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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Randomised, double‐blinded, parallel‐group trial conducted in Finland
2 treatment arms: OXC and PHT
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
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
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
Notes Participants experiencing inadequate seizure control, adverse events or those who were non‐compliant were withdrawn from the trial and excluded from analysis (5 from OXC group and 3 from PHT group).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
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