Evidence map›Paper›PMID 27027847›Full record

Trial reportActa neurologica Scandinavica2017

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

D A J E Lambrechts, R J A de Kinderen, J S H Vles, A J A de Louw, A P Aldenkamp, H J M Majoie

Open access · bronzeAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Acta neurologica Scandinavica, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 65 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 8 pooled it
7.4field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 8 syntheses or guidelines pooled it, 147 citations in OpenAlex.

  1. Pooled it
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  6. Ketogenic diets for drug-resistant epilepsy.The Cochrane database of systematic reviews · 2020
    Pooled it
  7. Ketogenic diet for the treatment of pediatric epilepsy: review and meta-analysis.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2020
    Pooled it
  8. Ketogenic diets for drug-resistant epilepsy.The Cochrane database of systematic reviews · 2018
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5 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 4 countries.

D A J E LambrechtsDepartment of Neurology, Academic Center for Epileptology Kempenhaeghe & Maastricht UMC+, Heeze, The Netherlands.
R J A de KinderenResearch School of Mental Health & Neuroscience, Maastricht University, Maastricht, The Netherlands.
J S H VlesDepartment of Neurology, Academic Center for Epileptology Kempenhaeghe & Maastricht UMC+, Heeze, The Netherlands.
A J A de LouwDepartment of Neurology, Academic Center for Epileptology Kempenhaeghe & Maastricht UMC+, Heeze, The Netherlands.
A P AldenkampResearch School of Mental Health & Neuroscience, Maastricht University, Maastricht, The Netherlands.
H J M MajoieDepartment of Neurology, Academic Center for Epileptology Kempenhaeghe & Maastricht UMC+, Heeze, The Netherlands.
Kempenhaeghe · NLEindhoven University of Technology · NLMaastricht University · NLMaastricht University Medical Centre · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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).

Indexed as

AdolescentChildChild, PreschoolDiet, KetogenicDrug Resistant EpilepsyFemaleHumansInfantMaleMedical RecordsNetherlandsTreatment Outcomechildrenketogenic dietRCTrefractory epilepsyseizure severity

Identifiers

PMID27027847
OpenAlexW4254531400

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.