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 |