Aiming to Please

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http://www.hsibaltimore.com/ea2003/ea_030721.shtml

 

Aiming to Please

 

As a clinical research tool, a placebo is often referred to as nothing but a

sugar pill - neutral and benign. In fact, " placebo " comes from the Latin word

meaning " I shall please. " Everything about the word would seem to be guileless.

Or that's what the general thinking is anyway.

 

In last week's e-Alert " Seeing Red " (7/16/03) I told you about two different

studies in which red clover extract was tested in the treatment of menopausal

hot flashes. In both studies, the group of women who received red clover showed

about the same rates of success in controlling hot flashes. But the subjects in

the placebo group in one study reported almost no effect at all, while in the

other study the placebo subjects had almost the same results as the red clover

group.

 

How could the results of these two placebo groups be so different? One strong

possibility: The placebos may have been very different. Because contrary to

common thinking, clinical research trials - especially pharmaceutical trials -

bring a whole new meaning to the old Latin idea of " I shall please. "

 

The importance of being inert

 

 

There was a time when doctors would prescribe phony medication - sugar pills -

to their patients who they regarded as hypochondriacs. They called the pills

" placebo " and when the patients reported positive results the idea of the

placebo effect was born.

 

These days, placebo pills are used in clinical trials to measure the true effect

of a drug or supplement. They are thought to be made of inert substances

designed to have no effect. But consider this: there's no such thing really as

an inert substance. For instance, placebo pills are still called sugar pills. Is

sugar inert? Far from it, of course. If you take a sugar pill, your body will

have a reaction, especially if you happen to have an insulin disorder. But if

you're given that same pill as part of a drug research trial, your reaction

becomes a factor in the research.

 

That may seem like nothing (what real difference could a little boost of sugar

make?) but sugar and other supposedly inactive ingredients are not the issue.

Not in the least.

 

A little secret

 

 

When a pharmaceutical company tests its products, where do you suppose they get

placebo pills? Do they place an order with a placebo pill manufacturer? Or does

Nestle's candy company run a little side business to supply researchers with

sugar pills?

 

The fact is, drug companies make their own placebo pills for research purposes,

and for each individual study they create a unique placebo formula - sometimes

purposely including ingredients that match ingredients in the drugs being

tested. But at no time do the contents of the placebos have to be revealed.

 

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 are often

fully aware of many of the side effects of the products they're testing. So, for

instance, if a drug is known to cause dizziness and nausea, the drug company

running the test wants the placebo to have the same side effects. And 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.

 

There are plenty of gray areas to debate in that logic, but for the moment let's

focus on the idea of what they call an " active placebo, " designed to mimic the

side effects of a tested drug. And with that in mind let's look at an

advertising campaign for the allergy medication called Claritin. In the Claritin

TV spots, when it comes to the moment to list the side effects, 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. "

 

A sugar pill? Really? Just what kind of " sugar pill " were the researchers using

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

sugar pill with a little something added. But they want us to believe that this

medication will produce side effects no more serious than what you'd get with a

TicTac.

 

The whistle blower

 

 

Dr. Beatrice Golomb, MD, PhD, is an assistant professor of medicine at the

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

establishment's 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.

 

As you might suspect, the drug companies are not very receptive to Dr. Golomb's

idea of letting go of this aspect of product testing that they have full control

over.

 

Meanwhile, what about physicians and researchers who work independently from the

pharmaceutical giants - do they know the truth about placebos supplied by drug

companies? Right now it's hard to tell just how widespread this knowledge is.

According to the National Center for Complementary and Alternative Medicine at

the National Institutes of Health (NIH), the placebo effect is defined as

" desirable physiological or psychological effects attributable to the use of

inert medications. " From that statement it would appear that NIH officials

either believe that placebos are genuinely inactive, or they're not admitting

that they know better.

 

Or maybe they're just feeling drowsy, dizzy, irritable and nauseous from a sugar

pill someone gave them.

 

....and another thing

 

 

You want complicated? Tea - now that's complicated.

 

In the e-Alert " Model T " (5/22/03) I told you about the amino acid in tea called

L-theanine, which helps the body fight viral, parasitic, fungal, and bacterial

infections. In response, I received an e-mail from an HSI member named Joseph

who had a question about another component of tea:

 

" All this tea news is great, but what about the tannic acid in tea? I recall

reading an article that said tannic acid (the same item used in tanning

leather!) wreaks havoc on joints, leading to arthritis. Supposedly the

tea-drinking Brits have a very high incidence of arthritis. "

 

After checking several sources, I can't confirm that the British have an

unusually high incidence of arthritis, so we'll have to take Joseph's word on

that one. Tannic acid is the astringent agent used in leather tanning, but

different plants have different tannic characteristics. More to the point: tea

isn't used to tan leather, but the tannins extracted from oak, birch,

eucalyptus, willow, and pine, are.

 

As for the tannins in tea, I'll have more on that, but first, here's HSI

Panelist Allan Spreen, M.D., with his take on Joseph's question:

 

" Tough one. There are nutrient therapists who deliberately use tannins as part

of their therapy, as some seem to have helpful properties. There's always the

question of what's doing the good (or bad), of course. Is it the tannins, the

theophylline, or something else in the tea?

 

" To complicate the picture there are green teas, well known to have benefits in

several areas. However, some have caffeine and some don't (as is true with other

compounds on board), which complicates the picture somewhat. Also, it's recently

been found that black teas have therapeutic abilities along with the green

varieties (and would be expected to have more tannins on board). "

 

In other words: there's no pat answer to this one. When you say " tea, " you're

talking about a universe of varieties with a wide range of characteristics. And

when you start sorting through the available literature about tea and tannic

acid, the picture doesn't get any clearer - anything but.

 

I found three sources claiming that research shows tea drinkers are less likely

to suffer from arthritis and rheumatoid arthritis (no specific references to

studies were named). But I found another piece - written by George E. Meinig,

D.D.S., F.A.C.D. - that made a case for the caffeine in tea increasing

rheumatoid arthritis risk by causing a calcium-phosphorus imbalance. And

according to Dr. Meinig, the problem is compounded when sugar is added.

 

As for the specific effects of tannin, one theory holds that mucin (the

protective mucous that lines the interior of the digestive system) protects us

from most of tannic acids' negative effects. Another source claims that tannic

acid has anti-inflammatory and germicidal properties.

 

And to top it all off, I found an article that simply stated: " There is no

tannic acid in tea. "

 

If that were true, it would make for a much simpler answer to Joseph's question.

 

To Your Good Health,

 

Jenny Thompson

Health Sciences Institute

 

Sources:

" Tannins " Animal Science Department, Cornell University, ansci.cornell.edu

" Caffeine " George E. Meinig, D.D.S., F.A.C.D., Price Pottenger Nutrition

Foundation, price-pottenger.org

" Green and Black Tea " The Happy Herbalist, happyherbalist.com

" Tannic Acid in Tea " MashTea Gholee Cyber Tea House, farsinet.com

 

 

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