Methods | Randomised, double‐blinded, parallel‐group trial conducted in Finland 2 treatment arms: OXC and PHT |
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Participants | Adult participants with newly diagnosed epilepsy and "normal intellectual capacity" with a minimum of 2 seizures in the last 2 years or 1 seizure and an epileptiform EEG Number randomised: OXC = 19, PHT = 18 Number completed and included in analysis: OXC = 14, PHT = 15 (see Notes) 11 male participants (38%) out of 29 included participants 21 participants with partial epilepsy (72%) out of 29 included participants Mean age of included participants (SD): OXC = 33.6 (14) years, PHT = 32.7 (12.5) years |
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Interventions | Monotherapy with OXC or PHT 4‐ to 8‐week titration period followed by a maintenance phase of 12 months. Doses achieved not stated Range of follow‐up not stated |
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Outcomes | Neuropsychological assessment and cognitive functioning in 3 major areas at baseline, 6 months' and 12 months' follow‐up: Verbal learning and memory Sustained attention Simple psychomotor speed |
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Notes | Participants experiencing inadequate seizure control, adverse events or those who were non‐compliant were withdrawn from the trial and excluded from analysis (5 from OXC group and 3 from PHT group). Results presented only for 29 participants (OXC = 14 and PHT = 15) completing the trial Outcomes chosen for this review were not reported; contact could not be made with trial author to provide IPD |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were "randomly assigned" to treatment; no further information provided |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "The study followed a double blind design" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "The study followed a double blind design"; no further information provided about whether outcome assessor was blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | ITT approach not taken: results reported only for 29 participants (OXC = 14 and PHT = 15) who completed 12‐month follow‐up. 8 participants experiencing inadequate seizure control, adverse events or those who were non‐compliant (OXC = 5 and PHT = 3) were excluded from analysis and results |
Selective reporting (reporting bias) | Low risk | No protocol available and outcomes chosen for this review not reported. Neuropsychological and cognitive outcomes well reported and treatment withdrawal rates reported |
Other bias | Low risk | None identified |