title: Health-related quality of life in women with newly diagnosed polycystic ovary syndrome randomized between clomifene citrate plus metformin or clomifene citrate plus placebo.
abstract: OBJECTIVE
  What is the health-related quality of life (HRQoL) in women with polycystic ovary syndrome (PCOS) undergoing ovulation induction with clomifene citrate (CC) combined with metformin compared with those using CC combined with placebo?
  
  
  CONCLUSIONS
  Overall quality of life in women with PCOS treated with CC plus metformin was significantly lower than in women treated with CC plus placebo.
  
  
  BACKGROUND
  There are no data on HRQoL in adult women who receive ovulation induction with the purpose of conceiving. Women with PCOS have higher scores on depression and anxiety scales and lower QoL scores than women without PCOS.
  
  
  METHODS
  This study was a secondary analysis of a multi-centre RCT completed between June 2001 and May 2004. The randomization was stratified per centre, and the centres received blinded, numbered containers with medication. There were172 women available for the HRQoL assessment: 85 were allocated to metformin and 87 were allocated to placebo.
  
  
  METHODS
  The Rotterdam Symptom Checklist (RSCL), a standard self-administered questionnaire, was used to assess physical symptoms, psychological distress, activity levels and overall HRQoL.
  
  
  RESULTS
  In the intention to treat analysis, we found differences between the treatment groups with respect to physical symptoms and overall HRQoL. Physical well-being was significantly impaired in women allocated to metformin but not in women allocated to placebo. The increase in physical symptoms in the metformin group was caused by side-effects typical of metformin, and was most pronounced at Week 1 (mean difference 12 [95% confidence interval (CI): 8-16] and still apparent at Week 16 [mean difference 7 (95% CI 2-12]. Overall well-being was significantly impaired in the metformin group compared with the placebo group [mean difference 13 (95% CI 6-20)].
  
  
  CONCLUSIONS
  RSCL measurements were available only for three quarters of the participants. Although the number of missing questionnaires and the baseline measurements, were comparable between the treatment groups, some form of selection bias cannot be ruled out.
  
  
  CONCLUSIONS
  Our finding that metformin was more burdensome than placebo, strengthens the recommendation that CC only and not CC plus metformin should be the drug of choice in this patient population.
  
  
  BACKGROUND
  None of the authors declared a conflict of interest. There was no study funding.
  
  
  BACKGROUND
  ISRCTN55906981.
authors.affiliation: Department of Obstetrics and Gynecology, Center for Reproductive Medicine, Amsterdam, The Netherlands. e.moll@amc.nl
authors.forename: E
authors.initials: E
authors.lastname: Moll
authors.forename: M
authors.initials: M
authors.lastname: van Wely
authors.forename: C B
authors.initials: CB
authors.lastname: Lambalk
authors.forename: P M M
authors.initials: PM
authors.lastname: Bossuyt
authors.forename: F
authors.initials: F
authors.lastname: van der Veen
mesh_terms: D000328:Adult; D001007:Anxiety / Q000209:etiology / Q000503:physiopathology; D002996:Clomiphene / Q000494:pharmacology*; D003863:Depression / Q000209:etiology / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D005300:Fertility Agents, Female / Q000494:pharmacology*; D006801:Humans; D006943:Hyperglycemia / Q000209:etiology / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007247:Infertility, Female / Q000209:etiology / Q000628:therapy*; D057194:Intention to Treat Analysis; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D009426:Netherlands; D010062:Ovulation Induction; D011085:Polycystic Ovary Syndrome / Q000503:physiopathology / Q000523:psychology*; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D015203:Reproducibility of Results; D012720:Severity of Illness Index
chemical_list: D005300:Fertility Agents, Female; D007004:Hypoglycemic Agents; D002996:Clomiphene; D008687:Metformin