改良生酮饮食治疗耐药性癫痫的安全性、疗效和耐受性：一项随机对照试验。
Safety, Efficacy, and Tolerability of Modified Atkins Diet in Persons With Drug-Resistant Epilepsy: A Randomized Controlled Trial.
机构信息
From the Departments of Neurology (M.M., R.D., K.K., M.T.), Paediatrics (S.G., S.S.), All India Institute of Medical Science; Neuropsychology (A.N.), and Biostatistics (R.M.P., A.D.U.), All India Institute of Medical Science, New Delhi.
出版信息
Neurology. 2023 Mar 28;100(13):e1376-e1385. doi: 10.1212/WNL.0000000000206776. Epub 2023 Jan 4.
BACKGROUND AND OBJECTIVES
Modified Atkins diet (MAD) has emerged as an adjuvant therapy in drug-resistant epilepsy (DRE). Most studies are in children; there is limited evidence for DRE in adults. This study aimed to investigate whether MAD along with standard drug therapy (SDT) was indeed more effective than SDT alone in reducing seizure frequency and improving psychological outcomes at 6 months in adolescents and adults with DRE (nonsurgical).
METHODS
A prospective randomized controlled trial was conducted at tertiary care referral center in India. Persons with DRE aged 10-55 years attending outpatient epilepsy clinics between August 2015 and April 2019, who had more than 2 seizures per month despite using at least 3 appropriate antiseizure medications (ASMs) at their maximum tolerated doses and had not been on any form of diet therapy for the past 1 year, were enrolled. Patients were assessed for the eligibility and randomly assigned to receive SDT plus MAD (intervention arm) or SDT alone (control arm). The primary outcome was >50% reduction in seizure frequency, and the secondary outcomes were quality of life (QOL), behavior, adverse events, and rate of withdrawal at 6 months. Intention-to-treat analysis was performed.
RESULTS
A total of 243 patients were screened for eligibility; 160 patients (80 adults and 80 adolescents) were randomized to either the intervention or control arm. Demographic and clinical characteristics in both groups were comparable at baseline. At 6 months, >50% seizure reduction was seen in 26.2% in the intervention group vs 2.5% in the control group (95% CI 13.5-33.9; < 0.001). Improvement in QOL was 52.1 ± 17.6 in the intervention group vs 42.5 ± 16.4 in the control group (mean difference, 9.6; 95% CI 4.3 to 14.9, < 0.001). However, behavior scores could be performed in 49 patients, and improvement was seen in the intervention vs control group (65.6 ± 7.9 vs 71.4 ± 8.1, = 0.015) at the end of the study. One patient had weight loss; 2 patients had diarrhea.
DISCUSSION
The MAD group demonstrated improvement in all aspects (reduction in seizure frequency and behavioral problems) compared with the control group at the end of the study. MAD is an effective modality in controlling seizures; further research is required to assess its efficacy in terms of biomarkers along with descriptive metabolomics studies.
TRIAL REGISTRATION INFORMATION
The clinical trial registry of India: CTRI/2015/07/006048.
CLASSIFICATION OF EVIDENCE
This study provides Class III evidence that the MAD increases the probability of seizure reduction in adolescents and adults with DRE.
背景与目的
改良型阿特金斯饮食（MAD）已成为耐药性癫痫（DRE）的辅助治疗方法。大多数研究都集中在儿童群体；关于成年人 DRE 的证据有限。本研究旨在探讨 MAD 联合标准药物治疗（SDT）是否确实比单独使用 SDT 更能有效降低癫痫发作频率，并改善青少年和成年人 DRE（非手术）患者的心理结局。
方法
在印度的三级医疗转诊中心进行了一项前瞻性随机对照试验。2015 年 8 月至 2019 年 4 月期间，每月发作两次以上的 DRE 门诊患者，在接受最大耐受剂量的至少 3 种适当抗癫痫药物（ASMs）治疗后，仍每月发作两次以上，且在过去 1 年内未接受任何形式的饮食治疗，符合纳入标准。对患者进行评估，随机分为接受 SDT 加 MAD（干预组）或 SDT 单独治疗（对照组）。主要结局是癫痫发作频率减少 50%以上，次要结局是生活质量（QOL）、行为、不良反应和 6 个月时的退出率。采用意向治疗分析。
结果
共有 243 名患者进行了资格筛查；160 名患者（80 名成年人和 80 名青少年）被随机分配到干预组或对照组。两组患者的基线人口统计学和临床特征相当。6 个月时，干预组有 26.2%的患者癫痫发作减少 50%以上，而对照组为 2.5%（95%CI 13.5-33.9；<0.001）。干预组的 QOL 改善率为 52.1±17.6，对照组为 42.5±16.4（平均差异，9.6；95%CI 4.3-14.9，<0.001）。然而，行为评分可在 49 名患者中进行，干预组的改善优于对照组（65.6±7.9 与 71.4±8.1，=0.015）。研究结束时。一名患者出现体重减轻，两名患者出现腹泻。
讨论
MAD 组在研究结束时在各方面（减少癫痫发作频率和行为问题）均优于对照组。MAD 是一种控制癫痫发作的有效方法；需要进一步的研究来评估其在生物标志物方面的疗效，以及描述性代谢组学研究。
临床试验注册信息
印度临床试验注册处：CTRI/2015/07/006048。
证据分类
本研究提供了 III 级证据，表明 MAD 增加了青少年和成年人 DRE 患者癫痫发作减少的可能性。
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