the validity of medical studies

Below is an article written by Jon Barron, an expert in alternative medicine. The first part is about the proposed health benefits on an active lifestyle vs. that of a sedentary lifestyle. On the surface it all makes sense, but as Mr. Barron goes on to point out, medical studies can have gaping flaws within them.

I re-printed this post from his web site, jonbarron.org because I think it is important for those of you who surf the internet looking for answers to medical questions (including this site) to be aware of the fact that many medical studies may be flawed for a number of different reasons. Some of the reasons may be as simple as flawed assumptions or premises to more sinister reasons like greed.

The study below is a good example of a conclusion drawn based on incomplete assumptions. Read it, then read Mr. Barron's essay on medical studies. Hopefully, you will find them enlightening as I did.

Sitting Versus Lifespan

Several weeks ago, the American Journal of Epidemiology published a study entitled "Leisure Time Spent Sitting in Relation to Total Mortality in a Prospective Cohort of US Adults."A shortened title might have read, "The More You Sit, the More You Die." As might be expected, it rippled through the wire services. And why not? It offered catchy headlines and high shock value -- just what the media craves these days during the decline of investigative journalism and the rise of wire service paraphrasing. Check out some of the headlines:

* Study Links More Time Spent Sitting to Higher Risk of Death

* More Time Spent Sitting Linked to Higher Risk of Death; Risk Found to Be Independent of Physical Activity Level

* The Longer You Sit, the Shorter Your Life Span

Then again, why it should receive so much press is curious since it's merely a repeat of a number of previous studies.

For example, there's the Australian study released earlier this year that demonstrated that Prolonged TV Viewing Linked To Higher Risk Of Death Even In Regular Exercisers

Or the study published last year in Medicine & Science in Sports & Exercise titled Sitting Time and Mortality from All Causes, Cardiovascular Disease, and Cancer.

In any case, despite all the drama, and despite the fact that all of these studies seem to make an undeniable case for the conclusion that sitting increases mortality regardless of whether you exercise or not, they are not as cut and dried as they might first appear. And in fact, as with many such studies, they contain holes so big in their methodology, you could drive a fleet of trucks through them. Talk about déjà vu! Didn't we just cover this same issue a mere three months ago when we examined the European Prospective Investigation into Cancer and Nutrition (EPIC)? We most certainly did!

So now let us examine this latest study and explore the giant holes in its methodology to see what "supportable" conclusions might actually be drawn from it and how you can use those conclusions to save your life. The study: sitting time in relation to mortality

As stated in the study's premise, it is now well established that the U.S. obesity epidemic will have major public health consequences and that the epidemic is attributed, at least in part, to reduced overall physical activity. It has long been recognized that physical activity has a beneficial impact on the incidence and mortality of many chronic diseases, including cardiovascular disease, diabetes, stroke, and various types of cancer. The premise, then, went on to state that it was the study's intent to refine those conclusions by better assessing the relationship between time spent sitting and total mortality, both independent of, and in combination with, physical activity.

To accomplish their objective, the researchers analyzed the data compiled by a study of 1.2 million U.S. adults conducted by the American Cancer Society. Starting in 1992, participants in this study, who were all 50-74 years of age, completed a 10-page questionnaire that included questions on demographic, reproductive, medical, behavioral, and lifestyle factors. From this group of 1.2 million, the researchers culled out a subgroup of 53,440 men and 69,776 women, who were disease free at enrollment, to examine the relationship of leisure time spent sitting and physical activity as they related to mortality over the 14 years of the study. The subgroup was culled out by adjusting for potential mitigating factors such as people who already had a personal history of cancer, heart attack, stroke, or emphysema at the time of enrollment, since they would likely be less active by definition and would have higher mortality rates out of the gate. Likewise, smokers and people who were obese were omitted, as were people who died within the first year and people with other, similar, negative qualifiers. In the end, the researchers identified 11,307 deaths in men and 7,923 deaths in women that occurred during the course of the study and which were suitable for analysis.

They found that people who spent more of their leisure time sitting had a higher risk of mortality, particularly in women. Women who reported more than six hours per day of sitting were 37 percent more likely to die during the time period studied than those who sat fewer than 3 hours a day. Men who sat more than 6 hours a day were 18 percent more likely to die than those who sat fewer than 3 hours per day. The association remained virtually unchanged after adjusting for physical activity level. Or to put it another way, intense physical activity during the other hours of the day could not mitigate the risk associated with prolonged sitting. It merely prevented it from getting worse. To be sure, when combined with a lack of physical activity, the association was even stronger. Women and men who both sat more and were less physically active were 94% and 48% more likely, respectively, to die compared with those who reported sitting the least and being most active. Associations were stronger for cardiovascular disease mortality than for cancer mortality.

Bottom line, at least according to the study, sitting for several hours a day during your leisure time increases your risk of dying independent of all other factors. Problems with the study

It is amazing how asking one little question can be like opening Pandora's box -- creating a world of doubt concerning the study's conclusions. What question?

* What were people doing while they were sitting, and where were they doing it?

The one question opens up a ton more that the study never addresses and could have a profound impact on its conclusions. For example:

* What were people doing while sitting? Were they watching TV or reading a book or drinking beer while sitting? Do different activities produce different outcomes?

o If they were watching TV or reading a book, what were they watching or reading? Does watching depressing soap operas day in and day out produce different outcomes than watching feel good comedies that make you laugh out loud?

o Were they listening to music? If so, was it grunge rock or Mozart?

o Were they killing time talking about the glory days with friends, or locked in deep prayer and meditation?

* Were they sitting outside in nature, or indoors surrounded by a number of wires and devices pumping out 60 Hz electromagnetic waves?

* When the study talks about being physically active, it does not differentiate between the different types of physical activity -- all of which produce different effects and provide different health benefits for the human body.

* Etc.

Do these things matter? In fact, numerous studies suggest that they do -- a great deal. Let's take a quick look at just a few of these factors.

Laughter

Quite simply, laughter causes physiological changes that promote healing. Perhaps the best known example is Norman Cousins, who cured himself of life-threatening ankylosing spondylitis by watching an endless stream of comedy films. He documented his journey in his book Anatomy of an Illness. In this case, the right kind of sitting saved his life.

Rock music

We've known for some time that music is a powerful relaxation tool. Music can decrease anxiety levels, lower blood pressure and heart rate, and change stress hormone levels. It affects your respiration, reduces muscle tension, increases endorphin levels, and boosts your immune system. The effect of music is so powerful, hospitals around the world use music to reduce stress in patients waiting for surgery.

But keep in mind that fast musical tempos increase heart rates, blood pressure, and respiration. Slow tempos reduce them. And then the body consolidates these changes during the silence in between.

The bottom line is that the music you listen to affects your health -- positively or negatively.

Prayer

In fact, there are almost two dozen studies that feature high-quality methodologies that analyze the impact of prayer on health. Of these studies, 57 percent found significant results supporting distant prayer's beneficial effects. And as for those people who depressingly sit around thinking their best days are behind them, depression has been shown to have a major adverse impact on health.

Electro magnetic fields

And now we come to an element ignored by the study that could potentially produce a profound effect on the study's outcomes, which is where people are spending that time sitting. There is a marked difference to the body as to whether you're sitting outside in nature, or inside, in a high tech environment, surrounded by computer equipment, duplicating machines, or television sets and walls riddled with electric wiring. (Keep in mind, this study took place during the era of cathode ray tube monitors, not LED and plasma screens.) In your home, there is also a marked difference in EMF levels depending on which room you sit in -- a living room, or an entertainment room. And again, the difference is determined by the amount of exposure to electromagnetic fields (EMF).

Make no mistake; this is not alternative health mumbo jumbo. There have been numerous studies demonstrating the profound negative effects produced from exposure to 60 cycle per second electric fields. These range from studies demonstrating increased mortality in mice -- through three generations, no less -- to negative changes in the endocrine system, including, notably, reductions in melatonin production. But the most profound impact may happen in the blood, both to the immune cells circulating in the blood to the very consistency of the blood itself. Continued exposure to EMFs causes immune cells to shrink and become less active. It also causes blood cells to shrink, become misshapen, and clump together. The net result is a dramatic reduction in the oxygen carrying capacity of the blood along with an increased tendency to form blood clots -- all of which means an increased risk of heart attacks and higher mortality rates.

Any study that talks about the effects of sitting but that doesn't account for where that sitting might take place, is seriously flawed. Indeed, if you were standing and physically active in that same negative environment, you would likely see the same mortality rates.

Exercise

Walking produces different physical outcomes then jogging. Plain aerobic exercise produces different outcomes than interval training. And weight lifting produces different results than yoga, tai chi, or rebounding. Any study that references physical activity and doesn't account for these differences is significantly compromised. For more on the different types of exercise and their varying health benefits, check out The Need for Exercise. Conclusion, mitigating the effects of prolonged sitting

The bottom line is that we know that prolonged sitting is harmful. The issue the new study brings into question is whether or not vigorous exercise mitigates that harm or not. At the very least, these studies say that physical activity at least prevents further harm. That's something! But they also say that activity doesn't undo the harm. For many people, this amounts to a death sentence since their jobs or activities require hours of prolonged sitting -- if it's true. The problem is that the methodologies incorporated in these studies don't tell us that for sure. And in fact, logic dictates that the conclusions are at least partially, if not completely, erroneous.

So what can be done to reduce the harmful effects of prolonged sitting?

First of all, exercise. Despite the spin many news agencies have given the study, physical activity is important. As the study says, although intense physical activity during the other hours of the day could not mitigate the risk associated with prolonged sitting, it did prevent it from getting worse. That is no small benefit in itself. And when you exercise, find a regimen that allows you to incorporate all different forms: cardio, aerobic (particularly in the form of interval training), weight bearing, stretching, resistance breathing, and balance. Each one benefits the body in different ways. To reduce mortality rates, you want all the benefits. As the saying goes, "You're only as strong as your weakest link." But truth be told, the reality is that the right types of physical activity really do reverse the effects of prolonged sitting. Too bad the study didn't actually differentiate activities in that way.

Then there's diet. If you're sitting a great deal, then choosing a diet that keeps blood flowing and that complements exercise's ability to cleanse the lymph system is that much more essential. Assuming that you're not smoking, simply changing your diet to a Mediterranean diet can cut your mortality rates in half. That alone more than offsets the increased mortality rates associated with sitting.

And finally, you need to neutralize your exposure to EMFs. There are multiple devices available on the internet that can accomplish this. To better understand how they work, check out Healing Energy, Part 1. Probably the best known device of this type is the Q-Link.

The Q-Link is not the only device that does this. There are a number of other choices on the market sold both retail and through network marketing companies. But, in fact, you can accomplish much the same changes in your blood using a good antioxidant, or my favorite, a good proteolytic enzyme formula. Conclusion

So, where does that leave us? What can we take away from this discussion?

Well first let me point out, if it wasn't obvious already, that this newsletter isn't really about the sitting study. That was merely a launching point for a discussion of studies in general. And, in fact, 90% of the newsletters and blogs I do about studies are not really about those studies -- but, again, use the studies as launching points for more philosophical discussions.

In this case, the meta topic is not "sitting" but, rather, the reliability of studies themselves. This is a topic I've covered many times before, but it needs to keep being brought up because people have become conditioned to think of studies as the absolute validator of the scientific world. I don't know how many times we've received questions at the Foundation that say something like, "Well, if this herb or formula is so effective, where are the studies to back it up?"

And yes, studies have value. But they are not the be all and end all of validation. There are many, many ways that studies can go astray. For example:

* The "sitting" studies we've discussed today, as well as the EPIC study we explored several months ago, are fatally flawed out of the gate because their methodologies did not include key data. This is an incredibly common problem. In the past I've cited beta carotene and vitamin E studies that don't differentiate between natural and synthetic forms of the tested supplements or Echinacea studies that use the wrong part of the plant or the wrong dosage in their testing.

* Oftentimes so called studies are not studies at all, but rather reviews of previously conducted studies. Referred to as case control studies, or meta analysis, they're only as good as the studies they reference. This can reach the heights of nonsense when the researchers conducting the meta analysis are the same researchers who conducted the flawed studies they are now referencing. Absurdum ad infinitum! The bottom line is that when the same people keep publishing negative studies and citing their previous flawed negative studies as proof of their new conclusions, you've got to question the validity of those conclusions.

* Another major problem is that even if the data gathering and tabulating are accurate, the researchers may end up inserting their personal biases when it comes to interpreting the data -- thus negating the accuracy of their data collection. We saw this problem insert itself in the calcium study that we analyzed in our last newsletter. And make no mistake, this problem is not restricted to the medical community. In the alternative health community, we are fully capable of doing the same thing. Again, take a look at last week's newsletter on calcium. I felt the data was accurate, but that the researchers' conclusions as to why it was accurate were questionable. My good friend, Mike Adams' NaturalNews site, on the other, questioned the actual data based on what they saw as a faulty methodology. This led to two diametrically opposed recommendations for calcium supplementation. Go figure!

* Doctors and researchers are not gods; often they are all too human and are hardly disinterested third parties. They have every reason in the world to promote their expertise. One hopes they can hold this urge in check, but sometimes they can't. And when taken up a notch, this can lead to out and out fraud. If one digs a little, the internet is riddled with countless stories of doctors who falsified study data to produce results that advance their interests -- whether ego related, or financially motivated. And one does not have to dig very far to find them. In fact, just a couple of years ago, the groundbreaking stem cell research of Hwang Woo Suk was found to be based on fabricated data.

* When researchers are financially supported in a manner that presents a potential conflict of interest (such as by a pharmaceutical company paying the researcher to study one of their drugs), they are required to announce that as part of their submission for publication. Unfortunately, this doesn't always happen. In fact, according to the New England Journal of Medicine, non-disclosure is surprisingly common. When money speaks, conflict of interest is never far off.

* And then of course, there are the studies that are just plain made up. Earlier this year, Dr. Scott Reuben, a former member of Pfizer's speakers' bureau, pled guilty to faking dozens of research studies that were published in medical journals. He cited data from studies that he'd never even conducted that "proved" the efficacy of the drugs in question. How cool is that! All kidding aside, this is not a one-off. It happens more often than you might think, and you never hear about it. Even more disturbing is that once these fake studies are published in peer review journals, they are often cited as proof, support, and references by subsequent studies. "Fruit of the poisonous tree," as they say in legal terms.

* One of my favorite issues is when multiple studies prove diametrically opposed points of view. We saw this with years of studies on hormone replacement therapy (HRT). "It's safe." "It's not safe." "It's safe." Etc. Doctors must love this since they can find support for whatever opinion they harbor. Unfortunately, this leads to problems such as even when HRT is proven unsafe, doctors continue to prescribe it with gay abandon.

Skeptical? So, am I saying that no study is to be trusted? Not at all -- only that peer reviewed studies are not quite the gold standard they are said to be. Take nothing for granted. Take no study you read in the news or see on TV at face value -- particularly if no contradictory point of view is presented as part of the story. That just means that the reporters performed no independent confirmation on the study -- but merely paraphrased what the researchers announced to the wire services. (The death of investigative journalism.) And don't be too dismissive of anecdotal evidence, the heart and soul of alternative medicine. Which would you rather rely on, a peer reviewed study with falsified data or 3,000 years of anecdotal evidence from millions of people supporting the use of garlic as an antipathogen. And keep in mind, when it comes to anecdotal evidence, doctors are more than happy to rely on reports from just one or two other doctors when it comes to prescribing a drug for off-label use. What kind of double standard is that?

In any case, when it comes to your health, question everything -- even what I tell you.

Jon Barron, August 2010

jonbarron.org