Pal 1998

Methods	Randomised, parallel‐group trial conducted in a rural district of West Bengal, India 2 treatment arms: PHB and PHT
Participants	Children from a rural district of a developing country (India) who had experienced 2 or more unprovoked seizures within the 12 months preceding the trial and had been untreated in the 3 months preceding the trial Number randomised: PHB = 47 ; PHT = 47 47 boys (50%) 60 children had partial epilepsy (64%) Mean age (range): 11 (2‐18) years
Interventions	Monotherapy with PHB or PHT Maintenance doses: PHT = 5 mg/kg/d, PHB = 3 mg/kg/d. Daily dose achieved not stated Range of follow‐up: 0.5‐13 months
Outcomes	Time to first seizure Proportion seizure‐free in each trial quarter Proportion of adverse events including behavioural side effects
Notes	IPD provided for remission and seizure outcomes of this review by the trial author. Withdrawal information not available
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	First 10 participants randomised from a pre‐prepared balanced random number list, following participants randomised by minimisation with stratification by age group and presence of cerebral impairment
Allocation concealment (selection bias)	Unclear risk	No information provided
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants, parents and treating physicians unblinded for “practical and ethical reasons.” Withdrawal information from treatments not available, however lack of blinding may have influenced withdrawal rates
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcome assessors single‐blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition rates reported, ITT approach, all randomised participants analysed from IPD provided (see footnote 2)
Selective reporting (reporting bias)	Low risk	All outcomes reported or calculated with IPD provided (see footnote 2)
Other bias	Low risk	None identified