Ravi Sudhir 1995.
| Methods | Single‐centre, randomised, parallel‐group trial of participants referred to the Neurology Clinic of Nehru Hospital, Chandigarh, India. 2 treatment arms: CBZ and PHT |
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| Participants | Newly diagnosed and drug‐naive adult participants > 14 attending the Neurology Clinic of Nehru Hospital, Chandigarh, India Number randomised: PHT = 20, CBZ = 20 28 male participants (70%) 11 participants with partial epilepsy (27.5%) Mean age (range): PHT group 23.4 (14‐44 years), CBZ 24.4 (14‐45 years) |
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| Interventions | Monotherapy with PHT or CBZ Initial daily dose: PHT = 5 mg/kg/d, CBZ = 10 mg/kg/d Trial duration 10‐12 weeks. Range of follow‐up not reported |
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| Outcomes | Cognitive measures before and after treatments (verbal, performance, memory, visuomotor, perceptomotor organisation, visual organisation, dysfunction) | |
| Notes | 6 participants on CBZ and 8 participants on PHT were excluded from final analysis of cognitive assessments who were lost to follow‐up or who had uncontrolled seizures Outcomes chosen for this review were not reported. IPD not available |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "The subjects were randomised to one of the two trial groups," no further information given on methods of randomisation |
| 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 | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 14/40 (35%) of participants excluded from analysis who were lost to follow‐up or experienced uncontrolled seizures. 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. 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 | Low risk | None identified |