Evaluation of efficacy and safety of spironolactone on clinical, metabolic and insulin sensitivity parameters among vitamin D replete women with PCOS: An observational study

Abstract

Objective: Polycystic ovary syndrome (PCOS) is one of the commonest endocrine disorders affecting 5-10% women in the reproductive age. PCOS is characterized by irregular menstrual cycles, chronic an-ovulation and hyperandrogenism in addition to many metabolic manifestations and some cancers. The study aimed to evaluate the efficacy and safety of spironolactone among PCOS women supplemented with vitamin D to make them vitamin D replete.
 Material & methods: Sixty eligible women who qualified Rotterdam 2003 criteria and satisfied inclusion /exclusion criteria and had been assigned two groups: Group I: spironolactone (50 mg daily) and cholecalciferol 60000 IU every two weeks and group II: spironolactone 50 mg daily. All women were assessed for clinical, laboratory, and safety parameters before, 3 and 6 months after the treatment.
 Results: Mean age, number of menstrual cycles per year, anthropometric parameters; FG score, metabolic parameters and hormonal profiles were comparable in the groups at baseline. Menstrual cycle frequency improved (8.2±4.6 to 14±4.5 cycles/year vs. 7.9 ± 3.2 to 12.9 ± 6.214.0 ± 4.5) significantly at 6 months after therapy with combination of spironolactone and cholecalciferol vs. spironolactone alone while as FG score decreased significantly (12.4±4.3 to 8.6±1.4 6 vs. 12 ± 3.88 to 10.7 ± 2.9 at 6 months) in the combination. Serum total testosterone levels also showed a significant decline (56.5±20.3 to 38.7±13.6 vs. 57.4 ± 52.1 to 43.8 ± 29.7 at 6 months in the combination. Insulin sensitivity showed a non-significant favorable trend in the combination. There was no significant effect on weight, BMI, BP, LH and FSH levels.
 Conclusion: The results of the observational study that women with PCOS rendered vitamin D replete have better efficacy of spironolactone on clinical, metabolic and insulin sensitivity parameters among women with PCOS without increasing adverse event rate.