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. 2017 Feb 27;2017(2):CD001911. doi: 10.1002/14651858.CD001911.pub3
Methods Prospective randomised study.
Three treatment arms: carbamazepine, phenytoin and sodium valproate
Dates conducted and country: Not stated (assumed conducted in Japan due to author affiliation)
Participants Children aged 1 to 14 with previously untreated partial seizures and/or generalised tonic‐clonic seizures
Number randomised: PHT = 51, CBZ = 66. 84 (72%) with partial seizures. No information on gender
Range of follow‐up: 6 to 66 months, mean follow‐up: 37 months in PHT group, 34 in CBZ group
Interventions Monotherapy with PHT or CBZ. Initial daily dose: PHT = 7.2 ± 1.4 mg/kg/day, CBZ = 13.0 ± 1.6 mg/kg/day
Outcomes Proportion of all randomised participants with seizure recurrence (by seizure type)
Proportion of participants with optimum plasma levels with seizure recurrence (by seizure type)
Notes Very limited information available.The study is reported in a summary publication of 3 different studies (other 2 studies are not CBZ vs PHT). Outcomes chosen for this review were not reported, and IPD not available
Funding: Not stated
Conflicts of interest: None stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study is described as "randomised" but no further details are provided
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) All outcomes Unclear risk No information provided; unclear if the study was blinded or not
Blinding of outcome assessment (detection bias) All outcomes Unclear risk No information provided; unclear if the study was blinded or not
Incomplete outcome data (attrition bias) All outcomes Low risk Ranges of follow‐up given for both treatment groups. Results reported "at the end of follow up," no withdrawals or exclusions mentioned, all participants included in analysis
Selective reporting (reporting bias) Unclear risk Seizure recurrence outcomes described and well reported. No adverse events reported; no protocol available so unclear if adverse events were planned a priori. Outcomes for this review not available
Other bias Low risk No other bias detected