Rowan 2005.
| Methods | Randomised, double‐blind, parallel‐group trial conducted in 18 Veterans Affairs Medical Centres in the USA 3 treatment arms: LTG, CBZ and GBP |
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| Participants | Adults > 60 years with newly diagnosed seizures, untreated or treated with sub‐therapeutic AED levels, with at least 1 seizure in the previous 3 months. Number randomised: CBZ = 198, GBP = 195, LTG = 200 570 male participants (96%) 446 participants with partial epilepsy (75%) Not stated how many participants had received previous AED treatment Mean age (years): CBZ = 71.9, GBP = 72.9, LTG = 71.9. Range not stated |
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| Interventions | Monotherapy with CBZ, GBP, LTG 6‐week escalation phase leading to CBZ = 600 mg/d, GBP = 1500 mg/d, LTG = 150 mg/d Trial duration: 12 months. Range of follow‐up: not stated |
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| Outcomes | Retention in the trial for 12 months Seizure freedom at 12 months Time to first, second, fifth and tenth seizure (time to seizures) Drug toxicity (incidence of systemic and neurologic toxicities) Serum drug levels and compliance Seizure‐free retention rates |
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| Notes | IPD requested from trial sponsor, the Department of Veterans Affairs, USA. At the time of review, IPD has not been received. Aggregate data extracted from graphs in the publication | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Block randomisation (varying sizes) performed by site via a computer‐generated list |
| Allocation concealment (selection bias) | Low risk | Telephone randomisation used and pharmacy dispensed a prescription of the allocated drug (part of a blinded drug kit) to participants |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double blind achieved with double dummy tablets, doses of both increased and decreased simultaneously |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rates reported. Most of the randomised participants included in analysis, 3 excluded due to site closure (not related to treatment) |
| Selective reporting (reporting bias) | Low risk | No protocol available but case report forms of data collected provided by the sponsor. Seizure outcomes and adverse events well reported |
| Other bias | Low risk | None identified |