| 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) |
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| 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 |
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| 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) |
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| 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 |
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| 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 |