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

  • Sobia Nisar Government medical college srinagar
  • Imtiyaz Ahmad Wani Department of Endocrinology SKIMS
  • Ishfaq Ahmad Wani Department of Endocrinology SKIMS
  • Mohd. Afzal Zargar Department of Biotechnology, Central University
  • Aafia Rashid
Keywords: Hyperandrogenism, spironolactone, cholecalciferol, polycystic ovary syndrome


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.

Author Biography

Mohd. Afzal Zargar, Department of Biotechnology, Central University



1) Daniilidis A, Dinas K. Long term health consequences of polycystic ovarian syndrome: a review analysis. Hippokratia 13(2), 90–92 (2009).
2) Panidis, D, Balaris, C., Farmakiotis, D. et al. (2005) Serum parathyroid hormone concentrations are increased in women with polycystic ovary syndrome. Clinical Chemistry, 51, 1691–1697.
3) Hahn, S, Haselhorst, U., Tan, S. et al. (2006) Low serum 25-hydroxyvitamin D concentrations are associated with insulin resistance and obesity in women with polycystic ovary syndrome. Experimental and Clinical Endocrinology and Diabetes, 114, 577– 583.
4) Yildizhan, R., Kurdoglu, M., Adali, E. et al. (2009) Serum 25-hydroxyvitamin D concentrations in obese and non-obese women with polycystic ovary syndrome. Archives of Gynecology and Obstetrics, 280, 559–563.
5) Wehr, E., Pilz, S., Schweighofer, N. et al. (2009) Association of hypovitaminosis D with metabolic disturbances in polycystic ovary syndrome. European Journal of Endocrinology, 0, EJE-9– EJE0432.
6) Pal, L., Shu, J., Zeitlian, G. et al. (2008) Vitamin D insufficiency in reproductive years may be contributory to ovulatory infertility and PCOS. Fertility and Sterility, 90, S14.7) Jones, G., Strugnell, S.A. & Deluca, H.F. (1998) Current understanding of the molecular actions of vitamin D. Physiological Reviews, 78, 1193–1231.
8) Wehr, E., Trummer, O., Giuliani, A. et al. (2011) Vitamin D associated polymorphisms are related to insulin resistance and vitamin D deficiency in polycystic ovary syndrome. European Journal of Endocrinology, 164, 741–749.
9) Borissova AM, Tankova T, Kirilov G, Dakovska L & Kovacheva R.(2003)The effect of vitamin D3 on insulin secretion and peripheral insulin sensitivity in type 2 diabetic patients. International Journal of ClinicalPractice,57,258–261.
10) Boucher BJ, Mannan N, Noonan K, Hales CN & Evans SJ.(1995) Glucose intolerance and impairment of insulin secretion in relation to vitamin D deficiency in East London Asians. Diabetologia,38,1239–1245.
11) Alvarez JA & Ashraf A. (2010)Role of vitamin D in insulin secretion and insulin sensitivity for glucose homeostasis. International Journal of Endocrinology.
12) Bikle D.(2009) Nonclassic actions of vitamin D. J Clin Endocrinol Metab.Jan;94(1):26-34.
13) Thys-Jacobs, S., Donovan, D., Papadopoulos, A. et al. (1999) Vitamin D and calcium dysregulation in the polycystic ovarian syndrome. Steroids, 64, 430–435.
14) Ozkan, S., Jindal, S., Greenseid, K. et al. (2010) Replete vitamin D stores predict reproductive success following in vitro fertilization. Fertility and Sterility, 94, 1314–1319.
15) Freundlich M, Quiroz Y, Zhang Z, Zhang Y, Bravo Y, Weisinger JR, Li YC, Rodriguez-Iturbe B.(2008) Suppression of renin-angiotensin gene expression in the kidney by paricalcitol. Kidney Int. 74(11),1394-402.
16) Kotsa K, Yavropoulou MP, Anastasiou O, Yovos JG.(2009) Role of vitamin D treatment in glucose metabolism in polycystic ovary syndrome. Fertil Steril. 92(3), 1053-8.
17) Firouzabadi Rd, Aflatoonian A, Modarresi S, Sekhavat L, MohammadTaheri S.Therapeutic effects of calcium & vitamin D supplementation in women with PCOS.Complement Ther Clin Pract. 2012 May;18(2):85-8.
18) Azziz R. (2005)Diagnostic criteria for polycystic ovary syndrome: a reappraisal.Fertility and Sterility.83,1343–1346
19) Balen AH, Laven JS, Tan SL, Dewailly D. Ultrasound assessment of the polycystic ovary: international consensus definitions. Hum Reprod Update. 2003;9:505–514
20) Zulian E, Sartorato P, Benedini S, et al. Spironolactone in the treatment of polycystic ovary syndrome: effects on clinical features, insulin sensitivity and lipid profile. J Endocrinol Invest. 2005;28:49–53.
21) Studen KB, Sebestjen M, Pfeifer M, Prezelj J. Influence of spironolactone treatment on endothelial function in non-obese women with polycystic ovary syndrome. Eur J Endocrinol. 2011;164:389–395.
22) Nakhjavani M, Hamidi S, Esteghamati A, Abbasi M, Nosratian-Jahromi S, Pasalar P. Short term effects of spironolactone on blood lipid profile: a 3-month study on a cohort of young women with hirsutism. British Journal of Clinical Pharmacology. 2009;68 (4):634-637.
23) Spritzer PM, Lisboa KO, Mattiello S, Lhullier F. Spironolactone as a single agent for long-term therapy of hirsute patients. Clin Endocrinol (Oxf). 2000;52:587–594
24) Wang H, Xia N, Yang Y, Peng D-Q. Influence of vitamin D supplementation on plasma lipid profiles: A meta-analysis of randomized controlled trials. Lipids in Health and Disease. 2012;11:42.
25) Selimoglu, H., Duran, C., Kiyici, S. et al. (2010) The effect of vitamin D replacement therapy on insulin resistance and androgen levels in women with polycystic ovary syndrome. Journal of Endocrinological Investigation, 33, 234–238.
26) Wehr, E., Pieber, T.R. & Obermayer-Pietsch, B. (2011) Effect of vitamin D3 treatment on glucose metabolism and menstrual frequency in PCOS women-a pilot study. Journal of Endocrinological Investigation, 34, 757–763.
27) Teegarden, D. & Donkin, S.S. (2009) Vitamin D: emerging new roles in insulin sensitivity. Nutrition Research Reviews, 22, 82–92.
How to Cite
Nisar S, Wani IA, Wani IA, Zargar MA, Rashid A. Evaluation of efficacy and safety of spironolactone on clinical, metabolic and insulin sensitivity parameters among vitamin D replete women with PCOS: An observational study. jms [Internet]. 2019Mar.29 [cited 2019Apr.22];22(1). Available from: http://jmsskims.org/index.php/jms/article/view/395
Original Articles