Methods |
Randomised, parallel group unblinded study. Follow‐up for 12 months. |
Participants |
38 drug naive participants, all with typical absence seizures, age 3 to 13 years. |
Interventions |
Monotherapy with VPS or LTG. |
Outcomes |
Total seizures freedom defined by clinical reports, 24 hours EEG and hyperventilation test. |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Random sequence was generated using a randomisation code. |
Allocation concealment (selection bias) |
Low risk |
Central allocation. |
Blinding (performance bias and detection bias) All outcomes |
High risk |
No blinding. It is not stated whether tables of VPA and LTG were indistinguishable. |
Blinding of participants and personnel (performance bias) All outcomes |
High risk |
No blinding. It is not stated whether tables of VPA and LTG were indistinguishable. |
Blinding of outcome assessment (detection bias) All outcomes |
High risk |
No blinding. It is not stated whether tables of VPA and LTG were indistinguishable. |
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. |