By Charles Cochran, DC
The medical costs of treating arthritis in the U.S. are quite staggering. Joint support supplements comprise a potentially profitable area for dietary supplement manufacturers.
It is estimated that more than 40 million Americans have been diagnosed with some form of arthritis, and that these numbers will increase to over 60 million by the year 2020, when the last of the baby boomers turn 55 years of age. I would imagine that these numbers might be conservative, since there are many of us, like myself, who have arthritis and do not use traditional medical treatment, and consequently never become part of these statistics.
Newsweek (Sept, 3, 2001) reported that Americans spend $6.6 billion annually on prescription medications to treat osteoarthritis, the most common form of arthritis (approximately 21 million sufferers), and 60 percent of this market has recently been captured by the highly touted COX-2 inhibitors Celebrex and Vioxx.
Every year in the U.S., more than 70 million prescriptions are written for prescription nonsteroidal anti-inflammatory drugs (NSAIDs), and more than 30 billion tablets are sold over-the-counter. Long term use of NSAIDs can cause stomach irritation, bleeding and ulceration in the gastrointestinal tract. Presently there are over 165,000 deaths and 105,000 major hospitalizations yearly in the U.S. due to the gastrointestinal side effects of NSAID use.
Opportunities For Alternatives
Fortunately, nature provides many safe substances that not only offer symptom relief, but also address the causes of many of these debilitating forms of arthritis.
There's considerable positive evidence for the use of chondro-regenerative or protective nutrients, such as glucosamine, chondroitin sulfate, methyl sulfonylmethane (MSM), hydrolyzed cartilage, and collagen, in treating the various types of arthritis.
The research is so strong for glucosamine that physicians are incorporating it into their treatment protocols.
Research is also very strong for the beneficial oils, such as flaxseed oil, evening primrose oil, and the cold-water fish oils that are high in EPA and DHA, which help regulate the favorable prostaglandins over the unfavorable pro-inflammatory and pain-producing prostaglandins.
These supplements are mainly beneficial for reducing the pain and inflammation of osteoarthritis (OA). Another beneficial oil that is not yet as well know is cetyl myristoleate (CM) which has been shown to provide relief from rheumatoid arthritis (RA). CM works by a completely different mechanism than glucosamine. While glucosamine builds up tissue and is effective for reducing the wear and tear of cartilage experienced by OA sufferers, CM is more effective on auto-immune forms of arthritis such as RA because it redirects the immune system to stop destroying the body's own tissues. Glucosamine does nothing to stop the degenerative process.
There's been quite a bit of confusion in the Industry as to the recommended doses, optimal delivery systems, what enhances its effectiveness, where it comes from, how it works, and what it really is.
The Discovery of Cetyl Myristoleate
In the late 1950s a friend of Harry W. Diehl developed a particularly dreadful form of arthritis known as rheumatoid arthritis. Diehl was a veteran research chemist at the National Institutes for Health (NIH) where he was responsible for isolating and identifying over 500 chemical compounds.
To help his friend, Diehl set up a laboratory in his own home wherein his research led him to use an animal that turned out to be resistant to adjuvant-induced arthritis. Diehl discovered the chemical that provided this immunity - cetyl myristoleate. CM is the cetyl alcohol ester of the 14 carbon mono-unsaturated fatty acid, myristoleic acid (C14:1n-5).
The results of his research also showed:
CM circulates in the bloodstream of mice at approximately 350 mg/kg body weight.
With proper doses of CM extracted from mice (450 to 500 mg/kg body weight), he could provide rats with 100 percent immunity of adjuvant-induced arthritis.
After injecting the CM into the rats, the highest concentrations were found in the liver.
Diehl also developed a method of synthesizing CM by combining cetyl alcohol with myristoleic acid, and found that the synthesized form was just as effective in providing rats immunity to arthritis as the naturally occurring form (extracted from mice).
There's been some confusion as to where cetyl myristoleate comes from. A health journal recently said cetyl myristoleate comes from palm and coconut oils. This is not true. CM has been found in animals only. Diehl's discovery showed that it circulates in the bloodstream of mice, and subsequently it was found in special glands in the male beaver, in sperm whale oil, and in a couple of species of laboratory rats.
All CM products available in the marketplace today are created using two natural substances, cetyl alcohol (derived from palm or coconut oils, often used as an emollient in cosmetics) and myristoleic acid (derived from bovine tallow or kombo nut butter).
There are no "100 percent pure cetyl myristoleate products"available. All the raw materials come with varying percentages of other fatty acids, including lauric acid, myristic acid, palmitic acid, palmitoleic acid, stearic acid, and oleic acid. Some of these raw materials are then put through distillation and crystallization processes to increase the desirable fatty acids and decrease the levels of the undesirable or inert fatty acids.
At this point, the complex is then mixed with cetyl alcohol, washed with sodium hydroxide, and evaporated under reduced pressure resulting in what is now called CM complex. The tables on this page contain several fatty acid profiles of starting raw materials that illustrate the diversity of CM products.
Aside from the great variety of starting raw materials, there are some other considerations that are critical in producing efficacious CM products. These include powdering techniques, delivery systems, and softgel or two-piece hard shell encapsulation techniques.
The CM complex can be a very difficult material to work with. At room temperature it is quite hard. One problem with softgel encapsulation, for instance, is that after heating the CM complex into a liquid state, it becomes so warm that the softgel capsules won't gel. The material tends to also cool during the encapsulation process, clogging up the machines.
There has also been reported difficulty in creating consistent viable powders. The concentrations of CM, in powders, have been all over the board. I pulled out six laboratory analyses of a CM product that was being sold a couple of years ago. The levels of CM ranged from 34.2 mgs to 156.2 mgs per capsule, and these capsules were from the same batch! It's no wonder that some people obtain wonderful results while others get nothing.
Recent CM Studies
The results of a fairly large double-blind, placebo-controlled study were presented at the March-April 2001 meeting of the Federation of American Societies for Experimental Biology (FASEB). Clincyte of San Diego, CA, constructed the study protocol and the clinical trial was performed by the Medical Center of Manipal, India. The objective of the study was to determine the benefit of cetylated fatty acids (CM Complex) on knee range of motion and function in patients with osteoarthritis.
Sixty-four patients with chronic osteoarthritis of the knee were divided into two groups and evaluated three times over 68 days. There were 31 patients in the placebo group and 33 patients in the treated group. Patients were excluded if they were using systemic corticosteroids, had inflammatory or autoimmune arthritis, or had their gall bladder removed. Patients using aspirin and NSAIDs were enrolled as long as their treatment remained stable. Each participant took three capsules twice daily for 68 days. The treatment capsules contained 350 mgs of CM complex (approximately 74 mgs of cetyl myristoleate), 75 mgs of fish oil, and 50 mg of soy lecithin.
Results showed a significant shift towards overall improvement compared to the placebo. The average responses to the MACTAR functional index questionnaire showed a significant improvement from the baseline of 5.76 compared to the placebo of 1.84. Ranges of motion with the CM complex treated group improved by 10.1° of knee flexion compared to the 1.1° of the placebo group.
Prior to the Clincyte study, a small open trial using CM complex was completed by the Genesis Center for Integrative Medicine in Graham, WA. This study was unique in that the patients were evaluated after taking the CM Complex for four weeks, followed by a two-week washout period, and then re-evaluated at week six. It was also distinct in that the test subjects were diagnosed with rheumatoid arthritis, rather than osteoarthritis.
In this study, 13 premenopausal women diagnosed with rheumatoid arthritis were treated with a daily dose of 2.2 g of a powdered CM complex material (11-15 percent CM). Treatment effectiveness was assessed using the Arthritis Impact Measurement Scale (AIMS2), a pain visual analog scale, a dynamometer to measure hand grip strength, and erythrocyte sedimentation rate (ESR).
Results: Pain visual analogue scale (Pain-VAS) values were found to be significantly lower after treatment (p<0.01), and left and right hand grip strengths increased by 20 percent (p<0.01).
Analyses of the AIMS2 using the three and five component models of health status showed no significant differences in physical activity, mood or RA symptoms. Analysis of individual sections of the AIMS2 questionnaire, however, revealed significant improvement in the subjects' ability to complete household tasks, improvement of overall mood (350 percent increase), and overall satisfaction with each health area.
Cetyl myristoleate can indeed make a viable contribution to natural formulas promoting joint health. NIE