Mitchell 1987

Methods	Randomised, double‐blind, single‐centre, parallel paediatric study conducted in Los Angeles, USA 2 treatment arms: CBZ and PB
Participants	Children with newly diagnosed epilepsy Number randomised: PB = 18, CBZ = 15 100% partial epilepsy, 100% newly diagnosed 20 (61%) male children Mean age (range): PB = 7.89 (2 to 12 years), CBZ = 6.07 (2 to 12 years) Study duration: 12 months Range of follow‐up: not reported
Interventions	Monotherapy with PB or CBZ. Doses started and achieved not stated
Outcomes	Change in cognitive, intelligence (IQ), behavioural, and psychometric scores between baseline, 6 months, and 12 months Compliance, drug changes, and withdrawal rates Seizure control at 6 and 12 months (excellent/good/fair/poor)
Notes	33 participants were randomised to PB (18) and CBZ (15) in this study; 6 children were enrolled into a six‐month pilot study (PB (4) CBZ (2)) prior to the randomised study. The 6 children were included in six‐month follow‐up psychometric data. Outcomes for this review were not reported; IPD were not available.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	33 children were "randomised using a scheme that balanced drug distribution by age and sex"; no further details were provided on the randomisation scheme. 6 non‐randomised children were also used in some analyses.
Allocation concealment (selection bias)	Unclear risk	No information was provided.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The trial blinded participants (and parents); clinicians were unblinded for clinical follow‐up.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The trial blinded psychometric (cognitive) testers blinded for clinical follow‐up.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition rates were reported; results were reported for all children who completed each stage of follow‐up.
Selective reporting (reporting bias)	Low risk	Cognitive/behavioural outcomes, seizure control outcomes, and adverse events were all well reported. No protocol was available; outcomes for this review were not reported.
Other bias	High risk	There was evidence that the study may have been underpowered to detect differences (e.g. 55% power to find a 5‐point difference in IQ score). The behavioural questionnaire was not fully validated. Non‐randomised children from a pilot study were included in the results for psychometric outcomes and medical outcomes.