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. 2016 Apr 28;2016(4):CD001769. doi: 10.1002/14651858.CD001769.pub3
Methods Parallel study design, outpatient setting
Study conducted in Eire (Republic of Ireland)
Randomisation based on two Latin squares and the preference of drug for the participant
An independent person selected “drug of first preference” from randomisation list
Participants Adults and children with a minimum of 2 untreated generalised or partial seizures in the 6 months preceding the trial
Number randomised: PHT = 58; SV = 64
48 participants (39%) with partial epilepsy. 67 (55%) men
Age range: 5‐71. Duration of treatment (range in months):3‐48
Interventions Monotherapy with PHT or SV
Mean daily dose achieved: PHT: 5.4 mg/kg; SV: 15.6 mg/kg
Outcomes Seizure control: excellent (complete freedom of seizures) good (> 50% reduction in seizure frequency) poor (< 50% reduction in seizure frequency)
Notes 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 Randomisation based on 2 Latin Squares without stratification. The first, second and third preference of drug for the participant appears to have been taken into account in the process. Unclear if assignment was completely random
Allocation concealment (selection bias) High risk An independent person (department secretary) selected the “drug of first preference” from randomisation list on a sequential basis. Allocation not adequately concealed
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 Low risk Attirition rates reported. ITT approach taken, all randomised participants analysed
Selective reporting (reporting bias) Low risk Primary outcomes (seizure control) and secondary outcomes (side effects) reported sufficiently. No protocol available, outcomes for this review not reported
Other bias Low risk No other bias detected