| Methods | Single‐centre, randomised, parallel‐group study of participants referred to the Neurology Clinic of Nehru Hospital, Chandigarh, India. Two treatment arms: carbamazepine and phenytoin Dates conducted: Not stated |
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| Participants | Newly‐diagnosed and drug naïve adults over the age of 14 attending the Neurology Clinic of Nehru Hospital, Chandigarh, India Number randomised: PHT = 20, CBZ = 20 11 participants with partial epilepsy (27.5%), 28 men (70%) Mean age (range): PHT group 23.4 (14 to 44 years), CBZ 24.4 (14 to 45 years) Study duration 10 to 12 weeks. Range of follow‐up not reported |
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| Interventions | Monotherapy with PHT or CBZ. Initial daily dose: PHT = 5 mg/kg/day, CBZ = 10 mg/kg/day | |
| 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 Funding: Not stated Conflicts of interest: None stated |
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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 study 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; unclear if study was blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided; unclear if study was blinded |
| 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 study |
| 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 | No other bias detected |
1For studies in which IPD were provided (De Silva 1996; Heller 1995; Mattson 1985; Ogunrin 2005) attrition and reporting bias are reduced as attrition rates and unpublished outcome data are requested.
CBZ: carbamazepine EEG: electroencephalograph IPD: individual participant data PHT: phenytoin