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. 2019 Dec 17;2019(12):CD013505. doi: 10.1002/14651858.CD013505

Karimzadeh 2007.

Methods RCT 
Setting: Iran 
Method of randomisation: computer‐generated sequences that was sealed in envelopes
Blinding: double 
Number randomised: 200 
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:
  • mean age (SD) 27.2 (6.8), 28.6 (7.4)

  • mean BMI (SD) 28.3 (3.18), 29.5 (4.75)


Dropouts: not mentioned
Interventions Main intervention: metformin 500 mg 3/d, placebo 
Duration: 3 months 
Co‐interventions: nil
Outcomes Primary: gastrointestinal side effects
Secondary: clinical pregnancy rate, ovulation: progesterone > 10 ng/mL, BMI, fasting insulin, miscarriage
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