Suresh 2015.
Methods | Randomised, single‐centre, open‐label trial conducted in Bengaluru, India. 2 treatment arms: CBZ and LEV |
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Participants | Participants aged 18‐60 years diagnosed newly with focal or partial seizures with or without secondary generalisation referred to the Department of Neurology at Vydehi Institute of Medical Sciences and Research Center Number randomised CBZ = 30, LEV = 30 30 male participants (50%) 100% participants with partial epilepsy Mean age (range): not provided for all randomised participants |
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Interventions | Monotherapy with CBZ or LEV Starting dose of CBZ = 200 mg/d, LEV = 500 mg/d titrated to a maximum dose of CBZ 1200 mg/d, LEV 300 mg/d Trial duration: 1 year, range of follow‐up: not stated |
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Outcomes | Quality of Life by the QOLIE‐10 questionnaire before and after 26 weeks of therapy Treatment efficacy (seizure freedom at 4 weeks, 12 weeks, 26 weeks and 6 months) Treatment safety (proportion of participants experiencing at least 1 adverse event) |
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Notes | Outcomes chosen for this review were not reported; contact could not be made with trial author to provide IPD | |
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 | High risk | Open‐label trial |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label trial |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition rates reported, two participants lost to follow‐up in each group not included in analysis. This is not an ITT approach but unlikely that this small amount of missing data would influence the overall results |
Selective reporting (reporting bias) | High risk | Only one outcome is predefined in the methods section (Quality of Life), other results reported were not predefined |
Other bias | Low risk | None identified |