Methods | Double‐blinded, parallel group, randomised study conducted in a single‐centre in Nigeria. 3 treatment arms: carbamazepine, phenytoin, phenobarbitone | |
Participants | Consectuive newly diagnosed participants aged 14 or over presenting at the outpatient neurology clinic of the University Teaching Hopsital, Benin City, Nigeria, with recurrent, untreated afebrile seizures Number randomised: PB = 18, CBZ = 19 7 participants with partial seizures (19%) 22 male participants (59%) Mean age (range): 23.62 years (14 to 38 years) Range of follow‐up: all participants followed up for 12 weeks |
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Interventions | Monotherapy with PB or CBZ. Median daily dose (range): PB = 120 mg (60 to 180 mg), CBZ = 600 mg (400 mg to 1200 mg) | |
Outcomes |
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Notes | We received IPD for all randomised participants. The study duration was 12 weeks; all participants completed the study without withdrawing; therefore, we could not calculate the outcomes 'time to withdrawal of allocated drug', 'time to six‐month remission', and 'time to 12‐month remission'. We calculated 'time to first seizure' from the IPD provided | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The study randomised participants using simple randomisation: Each participant was asked to pick 1 from a table of numbers (1 to 60); the numbers corresponded to allocation of 1 of 3 drugs (the author provided information). |
Allocation concealment (selection bias) | Low risk | Recruitment/randomisation of participants and allocations of treatments took place on different sites (the author provided information). |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were single‐blinded. The study did not blind the research assistant recruiting participants and counselling on medication adherence. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Investigators performing cognitive assessments were single‐blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants completed the study. We analysed all randomised participants from the IPD provided². |
Selective reporting (reporting bias) | Low risk | We calculated 1 outcome for this review from the IPD provided². Other outcomes for this review were not available because of short study length. All cognitive outcomes from the study were well reported. |
Other bias | Low risk | We detected no other bias. |