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zoom RSS 知的障害者のaggressionに向精神薬は効果なし

<<   作成日時 : 2008/01/04 22:12   >>

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 Lancet 原文はintellectual disability知的障害となっているが、 BBC ではLearning disability学習障害としている。
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 知的障害者の攻撃的な行動を抑制するために最も広く使用されている薬は、効果がない可能性があるとの報告があり、米国そして世界中の精神衛生クリニックや老人ホームで標準的な治療として行われていることに異論を投げかけている。
 最近では、いわゆる向精神薬−威嚇的な行動を落ち着かせる多目的鎮静剤で統合失調症の治療薬として開発された−を、ADHDの子ども、うつの大学生、アルツハイマー病の老人、知的障害者に対して多くの医師が処方している。
 86人の知的障害の成人に対して英国で治療研究が実施されたが、リスパダールやハルドールは有意な効果がなかった。こうした薬剤は年間売上高100億ドル以上あるが、半数は−攻撃性や興奮性−に対して適応外使用している。以前の研究で、突発的な攻撃性行動に対する効果は、ほとんど効果が無い場合と強い鎮静効果を示す場合とが混在していた。しかし、急速な体重増加と振戦を含め重大な副作用があり、使用するに値するような確実な証拠はほとんどなかった。十二分に考えてから処方し、慎重に副作用を監視すべきであり、そうでなければ処方はしない方がよい。行動療法により多くの患者は改善することがわかっているのだから。
 しかし、向精神薬が行動障害の治療に使う用途を持たないと解釈するべきではないが、攻撃性aggression に対して一律無前提に使用すべき薬剤ではない。(NYTimes)
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 学習障害の人たちに対して、攻撃的な行動を抑えるために一律に向精神薬を投与することは止めるようにとの警告が出された。86人の患者に関しての研究で、全く効果がなかったとのロンドンからの報告。
 英国では学習障害の人たち20,000人に向精神薬が投与されているが、体重増加や無気力、循環器系の緊張といった副作用のリスクがある。
 第1世代のハロペリドール服用群、、第2世代のリスペリドン服用群、プラセーボの3つのグループに分けて、4,12,26週で、攻撃性、逸脱行動、生活の質、副作用、介護人への気持ち、について評価した。攻撃性が4週後に明らかに軽快したが、プラセーボ群が最も大きく改善した。他の尺度でも改善はみられたが、3グループすべてに同じであった。
 学習障害の患者については、今まで効果についての証拠がなく、他の精神疾患と同様に考えてきていた。挑戦的な行動は、極端な苦痛、適切な意思疎通ができないためのフラストレーション、有意義な活動の不足などにより引き起こされるので、向精神薬なしで対応可能である。向精神薬は最後の手段と考えるべきだ。(BBC)
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Drugs Offer No Benefit in Curbing Aggression, Study Finds
http://www.nytimes.com/2008/01/04/health/04aggression.html?_r=1&oref=slogin
By BENEDICT CAREY
Published: January 4, 2008

The drugs most widely used to manage aggressive outbursts in intellectually disabled people are no more effective than placebos for most patients and may be less so, researchers report.

The finding, being published Friday, sharply challenges standard medical practice in mental health clinics and nursing homes in the United States and around the world.

In recent years, many doctors have begun to use the so-called antipsychotic drugs, which were developed to treat schizophrenia, as all-purpose tranquilizers to settle threatening behavior ― in children with attention-deficit problems, college students with depression, older people with Alzheimer’s disease and intellectually handicapped people.

The new study tracked 86 adults with low I.Q.’s in community housing in England, Wales and Australia over more than a month of treatment. It found a 79 percent reduction in aggressive behavior among those taking dummy pills, compared with a reduction of 65 percent or less in those taking antipsychotic drugs.

The researchers focused on two drugs, Risperdal by Janssen, and an older drug, Haldol, but said the findings almost certainly applied to all similar medications. Such drugs account for more than $10 billion in annual sales, and research suggests that at least half of all prescriptions are for unapproved “off label” uses ― often to treat aggression or irritation.

The authors said the results were quite likely to intensify calls for a government review of British treatment standards for such patients, and perhaps to prompt more careful study of treatment for aggressive behavior in patients with a wide variety of diagnoses.

Other experts said the findings were also almost certain to inflame a continuing debate over the widening use of antipsychotic drugs. Patient advocates and some psychiatrists say the medications are overused.

Previous studies of the drugs’ effect on aggressive outbursts have been mixed, with some showing little benefit and others a strong calming influence. But the drugs have serious side effects, including rapid weight gain and tremors, and doctors have had little rigorous evidence to guide practice.

“This is a very significant finding by some very prominent psychiatrists” ― one that directly challenges the status quo, said Johnny L. Matson, a professor of psychology at Louisiana State University in Baton Rouge, co-author of an editorial with the study in the journal Lancet.

While it is unclear how much the study by itself will alter prescribing habits, “the message to doctors should be, think twice about prescribing, go with lower doses and monitor side effects very carefully,” Dr. Matson continued, adding:

“Or just don’t do it. We know that behavioral treatments can work very well with many patients.”

Other experts disagreed, saying the new study was not in line with previous research or their own experience. Janssen, a Johnson & Johnson subsidiary, said that Risperdal only promotes approved uses, which in this country include the treatment of irritability associated with autism in children.

In the study, Dr. Peter J. Tyrer, a professor of psychiatry at Imperial College London, led a research team who assigned 86 people from ages 18 to 65 to one of three groups: one that received Risperdal; one that received another antipsychotic, the generic form of Haldol; and one that was given a placebo pill. Caregivers tracked the participants’ behavior. Many people with very low I.Q.’s are quick to anger and lash out at others, bang their heads or fists into the wall in frustration, or singe the air with obscenities when annoyed.

After a month, people in all three groups had settled down, losing their temper less often and causing less damage when they did. Yet unexpectedly, those in the placebo group improved the most, significantly more so than those on medication.

In an interview, Dr. Tyrer said there was no reason to believe that any other antipsychotic drug used for aggression, like Zyprexa from Eli Lilly or Seroquel from AstraZeneca, would be more effective. Being in the study, with all the extra attention it brought, was itself what apparently made the difference, he said.

“These people tend to get so little company normally,” Dr. Tyrer said. “They’re neglected, they tend to be pushed into the background, and this extra attention has a much bigger effect on them that it would on a person of more normal intelligence level.”

The study authors, who included researchers from the University of Wales and the University of Birmingham in Britain and the University of Queensland in Brisbane, Australia, wrote that their results “should not be interpreted as an indication that antipsychotic drugs have no place in the treatment of some aspects of behavior disturbance.”

But the routine prescription of the drugs for aggression, they concluded, “should no longer be regarded as a satisfactory form of care.”

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Last Updated: Friday, 4 January 2008, 03:02 GMT
Learning disability drug warning

画像Mental healthcare patient
About 200,000 people with learning disabilities are treated with the drugs

Doctors are being warned not to routinely give people with learning disabilities anti-psychotic drugs to curb aggressive behaviour.

An Imperial College London study of 86 patients found the drugs were no more effective than being given none at all.
Researchers said it was more important to address the underlying causes.
In the UK, 200,000 people with learning disabilities are given anti-psychotic drugs - even though there is a risk of side-effects, the Lancet reported.
These can include risk of weight gain, impotence and strain to the cardiovascular system.

The problem with patients with learning disabilities is that we haven't had the evidence on whether anti-psychotic drugs worked
Professor Peter Tyrer, lead researcher

The team studied patients in 10 inpatient and community settings in England, Wales and Australia.
One group was given haloperidol, a first-generation antipsychotic drug, a second group got risperidone, a second-generation version, while a third received a dummy pill.
Clinical assessments of aggression, aberrant behaviour, quality of life, adverse drug effects and feelings towards their carer were recorded at four, 12 and 26 weeks.
The researchers found that aggression had decreased substantially with all three treatments by week four, but patients receiving the dummy pill had the greatest change.
Improvements were seen with the other measures, but these were similar for all three groups.
Evidence
Lead researcher Professor Peter Tyrer said: "The problem with patients with learning disabilities is that we haven't had the evidence on whether anti-psychotic drugs work.
"Therefore, these patients were assumed to be the same as other mental health patients.
"But what our research shows is that drugs are no better than not giving any drugs. It seems what is important is the care a person receives.
"When people with learning disabilities are aggressive it is important they are given support and people communicate with them."
But he added that there would still be exceptional circumstances where such drugs were necessary.
Dr Jim Kennedy, prescribing spokesman at the Royal College of GPs, agreed.
But he added: "All too often the drugs are used as a chemical restraint. This can be poor practice."
And David Congdon, from the Mencap charity, said: "Anti-psychotic drugs should be seen as a last resort.
"Challenging behaviour is caused by many different factors - an undiagnosed health condition causing extreme pain, frustration at not being able to communicate properly, or boredom due to a lack of meaningful activity.
"All of this can be dealt with without the use of anti-psychotic drugs."

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The Lancet 2008; 371:57-63
DOI:10.1016/S0140-6736(08)60072-0
Articles

Risperidone, haloperidol, and placebo in the treatment of aggressive challenging behaviour in patients with intellectual disability: a randomised controlled trial

Prof Peter Tyrer FMedSci , etc

Summary
Background

Aggressive challenging behaviour is frequently reported in adults with intellectual disability and it is often treated with antipsychotic drugs. However, no adequate evidence base for this practice exists. We compared flexible doses of haloperidol (a typical, first-generation antipsychotic drug), risperidone (an atypical, second-generation antipsychotic), and placebo, in the treatment of this behaviour.
Methods

86 non-psychotic patients presenting with aggressive challenging behaviour from ten centres in England and Wales, and one in Queensland, Australia, were randomly assigned to haloperidol (n=28), risperidone (n=29), or placebo (n=29). Clinical assessments of aggression, aberrant behaviour, quality of life, adverse drug effects, and carer uplift (positive feelings about the care of the disabled person) and burden, together with total costs, were recorded at 4, 12, and 26 weeks. The primary outcome was change in aggression after 4 weeks' treatment, which was recorded with the modified overt aggression scale (MOAS). Analysis was by intention to treat. This study is registered as ISRCTN 11736448.
Findings

80 patients had adherence of 80% or more to prescribed drug. Aggression decreased substantially with all three treatments by 4 weeks, with the placebo group showing the greatest change (median decrease in MOAS score after 4 weeks=9 [95% CI 5–14] for placebo, 79% from baseline; 7 [4–14] for risperidone, 58% from baseline; 6·5 [5–14] for haloperidol, 65% from baseline; p=0·06). Furthermore, although no important differences between the treatments were recorded, including adverse effects, patients given placebo showed no evidence at any time points of worse response than did patients assigned to either of the antipsychotic drugs.
Interpretation

Antipsychotic drugs should no longer be regarded as an acceptable routine treatment for aggressive challenging behaviour in people with intellectual disability.

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