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.