Tag Archives: clinical trial

CORIOLUS MUSHROOM: Uses, Side Effects, Interactions and Warnings – WebMD

Coriolus mushroom is a fungus. People have used the fruiting body and other parts as folk medicine for a long time. Recently, researchers have started to isolate and identify substances in coriolus that might act like pharmaceutical drugs. Two of these substances are polysaccharide peptide (PSP) and polysaccharide krestin (PSK). Scientists think these chemicals might be able to fight cancer and boost the immune system. Coriolus mushroom, PSP, and PSK are used for stimulating the immune system; treating herpes, chronic fatigue syndrome (CFS), hepatitis, and pulmonary disorders; reducing phlegm; improving bodybuilding results; increasing energy; curing ringworm and a skin condition called impetigo; treating upper respiratory, urinary, and digestive tract infections; curing liver disorders including hepatitis; reducing the toxic effects and pain of chemotherapy and radiation therapy; increasing the effectiveness of chemotherapy; prolonging life and raising the quality of life of cancer patients; and increasing appetite.

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Clinical Trial China phase 3

Based on the PSP´s significant findings in the investigated cancers of the Phase II trial, permission was granted by the Chinese Administration of Health Bureau to carry out a multi-center Phase III clinical trial. Fourteen hospitals including the eight who participated in the phase II trial conducted this randomized study from April 1996 to September 1997.

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Clinical trial China phase 2

Polysaccharide-peptide (PSP) is a protein bound polysaccharide isolated from the COV-1 strain of Yunzhi (Coriolous versicolor mushroom) and made from modern alcohol extraction techniques. Each capsule contains 0.34 grams of PSP. Experimental in-vitro and in-vivo studies have shown PSP inhibits the proliferation of cancer cells including P338 leukemia cells, S 180 cells, Ehrlich ascites, and stomach and lung cancer cells. It also inhibits the growth of some tumors such as the lymphatic tumor of human skin tissue cells. In addition, PSP affects the immune system of mice by stimulating the production of ?\interferons, increasing the phagocytic index and metabolic rate of the reticuloendothilial system and by raising the HC 50 (median hemolytic dose), IgG and PFC (plaque forming cell) values. Human in-vivo experiments have also shown PSP can modulate the immune system by helping to prevent and partly eliminate the side effects of radiation and chemotherapeutic agents used by cancer patients.

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Add mushrooms to list of cancer treatment tools – By: Dr. Patrick Massey, M.D., Ph.D., Daily Herald Columnist

(Daily Herald – 9/8/2008) When it comes to cancer treatment, I believe that we have finally reached a point where we need to seriously consider incorporating mushrooms into the overall medical approach.

A review article outlining the importance of one specific mushroom – Coriolus versicolor – in the treatment of several types of cancer was published in the recent issue of the Journal of the Society for Integrative Oncology. The article summarizes more than three decades of solid research that showed patients who consumed Coriolus versicolor or one of its extracts during chemotherapy had better survival rates.

The use of mushrooms as a cancer therapy has been common in Asia for many years. Coriolus versicolor is often recommended because of its potent anticancer properties. This particular mushroom grows on the side of trees in many parts of the world, including the U.S. In China, it is called yun zhi (cloud fungus). In the U.S., it is commonly referred to as turkey tail.

Coriolus versicolor is the source of Krestin, arguably the most commonly used anticancer compound in the world. Krestin was first discovered by a Japanese chemical engineer in 1965 and is approved by the Japanese government as an anticancer therapy.

Standard treatments such as chemotherapy and radiation therapy can dramatically reduce the number of cancer cells in a person’s body, but ultimately the immune system is responsible for killing the remaining cancer cells. Mushrooms contain a number of unique long chain sugars called polysaccharides. Polysaccharide recognition is one way that our cells communicate and how natural killer cells differentiate between normal and cancer cells. A number of mushroom polysaccharides, especially from Coriolus versicolor, specifically enhance the activity of natural killer cells.

There is significant research to indicate that extracts from Coriolus versicolor show activity against lung, gastrointestinal and breast cancers, with more than 140 papers published in the medical literature, including 43 human clinical trials.

Although Coriolus versicolor and its extracts appear to be safe, I strongly recommend medical supervision during cancer therapy. In addition, safety in children, pregnant women and those with kidney disease has not been established.

• Dr. Patrick D. Massey, M.D., Ph.D., is medical director for complementary and alternative medicine for Alexian Brothers Hospital Network.

Source: Daily Herald, Chicagohttp://www.dailyherald.com/story/print/?id=232976

Clinical Trial Results Show Proof-of-Concept For Use Of Coriolus Versicolor As Immunonutrition In HPV Patients With Cervical Lesions (LSIL)

(Medical News Today – 4/29/2008) The results of a year long clinical trial examining the effects of mushroom supplementation in patients with Human Papillomavirus (HPV) have recently been presented at congress. Dr. Jose Silva Couto and Dr. Daniel Pereira da Silva of the Cervical Pathology Unit of the Portuguese Institute of Oncology in Coimbra, Portugal presented their findings at the 20th European Congress of Obstetrics and Gynaecology, in Lisbon Portugal. This study provides a promising set of results and demonstrates proof-of concept for the question as to whether immunonutrition supplements can be successfully used to improve HPV status in patients.

The poster presentation detailed the results of the evaluation of the Efficacy of Coriolus versicolor Supplementation in patients infected with HPV with low-grade squamous intraepthithelial lesions (LSIL). The Coriolus versicolor mushroom supplied for the study was produced by Mycology Research Laboratories Ltd in tablet form (500 mg/tablet).

Dr. Silva Couto et al. found that Coriolus versicolor supplementation over a period of one year substantially increased regression of the dysplasia (LSIL) and induced clearance of the high risk sub-types of the HPV virus responsible for cervical cancer.

a) Coriolus versicolor supplementation demonstrated a 72% regression rate in LSIL lesions compared to 47.5% without supplementation.

b) Coriolus versicolor supplementation demonstrated a 90% regression rate in the high risk HPV virus sub-types compared to 8.5% without supplementation.

Study Design

The year long study was funded by Mycology Research Laboratories Ltd. The Portuguese pharmaceutical firm Aneid-Produtos Farmacêuticos Lda acted as collaborative partners.

Forty-three (43) patients with HPV Lesions (LSIL) were divided into two groups:

– A Control group (21 patients) who did not receive any treatment

– A treatment group (22 patients) who each received Coriolus versicolor supplementation for a period of one year (6 tablets/day i.e. 3g/day)

Protocol Design

At first observation, patients were examined with colposcopy, biopsy and HPV tipification (hybrid capture). Cervical cytology exams (Pap smear tests) determined the patients’ LSIL status and this was confirmed through colposcopy and biopsy.

Four months after the first observations, colposcopy and cervical cytology was again carried out on all patients. At the same time, there was an evaluation of the possible side effects from Coriolus supplementation.

After one year, (at the end of the supplementation period), colposcopy, cervical cytology and HPV typing were carried out on all patients.

Success Parameters

The authors measured the efficacy of Coriolus supplementation in LSIL patients in terms of the evolution of HPV status from High Risk HPV+ status to High Risk HPV- status. High Risk HPV, refers to certain strains of HPV that are known to be associated with causing cervical cancer, such strains include HPV 16, 18, 31 and 45. The persistence of cervical lesions as measured by colposcopy and cytology was also determined.

Study Population

Out of the 43 patients enrolled, 39 completed the trial. Of the four (4) who did not complete the trial, 1 patient left the country and 3 discontinued supplementation due to mild side-effects. The side-effects were not serious and did not warrant further medical intervention.

The age distribution of the two groups was very similar. Patients receiving Coriolus versicolor supplementation had an average age of 31.7 years (minimum age of 19, maximum age of 49 years). The control group had an average age of 33.4 years (minimum age of 19 and a maximum of 51 years).


Of the 39 patients who completed one year of follow-up, 18 took Coriolus supplementation, while the other 21 patients received no therapy (Control group). After 1 year 13 of the 18 patients in the Coriolus group showed normal cervical cytology (72.5%) while only 10 of the patients in the control group did (47.5%).

Of the 39 patients, 22 were positive for high risk HPV subtypes.10 of these patients were in the Coriolus group and 12 in the control group. After 1 year 9 of the 10 in the Coriolus group had reverted to HPV- status (90%) while only 1 of the 12 in the control group had (8.5%).

What do these results mean for HPV patients?

The results from this study are encouraging and provide insight into the effectiveness of Coriolus versicolor as a useful immunonutrition agent. Using Coriolus supplementation for one year resulted in 72.5% of recipients reverting to normal cytology compares with only 47.5% of the control group. Encouragingly, 90% of the Coriolus recipients reverted to a HPV- status compared with only 8.5% in the control group.

While the study sample size is limited in number, the results strongly suggest that using Coriolus versicolor as a food supplementation agent offers doctors a useful nutritional tool when treating HPV (LSIL) patients over the age of 35 or those HPV (LSIL) patients with compromised immune systems.

It is also likely that Coriolus versicolor could be beneficial in HSIL patients who have undergone surgery but who experience recurrent lesions caused by persistent HPV viral infection; the eradication or “control” of the viral infection is key to both LSIL and HSIL patient care.

According to Dr Silva Couto, one of the study authors “At present, we believe that the optimal supplementation period may actually be as short as six months. Further testing is required to determine the best way to reduce the time period from the one year period used in this study.”. A shorter period of treatment would aid compliance as well as reducing the already minimal overall cost of therapy.

Why Coriolus versicolor?

As already stated, the mushroom Coriolus versicolor has been used in traditional Asian medicine for a long time. It is now known that Coriolus contains high quantities of Beta-glucans that act to stimulate the immune system. Studies have shown that Coriolus can double the number of natural killer cells after only 8-weeks of treatment.1,2 The benefits of treatment with the fungus has also been tested in patients with chronic fatigue syndrome. Coriolus versicolor (strain CV-OH1) is grown aseptically on sterile, edible grain, harvested and then produced as a tablet following good manufacturing practice according to pharmaceutical guidelines. It is free from pesticide, heavy metals and contaminants.

1. Jean A. Monro, Chronic Fatigue Immune Dysfunction Syndrome. J Integrative Medicine 2004;8:101-108

2. Jean A. Monro Treatment of Cancer with Mushroom Products. Arch Env Health 2003;58:533-537

Source: Medical News Today

Adjuvant PSK immunotherapy in patients with carcinoma of the nasopharynx.

A controlled study using adjuvant PSK immunotherapy in patients with nasopharyngeal carcinoma was initiated with the aim of improving survival by enhancing the host immune system against tumour cells. A total of 38 patients were randomly selected, all of whom had previously received radiotherapy with or without chemotherapy. Eight patients in the PSK immunotherapy group (n = 21) developed local recurrence, three of whom later died due to distant metastasis. In the control group (n = 17) three patients developed local recurrence while six patients developed distant metastasis. All of these six patients later died due to disease progression. It seems that PSK exerts its antitumour effect systemically; the risk of distant metastasis occurring is decreased, but it is apparently ineffective in improving local disease control. The estimated median survival time of the PSK-treated group compared with the control was significantly increased (35 months versus 25 months, P = 0.043). The 5-year survival rate was also significantly better in the PSK immunotherapy group (28% versus 15%, P = 0.043). It is concluded that PSK deserves careful consideration as an important immunotherapeutic agent in the management of nasopharyngeal carcinoma.

Hartford Hospital, Conneticut & Coriolus Vericolor PSK/PSP

What Hartford Hospital in Conneticut has to say about Coriolus Versicolor

“Currently, extracts of Coriolus versicolor called polysaccharide-K (PSK) and polysaccharopeptide (PSP) are under study as immune stimulants for use alongside chemotherapy in the treatment of cancer. These two related substances, made from slightly different strains of the fungus, are thought to act as “biological response modifiers,” meaning that they affect the body’s response to cancer.

According to most but not all reported trials, most of which were performed in Asia, both PSK and PSP can enhance the effects of various forms of standard cancer treatment. For example, in a 28-day double-blind , placebo-controlled study of 34 people with advanced non–small-cell lung cancer, use of Coriolus extracts along with conventional treatment significantly slowed the progression of the disease.

It is thought that Coriolus extracts work by stimulating the body’s own cancer-fighting cells. PSK and PSP may also have cancer-preventive effects.
In addition, very weak evidence hints that extracts of Coriolus versicolor might be helpful for HIV infection.”

(Source: www.hartfordhospital.org)