
The Placebo Effect Doesn’t Apply Just to Pills - Libertatea
http://www.nytimes.com/2014/10/07/upshot/the-placebo-effect-doesnt-apply-just-to-pills.html?partner=rss&emc=rss&abt=0002&abg=1&_r=0
======
Alex3917
> For a drug to be approved by the Food and Drug Administration, it must prove
> itself better than a placebo, or fake drug.

False, the FDA doesn't actually have any requirement to prove that a treatment
is better than placebo. Many trials don't even include a placebo arm, they
only compare themselves against existing drugs that were grandfathered into
the system without any efficacy testing. Or they compare themselves to inert
placebos rather than active ones, even if they are psychoactive drugs. Or they
only compare themselves against placebos for a few weeks, even if they are
meant to be used for long periods of time.

This is how we have drugs like antidepressants and ADHD drugs on the market
even the though research shows they are actually _worse_ than taking no drug
at all.

~~~
lisper
> inert placebos rather than active ones

Isn't "active placebo" a contradiction in terms?

~~~
beagle3
No.

Because people know they could be taking a placebo, then having undeniable
effect (psychoactive, redness, soreness, etc.) tells them that they are not
using the placebo. Conversely, having no undeniable side effects lets them
know that they are using the placebo. Thus, placebo usage is undermined.

"Active placebo" has an undeniable effect, but not the compound being tested,
so that the test subjects cannot tell if they have the placebo or the real
things.

~~~
nitid_name
Couldn't that raise the question of if the side effects themselves are a
source of benefit?

~~~
Alex3917
This is what the book The Emperor's New Drugs is about. The idea of the book
is that there was some well-known research showing that anti-depressants are
effective for severe depression, but not mild or moderate cases. But if you
actually only look at studies that used active placebos as controls, then
there is no evidence clinical efficacy even for severe depression. Meaning
that the nominal benefit for anti-depressants for severe depression that's
seen in many studies is in fact probably due to people thinking they are
better due to the side effects of the drug, rather than due to true drug
benefits.

~~~
mjevans
It could also be that participating in the study addresses sources of
depression by giving the subject a way that they are 'helping out' society, or
are 'cared about' etc.

There are probably many factors to depression which may include chemical or
structural causes; however the human brain is a complex self adapting analog
computer. It would be foolish to think that such a system can be reduced a
single or even simple set of controlled variables.

------
agarden
It strikes me that for something like knee surgery, at least, the recovery
routine might be what provides the benefit. What if you took a group and did
not pretend to give them surgery but made them rest and go through physical
therapy as if you had?

~~~
jobu
_" Less than a year ago, many were shocked when arthroscopic surgery for
meniscal tears performed no better than sham surgery. This procedure was the
most common orthopedic procedure performed in the United States."_

Earlier this year I re-injured the meniscus in my knee and was about to
undergo surgery when a radiologist in the family mentioned this study. I
cancelled the surgery and followed the alternative recovery method of ice,
ibuprofen and rest. It took a long three weeks for me knee to feel normal
again, but it would've been much longer had I undergone the surgery.

------
sniderlane
Try it yourself: [http://placebobutton.com/](http://placebobutton.com/)

~~~
Procrastes
I pressed the comforting, blue button and my chronic gullibility was cured
instantly! Thank you Placebo Button!

------
ChuckMcM
Perhaps we could create a placebo bureaucracy, say an FDA like agency which
just approved anything that came through it. And then we could compare the end
results of that agency with the FDA to see which one approved the most
'actually useful' medicines and the one which had the most 'later found to be
harmful' medicines.

~~~
tokenadult
Chuck, that's already done. That's the "natural supplements" industry[1] as it
has been regulated since the mid-1990s in the United States.

[1] "Dietary supplement industry says 'no' to more information for consumers
(again)" [http://www.sciencebasedmedicine.org/big-supp-resists-
giving-...](http://www.sciencebasedmedicine.org/big-supp-resists-giving-
consumers-safety-and-effectiveness-information/)

------
ucho
Very old news. Surgery for "Gastroesophageal reflux disease" was an famous
example:
[http://en.wikipedia.org/wiki/Placebo#cite_note-198](http://en.wikipedia.org/wiki/Placebo#cite_note-198)
. If I remember correctly in one study symptoms dissipated in 50% of patients,
who got sham surgery - just skin incisions.

------
ToastyMallows
Anyone interested in the Placebo Effect, I recommend Josh & Chuck's Stuff You
Should Know episode about it.

[http://www.stuffyoushouldknow.com/podcasts/how-the-
placebo-e...](http://www.stuffyoushouldknow.com/podcasts/how-the-placebo-
effect-works/)

------
sudowhodoido
I thought that was kind of obvious.

A friend of mine who repairs PCs occasionally finds nothing wrong with them
and does the usual "I'll run some maintenance on it" and the client is always
happier afterwards. He doesn't charge for stuff unless anything needs to be
done.

~~~
Toddarooski
Wouldn't your friend get happier clients if he charged them a little bit? It'd
probably give them a stronger placebo effect.

~~~
sudowhodoido
People are shallow. The computer is their best friend 95% of the time, but
they remember the last 5% and how much it cost them more than anything.

------
matkam
Any idea how placebos work so well, what they are, and if we're doing anything
to take advantage of the effect?

~~~
83457
There is actually a discipline of medicine dedicated to researching and
promoting the use of placebos to cure ailments called homeopathy.

~~~
tobinfricke
I assume you mean this as a joke, but homeopathic remedies are so popular here
in Germany -- the pharmacy shelves are loaded with them!! -- that I wonder
whether use of the placebo effect is an official component of the national
healthcare strategy.

~~~
TillE
Yeah, it's extremely weird to see homeopathic "medicine" all over in a country
with an otherwise excellent, modern medical system.

Germany generally does a good job on evidence-based herbal medicine (like
standardizing St. John's wort extract), but I worry that the line can easily
be blurred between them and homeopathic products in the eyes of most
consumers. You really have to look carefully - they're not clearly marked.

So honestly, you're probably quite right about it being a deliberate
exploitation of the placebo effect. Because otherwise, there's no reason not
to ban them.

~~~
pluma
No kidding. I went to the doctor with sleeping problems one time and he
suggested I look up a certain drug. He said I couldn't get a prescription for
it and it was to be taken therapeutically (i.e. indefinitely) and at the
normal dosage it would cost something like 50 bucks a month.

I went home and looked it up: a homeopathic panacea with only a single
"study". Not double blind, not even single blind -- they literally just gave
the drug to some participants and the self-reported symptoms "improved".

I'm still not sure whether the GP was just trolling me.

~~~
tobinfricke
I've had similar experiences. I find it very strange. You make a good point:
the homeopathic remedies aren't even cheap.

------
wdr1
BTW, if you haven't seen it already, you should check out his YT channel,
Healthcare Triage:

[https://www.youtube.com/user/thehealthcaretriage](https://www.youtube.com/user/thehealthcaretriage)

He does a great job covering a variety of subjects & explaining research to
the layman.

------
smegel
> They had an incision, and a procedure was faked so that they didn’t know
> that they actually had nothing done.

Is it just me, or does this seem ethically dubious? A sugar pill placebo does
no harm, but when you are cutting people open to "fake" surgery...just doesn't
sit right.

~~~
jonchang
The article, in fact, addresses your question.

> The ethical issues aren’t easily dismissed. Theoretically, a sugar pill
> carries no risk, and a sham procedure does. This is especially true if the
> procedure requires anesthesia. The surgeon must go out of his or her way to
> fool the patient. Many would have difficulty doing that.

> But we continue to ignore the real potential that many of our surgical
> procedures and medical devices aren’t doing much good — and might even be
> doing harm, since real surgery has been shown to pose more risks than sham
> surgery.

------
msolujic
Here is one more recent interesting research result in area of placebos
[http://www.coloradocollege.edu/newsevents/newsroom/the-
power...](http://www.coloradocollege.edu/newsevents/newsroom/the-power-of-
positive-sleeping)

------
marincounty
The Placebo Effect should be taught in grade school. We shouldn't have to wait
until college to realize just how many products, drugs, professions, etc. are
an absolute sham.

------
kylelibra
I clicked on this thinking "surely this is some NY Times article from their
archives." Nope.

------
briantakita
The prevalence of the Placebo Effect across many medicinal domains seems like
evidence that there is an underlying cause. Perhaps emotional well being has
an impact on health?

------
tokenadult
This article brings up a very important point, and I'm grateful that it was
submitted here. The professor of pediatrics who wrote the article is onto some
important issues, and I was especially glad he cited some of the research
literature with direct links. Reading a review he cited,[1] I see that one of
the problems here is the vagueness of what he calls "improvement" in many
medical studies. Is the treatment endpoint of a knee operation patients moving
better than they used to, as measured by trained observers watching the
patients do standardized movements? Or is "improvement" a patient self-report
of less pain? Several of the examples the author writes about are examples of
treatments indicated to relieve pain (angina, which is chest pain, or lower
back pain, and it looks like most of the knee surgery he mainly focuses on was
also done to relieve patient-reported pain). Patient self-reported pain is a
symptom, a matter important to the patient, but it is not a diagnostic sign
that can be objectively observed by anyone else (as, for example, blood
pressure or white cell count can be objectively observed).

Too many medical studies, and almost all "alternative medicine" testimonials,
are based on soft endpoints (patient self-reports of improvement) rather than
on "hard endpoints" (longer healthier life after reduction in all-cause
mortality, or resuming walking after being paralyzed, or something observable
objectively and lastingly important).

Pretty much all studies by all authors of whatever researcher background that
appear to show a "placebo effect" show that only for patient-reported
subjective symptoms that are usually temporary anyway like pain and nausea.
Nobody asks for a placebo treatment for a broken leg or a life-threatening
infection. The medical researchers who look at the issue with proper study
designs and statistical controls know that placebos are essentially useless,
as they at most have influence just on self-reported subjective symptoms, not
on any sign that affects the progression of a disease or maintenance of good
health.[2]

Findings on placebo effects by researchers who have considered the issue
carefully include

"Despite the spin of the authors – these results put placebo medicine into
crystal clear perspective, and I think they are generalizable and consistent
with other placebo studies. For objective physiological outcomes, there is no
significant placebo effect. Placebos are no better than no treatment at
all."[3]

"We did not find that placebo interventions have important clinical effects in
general. However, in certain settings placebo interventions can influence
patient-reported outcomes, especially pain and nausea, though it is difficult
to distinguish patient-reported effects of placebo from biased reporting. The
effect on pain varied, even among trials with low risk of bias, from
negligible to clinically important. Variations in the effect of placebo were
partly explained by variations in how trials were conducted and how patients
were informed."[4]

So, yes, let's make sure that studies of surgical techniques include studies
of sham surgery. (Studies of acupuncture had better always have sham
acupuncture arms in which "real" acupuncture points are disregarded or other
aspects of supposedly ancient Chinese technique are intentionally omitted
without the patient knowing that.) This will improve the evaluation of safety
and effectiveness of new surgical techniques. Just don't assume that ANY
placebo is ever good for ANYTHING that you couldn't achieve just by giving
yourself a good pep talk.

[1]
[http://www.bmj.com/content/348/bmj.g3253](http://www.bmj.com/content/348/bmj.g3253)

[2] [http://www.sciencebasedmedicine.org/michael-specter-on-
the-p...](http://www.sciencebasedmedicine.org/michael-specter-on-the-placebo-
effect/)

[http://www.sciencebasedmedicine.org/ted-kaptchuk-versus-
plac...](http://www.sciencebasedmedicine.org/ted-kaptchuk-versus-placebo-
effects-again/)

[3] [http://theness.com/neurologicablog/index.php/the-rise-and-
fa...](http://theness.com/neurologicablog/index.php/the-rise-and-fall-of-
placebo-medicine/)

[4]
[http://www.ncbi.nlm.nih.gov/pubmed/20091554](http://www.ncbi.nlm.nih.gov/pubmed/20091554)

~~~
pella
_" \- Administration of placebos should be considered when a patient is
refractory to standard treatment, suffers from its side effects, or is in a
situation where standard treatment does not exist."_

from:
[http://jme.bmj.com/content/40/4/219.full](http://jme.bmj.com/content/40/4/219.full)

"The moral case for the clinical placebo"

~~~
tokenadult
Thanks for the link. I note that it reports, "Nevertheless, it is important to
mention that according to an influential 2001 meta-analysis comparing placebo-
treatment arms with no treatment, placebos make no clinical difference." The
citation at that sentence is to an article that lives online in free full
text[1] that we can all download and read.

The same team's updated Cochrane review[2] still sums up the evidence by
saying, "We found an effect on patient-reported outcomes, especially on pain.
Several trials of low risk of bias reported large effects of placebo on pain,
but other similar trials reported negligible effect of placebo, indicating the
importance of background factors." They add a caution about experimental
methods consistent with the article submitted here on HN: "The use of placebos
in blinded randomised trials is a precaution directed against many forms of
bias, and not only against effects of placebo. Unblinded patients may differ
from blinded ones in their way of reporting beneficial and harmful effects of
treatment, in their tendency to seek additional treatment outside the study,
and in their risk of dropping out of the study. Furthermore, unblinded staff
may differ in their use of alternative forms of care and in their assessment
of outcomes. Thus, even if there were no true effect of placebo, one would
expect to record differences between placebo and no-treatment groups due to
bias associated with lack of blinding."

[1]
[https://math.dartmouth.edu/~doyle/docs/40/PlaceboArticle.pdf](https://math.dartmouth.edu/~doyle/docs/40/PlaceboArticle.pdf)

[2] [http://summaries.cochrane.org/CD003974/COMMUN_placebo-
interv...](http://summaries.cochrane.org/CD003974/COMMUN_placebo-
interventions-for-all-clinical-conditions)

~~~
pella
placebo paradoxon- different teams - different conclusions :)

I agree with this:

 _" It is evident that placebo effects are real and that they have therapeutic
potential. Laboratory evidence supports the existence of numerous placebo
mechanisms and effects in both healthy volunteers and patients with a variety
of medical conditions. Furthermore, clinically relevant evidence demonstrates
that placebo effects can have meaningful therapeutic effects, by virtue of
magnitude and duration, in different patient populations. Although substantial
progress has been made in understanding placebo effects, considerable
scientific work remains to be done in both laboratory experiments and
translational clinical trial research, \---> with the ultimate aim of
harnessing placebo effects to improve patient care."_

Damien G Finniss,corresponding author Ted J Kaptchuk, Franklin Miller, and
Fabrizio Benedetti

"Placebo Effects: Biological, Clinical and Ethical Advances"

[http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2832199/](http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2832199/)

