Modified Atkins Diet vs Low Glycemic Index Treatment for Drug-Resistant Epilepsy in Children: An Open Label, Randomized Controlled Trial.

Objective: To compare the efficacy of the modified Atkins diet (mAD) and low glycemic index treatment (LGIT) among children with drug-resistant epilepsy.

Design: Randomized, open labelled, controlled clinical trial.

Setting: Tertiary care referral center.

Participants: Children aged 6 months to 14 years with drug-resistant epilepsy.

Intervention: mAD (n=30) or LGIT (n=30) as an add-on to the ongoing antiseizure drugs.

Main Outcome Measures: Proportion of children who achieved seizure freedom as defined by complete cessation of seizure at 12 weeks as primary outcome measure. Secondary outcome measures were proportion of children who achieved >50% and >90% seizure reduction at 12 weeks, and adverse effects of the two therapies.

Results: Of the 60 recruited children, 3 in the mAD group, and 3 in LGIT group were lost to follow-up. The proportion of children with seizure freedom [16.6% vs 6.6%; relative risk reduction (RRR) (95% CI), 1.5 (-10.9, 0.5); P=0.42] and >90% seizure reduction [30% vs 13.3%; RRR, -1.2 (-5.5, 0.2); P=0.21] was comparable between the mAD and LGIT group at 12 weeks. The proportion of children with >50% seizure reduction was significantly higher at 12 weeks among those who received LGIT as compared to the mADgroup [73.3% vs 43.3%; RRR (95% CI) 0.4 (0.1-0.6); P=0.03] although the effect size was small. The diet was well tolerated with lethargy being the most common adverse effect in children in mAD (53.3%) and LGIT (66.7%) groups.

Conclusions: The present study with limited sample size shows that seizure freedom at 12 weeks was comparable between mAD and LGIT for the treatment of drug-resistant epilepsy.