Banu 2007

Methods	Single‐centre, double‐blind RCT of participants recruited from clinical referral to a multidisciplinary child development centre at a children's hospital in Dhaka, Bangladesh 2 treatment arms: CBZ and PHB
Participants	108 children aged 2‐15 years with 2 or more generalised tonic‐clonic, partial, or secondarily generalised seizures in the previous year Number randomised: CBZ = 54, PHB = 54 61 boys (56%) 59 participants with partial epilepsy (55%) 26 participants had previous AED treatment (24%) Mean age (range): 6 years (1‐15 years)
Interventions	Monotherapy with CBZ (immediate release) or PHB Starting daily dose: CBZ = 1.5 mg/kg/d, PHB = 5 mg/kg/d, maximum daily dose: CBZ = 4 mg/kg/d, PHB = 16 mg/kg/d Trial duration: 12 months, range of follow‐up: 0‐22 months
Outcomes	Seizure control: seizure freedom during the last quarter of the 12‐month follow‐up Time to first seizure after randomisation Time to treatment withdrawal due to adverse events Change in behaviour from baseline according to age‐appropriate questionnaire Incidence of behavioural side‐effects
Notes	We received IPD for all randomised participants from the trial author. We received reasons for withdrawal of allocated treatment as well as the date of the last follow‐up visit, but withdrawal of allocated treatment did not always coincide with the date of the last follow‐up visit (i.e. several participants had the allocated treatment substituted for the other trial drug and continued to be followed up). Dates of withdrawal of allocated treatment could not be provided; therefore, we could not calculate 'Time to withdrawal of allocated treatment'. We received the date of first seizure after randomisation, but dates of other seizures in the follow‐up time could not be provided; therefore, we calculated 'Time to first seizure' for all participants, but we could not calculate the time to 6‐ and 12‐month remission
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Participants were "randomly assigned to treatment"; the method of randomisation was not stated and not provided by the trial authors
Allocation concealment (selection bias)	Low risk	Allocation was concealed by sealed envelopes prepared on a different site to the site of recruitment of participants
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants, a psychologist, and a therapist were blinded throughout the trial. The treating physician was unblinded for practical and ethical reasons
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	A researcher performing outcome assessment was blinded throughout the trial but unblinded for analysis. It was unclear if this could have influenced the results
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition rates were reported. We analysed all randomised participants from the IPD provided (see footnote 2)
Selective reporting (reporting bias)	Low risk	We calculated 1 outcome for this review from the IPD provided (see footnote 2). We could not calculate other outcomes for this review as the appropriate data were not recorded/not available. All cognitive outcomes from the trial were well reported
Other bias	High risk	There were inconsistencies between rates of seizure recurrence between the data provided and the published paper, which the trial authors could not resolve