Skip to main content

Advertisement

SpringerLink
Log in

Fixed-dose combination PRO 160/120 of sabal and urtica extracts improves nocturia in men with LUTS suggestive of BPH: re-evaluation of four controlled clinical studies

  • Topic Paper
  • Published:
World Journal of Urology Aims and scope Submit manuscript

Abstract

Purpose

To determine the effects of the herbal fixed-dose combination PRO 160/120 (extracts from saw palmetto fruits and stinging nettle roots) on nocturnal voiding frequency, as measured by question 7 of the IPSS questionnaire, in patients with moderate-to-severe LUTS/BPH after 24 weeks of treatment compared to placebo, to the α-blocker tamsulosin, or to the 5α-reductase inhibitor finasteride.

Methods

The study is about post hoc evaluation of four published randomized, double-blind clinical trials on PRO 160/120, two compared with placebo, one with finasteride and one with tamsulosin. In addition, a pooled data analysis of the two placebo-controlled trials was conducted.

Results

We analyzed data from a total of 922 patients with a mean age of 66 years and a mean baseline nocturnal voiding frequency of 2.1. In the pooled analysis of placebo-controlled trials, nocturnal voids improved by 0.8 (29 %) with PRO 160/120 compared to 0.6 (18 %) with placebo (p = 0.015, Wilcoxon test, one-tailed). The 69 % responder rate to PRO 160/120 was significantly superior to the placebo response (52 %; p = 0.003, χ 2-test, two-tailed). The majority of responders improved by 1 void/night. Absolute improvements and response rates were consistently higher with PRO 160/120 than with placebo over a range of baseline nocturnal voiding frequencies. There were no differences between PRO 160/120 and finasteride or tamsulosin regarding absolute improvement of nocturnal voids or responds rates.

Conclusion

PRO 160/120 significantly improved nocturnal voiding frequency compared to placebo and similar to tamsulosin or finasteride.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

Abbreviations

BPH:

Benign prostatic hyperplasia

IPSS:

International Prostate Symptom Score

LUTS:

Lower urinary tract symptoms

PVR:

Post-void residual

Qmax :

Maximum urinary flow rate

References

  1. Cornu JN, Cussenot O, Haab F, Lukacs B (2010) A widespread population study of actual medical management of lower urinary tract symptoms related to benign prostatic hyperplasia across Europe and beyond official clinical guidelines. Eur Urol 58:450–456

    Article  PubMed  Google Scholar 

  2. Azimi H, Khakshur AA, Aghdasi I, Fallah-Tafti M, Abdollahi M (2012) A review of animal and human studies for management of benign prostatic hyperplasia with natural products: perspective of new pharmacological agents. Inflamm Allergy Drug Targets 11:207–221

    Article  PubMed  CAS  Google Scholar 

  3. Tacklind J, Macdonald R, Rutks I, Stanke JU, Wilt TJ (2012) Serenoa repens for benign prostatic hyperplasia. Cochrane Database Syst Rev 12: CD001423. doi:10.1002/14651858.CD001423.pub3

  4. Dreikorn K, Berges R, Höfner K, Madersbacher S, Michel MC, Muschter R, Oelke M, Reich O, Rulf W, Tschuschke C, Tunn U (2009) Therapy of benign prostate syndrome (BPS): guidelines of the German Urologists (DGU). Urologe A 48:1503–1516

    Article  PubMed  Google Scholar 

  5. Oelke M, Bachmann A, Descazeaud A, Emberton M, Gravas S, Michel MC, N’Dow J, Nordling J, de la Rosette JJ (2013) EAU guidelines on the treatment and follow-up on non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol 64:118–140

    Article  PubMed  Google Scholar 

  6. Metzker H, Kieser M, Hölscher U (1996) Wirksamkeit eines Sabal-Urtica-Kombinationspräparats bei der Behandlung der benignen Prostatahyperplasie (BPH). Eine doppelblinde placebokontrollierte Langzeitstudie. Urologe (B) 36:292–300

    Article  Google Scholar 

  7. 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 J Urol 23:139–146

    Article  PubMed  CAS  Google Scholar 

  8. Sökeland J, Albrecht J (1997) Combination of Sabal and Urtica extract vs. finasteride in benign prostatic hyperplasia (Alken stages I to II). Comparison of therapeutic effectiveness in a one year double-blind study. Urologe A 36:327–333

    Article  PubMed  Google Scholar 

  9. Engelmann U, Walther C, Bondarenko B, Funk P, Schläfke S (2006) Efficacy and safety of a combination of sabal and urtica extract in lower urinary tract symptoms. A randomized, double-blind study versus tamsulosin. Arzneimittelforschung 56:222–229

    PubMed  CAS  Google Scholar 

  10. van Dijk MM, Wijkstra H, Debruyne FM et al (2010) The role of nocturia in the quality of life of men with lower urinary tract symptoms. BJU Int 105:1141–1146

    Article  PubMed  Google Scholar 

  11. Scaglione F, Lucini V, Pannacci M, Caronno A, Leone C (2008) Comparison of the potency of different brands of Serenoa repens extract on 5alpha-reductase types I and II in prostatic co-cultured epithelial and fibroblast cells. Pharmacology 82:270–275

    Article  PubMed  CAS  Google Scholar 

  12. Tikkinen KA, Tammela TL, Huhtala H, Auvinen A (2006) Is nocturia equally common among men and women? A population based study in Finland. J Urol 175:596–600

    Article  PubMed  Google Scholar 

  13. Marschall-Kehrel D (2004) Update on nocturia: the best of rest is sleep. Urology 64(6 Suppl 1):21–24

    Article  PubMed  Google Scholar 

  14. Nakagawa H, Niu K, Hozawa A, Ikeda Y, Kaiho Y, Ohmori-Matsuda K et al (2010) Impact of nocturia on bone fracture and mortality in older individuals: a Japanese longitudinal cohort study. J Urol 184:1413–1418

    Article  PubMed  Google Scholar 

  15. Klotz T, Brüggenjürgen B, Burkart M, Resch A (2007) The economic costs of overactive bladder in Germany. Eur Urol 51:1654–1662

    Article  PubMed  Google Scholar 

  16. Tikkininen KA, Johnson TM 2nd, Tammela TL et al (2010) Nocturia frequency, bother, and quality of life: how often is too often? A population-based study in Finland. Eur Urol 57:488–496

    Article  Google Scholar 

  17. Mitropoulos D, Anastasiou I, Giannopoulou C et al (2002) Symptomatic benign prostatic hyperplasia: impact on partners’ quality of life. Eur Urol 41:240–244

    Article  PubMed  Google Scholar 

  18. Roehrborn CG, Van Kerrebroeck P, Nordling J (2003) Safety and efficacy of alfuzosin 10 mg once-daily in the treatment of lower urinary tract symptoms and clinical benign prostatic hyperplasia: a pooled analysis of three double-blind, placebo-controlled studies. BJU Int 92:257–261

    Article  PubMed  CAS  Google Scholar 

  19. Eisenhardt A, Schneider T, Cruz F, Oelke M (2014) Consistent and significant improvement of nighttime voiding frequency (nocturia) with silodosin in men with LUTS suggestive of BPH—pooled analysis of three randomized, placebo-controlled, double-blind phase III studies. World J Urol. doi:10.1007/s00345-013-1228-7

    PubMed  Google Scholar 

  20. Oelke M, Roehrborn CG, D’Ancona C, Wilson TH, Castro R, Manyak M (2014) Nocturia improvement with dutasteride in phase III studies in men with LUTS/BPH. World J Urol. doi:10.1007/s00345-014-1316-3

  21. Roehrborn CG, Siami P, Barkin J, Damião R, Major-Walker K, Nandy I, Morrill BB, Gagnier RP, Montorsi F, CombAT Study Group (2010) The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol 57:123–131

    Article  PubMed  Google Scholar 

  22. Oelke M, Roehrborn CG, D’Ancona C, Wilson TH, Castro R, Manyak M (2014) Nocturia improvement of Avodart and Tamsulosin (CombAT) study. World J Urol. doi:10.1007/s00345-014-1296-3

  23. Oelke M, Weiss JP, Mamoulakis C, Cox D, Ruff D, Viktrup L (2014) Effects of tadalafil on nighttime voiding (nocturia) in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a post hoc analysis of pooled data from four randomized, placebo-controlled clinical studies. World J Urol. doi:10.1007/s00345-014-1255-z

    Google Scholar 

  24. Bent S, Kane C, Shinohara K, Neuhaus J, Hudes E, Goldberg H et al (2006) Saw palmetto for benign prostatic hyperplasia. N Engl J Med 354:557–566

    Article  PubMed  CAS  Google Scholar 

  25. Barry MJ, Meleth S, Lee JY, Kreder KJ, Avins AL, Nickel JC et al (2011) Effect of increasing doses of Saw palmetto extract on lower urinary tract symptoms. JAMA 306:1344–1351

    Article  PubMed  CAS  PubMed Central  Google Scholar 

  26. van Kerrebroeck P, Abrams P, Chaikin D, Donovan J, Fonda D, Jackson S, Jennum P, Johnson T, Lose G, Mattiasson A, Robertson G, Weiss J (2002) The standardisation of terminology in nocturia: report from the Standardisation Sub-Committee of the International Continence Society. Neurourol Urodyn 21:179–183

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

The four studies on which these analyses were based were funded by Schwabe Pharma, Karlsruhe, Germany.

Conflict of interest

M. Oelke is a consultant, speaker, or trial investigator in the field of LUTS/BPH for Allergan, Apogepha, Astellas, Bayer, Ferring, GlaxoSmithKline, Lilly, Mundipharma, Pfizer, and Recordati. Richard Berges is a lecturer, advisor, and/or study participant in the field of LUTS/BPH for Astellas, GlaxoSmithKline, Ferring, Lilly, Pfizer, and Recordati. S. Schläfke and M. Burkart are employees of Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.

Author information

Authors and Affiliations

  1. Department of Urology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany

    Matthias Oelke

  2. Department of Urology, PAN-Klinik, Cologne, Germany

    Richard Berges

  3. Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany

    Sandra Schläfke & Martin Burkart

Authors
  1. Matthias Oelke
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Richard Berges
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Sandra Schläfke
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Martin Burkart
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Matthias Oelke.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Oelke, M., Berges, R., Schläfke, S. et al. Fixed-dose combination PRO 160/120 of sabal and urtica extracts improves nocturia in men with LUTS suggestive of BPH: re-evaluation of four controlled clinical studies. World J Urol 32, 1149–1154 (2014). https://doi.org/10.1007/s00345-014-1338-x

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00345-014-1338-x

Keywords

Search

Navigation