clinically provenClinically proven! We’ve all heard it trumpeted across the airwaves for health products.

Just the other day, I saw an advertisement on television for a metabolism booster pill which claimed to be “clinically proven” to work.

But wait! What does “clinically proven” actually mean anyway?

There are a number of aspects to consider in answering this question, so I’ll list them out point by point:

 

“Clinically proven” definition

First and foremost, within the realm of health product advertising, there is no official definition or regulation of the the terms “clinically proven.”

This can mean different things to different people and is often used by marketers to give a deceptive stamp of approval to a product which, in many cases, has no legitimate scientific evidence to support its efficacy.

Clinically proven? Says who?

When they say “clinically proven,” your first question should be, “oh yeah, says who?”

It is possible the company selling the supplement or infomercial ab gimmick did a poorly controlled “study” where they had people try the product and then tell the company about their results.

While this seems logical enough, it does not constitute legitimate research. Real research requires very careful and meticulous planning, experimental design, strict methods, statistical analyses, and interpretation in order to ascertain if, in fact, any results were due to the intervention (i.e., the supplement or exercise).

Two random examples (click images to expand):
clinically proven?

Clinically proven?

Research context

Research must be put into context.  Real research, as described above, must be carefully interpreted and applied to different life situations (i.e., is it relevant?).

For example, a study which used a VERY large dose of a dietary supplement to elicit relatively small reductions in body fat in morbidly obese middle-aged women living in a metabolic ward is VERY different from an 18 year old athletic male university student taking one-tenth the dosage of the same supplement.

The reason you can’t compare the two is because a morbidly obese middle-aged woman living in a metabolic ward is going to have a very different physiological response than a young, healthy, fit male university student.

Then consider the experimental dosage. The women in the study used a large dose where the university student used only a fraction of the dose.  It’s the same thing as taking 800mg vs. 8mg of ibuprofen for a headache.  You expect the 800mg to do something but, in all honesty, you don’t expect a Pink Floyd laser light show from the 8mg.

Were the results published in a journal?  

Scientists often prefer to see the results of studies published in peer-reviewed medical journals.

What does this mean in practical terms?  It means that the study and all its methods, results, and discussion have been reviewed by experts (peers) in the respective area of research under which that study falls.

These experts systematically dismantle the study, rake it over the proverbial coals, and try to blow holes in it, find weaknesses, and expose it for junk science. If it survives that, then it is accepted for publication (usually with suggested revisions).

The value of this process is that it shows the scientists conducting the research have been rigorous in their experimental protocols and that the research is worthy.

Research that isn’t worth its salt

Sometimes research is conducted but it never appears in a peer-reviewed journal.

There are a number of reasons for this but, in many cases, the work WAS submitted but was not worthy of publication.  Other times the research is not submitted for review at all because the scientists know it isn’t up to scratch.

“Clinically proven” is unregulated

As I said above, there is absolutely ZERO regulation of the terms “clinically proven” so marketers have a number of options for hoodwinking the general public.

Marketers can cite junk science which isn’t worth the paper upon which it’s written.  This is when they do an impromptu survey of their “satisfied” users and ask them for their subjective opinions.

There are no experimental controls so we have no real way of knowing the “results” were from the product or other uncontrolled factors (i.e., they started eating less and exercising more).

They cite legitimate peer-reviewed research but it is completely irrelevant or a major stretch to the product for sale.  As stated above, they cite research from morbidly obese women but they’re marketing it to young athletic men.

They cite a single study which may relate to their product but it has methodological flaws.  Usually limitations are mentioned in the study regarding the real life applicability of the results, but companies looking to make a buck often fail to disclose these limitations.  Not very ethical.

They cite a single study which might have solid methods and is published in a high quality peer-reviewed journal.  However, one single study is not a conclusive body of evidence to go and make sweeping claims that something is “clinically proven.”

Responsible scientists like to see a number of studies using different dosages across different populations in order to get some sort of scope on the relative effectiveness of a product.

The bottom line
In closing, it is very much a case of buyer beware.  “Clinically proven” might sound all flashy but when it comes to making a buck, you have to switch on your bullsh*t detector and do your own investigation.  Trust your instincts.  If a pill, potion, or gadget seems too good to be true, then it probably is.