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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Randomised double‐blind study conducted in the USA
2 treatment arms: CBZ and VPS
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)
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
Outcomes Proportion of participants free of complex partial seizures during the maintenance period
Proportion of participants reporting specific adverse events
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