de Silva 1996

Methods	Randomised, parallel group, open‐label paediatric study conducted in 2 centres in the UK 4 treatment arms: CBZ, sodium valproate, phenytoin, PB
Participants	Children with newly diagnosed epilepsy (2 or more untreated partial or generalised tonic‐clonic seizures in the 12 months preceding the study) Number randomised: PB = 10, CBZ = 54 (see notes) 35 children (55%) with partial epilepsy 34 (53%) male children Mean age (range): 9 (3 to 16) years Range of follow‐up: 3 to 88 (months)
Interventions	Monotherapy with PB or CBZ Median daily dose achieved: PB = not stated; CBZ = 400 mg/day
Outcomes	Time to first seizure recurrence after start of therapy Time to 12‐month remission from all seizures Adverse effects and withdrawals due to adverse events
Notes	6 of the first 10 children assigned to PB had unacceptable adverse effects, so no further children were assigned to PB. The 10 children randomised to PB were retained in analysis. We received IPD for all outcomes of this review.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A randomisation list was generated using permuted blocks of size 8 or 16 with stratification for centre, seizure type, and presence of neurological signs.
Allocation concealment (selection bias)	Low risk	Allocation was concealed via 4 batches of concealed opaque envelopes.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Unblinded ‐ the authors stated that masking of treatment would not have been "practicable or ethical" and would have "undermine[d] compliance". Lack of masking could have led to early withdrawal of the PB arm from the trial.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Unblinded ‐ the authors stated masking of treatment would not have been "practicable or ethical" and would have "undermine[d] compliance". Lack of masking could have led to early withdrawal of the PB arm from the trial, which was likely to have influenced the overall results.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition rates were reported; we analysed all randomised participants from the IPD provided²
Selective reporting (reporting bias)	Low risk	All outcomes were reported or calculated with the IPD provided²
Other bias	Low risk	We detected no other bias