Teng 2007.
Study characteristics | ||
Methods | Randomised controlled trial Location of the trial: quote: "Harbin" Method of randomisation: quote: "Randomly assigned to two groups" Method of allocation concealment: not stated Source of funding: not stated | |
Participants |
Inclusion criteria: Rotterdam criteria
Exclusion criteria: ?
Number of women randomised: 32 MET: 16 OCP: 16 Number of women analysed: 32 MET: 16 OCP: 16 Number of withdrawal and reasons: 0 Summary characteristics: PCOS |
|
Interventions | Treatment: MET from Day 5, 500 mg/time, three times a day, ½ hour after meal Control: OCP (Ethinyl Estradiol 35 mcg/ Cyproterone acetate 2 mg) from Day 5, one pill per day, continues for 21 days Duration: 3 months Co‐intervention(s): none | |
Outcomes |
Primary outcomes: none
Secondary outcomes: BMI (kg/m2) Serum total testosterone (nmol/L) Fasting insulin (mIU/L) Fasting glucose (mmol/L) |
|
Subjective outcomes | None | |
Objective outcomes | (a) Clinical parameters BMI (kg/m2) (b) Hormonal parameters Serum total testosterone (nmol/L) (c) Metabolic parameters Fasting insulin (mIU/L) Fasting glucose (mmol/L) |
|
Notes | Power calculation: no | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomly assigned to two groups" Insufficient information about the sequence generation process available to permit a judgement of 'low risk' or 'high risk' |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not stated. Insufficient information available to permit a judgement of 'low risk' or 'high risk' |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information available to permit a judgement of ‘low risk’ or ‘high risk’. Blinding not stated. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information available to permit a judgement of ‘low risk’ or ‘high risk’. Blinding not stated. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data. |
Selective reporting (reporting bias) | Low risk | The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre‐specified. |
Other bias | Low risk | The study appears to be free of other sources of bias. |