Primal
Defense Clinical Study Results
Homeostatic
soil organisms improve candida, asthma, and other
conditions in medically unresponsive chronic disease
states. A physician skeptic performs the study…
In January 2000, physician skeptic Paul A.
Goldberg, M.P.H., D.C., professor of gastroenterology
and public health at Life Chiropractic College, came
across promotional materials about a probiotic product
called Primal Defense™ containing homeostatic soil
organisms thought to be as old as the earth itself; a
number of patients had questioned him about this
product. Dr. Goldberg is not a big fan of nutritional
supplements. He believes the claims surrounding
products all too often exaggerate their benefits. He
therefore challenged Garden of Life, manufacturer of
Primal Defense, to allow him to do his own study
utilizing a patient population that had been largely
unresponsive to a wide range of medical treatments to
see whether this formula could live up to its claims.*
The completed study is scheduled to be published this
fall in the peer-reviewed journal Progress in
Nutrition.
Seventeen patients between 27 to 60 years of age,
suffering from chronic diseases unresponsive to
standard medical intervention for a minimum of three
years, were given eighteen
Primal Defense homeostatic
soil organism (HSO) caplets per day for 120 days.
Patients were evaluated by interview regarding their
conditions pre- and post-administration of the Primal
Defense caplets along with limited laboratory
evaluation. At the termination of the study there were
clinical improvements, of varying degrees, in
subjects.
Scientific Validation for
Primal Defense Soil Organisms
"Sixteen of seventeen subjects completing the
study reported improvements in their symptoms
including partial to complete relief from bowel
problems, decreases in asthmatic symptomatology,
increases in energy levels, improvement in skin
conditions, improvement in chronic sinus infection and
general improvements in overall well being,"
notes Dr. Goldberg. "No subjects reported any
worsening of their symptoms at the completion of the
study."
Notable Candida Yeast
Reductions
Stool and/or blood testing before and after
administration of Primal Defense revealed an
appreciable lowering in candida yeast counts in each
of the eight subjects who showed elevated yeast counts
initially. That is astounding! Every person with
elevated candida levels had a significant reduction.
No subjects exhibited any significant increase in
yeast counts. The results of the before and after
stool microbiologies were notable. Based on these
samples, the HSOs in Primal Defense appear to be
effective at reducing candida yeast growth, Dr.
Goldberg notes. Two subjects had candida antibody
titers done prior to and after the protocol. Both
showed a significant reduction in their titers along
with pronounced clinical improvement in their
symptoms.
Notable Improvements among
Asthmatics
Two subjects had a history of asthma with current
symptomatology for which they were on prescription
medications. Both of these subjects had a 50 percent
or greater reduction in their asthmatic symptoms and
in their usage of prescription inhalant medications
upon completing the protocol. "Particularly
notable was the reduction in asthmatic symptoms seen
in two patents who had been asthmatic for many
years," notes Dr. Goldberg. "This is
consistent with the 'hygiene hypothesis,' which
suggests that the upsurge in childhood asthma has
accompanied the decrease in bacterial exposure of
modern children in industrialized societies and that
through greater exposure to bacteria (and other
microorganisms) a decrease in the incidence of asthma
might be possible."
Notable Improvements in
Intestinal Conditions
Eleven of twelve subjects who initially experienced
intestinal difficulties reported improvement in their
overall bowel function consisting of one or more of
the following types: relief from chronic constipation,
less irritable bowel-type symptoms, reduced frequency
of diarrhea, and greater ease in elimination without
straining. None of the subjects reported any negative
effects on bowel functioning.
Results Explained
"I have long recognized the importance of the
gastrointestinal flora in good intestinal functioning
and in regards to a wide variety of systemic health
problems," notes Dr. Goldberg. "Dietary
modification, fasting, detoxification, lifestyle
alterations, all are of positive impact on the
gastrointestinal flora when properly applied; yet,
with so many forces in our modern lives working
against the maintenance of healthy gut flora I felt
that additional reinforcement to the flora would be
beneficial, particularly in clients with serious
chronic health problems."
Dr. Goldberg adds that it has been suggested as far
back as the Russian embryologist and immunologist Élie
Metchnikoff (1845-1916) that taking supplemental
beneficial bacteria to reinforce and balance
intestinal flora promotes intestinal well-being and
produces systemic benefits. "Mounting
epidemiological data and clinical studies support the
idea that exposure to a wide variety of bacteria, as
found in nature in the soil and general environment,
play an important role in the development of healthy
immune systems and the general state of resistance, to
a wide variety of ailments. Conversely, a theory known
as the 'hygiene hypothesis' suggests that many people
in modern societies have been too highly protected
from normal bacteria. This isolation from the bacteria
in our environment, according to the 'hygiene
hypothesis,' may contribute to the rise in chronic
degenerative diseases such as asthma, inflammatory
bowel disease, and a host of allergic conditions.
"It has been suggested that bacteria found in
the soil, referred to as homeostatic soil organisms (HSOs)
when ingested orally in a probiotic formulation, may
have advantages over non HSO-probiotic formulas due to
their ability to implant and survive in the gut. The
value of HSOs reportedly lies in promoting positive
intestinal function with corresponding systemic
improvements in the patient's overall nutritional,
immunological and gastrointestinal status.
"It has been postulated that human beings
ingested HSOs as part and parcel of the dietary intake
prior to the sanitizing of food products as it occurs
today in most Western nations. There is increasing
evidence that our well-intended attempts at sanitizing
our homes and food supply with antimicrobial cleaning
solutions, disinfectants and soaps may be excessive
and contributing to immune systems that do not develop
healthy responses to outside influences. This lack of
challenge to our immune systems is becoming
increasingly suspect in regards to the increasing
amounts of asthmatic children, raised under
increasingly sanitary conditions, in the United
States.
Individual Patient Results
Let's look at the results first, see what kinds of
conditions improved (if at all), and to what extent,
and then let's try to find the explanation for these
results.
Subject 1 A
53-year old male with a 27-year medical
history of progressive psoriatic arthritis and
ulcerative colitis experienced symptomatic improvement
during the first three weeks with improvements in
bowel function and arthritic pains followed by an
exacerbation with increases in joint inflammation and
bloody diarrhea. His Primal Defense dosage was reduced
from 18 to two caplets, two times per day, with a
reduction of symptoms. The patient increased his
dosage over the next several days, returning to 18
caplets per day, completing the 120-day protocol. He
reported that his bowel function improved 25 percent
by the end of the study with occasional days of
"near normal stools," which had not occurred
for over five years. Improvements were also noted with
less visible blood in his stool, better formed stools,
and reduced incidence of cramping. There was no
improvement in overall stiffness/joint discomforts.
His sedimentation rate fluctuated, but, at the end of
the study, remained close to what it had been at the
start (55mm/hr). A follow up of the stool microbiology
showed a significant reduction in the stool yeast
count.
Subject 2
A 42-year-old female radiologist with a
five-year history of chronic fungal infection of the
lungs also had significant (approximately 25 percent)
loss of lung function. She had chronic chest pain upon
breathing. Long-term use of the anti-fungal drug
Sporonox had not resolved the problem or allowed for
any significant improvement. She also had chronic
asthma and a significantly elevated serum yeast titer.
At completion of the study, the subject reported
feeling significant improvement. Her asthma
symptomatology had improved by 70 percent, as rated by
the subject. She reported greater ease in breathing,
improved bowel function, and more energy. She had a
reduction in chest pain and significant improvement in
spirometer testing by her medical pulmonologist in
January 2002. Yeast serum antibody testing performed
on this subject at the completion of the study showed
a marked drop in the titer from 900 to 438 U/ml.
Therefore, it would appear that her infectious state
had greatly improved, leading to improved lung
function.
Subject 3
A 36-year-old male with chronic psoriasis
widespread over his scalp, elbows, face, torso and
legs improved with approximately 25 percent of the
psoriatic lesions clearing and a lightening of the
remaining affected areas.
Subject 4
A 46-year-old male with chronic irritable
bowel syndrome since childhood that interfered with
social and work activities, reported at the end of the
protocol a reduction in symptoms of cramping /
diarrhea / irritable bowel of approximately 25 to 30
percent.
Subject 5
A 57-year-old female with chronic
diverticulitis, arthritis, and spinal degeneration,
did not improve.
Subject 6
A 35-year-old female with chronic
constipation of seven years duration and bowel
movements that occurred once every three to four days,
reported in the third week of the protocol that her
constipation had abated entirely with bowel movements
occurring every one to two days. She reported an
enhanced sense of well being.
Subject 7
A 40-year-old male suffered from chronic
fungal sinusitis of six years duration that had been
unresponsive to medical treatments including allergy
shots, antibiotics, and other drugs. The patient
reported excellent response to the 120-day protocol,
which was substantiated by examination of sinuses by
his physician, an ear, nose and throat specialist.
With the improvement of his sinuses, the patient also
reported improvement in chronic fatigue that he had
suffered from for approximately 10 years.
Subject 8
A 43-year-old female with chronic fatigue,
constipation with laxative dependency, and depression,
reported significant improvement in energy levels,
reduction of depression, and complete relief from
chronic constipation of five-plus year's duration with
her laxative dependency ended. (Prior to protocol,
this patient reported having a bowel movement once
every three days. After the protocol, the patient
reported a daily bowel movement without laxative
usage.)
Subject 9
A 43-year-old female with ulcerative
colitis of five years duration, experienced an overall
improvement in bowel function (approximately 33
percent as per subject) with reduced bleeding and
cramping.
Subject
10 A 34-year-old female with systemic
arthritis, joint and muscle pain and irritable bowel
syndrome, found that at completion of the protocol she
experienced a complete absence of "irritable
bowel" symptoms and 75 percent reduction in
joint/muscle pain (as per subject's evaluation).
Subject
11 A 22-year-old female was medically
diagnosed with rheumatoid arthritis, joint stiffness
and general fatigue. She reported 75 percent
improvement in joint stiffness and pain along with
increased energy levels at completion of protocol.
There was a decline in stool yeast growth, accompanied
by drop in candida antibody serum titer from 1,688 to
183 u/ml.
Subject
12 A 40-year-old female with chronic
diarrhea and fatigue found that after 40 days, her
diarrhea completely abated and she experienced
increased energy levels. Upon a follow-up examination
after 80 days, she continued to report her bowel
symptoms and energy improvement remained.
Subject
13 A 33-year-old female with chronic
fatigue, indigestion and constipation, said she moved
her bowels approximately once every 21 days. After 90
days, she reported that she was now having daily
movements, accompanied by resolution of fatigue and
digestive issues. A follow-up interview with the
subject 30 days later showed she continued to remain
well with absence of prior symptoms.
Subject
14 A 55-year-old female who had
approximately one third of her colon removed three
years earlier due to malignancy, had been experiencing
intestinal distress with diarrhea for about three
months. Following 60 days, she reported resolution of
symptoms. She reported that she continued to remain
symptom-free 60 days later.
Subject
15 A 35-year-old female had suffered
chronic irritable bowel syndrome accompanied by
cramping, diarrhea, and fatigue for over three years.
Following 120 days, she reported a 50 to 75 percent
symptomatic improvement in all symptoms. A follow-up
of stool microbiology showed elimination of yeast in
stool.
Subject
16 A 26-year-old male had a history of
chronic nausea. Medical analysis/treatment had not
been successful in alleviating the problem. Following
45 days, his nausea abated entirely. Upon follow-up 75
days later, his symptoms continued to be absent.
Subject
17 A 29-year-old female had chronic asthma.
After 60 days, her asthma symptomatology had improved
by 50 percent with a corresponding decrease in her
prescription asthma medications.
"Anecdotal evidence suggests that
a variety of chronic gastrointestinal, allergic,
autoimmune and degenerative conditions can be
positively affected by the consistent (three months or
longer) administration of an HSO formulation."
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disease, but rather are dietary supplements intended
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