Improved efficacy of low-dose spironolactone and metformin combination than either drug alone in the management of women with polycystic ovary syndrome (PCOS): a six-month, open-label randomized study.

CONTEXT: To improve the treatment outcomes in women with polycystic ovary syndrome (PCOS), various drugs like glitazones, oral contraceptive pills, or antiandrogens have been combined with metformin. OBJECTIVE: The aim of the study was to compare the efficacy of the combination of low-dose spironolactone and metformin with either drug alone in the management of women with PCOS. DESIGN AND SETTING: The present study was an open-label, randomized study conducted at a tertiary care referral center. PATIENTS AND INTERVENTION: Of 204 women who met the 2006 Androgen Excess-PCOS criteria for PCOS, 198 were randomized into 3 equal groups to receive metformin (1000 mg/d), low-dose spironolactone (50 mg/d), or a combination of both drugs for a period of 6 months. A total of 169 subjects (n = 56 metformin, 51 spironolactone, 62 combination) completed the study. MAIN OUTCOME MEASURES: Menstrual cycle pattern, Ferriman-Gallwey score, body mass index (BMI), waist-hip ratio, blood pressure, LH, FSH, total T, glucose and insulin sensitivity indices were measured at baseline (0 mo) and 3 and 6 months after the intervention. Recording of adverse events and drug compliance was assessed at each of the visits. RESULTS: The 3 groups had comparable mean age and BMI at baseline. By 6 months, menstrual cycles/y increased, whereas Ferriman-Gallwey score, serum total T, and area under the curve-glucose and -insulin decreased significantly (P < .05) in the combination group as compared to either drug alone. There was no significant change in body weight, BMI, waist-hip ratio, and blood pressure in any of the 3 groups. The combination group had better compliance than either drug alone, and the adverse event rate was not higher. CONCLUSION: The combination of low-dose spironolactone with metformin seems superior to either drug alone in terms of clinical benefits and compliance in women with PCOS.

Type 2 diabetes increases risk for obesity among subsequent generations.

BACKGROUND: Childhood obesity is increasing worldwide. Although the prevalence of obesity is low in India, it is being perceived as an emerging problem among affluent urban Indian children. There is little information regarding the profile of obese Indian children. The aim of this study was to assess the clinical profile of children and adolescents attending our hospital (a tertiary-care center) with the main complaint of obesity or overweight. STUDY DESIGN: Children and adolescents attending our pediatric and adolescent endocrine clinic with the main complaint of overweight or obesity were included in this study. All subjects underwent detailed history, physical examination, hemogram liver function tests, oral glucose tolerance test, plasma insulin, and body fat estimation. RESULTS: One hundred nine children (70 boys and 39 girls), ranging in age from 5 to 18 years (mean 13.8 +/- 2.9 years), were enrolled for the study. Twenty boys and 13 girls were overweight, while 50 boys and 26 girls were obese. Twenty-five of these children had hypertension, 48 had dyslipidemia, and 27 had abnormal glucose tolerance. Plasma insulin levels were significantly higher than what is observed in healthy lean controls. The most significant observation was that 75 children had grandparents and/or parents with diabetes mellitus. Possible reasons for this association are discussed. CONCLUSIONS: Children from families with diabetes mellitus are at risk for obesity. Hyperinsulinemia, by its action on the brain, induces behaviors and lifestyles conducive to obesity.