SANAD B 2007.
Methods | Randomised, multicentre, open‐label, parallel‐group trial conducted in the UK 3 treatment arms: LTG, GBP, TPM |
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Participants | Adults and children > 4 years with newly diagnosed or relapsed generalised or unclassified epilepsy, or failed treatment with a previous drug not used in this trial. Number randomised: LTG = 239, VPS = 238; TPM = 239 420 male participants (59%) 52 partial epilepsy (7%) 108 had received previous AED treatment (15%) Mean age (range): 22.5 (5‐77) years |
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Interventions | Monotherapy for LTG, GBP or TPM Titration doses and maintenance doses decided by treating clinician Range of follow‐up: 0‐83.5 months |
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Outcomes | Time to treatment failure Time to 1‐year (12‐month) remission Time to 2‐year remission Time to first seizure Health‐related quality of life via the NEWQOL (Newly Diagnosed Epilepsy Quality of Life Battery) Health economic assessment and cost effectiveness of the drugs (cost per QALY gained and cost per seizure avoided) Frequency of clinically important adverse events |
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Notes | IPD provided for time to treatment withdrawal, time to first seizure, time to six‐month, time to 12‐month and time to 24‐month remission (trial conducted at our site) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer minimisation programme stratified by centre, sex and treatment history |
Allocation concealment (selection bias) | Low risk | Telephone randomisation to a central randomisation allocation service |
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, all randomised participants analysed from IPD provided (see footnote 2) |
Selective reporting (reporting bias) | Low risk | Protocol provided. All outcomes reported or calculated with IPD provided (see footnote 2) |
Other bias | Low risk | None identified |