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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 referred to the Neurology Clinic of Nehru Hospital, Chandigarh, India.
2 treatment arms: CBZ and PHT
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)
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
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
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