Methods | Single‐centre, parallel‐design RCT conducted in Newcastle, UK 2 treatment arms: PHT and VPS |
|
Participants | Participants with ≥ 2 partial or generalised tonic‐clonic seizures in the past 3 years. Participants were previously untreated but started on AED treatment within 3 months of their most recent seizure Number randomised: PHT = 70, VPS = 70 73 male participants (52%) 63 participants with partial epilepsy (45%) Mean age (range): 35 (14‐70 years) |
|
Interventions | Monotherapy with PHT or VPS Starting doses: PHT 300 mg/d, VPS 600 mg/d. Dose achieved not stated Range of follow‐up: 3.5‐52 months |
|
Outcomes | Time to 2‐year remission Time to first seizure Adverse events |
|
Notes | IPD provided for all outcomes included in this review by trial author | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants randomised with stratification for age group, gender and seizure type. Method of randomisation not stated or provided by author |
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 | Low risk | Attrition rates reported, ITT approach, 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 |