Methods | Randomised, 'two compartment' parallel trial, conducted in the USA 2 treatment arms: CBZ and PHT |
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Participants | Adults, previously untreated, with at least 2 seizures or at least 1 seizure and an EEG with paroxysmal features Number randomised: PHT = 45, CBZ = 42 60 male participants (69%) 55 participants with partial epilepsy (63%) Mean age (range) 37.4 (18‐77) years |
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Interventions | Monotherapy with PHT or CBZ Mean daily dose achieved (for the 54 participants with no major side effects): PHT = 5.35 mg/kg/d, CBZ = 9.32 mg/kg/d Trial duration: 2 years. Range of follow‐up not reported |
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Outcomes | Laboratory measures Side effects (major and minor) Seizure control/treatment failure |
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Notes | 7 participants on CBZ and 10 participants on PHT were “dropped for non‐compliance” and excluded from analysis Outcomes chosen for this review were not reported. IPD not available |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants randomly assigned to treatment groups, method of randomisation not stated |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind (participants and personnel) achieved with additional blank tablet |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear if outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | 17/87 (19.5%) of participants excluded from analysis for "non‐compliance". Results presented only for participants who completed the trial |
Selective reporting (reporting bias) | Low risk | All efficacy and tolerability outcomes specified in the methods sections reported well in the results section. No protocol available. Outcomes chosen for this review were not reported |
Other bias | Low risk | None identified |