Use of the modified <scp>A</scp>tkins diet for treatment of refractory childhood epilepsy: A randomized controlled trial

Summary Purpose The aim of this study was to evaluate the efficacy of the modified A tkins diet in a randomized controlled trial in children with refractory epilepsy. Methods Children aged 2–14 years who had daily seizures despite the appropriate use of at least three anticonvulsant drugs were enrolled. Children were randomized to receive either the modified A tkins diet or no dietary intervention for a period of 3 months. The ongoing anticonvulsant medications were continued unchanged in both the groups. Seizure control at 3 months was the primary end point. Analysis was intention to treat. Adverse effects of the diet were assessed by parental reports ( ClinicalTrials.gov Identifier: NCT 00836836). Key Findings Among a total of 102 children, 50 were in the diet group and 52 in the control group. Four children discontinued the diet before the study end point, and three children in the control group were lost to follow‐up. The mean seizure frequency at 3 months, expressed as a percentage of the baseline, was significantly less in the diet group: 59 ± 54 (95% confidence interval [ CI ] 44–74.5) versus 95.5 ± 48 (95% CI 82–109), p = 0.003. The proportion of children with &gt;90% seizure reduction (30% vs. 7.7%, p = 0.005) and &gt;50% seizure reduction was significantly higher in the diet group (52% vs. 11.5%, p &lt; 0.001). Constipation was the most common adverse effect among children on the diet (23, 46%). Significance The modified A tkins diet was found to be effective and well tolerated in children with drug‐refractory epilepsy.