Dam 1989.
| Methods | Randomised, multicentre, double‐blind trial conducted in 20 centres across four European countries 2 treatment arms: CBZ and OXC |
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| Participants | Participants aged 15‐65 years with newly diagnosed and previously untreated epilepsy Number randomised: total of 235 but 41 excluded for protocol violations (number randomised by treatment group not stated). Number analysed: CBZ = 100, OXC = 94 96 male participants (49%) out of those analysed Proportion with partial epilepsy not stated Median age (range): 33 (14‐63) |
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| Interventions | Monotherapy with CBZ or OXC Starting daily dose CBZ: 200 mg OXC: 300 mg. Mean daily dose (range) achieved CBZ: 684 (300 mg‐1400 mg), OXC: 1040 (300 mg‐1800 mg) Titration period of 4‐8 weeks followed by a maintenance period of 48 weeks Mean (range) duration of follow‐up (maintenance period): 336 (10‐390) days |
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| Outcomes | Changes in seizure frequency between baseline and the end of each maintenance period Changes in EEG tracings between baseline and the end of each maintenance period Global evaluation of therapeutic efficacy and tolerability by the investigator at the end of each maintenance period Side effects observed by participants and investigators each visit Laboratory tests (while blood cell counts and liver function tests, blood pressure and pulse, drug trough serum levels) |
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| Notes | Trial authors could not be contacted to request IPD. Outcomes chosen for this review were not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Trial described as randomised, no further information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Trial was of double‐blind design |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Attrition rate reported, up to 30% of randomised participants who did not complete the trial were excluded from analyses; this is not an ITT approach |
| Selective reporting (reporting bias) | Low risk | Efficacy, and tolerability outcomes specified in the methods sections were reported well in the results section. No protocol was available. Outcomes chosen for this review were not reported |
| Other bias | Low risk | None identified |