Methods | Randomised double-blind PCB-controlled parallel multicentre (9 in Korea) trial. 2 treatment arms: 1 PCB, 1 PGB. Patients randomised to 1 of 2 treatment arms (no further information available). Duration of baseline period: 6 weeks. 12-week treatment period (no further details provided) | |
Participants | Patients 18 years and above (mean 34.2 years), 48.3% male, all with treatment-resistant partial epilepsy. Patients were on 1 to 3 baseline AEDs. 209 patients screened, 178 patients randomised: 59 patients to PCB (mean baseline 28-day seizure frequency: 13. 2) and 119 patients to 150 mg to 600 mg PGB (mean baseline 28-day seizure frequency 13.2) | |
Interventions | Group 1: PCB Group 2: 150 mg/day to 600 mg/day |
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Outcomes | Primary outcome: change in seizure frequency (response ratio) Secondary outcomes: responder rate, seizure freedom, anxiety/depression, sleep, quality of life, adverse events |
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Notes | All randomised patients included in ITT analysis. No information provided on methods of randomisation, concealment or blinding | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Patients randomised using 2:1 ratio. No further information given |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No information provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rates reported. ITT analysis employed |
Selective reporting (reporting bias) | Unclear risk | All outcomes stated in methods section of paper were reported in the results; however, there was no protocol available to check a priori outcomes |
Other bias | High risk | Sponsored by same pharmaceutical company (Pfizer Ltd.) as with all the other included trials |
AED: antiepileptic drug; BD: twice daily; EEG: electroencephalogram; GTCS: generalised tonic-clonic seizures; ITT: intention-to- treat analysis; LEV: levetiracetam; LTG: lamotrigine; PCB: placebo; PGB: pregabalin; TDS: three times a day