title: Metformin and/or clomiphene do not adversely affect liver or renal function in women with polycystic ovary syndrome.
abstract: BACKGROUND
  Nonalcoholic fatty liver disease is common to insulin-resistant states such as polycystic ovary syndrome (PCOS). Metformin (MET) is often used to treat PCOS but information is limited as to its effects on liver function.
  
  
  OBJECTIVE
  We sought to determine the effects of MET on serum hepatic parameters in PCOS patients.
  
  
  METHODS
  This was a secondary analysis of a randomized, doubled-blind trial from 2002-2004.
  
  
  METHODS
  This multi-center clinical trial was conducted in academic centers.
  
  
  METHODS
  Six hundred twenty-six infertile women with PCOS with serum liver function parameters less than twice the upper limit of normal were included.
  
  
  METHODS
  Clomiphene citrate (n = 209), MET (n = 208), or combined (n = 209) were given for up to 6 months.
  
  
  METHODS
  The percent change from baseline in renal and liver function between- and within-treatment arms was assessed.
  
  
  RESULTS
  Renal function improved in all treatment arms with significant decreases in serum blood urea nitrogen levels (range, -14.7 to -21.3%) as well as creatinine (-4.2 to -6.9%). There were similar decreases in liver transaminase levels in the clomiphene citrate and combined arms (-10% in bilirubin, -9 to -11% in transaminases) without significant changes in the MET arm. When categorizing baseline bilirubin, aspartate aminotransferase, and alanine aminotransferase into tertiles, there were significant within-treatment arm differences between the tertiles with the highest tertile having the largest decrease from baseline regardless of treatment arm.
  
  
  CONCLUSIONS
  Women with PCOS can safely use metformin and clomiphene even in the setting of mildly abnormal liver function parameters, and both result in improved renal function.
authors.affiliation: Department of Obstetrics, University of Missouri School of Medicine, Columbia, Missouri 65212, USA.
authors.forename: Mira
authors.initials: M
authors.lastname: Aubuchon
authors.forename: Allen R
authors.initials: AR
authors.lastname: Kunselman
authors.forename: William D
authors.initials: WD
authors.lastname: Schlaff
authors.forename: Michael P
authors.initials: MP
authors.lastname: Diamond
authors.forename: Christos
authors.initials: C
authors.lastname: Coutifaris
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Carson
authors.forename: Michael P
authors.initials: MP
authors.lastname: Steinkampf
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Carr
authors.forename: Peter G
authors.initials: PG
authors.lastname: McGovern
authors.forename: Nicholas A
authors.initials: NA
authors.lastname: Cataldo
authors.forename: Gabriella G
authors.initials: GG
authors.lastname: Gosman
authors.forename: John E
authors.initials: JE
authors.lastname: Nestler
authors.forename: Evan R
authors.initials: ER
authors.lastname: Myers
authors.forename: Richard S
authors.initials: RS
authors.lastname: Legro
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D001663:Bilirubin / Q000097:blood; D002996:Clomiphene / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005300:Fertility Agents, Female / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D007247:Infertility, Female / Q000188:drug therapy; D007668:Kidney / Q000187:drug effects*; D007677:Kidney Function Tests; D008099:Liver / Q000187:drug effects*; D008111:Liver Function Tests; D008687:Metformin / Q000009:adverse effects* / Q000627:therapeutic use; D011085:Polycystic Ovary Syndrome / Q000378:metabolism*
chemical_list: D005300:Fertility Agents, Female; D007004:Hypoglycemic Agents; D002996:Clomiphene; D008687:Metformin; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D001663:Bilirubin