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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Randomised, open‐label trial to evaluate event‐related potentials on the effect of CBZ and LEV cognitive functions, conducted in Italy
2 treatment arms, CBZ (controlled release) and LEV
Participants Participants with newly diagnosed partial epilepsy
Number randomised: CBZ = 14, LEV = 13
14 male participants (52%)
100% of participants had partial epilepsy
Mean age (years): CBZ = 38, LEV = 42, range not stated
Interventions Monotherapy with CBZ or LEV
Fifteen‐day titration to CBZ = 800 mg/d and LEV = 100 mg/d
Trial duration: 24 weeks (assessments at baseline and 12 weeks), range of follow‐up not stated
Outcomes Event‐related potential recordings
Neuropsychological assessments
Notes The trial was published in Italian; the characteristics and outcomes were translated. Outcomes chosen for this review were not reported; IPD were not available
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The trial was described as randomised ('randomizzazione' in Italian); no further information was available
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) All outcomes High risk Open‐label trial
Blinding of outcome assessment (detection bias) All outcomes High risk Open‐label trial
Incomplete outcome data (attrition bias) All outcomes Unclear risk Attrition rates reported (3 dropouts from the CBZ group, 11% of total participants). These participants are excluded from analysis; this is not an ITT approach
Selective reporting (reporting bias) Unclear risk Cognitive outcomes described in methods section well reported in results section. No seizure outcomes or adverse events reported and outcomes chosen for this review not reported. No protocol available so unclear if seizure outcomes were planned a priori
Other bias Low risk None identified