A randomized controlled trial of the ketogenic diet in refractory childhood epilepsy

被引：105
作者：
Lambrechts, D. A. J. E. [1 ,2 ]
de Kinderen, R. J. A. [2 ,3 ,4 ,5 ]
Vles, J. S. H. [1 ,2 ,3 ,6 ]
de Louw, A. J. A. [1 ,2 ,7 ]
Aldenkamp, A. P. [2 ,3 ,6 ,7 ,8 ]
Majoie, H. J. M. [1 ,2 ,3 ,6 ,9 ]
机构：
[1] Acad Ctr Epileptol Kempenhaeghe, Dept Neurol, POB 61, NL-5590 AB Heeze, Netherlands
[2] Maastricht UMC, POB 61, NL-5590 AB Heeze, Netherlands
[3] Maastricht Univ, Res Sch Mental Hlth & Neurosci, Maastricht, Netherlands
[4] Maastricht Univ, CAPHRI Sch Publ Hlth & Primary Care, Dept Hlth Serv Res, Maastricht, Netherlands
[5] Acad Ctr Epileptol Kempenhaeghe, Dept Res & Dev, Heeze, Netherlands
[6] Maastricht Univ, Med Ctr, Dept Neurol, Maastricht, Netherlands
[7] Eindhoven Univ Technol, Fac Elect Engn, Eindhoven, Netherlands
[8] Acad Ctr Epileptol Kempenhaeghe, Dept Behav Sci, Heeze, Netherlands
[9] Maastricht UMC, Sch Hlth Profess Educ, Fac Hlth Med & Life Sci, Maastricht, Netherlands
来源：
ACTA NEUROLOGICA SCANDINAVICA | 2017年 / 135卷 / 02期
关键词：
children; ketogenic diet; RCT; refractory epilepsy; seizure severity; RISK-FACTORS; CHILDREN; MANAGEMENT;
D O I：
10.1111/ane.12592
中图分类号：
R74 [神经病学与精神病学];
学科分类号：
摘要：
ObjectiveTo 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. MethodsChildren 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. ResultsFifty-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. ConclusionsThis 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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页码：231 / 239
页数：9
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