Pulliainen 1994.
| 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 |
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| 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) |
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| Interventions | Monotherapy with PHT or CBZ Dose information not reported Trial duration: 6 months, range of follow‐up not stated |
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| 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 |
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| 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 |