Thilothammal 1996

Methods	Parallel‐design RCT conducted in Madras (Chennai), India Three treatment arms: PHB, PHT, VPS
Participants	Children with more than 1 previously untreated generalised tonic clonic (afebrile) seizure Number randomised: PHB group = 51, PHT = 52, VPS = 48 81 boys (54%) 0% partial epilepsy (all had generalised epilepsy) Age range: 4‐12 years
Interventions	Monotherapy with PHT or VPS Starting doses: PHB: 3 mg/kg/d‐ 5 mg/kg/d PHT: 5 mg/kg/d‐ 8 mg/kg/d, VPS: 15 mg/kg/d‐ 50 mg/kg/d Dose achieved not stated Range of follow‐up (months): 22‐36
Outcomes	Proportion with recurrence of seizures Adverse events
Notes	Outcomes chosen for this review were not reported. IPD not available
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants randomised via a computer‐generated list of random numbers
Allocation concealment (selection bias)	Unclear risk	No information provided
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Double–blinded using additional placebo tablets, unclear who was blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Double–blinded using additional placebo tablets, unclear who was blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition rates reported, all randomised participants analysed
Selective reporting (reporting bias)	Low risk	No protocol available, outcomes chosen for this review not reported, Seizure and adverse event outcomes well reported
Other bias	Low risk	None identified