Methods |
Participants randomly assigned to either ESM or VPS treatment. Parallel open design. All were followed up for 1 to 2 years. 6 participants did not co‐operate; they were not included in the analysis. |
Participants |
20 participants with recent (less than 6 weeks) onset of 'simple absences' only, other types of seizures observed in 4 out of 5 participants whose seizures were not completely controlled. Age: 5 to 8 years old, 5 were male. |
Interventions |
Monotherapy with ESM or VPS. |
Outcomes |
Number of seizures per day as observed by parents. EEG . Number of children who achieved partial (50% to 75% decrease in seizure frequency) or full remission. Time to achieve complete seizure control. |
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. |