Yarali 2002.
Methods | RCT Setting: Turkey Method of randomisation: computer‐generated numbers. Centralised randomisation process* Blinding: double‐blind Number randomised: 32 |
|
Participants | Summary: metformin vs placebo in non‐obese PCOS, CC resistance Inclusion criteria: PCOS (oligomenorrhoea < 6 cycles/year, anovulation confirmed with progesterone < 5 ng/mL, testosterone > 2.4 nmol/L, exclusion of other endocrinopathy, US findings of PCO, CC resistance to 250 mg for 5 d for up to 6 months, normal semen analysis, normal HSG or laparoscopy within 6 months Exclusion criteria: diabetes mellitus, adrenal hyperplasia, Cushing’s syndrome, thyroid dysfunction, hyperprolactinaemia, medication known to alter insulin action, previous gonadotrophin treatment, infertility other than that caused by PCOS, previous pelvic surgery Baseline characteristics of each group: metformin (n = 16) vs placebo (n = 16)
Dropouts: 2 (6%) from the metformin/placebo part of the study owing to pregnancy. They were excluded from analysis |
|
Interventions | Main intervention: 1 of metformin 850 mg 2/d, placebo Duration: 6 weeks initially, then those who did not ovulate continued for 1 cycle Co‐interventions: those that did not ovulate after 6 weeks had recombinant FSH in a low‐dose, step‐up protocol No change in usual eating habits |
|
Outcomes | Primary: none Secondary: live birth rate, gastrointestinal side effects, pregnancy rate, ovulation: serum progesterone > 15.9 nmol/L weekly, BMI, fasting glucose, fasting insulin, total and free testosterone |
|
Notes | Free testosterone was significantly higher in the metformin group. Fasting insulin was non‐significantly higher with a wide SD compared with placebo *Information not in the original paper kindly provided by the study author |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated numbers. Centralised randomisation process* |
Allocation concealment (selection bias) | Unclear risk | Inadequate information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Inadequate information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Inadequate information |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropouts: 2 (6%) from the metformin/placebo part of the study owing to pregnancy. They were excluded from analysis |
Selective reporting (reporting bias) | Unclear risk | Inadequate information |
Other bias | Low risk | No evidence of other bias |