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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Randomised, 'two compartment' parallel trial, conducted in the USA
2 treatment arms: CBZ and PHT
Participants Adults, previously untreated, with at least 2 seizures or at least 1 seizure and an EEG with paroxysmal features
Number randomised: PHT = 45, CBZ = 42
60 male participants (69%)
55 participants with partial epilepsy (63%)
Mean age (range) 37.4 (18‐77) years
Interventions Monotherapy with PHT or CBZ
Mean daily dose achieved (for the 54 participants with no major side effects): PHT = 5.35 mg/kg/d, CBZ = 9.32 mg/kg/d
Trial duration: 2 years. Range of follow‐up not reported
Outcomes Laboratory measures
Side effects (major and minor)
Seizure control/treatment failure
Notes 7 participants on CBZ and 10 participants on PHT were “dropped for non‐compliance” and excluded from analysis
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) Unclear risk Participants randomly assigned to treatment groups, method of randomisation not stated
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) All outcomes Low risk Double‐blind (participants and personnel) achieved with additional blank tablet
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Unclear if outcome assessors were blinded
Incomplete outcome data (attrition bias) All outcomes High risk 17/87 (19.5%) of participants excluded from analysis for "non‐compliance". Results presented only for participants who completed the trial
Selective reporting (reporting bias) Low risk All efficacy and tolerability outcomes specified in the methods sections reported well in the results section. No protocol available. Outcomes chosen for this review were not reported
Other bias Low risk None identified