Nieto‐Barrera 2001.
Methods | Randomised, multicentre, open‐label, parallel‐group trial conducted in Europe and Mexico 2 treatment arms: LTG and CBZ randomised in a 2:1 ratio |
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Participants | Adults and children over the age of 2 years with newly diagnosed or currently untreated partial epilepsy with ≥ two seizures in the previous 6 months and with at least 1 seizure in the last 3 months Number randomised: LTG = 420, CBZ = 202 329 male participants (53%) 619 participants with partial epilepsy (99.5%) Not stated how many participants had received previous AED treatment Mean age (range): 27 (2‐84) years |
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Interventions | Monotherapy with LTG or CBZ 6‐week escalation phase leading to minimum of LTG 2 mg/kg/d age range 2‐12 years, 200 mg/d age range 13‐64 years and 100 mg/d age > 65 years. CBZ aged 2‐12 years 5 mg/kg‐40 mg/kg, age > 12 years 100 mg/d‐1500 mg/d Range of follow‐up: 0‐245 days |
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Outcomes | Proportion of participants seizure‐free during the last 16 weeks of treatment Efficacy success: proportion of participants who did not withdraw before the end of week 18 and were seizure‐free in the last 16 weeks of the trial Time to withdrawal from the trial (proportion of participants completing the trial) Proportion of participants experiencing adverse events Withdrawals due to adverse events |
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Notes | IPD provided by trial sponsor Glaxo Smith Kline for time to treatment withdrawal and time to first seizure (plus seizure‐freedom rates at 24 weeks) Dates of seizures during the first 4 weeks not provided with IPD |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random sequence. Participants randomised in a 2:1 ratio (LTG:CBZ), stratified by age group and country |
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 | 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 | Protocol provided. 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 |