Efficacy of daily versus intermittent low glycemic index therapy diet in children with drug-resistant epilepsy: A randomized controlled trial

Prateek Kumar Panda; Biswaroop Chakrabarty; Prashant Jauhari; Indar Kumar Sharawat; Anuja Agarwal; Vandana Jain; Ravindra M Pandey; Sheffali Gulati

doi:10.1016/j.eplepsyres.2024.107322

Efficacy of daily versus intermittent low glycemic index therapy diet in children with drug-resistant epilepsy: A randomized controlled trial

Epilepsy Res. 2024 Mar:201:107322. doi: 10.1016/j.eplepsyres.2024.107322. Epub 2024 Feb 15.

Authors

Prateek Kumar Panda¹, Biswaroop Chakrabarty², Prashant Jauhari², Indar Kumar Sharawat³, Anuja Agarwal², Vandana Jain⁴, Ravindra M Pandey⁵, Sheffali Gulati⁶

Affiliations

¹ Child Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi 110029, India; Pediatric Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, Rishikesh, Uttarakhand 249203, India.
² Child Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi 110029, India.
³ Pediatric Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, Rishikesh, Uttarakhand 249203, India.
⁴ Department of Pediatrics, All India Institute of Medical Sciences, New Delhi 110029, India.
⁵ Department of Biostatistics, All India Institute of Medical Sciences, New Delhi 110029, India.
⁶ Child Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi 110029, India. Electronic address: sheffaligulati@gmail.com.

PMID: 38402708
DOI: 10.1016/j.eplepsyres.2024.107322

Abstract

Introduction: The predominant reason for the discontinuation of low glycemic index therapy (LGIT) in children with epilepsy is the dietary restrictions imposed therein. This trial intended to compare the efficacy of daily and intermittent LGIT in children with drug-resistant epilepsy (DRE).

Methods: This study was performed between February 2018 and January 2019 to compare the efficacy of daily and intermittent LGIT in children aged 1-15 years with DRE following 24 weeks of dietary therapy. Compliance, the difficulty faced by caregivers, adverse effects, impact on behaviour, and social quotient in both arms were compared. Children in the intermittent LGIT arm received a liberalized diet for two days every week (Saturday and Sunday), which also allowed medium glycemic index foods. Carbohydrate calories were allowed up to 20% of the total caloric requirement in the liberalized diet, as compared to only 10% in standard LGIT.

Results: Out of 132 children randomized (66 in each group), 122 completed 24 weeks follow up. Mean weekly seizure frequency reduction at 24 weeks in the intermittent LGIT group was comparable with that of the daily LGIT group in both intention-to-treat (ITT) and per-protocol analysis (-50.95%± 22.34% vs -47.16%± 23.41%, p=0.36 in ITT and -53.88%±20.54% vs -49.20%±21.87%, p=0.23) in per-protocol analysis for intermittent and daily LGIT group respectively). The proportion with ≥50% reduction in seizure frequency was also comparable between both groups (p=0.73 and 0.56 in ITT and per protocol analysis respectively). The proportion of patients with adverse events and satisfactory compliance rate also had a trend towards favoring intermittent LGIT (p=0.06 and 0.51, respectively), while caregiver difficulty was lower with intermittent LGIT (p=0.001).

Conclusions: Intermittent LGIT is comparable to daily LGIT in terms of seizure frequency reduction after 24 weeks of dietary therapy.

Trial registration: ClinicalTrials.gov (Registration number- NCT03464487, https://clinicaltrials.gov/ct2/show/NCT03464487).

Keywords: Drug-resistant epilepsy; Epilepsy; Ketogenic diet; Low glycemic index therapy; Seizures.

Publication types

Randomized Controlled Trial

MeSH terms

Child
Drug Resistant Epilepsy* / drug therapy
Drug-Related Side Effects and Adverse Reactions*
Glycemic Index
Humans
Patient Compliance
Seizures

Associated data

ClinicalTrials.gov/NCT03464487