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October 2009
Special
Edition |
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In This Issue
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Stem Cell Treatment Benefits Merely a
Placebo Effect
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When Placebo Effects Go Wild Don Margolis www.RepairStemCells.org |
In the last newsletter we answered
the question: “DO STEM CELL
TREATMENTS WORK?” In this
newsletter we will answer the second most important question the prospective
stem cell treatment recipient faces: ARE STEM CELL TREATMENT BENEFITS MERELY A PLACEBO EFFECT?
Ok, what is the placebo
effect? H. K. Beecher evaluated 15
clinical trials concerned with different diseases and found that 35% of 1,082
patients were satisfactorily relieved by a placebo alone. A reanalysis of Beecher’s data by Kienle
and Kiene (1997) found "no evidence of any
placebo effect in any of the studies cited by him." The reported
improvements in heath were real but were due to other things that produced
"false impressions of placebo effects."
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In May
2001, The New England Journal of Medicine published an article that
called into question the validity of the placebo effect. "Is the Placebo
Powerless? An Analysis of Clinical Trials Comparing Placebo with No
Treatment" by Danish researchers Asbjřrn Hróbjartsson and
Peter C. Götzsche "found little evidence in general that placebos had
powerful clinical effects." Their meta-analysis of 114 studies found that
"compared with no treatment, placebo had no significant effect on
binary outcomes, regardless of whether these outcomes were subjective or
objective. For the trials with continuous outcomes, placebo had a beneficial
effect…The high levels of placebo effect which have been repeatedly
reported in many articles, in our mind are the result of flawed research
methodology," said Dr. Hróbjartsson, professor of medical philosophy
and research methodology at the University of Copenhagen.* And bear
in mind that while it is believed that the Placebo Effect can do some things,
there are limits: “Because placebos
often have an effect, even if it does not last long, some people think that
the placebo produced a "cure." But placebos do not cure. And in
studies where doctors are looking at whether a tumor shrinks, placebos would
be expected to have very little, if any, effect on cancer growth.” - http://www.cancer.org/docroot/ETO/content/ETO_5_3x_Placebo_Effect.asp
? Confused?
I don’t blame you. Sometimes hard science is anything but. If placebo effect was a huge problem and
completely understood then all trials would be placebo controlled,
right? In fact;
Let’s for
the sake of argument, define “Placebo Effect” and see if
benefits from stem cells meets that definition: “Placebo Effect: Also
called the placebo response. A remarkable phenomenon
in which a placebo -- a fake treatment, an inactive
substance like sugar, distilled water, or saline solution -- can sometimes improve
a patient's condition simply because the person has the expectation that it
will be helpful. Expectation to plays a potent role in the placebo effect.
The more a person believes they are going to benefit from a treatment, the more
likely it is that they will experience a benefit.” - http://www.medterms.com/script/main/art.asp?articlekey=31481 So Placebo
Effect is dependent upon:
Of
course, the gold standard for FDA approved drug testing is a clinical trial
utilizing the double-blind study. The
double blind study uses a “placebo” in order to eradicate any
possibility of a “placebo effect”. 50% of the patients receive the medicine
and 50% receive a placebo. In some
studies, 33% of the patients receive the medicine, 33% receive a placebo and
33% receive nothing. This type study
even more accurately limits the possibilities of a “placebo effect”. (Too bad for the 66% not getting any
therapy but I guess this falls under: “the needs of the many outweigh the
needs of the few.”)
Nocebo effect Side note:
the
opposite of a placebo effect is a “NOCEBO” or “negative
effect.” This is when the
patients report that they are getting worse or that unpleasant side effects
have occurred, a word derived from the Latin “nocere” and
meaning ‘inflicting damage.’ Turn on
the TV and you will see one commercial after another, describing the negative
effects of drugs. What are the chances
that current drugs, with their associated laundry list of complications
broadcasted over and over on the TV everyday are causing NOCEBO effects? Well, if NOCEBO are dependent upon the
patient’s expectations of negative effects…I would guess that there is an
epidemic of NOCEBO’s all over the US.
And the coup de gras?
The last line is always: “Ask your doctor if xyz-drug could help you,”
feeding directly into that concern. So… ARE STEM CELL TREATMENT BENEFITS
MERELY A PLACEBO EFFECT?
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