Karabacak 2004.
Methods | RCT Setting: Turkey, single centre Number of participants randomised: 16 |
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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 |
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Interventions | Treatment: sibutramine 10 mg/day Control: fluoxetine 20 mg/day Duration: 10 days Co‐interventions: no |
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Outcomes |
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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.