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 drug‐naive and drug‐resistant participants aged 3 to 18 years with AS (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 participants and 80% for drug‐resistant participants. |
Notes |
The work was supported by a contract from the Institute of Neurological and Communicative Disorders and Stroke (NINCDS). |
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 quote: "double‐blinded" without further details. |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Study was described as quote: "double‐blinded" without further details. |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Study was described as quote: "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. |