| Methods | Double‐blinded, parallel‐group, randomised study conducted in a single centre in Nigeria between October 2000 and October 2002 Three treatment arms: carbamazepine, phenytoin, phenobarbitone | |
| Participants | Consecutive newly‐diagnosed people 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: PHT = 19, CBZ = 19 8 participants with partial seizures (22%), 23 men (62%). Mean age (range): 29.8 years (14 to 38 years) All participants followed up for 12 weeks | |
| Interventions | Monotherapy with PHT or CBZ. Median daily dose (range): PHT = 200 mg (100 to 300 mg), CBZ = 600 mg (400 to 1200 mg) | |
| Outcomes | Cognitive measures (reaction times, mental speed, memory, attention) | |
| Notes | IPD provided for all randomised participants. Study duration was 12 weeks; all participants completed the study without withdrawing, so outcomes 'Time to withdrawal of allocated drug', 'Time to six‐month remission' and 'Time to 12‐month remission' could not be calculated. 'Time to first seizure' calculated from IPD provided Funding: Not stated Conflicts of interest: None stated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement | 
| Random sequence generation (selection bias) | Low risk | Study randomised using simple randomisation. Each participant was asked to pick 1 from a table of numbers (1 ‐ 60), numbers corresponded to allocation of 1 of 3 drugs (information provided by author) | 
| Allocation concealment (selection bias) | Low risk | Recruitment/randomisation of participants and allocation of treatments took place on different sites (information provided by author) | 
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants single‐blinded. Research assistant recruiting participants and counselling on medication adherence was not blinded | 
| 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. All randomised participants analysed from IPD provided1 | 
| Selective reporting (reporting bias) | Low risk | 1 outcome for this review calculated from IPD provided1. Other outcomes for this review not available due to short study length. All cognitive outcomes from the study well reported | 
| Other bias | Low risk | No other bias detected |