Methods | Randomised, open‐label trial conducted in 2 hospitals in Hong Kong 2 treatment arms: LTG and VPS |
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Participants | Chinese patients with newly diagnosed, untreated epilepsy or a recurrence of seizures after a period of remission with AED therapy completely withdrawn for at least a year, aged 18‐55 years and not receiving AED therapy were recruited from the Prince of Wales Hospital and United Christian Hospital in Hong Kong. Number randomised: LTG = 37, VPS = 44 40 male participants (49%) 29 participants with partial epilepsy (36%) Mean age (range): 34 (16‐56 years) |
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Interventions | Monotherapy with LTG or VPS Titration of 4 weeks to target dose of LTG = 100 mg/d and VPS = 800 mg/d Range of follow‐up: 0‐15 months |
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Outcomes | Difference in mean fasting serum insulin concentration at 12 months between the 2 treatment groups Difference in mean changes from baseline at various time points in metabolic and endocrine measurements and BMI between the 2 treatment groups and by gender Frequency of common adverse events experienced by at least 10% of participants by treatment group |
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Notes | IPD provided for all outcomes of this review by trial author | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised stratified for sex and hospital, 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 | Low risk | Attrition rates reported, ITT approach, all randomised participants analysed from IPD provided (see footnote 2) |
Selective reporting (reporting bias) | Low risk | All outcomes reported or calculated with IPD provided (see footnote 2) |
Other bias | Low risk | None identified |