Drugs Offer No Benefit in Curbing Aggression, Study Finds By BENEDICT
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
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