Comparison of efficacy of low glycemic index treatment and modified Atkins diet among children with drug-resistant epilepsy: A randomized non-inferiority trial

IF 6.6 1区医学 Q1 CLINICAL NEUROLOGY Epilepsia Pub Date : 2025-01-30 DOI:10.1111/epi.18292

Vaishakh Anand, Sheffali Gulati, Anuja Agarwala, Gautam Kamila, Aakash Mahesan, Vishal Sondhi, Kanak L. Gupta, Biswaroop Chakrabarty, Prashant Jauhari, Prateek Kumar Panda, Ravindra Mohan Pandey

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Abstract

Objective

The ketogenic diet has been the mainstay of treatment of drug-resistant epilepsy (DRE). No comparative trials have been conducted to assess the efficacy of the two less strict ketogenic diets: modified Atkins diet (MAD) and low glycemic index treatment (LGIT). This study assesses the non-inferiority of LGIT compared with MAD.

Methods

This was an open-label randomized non-inferiority trial. Children with DRE were randomized to receive either MAD or LGIT as an add-on to anti-seizure medications. The primary endpoint was percentage seizure reduction at the end of 24 weeks of therapy compared to the baseline. The non-inferiority margin of −15% was predefined to calculate the sample size.

Results

Ninety-one children were enrolled and randomized to receive either MAD (n = 45) or LGIT (n = 46). Intention-to-treat analysis done at the end of 24 weeks of therapy showed a mean (±standard deviation [SD]) percentage seizure reduction of 60.7% (±41.3) in the MAD sub-group and 57% (±39.4) in the LGIT sub-group (p = 0.664). The absolute difference between the means of percentage seizure reduction was −3.7 (−20.5 to 13.2) and crossed the non-inferiority margin. Ten children in the MAD group and nine children in the LGIT group did not complete 24 weeks of therapy. Adverse effects were comparable between the arms (MAD, 66.6%; LGIT, 50%), although serious adverse effects were higher in the MAD arm. The most common adverse effect was decreased acceptance (24.2%) followed by decreased satiety (9.9%), vomiting (9.9%), weight loss (5.5%), constipation (5.5%), and diarrhea (3.3%). Dyslipidemia was more commonly seen in the MAD group (MAD, six; LGIT, one). One death in the LGIT arm was unrelated to therapy. Although there was no statistically significant difference in improvement in cognition, behavior, and quality of life scales, improvement was noted from baseline scores.

Significance

LGIT may be non-inferior to MAD in the treatment of children with DRE with the advantage of increased acceptance and fewer adverse effects.

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低血糖指数治疗和改良阿特金斯饮食对儿童耐药癫痫的疗效比较：一项随机非劣效性试验。

目的：生酮饮食已成为治疗耐药癫痫（DRE）的主要方法。没有进行比较试验来评估两种不太严格的生酮饮食：改良阿特金斯饮食（MAD）和低血糖指数治疗（LGIT）的疗效。本研究评估LGIT与MAD的非劣效性。方法：这是一项开放标签随机非劣效性试验。患有DRE的儿童随机接受MAD或LGIT作为抗癫痫药物的补充。主要终点是与基线相比，治疗24周后癫痫发作减少的百分比。预先设定了-15%的非劣效性裕度来计算样本量。结果：91名儿童被纳入并随机接受MAD （n = 45）或LGIT （n = 46）。在治疗24周结束时进行的意向治疗分析显示，MAD亚组癫痫发作率平均（±标准差[SD]）减少60.7%（±41.3），LGIT亚组癫痫发作率减少57%（±39.4）（p = 0.664）。癫痫发作减少百分比平均值之间的绝对差异为-3.7(-20.5至13.2)，并越过非劣效性界限。MAD组的10名儿童和LGIT组的9名儿童没有完成24周的治疗。两组间不良反应具有可比性(MAD, 66.6%；LGIT, 50%)，尽管严重的不良反应在MAD组更高。最常见的不良反应是接受度下降（24.2%），其次是饱腹感下降（9.9%）、呕吐（9.9%）、体重减轻（5.5%）、便秘（5.5%）和腹泻（3.3%）。血脂异常在MAD组更为常见(MAD, 6；LGIT之一)。LGIT组的1例死亡与治疗无关。虽然在认知、行为和生活质量方面的改善没有统计学上的显著差异，但从基线得分来看，改善是明显的。意义：LGIT治疗DRE患儿的效果可能不逊于MAD，具有接受度高、不良反应少的优势。

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

Epilepsia 医学-临床神经学

CiteScore

10.90

自引率

10.70%

发文量

319

审稿时长

2-4 weeks

期刊介绍： Epilepsia is the leading, authoritative source for innovative clinical and basic science research for all aspects of epilepsy and seizures. In addition, Epilepsia publishes critical reviews, opinion pieces, and guidelines that foster understanding and aim to improve the diagnosis and treatment of people with seizures and epilepsy.