Acarbose versus orlistat in weight management of infertile women with polycystic ovarian syndrome: a prospective randomized controlled trial
DOI:
https://doi.org/10.18203/2320-1770.ijrcog20211099Keywords:
Acarbose, Infertile women and polycystic ovarian syndrome, Orlistat, Weight managementAbstract
Background: Polycystic Ovarian Syndrome (PCOS) affects about 4 to 12% of women worldwide. PCOS is the most common cause of anavulation in infertile women. The endocrine dysfunction of PCOS is aggravated by obesity. Weight management is the first line treatment of this condition. In this study, we tried to compare acarbose versus orlistat in weight management of infertile women with polycystic ovarian syndrome. The aim of this study was to compare the effects of acarbose and orlistat in weight management of infertile polycystic ovarian syndrome women.
Methods: This open label randomized controlled trial study was conducted in the Department of Reproductive Endocrinology and Infertility, BSMMU, Dhaka, Bangladesh. The study period was 1 year from July 2019 to June 2020. A total of 32 obese infertile women with PCOS were included in the study and randomized to two treatment arms: acarbose 100 mg tds for 3 months and orlistat 120 mg tds for 3-months.
Results: The response of adequate (>10%) weight reduction with acarbose was 67% of that with orlistat. The side effects with acarbose were 15% of that with orlistat. Acanthosis nigricans was reduced in 18.8% (n=3/16) of those receiving acarbose.Menstrual cycle regularized in 37.5% (n=6/16) in experimental (acarbose) group and in 18.8% (n=3/16) in control (orlistat) group.
Conclusions: The therapeutic potential of acarbose in reducing weight was relatively less than orlistat in obese infertile PCOS women.
References
Weyer C, Funahashi T, Tanaka S, Hotta K, Matsuzawa Y, Pratley RE, et al. Hypoadiponectinemia in obesity and type 2 diabetes: close association with insulin resistance and hyperinsulinemia. J Clinic Endocrinol Metabol. 2001;86(5):1930-5.
Dunaif A, Graf M, Mendeli J, Laumas V, Dobrjansky A. Characterization of groups of hyperandrogenic women with acanthosis nigricans, impaired glucose tolerance, and/or hyperinsulinemia. J Clinical Endocrinol Metabol. 1987;65:499-507.
Dunaif AKR, Segal W. Futterweit, Dobrjansky A. Profound peripheral insulin resistance, independent of obesity, in polycystic ovary syndrome, Diabetes. 1989;38:1165-74.
Fauser B, Tarlatzis, Fauser. Revised 2003 consensus on diagnostic criteria and long term health risks related to polycystic ovary syndrome, Human Reproduction. 2004;19:41-7.
Ehrmann DA, Rosenfield RL, Barnes RB, Brigell DF, Sheirh Z. Detection of functional ovarian hyperandrogenism in women with androgen excess. New English J Medic. 1992;327:157-62.
Rachmani R, Bar‐Dayan Y, Ronen Z, Levi Z, Slavachevsky I, Ravid M. The effect of acarbose on insulin resistance in obese hypertensive subjects with normal glucose tolerance: a randomized controlled study. Diabetes, Obesity and Metabolism. 2004;6(1):63-8.
Coniff RF, Seaton TB, Shapiro JA, Robbins D, Kleinfield R, MacGill JB, et al. Reduction of glycosylated hemoglobin and postprandial hyperglycemia by acarbose in patients with NIDDM. Diabetes Care. 1996;18:817-20.
Laube H. Acarbose. Clinical Drug Investigation. 2002;22:141-56.
Metwally M, Amer S, Li TC, Ledger WL. An RCT of metformin versus orlistat for the management of obese anovulatory women. Human Reproduction. 2009;24:966-75.
Ghandi S, Aflatoonian A, Tabibnejad N, Moghaddam MH. The effects of metformin or orlistat on obese women with polycystic ovary syndrome: a prospective randomized open-label study. Journal of assisted reproduction and genetics. 2011;28(7):591.
Ciotta L, Calogero AE, Farina M, De Leo V, La Marca A. Cianci A. Clinical, endocrine and metabolic effects of acarbose,an a-glucosidase inhibitor, in PCOS patients with increased insulinresponse and normal glucose tolerance. Human Reproduction. 2001;16:2066-72.
Geisthövel F, Frorath B, Brabant G. Endocrinology: Acarbose reduces elevated testosterone serum concentrations in hyperinsulinaemic premenopausal women: a pilot study. Human reproduction. 1996;11(11):2377-81.
Penna IARB, Canella RM, Reis MF. Silva de Sáand R. Ferriani A. Acarbose in obese patients with polycystic ovarian syndrome: a double-blind, randomized, placebo-controlled study. Human Reproductionvol. 2005;20:.2396-01.
Trikudanathan S, Raji A, Chamarthi B, Seely EW, Simonson DC. Comparison of insulin sensitivity measures in South Asians. Metabolism. 2013;62(10):1448-54.
WHO Expert Consultation. Appropriate body mass index for Asian population and its implication for policy and intervention strategies. Lancet 2004; 363:157-63.
NICE. Obesity, identification, assessment and management. Clinical guidelines [CG189] 2014.
Hanefeld M, Fischer S, Schulze J, Spengler M, Wargenau M, Schollberg K, et al. Therapeutic potentials of acarbose as first-line drug in NIDDM insufficiently treated with diet alone. Diabetes care. 1991;14(8):732-7.
Calle-Pascual A, Garcia-Honduvilla J, Martin-Alvarez PJ, Calle JR, Maranes JP. Influence of 16-week monotherapy with acarbose on cardiovascular risk factors in obese subjects with non-insulin-dependent diabetes mellitus: a controlled, double-blind comparison study with placebo. Diabetes & metabolism. 1996;22(3):201-2.
Mendes D, Alves C, Batel-Marquis F. Number needed to treat (NNT) in clinical literature: an appraisal. BMC Medicine. 2017;15:112.
Metwally M, Amer S, Li TC, Ledger WL. An RCT of metformin versus orlistat for the management of obese anovulatory women. Human Reproduction. 2009;24:966-75.