Skip to main content
. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Multicentre, randomised, parallel‐group, double‐blinded trial over 10 centres in the USA with separate randomisation schemes used for each seizure type.
4 treatment arms: CBZ, PHB, PHT and primidone
Participants Adults with previously untreated or under‐treated simple or complex partial or secondary generalised tonic‐clonic seizures
Number randomised: PHB: 155, PHT = 165, CBZ = 155
413 male participants (87%)
99.8% of participants with partial epilepsy
Mean age (range): 41 (18‐82) years
Interventions Monotherapy with PHT or CBZ
Median daily dose achieved: CBZ = 800 mg/d, PHB = 160 mg/d, PHT = 400 mg/d
Range of follow‐up: 0‐78 months
Outcomes Participant retention/time to drug failure (length of time participant continued to take randomised drug)
Composite scores of seizure frequency (seizure rates and total seizure control) and toxicity
Incidence of side effects
Notes IPD provided for all outcomes of this review by the Department of Veterans Affairs
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants randomised with stratification for seizure type. Method of randomisation not stated and not provided by authors
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 using an additional blank tablet
Blinding of outcome assessment (detection bias) All outcomes Unclear risk No information provided
Incomplete outcome data (attrition bias) All outcomes Low risk Attrition rates reported, all randomised participants analysed from IPD provided (see footnote 2)
Selective reporting (reporting bias) Low risk Protocol provided. All outcomes reported or calculated with IPD provided (see footnote 2)
Other bias Low risk None identified