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. "