Questions and Answers About Zyflamend
What is Zyflamend?
Zyflamend is a dietary supplement that contains 10 different herbs. Zyflamend contains extracts of rosemary, turmeric, ginger, holy basil, green tea, hu zhang (Polygonum cuspidatum, a source of resveratrol), Chinese goldthread, barberry, oregano, and Baikal skullcap.
The extracts found in Zyflamend have anti-inflammatory activity and possible anticancer benefits. There is limited evidence about how Zyflamend may act against tumor growth. Zyflamend has been shown to interfere with the activity of COX-1 and COX-2 enzymes, which are involved in the development of inflammation and possibly cancer. Zyflamend may also act against the NF-kappa B and lipoxygenase (LOX) families of proteins that stimulate tumor growth.
How is Zyflamend administered or consumed?
Zyflamend is taken as a dietary supplement in capsule form.
Have any preclinical (laboratory or animal) studies
been conducted using Zyflamend?
Studies of Zyflamend in the laboratory have shown the following:
- Human prostate cancer cells treated with different doses of Zyflamend had lower androgen (male hormone) receptor and prostate-specific antigen (PSA) levels compared with cells treated with a control substance; higher doses of Zyflamend were found to be more effective. Prostate cancer cells treated with both Zyflamend and bicalutamide (a nonsteroidal antiandrogen drug) showed lower levels of cell growth, PSA, and cancer survival proteins than prostate cancer cells treated with Zyflamend or bicalutamide alone.
- A study in human prostate cancer cells found that a higher concentration of Zyflamend blocked both COX-1 and COX-2 activity; a lower concentration of Zyflamend blocked COX-2 activity but had less effect on COX-1. Zyflamend was also found to limit the growth of prostate cancer cells. However, the prostate cancer cells in the study did not have high levels of COX-2, suggesting that Zyflamend may have effects on prostate cancer cells that are not related to COX activity.
- Prostate cancer cells were treated with insulin-like growth factor -1 (IGF-1, a protein linked with increased risk of prostate cancer) alone or together with Zyflamend. Cells treated with IGF-1 alone grew and spread more, while cells treated with both IGF-1 and Zyflamend grew and spread less. Zyflamend was also shown to decrease levels of the IGF-1 receptor and androgen receptor in prostate cancer cells.
Studies of Zyflamend in animal models of cancer have shown the following:
- Mice implanted with pancreatic tumor cells received either Zyflamend or a control treatment. The mice treated with Zyflamend showed lower levels of cancer survival proteins and higher levels of anticancer activity than mice in the control group.
- Mice implanted with pancreatic tumor cells received either Zyflamend, gemcitabine, or both. Tumor cells from mice that received the combination of Zyflamend and gemcitabine showed a much greater decrease in tumor growth than tumor cells from mice that received Zyflamend or gemcitabine alone. The findings suggested that Zyflamend may have made the pancreatic tumors more sensitive to treatment with gemcitabine.
Have any clinical trials (research studies with people)
of Zyflamend been conducted?
A report of one patient with high-grade prostatic intraepithelial neoplasia (HGPIN) who received Zyflamend 3 times/ day for 18 months showed that PSA levels were not affected. However, at the end of 18 months of treatment, repeat biopsies of the prostate did not show HGPIN or cancer.
In a phase I safety study of Zyflamend, patients with HGPIN took Zyflamend (780 mg) 3 times/ day for 18 months with additional dietary supplements (probiotic supplement, multivitamin, green and white tea extract, Baikal skullcap, docosahexaenoic acid, holy basil, and turmeric). Zyflamend and the added dietary supplements were well tolerated and there were no serious side effects. At the end of 18 months of treatment, more than half of patients had benign biopsy results, about one-fourth had HGPIN, and about one in 8 had prostate cancer.
Have any side effects or risks been reported from Zyflamend?
A phase I safety study of Zyflamend (described above) reported no toxicity or serious side effects. Some of the patients had mild heartburn that went away when Zyflamend was taken with food.
Is Zyflamend approved by the U.S. Food and Drug Administration (FDA)
for use as a cancer treatment in the United States?
Zyflamend is available in the United States as a dietary supplement. Because dietary supplements are regulated as foods, not as drugs, FDA approval is not required unless specific claims about disease prevention or treatment are made.