D A J E Lambrechts1, R J A de Kinderen2,3,4, J S H Vles1,2,5, A J A de Louw1,6, A P Aldenkamp2,5,6,7, H J M Majoie1,2,5,8. 1. Department of Neurology, Academic Center for Epileptology Kempenhaeghe & Maastricht UMC+, Heeze, The Netherlands. 2. Research School of Mental Health & Neuroscience, Maastricht University, Maastricht, The Netherlands. 3. Department of Health Services Research, CAPHRI School for Public Health & Primary Care, Maastricht University, Maastricht, The Netherlands. 4. Department of Research & Development, Academic Center for Epileptology Kempenhaeghe & Maastricht UMC+, Heeze, The Netherlands. 5. Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands. 6. Faculty of Electrical Engineering, University of Technology, Eindhoven, The Netherlands. 7. Department of Behavioral Sciences, Academic Center for Epileptology Kempenhaeghe & Maastricht UMC+, Heeze, The Netherlands. 8. Faculty of Health, Medicine and Life Sciences, School of Health Professions Education, Maastricht UMC+, Maastricht, The Netherlands.
Abstract
OBJECTIVE: To evaluate the efficacy and tolerability of the ketogenic diet (KD) during the first 4 months of a randomized controlled trial (RCT) in refractory epilepsy patients aged 1-18 years. METHODS:Children and adolescents with refractory epilepsy, not eligible for epilepsy surgery, were included. Following 1 month at baseline, patients were randomized to either the KD or to care as usual (CAU).Primary outcome is the proportion of patients with at least 50% reduction in seizure frequency at 4 months. Secondary outcomes are mean percentage of baseline seizures, seizure severity, and side effects. RESULTS:Fifty-seven patients were randomized; nine dropped out, leaving 48 for analysis (i.e., 26 KD, 22 CAU). In an intention-to-treat analysis, 13 patients (50%) treated with the KD and four patients (18.2%) of the CAU group were responders.Mean seizure frequency at 4 months compared to baseline, after removal of two outliers in the KD group, was significantly lower (P = 0.024) in the KD group (56%) (95% CI: 36-76) than in the CAU group (99%) (95% CI: 65-133%).Twice as many patients in the KD group had a relevant decrease in seizure severity score (P = 0.070).Patients treated with the KD had a significantly higher score for gastrointestinal symptoms (P = 0.021) without an increase in the total score of side effects. CONCLUSIONS: This trial provides class I evidence that the KD is an effective therapy in children and adolescents with refractory epilepsy compared with CAU. Most often reported side effects are gastrointestinal symptoms.The study has been registered with the Netherlands Trial Registry (NTR2498).
RCT Entities:
OBJECTIVE: To evaluate the efficacy and tolerability of the ketogenic diet (KD) during the first 4 months of a randomized controlled trial (RCT) in refractory epilepsypatients aged 1-18 years. METHODS:Children and adolescents with refractory epilepsy, not eligible for epilepsy surgery, were included. Following 1 month at baseline, patients were randomized to either the KD or to care as usual (CAU).Primary outcome is the proportion of patients with at least 50% reduction in seizure frequency at 4 months. Secondary outcomes are mean percentage of baseline seizures, seizure severity, and side effects. RESULTS: Fifty-seven patients were randomized; nine dropped out, leaving 48 for analysis (i.e., 26 KD, 22 CAU). In an intention-to-treat analysis, 13 patients (50%) treated with the KD and four patients (18.2%) of the CAU group were responders.Mean seizure frequency at 4 months compared to baseline, after removal of two outliers in the KD group, was significantly lower (P = 0.024) in the KD group (56%) (95% CI: 36-76) than in the CAU group (99%) (95% CI: 65-133%).Twice as many patients in the KD group had a relevant decrease in seizure severity score (P = 0.070).Patients treated with the KD had a significantly higher score for gastrointestinal symptoms (P = 0.021) without an increase in the total score of side effects. CONCLUSIONS: This trial provides class I evidence that the KD is an effective therapy in children and adolescents with refractory epilepsy compared with CAU. Most often reported side effects are gastrointestinal symptoms.The study has been registered with the Netherlands Trial Registry (NTR2498).
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Authors: Eric H Kossoff; Beth A Zupec-Kania; Stéphane Auvin; Karen R Ballaban-Gil; A G Christina Bergqvist; Robyn Blackford; Jeffrey R Buchhalter; Roberto H Caraballo; J Helen Cross; Maria G Dahlin; Elizabeth J Donner; Orkide Guzel; Rana S Jehle; Joerg Klepper; Hoon-Chul Kang; Danielle A Lambrechts; Y M Christiana Liu; Janak K Nathan; Douglas R Nordli; Heidi H Pfeifer; Jong M Rho; Ingrid E Scheffer; Suvasini Sharma; Carl E Stafstrom; Elizabeth A Thiele; Zahava Turner; Maria M Vaccarezza; Elles J T M van der Louw; Pierangelo Veggiotti; James W Wheless; Elaine C Wirrell Journal: Epilepsia Open Date: 2018-05-21