Skip to main content
. 2016 Apr 28;2016(4):CD001769. doi: 10.1002/14651858.CD001769.pub3
Methods Parallel study design, outpatient setting
Study conducted in Madras (Chennai), India
Random list generated using computer‐generated random numbers
Method of concealment not mentioned
Double‐blind achieved by providing additional placebo tablets    
Participants Children with more than 1 previously untreated generalised tonic‐clonic (afebrile) seizure
Number randomised: PHT = 52; SV = 48
0% partial epilepsy. 52 (52%) men. Age range: 4‐12 years
Range of follow‐up (months): 22‐36
Interventions Monotherapy with PHT or SV
Starting doses: PHT: 5‐8 mg/kg/day, SV: 15‐50 mg/kg/day
Dose achieved not stated
Outcomes Proportion with recurrence of seizures Adverse events
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) Low risk Participants randomised via a computer‐generated list of random numbers
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Double–blinded using additional placebo tablets; unclear who was blinded
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Double–blinded using additional placebo tablets; unclear who was blinded
Incomplete outcome data (attrition bias) All outcomes Low risk Attrition rates reported; all randomised participants analysed
Selective reporting (reporting bias) Low risk No protocol available; outcomes chosen for this review not reported
Other bias Low risk No other bias detected