title: 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.
abstract: BACKGROUND
  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.
  
  
  METHODS
  The present study was an open-label, randomized study conducted at a tertiary care referral center.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India. ashraf.endo@gmail.com
authors.forename: Mohd Ashraf
authors.initials: MA
authors.lastname: Ganie
authors.forename: Madan Lal
authors.initials: ML
authors.lastname: Khurana
authors.forename: Sobia
authors.initials: S
authors.lastname: Nisar
authors.forename: Parvaiz Ahmed
authors.initials: PA
authors.lastname: Shah
authors.forename: Zaffar Amin
authors.initials: ZA
authors.lastname: Shah
authors.forename: Bindu
authors.initials: B
authors.lastname: Kulshrestha
authors.forename: Nandita
authors.initials: N
authors.lastname: Gupta
authors.forename: Mohd Afzal
authors.initials: MA
authors.lastname: Zargar
authors.forename: Tariq Ahmed
authors.initials: TA
authors.lastname: Wani
authors.forename: Syed
authors.initials: S
authors.lastname: Mudasir
authors.forename: Farooq Ahmed
authors.initials: FA
authors.lastname: Mir
authors.forename: Shahnaz
authors.initials: S
authors.lastname: Taing
mesh_terms: D000293:Adolescent; D000328:Adult; D001786:Blood Glucose; D001794:Blood Pressure / Q000187:drug effects; D001823:Body Composition / Q000187:drug effects; D015992:Body Mass Index; D004359:Drug Therapy, Combination; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance; D007986:Luteinizing Hormone / Q000097:blood; D008597:Menstrual Cycle / Q000187:drug effects; D008687:Metformin / Q000008:administration & dosage / Q000627:therapeutic use*; D000451:Mineralocorticoid Receptor Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D011085:Polycystic Ovary Syndrome / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D013148:Spironolactone / Q000008:administration & dosage / Q000627:therapeutic use*; D013739:Testosterone / Q000097:blood; D016896:Treatment Outcome; D049629:Waist-Hip Ratio
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D000451:Mineralocorticoid Receptor Antagonists; D013148:Spironolactone; D013739:Testosterone; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone; D008687:Metformin