Objective
Recent published reports offer anecdotal evidence that Cetyl Myristoleate may provide significant amelioration of various arthritic conditions. We set out to perform controlled studies to determine if this material was efficacious, either in the short term, or in some measurable manner, over a much longer period.

Methods
A prospective, randomized study design was used to allocate patients to receive Cetyl Myristoleate, Cetyl Myristoleate plus Glucosamine hydrochloride (GH), sea cucumber (SC) and hydrolyzed cartilage (HC) and a placebo.Results. At the start of this study, the duration, severity, and pattern of arthritic episodes were found to be similar in the 3 treatment groups. At the end of the study it was found that the number of arthritic episodes was significantly reduced, and the duration of episode-free time was significantly prolonged, in the two Cetyl Myristoleate groups compared with the placebo group.

Conclusion
Cetyl Myristoleate treatment and Cetyl Myristoleate plus GH, SC & HC were demonstrated to offer significant benefits over the placebo in the prevention of arthritic episodes. It was further determined that these results could not be obtained with other standard arthritic therapies based upon exhaustive reviews of patient records prior to opening of the study. Cetyl Myristoleate and Cetyl Myristoleate plus GH, SC & HC treatment also seems to permit some relief to autoimmune inflammatory diseases, which may prove to be long-term. This finding could provide additional evidence for the theory, reflected by the earlier anecdotal evidence as well as some animal studies, that Cetyl Myristoleate and Cetyl Myristoleate plus GS, SC & HC may prove to be of major benefit in the future treatment of autoimmune diseases.

The terms ARTHRITIS AND PSORIASIS have come to some permanent and some transient. Each condition, however, is typified by certain common elements such as some sort of inflammatory response with resulting pain, various forms of cellular degeneration and frequently, permanent loss of mobility and quality of life.

With the exception of Osteoarthritis, most researchers are beginning to believe all arthritic conditions may have a common, albeit many-faceted, etiology - autoimmune dysfunction. Unfortunately the great number and complexity of immune system components and their diverse interplay has made this theory difficult to prove.

While it has not been proven, the original research done on Cetyl Myristoleate at NIH indicates a direct connection between the observed effect of Cetyl Myristoleate and some ability of Cetyl Myristoleate to correct certain immune dysfunction, which may cause many arthritic conditions.

Patients and Methods

Study design
The study was a 32 week (8 week cycle, 4 in-hospital & 4 in follow-up), multi-centric, double-blind, randomized, placebo-controlled parallel trial that compared the efficacy of Cetyl Myristoleate alone, and Cetyl Myristoleate plus GS, SC & HC, administered over a period of 30 days, with placebo, for the treatment of various forms of autoimmune diseases commonly characterized as arthritis and psoriasis. Out of a dose of 90 grams of total fatty acid esters, 18 grams constituted Cetyl Myristoleate. Those study patients who received the support nutrients GS, SC, & HC were given a total dosage of 18 grams each of these nutrients.

The study was conducted under the auspices of the Joint European Hospital Studies Program. This study was designed by a committee, which consisted of rheumatologists and biostatisticians experienced in the development and execution of clinical trials. Oversight of the study was accomplished by an executive committee, composed of the primary researcher and primary statistician, selected participating investigators, consultants; and an independent sight committee consisting of two experienced federally controlled, state health department rheumatologists and one state health department biostatistician.

Eligibility criteria
Patients were required to have inflammatory arthritis of at least one year duration in at least one peripheral joint, excluding the shoulders and hips. Included in this parameter, affected joints must have had joint tenderness and joint swelling of 2 on a four point scale and joint patient-physician overall assessment of involvement ranging from; none - mild - moderate - severe - very severe.

The patients inducted into this trial for the purposes of psoriatic testing were chosen on generally the same criteria - involvement of epidermal involvement from: none - mild - moderate - severe - very severe. Criteria for exclusion included unwillingness to stop the use of tobacco and caffeinated beverages, at least for the duration of the trial. Tobacco and caffeine use has been reported to greatly hamper the positive (if anecdotal) result of the use of Cetyl Myristoleate. It also should be noted here that the use of any other medication in all forms of arthritis as well as psoriasis were not excluded as it was determined this would limit participation. It was also deemed advisable to approximate as much as possible, conditions that would be found in the average arthritic. One exception to this condition was the exclusion of patients showing sensitivity to salicylates or ibuprofen, which were used as excipients in the placebo.

Potential participants with other severe chronic conditions were excluded, as it was the opinion of the primary investigator that this type of participant would limit the potential successful completion of the study period. All patients had failed to respond to therapy with therapeutic doses of one of the NSAIDs. All patients who took NSAIDs during the trial were required to be on stable dosages for one month prior to entry and throughout the trial. No systemic or intrarticular steroids were used. All patients were fully informed and voluntarily consented to participate in the research program. The study protocol was reviewed and approved by the federally controlled state oversight committee. Prior to entry into this trial, each potential study participant was informed of the nature, duration, and purpose of the study to be administered, and all the potential benefits, inconveniences, and hazards that could reasonably be expected.

Study medication
Patients received either one-half liter of pleasantly flavored oral liquid containing 18 grams of Cetyl Myristoleate or one-half liter of the same liquid with Cetyl Myristoleate. Both liquids were carefully compounded so as not to be able to be differentiated. Each patient was also given 180 capsules of the adjunctive medication containing a total each of 18 grams GL, SC and HC. Identical capsules containing the placebo compound were also distributed. The Cetyl Myristoleate topical liquid was distributed as a 25% concentration in 60-ccs. lightly scented lotion and an identical placebo lotion with Cetyl Myristoleate. The oral liquid was used with meals in one-teaspoon quantities, three times daily. Two capsules of GL, HC & SC were taken with each meal, three times daily. The topical lotion was used as needed and determined by each patient according to his or her own perceived requirement.

Clinical assessment
Outcome measures of disease activity and therapeutic efficacy were obtained at the time of screening (not more than four weeks before study entry), randomization at week zero, and thereafter at weeks; 1, 2, 3, and 4. Outcome measures included a variety of patient-reported, clinical, laboratory and radiographic assessments. Patient self-assessment measures included morning stiffness, night pain, patient overall assessment and Mobility Functional Index as determined by this published procedure. Clinical assessment measures included joint counts, dactylitis, Enthesopathy Index, Spondylitis Articular Index, chest expansion, modified Schober’s test, and finger-to-floor test as detailed elsewhere in this paper. Additionally, the presence of symptomatic keratoderma, phalangeal and digital deformation as measured from a normal range of vertical protrusion at rest were measured. These tests, singularly and collectively were then compiled into a patient-by-patient qualitative scale as; none = O, mild = 1, moderate = 2, severe = 3 and very severe =4. Laboratory assessment. Laboratory evaluation included a urinalysis and complete blood cell count, with leukocyte differential and reticulocyte count. Chemical surveys and a Westergren erythrocyte sedimentation rate (ESR) determination were done at every visit by secondary researchers daily in the two hospital settings. The C-reactive protein (CRP) level was evaluated at the first and last day of the hospital stay. At the screening times, blood was drawn for HLA-B27 typing and RF and ANA determinations.

Radiology assessment
At the screening visit, all patients had the following radiographs performed: anteroposterior views of the pelvis and oblique views of the sacroiliac joints. Adverse drug reactions (ADR’s). Patients were screened for ADR’s at every secondary researcher’s visit. Patients were withdrawn from the study medication if any of the following were found; WBC less than 3000/mm3, absolute polymorphonuclear count less than 100000/mm3, acute or progressive decrease in hemoglobin or hematocrit, proteinuria less than 500 mg. for 24 hours, drug fever or significant rash.

Compliance
The patients were queried at each secondary researcher’s visit regarding the dietary supplement or topical lotion they had used. A capsule count for the trial medication was done at each consultation to monitor compliance.

Biostatistical considerations
Each patient was classified as a treatment responder or nonresponder based on the following definition. Assessment measures were selected a priori, and criteria for clinical improvement and worsening were defined for each patient self-assessment and physician assessment (improvement category); joint pain/tenderness score and joint swelling score (improvement = decrease by 30%; worsening = increase by 30%). Treatment response was then defined as improvement in at least 2 of these 4 measures, one of which must be joint pain/tenderness or swelling, and ITO worsening any of the 4 measures. The study was designated with a 90% power for detecting a placebo response rate of 30% compared with a Cetyl Myristoleate and Cetyl Myristoleate plus GS, SC & HC response rate of 50%, assuming a 10% withdrawal rate. This resulted in a target sample size of 431 patients with an actual sample size of 382.

In short, the analytical method was the change in primary and secondary outcome measures from baselines to the last available follow-ups analyzed using t-tests for continuous data and chi-square tests for ordinal and categorical data. Mixed-model analyses were done to characterize the response patterns over time using SAS PROC MIXED for continuous data and a program named MIXOR for categorical and ordinal data. All other analyses were conducted using SAS version 6.08. All statistical tests were two-sided and P0.05 was the criterion for statistical significance.

Results Patient population
Four hundred thirty-one patients entered the study. Of these, 106 were randomized to receive Cetyl Myristoleate, 84 were randomized to receive Cetyl Myristoleate plus GS, SC & HC; 226 received a placebo. Fifteen psoriatics received Cetyl Myristoleate plus GS, SC & HC, plus CM-25% concentration topical at a 3X quantity ratio. Even though the study was sponsored by the owners of the respective private hospitals, recruitment was not limited to the typical fee-paying patients. Approximately 27% of the patients were actively recruited in the respective local area. Despite a prolonged accrual period and careful screening, the loss of approximately 11% of the starting participants occurred largely because of the inability to stop the use of tobacco and/or caffeinated beverages.

Fulfillment of final parameter of study size was accomplished by the substantial excess of volunteers wanting to enter the study - this coupled with the relatively short testing period required to validate the effects of Cetyl Myristoleate and Cetyl Myristoleate plus GS, SC & HC. Statistical Chart 1 outlines the baseline demographic, clinical, and laboratory variables. The duration of disease was 12 years. The Westergren ESR and CRP levels were mildly elevated. There were no statistically significant differences in any of these baseline parameters between the patients taking Cetyl Myristoleate and Cetyl Myristoleate plus GS, SC & HC and those taking placebo.

Compliance
Compliance for both the Cetyl Myristoleate and Cetyl Myristoleate plus GS, SC & HC and placebo groups was quite high. There was a statistical trend toward those in the Cetyl Myristoleate and Cetyl Myristoleate plus GS, SC & HC group taking more tablets per day (96% compliance) than those in the placebo group (86% compliance) (P = 0.08). The probability of this observation was due to the rapid response of pain relief in the Cetyl Myristoleate groups.

Primary outcome measures
The Oversight Committee defined response based on a decision rule as outlined in Patients and Methods. Statistical Chart 1 shows that based on that definition of treatment response, using the last-visit analysis, response rates were 63.3% in the Cetyl Myristoleate group and 87.3% in the Cetyl Myristoleate plus GS, SC & HC group and 14.5% in the placebo group. Trends favoring Cetyl Myristoleate and Cetyl Myristoleate plus GS, SC & HC groups were noted in components of the response definition. Physician overall assessment showed an improvement of 58.1% for the patients using Cetyl Myristoleate alone and 84.2% for the patients using Cetyl Myristoleate plus GS, SC & HC. Patients experiencing worsening or no reaction totaled 1.0% in all groups, compared with improvement of 13.9% in placebo gradient overall assessment demonstrated 59.2% improvement in the Cetyl Myristoleate alone group and 88.2% in the Cetyl Myristoleate plus GS, SC & HC. Patients experiencing worsening or no reaction totaled 1.0% in all groups, compared with improvement of 16.1% in placebo group. Joint swelling scores improved in 47.2% in patients using Cetyl Myristoleate alone and 77.2% in patients using Cetyl Myristoleate plus GS, SC & HC. Patients experiencing worsening or no reaction totaled 1.0% in all groups, compared with improvement of 21.1% in placebo group.

Secondary and laboratory outcome measures
Analysis of secondary outcome results (Statistical Chart 2) demonstrated a significant reduction in the Spondylitis Articular Index in the Cetyl Myristoleate group and in the Cetyl Myristoleate plus GS, SC & HC-treated patients. Trends favoring the Cetyl Myristoleate group and in the Cetyl Myristoleate plus GS, SC & HC group were also seen in a reduced duration of early stiffness and in an improvement in the fingers-to-floor result. Laboratory outcome measures showed some statistically significant changes. Total neutrophils decreased in the Cetyl Myristoleate group and in the Cetyl Myristoleate plus GS, SC & HC group compared with the placebo group. The Westergren ESR significantly decreased in the Cetyl Myristoleate group and in the Cetyl Myristoleate plus GS, SC & HC groups compared with the placebo group. The CRP values were not significantly different and the values in ESR for the responders was not statistically significant from the nonresponders.

Withdrawals and adverse drug reactions
Statistical Chart 3 summarizes the data of patient exits from the study. Forty-nine patients withdrew from the study before completing the study, 16 from the Cetyl Myristoleate and 10 from Cetyl Myristoleate plus GS, SC & HC groups, 2 from the psoriatic group, and 21 from the placebo group. Follow-ups in all groups averaged approximately these measurements were combined, combined average - (mean ± SD 6.97 ± .2.64 months) (P=.06). Withdrawal of consent was the most common reason for discontinuing the study. Seven patients withdrew because of no improvement or worsening disease. Two patients had to be withdrawn from the study because of concurrent illnesses requiring conflicting medication. The majority of withdrawals, however, was the result of patient addictions to nicotine, caffeine and alcohol and the patient inability to cease these activities during the study period.

Statistical chart 2 displays the percentages of study patients showing improvement in the primary outcome variables (columns 1-3). The numbers to the right display the significance levels for the differences between treatment groups (columns 4-6). All of the significant levels are much less than 0.05, which means the differences between groups are considered statistically valid. For all four primary outcome variables (treatment response, physician assessment, patient assessment and joint swelling score), Cetyl Myristoleate & GS, SC, and HC did significantly better than the Cetyl Myristoleate group, and the Cetyl Myristoleate group did significantly better than placebo. The chart also displays the results for the secondary outcome variables. The averages (mean average as opposed to median or mode) are presented in columns 1-3 along with their standard deviations (statistical measurement of data variations). Again, the numbers to the right display the significance levels for the difference between treatment groups (columns 4-6). “NS,” means that there was no significant difference between any measured groups labeled as such. When the groups are significantly different from each other, the significance is displayed. None of the secondary outcome variables were significantly different between the Cetyl Myristoleate group and placebo. The Cetyl Myristoleate & GS, SC, HC, group did significantly better than the placebo for dwelling score, Enthesopathy index, spondylitis articular index and the modified Schober’s test. The Cetyl Myristoleate & GS, SC, HC, group did better than Cetyl Myristoleate alone for the joint pain/tenderness score and the modified Schober’s test.

Discussion
The results of this trial suggest that Cetyl Myristoleate and Cetyl Myristoleate supporting formulas may be beneficial in the treatment of many forms of arthritic based diseases, including: psoriatic arthritis. The definition of response was determined a priori and included assessment of joint pain/tenderness and swelling as well as patient and physician overall assessments. Cetyl Myristoleate and supporting formulas produced the best treatment response by a factor of 72.8% more patients than did placebo. Considering the components of response individually Cetyl Myristoleate and supporting formulas resulted in 70.3% more patients having improved as assessed by physician, and 56.1% more having improved joint swelling. Therefore, while the amount of treatment response using Cetyl Myristoleate and Cetyl Myristoleate and supporting formulas seems to be consistent with the treatment affects on joint counts, it is obvious that there is a statistically significant improvement in the use of the CM with supporting formulas. The time-line based response rate of Cetyl Myristoleate and Cetyl Myristoleate supporting formulas, not adequately reflected in data, by patient, showed the majority of patients responding to Cetyl Myristoleate and Cetyl Myristoleate supporting formulas did so within the first three weeks. Also, not reflected in the data, was the continued use of Cetyl Myristoleate and Cetyl Myristoleate supporting formulas beyond the study time limits and dispensed on request to 21 patients. These 21 patients were determined to have received only marginal benefits from Cetyl Myristoleate and Cetyl Myristoleate supporting formulas but one more course of treatment showed responses approximately equal to the first patient response results.

Cetyl Myristoleate and Cetyl Myristoleate supporting formulas were well tolerated in this trial. This finding was not unexpected as Cetyl Myristoleate and the Cetyl Myristoleate supporting formula components are naturally occurring and have been used as diet supplementation for many years and are widely available singly and in various combinations. In summary, Cetyl Myristoleate and Cetyl Myristoleate supporting formulas appear to be beneficial in the treatment of a wide range of arthritic conditions including long standing and refractive cases.

References:
1. Lightfoot, R.W., Jr.: Intermittent and periodic arthritic syndromes. Arthritic and Allied Conditions. 12Th edition. Edited by D.J. McCarty, W.J. Koopman Phdadelphia, Lea & Febiger, 1993.

2. Aho, K., Ahoven, P., Sievers, K., Tlilikanien, A.; Yersinia Arthritis and Related Diseases; Clinical and Immunogenetic Implications. Infection and Immunology in the rheumatic Diseases. Edited by D.C. Dumonde. Oxford, Blacksell Scientific Publications, 1976.

3. Diggie, P., Laing, Zeger, S., Analysis of Longitudinal Data. Oxford, Clarendon Press, 1994.

4. SAS Institute, Inc. SAS Technical Report P-229, SAS/STAT: Changes and Enhancements, Release 6.07., Cary, N.C., SAS Institute, Inc. 1992.

5. Hedecker, D., A random-effects ordinal regression model for multilevel analysis, Biometrics, 1994.

6. SAS Institute Inc: SAS/STAT User Guide: Version 6., 4th Edition., Cary, N.C., SAS Institute, 1990.

7. Toivanen, A.: Reactive Arthritis., Mosby Year Book. Edited by Klippel, J.H., Dieppe, D.A., Brooks, P., Carette, S., Dequek Keats. A.S., Kimberlly, R.Pl, Liang, M.H., Maini. R.N., A van de Putts, L.B., Sturrock, M.B., Urowitz. M.B., Wollheim. F.A., Zvaifler, M.J., London, Mosby-Year Book, 1994.

8. Fan, P.T., Yu, D Y,: Spondyloarthropathies. Textbook of Rheuth-matology., Vol. 1, 4th edition. Edited by, Kelley, W.N., Harris, E.D., Ruddy, S., Jr., Sledge, C.B., Philadelphia W.B. Saunders. 1993.

9. Smiley, J.D., Psoriatic arthritis., Bulletin of Rheumatic Disease, 44:, 1995.

10. Botanical Lipids. Effects in Inflammation. Immune Response, and Rheumatoid Arthritis. Rothman. D., et al. Seminars in Arthritis and Rheumatism, October 1995.

11. Anti-inflammatory Diet in Rheumatic Disease. Adam, O. European Journal of Clinical Nutrition, 1995.

12. Botanical Lipids. Effects in Inflammation, Immune Response, and Rheumatoid Arthritis. Rothman. D., et al. Seminars in Arthritis and Rheumatism, October 1995.

13. Cetyl Myristoleate Isolated from Swiss Albino Mice: An Apparent Protective Agent against Adjuvant Arthritis in Rata. Diehl, H., and May, E.L. Journal of Pharmaceutical Science, Vol. 83 March 1994.

14. Effects of Modulation of Inflammatory and Immune Parameters in Patients with Rheumatic and Inflammatory Disease Receiving Dietary Supplementation of N-3 and N-6 Fatty Acids. Kremer, j., Md, Lipids, 1996.

15. Glycosaminoglycan Supplements as Therapeutic Agents. Bucci , L., PhD., Nutritional Report, January 1996.

16. Rheumatoid Arthritis and Foods: A Patient Study, Borok, G., South African Family Pracice, October 1989.

THE SAN DIEGO STUDY:
An informal human study was undertaken at a facility called the San Diego Clinic in late 1995. It was conducted by Dr. Len Sands, Ph.D. It started with some stated objectives:

THE QUESTIONS TO BE ANSWERED WERE:

1. What are the optimum dosage levels for treating the various types of arthritis with CMO?

2. Are different dosages important relative to the different types of arthritis?

3. What is the lag time between the start of the treatment and the expected relief of symptoms?

4. What percentage of patients respond to the treatment?

5. What factors, if any, contribute to non-responsiveness?

The study was conducted with 48 volunteer patients who had (OA) osteoarthritis, (RA) rheumatoid, and (PA) psoriatic arthritis. The group was comprised of 28 females and 20 males ranging from 32 to 82 years of age. All races and all ethnic backgrounds were represented. Age, gender, race and ethnic background appeared to be irrelevant to the results of the program.

CMO was administered orally in the form of 385 mg capsules. The number of capsules and duration of treatment varied for each group. The final protocol will be found later in this study.

At the end of each trial an evaluation was made using three parameters; inflammation, pain and motion. All but four of the subjects in the studies reported 80% to 100% return of articular mobility as well as 70% to 100% decrease in pain. Probably the most interesting finding was that the relief of inflammation frequently resulted in partial correcting of the deformities. In some cases it resulted in complete corrections. At the end of the entire study, only two subjects said they had failed to notice any change. An examination confirmed no changes in the pair. These two non-responders had prior hepatic problems, one from alcohol abuse resulting in cirrhosis of the liver and the other had abused steroids for the purpose of bodybuilding. It was concluded, then, that liver damage may have been the cause of the failures. This could, at least, be a working hypothesis for future study. Two other patients showed less than 75% return of articular mobility.

During the entire study and follow-up, there were no discernible side effects.

This was an informal and independent trial at a private medical clinic. It was undertaken by an individual doctor and other professionals without funding from the government or drug companies. Clinical studies such as these point out fruitful directions for future studies.

GROUP 1

Eleven (11) subjects, was comprised of mild to moderately severe osteoarthritis, including one case of reactive psoriatic arthritis. The eleven subjects took two capsules of CMO twice daily for five days and quit. That was the entire treatment.

Nine of the patients reported 20% to 30% improvement in articulation and inflammation and about 40% to 50% relief of arthritic pain within 36 hours. Improvements, in the same nine, continued rapidly for the next 60 hours, reaching 80% to 100% overall relief by the end of four days. The two remaining subjects reported a 70% to 80% improvement by the end of the fourth day, and both of them continued to see improvements over the next week even though they were no longer on the capsules.

Half of this entire group experienced a return of some mild arthritic symptoms after about 3 to 5 weeks following the study. All of them were re

The patient with reactive psoriatic arthritis also experienced an almost complete reversal of his arthritis as well as his associated severe psoriatic skin condition which affected about 20% of his total skin area.

GROUP 2

Nine patients (9) with severe rheumatoid arthritis were grouped together for a second study. Four patients in this group required wheelchairs. One of the patients was on crutches because of a hip fusion. The remaining 4 needed walkers or canes. All of them had pain, inflammation and marked deformations of all the joints in the fingers as well as restriction of motion. Five had some permanent lower back flexion as well as back pain. All of the patients in this study had difficulty grasping and manipulation common objects.

The dosage schedule was two 385 mg capsules twice a day for 7 days, then stop for 7 days and then resume for 5 and 1/2 days.

Within three days, six in this group reported a 30% to 50% decrease in pain. Three of the six noticed increased joint mobility, and another three subjects reported little change. In 7 days, five of the patients had a 70% to 90% decrease in pain and 70% to 80% improvement in joint mobility. Three reported themselves to be totally free of pain with almost complete return of joint mobility. The joint deformations which were previously severe seemed to show marked improvement. Only one failed to show changes.

After they had been off treatment for a week, roughly half said they had seen further improvements, but most of it was minor. Two of the patients stayed the same. There was no improvement in the individual who had not seen improvement from the start. They were then re-treated for another 5 days. By the end of the treatment period all but two subjects reported themselves to be 90% free of pain, with 70% to 90% improvement in joint mobility. The non

GROUP 3

Group 3 consisted of 14 subjects with severe rheumatoid arthritis. They were given two 385 mg capsules of CMO twice a day for six days and then nothing. After three days, eleven out of this group had 40% to 50% improvement in articulation and inflammation and 40% to 50% improvement in arthritic pain. All improved rapidly over the next four days, approaching 80% to 100% level. The remaining three had 70% to 80% improvement after seven days,

Most of the subjects continued to experience minor improvement during the first week off the treatment. Six patients, however, noticed some minor recurrence three or four weeks after the treatment and were re-treated in the same manner. Their symptoms disappeared.

GROUP 4

The fourth group organized contained 14 subjects severely crippled with osteoarthritis. They each took two 385 mg capsules of CMO twice a day for seven days, then off seven days, then back on for five and a half days.

At the onset, three of this group were unable to walk and required wheelchairs. The other eleven used walkers, canes or crutches. All of the patients in this group had pain, inflammation and deformations throughout their hands and fingers. Four of the patients had severely limited movement of their backs and lower back pain. Ten had difficulty grasping and holding objects.

Four days later, ten of the patients reported a 30% to 50% improvement in movement and lessening of inflammation. 40% to 50% of their pain was gone. Ten of them continued to see Improvement over the next 3 days. In seven days they were 80% to 100% better. One subject showed no change.

On the 14th day, at the end of their week off treatment, 9 had continued to feel improvements. Four stayed the same and the one who had failed to improve before stayed the same.

They re-started the CMO again for five and a half more days. At the end of the treatment, eleven had 80% to 100% improvement in pain and mobility. Two had 70% to 80% improvement in mobility and 70% to 90% lessening of pain. One patient, the same as before, experienced no relief.

CONCLUSIONS OF THE STUDY

The optimal dosage level appears to be equal for all three types of arthritis:

Osteoarthritis, Rheumatoid and Psoriatic Arthritis. This is evidenced by the gradual return of minor arthritic 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.

Dosage level requirements appear to be equal irrespective of the severity of the subject's condition.

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

The time for maximum attainable response appears to be from seven to twenty-one days, resulting in 70% to 100% overall improvement. (Apart from the 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.)

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.

There were no side effects of the treatment noted by the subjects or the doctors.

Some of the patients were not entirely happy with 70% improvement and so were re-treated 5 weeks later. In general, they benefited another 10% to 20%.

There are, in addition to these studies, hundreds of testimonials and success stories. And the success rate in most cases, if you count success as being a substantial improvement in symptoms, is an astonishing 98% and all of this without risk to the patient.

This concludes these studies and their results.

SAN DIEGO CLINIC
MEMORANDUM

Subject: Heart Disease Relative to CMO
There have been no formal studies conducted with respect to the effects of CMO on individuals with heart disease.

However, considering that CMO is a naturally derived nutritional supplement that has shown to help normalize various physiological and immunological body processes in humans, and since it appears to be completely non

On the contrary, we have received interesting reports regarding persons with certain other ailments who have taken CMO for arthritis as recommended by their physicians and other health care professionals.

1. There have been reports on individuals suffering from hypertension (high blood pressure) whose blood pressure has completely normalized or lowered substantially.

2. There have been reports of individuals suffering from hypotension (low blood pressure) whose blood pressure has completely normalized or raised substantially.

3. There have been reports of individuals with high and even extremely high blood sedi-mentation rates whose sed rates have normalized, even in Lupus patients.

4. There have been reports of individuals with cardiac arrhythmia (abnormal heartbeat rhythm) whose arrhythmia has disappeared.

Those reports are not the result of any formal study. They have been noted from comments provided to us by professionals who have been surprised at these secondary benefits of CMO which they have encountered in their patients during the treatment for arthritis. This tendency by CMO to normalize body processes confirms that it functions as an immunomodulator.

It must not be assumed that other patients will enjoy these same secondary benefits. No formal studies have been conducted to confirm that these benefits are repeatable on a consistent basis.

It must be emphasized that any individual with a serious ailment or condition of any sort should consult with and be closely monitored by their relevant health care professional any time that person undertakes any sort of therapeutic or even nutritional program.

January 1997

SAN DIEGO CLINIC
MEMORANDUM

Subject: CMOTM . and Horses
Our very first experience with horses involved a 19-year-old dressage stallion who is considered to be the best stud horse of that kind on the East Coast. The owners were distressed that the stallion was so severely afflicted with arthritis that he was unable to move out of his stall, much less participate in dressage practice or performances. In addition, the horse was not able to rest well because of the arthritic pain. Equally distressing was the fact that he could no longer perform his breeding duties without resorting to complicated artificial insemination procedures. We are happy to report that after the administration of four bottles of CMO the stallion was waking in the morning refreshed and free of pain and able to practice its dressage maneuvers.

Furthermore tic returned quite comfortably to breeding in the natural way. Needless to say, the owners were overjoyed - and we bet the stallion was too.

Another interesting case involved a 14-year-old mare who had become too lame to walk. In all three years of working with the horse, her trainer found that she had never been able to canter and sometimes just barely managed to trot. The mare had very distinct bulging in the tendons her lower front legs. After two bottles of CMO, the horse was no longer lame and the swollen bulges had disappeared. The mare was able to trot comfortably and even canter again for the first time in years. On a ten point scale estimating pain relief and mobility, the trainer estimated that the horse had improved form a 2.5 level before CMO to a 7.5 level after.

More subtle improvements were evident in a case involving another dressage horse that was progressively becoming more and more resistant to a right lead. In this instance the trainer had already experienced great results with CMO for her own neck and shoulder problems, probably the result of being hauled around an arena by 1000 pound animals for so many years. So why not try CMO on the horse as well? Even before finishing the second bottle the horse lost all resistance to the right lead and showed a marked increase in fluidity of motion which is so important in dressage work.

One horse was conclusively diagnosed as suffering from arthritis by x-ray which clearly revealed the presence of arthritic bone spurs. After administering three bottles of CMO the owner reports that the bone spurs have decreased in size and are disappearing. We are hoping soon to support the visual evaluation with X-Ray confirmation as well.

We recently submitted blood samples of a horse undergoing treatment with CMO for the standard analysis required on the show horse circuit in California. Nothing unusual appeared in the analysis.

Administering CMO to horses call sometimes be a problem with finicky caters. Some owners use a ball gun with great success, but some owners prefer to mix the contents of the capsules in with something of which the horse is particularly fond. Some find that applesauce works well. Others like grated carrots and apples. A commercial oat and molasses mixture often works well too. About 20 capsules a day seem to work well for an average size horse.

CMO has been effective an cats, dogs, hamsters, and pot-bellied pigs for arthritis and hip dysplasia as well. Small animals need only one capsule daily. Two capsules daily for each 50 pounds of body weight.