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 |
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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 |
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Interventions | Monotherapy with CBZ or PHB Dose started and achieved not stated Trial duration: 3 weeks; all participants completed in 3 weeks |
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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 |