Methods | Single‐centre, randomised, parallel‐group trial of participants referred for assessment at Cork Regional Hospital, Ireland 3 treatment arms: CBZ, PHT, VPS |
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Participants | Adults and children with a minimum of 2 untreated generalised or partial seizures in the 6 months preceding the trial Number randomised: PHT = 58, CBZ = 59, VPS = 64 95 male participants (52%) 79 participants (44%) with partial epilepsy Age range: 4‐75 years |
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Interventions | Monotherapy with CBZ, PHT or VPS Mean daily dose achieved: PHT = 5.4 mg/kg, CBZ = 10.9 mg/kg, VPS = 15.6 mg/kg Duration of treatment (range in months): 14‐24 months |
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Outcomes | Seizure control:
Side effects |
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Notes | 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 | Randomisation based on two Latin squares without stratification. The first, second and third preference of drug for the participant appears to have been taken into account in the process. Unclear if assignment was completely random |
Allocation concealment (selection bias) | High risk | An independent person (department secretary) selected the “drug of first preference” from randomisation list on a sequential basis. Allocation not adequately concealed |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information provided |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attirition rates reported. ITT approach taken, all randomised participants analysed |
Selective reporting (reporting bias) | Low risk | Primary outcomes (seizure control) and secondary outcomes (side effects) reported sufficiently |
Other bias | Low risk | None identified |