1. San Diego Clinic Immunological Center Clinical Study On Cetyl Myristoleate (CMO) vs.
Arthritis

A Study on Dose Effectiveness and Patient Response Conducted by the San Diego Immunological Center

The Purpose:

Having previously established the effectiveness and non-toxicity of CMO (cerasomal-cis-9-cetylmyristoleate) for Arthritis symptoms of pain, inflammation, and impaired mobility, the purpose of the study was:

A) To determine optimum dosage levels for various types of Arthritis.

B) To determine if different dosage levels would be required relative to the severity of each type of
Arthritis.

C) To observe response time required for initial and partial relief of symptoms.

D) To observe response time required for complete relief of symptoms.

E) To determine factors influencing subjects who may not respond to the protocol.

The Subjects:

Subjects were volunteers treated as outpatients. They presented with Osteoarthritis, Rheumatoid Arthritis and other forms of reactive Arthritis.

The Study:

The study involved 48 subjects. Female subjects (28) ranged from 33 to 83 years of age. Male subjects (20) ranged from 29 to 74 years of age. All races and many ethnic backgrounds were represented. Age, gender, race, and ethnological background appeared to be irrelevant to patient response in this study.

The Protocol:

CMO was administered orally in the form of 75mg capsules each morning and evening. The number of capsules and duration of treatment varied for each group of subjects. Subjects were advised to take capsules on an empty stomach with water only; and to avoid tea, chocolate, alcohol, coffee, cola, and other caffeinated drinks for five hours after taking the capsules.

Subjects were advised to completely avoid chocolate and alcohol during the entire trial period of two to three weeks duration.  With a few exceptions for subjects who could not function without them, steroids were also prohibited. Otherwise diet was not controlled in any way. Subjects were permitted to continue taking their customary pain and nonsteroidal anti-inflammatory medications until they were no longer needed. Subjects were asked to visit or call in to report progress at least twice weekly.

The Results:

Only two subjects failed to show marked or complete relief of all symptoms of pain and limited mobility normally associated with Arthritis. Both of these non-responding subjects had suffered prior hepatic problems: one from alcohol abuse resulting in cirrhoses of the liver; the other, a former professional athlete, presented with considerable liver damage from steroid abuse. Further studies are necessary to determine the role of liver function capacity with respect to this protocol. Liver damage resulting from steroids previously prescribed for arthritis may also prove to be a factor affecting patient response.

Group #1

Mild to moderately severe Osteoarthritis & and Reactive Psoriatic Arthritis

In Group #1, eleven (11) subjects presented with mild to moderately severe Osteoarthritis and one with Reactive Psoriatic Arthritis were supplied with 16 capsules, two 75mg capsules to be taken each morning and evening for four days.

Nine reported about 20% to 30% improvement in articulation and inflammation and about 40% to 50% relief of Arthritic pain within 36 hours. In these nine subjects, improvement continued rapidly for the next 60 hours, reaching a 70% to 80% improvement by the end of the four days. Two of the subjects continued to improve over the following week despite the fact they were no longer taking any capsules. However about half of this group experienced the return of some mild arthritic symptoms after about three to five weeks. (Although not included as part of this study, all the subjects in this group were treated again and their symptoms have not returned.) The patient with Reactive Psoriatic Arthritis also experienced an almost complete reversal of his associated very severe psoriatic skin condition affecting about 20% of his total skin area.

Group #2

Severe to crippling Rheumatoid Arthritis

In Group #2, nine (9) subjects presenting with severe to crippling Rheumatoid Arthritis were supplied with 50 capsules to be taken in two series, two 75mg capsules each morning and evening for seven days, with a seven day interval before repeating the same dosage for 5 1/2 more days. Four of these subjects were unable to walk and were accustomed to being transported by wheelchairs. One, her femur being fused at the hip, was unable to achieve a sitting position for wheelchair transport. She could, however, move about slowly on crutches as long as she was accompanied by someone to aid her in maintaining her balance.  Otherwise she could only stand or lie down. The remaining four could move about with canes or walkers. All nine subjects presented with pain, inflammation, and marked deformation of nearly all proximal interphalangeal and large joints. Five presented with limited lumbar flexion and pain in the vertebral column. All had difficulty grasping and manipulating common objects.

On the fourteenth day, at the end of the one week interval without treatment, six (6) subjects reported minor continuing improvement; two reported maintaining their improved status and one continued to show no improvement. Treatment was resumed at the fifteenth day for 5 1/2 more days.

By the end of the treatment period, all but two subjects reported to be 90% free of pain with a return of 70% to 100% mobility. The fused hip joint remained fused, of course, but with a return of over 70% mobility in other joints, the subject felt hip surgery now to be worth consideration. The nonresponsive subject proved to have cirrhoses of the liver, which may have been the reason for her inability to respond to treatment. Further investigation is necessary to determine the role of liver function in this protocol.

Group #3

Mild to moderately severe Rheumatoid Arthritis

In Group #3, fourteen (14) subjects presenting with mild to moderately severe Rheumatoid Arthritis were supplied with 24 capsules, two 75mg capsules to be taken each morning and evening for 6 days. After three days of treatment, eleven reported about 20% to 30% improvement in articulation and inflammation, and about 40% to 50% relief of arthritic pain. In these eleven subjects, improvement continued rapidly over the next four days, approaching the 80% to 100% level. The remaining three subjects reported similar improvement by the end of the fourth day, with an overall improvement of 70% to 80% after seven days.

Most of the subjects continued to report minor additional improvement for one week or more, even though they were no longer under treatment. However, six in this group began to experience the return of some mild arthritic symptoms after about three to four weeks. (Although not included as part of this study, all subjects in this group were treated again and their level of improvement has subsequently stabilized.)

Group #4

Severe to crippling Osteoarthritis

In Group #4, fourteen (14) subjects presenting with severe to crippling Osteoarthritis were supplied with 50 capsules to be taken in two series, two 75mg capsules each morning and evening for seven days, with a seven day interval before repeating the same dosage for 5 1/2 more days. Three of these subjects were unable to walk and were accustomed to being transported by wheelchairs. The other eleven could move with crutches, walkers and canes. All presented with pain, inflammation and marked deformation of nearly all interphalangeal and large joints. Four presented with limited lumbar flexion and pain in the vertebral column. Ten had difficulty grasping and manipulating common objects.

After four days of treatment, ten in this group reported 30% to 50% improvement in articulation and inflammation and about 40% to 60% relief of arthritic pain. In these ten subjects, improvement continued rapidly over the next three days, reaching 80% to 100% by the end of seven days. One reported no perceptible change.

On the fourteenth day, at the end of the one week interval with out treatment, nine subject reported continuing minor improvement, four reported maintaining their improved status and one continued to show no improvement. Treatment was resumed on the fifteenth day for 5 1/2 more days.

By the end of the treatment period, eleven subjects reported 80% to 100% relief of pain with a return of 80% to 100% mobility. Two subjects reported a 70% to 80% of articular mobility with a 70% to 90% reduction of arthritic pain. The one non-responsive subject proven to have previous liver damage as a result of sports related steroid abuse. Further studies are necessary to determine the role of liver function in this protocol.

Summary

The results of this study lead to several conclusions regarding its five principal objectives:

1) Optimum dosage levels appear to be equal for all three types of Arthritis investigated: Osteoarthritis, Rheumatoid Arthritis and Reactive Psoriatic Arthritis. This is evidenced by the gradual return of minor Arthritis symptoms in several of those treated with only 16 to 24 capsules, and no regression in those treated with 50 capsules in two series separated by one week without treatment.

2) Dosage level requirements appear to be equal irrespective of the severity of the subject’s condition.

3) Initial response time for minor improvement appears to vary from two to seven days, irrespective of the severity of the subject's condition.

4) The time for maximum attainable response appears to vary from seven to twenty one days, resulting in 70% to 100% overall improvement. (Apart from this study, three of the most severely afflicted subjects were treated again after a five week interval, resulting in an additional 10% to 20% overall improvement.)

5) The two non-responding subjects both proved to have suffered previous damage to the liver from steroid or alcohol abuse, indicating that impaired liver function may preclude success with this protocol.

In addition, it was evident that for many subjects, the relief of inflammation resulted in marked improvement in joint deformation.

2. Arthritis and Autoimmune Diseases

Following are excerpts reprinted from a memo released by Dr. Len Sands, Director of the San Diego International Immunological Center.

The Arthritis Process Step-By-Step with CMO Intervention

1. Infection, trauma, or excessive wear affects some joints. (Usual infections are rheumatic fever, flue, or bacteria. Traumas are auto wrecks, falls, sports injuries, etc. Excessive joint wear comes from being overweight, or from repetitive use of keyboards, jackhammers, etc.)

2. #1 causes damaged or infected cartilage particles to become dislodged. This happens regardless of whether it's "osteo" or "rheumatoid" or "reactive" arthritis.

3. Macrophages of the immune system begin cleanup of dislodged cartilage particles.

4. Macrophages report their activities to dormant memory T-cells (m/T-cells).

5. Dormant m/T-cells programs activate and develop aggressive anti-cartilage cleanup programs, which do not distinguish between healthy and damaged cartilage.

6. The m/T-cells programs stimulate more macrophage activity, which in turn activates even more dormant m/T-cells.

7. Increased m/T-cell population stimulates even more macrophage activity, and the self-perpetuating cycle of cartilage destruction expands. Because m/T-cell programs don't limit macrophage activity to damaged cartilage only, destruction of healthy cartilage also occurs. It has developed into a destructive autoimmune process. But, until sufficient cartilage has been destroyed, symptoms are not evident. The initiating factor (infection, trauma, or wear) may have disappeared months or even years ago, but the destructive autoimmune process remains active. It is self-perpetuating and no longer dependent upon the initiating factor.

8. The cycle is compounded by the fact that the mechanism which should deactivate certain m/T-cells (those that have completed their mission) fails to function. The constant restimulation of the m/T-cells keeps them active. So now there is an overabundance of m/T-cells propelling macrophage cartilage destruction. The immune system is totally out of control and massive cartilage destruction begins. Early symptoms of pain and inflammation appear.

9. Cartilage destruction accelerates. The cycle reaches critical mass. Macrophages are now scouring the body to find and destroy any cartilage anywhere it can be found. Symptoms become more severe. Pain, inflammation, and joint deformity appear at new sites as they suffer macrophage attacks.

10. Symptoms of pain, stiffness, swelling, nodules, and deformation often reach intolerable and crippling levels - especially as joint cartilage disappears and bone-on-bone erosion occurs. Conventional arthritis medications take their toll on the liver, kidneys, and heart. Normal life span is often shortened by up to ten or twenty years from both the ravages of arthritis and medication side effects.

11. By deactivating the m/T-cells, CMO INTERVENTION (the sooner the better) can stop the autoimmune process at any point.

3. The Work of Dr. Len Sands, PhD, with CMO, Memo excerpt found at http://healthenlightenment.com/arthritis-autoimmune.shtml

Dr. Len Sands, PhD, is the clinic director of the San Diego Immunological Center and the author of the books Arthritis Defeated at Last - the REAL Arthritis Cure and Arthritis Beaten Today, which have been translated into five languages so far, including Chinese. He is currently writing other books on arthritis, cancer, and viral diseases.

After ten years working on classified government projects, Dr. Sands began his direct active participation in clinical matters in 1970, as an associate of Manhattan Fifth Avenue Clinic in New York City. Within the next four years, he opened and became the owner and director of six medical clinics, as well as acquiring Southland General Hospital in Texas. Later, he opened two medical clinics in Mexico. He became involved in medical research projects concerning autoimmune diseases, viral diseases, diabetes, and cancer.

By the mid-1980s, he was thoroughly disillusioned by the limitations of conventional medicine and spent ten years traveling the world researching innovative therapies involving both conventional and alternative medicines, especially seeking those which were documented by exacting clinical trials in the major European countries. He also explored many unconventional as well as documented therapies in various Asian, Middle Eastern, Latin American, and Oceanic countries.

As clinical director of the San Diego Immunological Center, he encourages his researchers and medical staff to specialize in what he calls "curing the incurable" - diseased for which conventional medicine offers no hope of true remedy. Curing the Incurable was the title of a one-hour interactive weekly radio program Dr. Sands hosted in 1997.

Early in his career, he produced scientific and marketing material for industrial corporations, as well as for Parke-Davis and the pharmaceutical division of the Dow Chemical Company, among others.

It was Dr. Sands' own bone-grinding arthritis that prompted him to relentlessly prod his research associates into finally finding a lasting cure for arthritis. The research resulted in the development of the world's first and only true immunomodulator, a naturally occurring substance that is expected to impact the course of medical history. It certainly is changing the way autoimmune diseases will be treated in the future. That discovery, CMO (cerasomal-cis-9-cetylmyristoleate) in 1995, is now proving to be of great value for numerous other incurable diseases with strong autoimmune factor ailments like multiple sclerosis, fibromyalgia, lupus, ALS (Lou Gehrig's Disease), emphysema, Crohn's disease, scleroderma, sarcoidosis, and myasthenia gravis among others. It is also relieving or curing ankylosing spondylitis, psoriasis, carpal tunnel syndrome, prostate inflammation, Sjogren's syndrome, TMJ, Behcet's syndrome, macular degeneration, Reiter's syndrome, sciatica, tendonitis, and more - all of which have strong autoimmune components. CMO is now being used to treat autoimmune diseases on every continent in the world. Its phenomenal success with these diseases uncovers more options and the research goes on. Nothing could please Dr. Sands more, including the continuing research and clinical studies on even more diverse incurable diseases.

Therapies using CMO, combined with the proper supportive nutritional products and proper diet for a minimum of the first 30 days, have been proven to be beneficial for all autoimmune diseases, plus Muscular Dystrophy, Chronic Fatigue Syndrome, Alzheimer's, Parkinson's, Raynaud's, hypertension, and heart and vascular diseases, as well as ridding the body of conditions caused by environmental, dental amalgam, medicinal, chemical, metallic, and other toxins.

CMO is the world's first and only true adaptogenic autoimmune immunomodulator. CMO is not an immunosuppressant or an immunostimulant. CMO™ is considered "adaptogenic", meaning: it is capable of altering the course of a disease, because of its corrective and restorative immunomodulatory properties for autoimmune diseases and inflammatory processes. Other so-called "immunomodulators" are not. They function as immunosuppressants or immunostimulants. They are capable of one principle action, either temporarily suppressing or stimulating immune function, not correcting or restoring it. CMO, on the other hand, permanently corrects the programmed autoimmune attacks controlled by the memory T-cell (m/T-cells) themselves. That is why a single 30-day CMO therapy program ordinarily lasts indefinitely without any need to repeat the therapy or use any additional medications of any kind thereafter. To maintain protection against autoimmune diseases, one bottle per month is recommended with the necessary supporting nutritional products.

Some practitioners have theorized that, in the case of arthritis for example, CMO merely acts upon pain receptors at the arthritic site. It that were so, their theory cannot explain why CMO has the following effects:

1. It benefits virtually any and all ailments associated with autoimmune diseases.

2. It lowers blood sedimentation in lupus patients.

3. It relieves certain symptoms of multiple sclerosis.

4. It reverses lung inflammation in emphsema.

5. It lowers the need for insulin in diabetics.

6. It reverses prostate inflammation.

7. It corrects Crohn's disease.

8. It reverses fibromyalgia.

9. It improves the health of ALS (Lou Gehrig's Disease) patients.

10. It lowers high blood pressure, yet elevates low blood pressure.

Obviously, CMO is a general remedial immunomodulator that acts upon the memory T-cells, which control the autoimmune processes within our bodies. It is also important to understand the CMO acts only upon memory T-cells and does not inhibit the activities of any of the several other types of T-cells that are responsible for combating infective microorganisms or invading substances. Unlike the immunosuppressants commonly used to try to temporarily control the symptoms of autoimmune diseases, CMO does not leave the body vulnerable to attack by disease-causing agents. Nor does it inhibit the body's resistance to tumor formation, as do the dangerous new tumor necrosis factor (TNF) suppressants of some new arthritis drugs.

NOTE: This document is supplied for information and educational purposes only. It is not intended to recommend or prescribe any treatment for any condition or illness. Contact a doctor or medical professional who is trained in natural nutritional supplements before adding any new protocol or when starting any health or exercise program.

© Dr. Len Sands. All rights reserved

4. AN OPPORTUNITY TO OFFER A LITTLE CLARITY IN REGARD TO CETYL MYRISTOLEATE , by Charles Cochran, D.C.

Cetyl Myristoleate

The History

For those of you who have not heard or read about cetyl myristoleate, let me give you just a little background. The discovery occurred during a two-year period from 1962 to 1964 by Harry W. Diehl while on a personal quest to find a cure for arthritis. Harry was a research chemist working in sugar metabolism at the National Institutes for Health in Bethesda, Maryland. During his time there, over 40 years, he was responsible for isolating and identifying over 500 chemical compounds. Many of these were patented. His most notable discovery, prior to CM, was a sugar used in the preparation of Dr. Jonas Salk’s oral polio vaccination. His discovery of CM actually occurred in a laboratory that he had set up in his own home. The story of how he isolated the molecule that may one day be hailed as the most significant nutritional discovery of the 20^th century and nature’s answer to arthritis is simply wonderful. Unfortunately, I can’t relate the entire story in this short article. Hopefully, someday someone will write the story of this very intuitive researcher. In a nutshell, this is what Harry’s research revealed:

• Mice are immune to arthritis.

• The molecule that provides this immunity is Cetyl Myristoleate (the cetyl alcohol ester of the fourteen carbon chain fatty acid myristoleic acid).

• CM circulates in the bloodstream of mice at approximately 350 mg / kg bodyweight and with proper doses of CM extracted from mice (450 — 500 mg / kg body weight); he could provide rats with 100% immunity to adjuvant-induced arthritis.

• After injecting the CM into the rats, the highest concentrations were found in the liver.

• Harry developed a way of synthesizing CM by combining cetyl alcohol with myristoleic acid and found that the synthesized form was just as effective in providing rat’s immunity to adjuvant-induced arthritis as the naturally occurring form (extracted from mice).

Subsequent Research

A more recent study, performed by H. Siemandi, M.D., Ph.D., was published in the August / September 1997 issue of the Townsend Letter for Doctors & Patients. This study was performed as a randomized, double blind, placebo parallel trial with 382 patients who had been diagnosed with degenerative joint disease (DJD or osteoarthritis), rheumatoid arthritis, and psoriatic arthritis. This group was divided into three groups for testing. The first group (A) received a complex of fatty acids (90 grams) containing 12% CM, the second group (B) received the same complex of fatty acid esters plus glucosamine hydrochloride, sea cucumber (a sea animal commonly found in the Great Barrier Reef in Australia — related to the Starfish), and hydrolyzed cartilage, and the third group (C) received a placebo. Treatment consisted of a one-month protocol. Outcome measures included a variety of patient-reported, clinical, laboratory, and radiographic assessments. The results were as follows (expressed in percent improvement):

Group A Group B Group C

Treatment Response 63.3% 87.3% 14.5%

M.D. Overall Assessment 58.1% 84.2% 13.9%

Patient Overall Assessment 59.2% 88.2% 16.1%

Joint Swelling Score 47.5% 77.2% 21.1%

Mechanisms of Action and Indications

The exact mechanisms of action of CM are not fully understood. Several theories have been presented, but as of today, there has been no research in this regard. Being a fatty acid ester, one mechanism being presented is that it somehow manipulates the production of the favorable prostaglandins, (series 1 and/or 3) and leukotrienes over the unfavorable prostaglandins of the 2^nd series and pro-inflammatory leukotrienes. Prostaglandins and leukotrienes are unsaturated fatty acids that regulate many local metabolic processes including inflammation, platelet aggregation, pain, fluid balance, and nerve transmission. These effects could be accomplished by inhibition of the arachidonic acid cascade and the cyclo-oxygenase and lipoxygenase pathways.

Another mechanism being discussed is that these fatty acid esters are somehow incorporated into the phospholipid cell membranes and alter cell membrane permeability and receptor sites. This could explain the possible theory of altering T-lymphocyte function during the hyper-immune response related to autoimmune diseases.

Although the mechanisms are unknown, we can clinically observe CM’s effects. It seems to function, in at least, four different ways. One of the first observations noted when favorable results are seen is the lubricating quality. Decrease or loss of morning stiffness is commonly noted shortly after commencing treatment. Next, it functions as an anti-inflammatory. Lessening of swollen digits is often seen after the 4^th or 5^th week of treatment. Third, it functions as an immunomodulator or immune system regulator. Its ability to regulate or calm down hyper-immune responses is one of the most exciting qualities and shows that CM may be helpful in addressing the symptoms related to many autoimmune diseases. And finally, CM functions as an analgesic or pain killer and has been helpful for many sufferers of muscle tension headaches and fibromyalgia.

Recommended Dose

We have found that many of those individuals who have taken Cetyl Myristoleate (CM), and have not responded, have often taken doses far below what is recommended. Results are related to the quality of the product as well as the amount of CM taken orally (therapeutic or loading dose). If we do a little mathematics, and use the amount of CM circulating in the bloodstream of mice as a comparison (350 mg / kg), we conclude that a 160-pound person could require up to 24.5 grams. Fortunately, possibly because human and mouse metabolism differ greatly, we have found that doses of 12 grams to 18 grams of elemental CM as a therapeutic or loading dose taken over a three to four week period of time works fantastically well. However, there are those individuals that require a second protocol. And once the desired results have been achieved, there are many individuals that benefit from taking much smaller, perhaps daily, maintenance doses.

Concerning the quality, there is a wide degree of very diverse CM products available today. In fact, some of the CM formulas have no Cetyl Myristoleate in them at all! Before purchasing any of these formulas, please read the label to determine exactly how much CM is available. It is imperative that the formula contain a minimum of 12% CM levels. If the levels are below this amount, you’ll probably have to take a wheelbarrow full before seeing any results! In other words (let’s do a little math), if you’re trying to achieve a therapeutic dose of 12 grams of CM and the CM levels are at 12%, you will need a total of 100 grams of mixed fatty acid esters in this particular formula. If the CM levels are at 20%, you will need a total of only 60 grams. If the manufacturer has not listed the percentages and the total amount of fatty acid ester complex, I would be very hesitant in purchasing that particular product. Without this information, you have no way of determining how much you need to take, for how long, and what would be a good maintenance dose.

The Confusion

There are many different Cetyl Myristoleate and related products available today. There are several which, either through ignorance or unethical marketing, have contributed to extensive confusion in the nutritional and healthcare industry. There are several issues that I’d like to address in this regard. First, Cetyl Myristoleate (CM) is not CMO™. CMO™ is a trademarked product that is being sold as cerasomal cis-9 cetyl myristoleate, an analog of cetyl myristoleate. The term cerasomal (waxy body?) is not in your chemistry texts and was constructed by the manufacturer to set his product apart. The term analog is defined as a similarly structured molecule. In other words, CMO™ contains a similar molecule, but is not Cetyl Myristoleate. Chemical analysis performed on several occasions, using Gas Chromatography, Mass Spectrometry, and Flame Ionization Detection has revealed very little, if any, Cetyl Myristoleate in this product. Unfortunately, the manufacturer, as of today, has not disclosed exactly what his product is.

Another embarrassing mix up is that, at least, one of the manufacturers started with a raw material that contained high levels of myristic acid (C14:0) instead of myristoleic acid (C14:1). Myristic acid is the saturated analog of myristoleic acid and when esterified with cetyl alcohol produces Cetyl Myristate, not Cetyl Myristoleate. Before the sophisticated diagnostic procedures to analyze for CM were developed, many of these products were analyzed using improper or inadequate methods. These products are now on our health food store shelves and in the MLM industry being sold as Cetyl Myristoleate, but in fact are Cetyl Myristate. Interestingly, there have been many who have experienced benefits from these Cetyl Myristate products. And I have found that, in one particular formula, the Cetyl Myristate seems to enhance the effectiveness of the Cetyl Myristoleate. They may form a true synergism.

And, finally, all CM products are not created equally. Chemical analysis of several different products has revealed that the CM levels range from 1% up to 40%. And to add to the confusion, I have found products that contain lower percentages of CM (20% - 30%) that seem to work better than the CM products with higher levels. Please note that there are no CM products today that are 100% pure. With all of these products you will find a complex of other fatty acid esters, for example cetyl stearate, cetyl palmitate, cetyl palmitoleate, cetyl oleate, and cetyl myristate, in different proportions. What we’re now finding is that some of these fatty acid esters may inhibit the positive effects of the CM, while others work with the CM, as I mentioned above, in a cooperative way.

For those of you technical individuals out there, Gas Chromatography — Flame Ionization Detection (GC-FID) analysis is now considered one of the most accurate techniques for detecting these fatty acid esters. Here’s something that you may also find interesting. Further analysis of the product used by Dr. Siemandi in his study showed that it actually contained 10.8 grams of CM, and not 18 grams, as stated in his report. And one very current analysis of this same material indicated that the CM levels could have been only 9 grams delivered in a one- month protocol. It’s truly amazing what results were achieved with only 9 or 10 grams of active ingredient!

5. Cetyl-myristoleate: Remarkable relief from pain and inflammation, by Marcia Zimmerman, Nature's Impact, 09/30/1998

A lot of us are hurting!

Thirty-eight million Americans suffer from some form of connective tissue disease, encompassing 100 specific disorders of the joints, muscles, ligaments, and tendons. The most common are rheumatoid arthritis, osteoarthritis, gout, fibromyalgia, carpal tunnel syndrome, ankylosing spondylitis, and various types of back pain. These are all considered "rheumatic" conditions. However, others that do not involve the joints are also considered rheumatic: lupus erythematosus, Crohn's disease, Sjogren's syndrome, and polymyalgia rheumatica.

The costs are staggering

Treating rheumatic disorders costs an astounding $65 billion each year, according to the 1992 National Health Interview Survey. The distribution of costs among the disorders is uneven. The Massachusetts Health Maintenance Organization (HMO) estimates costs are four times greater for rheumatoid arthritis than for osteoarthritis, which is much more common. Treatment for a rheumatoid arthritis patient runs $2,162 per year, while osteoarthritis treatment costs $543. Most of the costs are for prescription drugs.

Is the treatment worse than the illness?

Current drug treatment for arthritis is potent and has numerous side effects. Since all rheumatic disorders involve pain and inflammation, treatment strategy is usually geared to reducing pain first, then delaying treatment for inflammation as long as possible. That is because these conditions never heal and treatment must be continued throughout life. Besides that, significant side effects are associated with even the most innocuous remedies, such as aspirin or acetaminophen.

Nevertheless, arthritis sufferers experience so much discomfort that they are often willing to suffer the consequences of pain relief. What are these consequences? Acetaminophen can cause liver damage, and aspirin can cause extreme irritation to the stomach. Occurrence of side effects depends on how much is taken, over what period of time, and an individual's susceptibility to problems.

Other treatments for advanced arthritis involve the anti-cancer drug methotrexate, corticosteroids, and cyclosporin. Corticosteroids (prednisone) cause severe side effects. Cyclosporin, a neurotoxin, can diminish cognitive function and nerve responsiveness. Methotrexate has been found to suppress bone marrow function and cause severe liver damage in some cases. Folic acid and vitamin B (12) supplements help guard against these side effects, yet physicians often specifically prohibit their use.

Wouldn't it be exciting if there were a treatment for rheumatic conditions that was effective, could heal the condition, cost very little, and came from natural sources?

The promise of cetyl-myristoleate

Cetyl-myristoleate is a naturally ring waxy alcohol. It was accidentally discovered during the 1970's by a chemist named Harry Diehl at the National Institutes of Health in Rockville, Maryland. Diehl had been working for years with a particular strain of white mice that never got arthritis, even when purposely exposed to it. The mice had such a bad reputation among investigators that they carefully avoided using them whenever they wanted to study arthritis.

Diehl was curious about why this type of mouse was so resistant to arthritis. Consequently, he looked for the chemical in the mouse's body that gave it immunity from the disease. After considerable trial and error, he isolated cetyl-myristoleate. When he injected the substance into mice and rats that were susceptible to arthritis, the compound prevented them from developing this condition.

Diehl continued his research with animal studies. He successfully synthesized the compound from beef fat, which worked as effectively as the mouse extract. He was awarded a U.S. Patent (#4,049,824) September 20, 1977, for his discovery.

Dramatic results

The secret might have never gotten out if Diehl himself hadn't developed severe osteoarthritis. Faced with a future of heavy medication, constant pain, and immobility, he decided to inject himself with some of his cetyl-myristoleate preparation. To his amazement, his pain disappeared almost immediately. The swelling in his joints decreased and his mobility increased dramatically. Without further injections, he continued to improve. In a matter of weeks, he could hardly believe he had ever had arthritis. Furthermore, his arthritis never returned and he had absolutely no side effects.

Following the surprising results of his self experimentation, Diehl applied for and was awarded U.S. Patent (#5,569,676) in October 29, 1996, for use of cetyl-myristoleate in the treatment of osteoarthritis.

The word gets out

His physician was so impressed that he urged Diehl to publish his findings. With the doctor's help, Diehl's paper was published in the Journal of Pharmaceutical Sciences in March 1994. The article caught the attention of a researcher at the San Diego Clinic Immunological Center in California. Physicians there began treating patients with cetyl-myristoleate for a host of autoimmune disorders. They witnessed remarkable results.

The evidence

Humberto Siemandi, M.D., Ph.D., the primary research administrator at the Hospital SM in Baja, California, conducted a 32-week multi-center trial with 106 patients. The trial was double-blind, randomized, and placebo-controlled. In other words, patients were randomly assigned to receive any of three preparations for 30 days: plain cetyl-myristoleate; cetyl-myristoleate enhanced with glucosamine hydrochloride, sea cucumber, and hydrolyzed cartilage; or a non-reactive compound. Approximately 20-percent of the patients withdrew from the study because they could not handle the withdrawal from nicotine, caffeine, or alcohol. These substances interfere with the action of cetyl-myristoleate and were not allowed during the trial.

The results strongly suggest that both cetyl-myristoleate alone and cetyl-myristoleate with supporting nutrients may help treat many forms of arthritis-based diseases, including psoriatic arthritis. Most of the patients responded with one treatment course, but a few required a second course to achieve complete and lasting results. Many of the patients included in the trial had long-standing chronic conditions.

L.S. Macklas, Ph.D., conducted a second clinical trial involving 48 subjects. The group represented a cross-section of ethnic and socioeconomic groups, and included 28 female participants between the ages of 33 and 82, and 20 males aged 28 to 74. All patients had either osteoarthritis or rheumatoid arthritis. The subjects received two 75-mg capsules of cetyl-myristoleate each morning and each evening for four to six days for symptoms that were mild-to-moderately severe. Those with severe-to-crippling arthritis were given the same number of capsules for seven days, followed by a seven-day, treatment-free period. A second trial of five-and-a-half days followed. All the patients showed improvement after just three days. They continued to improve, even if their condition was mild enough to not require additional capsules (see table on page 32).

Personal stories

Many anecdotal reports of cetyl-myristoleate's effectiveness have come across my desk. They come from physicians who have been impressed with the results their patients have received. Among them are patients like Anna: She not only experienced continued relief for her arthritis, but her asthma also improved. Another patient named Luke was suffering from emphysema as well as rheumatoid arthritis. Both conditions improved after he took two courses of treatment with cetyl-myristoleate.

Rick took an aggressive treatment for ankylosing spondylitis. His protocol included cetyl-myristoleate, vitamin C, curcumin, lipoic acid, and a low-calorie, high-protein diet. He wrote in a consumer response questionnaire: "The overall effect was extremely positive -- complete remission of all symptoms and indications." He added that he experienced improvement in five days, and continued toward maximum improvement of 90 percent in just 10 days. Rick is monitoring his status now and checking for recurrence. Although many patients have remained symptom-free, some need additional treatments periodically.

Safety

Cetyl-myristoleate is extremely safe, does not interfere with other nutrients, and even large doses -- up to several grams per trial -- usually cause no problem. Some patients have reported mild stomach upset. However, this can usually be avoided by taking digestive enzymes with the capsules. Others have reported some fatigue, but this may be due to the abrupt discontinuation of caffeine, nicotine, and alcohol.

What exactly is cetyl-myristoleate?

Cetyl-myristoleate is a waxy substance derived from the tallow of beef. It is similar in structure and activity to fatty acids. Although we don't know exactly how cetyl-myristoleate works, it is believed to act on memory T-cells in the immune system; i.e., it may "re-program" them so they do not attack one's own connective tissues. That is why it is so effective for autoimmune disorders, or those in which the body attacks itself. However, as I discussed above, several disorders that do not necessarily involve joints are rheumatic in nature. All these disorders cause pain, inflammation, and swelling. Cetyl-myristoleate can help relieve all these errant immune responses.

Dietary changes

You guessed it! For a natural treatment to work, you need to modify your diet. Cetyl-myristoleate can be difficult to absorb, and it is important to avoid foods that might interfere with it. As I mentioned above, you must avoid caffeine, chocolate, alcohol, and nicotine. Additionally, large amounts of competing fats, such as butter, margarine, and oils, should be restricted or eliminated.

At this time, cetyl-myristoleate is not widely available in health or natural food stores.

Conditions that cetyl-myristoleate may benefit:

• Rheumatoid arthritis

• Emphysema

• Osteoarthritis

• Lupus erythematosus

• Gout

• Crohn's disease

• Fibromyalgia

• Sjogren's syndrome

• Carpal tunnel syndrome

• Polymyalgia rheumatica

• Ankylosing spondylitis

• Back pain

6. Double-Blinded Evidence Supports Cetyl Myristoleate, by Steve Austin, Quarterly Review of Natural Medicine, 12-31-1997, p. 315-316

Interest in 9-cis-cetyl myristoleate (CMO) a fatty acid apparently found in mice -- and in a species known for immunity from arthritis -- has been intense at least since Dr. Jonathan Wright interviewed the discoverer, Harry Diehl, in Nutrition and Healing over a year ago. (1) Until recently, animal data provided by Diehl(2) were supported only by anecdotes in humans.(3)

For several months, the text of a double-blinded randomized trial with CMO executed by Humberto Siemandi, a medical doctor from Mexico has been circulating in the world of natural medicine. The full text was recently published in the Townsend Letter.(4) Whether the author of that report has any vested interest in "CM Plus" or other CMO products produced by Draco International was not clear from the Townsend Letter report.

In that report, placebo or 90 grams of oil containing 18 g of CMO was administered over the course of one month, with or without the addition of glucosamine HCl, sea cucumber, and cartilage, for "a total dosage of 18 grams each of these nutrients." Apparently this means 600 mg of each ingredient per day. Topical CMO was also applied as 60 cc of 25% solution -- again, this appears to have been the total dose for the month. ("CM Plus" contains all four ingredients; the same supplier sells topical CMO as a separate product.) The follow-up appears to have been done in eight week cycles.

The daily dose of glucosamine sulfate used in virtually all previous research is 2.5 times the amount of glucosamine HCl used in this trial. Moreover, The HCl version has not yet been tested; making its inclusion and the dose selected for it both poor choices for a multi-agent trial. Almost certainly, the 600 mg per day of cartilage is too low a dose to affect humans. Doctors of natural medicine generally use higher amounts if they use cartilage at all. The optimal amount of sea cucumber remain a matter of conjecture, but the support for this product in the treatment of rheumatoid arthiritis (RA) is weak enough to have made its inclusion in the protocol a potential mistake.

Although the study is labeled "multicentric," it has only one author. Nonetheless, the large number of subjects (N = 382 completed the study) appears to support this claim. Most patients had RA, though a few had psoriatic arthritis. Tobacco and caffeine were discouraged for participants in all groups. The placebo contained salicylates or ibuprofen as excipients -- a questionable choice that could have worked against an anticipated positive effect for CMO.

Among those receiving all interventions, 88% reported subjective improvement compared with 59% for CMO alone and 16% for placebo. The overall assessments by attending medical doctors were similar. Moreover, a treatment response was seen in 87% of those taking all interventions vs. 63% receiving only CMO and 14.5% on placebo. These results were highly statistically significant.

(1) Wright JV. Searching for a cure for arthritis. Nutr Healing 1996; Aug:5-6.

(2) Diehl HW, May EL. Cetyl myristoleate isolated from Swiss albino mice: an apparent protective agent against adjuvant arthritis in rats. J Pharmaceutical Sci 1994; 83:296-9.

(3) Cochran C, Dent R. Cetyl myristoleate -- a unique natural compound valuable in arthritis conditions. Townsend Letter for Doctors & Patients 1997; July:70-74.

(4) Siemandi H. The effect of cis-9-myristoleate (CMO) and adjunctive therapy on arthritis and autoimmune disease -- a randomized trial. Townsend Letter for Doctors & Patients 1997; Aug/Sept: 58-63.

Article copyright Natural Product Research Consultants, Inc.

Other CM/CMO Research and References

1. Diehl, Harry, and E.L. May, "Cetyl Myristoleate Isolated from Swiss Albino Mice: An Apparent Protective Agent against Adjuvant Arthritis in Rats". Journal of Pharmaceutical Sciences, Vol. 83, No. 3, March, 1994.

2.Siemandi, H., MD., et al. "The Effect of cis-9-Cetyl Myristoleate (CMO) and Adjunctive Therapy on the Course of Arthritic Episodes in Patients with Various Auto-Immune Diseases Characterized by the Common Terminology, 'Arthritis' and 'Psoriasis': A Randomized Clinical Trial."