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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Randomised, double‐blind trial to assess short‐term therapy of CBZ and PHB on cognitive and memory function conducted in Italy
Three treatment arms: CBZ, PHB, and placebo
Participants Participants with newly diagnosed and untreated temporal lobe epilepsy with no seizures in the previous month
Number randomised: CBZ = 6, PHB = 6
1 man and 5 women in each group
100% partial (temporal lobe epilepsy), 100% newly diagnosed
Mean age (SD): CBZ = 26.33 (9.73) years, PHB = 18.5 (2.56) years. Age range: 15‐45 years
Interventions Monotherapy with CBZ or PHB
Dose started and achieved not stated
Trial duration: 3 weeks; all participants completed in 3 weeks
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; contact could not be made with trial author to provide IPD
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 was 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
Incomplete outcome data (attrition bias) All outcomes Low risk All participants completed this short trial and contributed 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 trial was adequately powered and of sufficient duration to detect differences