Methods | Randomised double‐blind study conducted in the USA 2 treatment arms: CBZ and VPS |
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Participants | Participants between the ages of 10 and 70 who had experienced at least two complex partial seizures who were previously untreated or insufficiently treated Number randomised: CBZ = 17, VPS = 16 15 male participants (45%) 100% of participants with partial epilepsy Mean age (range): CBZ = 32.5 (13‐65), VPS = 31.3 (17‐57) |
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Interventions | Monotherapy with CBZ or VPS Doses started or achieved not stated 4‐week titration period followed by a 24‐week maintenance period. Range of follow‐up not stated |
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Outcomes | Proportion of participants free of complex partial seizures during the maintenance period Proportion of participants reporting specific adverse events |
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Notes | Outcomes for this review were not reported; IPD were not available due to time elapsed since the trial was conducted | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were randomised in a 1:1 ratio, no further information provided |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double blind study |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
Incomplete outcome data (attrition bias) All outcomes | High risk | Attrition rates reported. Only those who entered the maintenance period were included in analysis; this is not an ITT analysis |
Selective reporting (reporting bias) | Low risk | Efficacy, and tolerability outcomes specified in the methods sections were reported well in the results section. No protocol was available. Outcomes chosen for this review were not reported |
Other bias | Low risk | None identified |