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.
Bottom Line
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
Veterinary Glucosamine and Chondroitin
Growing skepticism about glucosamine for arthritis in dogs and cats
Is recommending glucosamine for arthritis evidence based medicine or wishful thinking?
Nope, glucosamine and chondroitin still don’t work in humans
Cognitive dissonance in action: Glucosamine no matter what!
References
- 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.
Thanks for another great article, Skeptvet.
I wonder though, whenever the term “no evidence of risk” is used, since supplements are almost always a proprietary ingredient blend, what of those ingredients, who knows what they include, and potential hidden risks of those ingredients not declared on a label for consumer evaluation. Such is the case with “natural” flea and tick products, “natural” skin and coat products, etc. I’m still confused where the FDA drug and cosmetic act comes in with the latter, concerning veterinary medicine/products, but what do we really know about all those proprietary ingredients in supplements?
You’re absolutely right. “No evidence of risk” certainly doesn’t mean “safe,” it just means there haven’t been any reports of problems yet. As I point out in the article, since nobody is looking in a systematic way, it’s hard to know if adverse reactions are being experienced and there is simply no record of it. I think it is fair to say that dramatic and direct toxicity is unlikely since there would probably be signs of this at the current level of use. But even with the extensive pre-market testing pharmaceuticals undergo, unexpected (or previously hidden) problems often emerge with post-marketing surveilance. With neither systematic pre-market testing nor any organized post-market surveillance, adverse evens could easily be overlooked.
So what IS proven to work for feline arthritis?
Very little. There has been very little clinical research on arthritis in cats, and it can be really difficult to assess pain in this species. As usual, part of the reason the area is so rife with bogus treatments is that there isn’t a perfect, safe and effective medicine available. This doesn’t mean it is a good idea to try anything that comes along. at owners have a tough choice between grasping at straws, which are as likely to harm as help their pets, or accepting that they can’t make their cats’ lives as good as they would like to. It’s a tough spot, and I understand why it drives people towards things like this.
The best evidence so far is for non-steroidal anti-inflammatory drugs, but unfortunately there are risks in older cats, who often have pre-existing kidney problems that make these drugs riskier than in people or dogs. Other pain medications (such as gabapentin, tramadol) are reasonable and seem very safe, but they are not well-studied, so it isn’t certain how much they help. Weight loss is certainly the safest and probably most effective treatment for many cats. Fish oils and injectable hyaluronic acid are plausible but unproven. Likewise, stem cell therapies are promising, but there is almost no clinical research in cats yet.
I don’t blame people for finding this situationg frustrating, but I do blame companies for taking advantage of it by aggressively marketing therapies with anecdotes and making no serious effort to find out if they are safe or effective first. The answer to not enough information is, of course, to demand better information, not to market these kinds of products which offer hope that usually turns out to be unfounded.
I have an older (appears to be around 10) rescue lab mix who has terrible gum disease. Over the course of the past 3 years, he has had to have 12 teeth extracted.
My vet suggested trying the EFAC for periodontal disease, saying there were no reliable studies that proved it worked, but it wouldn’t hurt to try.
I started brushing his teeth nightly (which he hates) and applying a capsule to his gums (which he loves). It seemed to make a big difference.
Like many good habits, I ran out of the pills and got lazy about the brushing. He now has 2 more bad teeth, and the vet is reluctant to do any more extractions due to his age. So, a month ago I started back on the regime. It seems less effective this time, but what else am I going to do?
I have used this for calici virus as have many of my friends who work closely with rescues fostering cats from the NYC shelter, where sanitary practices are lacking and too many come out with the latest virulent strain of whatever is going around. This seems to have worked really well to clear up ulcers in the mouth and on the nose and has gotten cats and kittens eating much faster than anything else I’ve tried. Don’t know the science of it but certainly seems to work. Used it multiple times and haven’t been disappointed.
I used this product on my elderly cat’s gums after a teeth cleaning for about a month or so. He didn’t have diseased gums. I bought it more for arthritis and skin improvement. Can’t say that I noticed any pain relief, but I definitely saw improvements in his skin and coat. Far less dandruff and no more dry skin. It stinks to high heaven, and I DO wonder about those “proprietary” ingredients, but he liked the taste.
He’s 19 and has a lot of arthritis pain. We’ve tried glucosamine/chondroitin, Adequan, hyaluronic acid liquid…nothing worked. He’s on gabapentin. So out of desperation, I’m going to try the powder form of this product. We also have compounded oral Buprenorphine coming which I pray will help relieve his pain.
Thank you, skeptivet, for responding to my earlier question about things that work for arthritic cats. I would love to put him on metacam or Onsior, but with CRF and heart disease, I’m frightened to do so. But if it comes down to having to euthanize due to pain, I guess I would try it as last resort. Sigh.
My husband is a retired chiropractor and gave me a page out of his Chiropractic Journal about this for dogs. we have a 12 year old Giant Schnauzer who has arthritis and a Rat Terrier who is 8 and has really bad allergies, itchy skin etc. Started them both on it and cannot believe the difference. the Giant is again obnoxious as she feels so good. This is a super product regardless if it is proven. I am now using it myself. People are usually slower to show results than animals in my experience, but my sore feet with fallen arches and cross over toes are definitely better after only a week. it is said to take 3-4 weeks. I am recommending to all my friends.
As I have pointed out many times, anecdotes like this exist for every therapy ever tried, including things like bloodletting and ritual sacrifice which no one today would recommend. They are inherently misleading, and the unprecedented success of modern science in more than doubling our life expectancy and improving our quality of life tremendously has come about by specifically decreasing our trust in such anecdotes and placing it in controlled research instead. Science works and stories don’t, so the reason to challenge stories like yours is to help people avoid being misled, as we have for thousands of years, by such stories.
Why We’re Often Wrong
Testimonials Lie
The Role of Anecdotes in Science-Based Medicine
Why We Need Science: “I saw it with my own eyes” Is Not Enough
Don’t Believe your Eyes (or Your Brain)
EFAC works. Two years ago, one of my dogs, had severe periodontal disease at a young age, despite his being on an excellent diet, and brushing his teeth daily. He just had a cleaning with a vet who is an oral surgeon. He has had a lot of work done, including guided tissue regeneration, so I am not saying EFAC is a cure all. However, the vet was very surprised at the results. The words “very clean” and “no inflammation” came up many times. Pockets that were a 9 are now 4s. Incisors he was ready to extract a year ago are in great shape now. Based on his experience, he told me he did not expect the procedures to work. The suggestion to use 1-TDC (EFAC) came from his office, so he was very interested in following up on it. I apply it to my dogs gums daily.
Sadly, anecdotes like mine are often dismissed, despite the success, which occurred in a real life setting. (I have X-rays to prove it). My complaint here goes beyond this product. I agree about the hype. That’s marketing. But, even though there aren’t a lot of studies to prove that EFAC works, I haven’t found any proving it doesn’t work either, not to mention my experience with it. Cases like mine need to be documented and presented. I have found a great benefit treating health problems by talking to other pet owners and doing my own research. So much good quality research coming from pet owners is lost. I do appreciate your report, however it would be helpful if you could report ways that quality data like mine could be collected and qualified.
Meant to send this with my last post. Here is another study on EFAC conducted at the Univ of Saskatchewan in May 25. This one, on cats. I didn’t see it mentioned in your article? I may have missed it. Here is the link: https://elitescience.net/wp-content/uploads/2016/04/EVDS-2012-Dr.-Anthony-1-TDC-research-presentation-05-25-12.pdf. I contacted Dr. Anthony as well. He said there is more research being conducted now, but it isn’t finished yet. Worth a follow up for your readers?
Unfortunately, there is a reason that anecdotes aren’t taken to be reliable evidence, and that is that they have misled us consistently, to the detriment of millions, throughout history. It’s understandable that people find these kinds of experience convincing, but the history of medicine is one long, sad tale of anecdotes fooling us until science came along. As I have pointed out many times, anecdotes like this exist for every therapy ever tried, including things like bloodletting and ritual sacrifice which no one today would recommend. Anecdotes are a test no treatment ever fails. They are inherently misleading, and the unprecedented success of modern science in more than doubling our life expectancy and improving our quality of life tremendously has come about by specifically decreasing our trust in such anecdotes and placing it in controlled research instead. Science works and stories don’t, so the reason to challenge stories like yours is to help people avoid being misled, as we have for thousands of years, by such stories.
Why We’re Often Wrong
Testimonials Lie
The Role of Anecdotes in Science-Based Medicine
Why We Need Science: “I saw it with my own eyes” Is Not Enough
Don’t Believe your Eyes (or Your Brain)
KSC,
Thanks for the link. The 2012 study is encouraging, though limited in a number of important ways: only 9 animals treated, not reviewed or published in a journal, not clear if the measurements taken would reflect meaningful clinical improvement for actual patients, etc. Still, it is useful to see that at least some controlled research in veterinary patients, not simply lab animals, has been done. I don’t think it dramatically changes the overall conclusions of the post, nor does it justify the over-the-top marketing, but it does suggest the product might be worth trying in cats with refractory periodontal disease.
Thanks again!
I have seen studies in the past by danny scott using oils that worked for inflammatory skin disease but only for a short period of time then they lost their efficacy. So if this study is repeated it would be nice to continue the study longer to see about its long term effect.
As I mentioned in a prior post, dismissing what is considered an anecdote is a mistake. Regarding EFAC, I recently talked to another veterinary oral surgeon who sells EFAC. His comment was “It works for some, not for to others”. This is in line with the reviews I have read about this product from pet owners. The problem is, if one trained in science does not report the results, how do we know what they are? We have a tremendous advantage when you consider that we live in an age when information is easily shared. I have found much greater success in reading posts from other pet owners than from scientific studies, (which I pay close attention to as well). This includes many forms of alternative medicine, especially nutrition, which sorry to say, is an area where too many veterinarians still lack knowledge. That is why reports from pet owners in real life situations are so important. I agree that marketing is over the top and irritating. But don’t throw the baby out with the bath water. We pet owners need the feedback.
Human version EFAC ( I believe) : Sorry, a little long. Not promoting the product per se, but I still think it deserves a closer look. The full article is a bit too much info, at least for me, so I posted a summary. Some marketing in that (i.e. “outstanding” results) But may be worth a look? If I am wrong about it being a similar EFAC, please let me know. Here is the post:
http://www.celadrininfo.com/studies/2005Mar-Kraemeretal.pdf
Summary:
Celadrin® is made from a patented complex blend of special esterified fatty acids, derived from bovine tallow oil.
EFAC or oral application, Celadrin® was studied using a double-blind, multi-center, placebo-controlled trial (the most scientifically validated type). Sixty-four participants between the ages of 37 to 77 were given Celadrin® capsules and were evaluated at the beginning of the trial, at 30 days and at the end of the 68 day study. Compared to those given a placebo, those who were given Celadrin® had more flexibility, fewer aches, less pain and were able to walk further distances than the placebo group. The study therefore concluded that Celadrin®, when taken orally improved joint and mobility problems.
For topical application of Celadrin® cream, a study was conducted at the University of Connecticut, involving 42 patients with osteoarthritis of the knee. Participants used either Celadrin® or a placebo cream. Patients were evaluated before application of the cream, 30 minutes after, and then again following a 30 day treatment period during which the cream was applied twice a day, morning and evening. The researchers evaluated physical function, postural movement, pain and range of motion. The test included how long it took the patient to get up and go from a chair, stair climbing, endurance, and mobility of the knee. The group receiving Celadrin® had outstanding results with reduced pain and stiffness, improved balance and strength and better mobility. 100% of the patients in the study showed significant benefit compared to the patients on the placebo.
Thanks for the links. A couple of comments:
1. The link for the .pdf trial report is looking at a topical product with menthol, which is pretty different from the oral product reviewed in my post. The study you link to is an uncontrolled study, so the level of evidence is quite low.
2. There have only been a few studies of cetylated fatty acid use in humans published, mostly looking at topical formulations. All are small and of pretty low quality (often without control groups), so while they suggest there might be some benefits, the evidence isn’t compelling. Many other treatments have had even better early results only to turn out not to be effective when larger, better quality studies were done (glucosamine, for example).
So I think my general conclusions from the original post are still accurate:
Thanks for for the clarification. In the abstract I saw this, which made me think there would be similarities to the EFAC product for pets? Sounds like I need to find the other study that didn’t have menthol added.
The % changes were consistent with our prior
work on the compound without menthol. Further work is needed
to determine the impact of menthol in such a cream. Nevertheless,
our data support the use of a topical cream consisting of
cetylated fatty acids (with or without menthol) for enhancing the
potential for exercise training in this population”
Could you explain to me where this study is flawed? I don’t understand how it is not a controlled study? I am looking at the “Subjects” and “Methods” sections. If you could shed light on the difference it would be a help as I do more research. Regarding the results, are the tables provided lacking or invalid for measuring results (possible results vs. proven results). I’m looking at the at “Results” paragraph that references the tables.
Thanks again for taking the time too to review the info I sent you. I know it’s a lot of work. I appreciate it.
The study you linked to lacked a control group receiving a placebo treatment: “We used a single treatment group with a pre-post experimental design” That’s what I meant when I said “uncontrolled.” The biggest problem this kind of design presents is that patients almost always report improvement, especially in subjective symptoms reported by subjects or evaluated by experimenters, when they receive any treatment, effective or not.
The authors did refer to a previous study that did include a control group. That was a better design but still had some limitations, discussed in this review.
There is also a table scoring the various trials evaluated in the review.
Oh, I see. Thanks!
Thanks for this. Our vet recommend this product for my arthritic cat, and I’m skeptical but ended up buying it. Turns out she loves the stuff, so if nothing else it’s a pleasant treat. A damned expensive one, but she’s very old and it’s nice to see her happy. I sure wish there were something that was proven to help with arthritis, though. She’s also got kidney disease, so our options are limited.
Is the animal EFAC the same as human variety
EFAC from Hope Science does work as claimed. Don’t waste your $ on buying glucosamine /chondroitin/etc no matter how expensive, they do not work on large dogs. I learned about EFAC, which is human grade, during a hiking trip where we came across this golden retriever with a full gray face yet he was walking very well and in uneven terrain, his owner told me that she had researched and tried many products out there but EFAC worked for him so I bought it and started using it on my two goldens, it worked like a charm and extended the life of one of my oldest one with severe hip issues by two years and also helped my younger one who has had hip issues since she was 7 years old but is still walking at 11 years old Thanks to EFAC. The vet had already told me that we’d have to put them down once they could not walk anymore but once we had them on EFAC for a month we started weaning them off off the steroids they were on because it ruins their liver, and would walk them on short walks morning and evening to keep them flexible, and they started walking noticeable better, had less trouble getting up, and without steroids or weekly injections, and I’m thankful to EFAC for allowing me to have my big pup for two extra years of quality life. After a couple of years, we had to also add Previcox which is a non-steroid anti-inflammatory but the combination with EFAC is great, the only way I could be happier is if someone came up with affordable hip replacement for dogs.
Is this the same type of product now marketed as 1-TDC?