Clinical trial results show proof-of-concept for use of Coriolus versicolor as immunonutrition in HPV patients with cervical lesions.

The results of a year-long clinical trial examining the effects of mushroom supplementation in patients with Human Papillomavirus (HPV) have recently been presented. 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 intraepithelial 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 and induced clearance of the high risk subtypes 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 subtypes compared to 8.5% without supplementation.

Study Design

The year-long study was funded by Mycology Research Laboratories, Ltd. 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 (six 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 were 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 a!l 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 who did not complete the trial, one patient left the country, and three 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).

Results

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 one year, 13 of the 18 patients in the Coriolus group showed normal cervical cytology (72.5%), while only ten of the patients in the control group did (47.5%). Of the 39 patients, 22 were positive for High Risk HPV subtypes. Ten of these patients were in the Coriolus group and 12 in the control group. After one year, nine of the ten in the Coriolus group had reverted to HPV negative status (90%), while only one 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 compared with only 47.5% of the control group. Encouragingly, 90% of the Coriolus recipients reverted to a HPV negative 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's 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 reduce 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 eight 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 pesticides, heavy metals, and contaminants.

Will Mycology Research Laboratories Be Furthering This Work?

The Mycology Research Lab's Managing Director, William Ahern stated: "We realize that the study sample size is small and that taking six tablets per day may be challenging for some individuals, from a compliance viewpoint. However, Dr. Silva Couto et al. have significantly contributed to the development of a nutritional approach to HPV care that is complementary with existing HPV treatment protocols."

Further research is ongoing to determine the optimal treatment period for HPV patients. This study has proven that Coriolus versicolor supplementation has a place in the management of HPV infection. The estimated cost per day for Coriolus versicolor supplementation under this protocol would be [euro] 52.00 per month ([euro] 1.75 per day) or $80.60 per month ($2.71 per day), making Coriolus treatment a viable treatment without undue increases in the cost of therapy.

(1.) Monro JA. Chronic fatigue immune dysfunction syndrome. J Integrative Medicine. 2004;8:101-108.

(2.) Monro JA. Treatment of cancer with mushroom products. Arch Env Health. 2003;58:533-537.

For more information on the clinical study, please contact Dr. Jose Silva Couto at [e-mail]. For more information on Coriolus versicolor, please contact Dr. Jean Monro at [e-mail]; Tel: [phone], Ext 314.

For more information on Mycology Research Laboratories, please contact William Ahern at info@ mycoiogyresearch.com.