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Drug
Shows No Benefit for Down Syndrome
NEW
YORK (Reuters Health) - The drug piracetam does not appear to
boost mental abilities in children with Down syndrome and is associated
with negative side effects, according to a new report.
Interest in
the drug skyrocketed in the mid-1990s after several television
news programs reported that piracetam improved the mental functioning
of children with Down syndrome. Thousands of children are believed
to currently be taking the drug, according to a report in the
April issue of the journal Archives of Pediatrics and Adolescent
Medicine.
``Our study
was conducted because there were reports in the popular press
and on the Internet news groups that the drug piracetam had immediate
and beneficial effects on cognition in children with Down syndrome.
When we talk about cognition, we are referring to processes related
to attention, memory and learning,'' said Dr. Nancy J. Lobaugh
of the University of Toronto in Canada, in an interview with Reuters
Health.
``The major
findings of this study were that there were no measurable beneficial
effects of this drug on these aspects of cognition in a group
of children with Down syndrome. Ours is the first study examining
this question, so the results are very important,'' added Lobaugh.
In the study,
18 children between the ages of 6 and 13 with Down syndrome were
randomly assigned to two different groups. The children were given
either a daily dose of piracetam or an inactive placebo pill for
4 months. After the study period, the children switched--those
who took the placebo received piracetam and those on piracetam
took the placebo.
Over the entire
study period, the children were given a battery of tests that
measure various mental abilities such as language skills, attention
span and memory. In addition, parents and teachers helped evaluate
the children's behavior, temperament, and social and academic
performance.
The researchers
found that piracetam did not ``substantially enhance mental abilities
or behavior.''
However, the
team found the drug was associated with various adverse side effects
in seven of the children, including aggressiveness, agitation,
irritability, sexual arousal, poor sleep and decreased appetite.
``The behavioral
side effects reported by the parents are...consistent with some
kind of stimulation effect. In some children, this effect was
quite strong, resulting in increased aggression and agitation,''
Lobaugh told Reuters Health.
``The results
of this study are strikingly different from the anecdotal testimonials
presented in the popular press,'' Lobaugh and colleagues write.
The fact that
piracetam acts as a behavior stimulant may be part of the reason
why caretakers of children with Down syndrome may confuse the
drug's effects with an increase in mental abilities, the authors
note.
Moreover,
the dose of piracetam used in the study was ''within the range
used in adults and in children with dyslexia,'' Lobaugh and her
team point out.
``Based on
the absence of any beneficial effect of this drug, and the potential
for undesirable side effects, we do not see any reason that parents
should give this drug to their children,'' Lobaugh said.
``We are not
surprised by the outcome of the study,'' said Jo Ann Simons, president
of the National Society for Down Syndrome Congress, a nonprofit
organization based in Atlanta, Georgia.
``Our group
has been calling all along for scientific studies that would evaluate
the efficacy of piracetam since we have always maintained that
there is no proof, aside from anecdotal stories, that the drug
works,'' Simons said.
``The potential
for negative side effects is something that we have been concerned
with,'' she added.
And Simons
stressed that other treatment options are available for Down syndrome
children.
One well-tested
method of improving the mental and physical development of some
children with Down syndrome is a well-rounded curriculum that
stimulates the child's physical skills, language skills and thinking
abilities, Simons noted.
SOURCE:
Archives of Pediatrics and Adolescent Medicine 2001;155:442-448.
Reference
Source 89
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