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

IF 2 4区医学 Q3 CLINICAL NEUROLOGY Epilepsy Research Pub Date : 2024-02-15 DOI:10.1016/j.eplepsyres.2024.107322

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

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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).

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药物难治性癫痫患儿每日低血糖生成指数饮食与间歇性低血糖生成指数饮食的疗效对比：随机对照试验

导言癫痫患儿停止低血糖指数疗法（LGIT）的主要原因是其中规定的饮食限制。本试验旨在比较每日和间歇性低血糖指数疗法对耐药性癫痫（DRE）儿童的疗效。方法本研究于2018年2月至2019年1月期间进行，旨在比较每日和间歇性低血糖指数疗法对1-15岁DRE儿童进行24周饮食治疗后的疗效。比较了两组儿童的依从性、护理人员面临的困难、不良反应、对行为的影响以及社交商数。间歇性低血糖饮食治疗组的儿童每周有两天（周六和周日）接受宽松的饮食，也可以吃中等升糖指数的食物。宽松饮食中碳水化合物热量最多可占总热量需求的 20%，而标准 LGIT 饮食中碳水化合物热量只占总热量需求的 10%。在意向治疗（ITT）和按协议分析中，间歇性LGIT组与每日LGIT组在24周时的每周平均癫痫发作频率减少率相当（ITT为-50.95%± 22.34% vs -47.16%± 23.41%，P=0.36；按协议分析中，间歇性LGIT组和每日LGIT组分别为-53.88%±20.54% vs -49.20%±21.87%，P=0.23）。两组癫痫发作频率减少≥50%的比例也相当（ITT和按方案分析中的P分别为0.73和0.56）。出现不良事件的患者比例和满意的依从率也有倾向于间歇性LGIT的趋势（分别为p=0.06和0.51），而间歇性LGIT的护理难度较低（p=0.001）。结论间歇性LGIT与每日LGIT相比，在饮食治疗24周后癫痫发作频率减少方面具有可比性。试验注册ClinicalTrials.gov（注册号- NCT03464487，https://clinicaltrials.gov/ct2/show/NCT03464487）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Epilepsy Research 医学-临床神经学

CiteScore

0.10

自引率

4.50%

发文量

143

审稿时长

62 days

期刊介绍： Epilepsy Research provides for publication of high quality articles in both basic and clinical epilepsy research, with a special emphasis on translational research that ultimately relates to epilepsy as a human condition. The journal is intended to provide a forum for reporting the best and most rigorous epilepsy research from all disciplines ranging from biophysics and molecular biology to epidemiological and psychosocial research. As such the journal will publish original papers relevant to epilepsy from any scientific discipline and also studies of a multidisciplinary nature. Clinical and experimental research papers adopting fresh conceptual approaches to the study of epilepsy and its treatment are encouraged. The overriding criteria for publication are novelty, significant clinical or experimental relevance, and interest to a multidisciplinary audience in the broad arena of epilepsy. Review articles focused on any topic of epilepsy research will also be considered, but only if they present an exceptionally clear synthesis of current knowledge and future directions of a research area, based on a critical assessment of the available data or on hypotheses that are likely to stimulate more critical thinking and further advances in an area of epilepsy research.