Craig 1994

Methods	Parallel design, RCT conducted in the UK 2 treatment arms: PHT and VPS
Participants	Participants > 60 years with newly onset seizures (1 or more generalised tonic‐clonic seizures or 2 or more partial seizures) Number randomised: PHT = 81, VPS = 85 71 male participants (43%) 80 participants with partial epilepsy (48%) Mean age (range): 78 (61‐95 years)
Interventions	Monotherapy with PHT or VPS Starting doses: PHT: 200 mg/d, VPS: 400 mg/d Median daily dose achieved: PHT 247 mg (range 175‐275); VPS: 688 mg (range 400‐1000) Range of follow‐up: 0‐22 months
Outcomes	Psychological tests (cognitive function, anxiety and depression) Adverse event frequency Seizure control
Notes	Trial paper reports on a subset of 38 participants. Full individual participant dataset provided by trial authors and used for this review includes all 166 participants randomised in the trial. IPD provided for 3/4 outcomes of this review ('withdrawal from allocated treatment' not available).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computerised stratified minimisation programme, stratified for age group, gender and seizure type
Allocation concealment (selection bias)	Low risk	Pharmacy‐controlled allocation, prescription disclosed to general practitioner and consultant
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel unblinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The main investigator performing cognitive testing was blinded to allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition rates reported. ITT analysis undertaken with all randomised participants from IPD (see footnote 2)
Selective reporting (reporting bias)	Low risk	All outcome measures reported in published report or provided in IPD (see footnote 2)
Other bias	Low risk	None identified