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Coriolus MRL-Clinical Development

Background and Clinical Development History - Coriolus versicolor

PSK (Krestin) is a extract of Coriolus versicolor developed by Kureha Chemical Industry Company and licensed to Sankyo Pharmaceuticals Ltd  in the 1980s for use as adjunct immunotherapy for cancer patients undergoing chemotherapy and radiotherapy. 

Coriolus-MRL

Mycology Research Laboratories Ltd was founded in the United Kingdom in 1997 to market the use of mushroom nutrition in both human and animal health. As with Traditional Chinese Medicine, MRL seeks to promote the use of mushroom nutrition in a preventative health application; more specifically MRL products should be used in conditions where a ‘virus’ has been identified with the use of mushroom nutrition to raise the immune state of the patient to fight the virus, so as to prevent a more serious condition, such as cancer.  

Clinical Research 1997-1999

With this focus in mind, MRL spent two years supplying Coriolus-MRL to twenty health care providers and assembled their clinical conclusions. As a result of this effort, two posters were presented at the 10^th International Congress of Mucosal Immunology in July, 1999 in Amsterdam, the Netherlands.

The Effectiveness of Coriolus versicolor in the Treatment of Secondary Phenomena Associated with HIV-Dra. G. Rotolo, Pavia, Italy

In this ‘curiosity’, three patients with low white blood count (WBC) were given Coriolus-MRL  (3,0 g per day-6 tablets -3 tablets in morning and 3 tablets in evening prior meals ) for 14 days and then (1,5 g per day-3 tablets in morning) for 30 days with a resulting increase in WBC of 45% in 45 days (section B).  

The Effectiveness of Coriolus versicolor Supplementation in the Treatment of Karposi Sarcoma
in HIV+ patients-J. Tindall and E. Clegg-Gateway Clinic, Community Health, South London,
NHS Trust 108 Landor Road, London UK.

Three AIDS patients, over the age of 35 years, with CD4 levels below 250 and suffering from Karposi sarcoma skin lesions were provided 3 g of Coriolus-MRL for a month before moving to 6 g or  9 g per day for four months.  Over a span of 6 months, the patients demonstrated increased CD4 levels and decreasing PCR viral levels to such a extent that there was a remission in Karposi sarcoma. However, once the supplementation ceased, the Karposi sarcoma returned (section C).

Research 2001

In 2000, MRL conducted a observational study on the impact of Coriolus-MRL supplementation (using the Rotolo Protocol) in eight Dutch HIV+ patients with poor CD4 levels and high viral load. The results after one year were:

• The supplementation level of 3,0 g per day for 14 days followed by 1,5 g was sufficient to increase CD4 levels and decrease viral loads in the patient group that had not been on ‘triple therapy’;
• Those patients previously on ‘triple therapy’ had to stay with 3 ,0 g per day throughout the study to have any increase in CD4 levels;
• Patients who had to take large spectrum antibiotics should cease using Coriolus-MRL supplemention as the product was not absorbed by the gastrointestinal system;
• One HIV patient with a PAP smear score of “3” reverted to a normal reading of “1” after one year.

The results of this study were published in the following publication (section D): 

The Clinical Use of Coriolus versicolor Supplementation in HIV+ Patients and Impact on CD4 Count and Viral Load-M. Pfeiffer. Mycology News, Edition5, page 4 - 7. March 2001.

Note

MRL decided not to promote Coriolus-MRL as a supplementation for HIV+ patients as there were various pharmaceutical treatment options. Instead, MRL focused on ‘niche’ syndromes where the pharmaceutical options were non-existent.  However, the experienced gained in the use of Coriolus-MRL in the HIV+ patient population was essential for the development of supplementation protocols.

Research 2002

In 2001 Dr Jean Monro, Founder of the Breakspear Clinic initiated a study on the use of Coriolus-MRL in 36 patients with Chronic Fatigue Syndrome (CFS).  The patients ranged from 17 years to 83 years with the female: male ratio of 2:1.

Most patients with CFS experience extreme fatigue with the following symptoms:

1. High viral levels of Herpes Simplex 6 (HHV6), Cytomegalovirus (CMV) and Epstein Barr Virus (EBV)); 
2. Low Natural Killer Cell Activity.

The CFS condition is poorly diagnosed; leading medical doctors to prescribe anti-depressants as opposed to addressing the underlying cause of the syndrome.

The study design was based on the Rotolo Protocol over eight (8) weeks and the results were the following:

1. Natural Killer Cells - before treatment the average NK cell level was 129.64/mm3. After treatment this had increased to 175/mm3, an increase of 35%;
2. T cells (CD3+CD26) - there was increased activation in 66% of patients.

Conclusion

Supplementation with Coriolus-MRL shows improvements in both immune parameters and viral levels, indicating that it has the potential to play a significant role in the treatment of CFIDS and other chronic viral conditions.

The results of this study were published in the following three  publications (sections E, F and G): 

• The Use of Coriolus versicolor Supplementation in Chronic Fatigue Syndrome (CFS) Patients-J. Monro, Mycology News 8: pages 6-7. February 2004.
• Coriolus-Monro, J, J Integrative Medicine 8:101-108. 2004.
• Treatment of Cancer with Mushroom Products, J Monro; Archives of Environmental Health Vol.56 (No 8). August 2003. 

Research 2003-2006

In 2002 MRL supplied the powdered form of Coriolus-MRL to Dr Julian Kenyon, Founder of the Dove Clinic (UK), who conducted an observational study on the use of Coriolus in supplementation in 30 cancer patients with Stage III and Stage IV.

Dr Kenyon´s supplementation schedule was 4,5 g / day for the first month and increased to 9,0 g /day for the second month before moving to 13,5 g/ day in the third month (and subsequent two months).  Dr Kenyon measured changes in telomerase, interleukin 5, interleukin 12 (both at gene expression level), and tumor necrosis factor beta, with recordings at day 0, 60 and 120.

The summary results were the following:   

Conclusion

This observational study on the use of Coriolus versicolor shows that there appears to be a differentiating effect on cancer cells by lowering telomerase activity and encouragement of an immune function move towards a cell mediated TH1 immune response.

The study was published in the following journal (section H).

Observational Non-Controlled Study of the Use of Coriolus versicolor Supplementation in 30 Cancer Patients-Dr. J Kenyon. Mycology News: page 2-4. March 2003.

In September of 2006, MRL organized a medical conference entitled HPV and Cervical Cancer: New Developments chaired by Jack Cuzick, a leading epidemiologists on HPV. The purpose of the conference was to provide the UK medical community with information on the initial results of a study in HPV as well as the potential benefits of the enzymes provided by  Coriolus-MRL supplementation. A DVD copy of the presentations is provided with this dossier.

MRL clinical research with Coriolus-MRL also extended to the investigation on the use of Coriolus versicolor  in small animals and horses. Again after a series of case studies were collated and analyzed, both Professor Tito Fernandes and Professor Amin Karmali presented a poster presentation at a major European small animal conference in Nantes France on October 4^th, 2006. The poster title is entitled (see section I ):

Karmali A and Fernandes TH. Cancer Prevention with Supplementation of Diets with Botanicals ESCVN/ECVCN. Nantes, France. 5-7 Oct 2006.

Research 2006-2008

In 2004, Dr Jose Silva Couto of the Portuguese Institute of Oncology in Coimbra Portugal initiated a study to determine whether Coriolus-MRL supplementation (3,0 g per day-6 tablets (3 tablets in morning and 3 tablets in evening)) could assist HPV-LSIL patients in reducing both cervical lesions and viral load in such patients. There are 40 different HPV sub-types virus, of which 8 sub-types are responsible for causing cervical cancer.

Cervical cancer takes the form of skin changes in the cervix in which the initial stage is called LSIL (low-grade squamous intraepithelial lesions) and in advanced, called HSIL (high-grade squamous intraepithelial lesions). If left untreated the condition can lead to a hysterectomy or death. HPV diagnosis is determined by undergoing a PAP smear test conducted under medical supervision.    

As the normal progress of cervical cancer takes between 10 to 15 years, medical doctors have noted that in the initial phase (LSIL), some patients have been able to revert a normal stage due to the strength of their immune system to address the HPV infection directly. This has lead medical doctors to take a ‘wait and see’ approach upon diagnosing a LSIL HPV patient.

However, in women over the age of 35 who smoke and/ or take oral contraceptives, their immune system may be compromised due to these factors along with the normal stress of every day life, rendering a ‘wait and see’ approach as a less effective treatment option.

With this situation in mind, Dr Silva Couto and Dr Pereira da Silva from the Portuguese Institute of Oncology in Coimbra Portugal initiated the following study with Coriolus-MRL in LSIL HPV patients. The study was approved by the ethics committee of the Institute of Oncology in Coimbra in 2005.   

Two patient groups of forty-three (43) LSIL patients were randomly divided into two groups after confirming their LSIL status with by (cytology, colposcopy and biopsy).

One group (22 patients) received supplementation with Coriolus-MRL for 1 year -3 g/day (6 tablets -3 tablets in morning and 3 tablets in evening with meals). The Control group (21 patients), did not receive any supplementation.

All patients submitted to colposcopy, biopsy and HPV typification (hyprid capture) at the first observation. These tests confirmed both LSIL status and viral load. Four months after the first observation, all patients were once again evaluated performing colposcopy and cervical cytology. At the same time there was an evaluation of possible side effects from Coriolus supplementation. After one year, all patients were examined for the third time (colopscopy, cervical cytology and HPV typification).

The efficacy of Coriolus supplementation in LSIL patients was evaluated considering the evolution of HPV typification (from HPV+ to HPV- status) as well as the persistence of the cervical lesions (persistence measured by colposcopy and cytology LSIL) both over the course of the study period. Of the 43 patients, 39 completed the trial. Of the four (4) who did not complete the trial, 1 patient left the country, and 3 left due to side-effects (gastric pain (1 patient), diarrhea (1 patient), and nausea (1 patient)). 

Results

Of the 39 patients who completed the study, 22 patients were HPV+ in high risk category. In the study population the original 22 patients was reduced to 18 patients due to 4 drop outs. The Control group remained at 21 patients.

Of the 18 patients who took Coriolus-MRL supplementation, 13 (72,5%) still showed normal cervical cytology after one year follow up.

Of the 22 patients in the Control group, 10 (47,5%) still showed normal cervical cytology after one year of follow-up.

Regarding HPV typification, from the 10 patients who had HPV+ High Risk and took Coriolus-MRL supplementation, 9 (90%) reverted to HPV- status, after one year. On the other hand, of the 12 High Risk status patients in the Control group who did not take Coriolus-MRL supplementation only 1 (8,5%) reverted to HPV- status.   

Conclusion

The use of Coriolus versicolor for 1 year revealed a great efficacy, whether in the regression of the dysplasia (LSIL), or in the disappearance of the High Risk HPV. It seems therefore, to be a very useful food supplementation with positive therapeutic impact, either in the reversion of LSIL (with High Risk HPV+), or in those HSIL patients, who have undergone surgery but experience continued High Risk HPV viral count.

The resulting poster was presented in March of 2008 (section J)

Evaluation of the Efficacy of Coriolus versicolor Supplementation in HPV Lesions (LSIL)-J. Silva Couto, D. Pereira da Silva-Gynaecology Department Cervical Pathology Unit, Portuguese Institute of Oncology, Coimbra, Portugal. Presented at the 20^th European Congress of Obstetrics and Gynaecology and the 19^th Portuguese Congress of Obstetrics and Gynaecology in Lisbon Conference Center Lisbon, Portugal. March 4-8 2008.

After a few years of additional clinical observation, Dr Couto and Dr Salgueiro made the following conclusion on Coriolus-MRL in HPV patients with the following poster conclusion presented in July of 2011.

Conclusion

The use of Coriolus versicolor for 1 year revealed a great efficacy, whether in the regression of the dysplasia of Low-grade Squamous Intraepithelial (LSIL), or in the disappearance of the High Risk HPV. It seems therefore to be a very useful food supplementation with positive therapeutic impact, either in the reversion of LSIL (with High Risk HPV+), or in those HSIL patients, who have undergone surgery but experience continued High Risk HPV viral count (section K).

Evaluation of the Efficacy of Coriolus versicolor in the Treatment of HPV Lesions (LSIL)-J. Silva Couto, L. Salgueiro. Presented at the 14^th World Congress of Cervical Pathology and Colposcopy-IFCPC. Rio de Janeiro, Brasil. July 4-7, 2011.

Research 2008-2012 

As a follow-up to Dr. Silva Couto´s work with Coriolus-MRL in HPV patients, Dr. Stoyan Borisov from the University Hospital of Obstetrics and Gynaecology, “Machin dom” in Sofia, Bulgaria did follow up work that resulted in the publication of three PubMed papers on the use of Coriolus-MRL in HPV patients (section L):

Akush Ginekol (Sofiia).47 Suppl 3:51-3. [Coriolus versicolor - innovation in prevention of oncogynecological diseases, especially HPV]. [Article in Bulgarian] Bogdanova J. 2008.

Abstract: Coriolus-MRL is a nutrient adjuvant, which contains biomass of the fungus Coriolus versicolor and is studied to reverse early stages of cervical cancer and to reduce risk factors of reoccurring HPV virus. PMID:19449722.

[PubMed - indexed for MEDLINE]

Akush Ginekol (Sofiia). 48 Suppl 2:31.[Coriolus-MRL-a new addition to the arsenal for complex treatment of oncogynecological diseases]. [Article in Bulgarian] Borisov S. PMID: 20380095 [PubMed - indexed for MEDLINE]. 2009.

Akush Ginekol (Sofiia). 48 Suppl 1:18. [Coriolus-MRL-a new addition to the arsenal for complex treatment of oncogynecological diseases]. [Article in Bulgarian] Trifonov G. PMID: 20383927 [PubMed - indexed for MEDLINE]. 2009.

In 2012, Dr Borisov published a new assessment study with HPV patients using Coriolus-MRL supplementation with the following study design and results:

One hundred patients (100), aged 16 to 50 years old, positive for low risk (4 patients) and high-risk HPV subtypes (96 patients). The group was divided into two subgroups:

One group of 73 patients were givien Coriolus-MRL (3 g per day) for a period of 6 months. The remaining 27 patients were subjected to a combined Coriolus-MRL supplementation (3 g per day) along with surgical intervention. Patient status was determined by cervical cytology exams and HPV typification. Colposcopy was performed in 53 patients and 51% of them were subjected to biopsy as well.

Results

Of the 73 patients with Coriolus-MRL supplementation; 62 patients (88,9%) became HPV negative after six months.

Of the 27 patients who had both Coriolus-MRL supplementation and surgical intervention; 25 patients (93%) were HPV negative after six months.  

This study was published in the Clinical Journal of Mycology (section M):

Dr S. Borisov. Coriolus versicolor-Assessment of the Effects on Patients Infected with Low-risk and High-risk HPV Subtypes. Clinical Journal of Mycology: 2-4. January 2012.