AHCC Clinical Evidence

 Healthy Adults

Journal of Evidence-Based Complementary & Alternative Medicine Takanari, J., et al. Effects of
Active Hexose Correlated Compound on the Seasonal Variations of Immune Competence in Healthy Subjects.
2015 Jan; 20(1): 28–34


Topic: 
What is the effect of active hexose correlated compound (AHCC) on immune competence in human subjects?

Background:
The immunocompetent cells include lymphoid cells (B cell, T cell, natural killer cell, etc.), granulocytic cells
(eosinophil, neutrophil, basophil, etc.), and antigenpresenting cells (macrophage, monocyte, dendritic cell, etc.) and are
affected by various factors including aging, stress, malnutrition, and various additional stressors. Seasonal changes can alter
the immune function, especially with decreases during winter, which is evidenced by infectious diseases having greater incidences
in winter correlated with air temperature. The nasal airway is exposed to cold and cools down, reducing the mucociliary clearance
and compromising the immune response of the nasal airway. In addition, the sympathetic nervous activity is stimulated, increasing
the number of granulocytes, and there is an increase in the secretion of adrenaline and noradrenaline from the adrenal gland.
The number of natural killer cells decreases by adaptive response to low temperature in winter. This study evaluated the effects
of active hexose correlated compound intake on immune competence in healthy volunteers. 

Study Type:
Human intervention, randomized, double-blind, parallel
group, placebo-controlled clinical trial.

Study Design:
Thirty-four subjects were randomized to receive placebo or AHCC for 4 weeks in early winter. All subjects took 4 capsules daily
of active hexose correlated compound (250 mg/capsule) or placebo (250 mg dextrin only/ capsule) for 4 weeks between November
and December. All subjects underwent peripheral blood testing and answered a questionnaire by the visual analog scale method.
Natural killer cell activity was assessed by chromium-51 release assay to measure radioactivity. Immune score was done by lymphocyte
subset analysis by a flow cytometric method for evaluating comprehensive immune strength by scoring various immune indexes,
including the number of T cells, CD8þ CD28þ T cells, naive T cells, B cells, natural killer cells, CD4/CD8 T cell ratio, and naive/memory
T cell ratio. The complete blood count assessed for red blood cells, hemoglobin, hematocrit, platelets, white blood cells, and differential
counts of white blood cells (neutrophil, lymphocyte, monocyte, eosinophil, and basophil).

Subjects:
34 subjects.

Dosage: 
1 gram a day

Results:
Natural killer cell activity significantly increased in both groups during the study period. The natural killer cell number, however,
was not altered in the active hexose correlated compound group, while the placebo group showed remarkable decline. In addition,
the score of immunological vigor, an index of total immune competence, was maintained in the AHCC group, although that of the
placebo group decreased during the test period. 

Conclusion:
The results suggest that continuous use of AHCC maintained immune competence against seasonal changes during winter.

 Healthy Adults 

Human Immunology
Yin Z, Fujii H, Walshe T. Effects of active hexose correlated compound (AHCC)
on the frequency of CD4+ and CD8+ T cells producing IFN-γ and/or TNF-α in healthy adults.
2010 Dec; 71(12): 1187-90


Topic:
Does AHCC have an effect on immune function of healthy adults aged 50 or greater?

Background:
AHCC has been shown to have an enhancing effect on immune function of humans and rodents, including an increase of natural
killer (NK) cell activity, interleukin-12 production and resistance to bacterial infection. Animal studies have shown that the effects of
AHCC are more evident in hosts with impaired immune function. However, it is largely unknown whether AHCC could enhance
immune parameters in humans, in particular, elderly adults.

Study: 
Type Human clinical intervention trial.

Study Design: 
Open-label trial: Subjects were treated with AHCC for 60 days. Peripheral blood was collected at base line, 30 and 60
days during supplementation and another 30 days after supplementation was discontinued. The production of interferon
IFN-γ and TNF-α by CD4+ and CD8 + T cells was measured by flow cytometry.

Subjects: 
30 healthy adults over the age of 50.

Dosage:
3 grams of AHCC per day (3-500 mg capsules twice daily).

Results:
AHCC supplementation resulted in the following significant changes compared with base line:
• The frequency of CD4+ and CD8 + T cells producing IFN-γ alone, TNF-α alone or both increased during AHCC intake
• The frequency of such cells remained high even 30 days after discontinuing AHCC

Conclusion:
“Our results suggest that AHCC can enhance CD4+ and CD8 + T cell immune responses in healthy persons via increasing production of cytokines IFN-γ and TNF-α from T cells. Effects were seen after 30 days, and remained up to 30 days after discontinuing the compound. AHCC may improve immune response against pathogens through this mechanism.”

 Healthy Adults 

Nutrition and Cancer
Terakawa N, Matsui Y, Satoi S, Yanagimoto H, Takahashi K, Yamamoto T, Yamao J, Takai S, Kwon AH, Kamiyama Y.
Immunological effect of active hexose correlated compound (AHCC) in healthy volunteers: a doubleblind, placebo-controlled trial.
2008; 60(5): 643-51


Topic:
Does AHCC have an effect on immune responses in healthy volunteers?

Background:
Biological response modifiers (BRMs) are substances that stimulate the body’s response to infection and disease.
Attempts have been made to treat cancer with BRMs, but their clinical efficacy has not been clearly confirmed. AHCC has had
numerous positive clinical results on cancer patients without any adverse effects, but has not been investigated for its effect
on immune response in humans.

Study Type:
Human clinical intervention trial.

Study Design:
Double-blind, randomized, placebo-controlled: Subjects were treated with AHCC daily for 4 weeks. Researchers took blood
samples at baseline and again after 4 weeks. The number of circulating dendritic cells (both DC1 and DC2 cells), natural
killer (NK) cells, and CD4+/ CD8+ T lymphocytes were measured by flow cytometry. In addition, other immune function
parameters were measured.

Subjects:
21 healthy volunteers.

Dosage:
3 grams of AHCC per day (n=10) or placebo (n=11)

Results:
Volunteers supplemented with AHCC had the following significant changes:
• Greater number of total DCs than at base line and compared with control
• The number of DC1 cells was greater after AHCC intake than at base line and the AHCC group had a tendency to have
   higher DC1s than control
• DC2s were significantly increased after 4 weeks compared with control
• The allo-stimulatory activity of DC1s was also increased after intake compared with control as measured by the mixed lymphocyte reaction (MLR)

Conclusion:
“These results suggest that AHCC could be an effective modulator of immunological function
in patients with cancer. AHCC acts as a promising BRM.”

Healthy Adults

Nutrition Research
Roman BE, Beli E, Duriancik DM, Gardner EM. Short-term supplementation with active hexose correlated compound
improves the antibody response to influenza B vaccine.
2013 Jan; 33(1): 12–7


Topic:
Does AHCC have an effect on immune response of healthy adults after influenza vaccinations?

Background:
AHCC, a mushroom extract, has been shown to protect mice against lethal primary influenza infection.
AHCC stimulates human immune response when given with a vaccination. AHCC given before vaccination in mice improved
protection from lethal avian flu infection when compared with mice that were only vaccinated. This study tested whether
AHCC also improved the immune responses of healthy individuals to influenza vaccine.

Study Type: 
Human clinical intervention trial

Study Design:
Randomized, placebo-controlled trial of the effects of AHCC supplementation on the immune response to the 2009–2010 seasonal
influenza vaccine. Blood was drawn before vaccination and 3 weeks after. Immediately following vaccination,
the AHCC group began oral supplementation with AHCC.

Subjects:
29 healthy adults

Dosage:
3 grams of AHCC per day (n=14), placebo (n=15).

Results: 
AHCC supplementation improved some lymphocyte percentages and influenza B antibody titers over the control.
Changes of lymphocyte subpopulations revealed that AHCC supplementation increases CD8 T cells and NK-T cells
following vaccination compared with controls. 

Conclusion:
"AHCC supplementation improves the overall response to influenza vaccination.

Healthy Adults

Journal of Nutritional Science and Vitaminology
Spierings E, Fujii H, Sun B, Walshe T. A Phase I study of the safety of the nutritional supplement active hexose
correlated compound, AHCC, in healthy volunteers.
2007 Dec; 53(6): 536-9


Topic:
Is AHCC safe and tolerable in healthy subjects?

Background:
AHCC has been used for many years as a dietary supplement to enhance the immune system and in clinical trials as
adjunctive treatment in hepatocellular cancer. Its safety has been previously based on anecdotal reports and its use in clinical practice.
Phase 1 clinical trials are used to make the initial safety assessment of compounds with potential medical uses

Study Type:
Human clinical intervention trial.

Study Design:
Phase I clinical trial: Subjects were treated with AHCC daily for 14 days. Laboratory data was obtained at base line and after
14 days of exposure to AHCC, and adverse events were monitored by a nondirected review of systems questionnaire 3 times during the trial.

Subjects:
26 healthy male or female subjects between 18 and 61 years of age.

Dosage:
9 grams of AHCC per day (liquid form).

Results:
Laboratory results and adverse events were reported as follows:
• Two subjects (7%) dropped out because of nausea and intolerance of the liquid
• Nausea, diarrhea, bloating, headache, fatigue and foot cramps occurred in a total of 6 subjects (20%) but were mild and transient
• There were no laboratory abnormalities

Conclusion:
“The adverse effects of 9 grams of liquid AHCC per day, a higher dose than used in routine clinical applications, are minimal and the
dose was tolerated by 85% of the subjects. This trial supports the anecdotal evidence that AHCC is a safe supplement in clinical
practice and that the side effects are generally mild and tolerable.

Prostate Cancer

Japanese Journal of Clinical Oncology

Sumiyoshi Y, Hashine K, Kakehi Y, Yoshimura K, Satou T, Kuruma H, Namiki S, Shinohara N.
Dietary administration of mushroom mycelium extracts in patients with early stage prostate cancers
managed expectantly: a phase II study.
2010 Oct; 40(10): 967-72


Topic:
Does AHCC have an effect on patients with early stage prostate cancer?

Background:
Owing to widespread use of PSA screening, most prostate cancers are discovered at an extremely early stage.
An alternative to active treatment, expectant management (also known as “watchful waiting”) has been adopted as a treatment
for prostate cancer. This has resulted in interest of prostate patients in using complementary and alternative medicine, such as
dietary supplements. Few clinical trials on dietary supplements on early stage prostate cancer have been conducted. AHCC has
been reported to have immunestimulating activity, anti-cancer activity and cancerpreventative actions.
What is its effect on early stage prostate cancer?

Study Type:
Human clinical intervention trial.

Study Design:
Open-label trial: Patients were treated with AHCC for 6 consecutive months, and for willing patients, the period was extended for an additional 6 months. A PSA test and biochemical examination were performed every 2 months. In addition, immune parameters such as T helper 1/T helper 2 ratio and NK cell activity were monitored. A questionnaire survey of the state-trait anxiety inventory (STAI) – a test for measuring anxiety – was given before treatment and after 6 months.

Subjects:
74 total: 40 prostate patients undergoing expectant management and 34 patients who had already undergone expectant management
for 6 months or more. 

Dosage:
4.5 grams of AHCC per day.

Results:
AHCC supplementation resulted in the following changes:
• Changes in PSA before and after treatment were substantially stable
• In patients for which expectant management had been continued for 6 months or more before the trial, a prolonged PSA doubling time
  (PSADT) was seen with AHCC administration
◊ Prior to AHCC, 12/31 (39%) of patients had PSADT of 120 months or more, and after 6 months of AHCC administration,
   17/31 (55%) had PSADT of 120 months or more
◊ To the lower end, 12/31 (39%) of patients showed a PSADT less than 24 months, and following 6 months of AHCC, this fell to 9/31 (29%)
• Anxiety significantly decreased after 6 months of treatment in patients exhibiting strong anxiety before the start of the trial

Conclusion:
“These results suggest that dietary uptake of AHCC contributes to the stabilization of the disease status in patients with
early stage prostate cancer who are expectantly managed.”

Prostate Cancer

International Journal of Immunotherapy
Ghoneum M, Wimbley M, Salem F, McKlain A, Attalah N, Gill G. Immunomodulatory and anti-cancer effects of active AHCC.
1995; X1(1): 23-28


Topic:
Does AHCC have immunomodulatory and anti-cancer effects in cancer patients?

Background:
The increased incidence of spontaneous tumors in immune-suppressed individuals, as well as those with congenital or acquired
immunodeficiencies, indicates that the immune system can provide a major mechanism for host resistance against cancer and
infectious diseases. Several biological response modifiers (BRMs) have been developed to stimulate the immune system for tumor
fighting, but their use is limited because of their severe side effects. AHCC possesses BMR activity, but without side effects.

Study Type:
Human clinical intervention trial.

Study Design:
Open-label trial: Subjects were treated with AHCC for up to 17 months. Tumor-associated antigens (TAAs) for
each type of malignancy was measured prior to AHCC treatment and at 3- to 40-week intervals. Natural killer
(NK) cell activity was also monitored.

Subjects:
11 cancer patients with advanced malignancies

Dosage: 
3 grams of AHCC per day.

Results:
Supplementation with AHCC had the following results:
• A significant decline in TAA occurred in 8 out of the 11 patients with different types of malignancies
• PSA levels in prostate cancer patients and CA 125 levels in ovarian cancer patients decreased as early as 1 to 2 months and reached
   normal levels within 1 to 4 months • 9 out of 11 patients demonstrated marked increase in NK activity as early as 2 weeks after treatment
• The percentages of patients with complete remission were as follows: (i) prostatic (66%); (ii) ovarian (66%). (iii) multiple myeloma
   (50%); (iv) breast, 33% complete remission and 2% partial • In vitro studies showed that AHCC possesses suppressive effects on
   tumor cell growth

Conclusion:
“The high augmentory effect of AHCC and the absence of notable side effects make AHCC a promising
immunotherapeutic agent for the treatment of cancer patients.”

Prostate Health

Anti-Cancer Drugs
Turner J, Chaudhary U. Dramatic prostate-specific antigen response with active hexose correlated compound in metastatic
castrationresistant prostate cancer.
2009 Mar; 20(3): 215-216


Topic:
Does AHCC have an effect on castration-resistant prostate cancer (CRPC)?

Background:
Castration-resistant prostate cancer is defined as progression of disease with serum testosterone controlled below a castrate level.
The median survival of patients CRPC is approximately 18 months. The use of herbal supplements in many malignancies has been
increasing over the last several years. Previous research has shown that AHCC has activity in prostate cancer, ovarian cancer
and multiplemyeloma. Will it be effective against CRPC?

Study Type:
Case study

Study Design:
A Caucasian male with CRPC with high-risk features who benefited less than 6 months from initial complete androgen
blockade began self-administration of AHCC. 

Subjects:
1 Caucasian male (66 years old) with CRPC

Dosage:
Not reported.

Results: 
The self-administration of AHCC resulted in a dramatic PSA decrease within 1 month, which continued to control
his disease for over 6 months from initial supplementation with AHCC. 

Conclusion:
“Based on limited studies to date, it seems that AHCC may have a role in the management of prostate cancer patients,
especially those who have failed hormonal therapy. Larger studies are required to analyze the impact on this
new therapy in prostate cancer patients.”

Liver Cancer

Journal of Hepatology
Matsui Y, Uhara J, Satoi S, Kaibori M, Yamada H, Kitade H, Imamura A, Takai S, Kawaguchi Y, Kwon AH, Kamiyama Y.
Improved prognosis of postoperative hepatocellular carcinoma patients when treated with functional foods:
a prospective cohort study.
2002 Jul; 37(1): 78-86


Topic:
Can AHCC improve the prognosis of hepatocellular carcinoma (HCC) patients following surgical treatment?

Background:
The prevention and treatment of the recurrence of hepatocellular carcinoma following hepatic resection has been studied extensively.
However, the prognosis for HCC remains unsatisfactory, with the 5-year survival rate after primary surgical treatment at approximately
40% in Japan. There have been many attempts to treat the cancer by stimulating with biological response modifiers (BRMs), but the
clinical efficacy of these substances has not been clearly confirmed. AHCC may be considered a potent BRM in the treatment of cancer patients.

Study Type:
Observational study.

Study Design:
Prospective cohort study: From February 1, 1992 to December 31, 2001, a total of 269 consecutive patients with histologically confirmed
HCC were studied. All of the patients underwent resection of a liver tumor. The enrolled patients were addressed to each arm of the
study based on their choice of the therapeutic options, and were trusted with the self-administration of AHCC. Researchers examined
time to treatment failure (disease recurrence or death) and ten parameters related to liver function after surgery.

Subjects:
269 consecutive patients with histologically confirmed HCC.

Dosage:
3 grams of AHCC per day (n=113).

Results:
The AHCC group had the following significant differences compared with control group:
• Longer non-recurrence period • Increased overall survival rate

Conclusion:
“This study suggests that AHCC intake can improve the prognosis of postoperative HCC patients.

Liver Cancer

Asian Pacific Journal of Allergy and Immunology
Cowawintaweewat S, Manoromana S, Sriplung H, Khuhaprema T, Tongtawe P, Tapchaisri P, Chaicumpa
W. Prognostic improvement of patients with advanced liver cancer after active hexose correlated compound (AHCC) treatment.
2006 Mar; 24(1): 33-45


Topic:
Does AHCC have an effect on patients with advanced liver cancer?

Background:
Liver cancer is the sixth most common cancer worldwide and is the third most common cause of cancer mortality.
Most patients with liver cancer are diagnosed at a late or advanced state.. AHCC, a promising biological response modifier
(BRM), has been found to improve the prognosis of hepatocellular carcinoma patients following surgical treatment.
Can it prolong survival and improve prognosis of patients with advanced liver cancer?

Study Type:
Human clinical intervention trial.

Study Design:
Randomized prospective, placebo-controlled trial: Patients received supplementation with AHCC or a placebo until the end of their lives.
Clinical parameters were monitored monthly, including quality of life, hematological parameters, biochemical parameters in serum and immunological parameters in citrated plasma. MRIs were also performed for patients who survived for more than 1 year.

Subjects:
44 patients with advanced liver cancer.

Dosage: 
6 grams of AHCC per day (n=34), placebo (n=10).

Results:
The following results were reported for patients supplemented with AHCC when compared with control group:
• A significantly prolonged survival
• Quality of life in terms of mental stability, general physical health status and the ability to have normal activities were significantly
  improved after 3 months of supplementation • Serum level of albumin and percentage of lymphocytes in blood, were significantly higher
• Slightly increased levels of total IL-12 and neopterin
• In the patient who survived more than 24 months, all 6 parameters seemed not to change vitally, showing a good prognosis,
  which correlated with survival. In addition, the spider naevi (an abnormal collection of blood vessels near the surface of the skin commonly
  found in liver cancer patients) on this patient’s chest disappeared after three months of treatment with no new occurrence during two
  years of follow-up. MRI pictures of his liver mass using magnetic resonance imaging from the year of 2002 (the start of treatment) to
  2005 showed that there was no change in tumor size and no new lesions appeared.

Conclusion: 
“This study suggests that AHCC intake could prolong the survival and improve the prognosis of patients with advanced liver cancer
and delay the gradual decline of their physiological status.”

Breast and Lung Cancer

International Journal of Integrative Medicine
Ishizuka, R., et. al. Review of Cancer Therapy with AHCC® and GCP®; The Long-Term Follow-Up Over 12 Years
For stage IV (M1) Cancer of the Lung and the Breast.
2010 July; vol. 2, no. 1


Topic:
Does AHCC in combination with GCP extend survival and quality of life in stage IV lung and breast cancer patients?

Background:
According to the domestic statistics on cancer death in 2006, lung cancer has been increasing and has the worst cancer mortality in
Japan. Breast cancer has become the fourth-most-common cancer. AHCC from a specially fermented shiitake mushroom extract, and GCP
(full name tK), which is derived from the isoflavone aglycone genistein from soybeans and combined with polysaccharides, when used
together have augmented immune properties. They have both been used in individual evidence-based medicine for stage IV lung and
breast cancer. This report does a long-term follow-up on these cases.

Study Type:
Observational study.

Study Design:
Retrospective cohort study: The subjects were breast and lung cancer patients who were treated with AHCC and GCP.
Lung cancer patients had already undergone evidence-based chemotherapy; however, most of them discontinued or refused, owing
to its noneffect or side effects. Immunotherapy administering AHCC daily to the patients for nearly 2 weeks, coadministered with GCP, was conducted when their appetite and mental well-being were restored. The results were compared with the prognosis of breast cancer
described in the investigation report of national breast cancer patient registration as a reference datum.

Subjects:
• 36 patients with stage IB-IV lung cancer.
• 34 patients with stage IV breast cancer.

Dosage:
• 2.25–4.5 grams of AHCC.
• 0.96–1.92 grams of GCP.

Results:
Compared with the survival rates in American Society of Clinical Oncology reference data, this retrospective study
reported the following observations:
• 1-year, 2-year, and 3-year survival rates for stage IV lung cancer increased to 75.0%, 52.1%, and 21.8%, respectively.
  4-year survival was 6.2%, and 5-year survival was 0%
• 41.7% of 36 M1 patients in classes A and B had improved quality of life (QOL)
• Improvement of 1-year to 3-year survival rates and prolongation of median survival time for stage IV lung cancer
• QOL scores of 35 cases were rated A to C by 77.2% of patients, which contributed to reducing final hospitalization time
• Survival terms for breast cancer patients for 1 year, 2 years, 3 years, 4 years, and 5 years were 100%, 84.4%, 68.3%, 36.8%,
  and 28.1%, respectively • Mean survival terms for breast cancer patients were 5 years, 2 months after recurrence and 7 years,
  11 months after initial diagnosis
• Survival terms for breast cancer patients for 3 years, 4 years, and 5 years were 65.6%, 43.8%, and 28.1%, respectively
• Extension of survival terms was confirmed. • QOL scores improved 67.7%

Conclusion:
“AHCC and GCP could contribute to the extension of survival terms and improved QOL for patients on cancer therapy as compared
to those using conventional therapy alone, according to clinical evidence-based medicine.

Breast and Lung Cancer

International Journal of Integrative Oncology
Matsui, Y, Kamiyama, Y. Retrospective study in breast cancer patients supplemented with AHCC. 2009; Vol. 3 No. 2


Topic: Does AHCC have an effect on patients with advanced breast cancer?

Background: Breast cancer ranks third as the cause of cancer deaths of Japanese women. Breast cancer can be detected early by self-examination, and a complete cure is also likely if it is excised at an early stage. However, advanced recurrent breast cancer is most often incurable and is mainly subjected to a supportive therapy and a treatment for quality-of-life improvement. Immunotherapy, in the form of AHCC, may affect the prognosis of advanced breast cancer patients.

Study Type: Retrospective cohort study.

Study Design:
Subjects received operative treatment of breast cancer during a 13-year period from October 1987 to September 2000 and took AHCC from May 1996 to 2002 (the period of the study). Most patients commenced AHCC due to reappearance of their cancer. The results were compared with the prognosis of breast cancer described in the investigation report of national breast cancer patient registration as a reference data.

Subjects:
47 patients with various stages of breast cancer.

Dosage:
Not reported.

Results:
Using the National Breast Cancer patient registration as reference data, this retrospective study reported that the AHCC supplementation
improved the prognosis in Stage IV as compared to the national counting.

Conclusion:
There was no improvement in patients with Stages I, II and III which may be explained by the fact that the earlier stage patients
seen at the research site had more serious cases than the national average.

Gastric & Colon Cancer

Natural Medicine Journal
Kawaguchi, Y. Improved survival of patients with gastric cancer or colon cancer when treated with active hexose correlated
compound (AHCC): effect of AHCC on digestive system cancer.
2009 September; 1(1): 1-6


Topic:
Does AHCC have an effect on the survival rate of patients with gastric cancer or colon cancer?

Background:
Gastric cancer is the second most common cause of cancer death and colorectal cancer is the third most commonly diagnosed cancer worldwide. Current treatment options include surgical resection and/or chemotherapy regimes. However, both forms of cancer have poor survival rates. The 5-year survival for patients with unresectable metastatic colon cancer is less than 10% and gastric cancer has an estimated age-adjusted survival rate of 33-44% in the United States and 51 - 54% in Japan. Tumor immunotherapy may provide another therapeutic option in an integrated approach. AHCC has demonstrated immune-stimulating activity and may be a potent biological response modifier (BRM) in cancer therapy

Study Type:
Observational study.

Study Design:
Prospective cohort study: Patients with a histopathological diagnosis of gastric or colon cancer were recruited to receive oral AHCC as a postoperative adjunctive therapy in conjunction with standard chemotherapy. The cumulative survival rates for gastric and colon cancer
patients were analyzed by KaplanMeier method.

Subjects:
132 patients diagnosed with gastric cancer, 113 patients diagnosed with colon cancer

Dosage:
For stage I, II or III patients: 3 grams of AHCC per day (1 g three times per day. For stage IV patients: 6 grams of AHCC per day
(2 g three times per day).

Results:
AHCC supplementation resulted in the following difference in survival rate: • Improved cumulative 5-year survival rates for patients with gastric cancer (stage IA to stage IIIA) compared with other Japanese institutions • Improved cumulative 5-year survival rates for patients with
colon cancer (stage II to stage IIIA) compared with other Japanese institutions

Conclusion:
“AHCC is a potent BRM that may improve survival in patients with early stage gastric or colon cancer and warrants further investigation
as an adjunctive immunotherapeutic in gastric and colon cancer treatment.”

 

Pancreatic & Biliary Cancer

Presented at the 40th APA (American Pancreatic Association), November 2009
Yanagimoto H, Satoi S, Toyokawa H, Yamamoto T, Hirooka S, Yamao J, Araki H, Matsui Y, Kwon A. The beneficial effect of active
hexose correlated compound (AHCC), a health food component, in patients with pancreatic or biliary tract cancer
who undergo chemotherapy


Topic:
Does AHCC have an effect on patients with pancreatic or biliary tract cancer who underwent chemotherapy?

Background:
AHCC has been previously shown to enhance immune function in healthy volunteers and to improve prognosis in hepatocellular carcinoma patients. Cancer chemotherapy is effective in many cases; however, it side effects can be severe. The effect of AHCC on chemother
patients with pancreatic or biliary tract cancer.

Study Type: Human clinical intervention trial.

Study Design:
Open-label, non-randomized phase II study: Researchers studied postoperative patients with histologically or cytologically proven
adenocarcinoma of pancreas or biliary tract, who underwent chemotherapy with gemcitabine. Gemcitabine was given intravenously at a dose
of 1,000 mg/mL once a week for 3 weeks, followed by 1 week of rest. Patients were divided into two groups, which were given AHCC (n=37) or nothing (n=38). The assessment of hematological and non-hematological toxicity was performed over 2 months during the chemotherapy

Subjects:
73 patients with PS of 0-1, and adequate organ function.

Dosage:
Not reported.

Results:
AHCC supplementation resulted in the following changes compared with the control group:
• The hemoglobin (Hb) level after chemotherapy in AHCC group was significantly higher
• The taste alteration after chemotherapy in AHCC group was significantly lower

Conclusion:
“It is suggested that AHCC could alleviate side effects of chemotherapy and that the nutritional state during chemotherapy might be
maintained by improving the taste alteration. Further clinical trials will be necessary to clarify the beneficial effect of AHCC.”

Head & Neck Cancer

International Journal of Clinical Medicine
arida D, Wakame K, Nomura T. Integrating complimentary and alternative medicine in the form of active hexose
correlated compound (AHCC) in the management of head & neck cancer patients.
2011, 2, 588-592 


Topic:
Can AHCC be used in the treatment of head and neck cancer patients?

Background:
In the state of Meghalay, India, the incidence of cancer of the head and neck region is highest in males, while esophageal cancer is highest in females. This is directly correlated to the high use of tobacco.

Study Type:
Human clinical intervention trial.

Study Design:
Open-label trial: Patients were administered AHCC every morning 3 days prior to chemotherapy and followed up to
1 week post chemotherapy.

Subjects:
25 patients of advance state (T3-T4) head and neck cancer.

Dosage
3 grams of AHCC per day

Results
AHCC supplementation resulted in the following observations:
• All patients tolerated AHCC with no added symptoms
• 20 patients reported feeling better and stronger than before at the time of initiation of chemotherapy cycles
• Almost all patients reported better appetites after they started to take AHCC
• In 12 patients who required blood transfusions before chemotherapy cycles, a decrease in the rate of fall of hemoglobin
  was observed and only 3 patients subsequently required blood transfusions prior to chemotherapy
• 22 patients has a reduction of chemotherapy side effects like nausea, vomiting, loose bowel movements/constipation, etc.
• Tumors regressed in 11 patients • 8 patients stabilized

Conclusion
“It can be concluded that AHCC is safe to administer and definitely helps cancer patients in reducing side effects of chemotherapy, improving sense of well-being and preparing them mentally and physically to continue and tolerate further chemotherapy cycles.

Reduction of Chemotherapy Side Effects

The Journal of Alternative and Complementary Medicine
Hangai, Sho, MD, et al. Effect of Active Hexose-Correlated Compound in Women Receiving Adjuvant Chemotherapy
for Breast Cancer: A Retrospective Study.
2013 Nov; 19(11): 1–6


Topic
What is the difference in chemotherapy treatment adverse effects and incidence in those receiving AHCC and those who didn’t?

Background
First-line chemotherapy used in treating breast cancer includes the use of anthracyclines and taxanes, which are associated with significant toxicity and side effects, including nausea, vomiting, hair loss, bone marrow suppression, hepatotoxicity, and many others. Very severe side effects may result in discontinuation or delay of chemotherapy. Side effects reduce healthrelated quality of life, however, active hexose-correlated compound (AHCC) in rodents has reduced such chemotherapy side effects as bone marrow suppression, hepatotoxicity, and nephrotoxicity. In this study, side effects from chemotherapy of those taking AHCC versus those who didn’t were compared.

Study Type
Human intervention, open-labeled, control study without placebo.

Study Design
Forty-one women who were treated with anthracyclines and taxanes were selected for this study. Comparison was made of occurrence of adverse events in patients who received AHCC with those who did not receive AHCC. Using Fisher’s exact tests, the worstgrade adverse events in each treatment cycle were determined. Generalized use of granulocyte colonystimulating factor in the two groups was analyzed using Student’s t-test. The medical records of women treated for breast cancer were used to select female patients who fulfilled the following criteria: 1) were between the ages of 20 and 64; 2) had pathologically proven breast cancer; and 3) were receiving doxorubicin and cyclophosphamide (AC therapy), followed by taxanebased regimens. Patients who had taken AHCC during chemotherapy were analyzed as the AHCC group. Each patient in this group had taken a total of 1.0 g of AHCC orally after each meal. Patients who had not taken AHCC were analyzed as the control group.

Subjects
41 women with breast cancer and using taxane or anthracyclines chemotherapy treatment.

Dosage
1 gram.

Results
It was found that compared with the control group, the AHCC group had significantly fewer neutrophilrelated events (odds ratio: 0.30; p = 0.016), significantly lower use of granulocyte colony-stimulating factor, and a higher (although not significant) rate of adverse events associated with c-glutamyl transpeptidase, a liver enzyme.

Conclusion
AHCC has the potential to reduce the severity of neutropenia induced by breast cancer chemotherapy and the need to use granulocyte-CSF during chemotherapy as a remedial therapy. Overall data suggest that AHCC may reduce the toxicity of chemotherapy and may then allow for intensification of the chemotherapy dosage. A prospective trial is needed to study the effects of AHCC related to adverse events associated with c-GTP.

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Reduction of Chemotherapy Side Effects

Nutrition and Cancer
Ito, T., et al. Reduction of Adverse Effects by a Mushroom Product, Active Hexose Correlated Compound (AHCC) in Patients With Advanced Cancer During Chemotherapy—The Significance of the Levels of HHV-6 DNA in Saliva as a Surrogate Biomarker During Chemotherapy. 2014 Apr; 66(3):377–82


Topic
What effect does AHCC have on the reduction of adverse effects in advanced cancer patients on chemotherapy with
weakened immune systems experiencing HHV-6 herpes virus infection and liver and blood toxicity?

Background
Chemotherapy causes adverse effects that include suppression of bone marrow function and liver toxicity. This study evaluated the safety and effectiveness of a mushroom-derived active hexose correlated compound (AHCC) on chemotherapy-induced adverse effects and quality of life (QOL) in patients with cancer. Cancer patients in their first cycle of chemotherapy without AHCC received their second cycle with AHCC. During chemotherapy, on a weekly basis the following parameters were evaluated: adverse effects and QOL via a blood test, EORTC QLQ-C30 questionnaire, and DNA levels of herpes virus type 6 (HHV-6) in saliva. 

Study Type
Human clinical intervention trial.

Study Design
Observational.

Subjects
24 patients with cancer

Dosage
3 grams

Results
The DNA levels of herpes virus type 6, often found in people with compromised immune systems and thought to be related to chronic fatigue syndrome, were significantly increased after chemotherapy. AHCC significantly decreased the levels of HHV-6 in saliva during chemotherapy, improved QOL scores in the EORTC QLQ-C30 questionnaire and reduced blood and liver toxicity.

Conclusion
The findings suggest that salivary HHV-6 levels may be a good biomarker of QOL in patients during chemotherapy, and that AHCC may have a beneficial effect in mitigating chemotherapy-associated adverse effects and improving quality of life in cancer patients undergoing chemotherapy. AHCC may also be helpful for individuals with chronic fatigue syndrome while further research needs to be conducted for this application.

Reduction Chemotherapy Side Effects

Biotherapy Jang Seok Won. The hematoimmunologic effect of AHCC for Korean patients with various cancers.
2002 November; 16(6): 560-564


Topic
Does AHCC have a hematoimmunologic effect on cancer patients?

Background
AHCC has immunomodulatory properties and is usually used as one of the complementary treatment agents for cancer patients.
However, the mechanism of its antitumor effect is not clear.

Study Type
Human clinical intervention trial.

Study Design
Open-label trial: Patients were administered AHCC for 9 months. A peripheral blood examination, including total leukocytes, peripheral lymphocytes, hemoglobin and hematocrit (a measure of the proportion of blood occupied by red blood cells) was performed before AHCC administration and then every 3 months for a total of 3 times. Assessment of immune parameters was also performed before intake and then every 3 months after for a total of 2 times.

Subjects
12 cancer patients.

Dosage
3-6 grams of AHCC per day.

Results
AHCC supplementation resulted in the following changes compared with baseline:
• The ratio of NK cells to total lymphocytes increased from 21.67% before taking AHCC to 26.21% and 26.0% 3 to 6
  months after taking AHCC, respectively
• There was no change in white blood cells, hemoglobin, hematocrit and thrombocyte numbers after taking AHCC,
  even though patients were undergoing radiotherapy or chemotherapy
• No adverse effects were observed

Conclusion
“This study suggests that AHCC can be used for the prevention of bone marrow depression and chemotherapy.
Also, from the hematoimmunologic point of view, AHCC treatment seems to be safe and good for cancer patients,
acting as a biological response modifier.”

Reduction of Chemotherapy Side Effects

Biotherapy
Uno K, Kosuna K, Sun B, Fujii H, Wakame K, Chikumaru S, Hosokawa G, Ueda Y. Active Hexose Correlated
Compound (AHCC) improves immunological parameters and performance status of patients with solid tumors.
2000 March; 14(3): 303-309


Topic
Does AHCC have a biological response modifier (BRM)- like effect in advanced-stage cancer patients?

Background
Biological response modifiers (BRMs) are substances that stimulate the body’s response to infection and disease, including tumors.
Several medicinal compounds obtained from polysaccharide-rich plants are known to have BRM effects. What is the effect of
AHCC on the production and activity of immune cells?

Study Type
Human clinical intervention trial.

Study Design
Open-label controlled trial: Subjects were administered AHCC for 6 months. NK cell activity in the peripheral monocytes and Th1 cytokine production (IFN-γ, IL-12) were the immunological parameters investigated. Performance status (PS) as an indicator of quality of life was also measured. Each parameter was measured and evaluated 4 times, before AHCC and after administration of AHCC at 2 months, 4 months and 6 months. 

Subjects
38 cancer patients and 117 healthy people

Dosage
6 grams AHCC per day (in 3 doses after meals)

Results
AHCC supplementation resulted in the following changes compared with the status before intake:
• Significant improvement in NK cell activity
• Significant improvement in IFN-γ and IL-2 production
• Significant improvement in PS evaluation

Conclusion
“The basal levels of 2 cytokines and NK activity in patients with tumors were lower than those in healthy people.
All of 3 immunological parameters of patients increased to the normal levels after the intake of AHCC.
These results demonstrate that AHCC improves both immunological abnormalities and clinical conditions.”

Reduction of Chemotherapy Side Effects

Topic
Does AHCC have an immunomodulating effect on cancer patients?

Background
AHCC is an enzyme-fermented extract of the basidiomycetes mushroom. The complex compound contains a mixture of polysaccharides, amino acids, lipids and minerals. The predominant components are oligosaccharides, totaling approximately 74% of the total dry weight. Of these, nearly 20% are partially acetylated α-1,4-glucans, which are believed to constitute the active compounds in AHCC.

Study Type
Human clinical intervention trial.

Study Design
Open-label trial: Cancer patients with different advanced malignancies participated in the study. Patients received
AHCC for 2–6 months. NK cell activity was examined by 4-hour Cr release assay against sensitive K562 and resistant Raji tumor cells.

Subjects
17 cancer patients.

Dosage
3 grams of AHCC per day.

Results
AHCC supplementation resulted in the following changes:
• Significant enhancement of NK activity against K562 as early as
2 weeks, two- to threefold increase compared with base line
• Activity was further increased at subsequent time periods up to
6 months post-treatment with AHCC • NK activation was also detected against Raji cells, but at later
stages 1-2 months with two- to ten fold increase compared with base line

Conclusion
“We conclude that AHCC is a potent immunomodulator and may be useful in immunotherapy of cancer.
 

Hepatitis-C & Liver Disease

The Medical News (Thailand)
Thaiudom S, Piyaniran W, Chutaputthi A. A study of the efficacy of active hexose correlated compound
(AHCC) in the treatment of chronic hepatitis C patients at Phramongkutklao Hospital
(2010) 325, 13-16


Topic
Does AHCC have an effect on patients with chronic hepatitis C?

Background
Hepatitis C virus (HCV) infection is now a worldwide important issue with over 170 million people throughout the world have been infected with this virus. Generally, 2–35% of people infected with HCV will finally develop cirrhosis and hepatocellular carcinoma. The treatment for chronic hepatitis C patients causes many side effects and is also expensive. Previous research has shown that AHCC can increase numbers and function of several kinds of immune cells, while reducing HCV and ALT, a liver enzyme involved in the progression of hepatitis C. Can AHCC reduce HCV RNA levels and improve liver function?

Study Type
Human clinical intervention trial.

Study Design
Prospective, randomized, double-blind placebocontrolled trial: Patients received AHCC (n=19) or placebo (n=20) for 24 weeks. All patients received HCV RNA levels & liver function test monitoring. Also, the reduction of HCV RNA and ALT enzyme levels was observed.

Subjects
39 chronic hepatitis C patients.

Dosage
6 grams of AHCC per day.

Results
AHCC supplementation resulted in the following changes:
• Although no significant reduction of HCV RNA levels was noticed in patients in the AHCC group compared to those in the placebo group, subgroup analysis of genotype-3 had a significant HCV RNA decline
• Although the reduction of ALT levels within AHCC group was not significant, a significant difference was found between AHCC and placebo groups
• The ALT levels were stable for the AHCC group, while ALT levels increased in the placebo group, and this difference was initially noted within the first six weeks of the study

Conclusion
“Based on the result of this study, AHCC showed significant HCV RNA reduction in group B but not group A,
and it could stabilize ALT levels when compared with placebo. This may delay the disease progression,
providing patients more opportunities to receive any other treatment later on.”
 

Hepatitis-C & Liver Disease

Presented at the 18th International Congress on Nutrition and Integrative Medicine (ICNIM), July 2010
Kim J. The Effect of AHCC in non-viral, chronic and abnormal liver function condition:
a randomized, double-blind, placebo-control study. (2010)


Topic
Can AHCC improve liver function in patients with nonviral, chronic and abnormal liver function conditions?

Background
AHCC has demonstrated potential antitumor and immune modulating properties. 

Study Type
Human clinical intervention trial.

Study Design
Randomized, double-blind, placebo-controlled: Subjects received AHCC or a placebo for 12 weeks. The inclusion criteria were one or more abnormal values among three liver function tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT) or γ-glutamyltransferase (γ-GT). Body weight, height, blood pressure, pulse rate and biochemical tests were measured after 4,8 and 12 weeks.

Subjects
30 male subjects with non-viral, chronic and abnormal liver function conditions.

Dosage
1 or 3 grams of AHCC per day.

Results
AHCC supplementation resulted in the following changes:
• 1 g AHCC significantly decreased AST, ALT and γ-GT values
• 3 g AHCC significantly decreased AST, ALT and γ-GT values except the 4-week γ-GT
• AHCC supplementation had a more dramatic effect on immune cell phenotypes after vaccination of subjects over 60 years old

Conclusion
“It was shown that the consumption of AHCC possessed beneficial effects on non-viral, chronic and abnormal liver function condition.”

Hepatitis-C & Liver Disease

Journal of Nutrition Science Vitaminology
Kim, Hyangkyoung, Jung-Ha Kim, and Jee-Aee Im. Effect of Active Hexose Correlated Compound (AHCC)
in Alcohol-Induced Liver Enzyme Elevation.
2014;60: 348–356


Topic
What is the effect of Active Hexose Correlated Compound (AHCC) in alcohol-induced liver enzyme elevation?

Background
The effect of AHCC supplementation and the mechanism of action of AHCC were tested in patients with alcohol-induced mildly elevated liver enzyme levels. AHCC is an enzyme-fermented extract of the shiitake mushroom available as a dietary supplement. The complex compound contains a mixture of polysaccharides, amino acids, lipids, and minerals. The predominant components are oligosaccharides, totaling approximately 71.2% of the total dry weight. This study was a randomized, controlled, double-blind clinical trial conducted at the Chung-Ang University Healthcare System in Seoul, South Korea. 

Study Type
Double-blind, randomized, placebo controlled human intervention trial (19 subjects in the placebo group,
21 in the 1-g AHCC group, 22 in the 3-g AHCC group).

Study Design
Participants were randomly given either the placebo, 1 g of AHCC, or 3 g of AHCC and took the supplement for 12 weeks. Subjects visited the hospital for clinical and biochemical measurements, to report adverse events, return unused supplements, and to obtain their next supplements. Assessments included biochemical tests of liver enzymes, a questionnaire survey, and anthropometric measurements that were collected at the beginning and after every 4 weeks. Fatigue and mental stress was measured by reporting in the questionnaire. The brief fatigue inventory was composed of simple numeric rating scales from 0 to 10 for assessing fatigue. Severe fatigue was defined as a score of 7 or greater. For mental stress assessment, the Korean brief encounter psychosocial instrument (BEPSI-K), a validated indicator of perceived stress, was used. BEPSI-K consists of 5 items on a 1–5 Likert scale. A single observer performed anthropometric measurements in the morning after overnight fasting by the subjects, who wore light clothing and no shoes. A body composition analyzer (In body 3.0, Biospace, Seoul, South Korea) was used to measure their heights and body weights. The body mass index (BMI) was calculated by dividing the measured weight (kg) by the square of height (m2). Subjects sat on a chair in a stable and relaxed state, and their blood pressure was measured using a mercurial blood pressure tonometer. Each capsule was a light brown color and contained 167 mg of AHCC with 333 mg of dextrin and malt extract or a placebo of dextrin and malt extract. The treatment duration was set at 12 weeks since the effect of AHCC appeared after 3 months in a previous study. Patients were treated 30 minutes before breakfast and dinner for 12 weeks with 3 g/d AHCC (500 mg of AHCC/ capsule, 3 capsules × 2 doses) for the 3-g AHCC group, 1 g/d of AHCC (167 mg of AHCC with 333 mg of dextrin and malt extract/capsule). When the value of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) in the study period increased 2-fold or more compared with the base line or previous value, subjects were dropped from this study. The primary outcomes evaluated were the value and the percentage change of three liver enzymes (AST, ALT, and gamma-glutamyl transferase (g-GT)) in each group. 

Subjects
62 adults with elevated liver enzymes from alcohol consumptio 

Dosage
1 gram and 3 grams.

Results
After 12 weeks of supplementation, the percentage change in alanine aminotransferase (ALT) levels was significantly different between the placebo and both AHCC groups (1 g of AHCC and 3 g of AHCC). Serum levels of tumor necrosis factor-α (p < 0.05) and interleukin-1β ( p < 0.01) were significantly lower, while those of adiponectin were higher in both AHCC groups than in the placebo group (p < 0.01). AHCC supplementation for 12 weeks may improve the levels of liver enzymes and circulating proinflammatory and anti-inflammatory cytokines in patients with alcohol-induced mildly elevated liver enzyme levels. The liver enzyme levels, lipid profiles, insulin resistance, and scores on fatigue and stress-related questionnaires did not show significant differences between the groups (p < 0.05); however, cytokine levels did show significant differences (TNF-α, IL-1β, and adiponectin, p < 0.05). Comparing the percentage changes at 12 weeks as analyzed by a paired t-test, a decrease in liver enzymes in both AHCC groups and a change in IL-1β and adiponectin in the 1-g AHCC group were found to be statistically significant. When analyzed with ANOVA, the percentage changes of serum levels of inflammatory cytokines, such as TNF-α (p < 0.05) and IL-1β (p < 0.01), were lower in the AHCC supplementation groups than in the placebo group. Serum levels of adiponectin were higher in both AHCC groups than in the placebo group (p < 0.05). 

Conclusion
Results demonstrated promising effects with a 12-week course of AHCC supplementation for improving liver enzyme levels and circulating proinflammatory and anti-inflammatory cytokines in patients with alcoholinduced liver enzyme elevation. AHCC supplementation for 12 weeks significantly improved ALT levels, decreased proinflammatory cytokines (TNF-α and IL-1β), and elevated anti-inflammatory cytokines (adiponectin) in both AHCC groups without any adverse events. Hepatoprotective effects accompanied by striking anti-inflammatory effects were observed regardless of the dosage. 

HPV

11th International Conference of the Society for Integrative Oncology, Houston, TX, October 26–28, 2014
Evaluation of active hexose correlated compound (AHCC) for the Eradication of HPV Infections in Women with HPV positive Pap Smears. Smith, Judith A., Pharm.D., BCOP, CPHQ, FCCP, FISOPP, Jonathan Faro, M.D., Yu Bai, M.D., Barbara Rech, RN, Anjali Gaikwad, M.S., MB(ASCP), Joseph A. Lucci III, M.D., Joseph A. Rodriguez, M.D., Teresa T. Byrd, M.D


Topic
Can women with HPV-positive Pap tests who don’t show signs of abnormal cytology (abnormal cervical cells) and are
treated with active hexose correlated compound (AHCC) undergo clearance of the infection?

Background
HPV DNA has been detected in over 99 percent of cervical cancer patients. HPV infection is one of the most important predisposing factors of cervical cancer, though not the only one. HPV appears to be an important cofactor in the development of dysplasia and cancer, but it does not cause either condition by itself. Smoking, drinking alcohol, and a poor diet may also be important cofactors. There is currently no known effective medicine or supplement for eradication of HPV infections. Previously completed preclinical in vitro and in vivo mouse data that suggested AHCC will eradicate HPV in 16 out of 18 infections attributed this to the modulation of the expression and signaling of interferon alpha and beta. It was suggested that AHCC may help prevent subsequent HPV-related cervical cancers. The virus infects epithelial and mucosal surfaces and is a very common viral infection — 230 subtypes of HPV have been identified, including 100 human subtypes. Fifteen of the human HPV subtypes are carcinogenic and include the common subtypes: HPV 16, 18, 31, 39, and 41. According to the U.S. Centers for Disease Control and Prevention, several other cancers are related to HPV through sexual transmission, including 95 percent of anal cancer, 60 percent of oropharyngeal cancer, 65 percent of vaginal cancer, 50 percent of vulvar cancer, and 35 percent of penile cancer. The primary objective of the pilot study was to confirm the preclinical findings to determine if AHCC is effective in eradicating HPV infections in women with negative-oncology Pap tests. AHCC is available over the counter as a nutritional supplement that functions by improving the innate immune system. Human and preclinical studies have shown that AHCC increases the number and/or activity of natural killer cells, dendritic cells, and cytokines. These help the body fight off infections, including those caused by viruses, and
help block tumor growth

Study Type
Human intervention dose-finding pilot study

Study Design
Case studies involving HPV-positive women treated orally with the extract AHCC once daily for up to 6 months. Patients who had documented persistent HPV-positive infections for greater than 2 years but were otherwise healthy and met the remaining eligibility criteria were enrolled in the study to evaluate the effectiveness of 3 g of AHCC by oral administration to eradicate HPV. The regimen was repeated every month until the patient tested HPV negative or until 3 months of active treatment had elapsed. Patients who tested positive after 6 months of treatment were considered treatment failures. HPV testing was completed with the Cervista® HPV HR Test (Hologic Inc., Bedford, MA) once a month, and a 2 mL blood sample was drawn for research purposes to monitor immune markers for response.

Subjects
10 women with HPV-positive status.

Dosage
3 grams, once a day on an empty stomach.

Results
Five subjects achieved a negative HPV test result — three with confirmed eradication after stopping AHCC — with the remaining two responders continuing on the study.

Conclusion
"The preliminary results from this pilot study confirm previous preclinical findings that AHCC appears to be effective for elimination of HPV infections. These results will justify further reinvestigation. A formal phase II randomized, placebo-controlled study is underway at
UTHealth–University of Texas Medical School at Houston."

Epilepsy

Presented at the 22nd International Congress on Nutrition and Integrative Medicine (ICNIM), July 2014
Mikhailichenko, N. Estimating efficacy of AHCC as immune therapy for patients diagnosed with pharmacoresistant epilepsy.


Topic
What effect does active hexose correlated compound (AHCC) supplementation have in patients diagnosed with pharmacoresistant
epilepsy, to what degree is there a role in the immune system disease pathogenesis, and what is the efficacy of immune therapy?

Background
Evidence of interaction between epilepsy and immunologic disorders has been growing over the last several decades. Clinical syndromes of secondary immunodeficiency have been found in 70–80 percent of cases involving mental patients with various severities of illness. Immunologic mechanisms may play a significant role in an integrated theory of epilepsy, and since infectious diseases such as ARVI, ENT diseases, urinary tract infections, and herpetic infections often attack patients with epilepsy, immune-correcting drugs have become a basis for treating these types of psychoimmunoneurological diseases. This study examined patients diagnosed with pharmacoresistant epilepsy and evaluated the effect of an immune-system role in pathogenesis of the disease and the efficacy of immune therapy using AHCC as a dietary supplement

Study Type
Human clinical intervention trial

Study Design
Case studies of several children with pharmacoresistant epilepsy were examined using clinical methods. Immunologic tests were performed to assess clinical syndromes of secondary immunodeficiency and to identify multiple defects in the immune system. Immunologic examination was performed according to standard methods. Immune status was measured by percentage of T- and B lymphocytes in peripheral blood (total number of lymphocytes, percentage and absolute number of mature T cells ( CD3+), T helpers (CD4+), and T killer-suppressors (CD8+), B lymphocytes (CD20+), and immunoregulatory balance between CD4+ and CD8+ concentrations. In addition, serum immunoglobulin A, G, and M (IgA, IgG, and IgM) were measured. All patients received combined treatment including base line antiepileptic and immune therapy using AHCC-2 for 1 month.

Subjects
Several children.

Dosage
Not reported.

Results
Children with pharmacoresistant epilepsy had decreased mature T lymphocytes (CD3+) and T cells and an imbalance in the subset. The amount of CD3+ T lymphocytes in the epilepsy group was 42.42%±14.65%, which is 82.8% of average. The amount of CD4+ T lymphocytes was 71.6%, and cytotoxic CD8+ was 112.7%. The CD4+/CD8+ lymphocytes subset distribution and regulatory balance had a ratio of 1.28±0.55, which was below average or only 58.6% of the average value. After AHCC intake, patients had positive changes of peripheral T cell pool (CD3+) and T-helpers (CD4+). They also showed an improvement and increase in the ratio of T suppressors-killers (CD8+) to lymphocytes to 1.4. Due to increases in the CD4+ lymphocytes subset, the immunoregulatory balance of the CD4+ to CD8+ ratio improved. There was a 35% decrease of frequency and intensity of epileptic seizures. The patients’ bodily health status and physiological functions also improved.

Conclusion
Patients with pharmacoresistant epilepsy have been found to have significant neuroimmune disorders, according to the results of immune cell testing. AHCC immunotherapy improves immune status by increasing the amount of T lymphocytes, by regulating the subset balance, and by activating phagocytes and humoral function. In addition, AHCC treatment decreased neurological immune dysfunction by regulating the amount of serum immunoglobulins, indicating a reversal of the autoimmune process that has significance in the development of epilepsy.