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. 2017 Feb 14;2017(2):CD003032. doi: 10.1002/14651858.CD003032.pub3
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.