The truth is that with several supplements an ingredient is added, which then enables a company to make the “Clinically Proven” statement without the actual combination product EVER BEING TESTED.

Often a different form of the ingredient is used than was actually studied. With glucosamine for example there are several forms of the supplement.

Or a reduced amount of an ingredient is added. If clinical trials on a medicine were conducted using 1 gram, would it then be fair to say that the product has been clinically proven if only a ¼ gram is in a formula?

The bottom line is that you have to ask if the health product has been clinically researched. And you should ask what the results were, as “Clinically Proven” can mean many things. For example, clinically proven can mean that a product was shown to be safe and have no reference to efficacy. If there is published research, then why not make it available?

As a case in point, in 2007 national TV ads were running in which a company claimed to have a clinically proven formula with the same ingredients (glucosamine hydrochloride and chondroitin sulfate) as used in the trial conducted by the National Institute for Health or NIH. The irony is that the stated results of this study (see below) were: “Overall glucosamine and chondroitin sulfate were not significantly better than placebo in reducing knee pain…”  Most people would assume that a clinical trial conducted by the NIH would be highly credible, which we believe it was. And most importantly that the medicine tested was found to be highly effective, otherwise why would a company even refer to it? In this instance, this just simply was not the case. Again you need ask just what the results were.

EFAC has been studied with seventeen (17) animal and clinical studies, with six (6) studies presented at scientific meetings and four (4) published in pre-eminent scientific journals – two of which have been published in the prestigious medical journal, The Journal of Rheumatology.

At Nutra Naturals we are committed to doing our best to help educate physicians and their patients. Below you will find the research conducted specifically on EFAC (Also called Cetylated Fatty Acids).  The results of these studies are the foundation for our enthusiasm and validate our use of the term “Clinically Proven”. Below you will find our interpretation of the research. The actual published studies can be found on the home page of Nutra Naturals.

This is recently completed research using EFAC as an oral supplement for osteoarthritis (OA) of the knee. This was a double blind, placebo controlled trial with 93 patients.

Patients receiving EFAC improved pain wise in comparison to those receiving the placebo pills. However a perhaps more interesting aspect of this study was that it measured an objective functional parameter in addition to pain, as pain is considered subjective. Patients were tested prior to starting medication and then after 2, 4 and 8 weeks to see how far they could walk in 6 minutes. Presumably the pain of OA of the knee would cause one to walk slower and if pain relief occurred, one could then speed up and walk farther in the given time. Patients receiving EFAC had less pain and were able to walk 233 feet farther after just 2 weeks. And they continued to improve over time with less pain and an increased walking distance. After 8 weeks they walked on average 537 feet farther than they could at the beginning of the clinical trial. A truly amazing result! Just as impressive was the difference between the two groups, as those receiving the placebo did not improve and in fact were able to walk a slightly shorter distance after 8 weeks.

This clinical trial was presented at the Scripps Medical Conference for Integrated Medicine in San Diego in 2007. The paper won first prize in the “Original Research Category” out of the 90 papers presented.

JOURNAL OF RHEUMATOLOGY-2004
Effect of a EFAC Topical Cream on Functional Mobility

This double blind, placebo controlled clinical trial investigated whether EFAC topical cream could improve the functional mobility of patients with OA of the knees, since these patients typically have impaired physical performance, presumably at least in part due to pain. Patients were tested at baseline and then 30 minutes later to determine the short-term affects and also 30 days later after applying the cream twice daily for long-term benefits.

The EFAC cream was found to increase the range of motion of the knees, improve the ability of patients to ascend and descend stairs, made it easier to get up from a sitting position and improved the balance of patients stepping down.

JOURNAL of STRENGTH AND CONDITIONING RESEARCH-2005
EFAC Topical Cream Reduces Pain and Improves Function in Arthritis Patients

Our EFAC cream called Superior To Glucosamine is comprised of EFAC and a minimal amount of menthol (1.25%). This clinical trial was designed to test whether menthol affected the efficacy, since previous tests were conducted without menthol. Patients with either OA of the knee, elbow or wrist were tested. One week of treatment of the cream containing menthol was found to be similarly effective for reducing pain and improving functional performance as prior tests that used EFAC cream without menthol.

JOURNAL of RHEUMATOLOGY-2002
EFAC Improves Knee Function in OA Patients

This placebo controlled clinical trial of EFAC as an oral supplement was the first to investigate whether EFAC  could be used to treat osteoarthritis (OA) of the knee. The overall function of the knees, as well the range of motion improved in the patients receiving EFAC. This very successful study paved the way for the other studies above.

NEW ENGLAND JOURNAL OF MEDICINE-2006 and 2008
Glucosamine and Chondroitin Sulfate in Combination for OA
This GAIT (Glucosamine/Chondroitin Arthritis Intervention Trial) is the largest multi center clinical trial completed to date for evaluating the efficacy and safety of glucosamine and chondroitin to treat osteoarthritis (OA). Conducted by the National Institute for Health (NIH), the trial was conducted at 16 medical sites across the country. There were 10 groups of patients- 5 with early stage OA and 5 groups with more advanced OA. Patients received: 1-glucosamine alone, 2-chondroitin alone, 3-glucosamine and chondroitin combined, 4-placebo or 5-Celebrex.

The conclusions of the initial part (first 6 months) of the study were published in 2006:
Glucosamine and chondroitin alone or in combination did not reduce pain effectively in the overall group of patients with osteoarthritis of the knee. Only one group of the 6 groups (2 glucosamine alone, 2 chondroitin alone and 2 glucosamine and chondroitin combined) was found to be better than placebo. Exploratory analysis suggests that the combination of glucosamine and chondroitin sulfate may be effective in the subgroup of patients with moderate-to-severe knee pain-however according to the researchers, because of the small size of this subgroup these findings should be considered preliminary and need to be confirmed in further studies.

Participants were allowed to continue on for another 18 months for a total of 24 months. The trial was continued to determine if there was any benefit to the cartilage. The results were published in Arthritis & Rheumatism, October 2008, showed that glucosamine and chondroitin sulfate, together or alone, appeared to fare no better than placebo in slowing loss of cartilage in knee osteoarthritis. Ironically the combination of glucosamine and chondroitin (the only group showing potential benefit in the first 6 months) resulted in slightly more cartilage loss than placebo. The difference was very small and not statistically significant, however there certainly did not appear to be any benefit.

Our interpretations of the results are that glucosamine and/or chondroitin if they do in fact help, offer on average only mild relief. To be considered effective in this trial only a 20% reduction in pain was needed. The fact that only 20% improvement was needed and did not occur often enough in the majority of those receiving glucosamine and/or chondroitin to be statistically different than placebo is a telling statistic. We feel based on this and the other studies presented here that EFAC is indeed much more effective than glucosamine and/or chondroitin. Hence the EFAC brand name: Superior to Glucosamine!