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 薬剤抵抗性の難治てんかんに対する高脂肪食療法(ケトン食療法)が非常に効果的であるとコントロールスタディの研究結果が英国から出された。食事療法の最初のランダム化された治験であり、1920年以来ずっと使用されてきたが、代替療法として日の目を見なかった治療に光をあてた。正確なメカニズムは不明瞭だが、エネルギー源として糖ではなく脂肪を使い、ケトン血症の状態に持ち込むことで作用する。朝食はベーコン、チーズと卵、一杯の薄めたヘビークリームといったようになる。脂肪を取るためにオイルを飲むこともある。炭水化物を厳しく制限する。
 ここ10年で食事療法に対する認知が大きく変わった。1993年にハリウッドのプロデューサーの自ら息子の経験から、映画"First Do No Harm,”邦題「メリル・ストリープ誤診」を作成し、チャーリー財団を設立した。
 食事療法は医学的に管理される必要があるけれども、それが広範な病院資源とスタッフの常時監視を必要としていると考えるのは誤りである。それぞれ地域で実施可能である。(NYT)
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 脂肪を多く、炭水化物を少なく蛋白をコントロール。1920年代以来の治療法だが、最初の比較研究。食事療法は疑似飢餓状態を作りだし、体の代謝を変更し、子どものけいれんが1/3に減少した。どのようの作用するかはよくわかっていないが、脂肪分解でできるケトンが発作を抑制するとされる。
 少なくとも2種類以上の薬物で制御できない2-16才の子ども145人が研究に参加、半分は直ちに食事療法開始し、半分は3ヶ月待った。食事療法により発作の数は2/3に減少したが、始めていないグループは変化無かった。食事療法グループのうち5人は90%以上発作が減少した。副作用として、便秘、嘔吐、空腹などがあった。(BBC)
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doi:10.1016/S1474-4422(08)70092-9
The ketogenic dietnext term for the treatment of childhood epilepsy: a randomised controlled trial
The Lancet Neurology, In Press, Corrected Proof, Available online 2 May 2008,
Elizabeth G Neal PhDa, b, Corresponding Author Contact Information, E-mail The Corresponding Author, Hannah Chaffe BSca, b, Ruby H Schwartz FRCPCHc, Margaret S Lawson PhDa, Nicole Edwards BSca, Geogianna Fitzsimmons BSca, Andrea Whitney MRCPa and J Helen Cross FRCPCHa, b

aInstitute of Child Health and Great Ormond Street Hospital for Children NHS Trust, University College London, London, UK

bNational Centre for Young People with Epilepsy, Lingfield, UK

cNW London Hospitals NHS Trust, London, UK

Available online 2 May 2008.

References and further reading may be available for this article. To view references and further reading you must purchase this article.

Summary
Background

The previous termketogenic dietnext term has been widely and successfully used to treat children with drug-resistant epilepsy since the 1920s. The aim of this study was to test the efficacy of the previous termketogenic dietnext term in a randomised controlled trial.
Methods

145 children aged between 2 and 16 years who had at least daily seizures (or more than seven seizures per week), had failed to respond to at least two antiepileptic drugs, and had not been treated previously with the previous termketogenic dietnext term participated in a randomised controlled trial of its efficacy to control seizures. Enrolment for the trial ran between December, 2001, and July, 2006. Children were seen at one of two hospital centres or a residential centre for young people with epilepsy. Children were randomly assigned to receive a previous termketogenic diet,next term either immediately or after a 3-month delay, with no other changes to treatment (control group). Neither the family nor investigators were blinded to the group assignment. Early withdrawals were recorded, and seizure frequency on the previous termdietnext term was assessed after 3 months and compared with that of the controls. The primary endpoint was a reduction in seizures; analysis was intention to treat. Tolerability of the previous termdietnext term was assessed by questionnaire at 3 months. The trial is registered with ClinicalTrials.gov, number NCT00564915.
Findings

73 children were assigned to the previous termketogenic dietnext term and 72 children to the control group. Data from 103 children were available for analysis: 54 on the previous termketogenic dietnext term and 49 controls. Of those who did not complete the trial, 16 children did not receive their intervention, 16 did not provide adequate data, and ten withdrew from the treatment before the 3-month review, six because of intolerance. After 3 months, the mean percentage of baseline seizures was significantly lower in the previous termdietnext term group than in the controls (62·0% vs 136·9%, 75% decrease, 95% CI 42.4–107.4%; p<0·0001). 28 children (38%) in the previous termdietnext term group had greater than 50% seizure reduction compared with four (6%) controls (p<0·0001), and five children (7%) in the previous termdietnext term group had greater than 90% seizure reduction compared with no controls (p=0·0582). There was no significant difference in the efficacy of the treatment between symptomatic generalised or symptomatic focal syndromes. The most frequent side-effects reported at 3-month review were constipation, vomiting, lack of energy, and hunger.
Interpretation

The results from this trial of the previous termketogenic dietnext term support its use in children with treatment-intractable epilepsy.
Funding

HSA Charitable Trust; Smiths Charity; Scientific Hospital Supplies; Milk Development Council.

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Evidence a High-Fat Diet Works to Treat Epilepsy
http://www.nytimes.com/2008/05/06/health/research/06epil.html?_r=1&adxnnl=1&oref=slogin&adxnnlx=1210047290-mFs2ahFRke1MbtEYBlgsNA
By ALIYAH BARUCHIN
Published: May 6, 2008

画像Meryl Streep and Seth Adkins in "First Do No Harm," a 1997 film about the diet and epilepsy.

A formerly controversial high-fat diet has proved highly effective in reducing seizures in children whose epilepsy does not respond to medication, British researchers are reporting.

As the first randomized trial of the diet, the new study lends legitimacy to a treatment that has been used since the 1920s but has until recently been dismissed by many doctors as a marginal alternative therapy.

“This is the first time that we’ve really got Class 1 evidence that this diet works for treatment of epilepsy,” said Dr. J. Helen Cross, professor of pediatric neurology at University College London and Great Ormond Street Hospital. She is a principal investigator on the study, which will appear in the June issue of The Lancet Neurology.

Though its exact mechanism is uncertain, the diet appears to work by throwing the body into ketosis, forcing it to burn fat rather than sugar for energy. Breakfast on the diet might consist of bacon, eggs with cheese, and a cup of heavy cream diluted with water; some children drink oil to obtain the fats that they need. Every gram of food is weighed, and carbohydrates are almost entirely restricted. Breaking the diet with so much as a few cookies can cause seizures to flare up.

For the British trial, the researchers enrolled 145 children ages 2 to 16 who had never tried the diet, who were having at least seven seizures a week and who had failed to respond to at least two anticonvulsant drugs.

One group began the ketogenic diet immediately. The control group waited three months before starting it. In the first group, 38 percent of the children had seizure rates reduced by half, compared with 6 percent in the control group. Five children in the diet group had reductions exceeding 90 percent.

Perceptions of the diet have changed sharply in the last decade. In 1993, a Hollywood producer, Jim Abrahams, took his 1-year-old son, Charlie, to Dr. John M. Freeman at the Pediatric Epilepsy Center at Johns Hopkins, which was one of the few centers championing the diet. Within three days of starting the diet, Charlie’s incapacitating seizures, which had resisted multiple medications and surgery, stopped entirely.

With his wife, Nancy, Mr. Abrahams founded the Charlie Foundation to Help Cure Pediatric Epilepsy to promote education about the diet. He produced an instructional video for parents and a made-for-television movie, “First Do No Harm,” starring Meryl Streep as a mother who seeks out the diet for her child.

As a result of the Johns Hopkins work, research on the diet blossomed and it became a standard treatment at hospitals and epilepsy centers in the United States and abroad.

Dr. Shlomo Shinnar, director of the Comprehensive Epilepsy Management Center at the Montefiore Medical Center in the Bronx, called the new study “an important trial that lays to rest the issue of ‘Does it really work or not?’ ”

Although the diet has to be medically supervised, Dr. Shinnar said, it is a mistake to believe that it requires extensive hospital resources and a staff’s constant attention. “Here they don’t have this,” he said of the British trial. “This study makes it clear that this actually can be made to work in a community setting.”

---------------------------------------------
Page last updated at 23:17 GMT, Friday, 2 May 2008 00:17 UK
Diet treatment call for epilepsy
http://news.bbc.co.uk/2/hi/health/7378178.stm

Epilepsy brain
Seizures are caused by bursts of electrical activity in the brain

A special high-fat diet helps to control fits in children with epilepsy, a UK trial suggests.

The number of seizures fell by a third in children on the "ketogenic" diet, where previously they had suffered fits every day despite medication.
The diet alters the body's metabolism by mimicking the effects of starvation, the researchers reported in the Lancet Neurology.
The researchers called for the diet to be more widely available on the NHS.
It is the first trial comparing the diet with routine care, even though it has been around since the 1920s.
Children are given a tailored diet very high in fat, low in carbohydrate and with controlled amounts of protein.

The parents say the first two weeks are quite difficult but then it becomes much easier because you can make foods in bulk and it especially helps if you can see the benefits from it
Professor Helen Cross

'My daughter seems calmer'
It is not exactly clear how it works but it seems that ketones, produced from the breakdown of fat, help to alleviate seizures.
A total of 145 children aged between two and 16 who had failed to respond to treatment with at least two anti-epileptic drugs took part in the study.
Half started the diet immediately and half waited for three months.
The number of seizures in the children on the diet fell to two-thirds of what they had been, but remained unchanged in those who had not yet started the diet, the researchers reported.
Five children in the diet group saw a seizure reduction of more than 90%.
However, there were some side-effects including constipation, vomiting, lack of energy and hunger.
Availability
Professor Helen Cross, study leader and consultant in neurology at Great Ormond Street Hospital in London, said the diet had been around for a long time but had fallen out of favour because it was thought to be too difficult to stick to.
"The parents say the first two weeks are quite difficult, but then it becomes much easier because you can make foods in bulk and it especially helps if you can see the benefits from it," she said.
"We have to be sensible about it, in this study we had children who had complex epilepsy.
"If your epilepsy is easily controlled on one medication then I wouldn't advocate the diet, but if at least two drugs have failed then it should be considered."
She said national guidelines recommend the diet as a treatment option, but a shortage of dieticians meant it was often unavailable.
A spokesperson for Epilepsy Action said: "The results of this trial add valuable information to what is already known about the diet, presenting evidence that it works for some children with drug-resistant epilepsy.
"In addition to this, however, we also recognise that the ketogenic diet is not without its side-effects, and that the risks and benefits should be considered before prescribing, as with drug treatment."
She said the results would hopefully encourage wider inclusion of the diet in the management of children with drug-resistant epilepsy.

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Special Diet Can Ease Epileptic Seizures in Kids
Strong support for ketogenic regimen from major randomized trial
-- Robert Preidt
Strong support for ketogenic regimen from major randomized trial.
http://health.msn.com/health-topics/neurological-cognitive-health/articlepage.aspx?cp-documentid=100202510
FRIDAY, May 2 (HealthDay News) -- The "ketogenic" diet, which features high levels of fat, low levels of carbohydrates and controlled protein intake, helps control and prevent seizures in children with drug-resistant epilepsy, a new study finds.

The trial is the first randomized controlled study to confirm that the ketogenic diet -- widely used since the 1920s -- is effective against epilepsy, the British researchers said.

Experts believe that the regimen's high fat and restricted carbohydrate content mimics the biochemical response to starvation, when compounds called ketone bodies (rather than sugar) provide the main source of energy for the brain.

Ketone bodies are byproducts produced when fatty acids are broken down for energy in the liver and kidneys. They are used as energy sources in the heart and brain. In the brain, ketone bodies are a crucial source of energy when a person fasts.

This University College London study included 145 children, aged 2 to 16, who suffered seizures at least once a day or more than seven seizures per week. These patients hadn't responded to treatment with at least two epileptic drugs, and hadn't previously been placed on the ketogenic diet.

Baseline information about the children's seizures was first recorded. Seventy-three of the children started the ketogenic diet immediately, while the other 72 started it after a three-month delay. The delay group acted as a control group during the study. Complete data was obtained from 54 children in the diet group and 49 children in the control group.

The overall number of seizures in the diet group declined by more than 38 percent, while seizures in the control group increased by 36.9 percent, the researchers report. The study found that 28 of the 54 children who completed three months in the diet group had a greater than 50 percent reduction in seizures, compared to four of 49 children in the control group. Five children in the diet group had more than 90 percent fewer seizures. None of the children in the control group experienced that kind of improvement.

The study appears in the current online edition of The Lancet Neurology and will appear in the June print issue.

"We have shown that the diet has efficacy and should be included in the management of children who have drug-resistant 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 such children," the study authors wrote.

More information is needed about the long-term effects of the ketogenic diet, such as changes in blood fat concentrations and ketosis, Dr. Max Wiznitzer, of Rainbow Babies and Children's Hospital in Cleveland, wrote in an accompanying comment article.

"Better identification of epilepsies that benefit from starting early on the ketogenic diet and comparisons between the choices of ketogenic diet are needed," he wrote.

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