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Ketogenic Diet Cuts Kids' Epileptic Seizures 5-5-08

Seizures in children with drug-resistant epilepsy were reduced by the ketogenic diet, which stresses high fat, low carbohydrates, and controlled protein, the first randomized trial of the regimen found.

In the first randomized trial of the diet, the number of seizures over three months declined by an average of about a third compared with a rise of about a third in a control group, Elizabeth G. Neal, Ph.D., of University College London, and colleagues reported online and in the June issue of Lancet Neurology.

Although the ketogenic diet has been widely used to treat children with drug-resistant epilepsy since the 1920s and was found beneficial in observational studies, a Cochrane review had found no randomized controlled trials in the literature.

Although the exact mechanisms of action are unclear, the high fat and restricted carbohydrate content of the diet is thought to mimic the biochemical response to starvation, when ketone bodies, rather than sugars, become the main fuel for the brain's energy.

The study included 145 children, ages two to 16, who had daily seizures (or more than seven a week), had failed to respond to at least two antiepileptic drugs, and had not been treated previously with a ketogenic diet. Enrollment ran from December 2001 through July 2006.

Children were seen at one of two hospital centers or a residential center for young people with epilepsy. Children were randomly assigned to a ketogenic diet, either immediately or after a three-month delay (control group), with no other changes in treatment for either group. All children were given vitamin and mineral supplements.

After the trial, the controls were crossed over to the ketogenic diet.

The ketogenic diet came in two forms. Classical diets (37 children) were started at a 2:1 fat:protein and carbohydrate ratio and gradually increased to a 3:1 or 4:1 ratio.

The medium-chain triglycerides ketogenic diet (39 children) was started with carbohydrate generally 15% of total energy, protein usually 10% and long-chain fat usually 30% of total energy. The medium-chain triglycerides fat content was increased over seven to 10 days, as tolerated, usually to 45% of total energy.

Early withdrawals were recorded, and seizure frequency on the diet was assessed after three months and compared with that of the controls. Tolerability of the diet was assessed by questionnaire at three months.

Seventy-three children were assigned to the ketogenic diets and 72 to the control group. Data from 103 children were available for analysis including 54 following ketogenic diets and 49 controls.

After three months, the mean percentage of baseline seizures was significantly lower in the diet group than among the controls (62% versus 136.9%, for a 75% decrease, 95% CI 42.4 to 107.4%, P<0.0001).

Of the children in the diet group, 28 (38%) of children who completed the three-month diet had more than a 50% seizure reduction compared with just four (6%) controls (P<0.0001).

Five children (7%) in the diet group had a greater than 90% seizure reduction compared with none in the control group (P=0.0582).

There was no significant difference in the efficacy of the treatment between symptomatic generalized or symptomatic focal syndromes.

The most frequent side-effects reported at the three-month review were constipation, vomiting, lack of energy, and hunger.

Discussing limitations, the authors noted that the study would have been improved by the inclusion of prospective seizure data from the children who either did not start treatment or who withdrew before three months.

The study would also have been improved by double-blind randomization, although that would have been impossible given the need for parents, care-givers, and children to cooperate.

The results from this controlled trial of the ketogenic diet support its use in children with treatment-intractable epilepsy. However, the diet is not without possible side-effects, which should be considered alongside the risk-benefit of other treatments when planning the management of these children, the researchers advised.

In an accompanying comment, Max Wiznitzer, M.D., of Rainbow and Children's Hospital in Cleveland, wrote that the study provides further support for the usefulness of this type of controlled study.

Clinically, he said, more information is needed about the long-term effects of the diet, including changes in blood lipid concentrations and persistent ketosis.

Also needed are better identification of epilepsies that benefit from starting early on the diet as well as comparisons among choices of the ketogenic diet.

Functionally, a better understanding of the mechanisms of action and the development of a medication that would duplicate the diet's effects are also needed, Dr. Wiznitzer wrote.