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The Berkson Clinical Study
The following paper was written by an American physician Dr. Burton Berkson. Despite his impressive credentials and the implications of this limited study, the results of his work were not published in the American medical journals. The study results were published in Germany’s medical journal "Medizinische Klinik". The article has been transcribed in English but is provided basically unchanged for your review.
Dr. Berkson’s Biography:
Undergraduate and Graduate Education:
BS:
Roosevelt University, Chicago (Biology/chemistry)
MD:
Autonomous University System, Mexico
MS,
Ph.D. University of Illinois, Urbana (Biological
Sciences)
Medical Post Graduate Training:
Internal Medicine Resident (St. Lukes Hopsital, Western
Reserve Univ. 77-78)
Pathology resident (Mt. Sinai Hospital, Western Reserve
Univ. 78-79
Mini-Residency Obstetrics (University of New Mexico
Hospital 1980)
Certification Hypnotherapy ASCH
ACLS
Certification
Academic Positions and Responsibilities:
Assist. Professor (Biology, Mycology) Rutgers University
68-72
Assoc, Professor (Biology, Microbiology) Chicago State
University 72-74
Visiting Professor Max Planck Institute, Heidelberg 78
Adjunct Professor (applies Biology, EPPWS) New Mexico
State Univ., Present
Consultant Mushroom Poisoning (ALA) Center for Disease
Control, Atlanta
Toxicology Consultant, New Mexico Poison Control Center
Principal Investigator, FDA, IV Thiocatic Acid
(Alpha-Lipoic Acid)
Member, New Mexico Medical/Legal Panel
Member, El Paso Fund Alternative Medicine Committee
Numerous Other Visiting Professorships and Research
Associate Positions
Medical Practices:
Integrative Medical Center of New Mexico 1996 – Present
Attending Physician, White Sands Missile Range, New
Mexico 1989-1997
Emergency room Physician, New Mexico 1979-1988
Private rural family practice, Hobbs & Lovington, New
Mexico 1980-1986
Author: "Alpha Lipoic Acid Breakthroughs"
[As
published in "Medizinishche Klinik", a German medical
journal.]
According to a recent article, the number of adults
seeking liver transplants for hepatitis C infection will
skyrocket in the next 20 years [11]. About 10,000
Americans die from this disease each year. Deaths are
estimated to increase because of the increasing risk of
infection, and the resulting cirrhosis, portal
hypertension, thrombocytopenia, bleeding from varices,
and liver cancer. Five
years ago, 20% of these hepatitis C patients were
candidates for liver transplantation and today the
number has increased to about 50%.
An
estimated 4 million Americans are infected with
hepatitis C and many of them are being evaluated for
liver transplant surgery. This expensive process costs
roughly $300,000 during the first 3 months, and can be
painful and incapacitating. Add to this the thousands of
dollars for anti-rejection drugs and the costs of more
frequent visits to health care facilities. Of course
some people do require liver transplant surgery,
however, the author believes that in many cases, an
effective alternative therapy exists.
Often, patients with progressive hepatitis C, who seeks
a more conservative treatment, prior to surgery present
to our facility. These patients are treated with a
program that includes and combines alpha-lipoic acid,
silymarin and selenium. Most patients recover quickly,
however, a few find it difficult to follow a healthy
nutritional and lifestyle program, or their condition is
so far advanced that they go on to liver transplant
surgery. In this paper, the case histories of 3 patients
are presented.
ABSTRACT
Background: There has been an increase in the number of
adults seeking liver transplantation for hepatitis C in
the last few years and the count is going up rapidly.
There is no reliable and effective therapy for chronic
hepatitis C since interferon and antivirals work no more
than 30% of the time, and liver transplant surgery is
uncertain and tentative over the long run. This is
because, ultimately, residual hepatitis C viremia
infects the new liver. Furthermore, liver
transplantation can be painful, disabling and extremely
costly.
Treatment Program: The author describes a low cost and
efficacious treatment program in 3 patients with
cirrhosis, portal hypertension and esophageal varies
secondary to chronic hepatitis C infection. This
effective and conservative regimen combines 3 potent
antioxidants (alpha-lipoic acid [thioctic acid],
silymarin, and selenium] that possess antiviral, free
radical quenching and
immune boosting qualities.
Conclusion: There are no remarkably effective treatments
for chronic hepatitis C in general use, Interferon and
antiviral have less than a 30% response rate and because
of the residual viremia, a newly transplanted liver
usually becomes infected again. The triple antioxidant
combination of alpha-lipoic acid, silymarin and selenium
was chosen for a conservative treatment of hepatitis C
because these substances protect the liver from free
radical damage, increase the levels of other fundamental
antioxidants, and interfere with viral proliferation.
The 3 patients presented in this paper followed the
tripleantioxidant program and recovered quickly and
their laboratory values remarkably improved.
Furthermore, liver transplantation was avoided and the
patients are back at work, carrying out their normal
activities, and feeling health. The author offers a more
conservative approach to the treatment of
hepatitis C, that is exceedingly less expensive. One
year of the triple antioxidant therapy described in this
paper costs less than $2,000, as compared to more than
$300,000 a year of liver transplant surgery. It appears
reasonable, that prior to liver transplant surgery
evaluation, or during the transplant evaluation process,
the conservative triple antioxidant treatment approach
should be considered. If there is a significant
betterment in the patient’s condition, liver transplant
surgery may be avoided.
Key
Words: Hepatitis C – treatment – antioxidant – alpha
lipoic acid – thioctic acid – silymarin – selenium
Background: More than 20 years ago, when the author was
in medical and pathology training at 2 hospitals in
Cleveland,
Ohio, he was assigned to 6 critical patients who were
suffering from acute hepatic necrosis secondary to
hepatotoxic mushroom poisoning. He ordered thiocgic acid
(alpha-lipoic acid, ALA) from the National Institutes of
Health and injected this antioxidant drug into the
patients. In spite of their highly threatening condition
the patients, as measured by laboratory values and
clinical parameters, recovered quickly. Dr. Fred Bartter
(then Chief of Hypertension and Endocrinology at the NIH)
and the author were astounded by their recoveries and
went on to treat many more mushroom poisoning patients.
Over the years, the author continued to treat additional
patients with other medial conditions using ALA, and
observed similar results. The author has recently added
silymarin and selenium to the regimen. In this paper he
will discuss the use to this triple antioxidant regimen
in the management of 3 chronic hepatitis c patients
Patients and Method: The 3 basic antioxidants there were
used in this report are alpha-lipoic acid (thioctic
acid), silymarin and selenium (selenomethionine). The
alpha-lipoic acid product was manufactured by Asta
Medica at Frankfurt Am Main, Germany. The silymarin was
a product distributed by NOW Foods of Bloomingdale,
Illinois, and the selenium was encapsulated by Metabolic
Maintenance Products Inc., of Sisters,
Oregon.
The
3 patients were selected at random from a group of
approximately 50 chronic hepatitis C charts at the
Integrative Medical Center of New Mexico in Las Cruces.
Each patient was maintained on a dose of 600 mg. Of
alpha-lipoic acid a day in 2 divided portions of 300 mg.
each. The silymarin dose was 900 mg. Per day in 3
divided portions of 300 mg. The selenomethiomine dose
was 400 mcg in 2 divided portions of 200 mcg.
Because alpha-lipoic acid depletes some of the B
vitamins, the patients were prescribed 2 B-100 capsules
a day. In addition, each patient also took between 1,000
and 6,000 mg. Of vitamin C, 400 IU of vitamin E, and a
mineral supplement. The patients were also requested to
eat a daily diet that included at least 6 servings of
fresh vegetables and fruits, only 4 oz or less of meat
per meal, and 8 glasses of fresh water. It was also
suggested that the patients reduce their stress levels,
and take part in an exercise program that included at
least a 1-mile walk 3 times a week.
The patients followed the nutritional supplement program carefully, however, it is not clearly known whether the other regimens were correctly followed.
CASE
STUDIES:
PATIENT 1:
Mrs.
M.P. is a 57-year-old woman who acquired hepatitis C
after a blood transfusion during surgery about 10 years
ago. She did not eat a nutritious diet and did not live
a very healthy lifestyle at that time. About 5 years
ago, she became very fatigues and nauseous, and was
diagnosed with non-A, non-B hepatitis. She was treated
with conventional therapies and continued to
degenerate into a poorer state of health. About 3 years
ago she was diagnosed with chronic hepatitis C.
cirrhosis, portal hypertension. esophageal varcies, and
thrombocytopenis, and treated with steroids and
interferon. She did not improve. Her AFP
(alpha-fetoprotein) level become elevated (16.1) and a
mass was located in her liver. Mrs. M.P. was told that
the mass was probably cancer and that there was no hope.
Mrs.
M.P. presented at our office last year appearing
fatigued, weak, pale, and her abdomen was grossly
enlarged. The abdominal distention was due to ascites.
She was administered oral furosaminde (40 mg) and
potassium chloride (10 meq)
with
a balanced die and wholesome lifestyle. She lost almost
50 lb of fluid in 1 month. Mrs. M.P. was treated with
600 mg. Of oral apha-lipoic acid in 2 divided doses (300
mg each), 900 mg of silymarin in 3 divided doses (300 mg
each) and 400 mg of selenium a day. A premium B complex
vitamin was added to her regimen because alpha-lipoic
acid depletes the body of thiamin, biotin and other B
vitamins. Adequate amounts of vitamin C (2,000 mg),
vitamin E (800 IU), Coenzyme Q10 (300 mg), and basic
mineral supplements were also prescribed. Figures 1 and
2 track the favorable changes in her ALT levels and her
AFP levels. Today, Mrs.
M.P.
is working 8 hours a day, feels healthy, looks good, and
is not tired. She is free of the signs and symptoms of
serious chronic hepatitis C infection.
PATIENT 2
Mrs.
P.P. is a 49-year-old woman who was infected with
hepatitis C following a blood transfusion prior to
trauma surgery more than 10 years ago. During surgery,
her spleen was excised because it was lacerated. About 3
years ago, a liver biopsy was performed that showed
moderate cirrhosis with active inflammation. As a result
of this pathology, Mrs. P.P. went on to develop portal
hypertension with esophageal varices. She never acquired
thrombocytopenia because of the spenectomy, and did not
show an elevated AFG. Mrs. P.P. was treated with
interferon therapy without any satisfactory results. She
was told that her condition was hopeless and that a
liver transplant was her only option. Her health
continued to decline and she presented at our office
with
fatigue, anxiety, and insomnia.
Mrs.
P.P. was prescribed 600 mg. Of alpha-lipoic acid each
day in 2 divided doses (300 mg each). To that, was added
silymarin (900 mg/day) and selenium (400 ug/day). To
combat the anxiety and insomnia, 0.5 of aprazolam was
prescribed, as needed at bedtime. Mrs. P.P. was put on a
balanced health and lifestyle program, and within 7
months regained her health. Figure 3 to 5 trace the
favorable changes in her ALT levels, viral load and
platelet levels. She is doing very well today and is
working at an arduous job and playing at sports without
any fatigue or other symptoms of serious disease.
PATIENT 3
Mrs.
L.M. is a 35-year-old mother of 3 children who developed
hepatitis secondary to a blood transfusion during the
birth of her baby girl 15 years ago. Three years ago she
became ill and was diagnosed with cirrhosis of the
liver, portal hypertension, and esophageal varcies. As a
result of the portal hypertension, she developed
splenomegaly and thrombcytopenia. Mrs. L.M.’s
hepatologist sent here to the university hospital for
liver transplant evaluation. When she presented to our
office, she was anxious, tired, and pale, and complained
of constant pain in the regions of her liver and spleen.
Mrs. l.’s fasting blood sugars were in the 300-mg/dc
range. She did not have hyperglycemia prior to the
hepatitis C infection. Mrs. L.M. decided that prior to
the liver transplant surgery, she wanted to investigate
a more conservative treatment regimen.
Mrs.
L.M. was prescribed alpha-lipoic acid (600 mg./day),
silymarin (900 mg./day) and selenium (400 ug) per day
with other supportive supplements. She was encouraged to
follow a health lifestyle program with a 2,000 calorie
diabetes diet. Within 2 weeks she began to feel much
better and recovered quickly. Her blood sugar fell into
the normal range and the pain in her liver
and
spleen ended. She became energized and was able to do
her normal work as a housewife. She returned to college
the next semester earning a 3.8 grade point average (A).
Figures 6 and 7 trace her favorable progress.
DISCUSSION
ALPHA-LIPOIC ACID
Alpha-lipoic acid (ALA) is a small organic molecule with
a disultide bond. It is a superb antioxidant that is
soluble in both water and fat. ALA is an important
coenzyme for the production of acetyl coenzyme A.
Dihydorlipoic acid (DHLA), it’s reduced form, is an
electron donor that recycles other fundamental
antioxidants (vitamin C, vitamin E, and glutathione).
ALA and DHJLA are superb free radical scavenger
themselves because they neutralize peroxyle radicals
[36], hydroxyl radicals [39] and singlet oxygen [38].
ALA
is also a metal chelator that removes mercury from
tissues [17], prevents
calcium oxalate crystals (stones) from forming in the
kidneys [21, chelates copper [28], and removes arsenic
[18].
Lately, there has been a great explosion in ALA
research. The lipoic acid/dihydrolipoic acid redox
couple inhibits viral replication by stabilizing the NFK
beta transcription factor [4], blocks the development of
cataracts [24], protects the kidneys form aminoglycoside
damage [35], insulates the pancreatic islet cells form
inflammatory assault [7], inhibits thymocyte apoptosis
[8], and stimulates the production of helper T cells
[15]. In addition, the toxic side effects of cancer
chemotherapy can be attenuated with the use of ALA [5]
and it protects bone marrow from free radical damage
secondary to ionizing radiation.[33].
Numerous other studies show that ALA is useful for the
treatment of diabetes mellitus and syndrome X because it
increased cellular glucose utilization [19]. And
significantly reduces insulin resistance [12,20].
Diabetic neuropathy originates from a decrease in blood
flow to various organs. This results in an accumulation
of free radicals that can destroy nerve function. In one
study, ALA
brought about a significant reduction of neuropathic
symptoms in 23 patients [46]. This was accomplished by
abolishing the products of lipid peroxidation and
increasing the entrance of glucose into the cell [27].
Due
to ALA’s lipophilic characteristics, it can cross the
blood-brain barrier quite easily and can scavenge free
radical toxins in the central nervous system.Both ALA
and DHLA protect animals from neuronal death following
laboratory-induced cerebral ischemia and reperfusion
experiments [9,16,32]. This effect is explained by the
fact the ALA
greatly increased glutathione levels in
nervous tissue, thus protecting the nerves from the
toxic products of oxidation.
For
many years, ALA was used as a treatment for liver
disease. As of yet, however, there are not many papers
on this subject, and some studies used entirely
sub-therapeutic dose [25].
Ethyl alcohol (ETOH) damages the liver by several
mechanisms that ultimately lead to the proliferation of
innumerable free radicals. These toxins damage the cell
membranes by lipid peroxidation. It has been reported
the ALA lowers the levels of ETOH metabolic breakdown
products, and in consideration of this ALA may be an
effective treatment for alcohol induced hepatitis, early
cirrhosis, and alcoholic coma [23, 37].
In
the late 1960’s and 1970’s, there were several studies
describing the successful treatment of hepatotoxic
mushroom poisoning with intravenous ALA [22, 47].
National Institutes of Health studies reported the
survival of 73 out of 79 seriously poisoned patients [3,
6]. In American, interest in the use of ALA for
hepatotoxic mushroom poisoning, and liver disease in
general, was in the main
lost, because of the growing fascination with liver
transplantation as a proposed "standard of care"
treatment for serious liver disease.
SILYMARIN
Silymarin is the mixed extract of the milk thistle plant
(sylibum marianum) and has been used for hundreds of
years as a treatment for liver disease. In the late
1960’s and 1970’s it was extensively used for serious
hepatotoxic mushroom poisoning with excellent results
[43]. It has been demonstrated to be a proficient
antioxidant, protecting the liver by neutralizing
dangerous hydroxyl radicals, superoxide ions and
hypochloric acid. In this way silymarin neutralized the
toxins that destroy the cellular membrane systems and
the hepatocyte’s genetic material [10, 26, 41].
Silymarin, like ALA, increases cellular glutathione
levels and decreases tumor promoter activity {1, 30].
Human viral hepatitis studies with silymarin demonstrate
quicker normalization of liver enzymes, expeditious
reduction of bilirubin levels, and shorter hospital
stays [31]. In addition, silymarin has been shown to be
an effective antidote for toluene and xylene toxicity,
and drug overdoes [14, 29, 40]. Alcoholic and other
chronic liver disease patients lowered their liver
enzymes, decreased their levels of procollagen III, and
improved the histology of their livers with daily oral
administration of silymarin [2,13, 34]. Taking this
intelligent reasoning into account, silymarin offers
another effective treatment choice for serious liver
disease.
SELENIUM
Selenium (Se) is an essential metal that is required for
normal antioxidant metabolism, reproduction and thyroid
function. It is also an important coenzyme for the
glutathione peroxidase detoxification system. Because of
this, selenium neutralized peroxides that proliferate
under oxidate stress and consequently protects cell
membranes from free radical damage.
Selenium often combines with amino acids and forms
selenoproteins. Viruses might benefit from being
directly involved in this selenoprotein encoding process
by monitoring selenium levels in the cell. Consequently,
this viral behavior could act as a barometer for
increasing or decreasing viral reproduction. If cellular
selenoprotein levels fall, the virus might become more
active and produce more viruses that attack new cells.
If selenoprotein levels rise, the virus may remain in a
dormant state for longer periods of time or remain
permanently dormant.
Research papers have reported that RNA viruses,
including hepatitis C virus, encode selenium-dependent
glutathione peroxidase genes. In view of this concept,
it is entirely possible that a specific viral gene could
generate a selenium shortage in the host. And in this
way, a selenium deficiency could stimulate viral
proliferation and thus promote the progression of
hepatitis C. To continue, in that case, the addition of
selenium might act as a "birth control pill" for the
virus, and thus show down it’s reproduction mechanisms.
According to several investigators this could give the
immune system a chance to control the hepatitis C or HIV
disease process [42,45].
CONCLUSION
There are no remarkably effective treatments for chronic
hepatitis C in general use. Interferon and antivirals
have less than a 30% response rate and liver
transplantation is uncertain and tentative. This is
partially due to the residual viremia; the newly
transplanted liver ultimately becomes infected again
[44].
The
triple antioxidant combination of alpha-lipoid acid,
silymarin and selenium were chosen for a conservative
treatment of hepatitis C because these substances
protect the liver from free radical damage, increase the
levels of other fundamental antioxidants and interfere
with virus proliferation. The 3 patients presented in
this paper followed the triple antioxidant program and
recovered quickly form this potentially devastating
viral infection. Furthermore, liver transplantation can
be painful, disabling, and extremely costly.
The
author offers a more conservative approach to the
treatment of hepatitis C that is exceedingly less
expensive. One year of the triple antioxidant therapy
described in this paper costs less than $2,000, as
compared to more than $300,000 a year for liver
transplant surgery. It appears reasonable, that prior to
liver transplant surgery evaluation, or during the
transplant evaluation
process, this conservative triple antioxidant treatment
approach should be considered. If there is a significant
betterment in the patient’s condition, liver transplant
surgery may be avoided.
References available upon request - contact Hepatitis
United
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