NYTimes Article: Drugs Offer No Benefit in Curbing Aggression, Study Finds

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Drugs Offer No Benefit in Curbing Aggression, Study Finds

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 ny 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 & 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. 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. "