Heller 1995

Methods	Randomised, parallel‐group, open‐label paediatric study conducted in 2 centres in the United Kingdom. Trial conducted between 1981 and 1987 Four treatment arms: carbamazepine, sodium valproate, phenytoin, phenobarbitone
Participants	Adults with newly‐diagnosed epilepsy (2 or more untreated partial or generalised tonic‐clonic seizures in the 12 months preceding the study) Number randomised: CBZ = 61, PHT = 63 52 participants (42%) with partial epilepsy. 64 (52%) men. Mean age (range): 31 (13 to 72) years Range of follow‐up (months): 1 to 91
Interventions	Monotherapy with PHT or CBZ. Median daily dose achieved: PHT = 300 mg/day, CBZ = 600 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	IPD provided for all randomised participants. All outcomes in this review calculated from IPD Funding: support provided by the Medical Research Council, the Health Promotion Trust, Ciba‐Geigy, Parke‐Davis, and Sanofi Conflicts of interest: None stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation list 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 concealed via 4 batches of concealed opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Unblinded; authors state masking of treatment would not be “practical” and would have “introduced bias due to a very large drop‐out rate.” Unclear if outcome was influenced
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Unblinded; authors state masking of treatment would not be “practical” and would have “introduced bias due to a very large drop‐out rate.” Unclear if outcome was influenced
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition rates reported, all randomised participants analysed from IPD provided1
Selective reporting (reporting bias)	Low risk	All outcomes reported or calculated with IPD provided1
Other bias	Low risk	No other bias detected