Department of Pediatrics (Neurology division), Kalawati Saran Children's Hospital and Lady Hardinge Medical College, New Delhi, India.
Department of Neurology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.
Seizure. 2022 Dec;103:61-67. doi: 10.1016/j.seizure.2022.10.015. Epub 2022 Oct 14.
This study was undertaken to compare the efficacy of modified Atkins diet (MAD) among children with non-surgical drug-resistant epilepsy (DRE) to levetiracetam, when added to on-going anti-seizure medications.
An open-label, randomized controlled trial among children aged 2-12 years with non-surgical DRE was conducted. Eligible children were randomized in a 1:1 ratio to receive add-on MAD or levetiracetam. Baseline and post-intervention seizure frequency at 12 weeks was determined from seizure logs maintained by parents. The primary outcome was the proportion of responders, i.e., patients who achieved > 50% seizure reduction from baseline. Adverse events were compared. Analysis was intention-to-treat. (NCT04172311) RESULTS: One hundred and one children were enrolled (MAD-51, levetiracetam-50). The majority of the enrolled children had generalized seizures of mixed types secondary to structural brain lesions and Lennox-Gastaut syndrome was the most common electroclinical syndrome (46%). The proportion of children with >50% seizure reduction at 12 weeks was significantly higher in the MAD arm compared to the levetiracetam arm (27/51(52.9%) vs 11/50(22%); p < 0.001). At 12-weeks post-intervention, the change in mean seizure frequency compared to baseline was -47.33 ± 39.57% in the MAD arm and -31.15 ± 32.18% in the levetiracetam arm (p = 0.03). Constipation (41.1%) was the most frequent adverse effect with MAD. Sedation/lethargy (18%) and anxiety and irritability (14%) were the most frequent adverse effects in the levetiracetam group.
Addition of MAD was found to be superior to levetiracetam among children with non-surgical DRE with predominant generalized seizures in achieving seizure reduction at 12 weeks. Both treatments were well tolerated. Adverse effects, although higher with MAD, were expected side effects.
本研究旨在比较改良的阿特金斯饮食（MAD）与左乙拉西坦在添加到正在进行的抗癫痫药物治疗中，对非手术耐药性癫痫（DRE）儿童的疗效。
对 2-12 岁非手术 DRE 儿童进行了一项开放标签、随机对照试验。符合条件的儿童以 1:1 的比例随机分为接受附加 MAD 或左乙拉西坦的组。从父母保留的癫痫日志中确定 12 周时的基线和干预后癫痫发作频率。主要结局是反应者的比例，即从基线减少≥50%的患者比例。比较不良反应。分析为意向治疗。（NCT04172311）
共有 101 名儿童入组（MAD-51，左乙拉西坦-50）。入组的大多数儿童有混合类型的全面性癫痫发作，继发于结构性脑病变，Lennox-Gastaut 综合征是最常见的电临床综合征（46%）。与左乙拉西坦组相比，MAD 组在 12 周时癫痫发作减少≥50%的儿童比例显著更高（27/51（52.9%）比 11/50（22%）；p<0.001）。干预后 12 周，与基线相比，MAD 组的平均癫痫发作频率变化为-47.33±39.57%，左乙拉西坦组为-31.15±32.18%（p=0.03）。便秘（41.1%）是 MAD 最常见的不良反应。镇静/嗜睡（18%）和焦虑和烦躁（14%）是左乙拉西坦组最常见的不良反应。
在主要为全面性癫痫发作的非手术 DRE 儿童中，与左乙拉西坦相比，添加 MAD 可在 12 周时更有效地减少癫痫发作。两种治疗方法均耐受良好。虽然 MAD 的不良反应更高，但都是预期的副作用。
