My attention was recently drawn to another dietary supplement product with pretty dramatic claims, this time for treating both oral disease (gingivitis and periodontal disease) and joint disease (osteoarthritis). As usual, the company web site and promotional materials are unequivocal about the benefits you can expect.
Comprehensive oral health care is now a reality!
Safe, No Side Effects…Only Side Benefits
A truly major advancement…
Far more effective and much faster acting than current natural joint products
Of course, there is the usual disclaimer, which one presumes is present because the company has not met the FDA requirements for making health claims:
This information is presented for informational purposes only and is not intended as an endorsement of any product. The information is not intended to be a substitute for visits to your local veterinarian. Rather, these testimonials / research pages and/or case studies offer the reader information written by pet owners and/or veterinarians concerning animal health and products that have shown results.
It is hard to imagine anyone actually claiming this information is “not intended as an endorsement of any product” given that the context is entirely product advertising, but that’s a relatively minor example of the weird things that happen when one tries to advertise a health care product not approved by the FDA as a health care product.
Several of the warning signs of bogus claims are present, including:
Claims of a major scientific breakthrough, initiated by a hunch or guess and an uncontrolled personal experience
Support for these claims primarily through testimonial and anecdote
Reference to scientific proof with few details
Claims of great benefits with absolutely no side effects
A money back guarantee
And while science is often used as a marketing point, this company goes farther, making several references to evidence-based medicine and making a number of statements about the need for meaningful scientific evidence with which I agree completely:
[this product is] not just another one of the multitude of unproven joint products, as it is also evidence-based. This is an often used term and at the same time an often abused term. As an example, we often see “contains clinically proven ingredients” In reality this usually implies that the actual product was in fact never tested clinically.
Esterified oils are the only evidence-based product for gum or periodontal health.
There is scientific support for natural approaches, but at the same time there are a lot of half truths and at times totally misleading statements made in order to sell products. We will let the science speak for itself.
The company also aggressively challenges the usefulness of what they appear to see as their major competition for the arthritis supplement market, glucosamine products. And here again, they make a case I am in complete agreement with about the lack of clinically meaningful, proven benefits for glucosamine supplements*:
It is quite amazing that so many people, including physicians just assume that glucosamine is effective. This is understandable when we consider how much joint health advertising that takes place. The sad reality is that in well controlled clinical trials that the placebo pills produced just as good effects as glucosamine.
Advertisers have frequently referred to GAIT and the 72 patient’s that seem to benefit, but they fail to mention the other 95% of trial participants or the fact that this 72 patient group went on to experience more cartilage loss than placebo.
So let’s take a look at this “evidence-based” product, what it is and what the evidence says about it.
What Is It?
The exact active ingredient in the product is listed as a “proprietary blend” of an “esterified fatty acid complex” from “beef tallow”. Esterified fatty acids are similar to other fatty acids, such as fish oils, with some chemical modifications. The other ingredients are a variety of vehicles and some compounds with Vitamin E activity, which are commonly included with fatty acid supplements since these tend to reduce Vitamin E activity in people or animals taking them.
Does It Work?
Given the heavy promotion of this as an “evidence-based” product, is there strong evidence to support the strong claims made for it? Well, not really.
The company claims, “EFAC has been studied with seventeen (17) animal and clinical studies, with six (6) studies presented at scientific meetings and six (6) published in pre-eminent scientific journals.” Of these, they provide links to 5 papers and once conference presentation, however all but one of the links are currently broken. It’s not clear what other studies they are referring to.
In terms of the use of esterified fatty acids in general (not this product specifically) for osteoarthritis, there are a few clinical trials that suggest some improvement in human patients with osteoarthritis. (1-3) These are the sort of small, early trials which can suggest a potential effect is worth investigating further, but the results often are not supported in larger, better controlled, and independently funded research. In fact, the clinical trial evidence supporting glucosamine as an arthritis treatment is far greater, and yet the largest and highest quality trials have turned out to show, as this company points out on their site, that there is not a real benefit. It seems a bit self-serving to correctly identify the weakness in the evidence for glucosamine and yet to aggressively promote their own product as “evidence-based” on the strength of far weaker clinical trial evidence.
As for the use of this product to prevent or treat gingivitis and periodontal disease, I have only found one related published paper, a report of a study involving the topical application of esterified fatty acids to the gums of 18 rabbits in which periodontal disease was artificially induced.(4) This is the sort of animal model study that is useful for providing proof of concept, but it is not appropriate to justify widespread clinical use in dogs and cats based on one laboratory study in rabbits. The company also claims a trial has been done in cats, and provides a testimonial from a veterinary dentist supporting the product, but apparently that study has not yet been published
The company also promotes the fact that they have been granted a patent for their product. This does not, however, have anything to do with whether or not it is effective. Evidence of clinical safety and efficacy is not required for a patent application, and patents have been granted for a wide range of bizarre and useless inventions.
Is It Safe?
A few safety studies in laboratory animals have been done and did not identify any hazards. I am also not aware of any reported side effects in humans or other species taking these supplements, though there does not appear to be any formal surveillance or reporting mechanism in place.
It is certainly possible that esterified fatty acids could have clinically meaningful benefits. There is no clearly established physiologic mechanism by which this would occur, but there are a few small clinical studies in humans suggesting a benefit for osteoarthritis and at least one animal model study suggesting some benefit for periodontal disease. There is no evidence of any risk at this time.
At this level of evidence, the proper assessment is that benefits are possible but unproven. Use of the product would certainly be appropriate in controlled research studies and situations in which established therapies are not available or tolerated. Substituting these products for established therapies is not appropriate. And, unfortunately, despite all the talk of being scientifically validated and “evidence-based,” the claims made for these products go well beyond anything justified by published scientific evidence. Such language indicates only a recognition of the marketing value of science and the term “evidence-based medicine,” not any qualitative difference between the level of evidence behind claims for these products and that supporting similar claims by other nutritional supplements marketed to treat or prevent disease.
*Articles I have written about glucosamine for arthritis
- Kraemer WJ, Ratamess NA, Anderson JM, et al. Effect of a cetylated fatty acid topical cream on functional mobility and quality of life of patients with osteoarthritis. J Rheumatol. 2004;31:767–74.
- Kraemer WJ, Ratamess NA, Maresh CM, et al. Effects of treatment with a cetylated fatty acid topical cream on static postural stability and plantar pressure distribution in patients with knee osteoarthritis. J Strength Cond Res . 2005;19:115–121.
- Hesslink R Jr, Armstrong D, Nagendran MV, et al. Cetylated fatty acids improve knee function in patients with osteoarthritis. J Rheumatol . 2002;29:1708–12.
- Hasturk H, Goguet-Surmenian E, Blackwood A, Andry C, Kantarci A. 1-Tetradecanol complex: therapeutic actions in experimental periodontitis.J Periodontol. 2009 Jul;80(7):1103-13.