Serenoa repens extract in the treatment of benign prostatic hyperplasia

Czech version

Authors: P. Geavlete; R. Multescu; B. Geavlete
Authors‘ workplace: Department of Urology, „Saint John“ Emergency Clinical Hospital, Rumunsko
Published in: Urol List 2012; 10(2): 62-65

Overview

We are experiencing a revival of interest in phytotherapeutic agents, both in Europe and North America, especially as a consequence of patients’ dissatisfaction with the adverse effects of the medical alternatives. One of the most frequently prescribed and studied such agents is Serenoa repens extract, derived from the berry of the dwarf palm tree. We aimed to review the most important published data regarding this type of treatment for benign prostatic hyperplasia. A review of the existing articles regarding the use of Serenoa repens extracts for benign prostatic hyperplasia was performed. The articles were analysed with regard to their relevance, scientific value and the size of the evaluated series. Multiple mechanisms of action have been attributed to this extract, including antiandrogenic action, an anti-inflammatory/anti-oedematous effect, prolactin signal modulation, and an antiproliferative effect exerted through the inhibition of growth factors. Regarding efficacy, European Association of Urology guidelines state that Serenoa repens extracts significantly reduce nocturia in comparison with placebo. However, the guideline committee is unable to make specific recommendations about phytotherapy of male lower urinary tract symptoms owing to the heterogeneity of the products and the methodological problems associated with meta-analyses. Most of the published trials regarding Serenoa repens phytotherapy demonstrate a significant improvement of urinary status and a favourable safety profile. Also, some authors have credited it with giving a significant improvement in erectile function and decreasing complications following transurethral resection of the prostate, especially bleeding. The results of phytotherapy with Serenoa repens extracts are very promising. More high-quality, randomized, placebo-controlled studies are required in order to demonstrate without doubt the true therapeutic value of these products. Particular attention must be focused on differentiating between registered preparations, which are regulated as drugs, and those considered to be food supplements.

Key words:
benign prostatic hyperplasia, lower urinary tract symptoms, phytotherapy, Serenoa repens

Sources

1. Oelke M, Bachmann A, Descazeaud A et al. Guidelines on the treatment of non-neurogenic male LUTS. EAU online Guidelines 2011. Available at: http://www.uroweb.org/gls/pdf/12_Male_LUTS.pdf.

2. Debruyne F, Boyle P, Calais da Silva F et al. Evaluation of the clinical benefit of Permixon and tamsulosin in severe BPH patients – PERMAL study subset analysis. Prog Urol 2004; 14(3): 326–331.

3. Carraro JC, Raynaud JP, Koch G et al. Comparison of phytotherapy (Permixon) with finasteride in the treatment of benign prostate hyperplasia: a randomized international study of 1,098 patients. Prostate 1996; 29(4): 231–240.

4. Giannakopoulos X, Baltogiannis D, Giannakis D et al. The lipidosterolic extract of Serenoa repens in the treatment of benign prostatic hyperplasia: a comparison of two dosage regimens. Adv Ther 2002; 19(6): 285–296.

5. Gerber GS, Kuznetsov D, Johnson BC et al. Randomized, double-blind, placebo-controlled trial of saw palmetto in men with lower urinary tract symptoms. Urology 2001; 58(6): 960–964.

6. Marks LS, Partin AW, Epstein JI et al. Effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia. J Urol 2000; 163(5): 1451–1456.

7. Bauer HW, Casarosa C, Cosci M et al. Saw palmetto fruit extract for treatment of benign prostatic hyperplasia. Results of a placebo-controlled double-blind study. MMW Fortschr Med 1999; 141(25): 62.

8. Tacklind J, MacDonald R, Rutks I et al. Serenoa repens for benign prostatic hyperplasia. Cochrane Database Syst Rev 2009; 15: CD001423.

9. Murray MT, Pizzorno J. Encyclopedia of Natural Medicine. Seattle, WA: John Bastyr University Publishing 1994.

10. Buck AC. Is there a scientific basis for the therapeutic effects of Serenoa repens in benign prostatic hyperplasia? Mechanisms of action. J Urol 2004; 172(5 Pt 1): 1792–1799.

11. Sinescu I, Geavlete P, Multescu R et al. Long-term efficacy of Serenoa repens treatment in patients with mild and moderate symptomatic benign prostatic hyperplasia. Urol Int 2011; 86(3): 284–289.

12. Pais P. Potency of a novel saw palmetto ethanol extract, SPET-085, for inhibition of 5alphareductase II. Adv Ther 2010; 27(8): 555–563.

13. Alyaev YG, Apolikhin OI, Mazo EB et al. First results of a clinical trial of the efficacy and safety of Prostamol Uno in patients with the early signs of prostatic hyperplasia. Eff Pharmacother Urol 2007; 8: 11.

14. Breza J, Kliment J, Valansky L et al. Phytotherapy of symptomatic benign prostatic hyperplasia using alcohol extract of Serenoa repens fruit (Prostamol Uno). Urologia 2005; 11: 6–10.

15. Rosler TW, Matusch R, Weber B et al. Analysis of the hydrodistillate from the fruits of Serenoa repens. Planta Med 2009; 75(2): 184–186.

16. Sultan C, Terraza A, Devillier C et al. Inhibition of androgen metabolism and binding by a liposterolic extract of Serenoa repens B in human foreskin fibroblasts. J Steroid Biochem 1984; 20(1): 515–519.

17. Scaglione F, Lucini V, Pannacci M et al. Comparison of the potency of different brands of Serenoa repens extract on 5alphareductase types I and II in prostatic co-cultured epithelial and fibroblast cells. Pharmacology 2008; 82(4): 270–275.

18. Breu W, Hagenlocher M, Redl K et al. Anti-inflammatory activity of sabal fruit extracts prepared with supercritical carbon dioxide. In vitro antagonists of cyclooxygenase and 5-lipoxygenase metabolism. Arzneimittelforschung 1992; 42(4): 547–551.

19. Tarayre JP, Delhon A, Lauressergues H et al. Anti-edematous action of a hexane extract of the stone fruit of Serenoa repens Bartr. Ann Pharm Fr 1983; 41(6): 559–570.

20. Vacherot F, Azzouz M, Gil-Diez-De-Medina S et al. Induction of apoptosis and inhibition of cell proliferation by the lipido-sterolic extract of Serenoa repens (LSESr, Permixon!) in benign prostatic hyperplasia. Prostate 2000; 45(3): 259.

21. Di Silverio F, Monti S, Sciarra A et al. Effects of longterm treatment with Serenoa repens (Permixon) on the concentrations and regional distribution of androgens and epidermal growth factor in benign prostatic hyperplasia. Prostate 1998; 37(2): 77–83.

22. Van Coppenolle F, Le Bourhis X, Carpentier F et al. Pharmacological effects of the lipidosterolic extract of Serenoa repens (Permixon) on rat prostate hyperplasia induced by hyperprolactinaemia: comparison with finasteride. Prostate 2000; 43(1): 49–58.

23. Vacher P, Prevarskaya N, Skyrma R et al. The lipidosterolic extract from Serenoa repens interferes with prolactin receptor signal transduction. J Biomed Sci 1995; 2(4): 357–365.

24. Hill B, Kyprianou N. Effect of Permixon on human prostate cell growth: lack of apoptotic action. Prostate 2004; 61(1): 73–80.

25. Willetts KE, Clements MS, Champion S et al. Serenoa repens extract for benign prostate hyperplasia: a randomized controlled trial. BJU Int 2003; 92(3): 267–270.

26. Descotes JL, Rambeaud JJ, Deschaseau P et al. Placebo-controlled evaluation of the efficacy and tolerability of Permixon in benign prostatic hyperplasia after exclusion of placebo responders. Clin Drug Invest 1995; 9: 291–297.

27. Pytel YA, Vinarov A, Lopatkin N et al. Long-term clinical and biologic effects of the lipidosterolic extract of Serenoa repens in patients with symptomatic benign prostatic hyperplasia. Adv Ther 2002; 19(6): 297–306.

28. Debruyne F, Boyle P, Calais Da Silva F et al. Evaluation of the clinical benefit of Permixon and tamsulosin in severe BPH patients – PERMAL study subset analysis. Eur Urol 2004; 45(6): 773–779.

29. Hizli F, Uygur MC. A prospective study of the efficacy of Serenoa repens, tamsulosin, and Serenoa repens plus tamsulosin treatment for patients with benign prostate hyperplasia. Int Urol Nephrol 2007; 39(3): 879–886.

30. Bent S, Kane C, Shinohara K et al. Saw palmetto for benign prostatic hyperplasia. N Engl J Med 2006; 354(6): 557–566.

31. Hutchison A, Farmer R, Verhamme K et al. The efficacy of drugs for the treatment of LUTS/BPH, a study in 6 European countries. Eur Urol 2007; 51(1): 207–215.

32. Giuliano F. Impact of medical treatments for benign prostatic hyperplasia on sexual function. BJU Int 2006; 97: 34–38.

33. Zlotta AR, Teillac P, Raynaud JP et al. Evaluation of male sexual function in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) treated with a phytotherapeutic agent (Permixon), tamsulosin or finasteride. Eur Urol 2005; 48(2): 269–276.

34. Pecoraro S, Annecchiarico A, Gambardella MC et al. Efficacy of pretreatmentwith Serenoa repens on bleeding associated with transurethral resection of prostate. Minerva Urol Nefrol 2004; 56(1): 73–78.

35. Anceschi R, Bisi M, Ghidini N et al. Serenoa repens (Permixon!) reduces intra- and postoperative complications of surgical treatments of benign prostatic hyperplasia. Minerva Urol Nefrol 2010; 62(3): 219–223.

36. Tuncel A, Ener K, Han O et al. Effects of short-term dutasteride and Serenoa repens on perioperative bleeding and microvessel density in patients undergoing transurethral resection of the prostate. Scand J Urol Nephrol 2009; 43(5): 377–382.

37. Agbabiaka TB, Pittler MH, Wider B et al. Serenoa repens (saw palmetto): a systematic review of adverse events. Drug Saf 2009; 32(8): 637–647.

38. Vinarov AZ, Aliaev IuG, Lokshin KL. Safety of continuous (more than 1 year) intake of Serenoa repens extract by patients with prostatic adenoma. Urologia 2009; 1: 84–87.

39. Avins AL, Bent S, Staccone S et al. A detailed safety assessment of a saw palmetto extract. Complement Ther Med 2008; 16(3): 147–154.

40. Bayne CW, Donnelly F, Chapman K et al. A novel coculture model for benign prostatic hyperplasia expressing both isoforms of 5 alpha-reductase. J Clin Endocrinol Metab 1998; 83(1): 206–213.