Randomised controlled trial: comparing effects of metformin versus myoinositol versus metformin and myoinositol on ovarian functions and metabolic factors in polycystic ovarian syndrome

Shikha Singh Thakur; Shaheen Anjum; S. S. Siddiqui

doi:10.18203/2320-1770.ijrcog20202345

Authors

Shikha Singh Thakur Department of Obstetrics and Gynecology, JNMCH, Aligarh Muslim University, Aligarh, Uttar Pradesh, India
Shaheen Anjum Department of Obstetrics and Gynecology, JNMCH, Aligarh Muslim University, Aligarh, Uttar Pradesh, India
S. S. Siddiqui Department of Endocrinology, JNMCH, Aligarh Muslim University, Aligarh, Uttar Pradesh, India

DOI:

https://doi.org/10.18203/2320-1770.ijrcog20202345

Keywords:

Insulin resistance, Metformin, Myoinositol, Polycystic ovarian syndrome

Abstract

Background: Polycystic ovarian syndrome (PCOS) characterized by anovulation and features of hyperandrogenism (clinical or biochemical) and insulin resistance. Metformin and myoinositol being insulin sensitizers improve clinical and biochemical parameters. This study was done to compare the effects of these drugs on clinical features and biochemical profile.

Methods: A randomized, comparative, clinical study was conducted on 72 patients. The patients were randomized with the help of computer-generated random numbers and were allocated to either of the three treatment groups A, B and C. Patients in group A received metformin 500 mg TDS, group B received myoinositol 1000 mg BD, group C received combination of metformin 500 mg and myoinositol 550 mg BD for 24 weeks. At first visit patients detailed history and baseline investigations were recorded. Follow up was done 24 weeks after start of therapy to assess the improvement in clinical and biochemical profile.

Results: There was significant improvement in menstrual irregularities, cutaneous manifestations, pregnancy rate, LH/FSH ratio, insulin sensitivity and HOMA-IR after 24 weeks of treatment in all three groups (p value <0.05), although there was greater improvement in cases treated with combination of metformin and myoinositol than metformin and myoinositol alone.

Conclusions: The combination of metformin and myoinositol has resulted in more significant reduction in insulin resistance and improvement in metabolic and hormonal profile along with regularization of menstrual cycles and spontaneous conception than metformin and myoinositol alone.

Metrics

Metrics Loading ...

References

Sirman SM, Pate KA. Epidemiology, diagnosis, and management of polycystic ovary syndrome. Clin Epidemiol. 2013;18(6):1-13.

Nidhi R, Padmalata V, Nagarathna R, Amritanshu R. Prevalence of polycystic ovarian syndrome in Indian adolescents. J Pediatr Adolesc Gynecol. 2011;24:223-7.

Nivetha M, Susan G. Suganya. Survey of poly cystic ovarian disease (PCOD) among the girl students of bishop Heber College, Trichirapalli, Tamil Nadu, India. IOSR-JNHS. 2016;5(4):44-52.

Hoffman, Schorge, Schaffer, Halvorson, Bradshaw, Cunningham. Williams gynaecolgy, 2nd edition, chapter 17; 2012:460-461.

Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004;19:41.

Gilvaz S, Presannakumari B. PCOS is now recognized to be a very heterogenous condition. Postgraduate Gynaecol. 2011;9:145-9.

Tsilchorozidou T, Overton C, Conway GS. The pathophysiology of polycystic ovary syndrome. Clin Endorinol (OXf); 2004:60:17.

Sirmans SM, Pate KA. Epidemiology, diagnosis and management of polycystic ovary syndrome. J Epidemiol. 2013:1-13.

Papalio E, Vitoriounefer V, Baillargeon JP, Fusi F, Occhi F, De Santis L. Myo-inositol may improve oocyte quality in intracytoplasmic sperm injection cycles. A prospective, controlled, randomized trial. Metabol Clin Exper. 1999;48(2):167-17.

Hull MG. Epidemiology of infertility and polycystic ovarian disease: endocrinological and demographic studies. Gynecol Endocrinol. 1987;1:235-45.

Franks S, McCarthy MI, Hardy K. Development of polycystic ovary syndrome: involvement of genetic and environmental factors. Int J Androl. 2006;29:278-85.

Liang SJ, Liou TH, Lin HW, Hsu CS, Tzeng CR, Hsu MI. Obesity is the predictor of impaired glucose tolerance and metabolic disturbance in polycystic ovary syndrome. Acta Obstet Gynecol Scand. 2012;91(10):1167-72.

Fritz MA, Speroff L. Clinical Gynecologic Endocrinology and Infertility, 8th edition (Lippincott Williams and Wilkins; 2010:505.

Ravn P, Haugen AG, Glintborg D. Overweight in polycystic ovary syndrome. An update on evidence-based advice on diet, exercise and metformin use for weight loss. Minerva Endocrinol. 2013;38(1):59-76.

Lujan ME, Chizen DR, Pierson RA. Diagnostic criteria for polycystic ovary syndrome: pitfalls and controversies. J Obstet Gynaecol Can. 2008;30(8):671-9.

Al-Inany H, Johnson N. Drugs for anovulatory infertility in polycystic ovary syndrome. BMJ. 2006;332:1461-2.

Nordio M, Proietti E. The combined therapy with myo-inositol and D-chiro-inositol reduces the risk of metabolic disease in PCOS overweight patients compared to myo-inositol supplementation alone. Eur Rev Med Pharmacol Sci. 2012;16(5):575-81.

Gerli S, Papaleo E, Ferrari A, di Renzo GC. Randomized, double blind placebo-controlled trial: effects of Myo-inositol on ovarian function and metabolic factors in women with PCOS. Eur Rev Med Pharmacol Sci. 2007;11(5):347-54.

Misra A, Chowbey P, Makkar BM, Vikram NK, Wasir JS, Chadha D, et al. Consensus statement for diagnosis of obesity, abdominal obesity and the metabolic syndrome for Asian Indians and recommendations for physical activity, medical and surgical management. J Assoc Physicians India. 2009;57:163-70.

Albareda M, Rodríguez-Espinosa J, Murugo M, deLeyva A, Corcoy R. Assessment of insulin sensitivity and β-cell function from measurements in the fasting state and during and oral glucose tolerance test. Diabetol. 2000;43:1507-11.

Momin AA, Bankar MP, Bhoite GM. Determination of HOMA IR cut off value, and efficiency of lipids and lipoprotein ratios as discriminator of insulin resistance in type 2 diabetes mellitus patients. IOSR J Pharma. 2014;4(6):9-14.

Radwan M, Youssry MA, El-saadany HM. Evaluation of different biochemical markers in prediction of metabolic syndrome in polycystic ovary syndrome patients. Int J Reprod Contracept Obstet Gynecol. 2017;6(7):2734-40.

Muniyappa R, Lee S, Chen H, Quon MJ. Current approaches for assessing insulin sensitivity and resistance in vivo: advantages, limitations, and appropriate usage. Am J Physiol Endocrinol Metab. 2008;294:15-26.

Minozzi M, Nordio M, Pajalich R. The combined therapy myo-inositol plus D-chiro-inositol, in a physiological ratio, reduces the cardiovascular risk by improving the lipid profile in PCOS patients. Age. 2013;26:5-1.

Nehra J, Kaushal J, Singhal SR, Ghalaut VS. A comparative study of efficacy and safety of myoinositol versus metformin in polycystic ovarian syndrome in women. World J Pharma Pharmaceut Sci. 2016;5(5):884-96.

Hu L, Shen H, Wu QF, Tian L, Hu MH. Treatment of polycystic ovarian syndrome with insulin sensitizer. Clin Exp Obstet Gynaecol. 2014;41:28892.

Chirania K, Misra S, Behera S. A randomized clinical trial comparing myoinositol and metformin in PCOS. Int J Reprod Contracept Obstet Gynecol. 2017;6:1814-20.

Angik R, Jajoo SS, Hariharan C, Chimote A. A comparative study of metabolic and hormonal effects of myoinositol vs. metformin in women with polycystic ovary syndrome: a randomised controlled trial. Int J Reprod Contracept Obstet Gynecol. 2017;4(1):189-4.

Nagaria T, Mohapatra A, Jaiswal J. Effect of myoinositol and metformin in combination on clinical and hormonal profile in patients of polycystic ovarian syndrome. Int J Reprod Contracept Obstet Gynecol. 2019;8(2):703.

Ranwa M, Nagaria T, Jaiswal J, Arya A. Study of effect of myoinositol on menstrual irregularities and skin problems in polycystic ovarian syndrome cases. Int J Reprod Contracept Obstet Gynecol. 2017;6(6):2310-7.

Genazzani AD, Lanzoni C, Ricchieri F, Jasonni VM. Myo-inositol administration positively affects hyperinsulinemia and hormonal parameters in overweight patients with polycystic ovary syndrome. Gynecol Endocrinol. 2008;24:139-44.

Papaleo E, Unfer V, Baillargeon JP, De Santis L, Fusi F, Brigante C, et al. Myo-inositol in patients with polycystic ovary syndrome: a novel method for ovulation induction. Gynecol Endocrinol. 2007;23(12):700-3.

Le Donne M, Alibrandi A, Giarrusso R, Lo MI, Muraca U. Diet, metformin and inositol in overweight and obese women with polycystic ovary syndrome: effects on body composition. Minerva Ginecol. 2012;64(1):23.

Nehra J, Kaushal J, Singhal SR, Ghalaut VS. A comparative study of myo inositol versus metformin on biochemical profile in polycystic ovarian syndrome in women. Int J Pharma Sci Res. 2017;8(4):1664.