Brodie 1995a.
Methods | Randomised, double‐blind, parallel‐group trial conducted in 8 centres in the UK. 2 treatment arms: LTG and CBZ |
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Participants | Adults and children > 13 years with newly diagnosed epilepsy. None had received previous AED treatment. Number randomised: LTG = 70, CBZ = 66 56 male participants (41%) 82 with partial epilepsy (60%); Mean age (range): 34 (14‐71) years |
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Interventions | Monotherapy with LTG or CBZ 4‐week escalation phase leading to LTG = 150 mg/d, CBZ = 600 mg/d Range of follow‐up = 0‐14 months |
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Outcomes | Time to first seizure after 6 weeks of treatment Time to withdrawal Proportion of randomised participants remaining seizure‐free during the last 40 and 24 weeks of trial Percentages of participants who reported adverse events |
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Notes | IPD provided by trial sponsor Glaxo Smith Kline 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 | Computer‐generated random sequence (information provided by drug manufacturer). Stratification by seizure type |
Allocation concealment (selection bias) | Low risk | Allocation concealed by individual sealed, opaque envelopes (information provided by drug manufacturer) |
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 | Protocol provided. All outcomes reported or calculated with IPD provided (see footnote 2) |
Other bias | Low risk | None identified |