Methods | Parallel‐design RCT conducted at 2 centres (Glasgow, Scotland and Wellington, New Zealand) 2 treatment arms: PHT and VPS |
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Participants | 21 (64%) of participants previously untreated, 12 (36%) of participants continued to have seizures on previous drug therapies. Original treatments gradually withdrawn before PHT or VPS treatment introduced. Number randomised: PHT = 15, VPS = 18 12 male participants (36%) 19 participants with partial epilepsy (58%) Mean age (range): 23 (7‐55 years) |
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Interventions | Monotherapy with PHT or VPS Starting doses: PHT: < 12 years 150 mg/d, older participants: 300 mg/d, VPS: < 12 years 300‐400 mg/d, older participants: 800‐1200 mg/d. Doses achieved not stated. Mean follow‐up (range): 30 (9‐48 months) |
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Outcomes | Seizures during treatment Adverse events |
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Notes | Outcomes chosen for this review were not reported IPD not available but could be constructed from the publication for the outcome 'Time to treatment withdrawal.' |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants "randomly divided", using telephone randomisation (information provided by trial author) |
Allocation concealment (selection bias) | Low risk | Centralised telephone randomisation used (information provided by trial author) |
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 | Results reported for all randomised participants, time on treatment reported for all randomised participants. No losses to follow‐up reported |
Selective reporting (reporting bias) | Low risk | No protocol available, outcomes chosen for this review not reported, Seizure and adverse event outcomes well reported |
Other bias | Low risk | None identified |