Paediatric Neurologist and Epileptologist, Gleneagles Global Hospital, Chennai, Tamilnadu, India.
Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, 110029, India.
Epilepsy Res. 2021 Mar;171:106574. doi: 10.1016/j.eplepsyres.2021.106574. Epub 2021 Feb 9.
A classic ketogenic diet, even though effective in children with drug-resistant epilepsy is not tolerated well by them and cumbersome to prepare. Low glycemic index therapy (LGIT), the least restrictive with minimal adverse effects among ketogenic dietary therapies has been proven effective in uncontrolled trials, but a placebo-controlled trial in this regard is still lacking.
In this open-label randomized controlled study, we randomized children above age two years with drug-resistant epilepsy into two groups (LGIT and control groups). Patients in the LGIT group received an add-on low glycemic index diet for 3 months along with the ongoing antiepileptic drugs and the patients in the control group did not receive any dietary intervention. Seizure frequency was assessed from the seizure diary maintained by the parents. Diet compliance was assessed using the diet diary that was maintained by the parents for three days just before the scheduled monthly visits of the patients.
Forty children with drug-refractory epilepsy (20 in each group) were enrolled. While 6/20 children in the LGIT arm have >50 % reduction in seizure frequency, none achieved this in the control arm (p = 0.02). The overall compliance with the low glycemic diet in the intervention group was 88.5 %. Out of six responders to LGIT, one child achieved seizure freedom and one achieved >90 % seizure reduction. Five continued LGIT further for a median duration of 8 months (range-4-12 months) successfully. The number needed to treat for more than 50 % seizure reduction was 3 and for more than 90 % seizure reduction was 10. The mean frequency of seizures for the intervention and control groups at three months of follow-up was not significantly different (p = 0.16), but the change in seizure frequency as compared to baseline was better in the intervention arm (p = 0.01). Three patients in the LGIT arm had non-serious adverse events (lethargy in two, vomiting in one).
In children aged 2-8 years with drug-refractory epilepsy, the administration of LGIT along with ongoing anti-seizure medications (ASM) is more efficacious in reducing seizure frequency as compared to ASM alone.
经典的生酮饮食，尽管对耐药性癫痫的儿童有效，但他们难以耐受，且准备起来很繁琐。低血糖指数疗法（LGIT）是生酮饮食疗法中限制最少、副作用最小的一种，已被证明在非对照试验中有效，但在这方面仍缺乏安慰剂对照试验。
在这项开放标签随机对照研究中，我们将 2 岁以上的耐药性癫痫患儿随机分为两组（LGIT 组和对照组）。LGIT 组患者在接受正在进行的抗癫痫药物治疗的同时，额外添加低血糖指数饮食，为期 3 个月；对照组患者则不接受任何饮食干预。通过父母记录的癫痫日记评估癫痫发作频率。父母在患者每月预约就诊前三天记录饮食日记，以评估饮食依从性。
共纳入 40 例耐药性癫痫患儿（每组 20 例）。LGIT 组 6/20 例患儿癫痫发作频率减少≥50%，而对照组无一例达到（p=0.02）。干预组对低血糖饮食的总体依从率为 88.5%。LGIT 治疗有效 6 例，其中 1 例患儿癫痫发作完全停止，1 例患儿癫痫发作减少≥90%。5 例患儿进一步接受 LGIT 治疗，中位时间为 8 个月（4-12 个月）。治疗有效需治疗≥50%的患儿人数为 3 例，治疗有效需治疗≥90%的患儿人数为 10 例。干预组和对照组在随访 3 个月时的癫痫发作频率无显著差异（p=0.16），但与基线相比，干预组的癫痫发作频率变化更好（p=0.01）。LGIT 组有 3 例患儿出现非严重不良事件（2 例患儿出现嗜睡，1 例患儿出现呕吐）。
在 2-8 岁耐药性癫痫患儿中，与单独使用抗癫痫药物（ASM）相比，LGIT 联合 ASM 治疗可更有效地降低癫痫发作频率。
