Methods | Randomised, open‐label trial conducted in several hospitals in Mexico 2 treatment arms: CBZ and TPM |
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Participants | Participants aged 2‐18 years with newly diagnosed partial epilepsy with or without secondary generalisation with at least two unprovoked seizures > 24 h apart and at least 1 seizure in the last 6 months. Participants must have no established treatment and have received no antiepileptic treatment within the past 30 days Number randomised: CBZ = 42, TPM = 46. Number included in analysis CBZ = 32, TPM = 33 100% partial epilepsy 33 male participants (60%) included in analysis Mean age (range): CBZ = 10 (5‐17) years, TPM = 8 (2‐16) years for participants included in analysis |
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Interventions | Monotherapy with CBZ or TPM Treatments titrated to a maximum of CBZ = 20 mg/kg/d‐25 mg/kg/d, TPM = 9 mg/kg/d Follow‐up assessments at 6 and 9 months, range of follow‐up not stated |
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Outcomes | Seizure freedom and frequency of seizures during the trial Adverse events during the trial Laboratory results |
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Notes | The trial was published in Spanish; the characteristics and outcomes were translated. Outcomes chosen for this review were not reported; contact could not be made with trial author to provide IPD Results presented only for those who completed the trial. Those with less than 35% reduction of seizures were excluded from analysis |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | Random number tables used to assign participants to treatment groups |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No information provided |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label trial |
Incomplete outcome data (attrition bias) All outcomes | High risk | Open‐label trial |
Selective reporting (reporting bias) | Low risk | Attrition rates reported (23 drops outs, 10 for CBZ and 13 for TPM). Only those who completed the trial were included in analysis (non responders to treatment excluded), this is not an ITT approach |
Other bias | Low risk | No protocol available. Seizure outcomes and adverse events well reported |