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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Randomised, open‐label trial conducted in 2 hospitals in Hong Kong
2 treatment arms: LTG and VPS
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newly diagnosed, untreated epilepsy or a recurrence of seizures after a period of remission with AED therapy completely withdrawn for at least a year, aged 18‐55 years and not receiving AED therapy were recruited from the Prince of Wales Hospital and United Christian Hospital in Hong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)
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
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
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