Saetre 2007.
| Methods | Randomised, double‐blind, parallel‐group trial conducted in 29 centres across Croatia, Finland, France, Finland and Norway. 2 treatment arms: LTG, CBZ | |
| Participants | Adults over the age of 65 with newly diagnosed seizures, with a history of at least 2 seizures and at least 1 seizure in the previous 6 months. Participants must not have taken antiepileptic medication for more than 2 weeks in the previous 6 months and never taken CBZ or LTG. Number randomised: LTG = 94, CBZ = 92 102 males (54%) Proportion with focal seizures not stated Not stated how many participants had received previous AED treatment Mean age: 74 (65 to 91) years |
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| Interventions | Monotherapy with LTG or CBZ for 40 weeks 4‐week escalation phase leading to LTG = 100 mg/day, CBZ = 400 mg/day Range of follow‐up: not stated |
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| Outcomes | Retention in the trial (time to treatment withdrawal for any cause) Seizure freedom after week 4 Seizure freedom after week 20 Time to first seizure Adverse event reports Tolerability according to the Liverpool Adverse Event profile (AEP) |
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| Notes | IPD requested from trial sponsor Glaxo Smith Kline but data could not be located Aggregate summary data extracted from the publication |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Described as randomised, no other information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinding achieved with double dummy tablets, packaged together |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not specifically stated |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rates reported; all participants who received trial treatment were included in an intention‐to‐treat analysis |
| Selective reporting (reporting bias) | Low risk | No protocol available but clinical trial summary provided by the sponsor. Seizure outcomes and adverse events well reported |
| Other bias | Low risk | None identified |