Lv 2005.
Study characteristics | ||
Methods | Randomised controlled trial Location of the trial: quote: Huazhong, China Method of randomisation: unclear, quote: “The subjects were randomized to either the CPA group (n=25) or to the CPA + metformin group (n=25).” Method of allocation concealment: not stated Source of funding: Not stated | |
Participants |
Inclusion criteria: PCOS was defined as the presence of: (1) chronic anovulatory disorders such as oligomenorrhoea, anovulatory cycles, or secondary amenorrhoea; (2) the ratio of LH/FSH was > 2 and (or) the plasma testosterone (T) level was > 2.6 nmol/L; (3) 10 or more follicles (2 mm to 8 mm in diameter) in one or both ovaries by transvaginal ultrasound examination. All the women were euthyroid and had normal prolactin levels.
Exclusion criteria: women who had any other known endocrinological disease, and those taking drugs known to affect carbohydrate or lipid metabolism and OGTT results during the 6 months preceding the study were excluded.
Number of women randomised: 50 MET + OCP: 25 OCP: 25 Number of women analysed: not stated Number of withdrawal and reasons: not stated Summary characteristics: PCOS, aged 16 to 36 years, all women were either of normal weight or thin BMI (≤ 25 kg/m2). Age (years): OCP + MET mean (+ SD): 24.5 (5.6) OCP mean (+ SD): 24.35 (5.11) BMI (kg/m2): OCP + MET mean (+ SD): 22.1 (2.46) OCP mean (+ SD): 21.81 (1.37) |
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Interventions | Treatment: OCP (Ethinyl estradiol 35 mcg Cyproterone acetate 2mg) 21 days stop 7 days + MET 500 mg/day Control: OCP (Ethinyl estradiol 35 mcg Cyproterone acetate 2 mg) 21 days stop 7 days Duration: 6 months Co‐intervention(s): Medroxyprogesterone for amenorrhoeic patients | |
Outcomes |
Primary outcomes: noneSecondary outcomes: BMI (kg/m2) Serum total testosterone (nmol/L) Fasting insulin (mIU/L) Fasting glucose (mmol/L) Fasting total cholesterol (mmol/L) Fasting HDL cholesterol (mmol/L) Fasting LDL cholesterol (mmol/L) Fasting triglycerides (mmol/L) |
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Subjective outcomes | None | |
Objective outcomes | (a) Clinical parameters 1. BMI (kg/m2) (b) Hormonal parameters 1. Serum total testosterone (nmol/L) (c) Metabolic parameters 1. Fasting insulin (mIU/L) 2. Fasting glucose (mmol/L) 3. Fasting total cholesterol (mmol/L) 4. Fasting HDL cholesterol (mmol/L) 5. Fasting LDL cholesterol (mmol/L) 6. Fasting triglycerides (mmol/L) |
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Notes | Authors contacted about: the number of patient randomised in each group and number of withdrawal.Power calculation: unclear | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “The subjects were randomized to either the CPA group (n=25) or to the CPA + metformin group (n=25).” 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 | Unclear risk | Paper does not provide any information on participant after randomisation. |
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 prespecified. |
Other bias | Low risk | The study appears to be free of other sources of bias. |