NEW YORK, Sep 20, 2004 /PRNewswire via COMTEX/ -- Columbia University Medical Center has launched the first clinical trial of a possible herbal preventative for prostate cancer. The Phase I study will determine whether Zyflamend(R), an herbal supplement commonly used as an anti-inflammatory, can prevent prostate cancer in patients with prostatic intraepithelial neoplasia (PIN).
PIN is a clinical precursor for prostate cancer. Without intervention, men diagnosed with PIN have a 50 to 70 percent likelihood of developing prostate cancer. Although there are tools that detect the early signs of prostate cancer, such as PIN or elevated prostate specific antigen (PSA) levels, there is no consensus as to the optimal therapy for these patients.
"Zyflamend has shown an ability, in vitro, to reduce prostate cancer cell proliferation by as much as 78 percent and to induce cancer cell death or apoptosis," says Aaron E. Katz, M.D., associate professor of urology at Columbia University College of Physicians and Surgeons, Director of the Center of Holistic Urology at Columbia University Medical Center and principal investigator of the study. "These results are exceptionally promising and have led us to initiate this clinical trial."
The herbal supplement, made by New Chapter, Inc., is composed of 10 herbs which inhibit the cyclooxygenase-2 (COX-2) inflammation pathway. Long-term chronic inflammation contributes to carcinogenesis in many organ systems (the origin of certain cancers); inhibiting this pathway appears to be key to preventing cancers like prostate and colon cancer. An herbal supplement such as this herbal supplement may inhibit this pathway without causing the adverse gastrointestinal side effects associated with the long-term use of other COX-2 inhibitors. The preparation of this herbal supplement differs from many herbal products in that it is not standardized to isolated chemicals. It delivers herbs in concentrated form, but the herbs retain their "food" status.
"We know more people are using herbal supplements as either their primary treatment or in tandem with their prescribed therapies, which is why it is important to study the safety and efficacy of herbal therapies," said Mark Blumenthal, founder and executive director of the non-profit American Botanical Council. "This study is an important step in a new direction for therapy in this area and holds much promise for millions of men with challenges in prostate health."
The Phase I study will evaluate the safety and tolerability of the herbal supplement in patients with PIN. Up to 48 men, between the ages of 40-75, will receive the herbal supplement three times a day for 18 months.
PIN and Prostate Cancer
PIN means that the top layer of cells or epithelial cells of the prostate are dividing more rapidly than normal epithelial cells. This development of pre-cancerous, abnormal tissue of the prostate gland puts men at high risk of developing prostate cancer.
Prostate cancer is a group of cancerous cells (a malignant tumor) that begins most often in the outer part of the prostate. It is the most common type of cancer (excluding skin cancer) diagnosed in American men. In 2003, an estimated 220,900 new cases of prostate cancer were diagnosed in the United States.
The Herbal Supplement
Zyflamend includes rosemary, turmeric, ginger, holy basil, green tea, hu zhang, Chinese goldthread, barberry, oregano, and Baikal skullcap.
Located in New York City, Columbia University Medical Center provides international leadership in basic and clinical research, medical education, and health care. The medical center includes the dedicated work of many physicians, scientists, and other health professionals at the College of Physicians & Surgeons, the School of Dental & Oral Surgery, the School of Nursing, the Mailman School of Public Health, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. The pioneering tradition of Columbia University health scientists, who have achieved some of the 20th century's most significant medical breakthroughs, continues today.
Columbia University Medical Center