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. 2016 Apr 28;2016(4):CD001769. doi: 10.1002/14651858.CD001769.pub3
Methods Parallel trial
Study conducted at 16 centres in the United States
Participants assigned via randomisation tables within each centre in a 2:1 ratio (SV:PHT)
Method of allocation concealment not stated
Unblinded
Participants Participants with at least 2 newly diagnosed and previously untreated primary generalised tonic‐clonic seizures within 14 days of starting the trial
Number randomised: PHT = 50; SV = 86
0% participants with partial epilepsy, 73 (54%) men
Mean age (range): 21 (3‐64 years). Participants followed up for up to 6 months
Interventions Monotherapy with PHT or SV
Starting doses PHT: 3‐5 mg/kg/day, SV: 10‐15 mg/kg/day, doses gradually increased
Doses achieved not stated
Outcomes Time to first generalised tonic‐clonic seizure
6‐month seizure recurrence rates
Adverse events
Notes IPD provided for 3/4 outcomes of this review (maximum follow‐up 6 months, therefore trial cannot contribute to outcome 'Time to achieve 12‐month remission')
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants randomised on a 2:1 ratio SV:PHT using randomisation tables in each centre (information provided by trial author)
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) All outcomes High risk Open‐label trial; authors state that differences in adverse events of PHT and SV would "quickly unblind" the trial anyway
Blinding of outcome assessment (detection bias) All outcomes High risk Open‐label trial, authors state that differences in adverse events of PHT and SV would "quickly unblind" the trial anyway
Incomplete outcome data (attrition bias) All outcomes Low risk Attrition rates reported, 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 No other bias detected