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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
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
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)
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
Outcomes Adverse effects
Withdrawals from allocated treatment
Seizure frequency (during second 6 months of trial)
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)