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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Randomised, multicentre, double‐blind trial conducted in 20 centres across four European countries
2 treatment arms: CBZ and OXC
Participants Participants aged 15‐65 years with newly diagnosed and previously untreated epilepsy
Number randomised: total of 235 but 41 excluded for protocol violations (number randomised by treatment group not stated).
Number analysed: CBZ = 100, OXC = 94
96 male participants (49%) out of those analysed
Proportion with partial epilepsy not stated
Median age (range): 33 (14‐63)
Interventions Monotherapy with CBZ or OXC
Starting daily dose CBZ: 200 mg OXC: 300 mg. Mean daily dose (range) achieved CBZ: 684 (300 mg‐1400 mg), OXC: 1040 (300 mg‐1800 mg)
Titration period of 4‐8 weeks followed by a maintenance period of 48 weeks
Mean (range) duration of follow‐up (maintenance period): 336 (10‐390) days
Outcomes Changes in seizure frequency between baseline and the end of each maintenance period
Changes in EEG tracings between baseline and the end of each maintenance period
Global evaluation of therapeutic efficacy and tolerability by the investigator at the end of each maintenance period
Side effects observed by participants and investigators each visit
Laboratory tests (while blood cell counts and liver function tests, blood pressure and pulse, drug trough serum levels)
Notes Trial authors could not be contacted to request IPD. Outcomes chosen for this review were not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Trial described as randomised, no further information provided
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) All outcomes Low risk Trial was of double‐blind design
Blinding of outcome assessment (detection bias) All outcomes Unclear risk No information provided
Incomplete outcome data (attrition bias) All outcomes High risk Attrition rate reported, up to 30% of randomised participants who did not complete the trial were excluded from analyses; this is not an ITT approach
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