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. 2016 Dec 15;2016(12):CD001904. doi: 10.1002/14651858.CD001904.pub3
Methods Randomised, double‐blind study to assess short‐term therapy of CBZ and PB on cognitive and memory function conducted in Italy 3 treatment arms: CBZ, PB, and placebo
Participants Participants with newly diagnosed and untreated temporal lobe epilepsy with no seizures in the previous month
Number randomised: CBZ = 6, PB = 6
100% partial (temporal lobe epilepsy), 100% newly diagnosed
Mean age (SD): CBZ = 26.33 (9.73) years, PB = 18.5 (2.56) years
Age range: 15 to 45 years
1 male and 5 females in each group
Study duration: 3 weeks; all participants completed in 3 weeks
Interventions Monotherapy with CBZ or PB, Dose started and achieved not stated
Outcomes
  • Changes in memory function from baseline after 3 weeks of treatment (verbal, visual, (visual‐verbal and visual‐non‐verbal), acoustic, tactile, and spatial)

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 Low risk Trial is described as double‐blind ('condizioni di doppia cecità' in Italian), we assume this refers to participants and personnel.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk No information provided on blinding of outcome assessment.
Incomplete outcome data (attrition bias) All outcomes Low risk All participants completed this short study and contribute to analysis.
Selective reporting (reporting bias) Unclear risk Cognitive and memory 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 High risk Very small participant numbers and very short‐term follow‐up. Unclear if this study was adequately powered and of sufficient duration to detect differences.