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. Author manuscript; available in PMC: 2014 Jun 16.
Published in final edited form as: Cochrane Database Syst Rev. 2008 Jan 23;(1):CD005612. doi: 10.1002/14651858.CD005612.pub2
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
Outcomes Primary outcome: change in seizure frequency (response ratio)
Secondary outcomes: responder rate, seizure freedom, anxiety/depression, sleep, quality of life, adverse events
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