Long-term clinical outcomes and economic evaluation of the ketogenic diet versus care as usual in children and adolescents with intractable epilepsy

Ben F M Wijnen; Reina J A de Kinderen; Danielle A J E Lambrechts; Debby Postulart; Albert P Aldenkamp; Marian H J M Majoie; Silvia M A A Evers

doi:10.1016/j.eplepsyres.2017.03.002

Long-term clinical outcomes and economic evaluation of the ketogenic diet versus care as usual in children and adolescents with intractable epilepsy

Epilepsy Res. 2017 May:132:91-99. doi: 10.1016/j.eplepsyres.2017.03.002. Epub 2017 Mar 21.

Authors

Ben F M Wijnen¹, Reina J A de Kinderen², Danielle A J E Lambrechts³, Debby Postulart⁴, Albert P Aldenkamp⁵, Marian H J M Majoie⁶, Silvia M A A Evers⁷

Affiliations

¹ Department of Health Services Research, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands; Department of Research and Development, Epilepsy Center Kempenhaeghe, Heeze, The Netherlands. Electronic address: B.wijnen@maastrichtuniversity.nl.
² Department of Health Services Research, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands; Department of Research and Development, Epilepsy Center Kempenhaeghe, Heeze, The Netherlands; Trimbos Institute, National Institute of Mental Health and Addiction, Utrecht, The Netherlands.
³ Department of Neurology, Academic Center for Epileptology Kempenhaeghe & Maastricht UMC+, Heeze, The Netherlands.
⁴ Department of Research and Development, Epilepsy Center Kempenhaeghe, Heeze, The Netherlands.
⁵ Department of Research and Development, Epilepsy Center Kempenhaeghe, Heeze, The Netherlands; Department of Behavioral Sciences, Epilepsy Center Kempenhaeghe, Heeze, The Netherlands; Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands; Faculty of Electrical Engineering, University of Technology, Eindhoven, The Netherlands.
⁶ Department of Research and Development, Epilepsy Center Kempenhaeghe, Heeze, The Netherlands; Department of Neurology, Academic Center for Epileptology Kempenhaeghe & Maastricht UMC+, Heeze, The Netherlands; Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands; School of Health Professions Education, Faculty of Health, Medicine and Life Sciences, Maastricht University, The Netherlands.
⁷ Department of Health Services Research, CAPHRI School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands; Trimbos Institute, National Institute of Mental Health and Addiction, Utrecht, The Netherlands.

PMID: 28364726
DOI: 10.1016/j.eplepsyres.2017.03.002

Abstract

Objective: To examine long-term retention rate, clinical outcomes, cost-utility and cost-effectiveness of the Ketogenic Diet (KD) compared with care as usual (CAU) in children and adolescents with intractable epilepsy from a societal perspective.

Methods: Participants were randomized into a KD or CAU group. Seizure frequency, quality adjusted life years (QALYs), side-effects, seizure severity, health care costs, production losses, patient and family costs were assessed at baseline and during 16-months of follow-up. Incremental cost-effectiveness ratios (ICERs) (i.e. cost per QALY and cost per responder) and cost-effectiveness acceptability curves are presented.

Results: 48 children were included in the analyses of this study (26 from KD group). In total, 58% of the KD group completed the follow-up of 16 months; 11 dropped-out for various reasons. At 16 months, 35% of the KD participants had a seizure reduction≥50% from baseline, compared with 18% of the CAU participants. Mean costs per patient in the CAU group were €53,367 (extrapolated) compared to €61,019 per patient in the KD group, resulting in an ICER of €46,564 per responder. Cost per QALY rose well above any acceptable ceiling ratio. At 4-months' follow-up, the KD group showed significantly more gastro-intestinal problems compared to the CAU group. At 16 months, the KD group reported fewer problems compared to CAU. Furthermore, 46.2% of the KD group reported a decrease in severity of their worst seizure compared to 32% of the CAU group.

Conclusion: The KD group resulted in more responders and showed greater improvement on seizure severity. Furthermore, the KD did not lead to worsening of side-effects other than gastro-intestinal problems (only at 4 months' follow-up). However, as only a minimal difference in QALYs was found between the KD group and the CAU group, the resulting cost per QALY ratios were inconclusive.

Keywords: Adolescents; Children; Economic evaluations; Epilepsy; Intractable epilepsy; Ketogenic diet.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Child
Child, Preschool
Cost-Benefit Analysis*
Diet, Ketogenic* / methods
Drug Resistant Epilepsy / diet therapy*
Drug Resistant Epilepsy / economics
Female
Health Care Costs*
Humans
Male
Quality of Life*
Quality-Adjusted Life Years
Time

Associated data

NTR/NTR2498