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A ketogenic diet was similar in efficacy and tolerability to further anti-seizure medication for infants with drug-resistant epilepsy, a randomized clinical trial in the U.K. found.

On the study's primary outcome, the median number of seizures per day at 8 weeks was 5 in the ketogenic diet group and 3 in the anti-seizure medicine group (incidence rate ratio 1.33, 95% CI 0.84-2.11), Helen Cross, PhD, of University College London in England, and colleagues reported in .

Of 63 infants in the ketogenic group with 8-week data available, 44% had more than 50% seizure reduction compared with 40% of 47 infants in the anti-seizure medication group. In the ketogenic group, 11% were seizure-free, compared with 14% of the anti-seizure medication group. Tolerability scores were similar for both groups.

"Our trial results showed that a ketogenic diet was not more efficacious than a further anti-seizure medicine but that the diet was safe to use in infants aged 1-24 months," Cross and colleagues wrote. "A ketogenic diet could be considered a treatment option for infants who continue to have seizures despite having tried two antiseizure medications."

For families struggling with medication, "the ketogenic diet really does make a difference," Cross told MedPage Today. Healthcare professionals should "be aware of this -- that it's not a quack diet," she said. "It is a medical diet, and it can work, essentially."

The ketogenic diet has been reported to treat epilepsy for . The high-fat, low-carbohydrate diet mimics the effects of starvation though its exact in epilepsy remain unsettled, Cross and co-authors noted.

"The of a ketogenic diet versus no changes to treatment in children with epilepsy aged 2-16 years was conducted in 2008, and has paved the way for evidence-based implementation and clinical guidance on the use of ketogenic diets in this age group," noted Manisha Patel, PhD, of the University of Colorado in Aurora, in an . "However, evidence for use of a ketogenic diet in very young children (aged ≤2 years) is scant."

"With drug resistance affecting around a third of people with epilepsy, alternative treatments that target other mechanisms are urgently needed," Patel observed.

Cross and colleagues included infants aged 1-24 months with confirmed epilepsy who had four or more seizures per week and who did not respond to two or more pharmacological treatments in their study.

Patients were observed for 2 weeks with no changes made to their regular anti-seizure medication, then were randomized to the ketogenic diet or anti-seizure medication groups. With the help of pediatric dietitians, those in the ketogenic diet group followed a protocol of a 2:1 to 4:1 ratio of grams of fat to carbohydrates in addition to their baseline anti-seizure medications. Parents or guardians received training on the diet, and diet implementation was monitored at 8 weeks and 12 months.

For the anti-seizure medication group, clinicians selected the most appropriate drug and followed a consensus protocol to deliver treatment. Follow-up visits for both groups were at 4 and 8 weeks, and at 6, 9, and 12 months. After an 8-week assessment, depending on the response to treatment, patients could change treatments (for example, to the ketogenic diet, outside the trial). The trial ended before all participants reached 12 months of follow-up due to slow recruitment and lack of funding.

In the ketogenic diet group of 78 patients, 50% were boys, 79% were white, and mean age was 1.23 years. Of 58 patients in the anti-seizure medication group, 62% were boys, 73% were white, and mean age was 1.10 years. Baseline median seizures per day were 7 in the ketogenic group and 9 in the medication group.

A similar number of infants in each group experienced at least one serious adverse event: 51% of the ketogenic diet group and 45% of the anti-seizure medication group. Three infants randomly assigned to the ketogenic diet group died during the trial, but the deaths were judged unrelated to treatment.

Cross noted that the anti-seizure medication group had a larger proportion of changes in drugs during the study period compared with the ketogenic diet group, suggesting that the ketogenic group may have been more clinically stable. Infants and families in the ketogenic group also had improvements in some quality-of-life measures, she added.

Study limitations included a potential placebo effect from unblinding, the researchers acknowledged. In addition, the trial had substantial loss to follow up, slow recruitment, and loss of funding.

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