Schoeler, N; Marston, L; Lyons, L; Halsall, S; Jain, R; Titre-Johnson, S; Balogun, M; ... Cross, JH; + view all Schoeler, N; Marston, L; Lyons, L; Halsall, S; Jain, R; Titre-Johnson, S; Balogun, M; Heales, S; Eaton, S; Orford, M; Neal, E; Eltze, C; Stephen, E; Mallick, A; O'Callaghan, F; Agrawal, S; Parker, A; Kirkpatrick, M; Brunklaus, A; McLellan, A; McCullagh, H; Samanta, R; Kneen, R; Tan, J; Devlin, A; Prasad, M; Rattihalli, R; Basu, H; Desurkar, A; Williams, R; Fallon, P; Nazareth, I; Freemantle, N; Cross, JH; - view fewer (2023) Ketogenic diet in infants with epilepsy (KIWE): a randomised controlled trial. Epilepsia , 64 (52) pp. 43-44. 10.1111/epi.17787.

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Abstract

Purpose: Many infancy-onset epilepsies are poorly responsive to anti-seizure medicines (ASMs) with poor prognosis for neurodevelopmental outcome. Ketogenic diets (KD) can reduce seizures in older children and adults. We aimed to assess the effectiveness of the KD in infants in a randomised controlled trial.// Method: Infants (age 1-24 months) with epilepsy, average ≥4 seizures/week and previous trial ≥2 ASMs, were randomised to receive a classical KD or further ASM. The primary outcome was difference in number of seizures during weeks 6-8 accounting for baseline.// Results: 78 children were randomised to KD and 58 to ASM. The median number of daily seizures was similar in both groups at 8 weeks (IRR 1.33 95% CI 0.84, 2.11). The odds ratio of achieving ≥50% seizure reduction was 1.21 (95% CI 0.55, 2.65), and 0.88 (0.27, 2.80) for seizure freedom. A higher proportion of infants in the ASM group changed the number or dose of concurrent ASMs during the intervention period (24/48 [50%]) compared to KD (9/66 [14%]). Side effect score at 8 weeks was similar in both groups (KD median 40 IQR 38,42; ASM 41 39,44). Overall health was numerically higher in the KD group (median 60 IQR 30, 60) at 8 weeks compared to ASM (median 30 IQR 30, 60). Communication (2.79 95% CI -8.14, 13.72) and socialisation (1.12 95% CI -17.13, 19.36) numerically improved in the KD group compared to ASM at 12 months. A similar proportion of infants in both groups reported at least one serious adverse event (43% ASM; 51% KD) - most commonly seizures.// Conclusion: KD appears numerically similar in efficacy and tolerability to further ASM in infants with drug-resistant epilepsy. The odds ratio of achieving seizure freedom at 8 weeks, and communication, socialisation and overall health scores numerically favoured KD compared to further ASM.

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