Clinical Trial Of A Mixture of Six

Medicinal Mushroom Extracts

John C. Holliday¹ Wang Ruwei² Xu Yiyuan²   Ji Peijun³   Wang Xingli⁴

  1. Hawaiian Health Products Inc, Next Labs Inc, Maui, Hawaii 

 2. People’s Hospital in Lishui City, Zhejiang Province, PRC  

               3. Zhejiang Qingyuan Fungi Medicinal & Health Products Co., Ltd  

           4. Qingyuan Oriental Medicinal Mushroom Development Center

ABSTRACT: This paper reports the results of a clinical trial conducted at the People’s Hospital of Lishui City, Zhejiang Province, Peoples Republic of China, showing the clinical manifestations of a mixture of six Medicinal Mushroom extracts as an adjunct therapy to improve the immune function of cancer patients undergoing other therapies.  Methods: the Zhejiang Qingyuan Fungi Medicinal & Health Products Co., Ltd produced the experimental mixture used in this clinical trial.  This mixture is marketed in the United States of America under the trade name Immune-Assist where it has shown good results in cancer treatment. This mixture includes Beta-Glucan and other polysaccharides, extracted from the following well-known medicinal mushrooms:

Agaricus blazei (polysaccharide  >40%) 

Lentinus edodes (polysaccharide >25%)

Grifola frondosa (polysaccharide >28%)

Ganaderma lucidium (polysaccharide >20%)

Coriolis versicolor (polysaccharide >30%)

Cordyceps sinensis mycelium (polysaccharide >30%)

These six extracts were mixed together into tablet form and co-administered to the patients undergoing conventional therapy as a daily regimen. This trial was conducted among 56 cancer patients, 30 chosen to receive the Medicinal Mushroom extract mix and another 26 comparable patients receiving the accepted pharmaceutical drug Polyactin-A as a control group. All patients were in the middle-late stages (Stage 3 and 4) of cancer.  Polyactin-A is made by Taixing Medicine Company, Ltd. in Chengdu, PRC and the batch number is 20000327. Results: There are apparent differences between the experimental group and the control group. The experimental group had improvements in the quality of living as compared to the control group of cancer patients.  Discussion: The pills of mixed polysaccharide made up of the six species of Medicinal Mushrooms named can become a new health product to improve immunity with high effectiveness and non-toxicity. Further trials are recommended.

Key words: Medicinal Mushroom extract, Beta-Glucan, polysaccharide, cancer, Immune function.

INTRODUCTION

It has been found recently that the Beta Glucans and other polysaccharides, which can be extracted from medicinal fungi, are bioactive in many ways.  Qingyuan County lies in the southwest of Zhejiang province in the Peoples Republic of China, and is one of the major sources of these medicinal fungi. We researched the folk remedies known in this area, and arranged the use of Royal Agaricus (A. blazei), Maitake (G. frondosa), Shiitake (L.edodes), Reishi (G. lucidium), Turkey Tails (C. versicolor), and Caterpiller fungus (C. sinensis) as the main materials from which to extract the polysaccharides and produce tablets according to the known roles of the polysaccharides, such as inhibiting the growth of tumors, improving the immunity etc. This research group found apparent roles of the polysaccharide tablets among the tumor patients during these trials conducted between August 2000 and April 2001. The patients were being treated concurrently with radiotherapy or chemotherapy. The polysaccharide materials were provided by Zhejiang Qingyuan Fungi Medicinal & Health Products Co., Ltd., and formulated in accordance with the Immune-Assist recipe developed by Hawaiian Health Products, Inc of Maui, Hawaii. The Government research permit number of the tablets used for this research is 99-118.  Each tablet is 500 mg, with a total polysaccharide content of 475 mg.     

MATERIALS AND METHODS

1.    Study subject selection criterion:

1)    The patients have apparent pathological diagnoses;

2)    The patients have had no operation before or have had an operation but had a relapse, or have new transference of tumor about focus.  They have clinical focus or the observation marker of X-ray and CT in order to estimate the curative effect;

3)    The patients have normal function of liver and kidneys before treatment, a Kafnofsky score >60, and can be expected to live more than 3 months;

4)    According to the international standard of TNM by stages, the middle-late cases are chosen;

5)    White Blood cell count > 40 X 10⁹ L. blood platelet count > 100 x 10⁹/L.

6)    The patients are being treated concurrently by radiotherapy or chemotherapy. 

The patients are all middle-late stage patients with malignant tumors in 56 cases.  Among the 56 cases, 30 cases are in the experimental group, and 26 cases are in the comparison group.  The cases of the two groups all come from co-operative hospitals.  The patients have similar conditions, such as physical condition, total number of white blood cell count and granular leukocyte count, appetite condition and the clinical treatment plans of radiotherapy or chemotherapy are almost the same.  The total number of white blood cells in the two groups has no apparent difference through comparison by statistical treatment before trials. The details about the two groups can be seen from tables 1 and 2.

                             Tab. 1. The common comparison between two groups

Tab.2 The comparison of total number of white blood cells between the two groups before trials

2) Experimental methods:

 The two groups have basically the same radiotherapy and chemotherapy plans, procedures and similar anti-nausea drug therapy (shudan). The patients in the experimental group begin to take the polysaccharide tablets for one week before radiotherapy and chemotherapy 3 x day, 4 tablets each time (total 6 grams/day). The patients in the comparison group begin to take the tablets of Polyactin A, which is made in Taixing Medicine Limited Company in Chengdu and the batch number is 20000327, for one week before radiotherapy and chemotherapy, 3 x day, 10 mg each time (total 30 mg/day). Both groups continue to take the pills during the course of treatment and afterwards for a total of 2 months.

3) Observation markers:

1)    4 classes of vomiting: 0 x/day, 1-2 x/day, 3-4 x/day, 5 or more x/day;

2)    Appetite, 3 conditions of taking food: almost none or less than half of common food, half of common food, common food;

3)    Alteration of hemogram test, total CBC: 3-4 times every 3 days before and after radiotherapy and chemotherapy.

4)    Observation of other poison reactions i.e. loss of hair, changes in organ function, such as stomach, intestines, heart, liver, kidney, etc. 

5)    Divide the conditions of 1-4 for the assessment of life quality: According to the KPS, adding 10 points after curing is considered improvement, increasing or decreasing by 4 points is stable, reducing 10 points or more is a decline of condition.

RESULTS

After radiotherapy or chemotherapy, the comparison group has little changes in reaction for the digestive tract and the reduction in the total number of white blood cells is less (P>0.05), the appetite and quantity of food taken shows great differences.  These can be seen from Tables 3, 4, 5 and 6.

Table 3   The alteration in blood count of the two groups after chemotherapy

P<0.1 from the comparison of the two groups as to the total number of white blood cells.

Table 4 Comparison of vomiting after treatment

 P<0.01

Table 5 Appetite comparison after treatment

The result indicates P<0.01

Table 6 Comparison of KPS value between the two groups

The result indicates the score of the experimental group is higher than that of the comparison group.

Poison reactions:

The reaction of the digestive tract is very light for the two groups, the experimental group is 30% (9/30), and the comparing group is 50% (13/26); The conditions of loss of hair is 8.3% in the experimental group and 10% in the comparison group.  The patients of the two groups show no abnormalities of the heart, liver and kidneys.  There are two cases of lung infection in the comparison group, which are brought under control after treatment with antibiotics.  No deaths occurred in either group during the course of these trials.

Typical examples:

Example 1: Female, 58 years old and has water retention in left thoracic cavity.  About 600 ml of fluid with blood was extracted on the second day after entering the hospital. The adenocarcinoma could be seen from testing, and the disease was determined to be membrana pleuralis transference of carcinoma of liver.  Addition of the Medicinal Mushroom polysaccharide tablets to the FM plan, and continue to take after chemotherapy.  The symptoms of respiratory tract were relieved apparently, and the water retention in the thoracic cavity was controlled. The patients condition was stable and only a loss of hair was noted.  She added 1 kg to her body weight and her KPS score increased by 60.  On retesting hemogram, white blood cell is 3.8 x 10⁹/L and the functions of liver and kidneys are normal.

Example 2: Male, 69 years old with carcinoma of right lung.  He entered the hospital for abdominal pain after chemotherapy of 2 months and radiotherapy of 1 month.  The disease was very aggressive with anemia, and a KPS score of 40.  Added the Medicinal Mushroom polysaccharide pill to FM plan and continued with the conventional therapy.  The abdominal pain was relieved, the appetite was improved, overall condition much better.

DISCUSSION

1) The mixed polysaccharide was extracted from 6 edible and medicinal fungi.  It was shown that the mixed polysaccharides can inhibit the protein synthesis of cancer cells, change the physiological condition of cancer cells, inhibit the growth and transference of cancer cells, relieve the poisoning action of the anti-cancer drugs, improve the patients sleep and appetite and result in overall improvement of the symptoms.

2) The mixed polysaccharides have an apparent role in controlling and improving the immunity. After taking the tablets, nonspecific immunity of the body is enhanced, improvements in the secretion of IGA, increase in the function of monocyte-macrophage and in the activity of NK cells, and in keeping the immunological balance and stability of the body.

3)The mixed polysaccharide has antagonistic action for the complications caused by the use of the anti-tumor drugs and the WBC reduction caused by various reasons of clinical therapy.

4) The main material of Polyactin-A used by the comparison group is gluco-mannosan peptide. This is a highly effective immune enhancement drug.  It can enhance the immunity and activate the function of phagocytes and white blood cells.  It is used for treatment of the reduction in white blood cells seen during cancer treatment using radiotherapy and chemotherapy.

5) The results shown during this trial from the treatment of cancer patients indicate that the mixed polysaccharides of Medicinal Mushrooms has an apparent role in the treatment of all kinds of cancer, protecting the haematopoiesis function of the bone marrow, inducing the action of the digestive tract, increasing the immunity of the cells, increasing the activity of the NK cells, the LAK cell and the ratio of the T_h/T_s cells. The curative effect of this polysaccharide mixture is higher than that of  Polyactin A, and has an excellent helper role as an adjunct for the treatment of tumor patients.

REFERENCES

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