Brodie 1999.
Methods | Randomised, multicentre, double‐blind, parallel‐group trial conducted in the UK 2 treatment arms: LTG and CBZ randomised in a 2:1 ratio |
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Participants | Adults over the age of 65 with newly diagnosed epilepsy with 2 or more seizures in the previous year with at least 1 seizure in the last 6 months Number randomised: LTG = 102, CBZ = 48 83 males (55%) 105 with focal seizures (70%) Not stated if any participants had received previous AED treatment Mean age (range): 77 (65 to 94) years |
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Interventions | Monotherapy with LTG or CBZ for 24 weeks 4‐week escalation phase leading to LTG = 100 mg/day, CBZ = 400 mg/day Range of follow‐up = 0 to 280 days |
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Outcomes | Time to first seizure after 6 weeks of treatment Time to treatment withdrawal Percentage of patients reporting an adverse event Proportion of patients who were both seizure‐free in the last 16 weeks of the trial and did not discontinue treatment |
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Notes | IPD provided by trial sponsor GlaxoSmithKline for time to treatment failure and time to first seizure (plus seizure freedom rates at 24 weeks) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random sequence (information provided by drug manufacturer). Participants randomised in a 2:1 ratio (LTG:CBZ) |
Allocation concealment (selection bias) | Low risk | Allocation concealed with pharmacy‐dispensed treatment packs labelled with participant's trial number |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind achieved using LTG tablets formulated to be identical in appearance to CBZ tablets |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Trial investigator blinded, not stated if other outcome assessors were blinded |
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 |