Maitake D Fraction Research
Maitake
*Health related statements made throughout this website have not been evaluated by the FDA.
Products offered are not intended to diagnose, cure, treat or prevent any specific disease.
Select below to learn more about Maitake Mushrooms
FDA pilot study information
Maitake History
What is D-Fraction
Maitake and Cancer
HIV AND AIDS
Maitake's efficacy for diabetes, weight loss, and
blood pressure
Maitake Research information
Suggested Dosage for Maitake products
Maitake Safety, Toxicity and Guidelines
FDA Grants Investigational New Drug
Application for advanced breast and prostate cancer.
MAITAKE D-FRACTION OBTAINED IND FOR CLINICAL STUDY
February 1, 1998
Maitake Products, Inc., Ridgefield Park, NJ, proudly announced today
that the company has obtained its IND (Investigational New Drug Application)
from the FDA to conduct a Phase II pilot study on the effect of Maitake
Mushroom D-fraction Extract (D-fraction) on advanced breast and prostate cancer
patients. The approved pilot study will investigate the effectiveness of
orally-administered D-fraction in patients with late stage III or early stage
IV adenocarcinoma of breast and prostate. This study will examine the effect of
D-fraction on the size of solid tumors, tumor makers, immune assays, clinical
characteristics of pain and weight changes as well as Karnofsky Score and
Quality of Life Score.
Maitake D-fraction, a unique protein-bound polysaccharide compound
based on 1,3 and 1,6 Beta glucans, has been marketed as a dietary supplement
both in the USA and Japan since 1995 and has demonstrated clinical
effectiveness in enhancing immune system function particularly in those
patients with various forms of cancers, HIV/AIDS and chronic fatigue syndrome.
Mr. Michael Shirota, President & CEO of the NJ-based company holding the
registered trademark of "D-fraction", mentioned that "To date there has been no
evidence to suggest any toxicity for either Maitake mushroom or Maitake
D-fraction extract and we are delighted that we were able to convince the FDA
to exempt Phase I testing for toxicity and to directly enter into the Phase II
study." Approximately, 181,000 new cases of breast cancer develop each year and
over 40,000 women die of it annually in this country. Prostate cancer is now
the most frequently diagnosed malignancy in the USA with over 120,000 new cases
and 32,000 deaths occurring annually (which is the second leading cause of male
mortality due to cancer).
Shirota says that this American pilot study is a follow-up to a
Japanese study that reported significant clinical remission of many types of
cancer, most notably of breast and prostate in those patients consuming
D-fraction. Numerous laboratory studies both in vitro and in vivo have shown
remarkable anti-tumor effects of Maitake D-fraction. He also mentioned that the
pilot study approval is a giant step for this company to demonstrate the
significance of a nutraceutical from the Orient to the American public
including medical professionals and that this will give us the real hard
scientific evidence to demonstrate the safety and effectiveness of Maitake
D-fraction.
Back to the top
By
Anthony J. Cichoke, MA, DC, DACBN
For over 3,000 years, Traditional Chinese Medicine (TCM) has enjoyed an
illustrious history. Today, TCM and Western medicine function side-by-side in
Japan, as can be witnessed by the frequent use of maitake mushrooms to deal
with conditions which, in the U.S., are usually treated with drugs. In Japan,
maitake (pronounced mytah-keh) mushrooms are highly prized both
as food and medicine. People with serious degenerative illnesses travel long
distances in search of the maitake mushrooms. However, until recently, Western
medicine has never viewed mushrooms as a treatment option for illness or
Disease. But the maitake mushroom has recently received increased clinical and
resaarch attention.
In the Orient, several types of mushrooms have been used for centuries
to maintain health, preserve youth, and increase longevity. The healing aspects
of mushrooms have been passed down through folklore and only recently (within
the last 20 years) has the scientific study of mushrooms and their healing
properties been initiated.
The maitake mushroom (Grifola frondosa) is native to
northeast Japan and has been prized in Japanese herbology for hundreds of years
to strengthen the body and improve overall health. Recent research indicates
that it is the most potent immunostimulant of all mushrooms. The compounds
contained in maitake have the capacity to not only stimulate immune function,
but also to inhibit tumor growth. These compounds include polysaccharides (such
as beta glucan) and high-molecular weight sugar polymers.<1>
Grifron Maitake is the original supplement product of Maitake mushroom
and first became available to American consumers in 1991. Since its
introduction, Grifron Maitake extablished the No. 1 product of Maitake mushroom
in sales as well as in quality. Grifron Maitake Caplet has been used for a
number of clinical studies.
Maitake D-Fraction, What is it? The real
exciting promise in light of the major diseases that our society is plagued
with today, lies with Maitake D-FRACTION'S ability to directly affect the
immune system. The D-FRACTION was discovered and named by Dr. Nanba, a Japanese
researcher who has devoted over fifteen years investigating the anti-cancer and
anti-tumor effects of Maitake. Maitake D-FRACTION is a direct result of Dr.
Nanba's research. The D-FRACTION is a 3-branched B.1, 6-glucan, which is a
previously mentioned, a specific beta-glucan. Beta-glucans are polysaccharides
that modern research is finding in a variety of 'superfoods' and that seem to
have a positive influence upon the immune system. One of the difficulties with
many of the medicinal mushrooms is that they lose much of their effectiveness
when taken orally. An essential point about the D-FRACTION is that current
research indicates it is the optimal form, and in some cases, the only
effective component of Maitake when taken orally. A significant body of
research shows that Maitake is the most effective of the medicinal mushrooms
when consumed orally. Research Studies & Clinical Experience Since the
middle of the 1980's, many laboratory and clinical studies have been conducted
in Japan and gradually elsewhere. Preliminary anti-HIV activity in vitro on
Maitake D-FRACTION has been studied at both the National Institute of health in
Japan and National Cancer Institute along with research at independent
laboratories and clinical settings. Initial research on the anti-cancer and
anti-tumor actions is being done in independent and university laboratories
again primarily in Japan along with the beginning explorations in several
clinical settings. Some extensive clinical trials are also being conducted at
various cancer treatment institutes. Maitake D-FRACTION has been indicated as
possibly being useful in conjunction with conventional chemotherapeutic agents.
Not only does it seem to improve the agent's positive benefits, but it also
aids in the amelioration of many of the side effects of this therapy.
Back to the top
Most research on maitake has been conducted relative to cancer
regression. In one study, the polysaccharide 'D-fraction' of maitake was used
to treat both allogenic and syngeneic tumors in mice. A Winn assay revealed
complete tumor inhibition. The amazing thing about this study is that the
extract was administered orally, and not by injection as are most mushroom
extracts.<2> Many researchers believe that maitake's anti-tumor activity
is due to the effect its polysaccharide fraction has on the immune system.
Another study on mice found that maitake had an anti tumor effect
against syngeneic tumors. The researchers stated that not only did it activate
various effector cells (such as macrophages and natural killer cells) to attack
the tumor cells, but it also potentiates the activities of various mediators,
including lymphokines and interleukin-1, as well as interieukin-2.' According
to the researchers (Drs. Adachi, Nanba, and Kuroda), maitake, therefore, acts
to potentiate cellular functions and at the same time to prevent a decrease of
immune functions of the tumor-bearing host."3
Research is presently being conducted at the Cancer Treatment Centers of
America, headed by Dr. Denis Miller, MD, to evaluate the anti-cancer and
immuno-stimulatory activities of maitake mushroom extract using a double-blind,
randomized study. The study, designed to last 6 months, involves patients with
stage IV (metastatic) colorectal cancer. The researchers hypothesize that the
polysacchadde Beta glucans (derived from the fruitbody of the maitake mushroom)
has antitumor and immuno regulatory activities.
432
Back to the top
Maitake may even help prevent the destruction of T-helper cells by HIV.
At a conference March 29, 1992, in Fukuoka, Japan, Dr. Hiroaki Nanba announced
his findings that a maitake extract was able to prevent HIV destruction of
T-helper lymphocytes by as much as 97% in vitro. This is
important because measuring a patient's T helper cell count is one way to trace
the progression of HIV to fullblown AIDS .<4> In a recent interview, Joan
Pricotley.M.D.(a world- renowned AIDS
specialist), stated the following:
1 . Kaposi's sarcoma is clearly improved by taking maitake for some of
her patients.
2. Maitake extract (D-f raction) seems to be working better with her
patients than maitake tablets.
3. Those patients with Kaposi's sarcoma, who had received radiation
treatment before taking maitake, showed dramatic improvement.
4. Many symptoms of AIDS were generally improved after taking
maitake.
5. More comprehensive and controlled studies are needed to investigate
maitake's activity against Kaposi's sarcoma (K.S.) because it is known that
natural remission sometimes occurs in K.S.<5>
Back to the top
In one study, the powdered fruit body of maitake was given orally to
hypertensive rats. In contrast to the control group (in which the blood
pressure increased with aging), the Maitake group experienced a reduction in
blood pressure."<6> When the Maitake group was returned to its normal
feed ration, blood pressure increased. However reduction in blood pressure
occurred when the animals were once again placed on the Maitake-containing
feed. Maitake appears to have a superior ability to lower blood pressure.
Diabetes
In a recent study by Dr. Hiroaki Nanha mice were placed on a diet
containing dried maitake powder. After eight weeks, levels of blood glucose,
blood serum insulin and blood serum triglycerides in the maitake group all
remained significantly lower than the control group (those not receiving
maitake). Especieilly significant was the fact that the maitake group had
glucose levels of 200 mg/dI, while the control group had levels of
400 mg/di. This result suggests that maitake inhibits the escalation of
blood glucose levels, thus indicating anti-diabetic activity (according to Dr.
Nanba). Dr. Nanba considers maitake's effect not to be dependent on the change
of body weight in the progress of diabetes, but is directly related to
metabolism, since bio chemical changes occurred prior to changes in body
weight.<7>
Weight Loss
The purpose of several recent studies have been to measure Maitake's
effect on obesity. Because Maitake is high in vitamins, minerals, protein and
other beneficial nutrients, yet low in calories, it is
hypothesized that Maitake could be of benefit in the baffle of the bulge.
Research. TOWNSEND LETTER for DOCTORS - MAY
1994
Regarding research on weight loss, In one study, rats were divided into
three groups to measure Maitake's effect on body weight. The control group (the
first group) was fed regular meals. The feed of the second group included an
additional 1 0% of dried Maitake powder, while the third group's feed contained
an additional 20% of dried Maitake powder. The rats used in this experiment
would normally be expected to gain 130g to 24og in one month on continuous
feeding. However, after one month it was clear that the Maitake-fed groups
(especially the 20% group) exhibited an inhibition of weight gain. In fact, the
maitake group increased by only 20g-30g during the month as opposed to the
control group who gained 130g-240g.<8>
In a study on humans by Dr. Masanori Yokota of the Koseikai Clinic in
Tokyo, Japan, thirty patients were given a powdered Maitake food supplement (20
tablets daily of 500 mg each) for a period of two months, with no change in
their regular diets.<9>
Dr. Yokota reports that all of the patients successfully lost weight
(between 3kg to 12kg) with an average loss of 5-6 kg per person. He computed
that to be about 40%, on average. What is amazing is that the patients obtained
these results after only 2 months on the maitake supplement. Dr. Yokota
anticipated-the patients would lose even more weight if they continued on the
programme
Dr. Ber's Clinical Applications:
Abram Ber, M.D., a homeopathic physician who practices orthomolecular
medicine in Phoenix, Arizona, has been using Maitake mushroom tablets for two
years to treat a number of conditions. Using independent ultrasound results as
a measure of progress, Dr. Ber gave six patients with uterine fibroids maitake
mushroom tablets and found substantial reduction of the fibroids six months to
one year after beginning Maitake treatment. The patients'conditions had
improved to a point where surgery was not indicated. In general, Dr. Ber's
treatment program is two tablets three times a day (3 grams) with a range of
4-8 grams, depending on the size of the individual patient.
According to Dr. Ber, at least 12 patients with prostatic cancer have
been treated with maitake mushroom tablets, resulting in amelioration of
symptoms. Especially, there was improved urinary flow, as well as decrease of
other symptoms of prostatic problems (including decreased frequency of
urination).
Using maitake mushrooms with HIV/AIDS patients, Dr. Ber related that he
was able to maintain T -lymphocyte cell counts and the number of associated
infections did not increase. The mushrooms appear to improve immune system
function, according to the doctor. "if the CD-4 cell count was 1 00, the count
did not decrease over the period of treatment (one year or longer)," says Dr.
Ber.
Finally, Dr. Ber seemed most excited when discussing treatment of
hypertension. He has treated over 30 patients with maitake mushrooms in the
last two to three months f.or this condition. "When
on medication the blood pressure is all over the place, but with Maitake
mushrooms there is a gradual decrease in blood pressure toward normalcy.
Further, there are absolutely no side effects," says Dr. Ber.
Dr. Ber's hypertension therapy program is as follows:
- Three grams per day for the first week.
- Four grams per day for the second week.
- Then five grams per day, as blood pressure indicates.
- 'Sometimes blood pressure is dose-related," says the doctor.
In conclusion
In applying Oriental medicine to Western culture, it appears that
Maitake mushrooms are a viable alternative to high-cost drugs and surgery, with
their frenuent aid severe side effects. As can be seen by our review on the
literature, Maitake can stimulate it. imunt: Turictiol 1 and inhibit tumor
growth. Maitake mushrooms not only taste good, but seem to be effective against
a variety of conditions, including cancer, HIV/AIDS, high blood pressure,
diabetes, and obesity. The 'King of Mushrooms," maitake brings its healing
powers from the Orient to you.
References
- Wagner, H. and Proksch, A., Immunostimulatory Drugs of Fungi and
Higher Plants, Ecorpomic and Medical Plant Research, Academic
Press, New York, 1985.
- Nariba, Hiroald, Anfitumor Activity of Orally Administered
'D-Fraction' from Maltake mushroom (Grifola frondosa), J. of Nat. Med.
1(4):10-15,1993.
- Adachi, K., Nanba, H., and Kuroda, H., Potentiation of Host-Mediated
Antitumor Activity in Mice by Beta-glucan Obtained from Grifola frondosa
(Maitake), Chem. Pharm. Bull. 35;262-270,1987.
- Nanba, H., Presented to the -Japan Society of Pharmacy Conference,
March 29, 1992 in Fukuoka, Japan
- Phestley, Joan, rlersunal Commur.ication,'993.
- Adachi, K., Nanba, H., Otsuka, M., and Kuroda, H., Blood Pressure
Lowering Activity Present in the Fruit Body of Gritola frondosa (Maitake),
Chem. Phann. Bu//36:1000-1006,1988.
- Nanba, H., working paper, Anti-Diabetic Activity by Maitake Mushroom
(Grifola frondosa), 1994.
- Ohtsuru, M., Anti-Obesity Activity Exhibited by Orally Administered
Powder of Maitake Mushroom (Gdfola frondosa), Anshin, July,l 992,
pp. 198.
- Yokota, Masanorl, Koselkai Clinic, Tokyo, Japan, Observatory Trial
at AntiObesfty Activity of Maitake Mushroom (Grifola frondosa), Anshin,
July, 1992, pp. 202.
Back to the top
SUGGESTED DOSAGE
Grifron( Maitake Mushroom can be taken one to four caplets each
time with water at each meal. People suggested to take large doses may also
take additional few caplets before going to bed. People on large doses are also
suggested to start-off with fewer caplets to avoid possible upset
digestion.
Dr. Fukumi Morishige, M.D., Ph.D., a renowned Japanese surgeon and a
member of the Linus Pauhng Institute of Science and Medicine, explained that
vitamin C reduces the high molecular weight of mushroom polysaccharides and
that, as the vitamin C breaks up these sugars, their viscosity or stickiness
drops and bio availability increases, thus rendering more accessibility to
immune system cells, such as macrophages and N-killer cers. Therefore, it is
suggested that vitamin C will be taken together with Grifronespecially
for the people suggested to take large doses of Grifron.
For preventive purpose 2-3 caplets per day
For hypertensive people 6 caplets per day. Once blood
pressure is lowered to the normal
level, take 3-6 caplets per day to
maintain.
For diabetic people 10 caplets per day. Once blood
sugar contents is reduced to the
normal level, take 3-6 caplets per
day to maintain.
For HIV positive people 4-10 caplets per day depending on
the conditions.
For people with AIDS/CFS 8-10 caplets per day.
For people with tumor 4-10 caplets per day depending on
the conditions
For people with cancer 8-10 caplets per day depending on
the condition
For general use as a dietary supplement, take 12 to 20 drops three times
daily of Maitake D-FRACTION liquid extract. Therapeutic dosing for Maitake
D-FRACTION is from .5 milligram to 1 milligram of pure D-FRACTION per kilo of
body weight. Dose should be spread out evenly through the day. Note: To find
your weight in kilos, multiply your weight in pounds times 0.4536. Example:
150lbs.. = 68 kilos (150 x. 4536=68.04) Dose range would be from 34 to 68 mg
throughout the day. The benefits of Maitake D-FRACTION may be maximized if
combined with a holistically balanced extract of Maitake or with the whole
mushroom.
WEIGHT TOTAL and DAILY DOSE:
70-79 lbs 15 to 35 mg, 81-89 lbs 18 to 40
mg, 90-99 lbs 20 to 44 mg
100-109lbs 22 to 49 mg, 110-119lbs 24 to
43 mg, 120-129 lbs 27 to 58 mg
130-139 lbs 29 to 63 mg, 140-149 lbs 31
to 67 mg, 150-159 lbs 34 to 72 mg
160-169 lbs 36 to 76 mg, 170-179 lbs 38 to
81 mg, 180-189 lbs 40 to 85 mg
190-199 lbs 43 to 90 mg, 200-209 lbs 45
to 94 mg, 210-219 lbs 47 to 99 mg
220-229 lbs 49 to 103 mg, 230-239 lbs 52
to 108 mg, 240-249 lbs 54 to 112 mg .
Back to the top
Safety: To date there has been no evidence
to suggest any toxicity for either the Maitake mushroom or the Maitake
D-FRACTION. Both are generally recognized as safe. Remember that Maitake has
been used as a food for several hundred years without any sign of problems. If
pregnant or in doubt it is best to check with the health practitioner of your
choice.
Grifron Maitake whole fruit body caplets Usage: To maintain your
health, please take 1 ~ 2 caplets with water twice of three times daily between
meals. (For those who have weak digestion, please take them with food) For
therapeutic use or complementary use to your therapy, double or triple the
daily amount, or as instructed by your health-care professionals.
Toxicity: There is no toxicity found with whole Maitake mushroom
nor with Grifron Maitake Caplet, even with large dose. Please remember, Maitake
is a popular culinary mushroom in many countries for hundreds of years.
However, although it is very rare, whole Maitake mushroom may cause light upset
stomach or soft bowels (which can be a side-benefit)
Applications: Whole Maitake mushroom fruit body have been
confirmed for its various health benefits as follows: (1) Immune-Enhancing or
Regulating Properties: a) Anti-Tumor Activities b) Anti-HIV/AIDS Activities c)
Anti-CFS (Chronic Fatigue Syndrome d) Anti-hepatic Activity and other
anti-inflammatory activities including against hay fever. e) Other Immune
Disorders. (2)Adaptogenic Properties: a)Lowering High Blood Pressure Activity
b)Anti-Diabetic Activiy c)Regulating Cholesterol and Triglyceride
d)Anti-Obesity (weight control)
(Note) *Health related statements made throughout this page have not been evaluated by the FDA.
Products offered are not intended to diagnose, cure, treat or prevent any specific disease.
The information provided above and below is for guidance only. People with illnesses should consult with a doctor for specific direction.
Back to the top
