Medical study ploys  Placebos  Never unvaccinated controls

Basis of Many Medical Studies Found to be Proved Fatally Flawed

By Dr. Mercola

November 20 2010
http://articles.mercola.com

A new study analyzed numerous research trials to determine the content of the supposedly "inactive" placebos used for research, but discovered that placebo disclosure is rare. Researchers examined 176 medical journal studies and found that the vast majority didn't mention the contents of the placebos at all.

The study authors argued that placebo ingredients may be important. Certain placebos could skew results in favor of the active drug.

According to the Los Angeles Times: http://articles.latimes.com/2010/oct/18/news/la-heb-placebo-20101018

A placebo is a placebo is a placebo ... or maybe not, a new study suggests

We've all heard of the placebo effect -- thinking a simulated treatment has an effect -- but what exactly is in that placebo, anyway, and could it have a noticeable effect? A new study published Monday in the Annals of Internal Medicine analyzed numerous research trials to find out, but discovered that placebo disclosure is rare.

Many drug trials involve a placebo, a sham drug whose results are compared with the results of the real medication. A placebo is supposed to contain a harmless substance, such as sugar or vegetable oil, which has no significant effect on the body. In this study, researchers delved into 176 studies published in reputable medical journals, such as the New England Journal of Medicine, the Journal of the American Medical Assn. and the Annals of Internal Medicine, from January 2008 to December 2009 to see if placebo contents were disclosed and if so, what they were.

In the mix were 86 studies of pills, 65 of injections and 25 of other treatments. The vast majority of studies didn't mention the contents of the placebos, with pill studies providing the least information. Only 8.2% of pill studies disclosed ingredients, compared with 26.7% of studies using injections and other treatments.

The study authors argue that placebo ingredients may not always be as inconsequential as some may think. They write: "For instance, olive oil and corn oil have been used as the placebo in trials of cholesterol-lowering drugs. This may lead to an understatement of drug benefit: The monounsaturated and polyunsaturated fatty acids of these 'placebos,' and their antioxidant and anti-inflammatory effects, can reduce lipid levels and heart disease."

Certain placebos, they add, may skew results in favor of the active drug. The researchers referenced a trial for a drug used to treat anorexia linked with cancer in which a lactose placebo was used. Since lactose intolerance is common among cancer patients, the fact that some suffered stomach problems from the placebo may have made the actual drug look more beneficial.

"Perfect placebo is not the aim," they write, "rather, we seek to ensure that its composition is disclosed."

The authors suggest that prominent journals begin to require studies to include placebo disclosure, and propose that the Consolidated Standards of Reporting Trials (which offers recommendations for improving reporting of randomized control trials) change its guidelines to advocate disclosure of placebo ingredients.

-- Jeannine Stein / Los Angeles Times

Dr. Mercola's Comments:


A placebo, by definition, is supposed to be an inert, innocuous substance that has no effect on your body. They are therefore used as a measure of control against which to measure the effects of modern-day medical treatments.

In fact, to win FDA approval a new drug must beat a placebo in at least two trials.

But there are some serious issues with the “double-blind, placebo-controlled, randomized clinical trial,” which is currently used as today’s gold standard of research.

First, simply taking a pill or receiving treatment (even if it’s a “fake”) has been known to prompt healing changes, and I’ll delve into this shortly. Second, as the Annals of Internal Medicine report showed, placebos are not always the inert substances they’re supposed to be.

What’s Really in Placebos?
The truth is, usually no one outside of the study’s researchers knows for sure.

In a study of 176 trials published in reputable medical journals, only 8 percent of those using pills for placebos disclosed the ingredients. Studies using placebo injections and other forms fared slightly better, with over 26 percent disclosing what the placebo was made of, but most still kept their placebos a secret.

This is a major omission in these studies, as ingredients in placebos can and do skew study results.

For instance, you may have seen headlines claiming a study found that consuming more omega-3 fats doesn’t help heart patients (even though it’s widely known that animal-based omega-3 fats (fish oil and krill oil) have amazing benefits for heart health).

In this case the study got incredibly flawed and misleading results because the researchers fed their volunteers margarine -- either plain or enriched with plant- or animal-based omega-3 fats. Margarine is made by hydrogenation, and it is notorious for containing loads of heart-damaging trans fats.

There are newer trans-fat-free margarines available, and the study did not specify whether they were used or not, but they would still contain trace amounts of trans fats plus contain rancid vegetable oils, which are pro-inflammatory and therefore harmful to your heart.

These oxidized fats actually raise your risk of heart disease and blood clots, so in no way should heart-damaging margarine have been used as a placebo in a study looking for effects on your heart.

Despite its flawed design, this study was published in the New England Journal of Medicine, one of the most prestigious and well respected medical journals out there.

The Los Angeles Times pointed out one example of a study using a lactose placebo in a study with cancer patients. Lactose intolerance is common among cancer patients so the lactose placebo may have caused a lot of stomach problems -- making the drug being tested look better for not causing those same problems.

So anytime a study uses a placebo with ingredients that are not disclosed -- which happens in the vast majority of studies -- the results are highly suspect.

 The Placebo Effect: Is it Real?
Depending on whether a placebo is truly inert or not, it can produce very real biological changes in your body. This is especially true when the placebo contains potentially harmful ingredients, like the margarine example noted above. But assuming a placebo is inert, can it still impact your ability to heal?

Absolutely!

Many illnesses, from Parkinson’s disease to irritable bowel syndrome, have been proven to improve after placebo pills and treatments. The jury is still out on whether the practice of taking a sugar pill or simply going through the ritual of treatment is what’s causing the beneficial responses … but either way studies show that if you think you’re receiving a treatment, and you expect that treatment to work, it often does.

As Scientific American reported:

“In recent decades reports have confirmed the efficacy of various sham treatments in nearly all areas of medicine. Placebos have helped alleviate pain, depression, anxiety, Parkinson’s disease, inflammatory disorders and even cancer.
Placebo effects can arise not only from a conscious belief in a drug but also from subconscious associations between recovery and the experience of being treated—from the pinch of a shot to a doctor’s white coat. Such subliminal conditioning can control bodily processes of which we are unaware, such as immune responses and the release of hormones.”

When Placebos Work BETTER Than Medical Treatments …

There are a few glaring modern-day examples that show just how powerful placebos can be … and how misleading some medical advice can be.

One has to do with antidepressants, which are one of the most prescribed drugs in the United States. Antidepressant drugs have been proven to be no more effective than sugar pills. Some studies have even found that placebo pills may produce better results than antidepressants!

Personally, I believe the reason for this astounding finding is that both pills work via the placebo effect, but the sugar pills produce far fewer detrimental side effects, making them far preferable to the antidepressants.

Another example of the power of the placebo effect was published in the classic New England Journal of Medicine knee surgery study.
This was, without question, one of the most amazing studies I have ever seen published, as it definitely proves the power of your mind in healing.
This double-blind, placebo-controlled, multi-center trial performed at some of the top U.S. hospitals found that most knee surgery results in a $3-billion hoax. It is not actually the surgery itself that is responsible for the improvement, but rather is the placebo effect. More precisely, it's the ability of your brain to produce healing when you believe it should be happening (such as after you receive knee surgery).

Placebo-Controlled Studies May be Next to Worthless …
It was over 50 years ago, in 1955, that anesthetist Henry Beecher’s paper “The Powerful Placebo” was published in The Journal of the American Medical Association. This was the first to bring up the very real fact that simply taking a pill or receiving treatment (even if it was “fake”) could prompt healing changes.

It was after this paper was published that the Food, Drug and Cosmetic Act was amended to require drug trials to use placebo control groups, and the “double-blind, placebo-controlled, randomized clinical trial” that is still used today was a result of Henry Beecher’s work.

What you need to be aware of, though, is that many placebos being used in medical studies may not be of the inert or beneficial variety. It’s very possible for a placebo to contain suspect ingredients that cause their own set of health issues -- issues that make the drug or other treatment being tested look better or safer than it actually is.

So unless a study discloses its placebo ingredients, and those ingredients are truly inert, a placebo-controlled study really can’t be trusted.

So when your conventional physician recommends the latest blockbuster drug or medical treatment, be sure you keep this in mind. Even if it’s been tested rigorously in a “double-blind, placebo-controlled, randomized clinical trial,” the results may not be what they seem.

And the possibility of a skewed placebo is only one way in which a medical study may be flawed. There are many other ways, too, and you can read more about the heavily manipulated process that modern medicine regards as science here.