Methods | Randomised, parallel‐group trial conducted among residents of the Nakuru district, a semi‐urban population of rural Kenya 2 treatment arms: CBZ and PHB |
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Participants | Participants had a history of generalised tonic‐clonic seizures and at least 2 generalised tonic‐clonic seizures within the preceding year (with or without other seizure types) and untreated in the 3 months prior to the trial. 79 (26%) participants had been treated in the past with AEDs Number randomised: PHB = 150, CBZ = 152 173 male participants (57%) 115 of participants with partial epilepsy (38%) Mean age (range): 21 (6‐65 years) |
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Interventions | Monotherapy with CBZ or PHB Starting doses: PHB: 6‐10 years: 30 mg/d, 11‐15 years: 45 mg/d, > 16 years: 60 mg/d CBZ: 6‐10 years of age: 400 mg/d, 11‐15 years of age: 500 mg/d, > 16 years of age: 600 mg/d Dose achieved not stated Range of follow‐up: participants followed up for up to 1 year |
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Outcomes | Adverse effects Withdrawals from allocated treatment Seizure frequency (during second 6 months of trial) |
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Notes | IPD were made available but not used because of inconsistencies and problems with the data provided (see Included studies for further details) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants randomised with random number list |
Allocation concealment (selection bias) | Low risk | Allocation concealed via sealed, opaque envelopes (information provided by trial author) |
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 | Attrition rates reported, results presented only for participants completing 12 months' follow‐up (results not presented for 53 (17.5%) participants out of 302 who withdrew from treatment), approach is not ITT |
Selective reporting (reporting bias) | Low risk | No protocol available, outcomes chosen for this review not reported. Seizure outcomes and adverse events well reported |
Other bias | High risk | Inconsistencies with IPD and published results so IPD could not be used (see Included studies for further details) |