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Greetings:
Below is an article that appeared in a recent issue of ADHD
RESEARCH UPDATE. The article summarizes two recent reports
about Concerta, a new FDA approved medication for treating
ADHD that is supposed to provide effective management of
ADHD symptoms with just a single daily dose.
I hope you find this information to be of interest to you.
Please feel free to forward this article to others you know
who may be interested in it.
Sincerely,
David Rabiner, Ph.D.
Duke University
P.S. Are you a health care professional? I have started a second
list to better meet your needs. To switch to this new list, just
mailto:[EMAIL PROTECTED] and I will make the change.
+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
CONFERENCE ON ALTERNATIVE TREATMENTS FOR ADHD
For those of you interested in learning more about alternative
treatment approaches for ADHD, I wanted to let you know about
a upcoming conference that looks like it will provide lots of
excellent information. The conference is titled:
"HELPING KIDS WITH ADD: Alternative Approaches to Optimum
Health and Peak Performance"
This all day conference is being held on Saturday, October 14, 2000
at George Mason University in Fairfax, VA. The conference will
offer a full day of expert panel presentations, case studies, discussion
and information sharing will offer local parents and educators an
opportunity to explore optional therapies for children of all
ages diagnosed with Attention Deficit Disorder (ADD). Nutrition,
neurofeedback, and naturopathic approaches to diagnosis and treatment
of ADD and its associated conditions have been considered controversial;
however, interest in such therapies is growing throughout the country
among health care consumers.
You can learn more about this conference by visiting
http://www.alt-research.com.
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
* CONCERTA: A NEW MEDICATION FOR TREATING
ADHD
For parents who have a child taking medication to help
manage ADHD symptoms, a frequent source of difficulty
is the need for multiple doses each day. Among children who
take Ritalin (the generic is methylphenidate), a second dose
while at school and a third dose in the late afternoon
is often necessary to provide good control of symptoms
over the course of the day. Administration during the
school day can be associated with complications, and is
often a source of concern or embarrassment for the child.
As children move into adolescence, this can frequently lead
to a refusal on the part of the teen to continue on meds, even
though medication may still be necessary to help manage the
child's symptoms and help with behavior and academic
performance.
Although sustained release forms of Ritalin last longer and can help
somewhat with this problem, the additional duration of benefit
provided by a single dose varies substantially across children.
Adderall, a more recently approved stimulant medication for
treating ADHD, also has a therapeutic effect that lasts longer
than Ritalin, and many children on Adderall can get by with
a single dose during the school day. Even with Adderall,
however, a second dose in the afternoon is often required.
Recently, a new medication called Concerta was approved
by the FDA for the treatment of ADHD and is expected to be
widely available very shortly. Concerta is simply methylphenidate
in which a unique and patented system is used to maintain a
smooth and optimal level of medication in a child's system
throughout the entire day. In fact, the benefits of Concerta are
reported to persist throughout the school day and into the evening.
This would make the administration of medication to children with
ADHD much more convenient, and should help to eliminate many
of the problems associated with multiple daily doses.
Results of a study on the effectiveness of Concerta was presented at
the May meeting of the American Academy of Pediatrics. This study
was supervised by Dr. James Swanson from the University of California
at Irvine, a leading researcher in the field of ADHD. His work
has included studies of both medication and behavioral treatment so
I believe he has a broad perspective on the treatment of ADHD.
Participants in this study were 64 6-to-12 year old children with a
confirmed diagnosis of ADHD, all of whom were being treated
currently with methylphenidate. During the study each child
received 3 different treatments: methylphenidate on their regular
dose 3 times per day, Concerta once per day, and a placebo. Each
treatment was received for 7 consecutive days and neither parents,
teachers, nor children were aware of what treatment the child was
receiving each week. At the end of each week, standardized
behavior rating forms were completed by parents and teachers,
as were ratings of possible adverse side effects. (To be sure
that participants would not know when the child was on the
Concerta, one "real" dose and 2 placebo pills were given each
day. This way, 3 "doses" each day were required during every
week of the trial.)
Results indicated that both Concerta and the 3 daily doses of
methylphenidate resulted in significantly lower symptom ratings
compared to placebo from both parents and teachers. The two
medications, in contrast, did not differ from one another. This
means, of course, than a single daily dose of Concerta was as
effective as 3 doses of regular methylphenidate in managing the
symptoms of ADHD. Side effects were reported to be mild
and were quite similar to regular methylphenidate. Only 3 side
effects were reported to occur in over 2% of the children - abdominal
pain, headaches, and fever - and these all occurred in less than
5% of the participants.
Overall, parents reported preferring Concerta to the methylphenidate
used during the study and to the treatment their child had been receiving
prior to the study. Remember, this preference for Concerta was reported
even though during the study, all children received 3 doses per day.
(During the time they were receiving Concerta, it was just the first
dose each day that was real medication. The second two "doses"
were actually placebos.) The most likely reason for this, I think, is
that with Concerta, the smoother release of medication throughout
the day may have resulted in more consistent management of
symptoms than regular methylphenidate.
A SECOND STUDY OF CONCERTA
I also recently saw a press release describing a second study
involving Concerta. A larger number of participants - 407
children with a confirmed diagnosis of ADHD - were included and
these children were followed over the course of an entire school
year. Children in the study ranged in age from 6 to 13 and had
previously completed a short-term controlled study that included
regular methylphenidate, Concerta, and placebo conditions.
In this second study, children were assigned to one of three dosing
levels - 18, 36, or 54 mg. - based on the dose level administered
in the short-term study. Data on the results of this study are not yet
published in a peer reviewed journal, but were presented at a recent
meeting of the American Psychiatric Association.
During the course of the year, children were evaluated with varying
frequency using standardized ratings of behavior and attention.
Results indicated sustained improvement in behavior and attention
over the course of the year. In a global assessment of treatment
effectiveness obtained at the end of the study, over 60% of teachers
and 84% of parents rated treatment as good or excellent. Thus,
it appears from these results that the once per day treatment with
Concerta provide effective symptom management over the course
of the entire year. Side effects reported were similar to those
that have been reported before for regular methylphenidate.
Note: I was previously advised by a subscriber to note when studies
reporting effective medication treatment have been funded by
the pharmaceutical company who manufactures the drug. I
believe this is the case here. While some would argue that this
means the results are suspect, I do not personally feel this to be
correct.
Such medication studies are typically conducted by independent
academicians, and I have several colleagues who are routinely
involved in pharmaceutical trials. The clinic where they work is paid by
the drug company to conduct the study, but this does not influence -
in my opinion - the integrity with which the data is collected and reported.
It is also important to be aware that there is not really an alternative
to the drug company paying for such studies. These studies are
necessary to obtain FDA approval and no one else is going to fund
studies of a medication that has not yet been approved by the FDA.
Should you make the switch to Concerta for your child?
The answer to this question is not necessarily straight forward.
If your child is currently taking another medication that is
working well, and having to take multiple doses each day is
not a problem, there may be no good reason to switch. Basically,
why tinker around if everything is going fine?
If you and your child's physician do elect to try Concerta, you
should be aware that because Concerta is methylphenidate that is
being delivered in a way that maintains a steady dose over the entire
day, children doing well on regular methylphenidate should do well
on Concerta. If your child has been on another type of medication
such as Adderall or Dexedrine, however, one could not necessarily
assume that Concerta would be equally effective in managing
ADHD symptoms. It is possible, for example, that your own child's
symptoms would not be managed as well if the switch were made.
If your child's current medication seems to be working well,
but he/she requires multiple doses each day which is resulting
in compliance problems, than discussing a switch to Concerta
with your child's physician should be considered. As noted above,
the need for only once-a-day dosing may be especially helpful
with teens who often balk at needing to take medication during
the school day.
If your child is not currently taking medication to manage ADHD
symptoms, but this is something you are considering, it may
be worth asking your doctor about starting out with Concerta.
So far, it appears to be as effective as regular methylphenidate in
managing ADHD symptoms, and to produce no additional side
effects. The caution to keep in mind, however, is that it has not
yet been studied as extensively as regular methylphenidate or even
Adderall, and there can be no guarantee that these initially encouraging
results will hold up to further study. There is no compelling
reason, however, to think that they will not. My own personal
expectation is that they will.
One other issue that I think is important in the decision to use
Concerta is whether a child really needs medication throughout the
entire day, which is what Concerta provides. For example, some
children require medication primarily to assist with academic functioning
during the school day, and really do not need it except for these times.
For these children, a single morning dose of methylphenidate or Adderall
may be all they require. In such instances, it seems like a
legitimate question to ask is whether Concerta would really be preferable.
In summary, although Concerta appears like it will be an extremely helpful
and valuable new medication for many children with ADHD, it is not
necessarily going to be the best choice for everyone. As always,
carefully evaluating what is required by each individual child is still
required to make the best decisions about medication.
=================================================================
Hello again:
I hope you enjoyed the article above. If it has been forwarded to
you by a friend and you are interested in receiving regular reports
of new research on ADHD, just visit http://www.helpforadd.com/nresearch.htm
to sign up.
Take care.
David Rabiner, Ph.D.
Duke University
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