The NIMH's ($35 million taxpayer-funded) STAR*D
4-step depression treatment (mostly
antidepressants) study is "a piece of work." One
can write a book on the lack of science and
duplicity in this study -- but I'll try to stick
to key crap:
1. There was no placebo control in any of the 4
steps of treatment. (In Step One, all
participants received Celexa; those who failed
to gain remission had the Celexa augmented or
replaced with other antidepressants in Step Two;
and for those who failed that treatment, they
were given another Step Three treatment; those
who failed that were given Step Four Treatment.
2. If there had been a placebo-control, we know
from other research that the placebo-control
would have most certainly equaled or bested each
treatment step results, which study authors
claim ranged from 37 percent for Step One
descending to 13 percent for Step Four. However,
when one looks at the primary outcome measure in
STAR*D, the Hamilton Rating Scale for Depression
(the one that is used in most of these type of
studies), they never had higher than 30 percent
for each step.
3. In March of 2006, NIMH and STAR*D
researchers triumphantly announced the
cumulative success rate of 50 percent for Steps
One and Two, neglecting to tell the world that
in the time that it took for those two steps
(slightly more than 6 months), other researchers
have found a spontaneous remission rate
(remission with no treatment at all) of 50
percent.
4.STAR*D researchers continued to Steps 3 and 4,
with pathetic remission rates of lower than 14
percent for each step.
5. But in November 2006 they decided to
advertise a new cumulative remission rate of 67
percent for all four steps -- neglecting a huge
RELAPSE rate (for patients who in previous steps
considered to have been successfully treated).
6. While the Wall Street Journal reported
a relapse rates of 71.1 percent
(by Avery Johnson, "A Study Looks at Resistance
to Depression Treatment, November 1, 2006,
The Wall Street Journal, p. D9),
it would be safer to estimate relapse rate at
somewhere between 60 to 70 percent. One can say
for certain that the relapse rate is HUGE, but
one cannot really say exactly how huge because
the tables are so poorly labeled and unclear in
the published study (A.
John Rush, Madhukar H. Trivedi, et al., "Acute
and Longer-Term Outcomes in Depressed
Outpatients Requiring One or Several Treatment
Steps: A STAR*D Report," American Journal of
Psychiatry 163:11 (November 2006), pp.
1905-1917)
7. What then was the true overall remission
rate? A "cumulative sustained recovery rate" of
43 percent was estimated by Craig Nelson in an
editorial jointly appearing with the study in
the same issue of the American Journal of
Psychiatry. Nelson notes while that the
STAR*D authors state that after four treatments
the cumulative rate is 67%, this does not
account for relapse and that he "found a
cumulative sustained recovery rate of 43%,
(Craig Nelson, "The STAR*D Study: A Four-Course
Meal That Leaves Us Wanting More," American
Journal of Psychiatry 163:11 (November 2006),
pp. 1864-1866.)
Again, because of unclear tables in the
published study, there is some ambiguity here,
and the cumulative remission rate is probably
closer to 40 percent.
8. The true remission rate is even lower than 40
percent if one takes into account the fairly
large number of subjects who dropped out of the
study -- who most likely were not getting
anything out of it -- as well as other
variables.
9. As bad as all this is, a few years ago it was
even sillier. The psychiatry establishment would
always quote a 2000 New England Journal of
Medicine article that said, "More than 80
percent of depressed patients have a response to
at least one medication, although individual
antidepressants are effective in only 50 to 60
percent of patients." For those statistics, that
particular article referenced a 1998 Archives
of General Psychiatry article where there is
NO mention at all of this 80 percent statistic.
10. There is an old saying, "There are lies,
damn lies, and statistics." But when it comes to
the psychiatry establishment, "There are lies,
damn lies, and arrogant liars who don't even
bother to cleverly manipulate statistics."
Bruce
Bruce E. Levine, Ph.D.
Clinical Psychologist
5725 Dragon Way, Suite 303
Cincinnati, Ohio 45227
513-271-1777
brucelevine.netI also suspect that the
STARD participants were not "tested" for
compliance,
in other words, blood levels of the drug were
not taken. Dr. Watson
New York Times, October 2, 2007
Talk
Therapy Pivotal for Depressed Youth ,
By
BENEDICT CAREY
A talking cure for
depression called cognitive behavior therapy
appears to cancel the risk of
suicidal thinking or behavior associated
with taking antidepressant medication, according
to the most comprehensive and long-running study
to date of depression treatment among
adolescents.
The study, which followed for a year more than
600 adolescents being treated for chronic
depression, found that four in five recovered
entirely, or nearly so, when treated over nine
months with medication, talk therapy or a
combination of the two.
Patients taking medication showed significant
signs of improvement up to six weeks earlier
than those who received talk therapy alone, but
were about twice as likely to report feeling
suddenly suicidal. The combination of the two
therapies, the authors found, produced the most
rapid recovery and protected against sudden
suicidal urges.
For several years experts have been debating the
risks to children and adolescents who take
antidepressants like Prozac and
Paxil. In 2004, health regulators required
that all labels for antidepressants carry
prominent warnings that the drugs were
associated with increased risks of suicidal
thinking and behavior in young patients, a link
that many
psychiatrists say has been blown out of
proportion, scaring off patients who could
benefit from drug treatment.
In this study, antidepressants lowered the risk
of suicidal thoughts and actions over all, but
significantly less so than talk therapy.
“What this study shows, convincingly and for the
first time, is that there are very good options
for a child who is thought to be at risk for
suicidal thinking,” said Kevin Stark, a
psychologist at the
University of Texas, who was not involved
with the research. “Psychosocial therapies do
work on their own, with time. But they also help
prevent relapse, and this shows that they can
help make drug treatment safer.”
In the study, which began in 1999, researchers
recruited 654 youths ages 12 to 17 who had been
moderately to severely depressed for up to a
year or longer. The adolescents were randomly
assigned to be treated with Prozac, the
antidepressant made by Eli Lilly; cognitive
behavioral therapy for a weekly hourlong
session; placebo pills; or a combination of
Prozac and talk therapy.
After 12 weeks, about three in four of the
patients receiving both talk therapy and
medication were rated as “much better” or “very
much better,” and two-thirds taking just the
drug fared just as well. Talk therapy by itself
was no better than the placebo.
After four months, about two-thirds of those
receiving any treatment were rated as much or
very much improved — significantly better than a
typical response to placebo pills.
By nine months, 8 in 10 adolescents had shaken
off their depression, entirely or almost
entirely, no matter the treatment.
Talk therapy was a safer alternative. Almost 15
percent of the patients taking just Prozac
reported what were described as “suicidal
events,” mainly talk and thoughts of suicide so
alarming that doctors called in the patients
and, often, altered dosages.
The rate of such events for those receiving just
cognitive behavior therapy was 6 percent. The
results for combination therapy were about the
same.
“The message is that medication accelerates
recovery, but cognitive therapy protects against
these bad reactions, and the combination is the
best option,” said Dr. John March, chief of
child and adolescent
psychiatry at the Duke University Medical
Center and the principal investigator for the
study.
The talk therapy promoted changes in behavior
like getting patients out of bed and doing
something that they enjoy, like playing
basketball or going to a party. It also provided
cognitive therapy, in which patients are taught
to diffuse poisonous assumptions like “I’m a
loser” or “I’ll never get a girlfriend.”
Experts say it is not easy to find specialists
in this therapy outside large cities. The
techniques have been widely published in manuals
and books, and Dr. March said a good therapist
could usually work such techniques into a
treatment plan.
“The trick,” he said, “is to be an intelligent
consumer and find a skilled therapist who’s
willing to work with you on these methods.”
Benedict Carey writes,
"The rate of such [suicidal] events for those
receiving just cognitive behavior therapy was 6
percent. The results for combination therapy
were about the same."
Not really
"about the same." The actual percentage of
patients experiencing suicidal events were:
14.7% of those receiving Prozac alone.
8.4% of those receiving Prozac and talk therapy.
6.3% of those receiving talk therapy alone.
Treatment WITHOUT medication is safer, even
according to a biased study like this one!
looked at another way:
15% of the
patients taking Prozac alone were suicidal
during treatment (not BEFORE treatment)
6% of those
receiving talk therapy alone.
for those
receiving Prozac + talk therapy, the rate of
suicidality fell from 15% to 8%.
conclusion:
1) Prozac
doubled the risk of suicide in this study
2) talk
therapy may partly (but not completely) offset
the suicide-enhancing effects of Prozac.
Read the abstract here:
http://archpsyc.ama-assn.org/cgi/content/abstract/64/10/1132?lookupType=volpage&vol=64&fp=1132&view=short
The Treatment for Adolescents With Depression
Study (TADS)
Long-term Effectiveness and Safety Outcomes
Arch Gen Psychiatry. 2007;64:1132-1143.
On the
latest Medscape (Feb. 2009), this highlight came
out of some new TADS data...
"The most recent results
from the Treatment for Adolescents with
Depression Study (TADS) show that the overall
remission rate at 36 weeks was about 60%. The
rates were similar in each of the 3 treatment
groups: antidepressant fluoxetine alone (55%),
cognitive behavior therapy (CBT) alone (64%), or
a combination of these 2 therapies (60%)"
Thus, it would appear that on a small scale,
CBT's effectiveness is actually interfered with
by prozac.
CBT alone did much better than prozac in
remission rates, but its effectiveness was
slightly diminished when combined with prozac.
It would be nice if the sample had been bigger
to see if this effect would have been enhanced.
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