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. 2016 Apr 28;2016(4):CD001769. doi: 10.1002/14651858.CD001769.pub3
Methods Parallel study design, outpatient setting
Study conducted in Meerut, India
No information provided on method of generation of random list, allocation concealment or blinding
Participants Participants with at least 2 partial or generalised tonic‐clonic seizures per month
Unclear if participants were newly diagnosed
Number randomised: PHT = 45; SV = 49
27 participants (29%) partial epilepsy, 70 (74%) men
Age range: PHT: 12‐42 years; SV: 8‐52 years
Participants were evaluated after 4, 12 and 24 weeks of treatment
No information on range of follow‐up
Interventions Monotherapy with PHT or SV
Average daily dose achieved: PHT: 5.6 mg/kg/day, SV: 18.8 mg/kg/day
Outcomes Reduction in frequency of seizures: excellent (100% reduction) good (75‐99% reduction) fair (50‐74% reduction) poor (< 50% reduction) Adverse effects
Seizure control
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) Unclear risk Participants "randomly allocated irrespective of seizure type," no further information provided
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 Unclear risk Frequency of seizures reported for all randomised participants, no information provided on withdrawal rates/attrition rates etc.
Selective reporting (reporting bias) Low risk Frequency of seizures during treatment well reported, most common adverse events reported
No protocol available to compare with a priori analysis plan, outcomes for this review not reported
Other bias Low risk No other bias detected