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 |
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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 |
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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 |
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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 |
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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 |