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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Prospective, randomised trial of participants newly referred to the pediatric clinic of Kitasato University School of Medicine, Japan
3 treatment arms: CBZ, PHT and VPS
Participants Children aged 1‐14 with previously untreated partial seizures and/or generalised tonic‐clonic seizures
Number randomised: CBZ = 66, PHT = 51, VPS = 46
116 participants with partial epilepsy (71%)
No information on age and gender
Interventions Monotherapy with PHT or CBZ
Initial daily dose: CBZ = 13.0 +/‐ 1.6 mg/kg/d, PHT = 7.2 +/‐ 1.4 mg/kg/d, VPS = 22.9 +/‐ 4.9 mg/kg/d
Range of follow‐up: 6‐66 months, mean follow‐up: 34 months in CBZ group, 37 in PHT group and 40 in VPS group
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 trial was reported in a summary publication of 3 different studies (other 2 studies are not monotherapy designs). 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 Trial was described as "randomised" but no further details were provided
Allocation concealment (selection bias) Unclear risk No information provided
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 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 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 None identified