The placebo effect

[Guest guest]

I just ran across these two short pieces which, although not new seem

quite interesting. This is about the placebo effect and the

controversy currently raging over homeopathy (especially in the UK).

 

They are part of a longer article in New Scientist about " 13 things

that do not make sense " .

 

http://space.newscientist.com/article.ns?id=mg18524911.600

 

Kind regards

Sepp

 

 

 

Belfast homeopathy results

 

MADELEINE Ennis, a pharmacologist at Queen's University, Belfast, was

the scourge of homeopathy. She railed against its claims that a

chemical remedy could be diluted to the point where a sample was

unlikely to contain a single molecule of anything but water, and yet

still have a healing effect. Until, that is, she set out to prove

once and for all that homeopathy was bunkum.

 

In her most recent paper, Ennis describes how her team looked at the

effects of ultra-dilute solutions of histamine on human white blood

cells involved in inflammation. These " basophils " release histamine

when the cells are under attack. Once released, the histamine stops

them releasing any more. The study, replicated in four different

labs, found that homeopathic solutions - so dilute that they probably

didn't contain a single histamine molecule - worked just like

histamine. Ennis might not be happy with the homeopaths' claims, but

she admits that an effect cannot be ruled out.

 

So how could it happen? Homeopaths prepare their remedies by

dissolving things like charcoal, deadly nightshade or spider venom in

ethanol, and then diluting this " mother tincture " in water again and

again. No matter what the level of dilution, homeopaths claim, the

original remedy leaves some kind of imprint on the water molecules.

Thus, however dilute the solution becomes, it is still imbued with

the properties of the remedy.

 

You can understand why Ennis remains sceptical. And it remains true

that no homeopathic remedy has ever been shown to work in a large

randomised placebo-controlled clinical trial. But the Belfast study (

Inflammation Research, vol 53, p 181) suggests that something is

going on. " We are, " Ennis says in her paper, " unable to explain our

findings and are reporting them to encourage others to investigate

this phenomenon. " If the results turn out to be real, she says, the

implications are profound: we may have to rewrite physics and

chemistry.

 

 

 

The placebo effect

 

 

DON'T try this at home. Several times a day, for several days, you

induce pain in someone. You control the pain with morphine until the

final day of the experiment, when you replace the morphine with

saline solution. Guess what? The saline takes the pain away.

 

This is the placebo effect: somehow, sometimes, a whole lot of

nothing can be very powerful. Except it's not quite nothing. When

Fabrizio Benedetti of the University of Turin in Italy carried out

the above experiment, he added a final twist by adding naloxone, a

drug that blocks the effects of morphine, to the saline. The shocking

result? The pain-relieving power of saline solution disappeared.

 

So what is going on? Doctors have known about the placebo effect for

decades, and the naloxone result seems to show that the placebo

effect is somehow biochemical. But apart from that, we simply don't

know.

 

Benedetti has since shown that a saline placebo can also reduce

tremors and muscle stiffness in people with Parkinson's disease

(Nature Neuroscience, vol 7, p 587). He and his team measured the

activity of neurons in the patients' brains as they administered the

saline. They found that individual neurons in the subthalamic nucleus

(a common target for surgical attempts to relieve Parkinson's

symptoms) began to fire less often when the saline was given, and

with fewer " bursts " of firing - another feature associated with

Parkinson's. The neuron activity decreased at the same time as the

symptoms improved: the saline was definitely doing something.

 

We have a lot to learn about what is happening here, Benedetti says,

but one thing is clear: the mind can affect the body's biochemistry.

" The relationship between expectation and therapeutic outcome is a

wonderful model to understand mind-body interaction, " he says.

Researchers now need to identify when and where placebo works. There

may be diseases in which it has no effect. There may be a common

mechanism in different illnesses. As yet, we just don't know.

 

 

 

 

--

 

 

The individual is supreme and finds its way through intuition.

 

Sepp Hasslberger

 

 

Critical perspective on Health: http://www.newmediaexplorer.org/sepp/

 

My blog on physics, new energy, economy: http://blog.hasslberger.com/

 

 

 

 

[Guest guest]

The Placebo Effect - One gadfly health researcher's notes on a

practice employed in the majority of clinical trials, plus her take on

the active placebo and the nocebo - " placebo's evil twin "

 

by June Russell

ImmuneSupport.com

09-20-2007

 

 

This article is reproduced with permission from June Russell's Health

Facts Website http://www.jrussellshealth.org. A " retired health

educator, researcher, and journalist, " she says her purpose is " to

educate the public about health issues and balance some of the media

facts that are deceptive, inaccurate, or biased. " The views expressed

here are the author's.*

 

 

PLACEBO: In Latin, placebo means " I shall please. "

 

 

A study in the Journal of Neuroscience provided direct evidence that

the brain's own pain-fighting chemicals, called endorphins, play a

role in the phenomenon known as the placebo effect, resulting in a

reduction of pain. Dr. Jon-Kar Zubieta, Associate Professor of

Psychiatry and Radiology [at the University of Michigan], says this

is

the first study to pinpoint specific brain chemistry for the placebo

effect.1

 

 

Placebos are not always inert; they can have actual ingredients. When

a study is reported as being " placebo controlled " (in addition to

being large, randomized, and double blind) - the " gold standard " -

the

public is led to believe that the outcome is reliable.

 

 

Actually, some studies have excluded important variables (such as

weight or diet), or have used smaller (clinically ineffective)

amounts

of the tested substance. When small amounts of the tested substance

are used, in a dosage previously shown to be ineffective, the outcome

of the study is guaranteed. For example, in the studies showing

negative effects of zinc lozenges. Studies constructed in this manner

skew the outcome and results, resulting in misleading conclusions.

Follow-up studies that reveal the flaws or show differing results are

rarely reported in the media.

 

 

In research, a placebo refers to a treatment with no known effect on

the condition being studied. For a variety of reasons, ranging from

narrow financial self-interest to altruistic hope of finding a cure,

researchers who are not " blinded " will usually see more improvement

from a drug or new therapy than there actually is. The size of the

placebo effect varies from study to study and depends on the

condition

under investigation, but 35 percent is a frequently cited figure.

What

we call the placebo effect may be the natural tendency of many

illnesses to get better. In drug trials, the placebo is a " dummy "

pill

that closely resembles the real thing. It is often made with lactose,

the sugar in milk.2

 

 

To get permission from the Food and Drug Administration to market a

new drug, its maker must show that it works better than a placebo in

at least two large, controlled studies. People in the placebo group

are actually getting treatment of a kind. They still have the

doctors'

visits with someone paying attention to their distress and trying to

address it. That medical interaction, and the hope engendered by

simply being in a study, may be responsible for improvement.3

 

 

One of the most strongly held beliefs in medicine, that dummy pills

or

other sham treatments greatly help many patients, has been called

into

question by Danish researchers who found little or no " placebo

effect "

in 114 studies.4 Researchers and other experts said that improvements

might be explained by " reporting bias, " where patients, thinking they

are getting a powerful treatment, incorrectly judge their condition

or

overstate any improvement to please their doctor.

 

 

Dr. Stephen Schneider, Professor of Medicine at the University of

Medicine and Dentistry of New Jersey in New Brunswick, has worked in

many trials where the patients on a placebo improved. He said that

simply participating in a medical study induces patients to eat

better, exercise more, or otherwise pay more attention to their

health. Many doctors still routinely give placebos to reassure

patients who want every possible treatment - for example, antibiotics

to people with colds (which cannot help), or prescribing a drug that

is unlikely to work.5

 

 

In industry-sponsored studies of MSG, large numbers of subjects were

reacting to a placebo which, by definition, should be made up of

inert, non-reactive material. The placebo contained aspartame! J.R.'s

comment: Proof was found in an industry association letter in an FDA

file. After objections were raised to the use of aspartame, sucrose

11

was substituted. Sucrose 11 is a substance that will also affect the

findings of any study on MSG intolerance and diminish the effect of

MSG. The FDA knows that sucrose and other carbohydrates diminish the

effect of MSG.6

 

 

Vaccination is built around a " belief " system, and challenging the

validity of vaccines challenges long-held foundational beliefs.

However, beliefs are based on faith not facts. With only a cursory

review of the literature and CDC documents, one will find the

following facts:

 

 

n No vaccine has ever been proven to be completely safe. Safety

studies are small and only include " healthy " children. However, after

a study is completed, vaccines are given to ALL children, regardless

of underlying health conditions or genetic predispositions. Our

national vaccine policy does not allow for individualized options,

and

it has caused a myriad of health problems for many.

 

 

n Observations for side effects continue for a maximum of 14 days

during a " safety " study, but complex problems involving the immune

system can take weeks or even months to appear.

 

 

n A vaccine " safety " study is designed to compare a new vaccine to a

" placebo, " but when we examine the study more closely we discover

that

the " placebo " is NOT a benign, inert substance, such as saline or

water. The " placebo " is another vaccine with a " known safety

profile, "

so if the new vaccine has the same side effects as the " placebo, " the

vaccine is considered to be " safe. " We want to " believe " that a

vaccine will protect us from infection, but several medical journal

articles document that this is not necessarily so. J.R.'s note: There

are seven studies listed to support this statement.

 

 

Researching vaccinations and the vaccine industry will seriously

change your " beliefs " in vaccines.7

 

 

" Real " acupuncture no better than placebo for migraines? A new study

of more than 300 patients, published in the Journal of the American

Medical Association, reported that both " real " and " sham " acupuncture

reduced migraine pain, compared with no treatment at all. The problem

is, there's no such thing as " sham " acupuncture - acupuncture

anywhere

in the body has the ability to affect the nervous system and lead to

the reduction in pain. So the first problem with the study was that

the placebo wasn't really a placebo. Second, the treatment was the

same for each patient - in reality, acupuncturists develop

individualized treatment plans based on a person's unique symptoms.

 

 

J.R.'s note: Also, researcher Dr. Dedra Buchwald noted that

acupuncturists generally customize treatments for each patient and

often combine acupuncture with other forms of treatment, something

that cannot be done in a clinical trial. Acupuncture certainly works

in acute pain control and in some conditions of chronic pain.9

 

 

An article in The Wall Street Journal (June 18, 2004) reported that

" Drug makers seek to bar 'placebo responders' from trials. " In other

words, spot the troublemakers, keep them out of the trials, and the

outcome will be much more in line with desired results. Accurate

results are secondary to desired results when an FDA approval of a

cash cow pharmaceutical is in the balance. This would corrupt the

basic design of clinical studies.10

 

 

By subtracting the placebo response from the drug response, it then

is

expected to determine the " real " effects of the drug itself. This is

an illusion. The placebo response may actually determine the drug

response. When given by a non-caring physician, both drugs and

placebos are less effective, and the distinction in response between

the " active " drug and placebo can be wiped out (Lancet, 1994).

Physicians tend to be as confused as researchers about the nature of

placebo. The effectiveness of a medical treatment is not a fixed

property of the treatment itself; it is a highly variable quantity

that may be more strongly influenced by the relationship between the

doctor and patient than by any other factor.11

 

 

A different research group found that some simple dietary changes may

help protect the heart of people over age 60. Heart rate variability

is an important marker of cardiac health. Taking 2 g of fish oil a

day

increased the positive index more than the placebo, which was soy

oil.

12

 

 

Greek researchers found that dark chocolate makes blood vessels less

thick and more flexible. This study was in the American Journal of

Hypertension (2005), a peer-reviewed journal - reputable research.

Terri Graedon reported that the poor people on placebo didn't get

anything. They didn't get a low flavonoids chocolate. They just had

to

pretend they were eating chocolate.13 J.R.'s comment: The placebo was

" nothing? " Time and again we see that studies, even studies that are

published in a peer-reviewed journal, don't guarantee accuracy.

 

 

" Active " Placebos

 

 

More recently, drug companies have begun to produce " active

placebos. "

These pills, unlike the sugar or starch pills of old, contain

ingredients that mimic the common side effects of the drug under

study. An active placebo might, for example, cause dry mouth if the

drug to be tested was Elavil, but it probably wouldn't cause

drowsiness because Elavil is used to treat sleep disorders. It

would

be important to know whether people slept better with a placebo that

wouldn't have that effect.

 

 

Sometimes a prescription medication is used as an active placebo. In

a

study published in the New England Journal of Medicine (March 2005),

the combination of morphine and gabapentin for relief of neuropathic

pain was compared to each drug alone and to an active placebo. The

placebo used was lorazepam, a benzodiazepine medication with

[anti]anxiety and sedative properties, with a common effect of

dizziness. Two of the most common side effects of both morphine and

gabapentin are dizziness and sleepiness. Approximately one-third of

the patients, reported Medscape, guessed that they were receiving an

active drug while they were receiving the lorazepam placebo, which

could have decreased the difference between treatment with gabapentin

or placebo. However, even so, the trial results showed significantly

better results for the combination of gabapentin and morphine than

either drug alone, and the poorest results from the lorazepam

placebo.

14

 

 

It seems that pharmaceutical companies routinely make their own

placebo pills for each trial and even formulate them to mimic

expected

drug reactions. This tends to destroy any pretense of " scientific

drug

testing. " Could that be the reason for some of those hundreds of

thousands of deaths reportedly caused by pharmaceutical drugs every

year and why the medical system has become a leading cause of death

in

the western world?15

 

 

There is really no such thing as an inert substance. Placebo pills

are

still called sugar pills. Is sugar inert? If you take a sugar pill,

your body will have a reaction, especially if you have an insulin

disorder. If you are given that pill as a part of a drug research

trial, your reaction becomes a factor in the research. The drug

companies choose the ingredients and they make their own placebo

pills

for research purposes. Sometimes they purposely put ingredients in

the

placebos that match those in the drug, thereby affecting results of

the trial. They are not required to disclose the ingredients they

use.

Does that sound " inert " or " inactive " to you? Suddenly the idea of a

" sugar pill " doesn't seem so innocent anymore.

 

 

Before conducting human trials for drugs, pharmaceutical companies

often are fully aware of the many side effects of the products

they're

testing. So, for instance, if a drug is known to cause dizziness and

hypertension, the drug company running the test wants the placebo to

have the same side effects. They have an explanation for this. They

say the placebo should mimic the drug being tested so that the

control

group of the experiment will have side effects similar to the placebo

group. Without that, they claim, the results of a blind study would

be

compromised.

 

 

In the TV ads for the allergy medication Claritin, the voice-over

says " The most common side effects with Claritin, including

headache,

drowsiness, fatigue and dry mouth, occurred about as often as they

did

with a sugar pill. " Just what kind of " sugar pill " were they using

that caused headache, drowsiness, fatigue, and dry mouth? Sounds to

me

like a sugar pill with a little something added. They want us to

believe that their powerful medication will produce side effects no

more serious than what you'd get with a little dab of sugar.

 

 

Dr. Beatrice Golomb, MD, PhD, Assistant Professor of Medicine at the

University of California, San Diego, has been actively fighting the

research establishments that claim that placebos are inactive

substances. Dr. Golomb wants scientists to provide a list of placebo

ingredients so trial results can be properly evaluated. To level the

playing field, Dr. Golomb suggests that drug companies start

divulging

all placebo ingredients. She also recommends that a standardized set

of placebos be developed that would have known and predictable side

effects. This would go a long way toward eliminating the

pharmaceutical industry's cynical manipulation of test data. Do the

physicians and researchers who work independently from the

pharmaceutical giants know the truth about the placebos?16

 

 

The Nocebo Effect: Placebo's Evil Twin

 

 

While the placebo effect refers to health benefits produced by a

treatment that should have no effect, patients experiencing the

nocebo

effect experience the opposite: Nocebo is Latin for " I will harm. "

They presume the worst, health-wise, and that's just what they get.

" Nocebos often cause a physical effect, but it's not a physically

produced effect, " said Irvin Kirsch, a psychologist at the University

of Connecticut in Storrs who studies the ways that expectations

influence what people experience. " What's the cause? In many cases

it's an unanswered question. "

 

 

The flood of brain chemicals, it appears, has everything to do with

what the mind expects. One of the most important things about a pill

is its color. A Dutch study found that most people considered red and

orange pills to be stimulating, with blue and green-colored pills

more

likely to have a depressant effect.17

 

 

* * * *

 

 

Footnotes: [Note: readers who have questions about any of these

footnotes should direct them to June Russell at

http://www.jrussellshealth.com.]

 

 

1. " Placebo effect not purely psychological, " Health Tips,

ez..., September 2005 [reporting on " Placebo

Effects

Mediated by Endogenous Opioid Activity on u-Opiod Receptors, " Journal

of Neuroscience, by Jon-Kar Zubieta, et al., August 24, 2005].

 

 

2. " Study casts doubt on the placebo effect, " Harvard Health Letter,

August 2001.

 

 

3. " Drug makers seek to bar 'placebo responders' From Trials, " by

Leila Abboud, staff reporter for The Wall Street Journal, June 18,

2004.

 

 

4. New England Journal of Medicine, May 24, 2001.

 

 

5. " Danish researchers take aim at 'placebo effect' - Scientists find

dummy pill to be of little or no value, " Associated Press, printed in

The Daily Progress newspaper, Charlottesville, VA, May 24, 2001.

 

 

6. " Placebo problems: MSG dangers and deceptions, "

www.price-pottenger.org/articles/MSG.html, October 6, 2003.

 

 

7. " The belief in vaccines, " by Dr. Sherri Tenpenny (nationally

renowned and respected vaccine expert), New Awareness Seminars, as

cited in mercola.com, August 2004.

 

 

8. " About alternative med, " Cathy Wong, ND,

altmedicine.gu..., May 2005.

 

 

9. " Acupuncture not effective for Fibromyalgia: Study, " HealthScout,

July 2005.

 

 

10. " Guarded Response, " Health Sciences Institute e-Alert, July 22,

2004.

 

 

11. The Four Pillars of Healing, book by Leo Galland, MD, 1997.

 

 

12. " People's Pharmacy, " National Public Radio health show, April 16,

2005.

 

 

13. " People's Pharmacy, " National Public Radio, July 2, 2005, show

#548.

 

 

14. " What is a placebo? " bipolar.about.com, November 2005.

 

 

15. " Prescribing a placebo, " Health Supreme news blog, by Sepp

Hasslberger, newmediaexplorer.org, November 2003.

 

 

16. Health Sciences Institute e-Alert, July 25, 2002.

 

 

17. " The nocebo effect: Placebo's evil twin, " Washington Post Health,

April 30, 2002.

 

 

* The disclaimer at http://www.jrussellshealth.com is as follows:

" Information on June Russell's Health Facts site is collected and

condensed from various print and electronic sources. Though I make

every effort to provide the correct information, I do not guarantee

accuracy. I am not liable for errors, omissions, or use or misuse of

information, services, or products mentioned on this site. I make no

medical claims for the authenticity or efficacy of the information

presented within this site or links to other sites. If you have, or

suspect you have, an illness or medical condition, see your

physician,

naturopath, or other qualified health professional for diagnosis,

guidance and supervision prior to self-treatment. By visiting or

viewing this site you make a contractual agreement to all terms and

conditions of this disclaimer. "

 

 

 

Note: The information provided here is not intended to diagnose,

treat, cure, mitigate, or prevent any disease. If you have a health

condition, see your physician for diagnosis and treatment advice.

Never make any changes in your nutritional and other health support

plans without your physician's explicit review and consent. It is

essential for you and your healthcare providers to work as a mutually-

informed team.

 

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