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. 2017 Feb 27;2017(2):CD001911. doi: 10.1002/14651858.CD001911.pub3
Methods Single‐centre, randomised, parallel‐group trial of people referred for assessment at Cork Regional Hospital, Ireland.
Three treatment arms: carbamazepine, phenytoin, sodium valproate
Dates conducted: Not stated
Participants Adults and children with a minimum of 2 untreated generalised or partial seizures in the 6 months preceding the study
Number randomised: PHT = 58, CBZ = 59
52 participants (44%) with partial epilepsy. 61 (52%) men
Age range: 4 to 75 years. Duration of treatment (range in months): 3 to 47
Interventions Monotherapy with PHT or CBZ
Mean daily dose achieved: PHT = 5.4 mg/kg, CBZ = 10.9 mg/kg
Outcomes Seizure control:
excellent (complete freedom of seizures)
good (> 50% reduction in seizure frequency)
poor (< 50% reduction in seizure frequency or no response)
Side effects
Notes Outcomes chosen for this review were not reported. IPD not available
Funding: Grants provided by Labaz, Geigy, and Warner‐Lambert. Conflicts of interest: None stated
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 Attrition rates reported. Intention‐to‐treat approach taken, all randomised participants analysed
Selective reporting (reporting bias) Low risk Primary outcomes (seizure control) and secondary outcomes (side effects) reported sufficiently
Other bias Low risk No other bias detected