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JLeslie's avatar

What does clinically proven mean?

Asked by JLeslie (54488points) July 12th, 2012

I have noticed that a lot of commercials say that a product, usually a supplement of some sort, has been clinically proven. Is there any regulation or parameters set forth to be able to make such a claim?

The commercial I saw this morning was for a supplement to treat hot flashes.

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18 Answers

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DrBill's avatar

Clinically proven means the manufacture proved it does what they claim in a controlled environment. The other side of this is it is usually the manufacturer that runs, and oversees the test. If they use an outside firm to do the study then they can can use the word “Independent” in their claims. Most “non-slanted” studies will tell you who did the study. Another thing to consider is the product could have been tested 100 times and if it passes once, they can use the “clinically proven” tag on it.

marinelife's avatar

It means that it was efficacious in a clinical trial.

JLeslie's avatar

But not scientifically proven, right? It doesn’t rise to the level of what a scientist would consider proven, does it? I assume they aren’t double blind studies? And, do they need to use a minimum amount of particpants?

elbanditoroso's avatar

Not very much. The issue is that they don’t give you enough information to evaluate the claim. It could have been “Pop’s For Profit Liars Clinic” that did the testing and gave the product a gold star.

Basically, without names, numbers, and verifiable results, the words “clinically proven” are totally meaningless – they are marketing speak, but nothing more.

My own view is if some ad says “clinically proven” and that’s all, I figure they are trying to bullshit me.

bolwerk's avatar

@JLeslie: a clinical trial is a scientific process. A control group and treatment group are compared to see how well a treatment works. In the case of something medical, the control group probably gets a placebo.

Whether to believe those who claim their products are “clinically proven” actually went through a clinical trial is another question, of course. First of all, to say something is proven scientifically is rather incredulous to begin with – a scientific experiment, which is what a clinical trial basically is, should support a hypothesis, but not prove it. Second, they could be lying anyway.

JLeslie's avatar

@bolwerk Are you sure clinical trial means there is a control group? I understand that studies that have control groups go through clinical trials, but I am not so sure that term strictly means there was a control group.

nikipedia's avatar

@JLeslie, a clinical trial does have a control group. They are generally considered the gold-standard of medical research. One thing to keep in mind is that the “control” might not be a no-treatment or placebo group. If there is an established standard of care, and a new treatment is being tested, it is considered unethical to fail to provide the established care, so the new treatment would be compared to the old treatment, rather than to a group receiving no treatment.

That said, I am not sure if there is enough oversight to require advertisers who use the term “clinically proven” to mean “has been shown to be statistically significantly effective in a clinical trial.”

poisonedantidote's avatar

It means that for some reason they want to say “scientifically proven” but can’t. It’s trickery of some kind.

gasman's avatar

It means practically nothing. No reputable clinical scientist would ever claim a treatment is “proven.” The phrase is pure advertising hype, usually attached to the most dubious of products.

bolwerk's avatar

@JLeslie: it damn well better, or there is a serious safety issue with any conclusion drawn.

I concur with @nikipedia. “Clinically proven” seems more to be a marketing buzz word, and definitely not a meaningful medical term.

nikipedia's avatar

I did some research and I think I have to retract my previous statement. It appears that the FDA has very specific guidelines for what can be stated to be “clinically proven,” and that it enforces these. I had trouble finding the specific terms, but apparently it is regulated by the Federal Food, Drug, and Cosmetic Act. On the FDA website, there are numerous documents legally requiring companies to stop using the term “clinically proven” when they couldn’t justify it, including a warning letter to Cheerios and to Novartis regarding a motion sickness patch.

athenasgriffin's avatar

What I think people sometimes equate this with is drug trials. This is incredibly misleading, as in drug tests or academia, the entire proccess of the trial generally is submitted to a peer reviewed journal where other doctors or scientists or professors may redo the tests to confirm or deny the results, encouraging legitimate results. This is not true of “clinically proven” cosmetics or beauty potions.

Rarebear's avatar

In the context that you’re talking about, absolutely nothing.

JLeslie's avatar

My father used to approve federal grants for research for NIMH and my mom actually worked for the FDA, so I am aware of clinical trials regarding medication and medical methods, but it just seemed to me on these commercials clinical trial meant nothing, or could mean anything.

I really appreciate everyone’s answers. Thanks.

flutherother's avatar

I try to avoid advertisements. I think it means that the manufacturers legal advisors believe the company can use the phrase and not be sued.

RocketGuy's avatar

“Clinically proven to reduce cavities” – reduced relative to what, not brushing at all? You need the fine print to know what they are actually claiming. Usually it’s pretty tame, not breakthroughs.

WMFlight's avatar

Defined by the Urban Dictionary.

Clinically proven may mean virtually anything… including nothing. A “clinically proven” statement in advertising is an effective sales pitch, usually a vague claim that requires no hard evidence and isn’t easy to disprove. As long as the mandatory “These statements have not been evaluated by the FDA (...)” disclaimer is on the label, it’s not necessary to have competent and reliable scientific evidence to back it up.

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