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

Xiao 2009.

Methods Randomised, double‐blind, placebo‐controlled trial
2 treatment arms: 1 PCB and 1 LEV
Randomisation concealment: numbered containers containing either LEV or PCB. Random list generation:
randomisation codes were generated by the study sponsor. Each patient who qualified to receive double‐blind treatment was assigned a randomisation number and given LEV or PCB accordingly
Blinding: identical tablets and packages. Investigators were described as blinded to treatment assignment
Baseline: 8 weeks. Treatment period = 16 weeks (4 weeks' titration, 12 weeks' maintenance)
Participants All adults. Single centre (China)
Total randomised 56 adults; all with drug‐resistant focal epilepsy
28 adults to PCB
28 adults to LEV 3000 mg
42.9% male in PCB, 42.9% male in LEV
Age range 16 to 70 years
Other AEDs: 1 or 2
≥ 4 focal seizures per month over preceding 2 months
≥ 10 weeks' background AED treatment
Mean duration of epilepsy (± SD) (years): LEV = 14.1 ± 9.4 (range 2 to 40), PCB = 16.1 ± 12.5 (range 2 to 48)
Mean baseline seizure frequency per week: LEV 4.9; range 1 to 23.6, PCB 5.6; range 1 to 50
Interventions LEV 3000 mg
PCB add‐on
Up‐titration dosages: received LEV 1000 mg/day (administered twice a day) and increased to 2000 mg/day after 2 weeks, and to 3000 mg/day after another 2 weeks
Outcomes ≥ 50% reduction in seizure frequency
Treatment withdrawal
Adverse effects
Notes 2 LEV‐treated patients decreased dose to 2000 mg (owing to adverse effects)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk B ‐ Unclear
Allocation concealment (selection bias) Low risk A ‐ Adequate
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk A ‐ Adequate
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk A ‐ Adequate
Incomplete outcome data (attrition bias) 
 All outcomes Low risk A ‐ Adequate
Selective reporting (reporting bias) Low risk A ‐ Adequate