Methods |
Randomised, parallel open study designed to compare ESM with VPS treatment. Followed up for 18 months to 4 years, mean 3 years. |
Participants |
28 drug naive participants (13 male, 15 female), aged between 4 to 15 years. All participants with typical absence seizures. |
Interventions |
Monotherapy with ESM or VPS. |
Outcomes |
Complete or partial (50% to 90%) remission of seizures confirmed by 6 hours telemetry and observation by parents and teachers. |
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 |
Unclear risk |
Insufficient information to permit judgement. |
Blinding of participants and personnel (performance bias) All outcomes |
Unclear risk |
Insufficient information to permit judgement. |
Blinding of outcome assessment (detection bias) All outcomes |
Unclear risk |
Insufficient information to permit judgement. |
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. |