Miura 1990.
| 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 |
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| 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 |
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| 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 |
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| 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 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 |