Methods | Randomised, parallel group unblinded study. Follow‐up 12 months. | |
Participants | 48 drug naive participants, all with typical absence seizures, age 6 to 10 years | |
Interventions | Monotherapy with VPS or LTG. | |
Outcomes | Seizure freedom at 1, 3, 6 and 12 months. Complete normalisation of EEG with seizure freedom. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information to permit judgement. |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement. |
Blinding (performance bias and detection bias) All outcomes | High risk | No blinding. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data. |
Selective reporting (reporting bias) | Low risk | The study protocol is not available but it is clear that the published reports include all expected outcomes. |