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Accused of Lying about ASEA: Not Guilty

I wrote about ASEA in August, 2012. To quote the company’s website, “ASEA is trillions of stable, perfectly balanced Redox Signaling Molecules suspended in a pristine saline solution—the same molecules that exist in the cells of the human body.” Molecules that supposedly have all kinds of antioxidant benefits for health and for athletic performance through “redox signalling.” They claim it is “a mixture of 16 chemically recombined products of salt and water with completely new chemical properties.” But they never specify exactly which molecules those are, what they mean by balanced, or how they can determine that they remain stable. The product label only lists salt and water. If those 16 recombined molecules are really in the product, the FDA can and should act against them for false labeling.

An ASEA distributor (part of the company’s multi-level marketing cadre) recently wrote an e-mail, not to me, and not to the editors of SBM, but to an assistant editor, to demand that my article be taken down, or that at least the comments for that article be re-opened. Since the e-mail was not sent to me, and I don’t have the writer’s permission, I won’t name him or quote him directly but will paraphrase what he said. He said my article had prevented thousands of people from benefitting from the health effects of ASEA. Thousands? I don’t think I’m that influential; I only wish I were! Anyway, it has not been established that ASEA offers any health benefits. He complains that I don’t have any evidence that ASEA doesn’t work, and of course I don’t. The burden of proof is not on me to prove it doesn’t work, but on those making the claims to prove it does.

He says there is real scientific evidence showing that it does work. My article said there was nothing about ASEA listed in PubMed, and he countered that there are 102 mentions. I was skeptical, so I checked for myself. What I found left me rolling on the floor in paroxysms of laughter.

There are indeed 102 citations on PubMed when you search for “ASEA”:

  • 84 of them were listed because they were written by an author whose last name was Asea!
  • 2 were about alfalfa extracts
  • 1 about acoustics
  • 1 about nuclear power plants
  • 1 about percutaneous coronary intervention for heart attacks
  • 1 about the response of Bacillus subtilis to metal ion stress
  • 1 about radiotherapy for glioma
  • 1 about coronary angiograms
  • 1 about training surgeons
  • 1 about ceramics to repair skull bone defects in a rabbit
  • 1 about another kind of “ASEA”: Alkaline soluble Trypanosoma cruzi epimastigote antigen
  • 1 about balancing corporate power
  • 1 about industrial robots
  • 1 about the driver’s cab in the Rc5 engine
  • 1 about electromyography
  • 1 about industrial robots
  • 1 about an enzyme in the white bloods cells of cattle
  • 1 about back disorders
  • 0 (that’s ZERO) about the product ASEA or even with any remote connection to redox signaling

And the dates of these articles go back to the 1950’s. According to the company’s website, ASEA wasn’t invented until 6 years ago.

I am still flabbergasted. What was he thinking? Did he even bother looking to see what the articles were about, or did he simply stop reading after he located the number of citations? Did he think we would take his word for it without looking? Does he think the number of citations for a search word means anything about the efficacy of his product? Apparently he does, since he goes on to cite the 11,121 mentions of “redox signaling” on PubMed. So what? There are 20,292 citations for homeopathy. There are 1,665,853 citations for “bacteria;” perhaps he imagines that citing those numbers would be sufficient to prove that any new antibiotic was effective.

One controlled human study

The company website brags about a 2012 study done in the Appalachian State Human Performance Laboratory in North Carolina. The e-mail writer emphasizes that the laboratory and the researchers were reputable, and that the company agreed to publish the results of the tests regardless of whether the findings were favorable. I don’t question any of that. I do question the results and significance.

It was a double blind crossover study of 20 cyclists. Athletes drank either 4 oz of ASEA or a placebo daily for a week. They measured VO2Max, body composition, and 43 metabolites before and after strenuous exercise. Compared to those on placebo, the group taking ASEA had higher levels of myristic acid, palmitic acid, oleic acid, stearic acid, palmitelaidic acid, capric acid, glycerol, lower levels of 7 amino acids, higher levels of fumarate, citrate, and malate, lower levels of ascorbic acid, fructose and threonic acid, and increases in aminomalonic acid, serum creatinine and urea. These are all reported as “least square mean area” (why?) and no measure of significance is provided (why not?).

They found that ASEA did not cause any changes in creatinine, BUN, bilirubin, alkaline phosphatase, AST and ALT; these are reported in mg/dl and “treatment x time p-values” are provided, ranging from 0.7717 to 0.9971. You will notice that creatinine is listed as both higher and as unchanged: it was higher by least square mean area but not by mg/dl.

The study was not published except in the form of slides and videos on the company website. I don’t know whether it was ever even submitted to a peer-reviewed journal for publication; but if it was, I think any reviewer worth his salt would have sent it back for significant revision. They said they knew they could not publish without first analyzing ASEA to see what was in it, and they said their analysis found “signaling molecules,” one of which was a superoxide. They don’t tell us which superoxide or what the other molecules were. I doubt if that would be enough to satisfy any journal editor. At any rate, before we can say anything about such a study it must be published so other experts can review it and offer comments and criticisms and can attempt to replicate the study if they are interested; that’s how science works. The information that they provide online is insufficient to judge the quality of the study. They don’t describe their methods in the detail expected for a published study, and we don’t know whether subjects could distinguish ASEA from placebo by taste, or what their previous experience and beliefs about ASEA were.

What does it mean?

What does all that data mean? I have no idea. The researchers themselves professed to be completely surprised by their results, which they did not expect from what they knew about the effects of the redox signaling molecules that they presumed were in the product. But of course that didn’t stop them from speculating about ASEA’s mechanism of action and its possible clinical benefits. When a study gives such unexpected results, it is prudent to question whether they might be spurious. There are any number of things that can go wrong in a study to generate false findings.

We need to hear from experts in the field who can comment on what these results might mean and whether the study methodology and statistical analyses were appropriate. This was an unpublished, small, preliminary “pilot” study; this kind of study is all too often followed by larger, better studies that reverse the findings. Studies like this are not sufficient to guide clinical practice; all we can do at this point is to suspend judgment and wait for further evidence. Customers who rely on this evidence might want to ask themselves whether they would want to take a prescription drug if the evidence from human trials consisted of a single trial with 20 patients.

I would want to ask those experts about some additional things. They found elevated levels of free fatty acids (FFAs). Is this a good thing? FFAs are elevated in obesity; they cause insulin resistance and may play a role in coronary atherosclerosis. Elevated levels suppress muscle glucose transport, leading to reduced muscle glycogen synthesis and glycolysis. Lowering FFAs should help treat obesity and type 2 diabetes. If this effect of ASEA is real, wouldn’t it be possibly harmful? How accurate are the measurements? I found one comment that “It is very easy to generate FFAs artefactually by faulty storage or extraction.”

Patents

My critic says they have “a boatload” of patents. I guess so, if you define a boatload as 4 (maybe it’s a small boat); but the existence of a patent says nothing about whether the product is effective. The company tells us that the foundational technology for ASEA is completely protected by US patents 5,507,932; 5,674,537; 6,007,686; and 6,117,285. It’s easy enough to look them up by number in the patent database. I did, and I found nothing about ASEA or about generating redox signaling molecules.

  • 5,507,932 This patent is for an apparatus for electrolyzing fluids, to produce disinfecting agents such as chlorine and ozone.
  • 5,674,537 Electrolyzed saline solution containing concentrated amounts of ozone and chlorine species for in vitro treatment of microbial infections.
  • 6,007,686 An apparatus for electrolyzing fluids to disinfect blood, dental drills, and other materials.
  • 6,117,285 A system for carrying out sterilization of equipment.

These patents say nothing about ASEA or about a unique proprietary method of producing redox signaling molecules. They simply show that the company has patents on a method of electrolysis that offers some advantages for the production of chlorine and ozone. Whoa! Those substances are toxic. There is no evidence to support their claims that the molecules in ASEA are the same ones as in the human body, that they have been somehow stabilized in solution (this would be very hard to do, since they are very reactive molecules), that the “clusters” described on their website exist, that the solution is “balanced” in any sense except in the trivial one that electrolysis necessarily produces equal numbers of positive and negative ions, that it produces “16 chemically recombined products of salt and water with completely new chemical properties,” or that it has any health benefits for humans.

Safety data

They claim that ASEA is “Safer than water” (?!) but they have no evidence to support that claim. They list the safety studies here. They are studies in cell culture of hamster ovary cells, bacterial cells, rabbits, several beagle dogs, and some mice. They have not studied safety in humans. If, as I suspect, ASEA amounts to nothing but salt water, adverse effects would not be expected unless large quantities were ingested. Again, I would ask customers if they would be willing to take a prescription drug that had not been shown toxic to animals but that had never been tested for safety in humans.

An analogy

This study attempted to show that there must be therapeutic molecules in ASEA because it “did something” to 43 metabolites. It reminded me of a study for Vitamin O. The product supposedly contained oxygen, but independent laboratory analysis found no oxygen in it. The company argued that there was so much oxygen in it that it didn’t register on the machines! So they did an experiment to show that there must be oxygen in vitamin O because vitamin O raised the abnormally low blood oxygen pressure (PaO2) of anemic patients (even though PaO2 is not abnormally low in anemia). The study was perhaps the most flawed one I have ever read. They got results that were not only “surprising” but impossible, given what we know about physiology.

More criticism

The e-mail writer goes on to use the fallacious argument from popularity (lots of happy customers) with no understanding of how people might come to believe an ineffective product is helping them. Apparently he doesn’t realize that water scams and quack remedies all have plenty of testimonials from grateful customers. He accuses SBM of being in the business of publishing lies, and he suggests we are doing it for the money (!?), which is pretty ironic given that he is the one selling ASEA to make money and SBM writers are not paid.

Conclusion

Did I lie? I don’t think so. I may have been guilty of a mis-statement in saying there were “no” placebo-controlled studies; but there certainly were no published placebo-controlled studies, which, for the purpose of scientific evidence, amounts to the same thing. I still have no reason to think ASEA is anything more than expensive water.

Now that I have written a new article, my critic and his fellow ASEA distributors and their customers are welcome to join in the comments. They may want to further demonstrate the level of ignorance that led him to cite the irrelevant 102 PubMed articles. I didn’t particularly want to write about ASEA again, but that was just too delicious not to share. I’m still laughing about it! It’s almost enough to make me wonder if ASEA causes brain damage…

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