A novel herbal extract is showing evidence that it may reverse the effects of high-grade prostatic intrÃ¦pithelial neoplasia (PIN), a known precursor to prostate cancer.
A novel herbal extract is showing evidence that it may reverse the effects of high-grade prostatic intraepithelial neoplasia (PIN), a known precursor to prostate cancer, according to recent research.
"Early clinical results in our laboratory show that Zyflamend, an herbal anti-inflammatory agent, can inhibit prostate tumor cell growth and induce cell apoptosis in the human prostate cancer cell line," said Aaron E. Katz, MD, associate professor of clinical urology and director of the Center of Holistic Urology at Columbia University Medical Center, New York. "We have identified several key molecules in which Zyflamend appears to be acting upon."
Zyflamend is comprised of 10 herbs (barberry, Chinese goldthread, ginger, green tea, holy basil, hu zhang, oregano, rosemary, Scutellaria baicalensis Georgi, and turmeric). This combination of herbs appears to inhibit both cyclooxegenase-1 and cyclooxegenase-2 enzymes, which are involved in initiating an inflammatory response. Recent studies suggest that inflammation and some cancers may be related.
Efficacy was assessed with biopsy at 6, 12, and 18 months and immunohistochemistry. Toxicity was assessed at baseline, at 3-month intervals, and at the 18-month endpoint.
Preliminary results indicated no significant toxicity in any patient. Mild dyspepsia in seven patients (24%) disappeared when the agent was consumed with food. No other significant toxicity was reported.
PSA values decreased in 13 of 26 patients (50%). Of these, the PSA values in 12 men (46%) decreased more than 10%; in seven men (27%), PSA values decreased by more than 50%. In nine men (35%), PSA increased, and the remaining four men (15%) showed no change in PSA. Of 35 biopsies from 21 patients, 31 (89%) were negative for cancer. Four adenocarcinomas were detected, all of which were Gleason 6 and were detected in 5% of all cores. The prostate returned to normal in 21 (62%) of patients.
The first patient to complete the trial was a 66-year-old man with an initial PSA of 12.0 ng/mL and multiple areas of PIN detected on biopsy.
"He was weakly staining for cyclooxygenase-2 (COX-2) at the beginning of the trial, and at 18 months, he was cyclooxegenase negative," Dr. Katz reported. "He was positive for NF-kB, a molecular switch for cancer, at the beginning of the trial, and negative for NF-kB at the end."
The patient's PSA decreased to 10.0 ng/mL. Biopsies at 6, 12, and 18 months showed no PIN and no cancer. He reported no side effects.
"These early results are extremely positive," Dr. Katz said.
"The big question is, 'Can we use an herbal approach to prevent prostate cancer?' I think preliminary results show that we can."
The phase I trial is expected to be completed later this year.