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 |
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Interventions | Monotherapy with CBZ or PB, Dose started and achieved not stated | |
Outcomes |
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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. |