Karimzadeh 2007.
Methods | RCT Setting: Iran Method of randomisation: computer‐generated sequences that was sealed in envelopes Blinding: double Number randomised: 200 |
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Participants | Summary: metformin vs placebo in non‐obese PCOS Inclusion criteria: Rotterdam criteria 2003 Exclusion criteria: hyperprolactinaemia, CSH, thyroid disease, Cushings syndrome, androgen‐secreting tumour Baseline characteristics of each group:
Dropouts: not mentioned |
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Interventions | Main intervention: metformin 500 mg 3/d, placebo Duration: 3 months Co‐interventions: nil |
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Outcomes | Primary: gastrointestinal side effects Secondary: clinical pregnancy rate, ovulation: progesterone > 10 ng/mL, BMI, fasting insulin, miscarriage |
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Notes | Women were recruited from a single centre. The primary objective of this study was to investigate the effect of metformin on lipid profile. The duration of the trial was relatively short. Therefore, it was difficult to ascertain the reliability on both of the ovulation rates and the improvement in menstrual patterns. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated sequences that were sealed in envelopes |
Allocation concealment (selection bias) | Low risk | Sequences sealed in opaque envelopes and code kept in the pharmacy department |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of participants and personnel |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of investigators |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not stated |
Selective reporting (reporting bias) | Unclear risk | Insufficient information in the study |
Other bias | Low risk | No evidence of other bias |