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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Open‐label, parallel‐design, multicentre RCT conducted at 16 centres in the USA
2 treatment arms: PHT and VPS randomised in a 2:1 ratio
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, VPS = 86
73 male participants (54%)
0% participants with partial epilepsy (all generalised epilepsy)
Mean age (range): 21 (3‐64 years)
Interventions Monotherapy with PHT or VPS
Starting doses PHT: 3 mg/kg/d‐ 5 mg/kg/d, VPS: 10 mg/kd/d‐15 mg/kg/d, doses gradually increased. Doses achieved not stated
Range of follow‐up: 0‐11 months
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 by the Department of Veteran's Affairs (maximum follow‐up 6 months, therefore trial could not contribute to outcome, 'Time to 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 VPS: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; trial authors state that differences in adverse events of PHT and VPS would "quickly unblind" the trial anyway
Blinding of outcome assessment (detection bias) All outcomes High risk Open‐label trial; trial authors state that differences in adverse events of PHT and VPS 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 None identified