What Does “Clinically Proven” Mean in Advertising?

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Clinically proven!

You’ve seen it plastered across health products and strategically peppered through advertisements and marketing scripts.

I recently saw an advertisement for a metabolism booster pill which claimed to be “clinically proven” to work.

But wait! What the heck 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 phrase “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.

Objective vs subjective evidence

When a product is claimed to be “clinically proven,” your first question should be, “oh yeah, says who?”

In the haste to rush to market, some companies may give their supplement, infomercial ab gadget, or balance device to a number of people and then solicit testimonials for advertising purposes.

Or the marketer may try a product on a small number of people in an unpublished pilot study.

While this may provide suggestive evidence that a product works, it can be subject to bias and does not constitute legitimate research.

Real research requires very careful and meticulous planning, experimental design, strict methods, statistical analyses, and interpretation in order to determine if, in fact, any results were due to the intervention (i.e., the supplement or exercise). Have a look at the Consolidated Standards of Reporting Trials statement which gives a deep dive into what is required for conducting and reporting randomised clinical trials.

Two random examples:

Also check out my Wonder Core Smart article and you’ll see how they ambiguously cite “university lab testing” but provide no details to corroborate this.

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.

Statistically “significant” but not practically meaningful

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

Back in the 1990s, I authored a comprehensive review of the marketing claims being made at the time around pyruvate, a dietary supplement being touted as a fat burner, performance enhancer, antioxidant, and cholesterol reducing agent (get the full article PDF here)

However, as I dug into the actual research from which the claims were being derived, I soon realised that it was all marketing sleight of hand. Many of the claims exaggerated the statistics where a seemingly large mathematical difference between pyruvate and placebo actually amounted to a very small and clinically unimportant real world difference.

Consider the research participants

In the case of pyruvate, grandiose weight loss claims were made based on two studies that included participants who were morbidly obese women confined to bed in a hospital metabolic ward for 21 days (except for using the toilet and kitchen) consuming a 500 to 1000 calorie liquid diet (Stanko et al 1992a; and Stanko et al 1992b).

The inherent limitation here is that the results of studies with such strictly defined criteria are not readily applicable to the general population at large. Women who are able to eat and move freely and may only have a small amount of body fat to lose will likely have a very different metabolic response to morbidly obese women confined to a hospital bed.

Dosage effect

Next, the dosages used in the pyruvate obesity studies was quite large compared to what was being offered to consumers.

For example, the women in the study consumed up to 28 grams of pyruvate which was in stark contrast to the smaller 3 – 5 g per day dosages of pyruvate provided by commercial supplements. In short, while it is true that large doses of pyruvate can elicit small changes in body fat in bed-ridden morbidly obese women, these results have not been replicated in free-living healthy weight women.

In 2014, a comprehensive systematic review and meta-analysis of randomised clinical trials concluded that the evidence does not convincingly show pyruvate is efficacious in reducing body weight.

Single ingredient vs whole product

It is quite common for health marketers to cite legitimate research conducted on a single ingredient in isolation and claim that it supports their finished product.

This is an important distinction because testing on a single ingredient is not the same thing as testing on the finished product. In many cases, the finished product has no scientific research whatsoever to support marketing claims. And further to the issue of dosage, while a single ingredient may have research that supports its efficacy in high amounts, including a tiny amount in a multi-ingredient formulation would likely not have the same effect.

Unregulated jargon

Buyer beware: there is absolutely ZERO regulation of the terms “clinically proven” so crafty marketers have a number of options for hoodwinking the general public.

Consider the following sleights of hand:

• Marketers can cite junk science or irrelevant studies published in a pay-for-play predatory journal.
• They can cite surveys of “satisfied” users’ subjective opinions. If they’re paid testimonials, then this raises other ethical concerns.
• Testimonials do not distinguish if the “results” were from the product or other uncontrolled factors (i.e., they started eating less and exercising more).
• They cite legitimate research but the study participants are not relevant to most free-living adults (i.e., morbidly obese women housed in a metabolic ward vs the average woman looking to lose a couple pounds).
• They cite a single study which may relate to their product but it has methodological flaws. 
• They may cite only the highlights of a study but fail to disclose the limitations listed by the study authors (which might work against their marketing efforts).
• They cite a single legitimate peer-reviewed study, but one single study is not a conclusive body of evidence to go and make sweeping claims that something is “proven” to work.

The bottom line

“Clinically proven” is a popular marketing buzz word but you have to arm yourself with knowledge about the hidden meaning.

As a general rule, “science-y” jargin might sound convincing but, in many cases, it’s just glossy marketing copy meant to sell products. I cover a lot of these claims in my article 37 Bullshit Health Marketing Phrases You Should Ignore.

Bottom line: Trust your instincts.  If a pill, potion, or gadget seems too good to be true, then it probably is.

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