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. 2016 Apr 28;2016(4):CD001769. doi: 10.1002/14651858.CD001769.pub3
Methods 36‐month randomised comparative trial
Parallel study design
Study conducted in Poland
Method of generation of random list and allocation concealment not stated
Participants Adults with newly diagnosed epilepsy
Number randomised: PHT = 30; SV = 30
100% partial epilepsy, age range: 18 to 40 years
Percentage men and range of follow‐up not mentioned
Interventions Monotherapy with PHT or SV
Starting doses: PHT: 200 mg/day, SV: 600 mg/day. Dose achieved not stated
Outcomes Proportion achieving 24‐month remission at 3 years Exclusions after randomisation due to adverse events or no efficacy
Notes Abstract only. Outcomes chosen for this review were not reported. IPD pledged but not received
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Trial "randomised" but no further information provided
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) All outcomes Unclear risk No information provided
Blinding of outcome assessment (detection bias) All outcomes Unclear risk No information provided
Incomplete outcome data (attrition bias) All outcomes Unclear risk "Exclusion rates" (interpreted as withdrawal rates) reported for all treatment groups, no further information provided
Selective reporting (reporting bias) Unclear risk No protocol available and trial reported only in abstract form, outcomes for this review not available
Other bias Unclear risk Insufficient detail provided in abstract to allow judgement