NEW ENGLAND JOURNAL of MEDICINE – 2006
GAIT (Glucosamine/Chondroitin Arthritis Intervention Trial)
“Overall, there were no significant differences between the other treatments tested and placebo.” Other treatments being Glucosamine and or Chondroitin.
Scripps San Diego Integrated Medical Conference 2007
Osteoarthritis
1st Prize of 90
Papers Presented
A double blind clinical trial using esterified fatty acids (also called cetylated fatty acids) to treat osteoarthritis of the knees demonstrated dramatic improvement compared to the placebo. In addition to pain relief patients could walk an extra 233 feet in a timed 6 minute walk after only 2 weeks, 330 feet after 4 weeks and a remarkable 537 feet after 8 weeks.



Glucosamine Facts and Information
Glucosamine is the highest selling supplement in history. This success is largely due to the enormous number of the osteoarthritis (OA) patients. Since the introduction of glucosamine in 1994, there have been a multitude of brands offering various combinations. There are several forms of glucosamine, such as sulfate and hydrochloride etc. In addition, a number of other supplements are commonly combined with glucosamine, such as chondroitin and MSM (methylsulfonylmethane). As a consumer, to choose the most effective formula is difficult to say the least.
The truth is that many joint care products are sold without ever being tested clinically. A common statement you may hear or read is that a product “contains clinically proven ingredients”. In essence this can be a way of saying that the product was NEVER tested clinically.
Glucosamine Testing & Clinical Research
As a consumer, or a physician for that matter, there are two important questions that must be asked:
1- Was the product tested?
2- If the product was tested, then what were the results?
Asking the results is crucial. As an example, the National Institute for Health or NIH conducted the largest and most rigorous double blind study of glucosamine and chondroitin ever. The study is referred to as the GAIT trial, which stands for Glucosamine/chondroitin Arthritis Intervention Trial. . The authors concluded: “Overall, there were no significant differences between the other treatments tested and placebo.” The “other treatments” being glucosamine and/or chondroitin. Amazingly there are companies now referencing this study as if the results were positive, when in fact glucosamine and chondroitin overall showed very little efficacy. And to top it off, only a 20% reduction in symptoms were required to be considered a positive outcome. The bar was set very low and still glucosamine and chondroitin were unable to demonstrate clear advantage over the placebo.
The GAIT trial included 1,583 patients with symptomatic knee arthritis. Patients were randomized into one of five treatment arms: glucosamine hydrochloride (n=317), chondroitin sulfate (n=318), combination glucosamine/chondroitin (n=317), celecoxib (n=318) or placebo (n=313).
Glucosamine or chondroitin on their own were not statistically different than placebo.
In the combined glucosamine and chondroitin group, again there was not a statistical difference from placebo, except in one small subset of 72 patients. This small subset of 72 patients was the only group to show statistical efficacy over the placebo. And the authors were clear when they stated: “because of the small size of this subgroup these findings should be considered preliminary and need to be confirmed in further studies”. Somehow companies are forgetting to mention the other 1511 patients in the trial. Info on the GAIT trial can be viewed at: http://nccam.nih.gov/research/results/gait/qa.htm
Besides efficacy, product quality is another issue. GAIT was conducted under an investigational new drug application, with study agents subject to pharmaceutical regulation by the Food and Drug Administration (FDA). Investigators found many discrepancies among commercially produced supplements and raw products before identifying suppliers who could provide ingredients of sufficient purity, potency, and quality. For example, an evaluation of chondroitin quality conducted for GAIT found that among 32 commercially available dietary supplements, chondroitin content ranged from 0% to 115% of the labeled claim. Most importantly they concluded that none of the commercial products was appropriate for use in the GAIT trial. (J Am Pharm Assoc. 2006;46[1]:14-24) A consumer supplement testing company www.consumerlab.com offers independent supplement testing of products. Product testing posted in 2007 found that 8 of 41 glucosamine, chondroitin and MSM containing joint products did not meet their criteria.
Another very highly regarded medical institution, the Cochrane Collaboration www.cochrane.org reviewed 20 clinical trials on glucosamine. The Cochrane Collaboration is a not for profit, international medical institution that attempts to improve healthcare decision–making globally through systematic review of the effects of healthcare interventions. They are unbiased as they do not accept donations from drug companies, or in this case supplement companies. Basically they try to determine if interventions, glucosamine in this instance, work or not. There analysis casts further doubt as to the efficacy. See http://www.cochrane.org/reviews/en/ab002946.html
The bottom line is that you need to know the results. And if a study was completed on a particular product, then why not share the results. You need to have the truth! How else are you going to make an informed decision?
Joint Health: A New, Clinically PROVEN Advancement
A safe, natural, and clinically proven breakthrough is now available after years of research.
The key components are esterified fatty acids or EFAs, which are extracted from beef tallow. They are a fatty acid supplement similar to fish oils. However EFAs possess a much greater ability to limit inflammation. Beef typically causes inflammation and is the reason we are recommended to eat more fish. Every time we eat beef we consume EFAs. However EFAs make up only a tiny percentage of the beef, which results in the potent anti-inflammatory properties of the EFAs being masked by the rest of the beef. Who knew that a beef extract would turn out to be such an effective natural anti-inflammatory supplement! And in addition to use as an oral anti-inflammatory supplement, EFAs are readily absorbed through the skin and are therefore very useful in topical cream form.
Providing scientific support are 17 animal and human studies, with six of the studies presented at scientific meetings and four published in pre-eminent scientific journals – two of which have been published in The Journal of Rheumatology.
The Journal of Rheumatology published the results of an oral (2002) and a topical (2004) EFAs trial. In the topical cream trial patients were tested before using the cream, 30 minutes after applying the cream and after 30 days of using the cream twice daily. Range of motion of their knees, their ability to ascend and descend stairs, ease of getting up from a sitting position and the balance of patients stepping down was tested. Remarkably after only 30 min the cream improved the ability to perform the above tasks. In addition, there were long-term benefits. After 30 days the patients improved significantly.
At the 2007 Scripp's Integrated Medical Conference a research paper using EFAs to treat osteoarthritis (OA) of the knees was voted the outstanding paper of the 90 presented. Presumably patients with OA of the knees would walk slower due to pain and/or stiffness. EFAs in capsule form dramatically improved the walking of patients with osteoarthritis of the knees. Patients were able to walk an extra 233 feet in 6 minutes after only 2 weeks and a remarkable 537 feet after 8 weeks. And very significantly the patients that received the placebo did not improve, so the differences between the treatment and placebo groups was dramatic, unlike the GAIT trial above. The clinical trials can be read on this website or at: http://www.pain.us/research.html
My Experience with Glucosamine and Esterified Fatty Acids (EFAs)
In 1994 I was part of the team that introduced glucosamine and have been dispensing it ever since. Having extensive experience with glucosamine, I have a very good idea of what to expect clinically. Ten years later in 2004, I had the opportunity to use esterified fatty acids with my patients. EFAs are very unique in that they are absorbed very well through the skin. These oils can therefore be used topically as well as orally. What I witnessed clinically was nothing short of amazing. The topical cream often provided pain relief in 5 or 10 minutes, and it did so for a high percentage of patients with pronounced discomfort. Besides being fast, the cream had far more impact than I had ever seen with glucosamine, MSM or chondroitin. And for long-term use I have found the EFA capsules and the degree of relief provided much greater. In my experience EFAs are far more effective and much faster acting than glucosamine, hence the product name: Faster Than Glucosamine!
My dad John is a great example of the difference in impact between the EFAs and glucosamine. My dad broke his heel in 5 places 18 years ago and developed arthritis. I gave him glucosamine and the result was that it would take the edge off just a little, but a little was better than nothing. Every morning he would walk very awkwardly almost dragging his one leg behind him for 30 to 45 minutes until it would loosen up. He walked like this because he couldn’t put much weight on his heel. A few times over the years he ran out and went a month or so without glucosamine, in which case he did notice a slight difference. Then he tried EFAs! Now in the mornings very little loosening up of the leg is required. At 73, he now walks 3 to 5 miles a day for exercise, which he has not done for decades. As a side benefit he had very stiff painful hands and could not clench his hands to make a proper fist, however 2 weeks or so after applying the cream to his ankle, his hands were no longer sore or stiff. After a few months he no longer needed the cream and instead now relies solely on the capsules.
Which is Better-Glucosamine or EFAs?
From a controlled, scientific trial perspective it appears to me that the research clearly indicates EFAs are far more effective, both orally and topically. And from a clinical perspective, I personally am convinced that EFAs offer patients far greater relief.
If you want to use a joint health product, I strongly encourage you to consider the science when making a supplement choice. Please remember to ask and seek answers to the following 2 questions:
1-Was the product itself, and not just some of the ingredients researched?
2-And if it was researched, what were the results?
Sincerely
Dr. Kim Vanderlinden
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