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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Single‐centre, parallel‐design RCT conducted in Newcastle, UK
2 treatment arms: PHT and VPS
Participants Participants with ≥ 2 partial or generalised tonic‐clonic seizures in the past 3 years.
Participants were previously untreated but started on AED treatment within 3 months of their most recent seizure
Number randomised: PHT = 70, VPS = 70
73 male participants (52%)
63 participants with partial epilepsy (45%)
Mean age (range): 35 (14‐70 years)
Interventions Monotherapy with PHT or VPS
Starting doses: PHT 300 mg/d, VPS 600 mg/d. Dose achieved not stated
Range of follow‐up: 3.5‐52 months
Outcomes Time to 2‐year remission
Time to first seizure
Adverse events
Notes IPD provided for all outcomes included in this review by trial author
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants randomised with stratification for age group, gender and seizure type. Method of randomisation not stated or provided by author
Allocation concealment (selection bias) Unclear risk No information provided
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, ITT approach, all randomised participants analysed from IPD provided (see footnote 2)
Selective reporting (reporting bias) Low risk All outcomes reported or calculated with IPD provided (see footnote 2)
Other bias Low risk None identified