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. 2013 May 31;2013(5):CD008575. doi: 10.1002/14651858.CD008575.pub2

Karabacak 2004.

Methods RCT
Setting: Turkey, single centre
Number of participants randomised: 16
Participants Summary: PCOS
PCOS diagnostic criteria: observance of polycystic ovaries by transvaginal ultrasound examination performed during the first days of menstruation; oligo/amenorrhoea (intermenstrual interval ≥ 36) and hirsutism (Ferriman‐Gallwey score ≥ 7); with or without raised serum testosterone level
Inclusion criteria: PCOS
Exclusion criteria: did not mention in the article. The authors had been contacted, but no reply
Baseline characteristics: the sibutramine group and the fluoxetine group are comparable in age, BMI, FSH, LH, androstenedione, free testosterone, insulin
Reasons for withdrawals: not applicable.
 All participants completed the study and were included in the analysis
Interventions Treatment: sibutramine 10 mg/day
Control: fluoxetine 20 mg/day
Duration: 10 days
Co‐interventions: no
Outcomes
  1. Endocrine factors: FSH (mIU/L), LH (mIU/L), LH/FSH ratio

  2. Metabolic factors: insulin (μIU/mL), glucose (mmol/L), leptin (ng/mL)

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Did not describe in the article. The authors had been contacted, but no reply
Allocation concealment (selection bias) Unclear risk Did not describe in the article. The authors had been contacted, but no reply
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Does not state how many women were analysed
Selective reporting (reporting bias) Unclear risk Adverse events not reported
Other bias Low risk None detected
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Did not describe in the article. The authors had been contacted, but no reply
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Did not describe in the article. The authors had been contacted, but no reply

BMI: body mass index; FSH: follicle‐stimulating hormone; LH: luteinising hormone; PCOS: polycystic ovary syndrome; RCT: randomised controlled trial.