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. 2017 Jun 29;2017(6):CD011412. doi: 10.1002/14651858.CD011412.pub2
Methods Randomised, single‐centre, open‐label trial conducted in Scotland, UK
2 treatment arms LTG and VPS
Participants Participants of at least 13 years with a minimum of 2 newly onset unprovoked seizures of any type and no previous exposure to LTG or VPS
Number randomised: LTG = 117, VPS =109
114 male participants (50%)
154 participants with partial epilepsy (68%)
Mean age (range): 36 (13 ‐ 80 years)
Interventions Monotherapy with LTG or VPS
Titration of 5‐10 weeks to target doses of LTG = 200 mg/d and VPS = 1000 mg/d
Range of follow‐up: 0‐51 months
Outcomes Percentage of randomised participants achieving a minimum period of 12 months' seizure freedom
Percentage of randomised participants withdrawing due to adverse events
Percentage of randomised participants with lack of efficacy at maximum tolerated dose
Changes in levels of androgenic hormone levels (testosterone, androstenedione and sex hormone‐binding globulin levels)
Changes in weight and BMI from baseline
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 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 Low risk Attrition rates reported, ITT approach, all randomised participants from the ITT population 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 High risk There were inconsistencies between rates of seizure recurrence and reasons for withdrawal between the data provided and the published paper, which the authors could not resolve