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. 2017 Feb 14;2017(2):CD003032. doi: 10.1002/14651858.CD003032.pub3
Methods Randomised double‐blind response ‐ conditional cross‐over study. VPS with PCB for 6 weeks followed by ESM with PCB for 6 weeks for one group. The other group followed the same regimen in a reverse order. Follow‐up 3 months.
Participants 45 naive and drug resistant participants aged 3 to 18 years with absence seizures (not specified if typical or atypical). 18 male.
Interventions Drug naive participants were on monotherapy (ESM or VPS) while refractory to previous treatment participants were on polytherapy.
Outcomes Reduction in seizure frequency as judged by 12‐hour EEG telemetry, 100% for drug naive and 80% for drug‐resistant participants.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported how patients were randomly assigned to treatments.
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement.
Blinding (performance bias and detection bias) All outcomes Unclear risk Study was described as "double‐blinded" without further details.
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Study was described as "double‐blinded" without further details.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Study was described as "double‐blinded" without further details.
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.