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Protocol development in integrative medicine is not typically a simple process. Individuals require individualized care, and what works for one patient may not work for another.

To establish these protocols, we first developed a Rating Scale that could be used to discern the rigor of evidence supporting a specific nutrient’s therapeutic effect.

The following protocols were developed using only A through C-quality evidence.

Class
Qualifying studies
Minimum requirements
A
Systematic review or meta-analysis of human trials
 
B
RDBPC human trials
2+ studies and/or 1 study with 50 + subjects
C
RDBPC human trials
1 study

As men age, it is important to address common health concerns such as lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH). BPH has been cited to affect up to 50% of men aged 51-60, and up to 70% in men aged 61-70. (11) Although it may seem natural to associate LUTS and BPH with prostate cancer, there is currently no direct link between the two. (11) However, prostate cancer is the second most common cancer affecting men. (19) Due to the nature of prostate cancer, risk also increases with each decade of age, similar to BPH. (1)

Men over the age of 50, in particular, should consider screening. A preventative regime may be suggested for those at higher risk. There are a variety of mechanisms to support the prostate and prevent symptomatic problems. Addressing inflammatory status, optimizing function, and downregulating problematic gene expression have shown promising outcomes. If symptoms are already present, slowing the progression of BPH or prostate enlargement helps to ameliorate symptoms. 

The ingredients provided below represent research findings that demonstrate efficacy in improvements and prevention of symptoms associated with the prostate.

Saw palmetto (Serenoa repens)

320-960 mg, total per day, minimum 3 to 5.5 months (7)(22)

  • Decrease in inflammatory markers that contribute to the evolution of chronic prostatic inflammation and subsequent hyperplasia (22)
  • Saw palmetto supplementation resulted in an increase in average flow rate values, and decreases in prostate volume and mean IPSS score (15)
  • Patients treated with hexanic extract of Serenoa repens performed better than those taking tamsulosin as shown by improvements in mean gene expression of inflammatory markers (decreases observed in 65% of markers for treatment group, vs. 46.7% for control group taking tamsulosin (7)
  • Improvements were seen in IPSS and IIEF scores, quality of life, male sexual function, peak urinary flow, storage and voiding symptoms when supplemented (18)
  • Mean decrease in inflammation grading was greater for patients taking 320 mg/day hexanic extract vs. control for six months (5)
Saw palmetto in the Fullscript catalog

160 mg sabal fruit with extract 120 mg urtica root extract, 1-2 times per day, minimum 24 weeks (9)(10

459 mg nettle root extract, ongoing (16)

  • Decreased LUTS by improving obstructive and irritative symptoms subsequently decreasing I-PSS when given standardized extract of nettles and sabal PRO 160/120 for 24 weeks compared to placebo (8)
  • Decreases in IPSS by 53% and residual volume by 44% were observed as well as an increased peak and average urinary flow by 19% with supplementation of sabal fruit extract mixed with urtica root extract (9)
  • Sabal fruit extract with Urtica root extract reduced IPSS score by 6 points compared to 4 points in placebo after 16 weeks (10)
  • 81% of patients in treatment group of urtica/sabal combination experienced improvements compared to 16% in placebo; IPSS decreased from 19.8 to 11.8, postvoid residual decreased from 73 mL to 36 mL, and prostate size decreased from 40.1 cc to 36.3 cc (14)
  • Stinging nettle dry extract given at a dose of 459 mg is effective in decreasing IPSS and median residual urine volume (16)
Nettles/Sabal combo in the Fullscript catalog

Lycopene 

15 mg, total per day, minimum 6 months (17)

  • Consistent lycopene supplementation has been shown to inhibit the overall progression of BPH, reduce prostate-specific antigen (PSA) levels, and improvement of IPSS score (13
  • Progression of BPH decreased as shown by no changes in prostate size in treatment group while placebo group experienced prostate enlargement and prostate-specific antigen decreasing inversely with plasma lycopene concentration rising (17)
  • High lycopene intake between 9 and 21 mg per day and high circulating lycopene levels between 2.17 and 85 μg/dL correlated with lower prostate cancer risk (4)
  • Dietary supplementation of 30 mg per day with green tea decreased PSA 2.9% compared to an increase of 6.5% in control (12)
Lycopene in the Fullscript catalog

Beta-sitosterol


Dose may vary, minimum 130 mg, total per day, minimum 6 months (6

  • Beta-sitosterol has been shown to improve IPSS score (2
  • Overall improvement of quality of life (QOL), urinary and flow scores, which include maximum urinary flow and postvoid residual urine volume (21)(2)
Beta-sitosterol in the Fullscript catalog

Pygeum (Pygeum africanum)


100 mg, total per day, minimum 2 months (3

  • IPPS score and QOL were improved by 38% and 35%, respectively, in symptomatic BPH patients at a dose of 100 mg daily, either administered all at once or 50 mg twice per day (3
  • A decrease of 19% in nocturia, 24% in residual urine volume and an increase of 23% in peak urine flow was observed; patients were also twice as likely to report improvements compared to placebo (20)
Pygeum africanum in the Fullscript catalog

Disclaimer

The Fullscript Integrative Medical Advisory team has developed or collected these protocols from practitioners and supplier partners to help health care practitioners make decisions when building treatment plans. By adding this protocol to your Fullscript template library, you understand and accept that the recommendations in the protocol are for initial guidance and may not be appropriate for every patient.

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References
  1. Bell, K. J. L., Del Mar, C., Wright, G., Dickinson, J., & Glasziou, P. (2015). Prevalence of incidental prostate cancer: A systematic review of autopsy studies. International Journal of Cancer. Journal International Du Cancer, 137(7), 1749–1757. https://pubmed.ncbi.nlm.nih.gov/25821151/ (A) 
  2. Berges, R. R., Kassen, A., & Senge, T. (2000). Treatment of symptomatic benign prostatic hyperplasia with beta-sitosterol: an 18-month follow-up. BJU International, 85(7), 842–846. https://pubmed.ncbi.nlm.nih.gov/10792163/ (B)
  3. Chatelain, C., Autet, W., & Brackman, F. (1999a). Comparison of once and twice daily dosage forms of Pygeum africanum extract in patients with benign prostatic hyperplasia: a randomized, double-blind study, with long-term open label extension. Urology, 54(3), 473–478. https://pubmed.ncbi.nlm.nih.gov/10475357/ (B)
  4. Chen, P., Zhang, W., Wang, X., Zhao, K., Negi, D. S., Zhuo, L., Qi, M., Wang, X., & Zhang, X. (2015). Lycopene and Risk of Prostate Cancer: A Systematic Review and Meta-Analysis. Medicine, 94(33), e1260. https://pubmed.ncbi.nlm.nih.gov/26287411/ (A)
  5. Gravas, S., Samarinas, M., Zacharouli, K., Karatzas, A., Tzortzis, V., Koukoulis, G., & Melekos, M. (2019). The effect of hexanic extract of Serenoa repens on prostatic inflammation: results from a randomized biopsy study. World Journal of Urology, 37(3), 539–544. https://pubmed.ncbi.nlm.nih.gov/30027406/ (C)
  6. Klippel, K. F., Hiltl, D. M., & Schipp, B. (1997). A multicentric, placebo-controlled, double-blind clinical trial of beta-sitosterol (phytosterol) for the treatment of benign prostatic hyperplasia. German BPH-Phyto Study group. British Journal of Urology, 80(3), 427–432. https://pubmed.ncbi.nlm.nih.gov/9313662/ (B)
  7. Latil, A., Pétrissans, M.-T., Rouquet, J., Robert, G., & de la Taille, A. (2015a). Effects of hexanic extract of Serenoa repens (Permixon® 160 mg) on inflammation biomarkers in the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia. The Prostate, 75(16), 1857–1867. https://pubmed.ncbi.nlm.nih.gov/26306400/ (C)
  8. Lopatkin, N. A., Sivkov, A. V., Medvedev, A. A., Walter, K., Schlefke, S., Avdeĭchuk, I. I., Golubev, G. V., Mel’nik, K. P., Elenberger, N. A., & Engelman, U. (2006). [Combined extract of Sabal palm and nettle in the treatment of patients with lower urinary tract symptoms in double blind, placebo-controlled trial]. Urologiia , 2, 12, 14–19. https://pubmed.ncbi.nlm.nih.gov/16708583/ (B)
  9. Lopatkin, N., Sivkov, A., Schläfke, S., Funk, P., Medvedev, A., & Engelmann, U. (2007). Efficacy and safety of a combination of Sabal and Urtica extract in lower urinary tract symptoms–long-term follow-up of a placebo-controlled, double-blind, multicenter trial. International Urology and Nephrology, 39(4), 1137–1146. https://pubmed.ncbi.nlm.nih.gov/18038253/ (B)
  10. Lopatkin, N., Sivkov, A., Walther, C., Schläfke, S., Medvedev, A., Avdeichuk, J., Golubev, G., Melnik, K., Elenberger, N., & Engelmann, U. (2005). Long-term efficacy and safety of a combination of sabal and urtica extract for lower urinary tract symptoms–a placebo-controlled, double-blind, multicenter trial. World Journal of Urology, 23(2), 139–146. https://pubmed.ncbi.nlm.nih.gov/15928959/ (B)
  11. Miah, S., & Catto, J. (2014). BPH and prostate cancer risk. Indian Journal of Urology: IJU: Journal of the Urological Society of India, 30(2), 214–218. https://pubmed.ncbi.nlm.nih.gov/24744523/ (F)
  12. Paur, I., Lilleby, W., Bøhn, S. K., Hulander, E., Klein, W., Vlatkovic, L., Axcrona, K., Bolstad, N., Bjøro, T., Laake, P., Taskén, K. A., Svindland, A., Eri, L. M., Brennhovd, B., Carlsen, M. H., Fosså, S. D., Smeland, S. S., Karlsen, A. S., & Blomhoff, R. (2017). Tomato-based randomized controlled trial in prostate cancer patients: Effect on PSA. Clinical Nutrition , 36(3), 672–679. https://pubmed.ncbi.nlm.nih.gov/27406859/ (C)
  13. Rowles, J. L., 3rd, Ranard, K. M., Smith, J. W., An, R., & Erdman, J. W., Jr. (2017). Increased dietary and circulating lycopene are associated with reduced prostate cancer risk: a systematic review and meta-analysis. Prostate Cancer and Prostatic Diseases, 20(4), 361–377. https://pubmed.ncbi.nlm.nih.gov/28440323/ (A)
  14. Safarinejad, M. R. (2005). Urtica dioica for treatment of benign prostatic hyperplasia: a prospective, randomized, double-blind, placebo-controlled, crossover study. Journal of Herbal Pharmacotherapy, 5(4), 1–11. https://pubmed.ncbi.nlm.nih.gov/16635963/ (B)
  15. Saidi, S., Stavridis, S., Stankov, O., Dohcev, S., & Panov, S. (2017). Effects of Serenoa repens Alcohol Extract on Benign Prostate Hyperplasia. Prilozi (Makedonska Akademija Na Naukite I Umetnostite. Oddelenie Za Medicinski Nauki), 38(2), 123–129. https://pubmed.ncbi.nlm.nih.gov/28991765/ (C)
  16. Schneider, T., & Rübben, H. (2004). [Stinging nettle root extract (Bazoton-uno) in long term treatment of benign prostatic syndrome (BPS). Results of a randomized, double-blind, placebo controlled multicenter study after 12 months]. Der Urologe. Ausg. A, 43(3), 302–306. https://pubmed.ncbi.nlm.nih.gov/15045190/ (B)
  17. Schwarz, S., Obermüller-Jevic, U. C., Hellmis, E., Koch, W., Jacobi, G., & Biesalski, H.-K. (2008). Lycopene inhibits disease progression in patients with benign prostate hyperplasia. The Journal of Nutrition, 138(1), 49–53. https://pubmed.ncbi.nlm.nih.gov/18156403/ (C)
  18. Veltri, R. W., Marks, L. S., Miller, M. C., Bales, W. D., Fan, J., Macairan, M. L., Epstein, J. I., & Partin, A. W. (2002). Saw palmetto alters nuclear measurements reflecting DNA content in men with symptomatic BPH: evidence for a possible molecular mechanism. Urology, 60(4), 617–622. https://pubmed.ncbi.nlm.nih.gov/12385921/ (C)
  19. Vuichoud, C., & Loughlin, K. R. (2015). Benign prostatic hyperplasia: epidemiology, economics and evaluation. The Canadian Journal of Urology, 22 Suppl 1, 1–6. https://pubmed.ncbi.nlm.nih.gov/26497338/ (A)
  20. Wilt, T., Ishani, A., Mac Donald, R., Rutks, I., & Stark, G. (2002). Pygeum africanum for benign prostatic hyperplasia. Cochrane Database of Systematic Reviews , 1, CD001044. https://pubmed.ncbi.nlm.nih.gov/11869585/ (A)
  21. Wilt, T. J., MacDonald, R., & Ishani, A. (1999). beta-sitosterol for the treatment of benign prostatic hyperplasia: a systematic review. BJU International, 83(9), 976–983. https://pubmed.ncbi.nlm.nih.gov/10368239/ (A)
  22. Wyatt, G. K., Sikorskii, A., Safikhani, A., McVary, K. T., & Herman, J. (2016). Saw Palmetto for Symptom Management During Radiation Therapy for Prostate Cancer. Journal of Pain and Symptom Management, 51(6), 1046–1054. https://pubmed.ncbi.nlm.nih.gov/26891611/ (C)

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