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A randomized controlled trial of the ketogenic diet in refractory childhood epilepsy
D A J E Lambrechts1, R J A de Kinderen2,3,4, J S H Vles1,2,5
1Department of Neurology, Academic Center for Epileptology Kempenhaeghe & Maastricht UMC+, Heeze, The Netherlands.
Insights
The ketogenic diet (KD) effectively reduced seizures in children with refractory epilepsy. While gastrointestinal issues were common, KD offers a significant therapeutic option compared to standard care.
Area of Science:
- Neurology
- Pediatric Epilepsy
- Dietary Therapies
Background:
- Refractory epilepsy in children poses significant treatment challenges.
- Limited surgical options exist for many pediatric epilepsy patients.
- Investigating alternative therapies like the ketogenic diet is crucial.
Purpose of the Study:
- To assess the efficacy and tolerability of the ketogenic diet (KD) in pediatric patients with refractory epilepsy.
- To compare KD with care as usual (CAU) in a randomized controlled trial (RCT).
Main Methods:
- A randomized controlled trial (RCT) involving children and adolescents with refractory epilepsy.
- Patients were randomized to either KD or CAU after a baseline month.
- Primary outcome: proportion of patients with ≥50% seizure reduction at 4 months.
Main Results:
- 50% of KD patients were responders versus 18.2% in the CAU group.
- KD group showed a significantly greater reduction in seizure frequency (56%) compared to CAU.
- Gastrointestinal symptoms were more frequent in the KD group, but overall side effect scores did not increase.
Conclusions:
- The ketogenic diet (KD) provides class I evidence of efficacy for refractory epilepsy in children and adolescents.
- KD is a viable therapeutic option when compared to standard care.
- Gastrointestinal symptoms are the most frequently reported side effects of KD.
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).
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