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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Single‐centre, randomised, parallel‐group trial of participants, referrals to the outpatient department of neurology of the Central Hospital of Paijat‐Hame, Finland.
2 treatment arms: CBZ and PHT
Participants Adults (eligible age range 15‐57) with newly diagnosed epilepsy
Number randomised: PHT = 20, CBZ = 23
20 male participants (47%)
10 participants with partial epilepsy (23%)
Mean age (SD) years: PHT = 31.5 (11.3), CBZ = 26.8 (13.2)
Interventions Monotherapy with PHT or CBZ
Dose information not reported
Trial duration: 6 months, range of follow‐up not stated
Outcomes Cognitive assessments (visual motor speed, co‐ordination, attention and concentration, verbal and visuospatial learning, visual and recognition memory, reasoning, mood, handedness)
Harmful side effects
Notes 59 participants were randomised but 16 were subsequently excluded. Results were presented only for the 43 participants who completed the entire trial. Outcomes chosen for this review were not reported. IPD not available
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants were randomly assigned to treatment groups, method of randomisation not stated
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) All outcomes Unclear risk No information provided
Blinding of outcome assessment (detection bias) All outcomes Low risk Cognitive outcome assessor was blinded
Incomplete outcome data (attrition bias) All outcomes High risk 16/59 (27%) of participants excluded from analysis. Results presented only for participants who completed the trial
Selective reporting (reporting bias) Unclear risk Cognitive outcomes described in methods section well reported in results section. Adverse effects reported, no seizure outcomes reported and outcomes chosen for this review not reported. No protocol available so unclear if seizure outcomes were planned a priori
Other bias Low risk None identified