Prostavor Information Catalog

Prostavor®

Prostavor® combines a selection of ingredients to promote general prostate wellness and assist in the treatment of symptoms associated with an enlarged prostate and has been the leading Category D prostate supplement (in terms of sales) for several years. The formulation has stood the test of time having been developed in 2006 by Dr Paul Bosman.

The product has gained more exposure since after DB Pharmaceuticals acquired the product from Tara Pharmaceuticals in 2017. Since the acquisition, the amount of patient’s using Prostavor® chronically is estimated to have increased by more than 10 000.

The below summary provides an overview of the studies conducted on the ingredients contained in Prostavor®. Although the formulation is older than many of the studies the latest studies have shown what we have known all along – that our formulation is effective and has stood the test of time.

Dosage

Take 1 capsules in the morning and 1 capsule in the late afternoon/early evening with at least 300 ml of water

Ingredients

(Each capsule contains)

Beta Sitosterol 172 mg

Serenoa repens (Saw Palmetto Extract) 30 mg

Zinc Gluconate (equivalent to 10 mg elemental Zinc) 72 mg

Selenium AAC 0,2% (equivalent to 30 µg elemental Selenium) 15 mg

Vitamin D3 250 iu

Vitamin E 10 mg

Urticae folium (Nettle Leaf Powder) 25 mg

Pyridoxine HCL (Vitamin B6) 25 mg

Polygonum cuspidatum (Resveratrol Extract) 25 mg

Lycopene Extract 10% 5 mg

Cucurbita moschata (Pumpkin Seed Extract) 50 mg

Piper nigrum (Bioperine) Extract 5 mg

Terminology

Benign Prostate Hyperplasia (BPH)/ enlarged prostate

BPH refers to the nonmalignant growth of the prostate in men- BPH develops mostly in men from age 40 but studies have shown that there has been evidence op BPH in men from 30 years of age (Roehrborn, 2005). BPH is associated with lower urinary tract symptoms (Roehrborn, 2005)- some

Stinging Nettle

Stinging Nettle has been shown to have benefits such as anti-inflammatory effects, anti-viral effects, modulating of immune system and to relieve the symptoms of BPH due to compounds such as phytosterols, lignans and polysaccharides (Ghorbanibirgani, Khalili, & Zamani, 2013). In a clinical trial, 287 Benign Prostatic Hyperplasia (BPH) patients who had been treated with Stinging Nettle showed a significant reduction in IPSS (International Prostate Symptom Score), serum PSA and prostate size (Ghorbanibirgani, Khalili, & Zamani, 2013).

After this clinical trial, researchers aimed to further investigate the efficacy of stinging nettle on the reduction of symptoms of BPH- 100 patients were randomly divided into two groups of fifty and one group was given Stinging nettle and the other group a placebo (Ghorbanibirgani, Khalili, & Zamani, 2013).

The results at the end of the study showed that nettle had a better effect in relieving the symptoms of BPH and its safety in terms of side effects are well established (Ghorbanibirgani, Khalili, & Zamani, 2013). One of the most prominent benefits of stinging nettle (Urticate Folium) is its activity against BPH and urinary tract infections- studies suggest that stinging nettle contains compound that affect hormones responsible for BPH as well as activity against prostate cancer cells (Kregiel, Pawlikowska, & Antolak, 2018).

Stinging Nettle is usually used in combination with saw palmetto and studies suggest that it is a powerful combination for relieving symptoms of BPH (Kregiel, Pawlikowska, & Antolak, 2018). In a study conducted with 431 patients to compare a combination of Saw Palmetto and Stinging Nettle with the synthetic 5-alha-reductase inhibitor finasteride results showed an equivalent in efficacy for both treatments (slightly better results in voiding symptoms of Saw Palmetto and Stinging

Nettle however the safety analysis showed that more patients in the finasteride group reported adverse events than in the group treated with Saw Palmetto and Stinging Nettle (better tolerability was noted) (Sokeland, 2000).

Saw Palmetto (Serenoa Repens)

Saw Palmetto (Serenoa Repens) is a plant extract from the American dwarf palm and contain several phytosterols, including B-Sitosterol, camper sterol and stigmasterol (Buck, 2004). Clinical studies have confirmed the efficacy of saw palmetto on BPH and lower urinary tract symptoms and has indicated that saw palmetto had antiandrogenic action, anti-inflammatory effect and antiproliferative influence (Buck, 2004).

5-alpha-reductase inhibitors are a group of drugs that are used in the treatment of BPH; finasteride is one of its steroidal inhibitors (Schmidt & Tindall, 2011). A 5alpha-reductase inhibitor prevents the conversion of testosterone to dihydrotestosterone (DHT), DHT can contribute to benign prostate enlargement as well as male pattern baldness (Plosker & Brogden, 2012). Numerous studies have shown that Saw Palmetto can be an effective inhibitor of the 5alphareductase 1-receptor which shows it to be a useful alternative to Finasteride (Bayne, Donnelly, Ross, & Habib, 1999). In controlled clinical trials in men with BPH, Serenoa Repens (twice daily oral administration) was generally superior to placebos in improving symptoms and showed similar effects as finasteride (Plosker & Brogden, 2012).

Serenoa Repens has also been studied for its function in reducing inflammation and has shown to decreases the androgenic support to prostatic cell growth (Minutoli, et al., 2013). Studies have shown that a combination of Lycopene, Selenium and Serenoa Repens (saw palmetto) has a greater and enhanced antiinflammatory activity with regards to BPH, reducing prostate weight and hyperplasia, and suppressing the vascular endothelial growth factor in hyperplastic prostates (Minutoli, et al., 2013). Therefore, many studies have suggested that the combination of Lycopene, Selenium and Saw Palmetto is more effective than any single treatment in improving prostate symptoms and lower urinary tract symptoms (Morgia, et al., 2014).

Pumpkin Seed Extract (Cucurbita Moschata)

Pumpkin Seed contains many useful nutrients such as amino acids, phytosterols, unsaturated fatty acids, phenolic compounds and minerals important to healthy life and wellbeing (Dotto & Chacha, 2020). Compounds in pumpkin seeds show promising anthelmintic, antidiabetic, antidepressant, antioxidant,

Pumpkin seed has also been seen to treat lower urinary tract symptoms caused by BPH (Vahlensieck, et al., 2015). In a study of 1431 men (where half were given pumpkin seed and other half placebo) the results showed that the men with BPH after a 12 months treatment on pumpkin seed capsules showed significant reduction in symptoms of BPH (Vahlensieck, et al., 2015). In another study of 45 subjects, pumpkin seed oil extracts have shown to be an effective

Beta Sitosterol

Beta Sitosterol is one of the sterols that come from plants (Phytosterols) and have been shown to relieve symptoms of BPH and lower cholesterol levels (Saeidnia, Manayi, Gohari, & Abdollahi, 2014)In a double blind, placebo-controlled randomized comparative study results have shown a significant decrease in IPSS (International Prostate Symptom Score), AMS (Aging Male Symptoms) and ADAM ( Androgen Deficiency in the Aging Male) scores along with reduced postvoiding residual volume and PSA in patients treated with Beta sitosterol and a Saw palmetto combination (Sudeep, Thomas, & Shyamprasad, 2020).

Beta- Sitosterol has also been shown to improve urinary symptoms and flow measures caused by BPH (Wilt, et al., 2000). 519 men from 4 trials were assessed who used B-Sitosterol’s for urinary and flow restrictions caused by BPH; and from all four trials the results showed men had improvements in urinary flow measures and urinary symptoms (Wilt, et al., 2000).

Vitamin D

Some studies have suggested that a vitamin D deficiency in the male urological population may contribute to BPH (Espinosa, Esposito, Kazzazi, & Djavan, 2013). Intake of vitamin D has shown a correlation with decreased BPH prevalence and decrease prostate volume in males suffering from BPH (Espinosa, Esposito, Kazzazi, & Djavan, 2013). Laboratory and animal studies suggest that Vitamin D can inhibit carcinogenesis and slow tumour progression by promoting cell differentiation and inhibiting metastasis (Chakraborti, 2011).

Zinc

Zinc is an essential mineral required in many biochemical pathways, it is required for the catalytic activity of approximately 100 enzymes and plays a role in immune function, protein synthesis, wound healing, DNA synthesis and cell division (Roohani, Hurrell, Kelishadi, & Schulin, 2013).

Studies have also shown that BPH may be associated with a reduction in the levels of tissue zinc, plasma zinc, and an increase in urine zinc (Christudoss, Selvakumar, Fleming, & Gopalakrishnan, 2011).

Zinc has also been seen as an important component of prostatic fluid and plays an important role in the development and normal functioning of the prostate as normal prostate tissues from healthy persons collect the highest levels of zinc in the body (Christudoss, Selvakumar, Fleming, & Gopalakrishnan, 2011). Therefore, Zinc is important for overall health and wellbeing as well as for prostate health.

activity with regards to BPH, reducing prostate weight and hyperplasia, and suppressing the vascular endothelial growth factor in hyperplastic prostates (Minutoli, et al., 2013).

Therefore, many studies have suggested that the combination of Lycopene, Selenium and Saw Palmetto is more effective than any single treatment in improving prostate symptoms and lower urinary tract symptoms (Morgia, et al., 2014).

Selenium might has also shown play a role in cancer prevention through its many effects that include DNA repair, apoptosis, hormone metabolism and protection against oxidative damage (Hodgson, 2021).

Lycopene

Lycopene is a member of the carotenoid family which are essential components for all photosynthetic organisms due to its photoprotective and antioxidant properties (Ilic & Misso, 2012). Due to these properties, Lycopene can assist in treatment of BPH and in some cases prostate cancer (Ilic & Misso, 2012). Studies have shown that a combination of

Lycopene, Selenium and Serenoa Repens (saw palmetto) has a greater and enhanced anti-inflammatory activity with regards to BPH, reducing prostate weight and hyperplasia, and suppressing the vascular endothelial growth factor in hyperplastic prostates (Minutoli, et al., 2013). Therefore, many studies have suggested that the combination of Lycopene, Selenium and Saw Palmetto is more effective than any single treatment in improving prostate symptoms and lower urinary tract symptoms (Morgia, et al., 2014).

A study of 118 men to compare the relationship between plasma carotenoids, particularly lycopene, and prostate cancer risk has shown that lycopene may contribute to lower prostate cancer risk but not disease progression (Chang, et al., 2005). This means lycopene can be used prophylactically against prostate cancer. In another study the effects of lycopene were examined on oxidative damage and Prostate Specific Antigen (PSA) levels in patients already diagnosed with prostate cancer -the results of this study showed that the serum PSA concentrations decreased by 17.5% (Chen, et al., 2001).

Vitamin E

Vitamin E is a powerful antioxidant that protect the cells from the damaging effects of free radicals that if unchecked can contribute to cancer development (Dunn, Richmond, Minasian, Ryan, & Ford, 2010). Studies have suggested that when Vitamin E is used in conjunction with saw palmetto and B-Sitosterol, the combination can significantly reduce nocturia (frequent urination at night) and reduce overall symptoms of BPH (Preuss, et al., 2001).

This was established through a study where 70 patients were in the test group who took the combination and 57 in the placebo group- results showed nocturia showed a significant decrease and daytime frequency decreased (Preuss, et al., 2001). Vitamin E can also enhance the body’s immune function and reduce the risk of infection (Lewis, Meydani, & Wu, 2019).

Resveratrol Extract (Polygonum Cuspidatum)

Resveratrol is a naturally occurring polyphenol and has anti-inflammatory, anti-tumorigenic, antioxidant, anticarcinogenic, cardioprotective, Phyto estrogenic and neuroprotective properties (Ramírez-Garza, et al., 2018). Resveratrol’s very high antioxidant potential has exhibited antitumor activity and these anticancer properties have been confirmed by many in vitro and in vivo studies (Salehi, et al., 2018).

Because BPH is related to inflammation and imbalance of cell growth- studies showed that Resveratrol may decrease prostate weight and cell proliferation (Resveratrol produced an antiproliferative effect by regulating the appearance levels of proteins involved in inflammation and apoptosis during BPH) (Chung, Cheon, & An, 2015).

These ingredients together make a potent combination in assisting BPH symptoms and overall prostate health. Prostavor® combines all these benefits for a natural and effective treatment option.

References

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Buck, A. (2004). Is there a Scientific Basis for the therapeutic effects of serenoa repens in benign prostatic hyperplasia? Mechanisms of Action. The Journal of Urology, 172(5), 1792-1799. doi:10.1097/01.ju.0000140503.11467.8e

Butt, M., Pasha, I., Sultan, M., Randhawa, M., Saeed, F., & Ahmed, W. (2013). Black pepper and health claims: a comprehensive treatise. Crirical Revieews in food science and nutrition, 53(9), 875-886. doi:10.1080/10408398.2011.571799.

Chakraborti, C. (2011). Vitamin D as a promising anticancer agent. Indian Journal of Pharmacology, 43(2), 113-120. doi:10.4103/0253-7613.77335

Chang, S., Erdman, J., Clinton, S., Vadiveloo, M., Strom, S., Yamamura, Y., . . . Hursting, S. (2005). Relationship Between Plasma Carotenoids and Prostate Cancer. Nutrition and Cancer, 53(2), 127-134. doi:10.1207/s15327914nc5302_1

Chen, L., Stacewicz-Sapuntzakis, M., Duncan, C., Sharifi, R., Ghosh, L., van Breemen, R., . . . Bowen, P. (2001). Oxidative DNA Damage in Prostate Cancer Patients Consuming Tomato Sauce-Based Entrees as a Whole-Food Intervention. Journal of the National Cancer Institute, 93(24), 1872-1879. doi:10.1093/jnci/93.24.1872

Cho, Y., Lee, S. J., Choi, E., Kim, Y., Lee, J., Yi, Y., & Cha, H. (2014). Effect of Pumpkin Seed Oil on Hair Growth in Men with Androgenetic Alopecia: A Randomized, Double-Blind, Placebo-Controlled Trial. Evidence-Based Complementary and Alternative Medicine, 2014. doi:10.1155/2014/549721

Christudoss, P., Selvakumar, R., Fleming, J., & Gopalakrishnan, G. (2011). Zinc status of patients with benign prostatic hyperplasia and prostate carcinoma. Indian Journal of Urology, 27(1), 14-18. doi:10.4103/0970-1591.78405

Chung, K., Cheon, S., & An, H. (2015). Effects of Resveratrol on Benign Prostatic Hyperplasia by the Regulation of Inflammatory and Apoptotic Proteins. Journal of Natural products, 78(4), 689-694.

Dotto, J., & Chacha, J. (2020). The potential of pumpkin seeds as a functional food ingredient: A review. Scientific African, 10. doi:10.1016/j.sciaf.2020.e00575

Dunn, B., Richmond, E., Minasian, L., Ryan, A., & Ford, L. (2010). A Nutrient Approach to Prostate Cancer Prevention: The Selenium and Vitamin E Cancer Prevention Trial (SELECT). Nutrition and Cancer, 62(7), 896-918. doi:10.1080/01635581.2010.509833

Espinosa, G., Esposito, R., Kazzazi, A., & Djavan, B. (2013). Vitamin D and benign prostatic hyerplasia- a review. The Canadian Journal of Urology, 20(4), 6820-6825.

Ghorbanibirgani, A., Khalili, A., & Zamani, L. (2013). The Efficacy of Stinging Nettle (Urtica Dioica) in Patients with Benign Prostatic Hyperplasia: A Randomized DoubleBlind Study in 100 Patients. Iranian Red Crescent medical Journal, 15(1), 9-10. doi:10.5812/ircmj.2386

Hodgson, L. (2021, June 29). Selenium: What it does and how much you need. Retrieved from Medical News Today: https://www.medicalnewstoday.com/ articles/287842

Ilic, D., & Misso, M. (2012). Lycopene for the prevention and treatment of benign prostatic hyperplasia and prostate cancer: A systematic review. Maturitas, 72(4), 269-276. doi:10.1016/j.maturitas.2012.04.014

Kregiel, D., Pawlikowska, E., & Antolak, H. (2018). Urtica spp.: Ordinary Plants with Extraordinary Properties. Molecules, 23(7), 1664. doi:10.3390/molecules23071664

Lewis, E., Meydani, S., & Wu, D. (2019). Regulatory role of vitamin E in the immune system and inflammation. IUMB Life, 71(4), 487-494. doi:10.1002/iub.1976

Manayi, A., Nabavi, S., Setzer, W., & Jafari, S. (2018). Piperine as a Potential Anticancer Agent: A Review on Preclinical Studies. Current Medicinal Chemistry, 25(37), 4918-4928. doi:10.2174/0929867324666170523120656.

Minutoli, L., Bitto, A., Squadrito, F., Marini, H., Irrera, N., Morgia, G., . . . Altavilla, D. (2013). Serenoa Repens, Lycopene and Selenium: A Triple Therapeutic Approach to Manage Benign Prostatic Hyperplasia. Current Medicinal Chemistry, 20(10), 1306-1312.

Mochtar, C., Kiemeney, L., Riemsdijk, MM, Barnett, G., Laguna, M., . . . de la Rosette, J. (2003). Prostate-Specific Antigen as an Estimator of Prostate Volume in the Management of Patients with Symptomatic Benign Prostatic Hyperplasia. European Urology, 44(6), 695-700. doi:10.1016/S0302-2838(03)00384-1

Mooney, S., Leuendorf, J., Hendrickson, C., & Hellmann, H. (2009). Vitamin B6: A Long Known Compound of Surprising Complexity. Molecules, 14(1), 329-351. doi:10.3390/molecules14010329

Morgia, G., Russo, G., Voce, S., Palmieri, F., Gentile, M., Giannantoni, A., . . . Pareo, R. (2014). Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double-blinded randomized study between single or combination therapy (PROCOMB trial). The Prostate, 74(15), 1471-1480. doi:10.1002/pros.22866

Niskimura, M., Ohkawara, T., Sato, H., Takeda, H., & Nishihira, J. (2014). Pumpkin Seed Oil Extracted From Cucurbita maxima Improves Urinary Disorder in Human Overactive Bladder. Journal of Traditional and Complementary Medicine, 4(1), 7274. doi:10.4103/2225-4110.124355

Plosker, G., & Brogden, R. (2012). Serenoa repens (Permixon®): A Review of its Pharmacology and Therapeutic Efficacy in Benign Prostatic Hyperplasia. Drugs & Aging, 9, 379-395.

Preuss, H., Marcusen, C., Regan, J., Klimberg, I., Welebir, T., & Jones, W. (2001). Randomized trial of a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) on symptoms of benign prostatic hyperplasia (BPH). International Urology and Nephrology, 33, 217-225.

Ramírez-Garza, S., Laveriano-Santos, E., Marhuenda-Muñoz, M., Storniolo, C., Tresserra-Rimbau, A., Vallverdu-Queralt, A., & Lamuela-Raventos, R. (2018). Health Effects of Resveratrol: Results from Human Intervention Trials. Nutrients, 10(12), 1892. doi:10.3390/nu10121892

Roehrborn, C. (2005). Benign Prostatic Hyperplasia: An Overview. Reviews in Urology, 7(9), s3-s14.

Roohani, N., Hurrell, R., Kelishadi, R., & Schulin, R. (2013). Zinc and its importance for human health: An integrative review. Journal of Research in Medical Sciences, 18(2), 144-157.

Saeidnia, S., Manayi, A., Gohari, A., & Abdollahi, M. (2014). The Story of Betasitosterol- A Review. European Journal of Medicinal Plants, 4(5), 590-609.

Salehi, B., Mishra, A. P., Nigam, M., Sener, B., Kilic, M., Sharifi-Rad, M., . . Sharifi-Rad, J. (2018). Resveratrol: A Double-Edged Sword in Health Benefits. Biomedicines, 6(3), 91. doi:10.3390/biomedicines6030091

Schmidt, L., & Tindall, D. (2011). Steroid 5 α-reductase inhibitors targeting BPH and prostate cancer. The Journal of Steroid Biochemistry and Molecular Biology, 125(1-2), 32-38. doi:10.1016/j.jsbmb.2010.09.003

Sokeland, J. (2000). Combined sabal and urtica extract compared with finasteride in men with benign prostatic hyperplasia: analysis of prostate volume and therapeutic outcome. BJU International, 86(4), 439-442. doi:10.1046/j.1464410x.2000.00776.x.

Srinivasan, K. (2007). Black pepper and its pungent principle-piperine: a review of diverse physiological effects. Critical reviews in food science and nutrition, 47(8), 735-748. doi:10.1080/10408390601062054.

Sudeep, H., Thomas, J., & Shyamprasad, K. (2020). A double blind, placebocontrolled randomized comparative study on the efficacy of phytosterol-enriched and conventional saw palmetto oil in mitigating benign prostate hyperplasia and androgen deficiency. BMC Urology, 20(86). doi:10.1186/s12894-020-00648-9

Vahlensieck, W., Theurer, C., Pfitzer, E., Patz, B., Banik, N., & Engelmann, U. (2015). Effects of Pumpkin Seed in Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in the One-Year, Randomized, Placebo-Controlled GRANU Study. Urologia Internationalis, 94(3). doi:10.1159/000362903

Wilt, T., Ishani, A., MacDonald, R., Stark, G., Mulrow, C., & Lau, J. (2000). Betasitosterols for benign prostatic hyperplasia. The Cochrane database of systematic reviews, 1999(2). doi:10.1002/14651858.CD001043.

Quality and Product Development

DB Pharmaceuticals is a registered, Grade A certified pharmacy under the South African Pharmacy Council (SAPC) – with registration number Y60310.

We are fully compliant with the current South African Health Products Regulatory Authority (SAHPRA) and the Medicines and Related Substances Control Amendment Act, No. 19 of 1976 requirements for Category D – Complementary Medicines.

DB Pharmaceuticals welcomes SAHPRA’s approach to regulate the manufacture and sale of Complementary Medicines and Health Supplements which we believe will result in a safer, more efficient experience for patients who seek quality natural health products.

The manufacturing facility is licensed with the South African Health Products Regulatory Authority (SAHPRA) which is only granted after a positive GMP inspection by the regulator.

The manufacturing plant is further accredited by the South African Pharmacy Council as a pharmacy owner, grading certificate Grade A, and recording of a pharmacy.

Certification of the manufacturing plant also includes a Department of Health Manufacturing Pharmacy certificate and a Certificate of Acceptability for Food Premises and is registered with the South African National Department of Health.

All our products old and new have been developed by our two in-house responsible pharmacists who have 37 years of experience between them.

Once products and formulations have been researched and developed the formulation is sent to our team of specialist formulary pharmacists at the manufacturing site who review and test formulations against recent research to ensure safety, quality, and efficacy.

36 Sovereign Drive, Route 21 Corporate Park, Irene, Centurion Gauteng, South Africa 0062 info@prostavor.com www.prostavor.com Helpline: 012 111 8313