Evaluation Of The Efficacy Of The Modified Atkins Diet In Children With Refractory Epilepsy: A Randomized Controlled Trial.

Several severe catastrophic epilepsies present in childhood, including severe infantile myoclonic epilepsy, Lennox Gastaut syndrome and myoclonic-astatic epilepsy (Doose syndrome). Seizures in these disorders are difficult to control; sometimes only at the expense of multiple and toxic levels of antiepileptic medications.Epilepsy surgery is feasible only in a very small number, also the costs are prohibitively high.

Uncontrolled seizures pose a variety of risks to children, including higher rates of mortality, developmental delay and/or regression, and cognitive impairment. Thus effective treatment to control seizures is fundamental to improving overall outcome in childhood epilepsy. The shortcomings of antiepileptic drug therapy and epilepsy surgery have made the need for alternative treatments.

The ketogenic diet is one of the oldest available treatments for epilepsy. It is a medically supervised high fat, low carbohydrate, and restricted protein diet that maintains a chronic state of ketosis while providing proteins and calories for adequate growth. The ketogenic diet compares favourably with the newer antiepileptic drugs (AED's) which have been developed for the treatment epilepsy in children Studies on the newer antiepileptic drugs such as vigabatrin, lamotrigine, tiagabine and gabapentin indicate that only 3% to 10% of all intractable patients achieve complete relief of seizures with the introduction of these newer drugs. Whereas with the ketogenic diet, 33% of patients with intractable epilepsy have more than 50% reduction in seizures and 15-20% become seizure free.Also, many of the children who are maintained on the diet are able to have their antiepileptic drugs decreased or withdrawn. This leads to improvement in alertness, behaviour and cognition.

The traditional ketogenic diet, with 4:1 ratio of fat: carbohydrate + protein has its drawbacks. It restricts calories and fluids, and requires weighing of foods. Protein is generally restricted to 1 g/kg/day, with the majority of remaining calories in the form of fat. This may lead to hypoproteinemia and growth problems. Hospitalization is generally advocated for diet initiation, both for fasting and non-fasting initiation. Side effects of the diet include kidney stones, constipation, acidosis, diminished growth, weight loss, and hyperlipidemia.

The modified Atkins diet is a nonpharmacologic therapy for intractable childhood epilepsy that was designed to be a less restrictive alternative to the traditional ketogenic diet. This diet is started on an outpatient basis without a fast, allows unlimited protein and fat, and does not restrict calories or fluids. Early studies have demonstrated efficacy and safety.13-20 However these studies have been uncontrolled, and have enrolled small numbers of patients. There are no randomized control trials evaluating the efficacy of the modified Atkins diet in children and adults with refractory epilepsy. Hence this study has been was planned to investigate whether there are clear benefits in terms of seizure control in children with refractory epilepsy who are treated with the modified Atkins diet, versus controls.