Do clinical tests need a control group?

I came across this stuff. It is a dietary supplement that supposedly increases HGH levels. Unlike most quack sites*, this place at least reports their clinical trials (in the above link). However, the methodology leaves much to be desired AFAIC. There is no control group and there is nothing that mentions whether the levels of IGF-1 are subject to fluctuation because of other causes.

How much creedance do you put in this methodology never minding that the results aren’t in NEJM or other reviewed source.

*At least this isn’t that stuff on TV where they say their clinical results have been published in Red Book and Ladies Home Journal, both are peer reviewed publications, of course.

Zero.

Real drug trials involve a little nifty item called a placebo.

The scientific method requires a control.

I blame this all on Ronald Reagan.

Clinical research doesn’t have to be in NEJM or The Lancet to be credible – but it does have to appear in a peer-reviewed journal. Also, not all research requires a control to be scientific. Chemical synthesis, for example, doesn’t require mixing together solvents without reagents in order to prove the molecule in question won’t arise spontaneously. (At least, a control isn’t always required.) A lot of experiments in physics don’t require a control either.

That being said, clinical research, by its nature, lends itself well to controls, and controls are almost always required. Especially in testing the effectiveness of a drug. (Even surgical procedures involve a control where the patients actually receive ‘fake’ surgery – they’re anesthetized, then a ‘dummy’ incision is made and sutured.)

The methodology here is flawed. The lack of a control is the most obvious and probably most important flaw. But there’s also only one experimental group: the product the website is trying to sell. The tests should have been conducted with competitors’ products as well, to see how other supposed HGH-increasing supplements compare to this one. Perhaps more importantly, they should have had groups receiving each of the components of the product, and each combination of the components. Just from reading their results, I can predict that it’s quite likely that the ‘homeopathic HGH (Somatotropin)’ would have had no effect. Homeopathy is a widely discredited pseudoscience that has roughly as much merit as phrenology. The supplements that are ‘nothing more than simple amino acids that you could buy for a few pennies’ are probably just as good as GH+Releaser, because I think the actual results, if any, are caused by the amino acids.

One other thing that isn’t mentioned anywhere is whether the test subjects changed any aspect of their routine besides taking the supplement. If they changed their diet or sleep patterns or began an exercise regimen, the product may in fact do nothing at all. One thinks of the Ab* products that promised Great Results In 30 Days… if you follow the diet and exercise regimen included with the product. “Your results may vary.”

In some drug trials they are testing 1 drug vs. another so the “control” is actually a drug, not a placebo. This is normally when a new drug for a treatment is tested to see if it’s better than the current drugs available.

Also if the drug being tested is for a very serious illness such as advanced cancer, they will cut short the trial as soon as the treatment shows some promise - at that point the placebo people all get the new drug.

FWIW, there’s no theoretical reason to believe that any of the various HGH supplements actually work. My guess is that the designers of the study were very aware of that fact.

Especially if it’s homeopathic.

As an epidemiologist, I can say that I do not find the study reported on the linked web site at all credible. In my opinion the authors of that report did not know enough about a clinical trial to accurately describe one, let alone conduct it.

Of course, the report on the web page was probably written by marketers, but it should have been reviewed by a scientist. If there weren’t big red flags before that, that’s one.

In order to evaluate the efficacy of a medication or supplement, it is necessary to conduct a randomized clinical trial. A control or comparison group is essential. A well-conducted trial will usually be double-blinded, meaning that neither the investigator nor the subject will know which of the two conditions the subject was assigned to until after all the data collection is complete. Just putting the word “random” in the report is not sufficient.

There are plenty of resources for learning more about randomized clinical trials, so I won’t go on at length here.

My lovely wife is very smart and knows whereof she speaks.

And I’m sure you’re completely unbiased in your little assertion.

:smiley:

In my rather less educated view, a control is essential. Even if you don’t go so far as a double-blind with strict segregation of the researchers and the people administering the drugs, you still need a way to show that a placebo probably wouldn’t have done just as well as (if not better than) your Product X.

“Why are you selling me sugar pills? Where is the ultra-refined aquamemoized oak mould?”
“Well, ya see, when we ran the tests, the sugar pills worked a lot better.”

Thanks all for your input. It pretty much validates what I thought. I just wonder how many people are going to get suckered in and dump a boatload of money on those pills. They aren’t cheap. Then again, if somebody wants the fountain of youth in a pill (IE avoid exercise and smart diet) they probably get what they deserve, as long as the pills don’t kill anybody.

Oops, not Reagan, it’s all Clinton’s fault.