Methods | Parallel study design, outpatient setting Study conducted in Madras (Chennai), India Random list generated using computer‐generated random numbers Method of concealment not mentioned Double‐blind achieved by providing additional placebo tablets |
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Participants | Children with more than 1 previously untreated generalised tonic‐clonic (afebrile) seizure Number randomised: PHT = 52; SV = 48 0% partial epilepsy. 52 (52%) men. Age range: 4‐12 years Range of follow‐up (months): 22‐36 |
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Interventions | Monotherapy with PHT or SV Starting doses: PHT: 5‐8 mg/kg/day, SV: 15‐50 mg/kg/day Dose achieved not stated |
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Outcomes | Proportion with recurrence of seizures Adverse events | |
Notes | Outcomes chosen for this review were not reported. IPD not available | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants randomised via a computer‐generated list of random numbers |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double–blinded using additional placebo tablets; unclear who was blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double–blinded using additional placebo tablets; unclear who was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rates reported; all randomised participants analysed |
Selective reporting (reporting bias) | Low risk | No protocol available; outcomes chosen for this review not reported |
Other bias | Low risk | No other bias detected |