El Maghraby 2015.

Study characteristics
Methods	Randomised controlled trial Location of the trial: quote: Alexandria, EgyptMethod of randomisation: quote: "computer‐generated random‐number tables"Method of allocation concealment: not statedSource of funding: Not stated
Participants	Inclusion criteria: PCOS was defined in these girls by the presence of oligomenorrhoea (< 6 cycles/year) and serum testosterone >1 mcg/mL (The Rotterdam consensus workshop group, 2004). Exclusion criteria: suprarenal dysfunction, hyperprolactinaemia, thyroid dysfunction, or recent intake of medications likely to affect hormonal profile was a reason for exclusion from the study. Number of women randomised: 80 MET: 40 OCP: 40 Number of women analysed: 65 MET: 32 OCP: 33 Number of withdrawal and reasons: MET: adverse events 4/ 10% Non compliant 2 /5% Not satisfied 1 / 2.5% Loss F/U 1 / 2.5% OCP: side effect 2 / 5% Non compliant 1/ 2.5% Weight gain 4 / 10% Summary characteristics: PCOS, adolescent 15 to 20 years, all presented with hirsutism, acne and menstrual disorder Age (years): MET mean (+SD): 17.2 (2) OCP mean (+SD): 16.9 (1.6)
Interventions	Treatment: MET 1700 mg/dayControl: OCP (Ethinyl Estradiol 30 mcg progestin 15 mg)Duration: 24 monthsCo‐intervention(s): none
Outcomes	Primary outcomes: Hirsutism score Adverse events: severe (requiring stopping of medication) and minorSecondary outcomes: Menstrual cyclicity, initiation of menses or significant shortening of cycles Body weight (kg) Serum total testosterone (nmol/L) Fasting insulin (mIU/L) Fasting glucose (mmol/L)
Subjective outcomes	(a) Clinical parameters 1. Hirsutism score
Objective outcomes	(a) Clinical parameters 1. Adverse events: severe (requiring stopping of medication) and minor 2. Menstrual cyclicity, initiation of menses or significant shortening of cycles 3. Body weight (kg) (b) Hormonal parameters 1. Serum total testosterone (nmol/L) (c) Metabolic parameters 1. Fasting insulin (mIU/L) 2. Fasting glucose (mmol/L)
Notes	Authors contacted about: results, because total testosterone and fasting insulin were in wrong unit. Power calculation: done, a priori, on glucose/insulin ratio outcome
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “computer‐generated random‐number tables”
Allocation concealment (selection bias)	Unclear risk	Method of 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	High risk	Quote: "The study was not blinded”.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "The study was not blinded”.
Incomplete outcome data (attrition bias) All outcomes	High risk	10% drop out for side effect in MET group/ 10% drop out for weight gain in OCP group, both different yet related to intervention. Quote “statistical analysis of data was done on an intention‐to‐treat basis” but method used not described.
Selective reporting (reporting bias)	High risk	Fasting glucose and Ferriman‐Gallwey score not reported in the results. Instead of Ferriman‐Gallwey score: subjective assessment of hirsutism. Total testosterone and fasting insulin cannot be used because are expressed with wrong units. Not all of the study's prespecified primary outcomes have been reported.
Other bias	Low risk	The study appears to be free of other sources of bias.