Zhou 2008.
Methods | Randomised, double‐blind, placebo‐controlled trial 2 treatment arms: 1 PCB and 1 LEV Randomisation concealment: participants received an exclusive random number consecutively on entry into the study, and received treatment on the basis of this random number. Random list generation: random numbers table Blinding: described as double‐blind with no further specification. Medications were supplied and packaged by UCB S.A|. Pharma Baseline: 8 weeks. Treatment period = 16 weeks (4 weeks' titration, 12 weeks' maintenance) |
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Participants | All adults. 1 centre in China. Total randomised 28 adults 14 adults to PCB 14 adults to LEV 3000 mg 55% male in PCB, 54% male in LEV Age range 16 to 70 years. Other AEDs: 1 or 2 ≥ 8 seizures during 8‐week baseline with 2 per 4 weeks Mean duration of epilepsy (± SD) (years): LEV = 8.7 ± 6.4, PCB = 16.5 ± 7.2 Mean baseline seizure frequency per week (± SD) 6.55 ± 10.79 in LEV, 6.15 ± 11.20 in PCB |
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Interventions | LEV 3000 mg/day PCB add‐on Up‐titration dosages: 500 mg twice daily in the first 2 weeks, 1000 mg twice daily in the third and fourth weeks) |
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Outcomes | ≥ 50% reduction in seizure frequency Treatment withdrawal Cognitive function QoL |
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Notes | Cognitive function assessment was with a battery of neuropsychological tests: Wisconsin Card Sorting Test, Verbal Fluency, Trail Making Test, Digit Symbol, Stroop Color–Word Interference Task, Logic Memory, Delayed Logic Memory, Visual Memory, Delayed Visual Memory, Calculation QoL assessment was with the use of QOLIE‐31 Drop‐outs (1 in LEV, 3 in PCB) were excluded from the study author's analysis |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A ‐ Adequate |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | B ‐ Unclear |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | B ‐ Unclear |
Incomplete outcome data (attrition bias) All outcomes | Low risk | A ‐ Adequate |
Selective reporting (reporting bias) | Low risk | A ‐ Adequate |
AEDs: antiepileptic drugs; CBCL: Achenbach Child Behavior Checklist; CHQ‐PF50: Child Health Questionnaire‐Parent Form 50;
ESI: Epilepsy Surgery Inventory scale;
IQR: interquartile range;
ITT: intention to treat;
Leiter‐R AM: Leiter International Performance Scale‐Revised Attention and Memory; LEV: levetiracetam; Leiter‐R ERS: Leiter International Performance Scale‐Revised, Examiner’s Rating Scale;
PCB: placebo;
QOLIE: Quality of life in epilepsy inventory ;
QoL: quality of life;
WRAML‐2: Wide Range Assessment of Memory and Learning‐2;
XR: extended release.