Methods | Parallel‐design RCT conducted in Meerut, India 2 treatment arms: PHT and VPS |
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Participants | Participants with at least 2 partial or generalised tonic‐clonic seizures per month Unclear if participants were newly diagnosed Number randomised: PHT = 45; VPS = 49 70 male participants (74%) 27 participants with partial epilepsy (29%) Age range: PHT: 12‐42 years; VPS: 8‐52 years |
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Interventions | Monotherapy with PHT or VPS Average daily dose achieved: PHT: 5.6 mg/kg/d, VPS: 18.8 mg/kg/d Participants were evaluated after 4, 12 and 24 weeks of treatment No information on range of follow‐up |
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Outcomes | Reduction in frequency of seizures:
Adverse effects Seizure control |
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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 | None identified |