Methods | Randomised, parallel group study conducted in Taiwan 3 treatment arms: CBZ, PB, sodium valproate |
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Participants | Children with 2 or more previously untreated unprovoked epileptic seizures Number randomised: PB = 25, CBZ = 26; number analysed: PB = 23, CBZ = 25 (see notes) Mean age (range): PB = 9.9 (7 to 15 years), CBZ = 10.8 (7 to 15 years) CBZ versus PB: 26 (54%) participants with partial epilepsy 25 (52%) male participants Study duration: 12 months Range of follow‐up: not stated |
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Interventions | Monotherapy with PB or CBZ. Dose started or achieved not stated | |
Outcomes |
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Notes | 2 children from the PB group and 1 child from the CBZ group withdrew from the study because of allergic reactions. Published results were presented for children who completed the study only. Outcomes chosen for this review were not reported; IPD were not available. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were allocated with "simple randomisation of block size 3." |
Allocation concealment (selection bias) | Unclear risk | No information was provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | The cognitive assessor was 'single‐blinded', implying that participants and personnel were unblinded, but no further information was provided. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The cognitive assessor was single‐blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Withdrawal rates were reported; results were presented only for those who completed the study (CBZ versus PB: 3/51 (6%) excluded from analysis). An ITT approach was not taken. |
Selective reporting (reporting bias) | Low risk | All cognitive, efficacy, and tolerability outcomes specified in the methods sections were reported well in the results section. No protocol was available. Outcomes chosen for this review were not reported. |
Other bias | Low risk | We detected no other bias |