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. 2012 Sep 12;2012(9):CD001901. doi: 10.1002/14651858.CD001901.pub2

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)
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
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)
Outcomes ≥ 50% reduction in seizure frequency
Treatment withdrawal
Cognitive function
QoL
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
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.