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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Randomised, multicentre, open‐label, parallel‐group trial conducted in 7 hospitals in Republic of Korea
2 treatment arms: LTG and CBZ
Participants Children aged 6‐12 years with a new diagnosis of partial epilepsy and at least 2 seizures in the last 6 months. Number randomised: LTG = 43, CBZ = 41
48 male participants (57%)
100% of participants had partial epilepsy
Not stated if any participants had received previous AED treatment
Mean age (range): 9 (5‐13) years
Interventions Monotherapy with LTG or CBZ
8‐week escalation phase leading to LTG = 3‐6 mg/kg/d, CBZ = 10‐20 mg/kg/d
Range of follow‐up: 0.5‐28 months
Outcomes Seizure‐free rate over 6 months (maintenance period) by treatment group
Change in cognition (neuropsychological), behaviour and quality of life from screening to the end of the maintenance phase by treatment group
Incidence of adverse events
Notes IPD provided by trial author for time to treatment withdrawal, time to first seizure and time to 6‐month remission
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Each centre received a separate and independent computer‐ generated random code list
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) All outcomes High risk Open‐label trial
Blinding of outcome assessment (detection bias) All outcomes High risk Open‐label trial
Incomplete outcome data (attrition bias) All outcomes Low risk Attrition rates reported, 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