San Diego
Clinic Immunological Center Clinical Study On Cetylmyristoleate
(CM) vs Arthritis A Study on Dose Effectiveness
and Patient Response Conducted by the San Diego Clinic Immunological
Center
The Purpose:
Having previously established the effectiveness
and nontoxicity of CMO tm (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, and
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
CM 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 nonresponding 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
resume an 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 subject
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 appears 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 subjects 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.
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 (CM) and Ajunctive 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."
|