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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Randomised, open‐label trial conducted in several hospitals in Mexico
2 treatment arms: CBZ and TPM
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
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
Outcomes Seizure freedom and frequency of seizures during the trial
Adverse events during the trial
Laboratory results
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
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