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Prostate Formula

Other Ingredients: Natural Vegetable Capsules. This product may contain one or more of the following: Calcium Silicate, Magnesium Stearate, Microcrystalline Cellulose and Silicon Dioxide. TRAACS is a registered trademark of Albion Laboratories, Inc.

SUGGESTED USE: 1-2 capsules per day or as recommended by your health care professional.

Formulated to be free of allergens derived from: Gluten, yeast, artificial colors and flavors. Contains soy. Do not consume this product if you are pregnant or nursing. Consult your physician for further information. As with all dietary supplements, some individuals may not tolerate or may be allergic to the ingredients used. Please read the ingredient panel carefully prior to ingestion. Cease taking this product and consult your physician if you have negative reactions upon ingestion.

Contraindications: Mild stomach upset or allergic reaction may occur with any herbal product. Move dose closer to meals or cease product use if symptoms persist.

DISCLAIMER: The information contained on this web site has not been evaluated by the FDA. It is not intended to treat, diagnose, cure or prevent any disease. Material on the Imupharm web site is provided for educational purposes only. Always seek the advice of your physician or other qualified health care provider with any questions you have regarding a medical condition, and before undertaking any diet, exercise or other health program.



Pygeum Africanum

Extracts of Pygeum africanum bark have been used for more than 20 years in France in men suffering from poor prostate health. (Reference 4) Pygeum extracts are known to inhibit the proliferative effects of growth factors.

In a study of the effect of Pygeum africanum extracts on the in vitro proliferation of human prostate cells, the ethanolic P. africanum extracts were shown to have an antimitogenic effect on prostate cancer cells and benign prostatic hyperplasia epithelial cells. Such effect is associated with the inhibition of the mitogenic action of EGF, and it is accompanied by a decrease of cells entering the S Phase of the cell cycle. (Reference 1) Another study examined extracts of these plants for their antiandrogenic activity using an AR responsive reporter gene assay for drug discovery. (Reference 3) A selective dichloromethane extract from the stem barks of Pygeum africanum revealed the highest antiandrogenic effect compared to Serenoa repens and Cucurbita pepo extracts. Bioactivity-directed fractionation of Pygeum extract led to the isolation of N-butylbenzenesulfonamide (NBBS) indicating that extracts of the stem bark of P. africanum harbour androgen antagonistic activity. This compound may provide a novel approach for the prevention and treatment of BPH and human PCa. (Reference 2)

Additionally, pygeum extracts antagonize the production of metabolites in the 5-Lipoxegenase pathway (pathway in the aracadonic acid inflammation pathway). (Reference 4) This activity will further reduce the inflammatory process in the prostate. Pygeum has been dosed anywhere from 50-200 mg per day in combination with other herbs for prostatic issues.

Saw Palmetto

Saw Palmetto or Serenoa repens L. (Sr) has been used extensively and for many years as the supplement of choice for poor prostate health in Europe and has been getting more and more attention here in the United States.

Saw Palmetto, by competing with both the enzyme and receptor that stimulates growth factor secretion, inhibits prostatic hyperplasia. Sr selectively induces apoptotic cell death of prostate cancer cells through the intrinsic pathway, and activation of the mitochondrial PTP might play a central role in this process. (References 5,6)

Studies have shown Saw Palmetto to increase urinary tract function, reducing symptom scores, nocturia, and improving peak urine flow rate. Published trials for treating men with benign prostatic hyperplasia showed a significant improvement in peak flow rate and reduction in nocturia above placebo, and a 5-point reduction in the IPSS. (Reference 7)

A careful assessment of a randomized clinical trial performed among 225 men with moderate-to-severe symptoms of benign prostatic hyperplasia, comparing a standardized extract of the saw palmetto berry (160 mg twice daily) with a placebo over a 1-year period, showed no evidence for serious toxicity of saw palmetto was observed in this clinical trial. (Reference 8)

Stinging Nettles:

Root extracts of stinging nettle root have been used, singly or in combination with other botanicals for poor prostate health. (Reference 9) Nettles root extracts are approved by the German government as an official treatment for BPH. Two activities have been identified in nettle root extracts that may be responsible for the activity. The first is the inhibition of prostate Na+/K+ ATPase enzymes. (Reference 10) By inhibiting this crucial enzyme, prostate cells are prevented from proliferating; and inhibiting this crucial enzyme inhibits hyperplasia. The second activity is an interference of the human sex-hormone binding globulin (SHBG). SHBG is responsible for the estradiol-induced androgen sensitive prostatic growth. (Reference 11)

The risk for adverse events during nettle root treatment is very low, as is its toxicity. (Reference 11)

Zinc:

Zinc is a homeostatically regulated essential mineral in human nutrition, but many people have insufficient zinc status due to low dietary intake. Zinc functions as an antioxidant and is involved in many critical biochemical reactions. It helps protect DNA from damage and assists in its repair. Zinc is especially important in the prostate and may protect it from early damage that could lead to cancer. (Reference 12)

The role of zinc in a wide range of cellular processes, including cell division and proliferation, immune function, and defense against free radicals, has been well established. Zinc is the most abundant trace element in cells, and increasing evidence emphasizes zinc’s important role in both genetic stability and function. For example, about 25% of the total zinc present in rat liver is found within the nuclei of cells, which also contain the DNA. Zinc is a component of chromatin, which is the stable complex of DNA and proteins in the cell’s nucleus, and also plays a role in DNA replication, transcription, and repair. Zinc is found in over 300 enzymes, including copper/zinc superoxide dismutase, which is an important antioxidant enzyme, and in several proteins involved in DNA repair. Zinc also helps to protect cellular components from oxidation and damage. Zinc deficiency can lead to immune dysfunction and impairments in growth, cognitive function, and hormonal function.

The minerals Copper and Zinc in synergy support the production of super oxide dismutase, which is an essential cellular enzyme. (Reference 12)

Selenium is an essential nonmetal trace element that has been shown to be very important for immune health. A study revealed that higher serum selenium was associated with lower prostate cancer risk. (Reference 13)



Pygeum

(1) Santa María Margalef A, Paciucci Barzanti R, Reventós Puigjaner J, Morote Robles J, Thomson Okatsu TM. [Antimitogenic effect of Pygeum africanum extracts on human prostatic cancer cell lines and explants from benign prostatic hyperplasia] [Article in Spanish]  Arch Esp Urol. 2003 May;56(4):369-78.

OBJECTIVES: To analyze the effect of Pygeum africanum extracts on the in vitro proliferation of human prostate cells. METHODS: Prostate cancer cell lines and benign prostatic hyperplasia derived epithelial cells were cultured and treated with P. africanum extracts. The effect on cell proliferation was monitored by H3-thymidine and bromodeoxyuridine uptake and flow cytometry assays. RESULTS: The incubation with P. africanum extracts, with or without addition of amino acids, significantly and in a dose-dependent manner inhibits the proliferation of prostate cancer derived cells LnCaP, PZ-HPV-7, and CA-HPV-10. In the PZ-HPV-7 cells P. africanum extracts counteract the mitogenic action of EGF and block the transition from G1 to S in the cell cycle. P. africanum extracts also exert a potent antimitogenic action on the epithelial cells derived from benign prostatic hyperplasia explants. CONCLUSION: The ethanolic P. africanum extracts have an antimitogenic effect on prostate cancer cells and benign prostatic hyperplasia epithelial cells. Such effect is associated with the inhibition of the mitogenic action of EGF, and it is accompanied by a decrease of cells entering the S Phase of the cell cycle.

(2) Schleich S, Papaioannou M, Baniahmad A, Matusch R. Extracts from Pygeum africanum and other ethnobotanical species with antiandrogenic activity. Planta Med. 2006 Jul;72(9):807-13. Epub 2006 Jun 19.

Extracts from Pygeum africanum, Serenoa repens and Cucurbita pepo are used in the treatment of benign prostatic hyperplasia (BPH) and prostate cancer (PCa). The activity of the androgen receptor (AR) is known to control growth of the prostate. Here, we examined extracts of these plants for their antiandrogenic activity using an AR responsive reporter gene assay for drug discovery. A selective dichloromethane extract from the stem barks of Pygeum africanum revealed the highest antiandrogenic effect. Bioactivity-directed fractionation of this extract led to the isolation of N-butylbenzenesulfonamide (NBBS) indicating that extracts of the stem bark of P. africanum harbour androgen antagonistic activity. This compound may provide a novel approach for the prevention and treatment of BPH and human PCa.

(3) Schleich S, Papaioannou M, Baniahmad A, Matusch R. Activity-guided isolation of an antiandrogenic compound of Pygeum africanum. Planta Med. 2006 May;72(6):547-51.

Inactivation of the androgen receptor (AR) through androgen ablation and treatment with antiandrogens is a major goal in the therapy for prostate hyperplasia and prostate cancer. Bioactivity-directed fractionation of a selective dichloromethane extract from the stem bark of Pygeum africanum led to the isolation of the antiandrogenic compound atraric acid. Its activity was examined by an androgen receptor responsive reporter gene assay. For lead structure optimization we transformed the natural occurring compound atraric acid into its ethyl, N-propyl and N-butyl esters and their antiandrogenic activities were examined as well. In addition, benzoic acid was isolated. The structures of all compounds were determined and characterized by means of 1H- and 13C-NMR, HR-EI-mass, IR and UV spectroscopy.

(4) Paubert-Braquet M, Cave A, Hocquemiller R, Delacroix D, Dupont C, Hedef N, Borgeat P. Effect of Pygeum africanum extract on A23187-stimulated production of lipoxygenase metabolites from human polymorphonuclear cells. J Lipid Mediat Cell Signal. 1994 May;9(3):285-90.

Pygeum africanum extract has been used for more than 20 years in France in patients suffering from benign prostatic hypertrophy (BPH). The extract displays anti-inflammatory activity and inhibits bladder hyperreactivity during the above conditions. However, the mechanism of action of P. africanum extract has never been clearly resolved. It has been recently demonstrated that infiltration by inflammatory cells may be involved in the development of BPH. Certain of these cell types, such as macrophages, are known to produce chemotactic mediators including leukotrienes, and thus may contribute to the development of the disease. In order to investigate the potential effect of P. africanum extract on arachidonate metabolism, we examined its effect in vitro on leukotriene (LT) synthesis in human polymorphonuclear cells stimulated with the calcium ionophore A23187. Two formulations of the extract were tested, one dissolved in DMSO and one aqueous solution obtained after alkalinization (0.1 N; NaOH/acidification (0.1 N; HCl). Neither formulation had any effect on cell viability which was above 95% in both cases. P. africanum extract dissolved in DMSO significantly inhibited the production of 5-lipoxygenase metabolites (5-HETE, 20-COOH LTB4, LTB4 and 20-OH LTB4) at concentrations as low as 3 micrograms/ml (p < 0.01), while the same extract dissolved in NaOH/HCl only exhibited an inhibitory effect at 10 micrograms/ml (p < 0.01). This difference apparently reflects the greater solubility of the active components in the extract in DMSO. The ability of P. africanum to antagonize 5-lipoxygenase metabolite production may contribute, at least in part, to its therapeutic activity in inflammatory component of BPH.

Saw Palmetto

(5) Baron A, Mancini M, Caldwell E, Cabrelle A, Bernardi P, Pagano F. Serenoa repens extract targets mitochondria and activates the intrinsic apoptotic pathway in human prostate cancer cells. BJU Int. 2009 Jan 12. [Epub ahead of print]

OBJECTIVE To investigate the effects of Serenoa repens extract (Sr) in human PC3 and LNCaP prostate cancer and MCF7 breast cancer cells, with specific emphasis on the role of the mitochondrial apoptotic pathway, as the molecular pathway through which Sr, a natural product of plant origin, induces death of prostate cancer cells in culture is still unknown. MATERIAL AND METHODS Cellular and mitochondrial structure and function, and the cell cycle, were analysed using light, electron and fluorescence microscopy, spectrophotometry and flow cytometry. Apoptosis was evaluated using biochemical and cytohistochemical methods. RESULTS Cells treated with Sr underwent massive vacuolization and cytosolic condensation, followed by cell death only in the prostate lines. Within minutes of adding Sr to prostate cells, it caused opening of the permeability transition pore (PTP), which led to complete mitochondrial depolarization within 2 h, and to the appearance of small, pycnotic mitochondria. Release of cytochrome c and SMAC/Diablo to the cytosol was detectable after 4 h of treatment, while caspase 9 activation and poly(ADP-ribose) polymerase 1 cleavage occurred at 16 h, followed by appearance of a sub-G1 peak and apoptosis at 24 h. CONCLUSION Sr selectively induces apoptotic cell death of prostate cancer cells through the intrinsic pathway, and activation of the mitochondrial PTP might play a central role in this process.

(6) Yang Y, Ikezoe T, Zheng Z, Taguchi H, Koeffler HP, Zhu WG.  Saw Palmetto induces growth arrest and apoptosis of androgen-dependent prostate cancer LNCaP cells via inactivation of STAT 3 and androgen receptor signaling. Int J Oncol. 2007 Sep;31(3):593-600.

PC-SPES is an eight-herb mixture that has an activity against prostate cancer. Recently, we purified Saw Palmetto (Serenoa repens) from PC-SPES and found that Saw Palmetto induced growth arrest of prostate cancer LNCaP, DU145, and PC3 cells with ED50s of approximately 2.0, 2.6, and 3.3 microl/ml, respectively, as measured by mitochondrial-dependent conversion of the the 3-(4, 5-dimethylthiazol-2-yl)-2, 5-diphenyltetrazolium bromide (MTT) assay. Saw Palmetto induced apoptosis of LNCaP cells in a time- and dose-dependent manner as measured by TUNEL assays. Also, Saw Palmetto increased the expression of p21waf1 and p53 protein in LNCaP cells. In addition, we found that Saw Palmetto down-regulated DHT- or IL-6-induced expression of prostate specific antigen in conjunction with down-regulation of the level of androgen receptor in the nucleus as measured by Western blot analysis. Moreover, Saw Palmetto down-regulated the IL-6-induced level of the phosphorylated form of STAT 3 in LNCaP cells. Furthermore, Saw Palmetto inhibited the growth of LNCaP cells present as tumor xenografts in BALB/c nude mice without adverse effect. These results indicate that Saw Palmetto might be useful for the treatment of individuals with prostate cancer.

(7) Boyle P, Robertson C, Lowe F, Roehrborn C. Updated meta-analysis of clinical trials of Serenoa repens extract in the treatment of symptomatic benign prostatic hyperplasia. BJU Int. 2004 Apr;93(6):751-6.

OBJECTIVES: To determine, by analysing all available clinical trial data, the clinical efficacy against placebo of an extract from the fruit of the American dwarf palm tree, Serenoa repens (Permixon, Pierre Fabre Médicament, Castres, France), as there is controversy about the use of phytotherapeutic agents in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). METHODS: All clinical trial data published on Permixon, comprising 14 randomized clinical trials and three open-label trials, involving 4280 patients, were analysed. These trials were of different size (22-1100 patients) and duration (21-720 days). The peak urinary flow rate and nocturia were the two common endpoints. The statistical analysis was based on a random-effects meta-analysis. RESULTS: Permixon was associated with a mean (sem) reduction in the International Prostate Symptom Score (IPSS) of 4.78 (0.41). The mean placebo effect on peak urinary flow rate was an increase of 1.20 (0.49) mL/s. The estimated effect of Permixon was a further increase of 1.02 (0.50) mL/s (P = 0.042). Placebo was associated with a reduction in the mean number of nocturnal voids of 0.63 (0.14); there was a further reduction attributable to Permixon of 0.38 (0.07) (P < 0.001). There was some heterogeneity among the studies for nocturia; one over 2 years involving 396 patients and showing no difference between placebo and Permixon had a large effect on the results. CONCLUSIONS: This meta-analysis of all available published trials of Permixon for treating men with BPH showed a significant improvement in peak flow rate and reduction in nocturia above placebo, and a 5-point reduction in the IPSS.

(8) Avins AL, Bent S, Staccone S, Badua E, Padula A, Goldberg H, Neuhaus J, Hudes E, Shinohara K, Kane C. A detailed safety assessment of a saw palmetto extract. Complement Ther Med. 2008 Jun;16(3):147-54. Epub 2008 Feb 20.

BACKGROUND: Saw palmetto is commonly used by men for lower-urinary tract symptoms. Despite its widespread use, very little is known about the potential toxicity of this dietary supplement. METHODS: The Saw palmetto for Treatment of Enlarged Prostates (STEP) study was a randomized clinical trial performed among 225 men with moderate-to-severe symptoms of benign prostatic hyperplasia, comparing a standardized extract of the saw palmetto berry (160 mg twice daily) with a placebo over a 1-year period. As part of this study, detailed data were collected on serious and non-serious adverse events, sexual functioning, and laboratory tests of blood and urine. Between-group differences were assessed with mixed-effects regression models. RESULTS: There were no significant differences observed between the saw palmetto and placebo-allocated participants in the risk of suffering at least one serious adverse event (5.4% vs. 9.7%, respectively; p=0.31) or non-serious symptomatic adverse event (34.8% vs. 30.1%, p=0.48). There were few significant between-group differences in sexual functioning or for most laboratory analyses, with only small differences observed in changes over time in total bilirubin (p=0.001), potassium (p=0.03), and the incidence of glycosuria (0% in the saw palmetto group vs. 3.7% in the placebo group, p=0.05). CONCLUSIONS: Despite careful assessment, no evidence for serious toxicity of saw palmetto was observed in this clinical trial. Given the sample size and length of this study, however, these data do not rule out potential rare adverse effects associated with the use of saw palmetto.

Stinging Nettles

(9) Safarinejad MR. Urtica dioica for treatment of benign prostatic hyperplasia: a prospective, randomized, double-blind, placebo-controlled, crossover study. J Herb Pharmacother. 2005;5(4):1-11.

PURPOSE: To determine the effects of therapy with Urtica dioica for symptomatic relief of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). MATERIAL AND METHODS: A 6-month, double-blind, placebo-controlled, randomized, partial crossover, comparative trial of Urtica dioica with placebo in 620 patients was conducted. Patients were evaluated using the International Prostate Symptom Score (IPSS), the maximum urinary flow rate (Qmax), postvoid residual urine volume (PVR), Serum Prostatic- Specific Antigen (PSA), testosterone levels, and prostate size. At the end of 6-month trial, unblinding revealed that patients who initially received the placebo were switched to Urtica dioica. Both groups continued the medication up to 18 months. RESULTS: 558 patients (90%) completed the study (287/305, 91% in the Urtica dioica group, and 271/315, 86% in the placebo group). By intention- to-treat analysis, at the end of 6-month trial, 232 (81%) of 287 patients in the Urtica dioica group reported improved LUTS compared with 43 (16%) of 271 patients in the placebo group (P < 0.001). Both IPSS and Qmax showed greater improvement with drug than with placebo. The IPSS went from 19.8 down to 11.8 with Urtica dioica and from 19.2 to 17.7 with placebo (P = 0.002). Peak flow rates improved by 3.4 mL/s for placebo recipients and by 8.2 mL/s for treated patients (P < 0.05). In Urtica dioica group, PVR decreased from an initial value of 73 to 36 mL (P < 0.05). No appreciable change was seen in the placebo group. Serum PSA and testosterone levels were unchanged in both groups. A modest decrease in prostate size as measured by transrectal ultrasonography (TRUS) was seen in Urtica dioica group (from 40.1 cc initially to 36.3 cc; P < 0.001). There was no change in the prostate volume at the end of study with placebo. At 18-month follow-up, only patients who continued therapy, had a favorable treatment variables value. No side effects were identified in either group. CONCLUSION: In the present study, Urtica dioica have beneficial effects in the treatment of symptomatic BPH. Further clinical trials should be conducted to confirm these results before concluding that Urtica dioica is effective.

(10) Hirano T, Homma M, Oka K. Effects of stinging nettle root extracts and their steroidal components on the Na+,K(+)-ATPase of the benign prostatic hyperplasia. Planta Med. 1994 Feb;60(1):30-3.

The effects of organic-solvent extracts of Urtica dioica (Urticaceae) on the Na+,K(+)-ATPase of the tissue of benign prostatic hyperplasia (BPH) were investigated. The membrane Na+,K(+)-ATPase fraction was prepared from a patient with BPH by a differential centrifugation of the tissue homogenate. The enzyme activity was inhibited by 10(-4)-10(-5) M of ouabain. The hexane extract, the ether extract, the ethyl acetate extract, and the butanol extract of the roots caused 27.6-81.5% inhibition of the enzyme activity at 0.1 mg/ml. In addition, a column extraction of stinging nettle roots using benzene as an eluent afforded efficient enzyme inhibiting activity. Steroidal components in stinging nettle roots, such as stigmast-4-en-3-one, stigmasterol, and campesterol inhibited the enzyme activity by 23.0-67.0% at concentrations ranging from 10(-3)-10(-6) M. These results suggest that some hydrophobic constituents such as steroids in the stinging nettle roots inhibited the membrane Na+,K(+)-ATPase activity of the prostate, which may subsequently suppress prostate-cell metabolism and growth.

(11) Chrubasik JE, Roufogalis BD, Wagner H, Chrubasik S. A comprehensive review on the stinging nettle effect and efficacy profiles. Part II: urticae radix. Phytomedicine. 2007 Aug;14(7-8):568-79. Epub 2007 May 16.

Nettle root is recommended for complaints associated with benign prostatic hyperplasia (BPH). We therefore conducted a comprehensive review of the literature to summarise the pharmacological and clinical effects of this plant material. Only a few components of the active principle have been identified and the mechanism of action is still unclear. It seems likely that sex hormone binding globulin (SHBG), aromatase, epidermal growth factor and prostate steroid membrane receptors are involved in the anti-prostatic effect, but less likely that 5alpha-reductase or androgen receptors are involved. Extract and a polysaccharide fraction were shown to exert anti-inflammatory activity. A proprietary methanolic nettle root extract and particular fractions inhibited cell proliferation. Isolated lectins (UDA) were shown to be promising immunomodulatory agents, having also anti-viral and fungistatic effects. However, despite these in vitro studies it is unclear whether the in-vitro or animal data are a surrogate for clinical effects. The clinical evidence of effectiveness for nettle root in the treatment of BPH is based on many open studies. A small number of randomised controlled studies indicate that a proprietary methanolic extract is effective in improving BPH complaints. However, the significance and magnitude of the effect remains to be established in further confirmatory studies before nettle root treatment may be accepted in the guidelines for BPH treatment. The risk for adverse events during nettle root treatment is very low, as is its toxicity. Pre-clinical safety data remain to be completed.

(12) Emily Ho, Ph.D., Michelle Yan. Zinc and Prostate Cancer. Linus Pauling Institute Spring/Summer 2005 Research Report [http://lpi.oregonstate.edu/ss05/zinc.html]

(13) Selenium and Multivitamins Improve Prostate Health

Men who consume selenium and multivitamin supplements have a reduced risk of developing prostate cancer, a new study has found.

Past studies have indicated that selenium is a potential chemopreventive agent against prostate cancer, whose chemoprotective effects are possibly mediated through the antioxidative properties of selenoenzymes. It is not known, however, if there are additive effects of combining other antioxidants with selenium and what effect this has on oxidative stressors, such as smoking.

In the current study, researchers investigated the association between serum selenium and prostate cancer risk and examined interactions with other antioxidants and tobacco use. In a case-control study that included subjects from the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial, researchers collected serum selenium and compared samples between 724 incident prostate cancer case subjects and 879 controls. The men were followed for up to 8 years.

Overall, serum selenium was not associated with prostate cancer risk. However, higher serum selenium was associated with lower prostate cancer risk in men reporting a high (more than 28 IU per day) vitamin E intake. A lower prostate cancer risk also occurred in men with high selenium concentrations who also consumed a multivitamin. High selenium concentrations combined with multivitamins resulted in a roughly 40 percent reduction in prostate cancer risk. Furthermore, among smokers, high serum selenium concentrations were related to reduced prostate cancer risk.

The researchers concluded that greater concentrations of selenium were associated with reduced prostate cancer risk in men who reported a high intake of vitamin E, in multivitamin users, and in smokers.

Reference:
Peters U, Foster CB, Chatterjee N, Schatzkin A, Reding D, Andriole GL, Crawford ED, Sturup S, Chanock SJ, Hayes RB. Serum selenium and risk of prostate cancer-a nested case-control study. Am J Clin Nutr. 2007 Jan;85(1):209-17.