammatory markers.

Oral contraceptives (OCs) in combination with metformin versus OCs alone on metabolism in nonobese polycystic ovary syndrome: A meta‐analysis and systematic review of randomized controlled trials

“…Fasting insulin was assessed in 11 studies. [28][29][30][31][32]34,36,[38][39][40][41] OCs+metformin administration was related to a significantly decreased fasting insulin level compared with OCs alone (MD = −2.54 [95% CI = −4.04, −1.04], p = .0009) (Figure 4).…”

“…Finally, 14 studies with a total of 707 participants aged 16-40 years with mean BMI < 30 kg/m 2 were included in the meta-analysis. [28][29][30][31][32][33][34][35][36][37][38][39][40][41] The flow chart for study selection is shown in Figure 1.…”

“…For the progesterone type of OCs, nine studies used cyproterone acetate (CA), 28,[30][31][32]34,36,[38][39][40] drospirenone (DRSP), 33,35,37 one study used norgestimate (NMG) 29 and one study used desogestrel (DSG). 41 The duration of follow-up were 3 months, [30][31][32][38][39][40] 4 months, 28 6 months 29,33-37 and 12 months.…”

“…A regimen of 500 mg qd was used in one study. 36 Gradual dose escalation was applied in five studies 28,31,34,38,39 to reduce gastrointestinal side effects. Participants were nonobese with a mean BMI < 30 kg/m 2 .…”

A PCOS Paradox: Does Inositol Therapy Find a Rationale in All the Different Phenotypes?

“…Frequently, the first-line medical treatment for women with PCOS is OCPs [ 22 ]. They are recommended to reduce the hyperandrogenic signs of the syndrome and to regulate the menstrual cycle [ 23 ], and OCPs are widely prescribed for the teenage population, where the dermatological impact of the syndrome is particularly burdensome [ 20 ]. However, OCPs only treat the hyperandrogenism symptoms of the syndrome, without addressing ovarian issues or metabolic alterations.…”