Methods | Randomised, multicentre, open‐label, parallel‐group trial conducted in the Korea 2 treatment arms: LTG and CBZ |
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Participants | Adults over the age of 16 with newly diagnosed partial epilepsy or untreated partial epilepsy for at least one year Number randomised: LTG = 57, CBZ = 53 57 male participants (52%) 95 participants with partial epilepsy (86%) Not stated how many participants had received previous AED treatment Mean age (range): 36 (16‐60) years |
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Interventions | Monotherapy with LTG or CBZ 8‐week escalation phase leading to LTG = 200 mg/d, CBZ = 600 mg/d Range of follow‐up: 0‐16.5 months |
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Outcomes | Change of neuropsychological and cognitive scores from baseline: general intellectual ability, learning and memory, attention and executive function (group‐by‐time interaction) Frequency of psychological and health‐related quality of life symptoms Proportion with seizure freedom during the maintenance period |
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Notes | IPD provided by trial author for time to treatment withdrawal, time to first seizure and time to six‐month remission | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomisation (block size four) via a computer randomisation programme (information provided by trial author) |
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 |