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Randomized double-blind controlled clinical trials with herbal preparations of Serenoa repens fruits in treatment of lower urinary tract symptoms

An overview

Randomisierte doppelblinde kontrollierte klinische Studien mit pflanzlichen Arzneimitteln aus Früchten von Serenoa repens in der Behandlung von „lower urinary tract symptoms“

eine Übersicht

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Summary

In this review, results of randomized double-blind controlled clinical trials (RCTs) with extracts of Serenoa repens fruits at a dose of 320 mg/d for the treatment of lower urinary tract symptoms (LUTS) are assessed. Of the RTCs conducted for up to 6 months, a benefit was seen in three of three RTCs with ethanolic, in eight of nine RTCs with hexane, and in one of two RTCs with CO2 extracts. Of the RTCs conducted for more than 6 months, a benefit was seen in two RTCs with hexane and in one RTC with CO2 extracts, whereas one RTC with an ethanolic, two RTCs with hexane, and one RTC with CO2 extracts did not show positive results. As LUTS are dynamic conditions with strong spontaneous fluctuation over time, the majority of patients might expect improvement of single symptoms and thus of quality of life, particularly as the extracts are well tolerated even in long-term treatment.

Zusammenfassung

In dieser Übersicht werden die Ergebnisse randomisierter kontrollierter Doppelblindstudien mit Extrakten aus den Früchten der Sägepalme, Serenoa repens, in einer Dosierung von 320 mg/Tag bei Beschwerden des unteren Urogenitaltrakts („lower urinary tract symptoms“, LUTS) bewertet. Von den Studien mit einer Studiendauer von bis zu 6 Monaten zeigten 3 von 3 Studien mit ethanolischen, 8 von 9 Studien mit Hexan- und 1 von 2 Studien mit CO2-Extrakten eine Wirksamkeit. Von den Studien mit einer Dauer von mehr als 6 Monaten ergaben 2 Studien mit Hexanextrakten und 1 Studie mit CO2-Extrakten eine Wirksamkeit, während 1 Studie mit einem ethanolischen Extrakt, 2 Studien mit einem Hexanextrakt und 1 Studie mit einem CO2-Extrakt kein positives Ergebnis zeigten. Da Beschwerden des unteren Urogenitaltrakts dynamische Erkrankungen mit starken spontanen Fluktuationen über die Zeit sind, kann die Mehrzahl der Patienten eine Verbesserung von Einzelsymptomen und damit der Lebensqualität erwarten, zumal die Extrakte selbst bei Langzeitanwendung gut verträglich sind.

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Notes

  1. Both, the AUA and IPSS use the identical scale of 0 to 35, with mild symptoms scored 1 to 8, medium 9 to 18, and severe ≥19.

  2. Committee on Herbal Medicinal Products

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Acknowledgements

The authors thank Dr. Samuel Okpanyi, Wiesbaden, Germany, and Prof. Dr. Karin Kraft, Rostock, Germany, for discussions and proof reading.

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Authors and Affiliations

  1. Working group “Efficacy and Safety” of the Kooperation Phytopharmaka GbR, Plittersdorfer Str. 218, 53173, Bonn-Bad Godesberg, Germany

    Rainer C. Görne, Tankred Wegener, Olaf Kelber, Björn Feistel & Jürgen Reichling

  2. Praxis für Diabetologie und Naturwissenschaftliche Medizin, Karl-Helfferich-Str. 9A, 67433, Neustadt an der Weinstraße, Germany

    Rainer C. Görne

  3. Consulting Herbal Medicinal Products, Brückstr.11, 69469, Weinheim, Germany

    Tankred Wegener

  4. Scientific Department, Steigerwald Arzneimittelwerk GmbH, Havelstr. 5, 64295, Darmstadt, Germany

    Olaf Kelber

  5. Finzelberg GmbH & Co KG, Koblenzer Str. 48-56, 56626, Andernach, Germany

    Björn Feistel

  6. Institut für Pharmazie und Molekulare Biotechnologie, Universität Heidelberg, Im Neuenheimer Feld 364, 69120, Heidelberg, Germany

    Jürgen Reichling

  7. Sachverständigenbüro für Klinische Pharmakologie und Toxikologie, Kurpfalzstr. 68, 67435, Neustadt an der Weinstraße, Germany

    Rainer C. Görne

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  1. Rainer C. Görne
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Correspondence to Rainer C. Görne.

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Conflict of Interest

All authors are members of the working group “Efficacy and Safety” of the Kooperation Phytopharmaka, GbR, Bonn, Germany. The paper was written in behalf of the working group and there was no competing financial interest.

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Görne, R.C., Wegener, T., Kelber, O. et al. Randomized double-blind controlled clinical trials with herbal preparations of Serenoa repens fruits in treatment of lower urinary tract symptoms. Wien Med Wochenschr 167, 177–182 (2017). https://doi.org/10.1007/s10354-016-0526-2

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  • DOI: https://doi.org/10.1007/s10354-016-0526-2

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