Wu 2009.
| Methods | Randomised, double‐blind, placebo‐controlled trial 2 treatment arms: 1 PCB and 1 LEV Randomisation concealment: method not stated. Study medications were supplied and packaged by UCB S.A. Pharma. Method of sequence generation: not stated Blinding: "matched placebo" was used. No further specification Baseline: 8 weeks. Treatment period = 16 weeks (4 weeks' titration, 12 weeks' maintenance) |
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| Participants | All adults. Multicentre (6 centres in China)
Total randomised 206 adults
103 adults to PCB 103 adults to LEV 3000 mg 54% male in PCB and 50% male in LEV Age range: 16 to 70 years Other AEDs: 1 or 2 ≥ 8 focal seizures during 8‐week baseline Diagnosis of focal epilepsy made ≥ 6 months before screening Mean duration of epilepsy (± SD) (years): LEV = 16.5 ± 12.7, PCB = 17.3 ± 12.1 Median baseline seizure frequency per week: LEV 1.81 (IQR = 1.13 to 3.38), PCB 1.75 (IQR = 1.13 to 4.00) |
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| Interventions | LEV 3000 mg PCB Up‐titration dosages: started with 500 mg (1 tablet) twice daily and was up‐titrated in twice‐daily increments of 500 mg (1 tablet) at 2‐week intervals; the dose was increased to 2000 mg/day after 2 weeks and to 3000 mg/day after an additional 2 weeks |
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| Outcomes | ≥ 50% reduction in seizure frequency Treatment withdrawal Adverse effects |
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| Notes | 4 participants excluded from 50% responder analysis: 1 in LEV 3000 mg and 3 in PCB A few participants (1 in LEV, 2 in PCB) had primary generalised‐onset seizures in addition to partial‐onset seizures. 1 patient (1.0%) in the LEV group and 2 (1.9%) in the PCB group temporarily discontinued the study drug, while 8 (7.8%) and 2 (1.9%) patients in the LEV and PCB groups, respectively, reduced the dosage because of adverse events |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | B ‐ Unclear |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | A ‐ Adequate |
| 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 |