In an open-label extension of a randomized, double-blind clinical trial, the long-term efficacy and tolerability of a fixed combination of 160 mg Sabal fruit extract WS 1473 and 120 mg Urtica root extract WS 1031 per capsule (PRO 160/120) were investigated in elderly men with moderate or severe lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). Two hundred and fifty-seven patients were randomly treated with 2 × 1 capsule/day PRO 160/120 or placebo for 24 weeks, followed by a 24-week control period and a 48-week follow-up period in which all patients received PRO 160/120. Efficacy measures included the assessment of LUTS [International Prostate Symptom Score ((I-PSS) self-rating questionnaire] and uroflow and sonographic parameters. Two hundred and nineteen subjects participated in the follow-up. Between baseline and end of observation (week 96) the I-PSS total score was reduced by 53% (P < 0.001), peak and average urinary flow increased by 19% (P < 0.001), and residual urine volume decreased by 44% (P = 0.03). The incidence of adverse events during follow-up was one in 1,181 treatment days; in only one event a causal relationship with intake of PRO 160/120 could not be excluded. Treatment with PRO 160/120 thus provides a clinically relevant benefit over a period of 96 weeks.
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Marketed in Germany under the trade name Prostagutt forte, Dr. Willmar Schwabe, Karlsruhe, Germany.
WS 1473 and WS 1031 are registered trademarks of Dr. Willmar Schwabe GmbH & Co. KG.
Verhamme KM, Dieleman JP, Bleumink GS, van der Lei J, Sturkenboom MC, Artibani W et al (2002) Incidence and prevalence of lower urinary tract symptoms suggestive of benign prostatic hyperplasia in primary care—the Triumph project. Eur Urol 42:323–328
Gades NM, Jacobson DJ, Girman CJ, Roberts RO, Lieber MM, Jacobsen SJ (2005) Prevalence of conditions potentially associated with lower urinary tract symptoms in men. BJU Int 95:549–553
Clifford GM, Farmer RD (2000) Medical therapy for benign prostatic hyperplasia: a review of the literature. Eur Urol 38:2–19
Lowe FC, Fagelman E (2002) Phytotherapy in the treatment of benign prostatic hyperplasia. Curr Opin Urol 12:15–18
Boyle P, Robertson C, Lowe F, Roehrborn C (2004) Updated meta-analysis of clinical trials of Serenoa repens extract in the treatment of symptomatic benign prostatic hyperplasia. BJU Int 93:751–756
Gerber GS, Fitzpatrick JM (2004) The role of a lipido-sterolic extract of Serenoa repens in the management of lower urinary tract symptoms associated with benign prostatic hyperplasia. BJU Int 94:338–344
Gong EM, Gerber GS (2004) Saw palmetto and benign prostatic hyperplasia. Am J Chin Med 32:331–338
Wilt T, Ishani A, Mac Donald R (2002) Serenoa repens for benign prostatic hyperplasia. Cochrane Database Syst Rev CD001423
Dathe G, Schmid H (1987) Phytotherapie der benignen Prostatahyperplasie (BPH). Doppelblindstudie mit Extractum Radicis urticae (ERU). Urologe B 27:223–226
Vontobel HP, Herzog R, Rutishauser G, Kres H (1985) Ergebnisse einer Doppelblindstudie über die Wirksamkeit von ERU-Kapseln in der konservativen Behandlung der benignen Prostatahyperplasie. Urologe A 24:49–51
Schneider T, Rübben H (2004) Brennnesseltrockenextrakt (Bazoton-uno) in der Langzeittherapie des benignen Prostatasyndroms (BPS). Ergebnisse einer randomisierten, doppelblinden, placebokontrollierten Multicenterstudie über 12 Monate. Urologe A 43:302–306
Goldmann WH, Sharma AL, Currier SJ, Johnston PD, Rana A, Sharma CP (2001) Saw palmetto berry extract inhibits cell growth and Cox-2 expression in prostatic cancer cells. Cell Biol Int 25:1117–1124
Koch E (2001) Extracts from fruits of saw palmetto (Sabal serrulata) and roots of stinging nettle (Urtica dioica): viable alternatives in the medical treatment of benign prostatic hyperplasia and associated lower urinary tracts symptoms. Planta Med 67:489–500
Marks LS, Hess DL, Dorey FJ, Luz Macairan M, Cruz Santos PB, Tyler VE (2001) Tissue effects of saw palmetto and finasteride: use of biopsy cores for in situ quantification of prostatic androgens. Urology 57:999–1005
Hirano T, Homma M, Oka K (1994) Effects of stinging nettle root extracts and their steroidal components on the Na+,K(+)-ATPase of the benign prostatic hyperplasia. Planta Med 60:30–33
Lichius JJ, Lenz C, Lindemann P, Müller HH, Aumüller G, Konrad L (1999) Antiproliferative effect of a polysaccharide fraction of a 20% methanolic extract of stinging nettle roots upon epithelial cells of the human prostate (LNCaP). Pharmazie 54:768–771
Mitropoulos D, Kyroudi A, Zervas A, Papadoukakis S, Giannopoulos A, Kittas C et al (2002) In vivo effect of the lipido-sterolic extract of Serenoa repens (Permixon) on mast cell accumulation and glandular epithelium trophism in the rat prostate. World J Urol 19:457–461
Talpur N, Echard B, Bagchi D, Bagchi M, Preuss HG (2003) Comparison of Saw Palmetto (extract and whole berry) and Cernitin on prostate growth in rats. Mol Cell Biochem 250:21–26
Wadsworth TL, Carroll JM, Mallinson RA, Roberts CT Jr, Roselli CE (2004) Saw palmetto extract suppresses insulin-like growth factor-I signaling and induces stress-activated protein kinase/c-Jun N-terminal kinase phosphorylation in human prostate epithelial cells. Endocrinology 145:3205–3214
Metzker H, Kieser M, Hölscher U (1996) Wirksamkeit eines Sabal-Urtica-Kombinationspräparats bei der Behandlung der benignen Prostatahyperplasie (BPH). Urologe B 36:292–300
Sökeland J, Albrecht J (1997) Kombination aus Sabal- und Urticaextrakt vs Finasterid bei BPH. (Stad. I bis II nach Alken)—Vergleich der therapeutischen Wirksamkeit in einer einjährigen Doppelblindstudie. Urologe A 36:327–333
Sökeland J (2000) Combined sabal and urtica extract compared with finasteride in men with benign prostatic hyperplasia: analysis of prostate volume and therapeutic outcome. BJU Int 86:439–442
Barry MJ, Fowler FJ Jr, O’Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK et al (1992) The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol 148:1549–1557; discussion 1564
Engelmann U, Bondarenko B, Walther C, Funk P, Schläfke S (2006) Efficacy and safety of a combination of sabal and urtica extract in lower urinary tract symptoms. Arzneimittelforschung 56:222–229
Lopatkin N, Sivkov A, Walther C, Schläfke S, Medvedev A, Avdeichuk J et al (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 J Urol 23:139–146
Roehrborn CG, Abbou CC, Akaza H, Allona-Almagro A, Boccon-Gibod L, Ekman PE et al (2001) Clinical research criteria for studies of: lower urinary tract symptoms (LUTS), enlarged prostate gland (EPG), bladder outlet obstruction (BOO) and benign prostatic hyperplasia (BPH). In: Chatelain C, Denis L, Foo KT, Khoury S, Mc Connell J (eds) Benign prostatic hyperplasia. 5th International Consultation on Benign Prostatic Hyperplasia (BPH), Paris, 25–28 June 2000. Health Publication Ltd, Plymouth, pp 317–395
Pytel YA, Vinarov A, Lopatkin N, Sivkov A, Gorilovsky L, Raynaud JP (2002) Long-term clinical and biologic effects of the lipidosterolic extract of Serenoa repens in patients with symptomatic benign prostatic hyperplasia. Adv Ther 19: 297–306
Marberger MJ (1998) Long-term effects of finasteride in patients with benign prostatic hyperplasia: a double-blind, placebo-controlled, multicenter study. PROWESS Study Group. Urology 51:677–686
The study was funded by Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany, manufacturer of PRO 160/120.
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Lopatkin, N., Sivkov, A., Schläfke, S. et al. 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. Int Urol Nephrol 39, 1137–1146 (2007). https://doi.org/10.1007/s11255-006-9173-7