Skip to main content
Erschienen in: Wiener Medizinische Wochenschrift 7-8/2017

01.05.2017 | main topic

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

An overview

verfasst von: Rainer C. Görne, Tankred Wegener, Olaf Kelber, Björn Feistel, Jürgen Reichling

Erschienen in: Wiener Medizinische Wochenschrift | Ausgabe 7-8/2017

Einloggen, um Zugang zu erhalten

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.
Fußnoten
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
 
Literatur
1.
Zurück zum Zitat Coyne KS, Sexton CC, Thompson CL, et al. The prevalence of lower urinary tract symptoms (LUTS) in the USA, the UK and Sweden: results from the Epidemiology of LUTS (EpiLUTS) study. BJU Int. 2009;104(3):352–60.CrossRefPubMed Coyne KS, Sexton CC, Thompson CL, et al. The prevalence of lower urinary tract symptoms (LUTS) in the USA, the UK and Sweden: results from the Epidemiology of LUTS (EpiLUTS) study. BJU Int. 2009;104(3):352–60.CrossRefPubMed
2.
Zurück zum Zitat Rosenberg MT, Staskin DR, Kaplan SA, et al. A practical guide to the evaluation and treatment of male lower urinary tract symptoms in the primary care setting. Int J Clin Pract. 2007;61(9):1535–46.CrossRefPubMed Rosenberg MT, Staskin DR, Kaplan SA, et al. A practical guide to the evaluation and treatment of male lower urinary tract symptoms in the primary care setting. Int J Clin Pract. 2007;61(9):1535–46.CrossRefPubMed
3.
Zurück zum Zitat AWMF-Leitlinie. Therapie des Benignen Prostatasyndroms der Qualität S2e – Therapy of benign prostate syndrome S23. Register Nr. 043/035. 2014. AWMF-Leitlinie. Therapie des Benignen Prostatasyndroms der Qualität S2e – Therapy of benign prostate syndrome S23. Register Nr. 043/035. 2014.
4.
Zurück zum Zitat Madersbacher S, Marszalek M. Benign prostate hyperplasia: success and limitations of pharmacological therapy. Internist (Berl). 2007;48(10):1157–64.CrossRef Madersbacher S, Marszalek M. Benign prostate hyperplasia: success and limitations of pharmacological therapy. Internist (Berl). 2007;48(10):1157–64.CrossRef
5.
Zurück zum Zitat Oelke M, et al. Medikamentöse Therapie der benignen Prostatahyperplasie. Urologe. 2009;48:1365–77.CrossRefPubMed Oelke M, et al. Medikamentöse Therapie der benignen Prostatahyperplasie. Urologe. 2009;48:1365–77.CrossRefPubMed
6.
Zurück zum Zitat Wehrberger C, Dreikorn K, Schmitz-Drager BJ, et al. Phytotherapie bei benignem Prostatasydrom und Prostatakarzinom. (Phytotherapy of benign prostate syndrome and prostate cancer: better than placebo). Urologe. 2012;51(12):1674–82.CrossRefPubMed Wehrberger C, Dreikorn K, Schmitz-Drager BJ, et al. Phytotherapie bei benignem Prostatasydrom und Prostatakarzinom. (Phytotherapy of benign prostate syndrome and prostate cancer: better than placebo). Urologe. 2012;51(12):1674–82.CrossRefPubMed
7.
Zurück zum Zitat Mohanty NK, Jha H, Dutt C. Randomized double-blind controlled clinical trial of Serenoa repens versus placebo in the management of patients with symptomatic grade I to grade II benign prostatic hyperplasia (BPH). Indian J Urol. 1999;16:26–31. Mohanty NK, Jha H, Dutt C. Randomized double-blind controlled clinical trial of Serenoa repens versus placebo in the management of patients with symptomatic grade I to grade II benign prostatic hyperplasia (BPH). Indian J Urol. 1999;16:26–31.
8.
Zurück zum Zitat 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;58:960–5.CrossRefPubMed 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;58:960–5.CrossRefPubMed
9.
Zurück zum Zitat Shi R, Xie Q, Gang X, et al. Effect of saw palmetto soft gel capsule on lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized trial in Shanghai, China. J Urol. 2008;179:610–5.CrossRefPubMed Shi R, Xie Q, Gang X, et al. Effect of saw palmetto soft gel capsule on lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized trial in Shanghai, China. J Urol. 2008;179:610–5.CrossRefPubMed
10.
Zurück zum Zitat Mattei FM, Capone M, Acconcia A. Medikamentöse Therapie der benignen Prostatahyperplasie mit einem Extrakt der Sägeplame. TW Urol Nephrol. 1990;2:346–50. Mattei FM, Capone M, Acconcia A. Medikamentöse Therapie der benignen Prostatahyperplasie mit einem Extrakt der Sägeplame. TW Urol Nephrol. 1990;2:346–50.
11.
Zurück zum Zitat Löbelenz J. Extractum Sabal fructus bei benigner Prostatahyperplasie (BPH). Therapeutikon. 1992;6(1–2):34–7. Löbelenz J. Extractum Sabal fructus bei benigner Prostatahyperplasie (BPH). Therapeutikon. 1992;6(1–2):34–7.
12.
Zurück zum Zitat Argirovic A, Argirovic D. Does the addition of Serenoa repens to tamsulosin improve its therapeutical efficacy in benign prostatic hyperplasia? Vojnosanit Pregl. 2013;70(12):1091–6.CrossRefPubMed Argirovic A, Argirovic D. Does the addition of Serenoa repens to tamsulosin improve its therapeutical efficacy in benign prostatic hyperplasia? Vojnosanit Pregl. 2013;70(12):1091–6.CrossRefPubMed
13.
Zurück zum Zitat Barry MJ, Meleth S, Lee JY, et al. Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial. JAMA. 2011;306(12):1344–51.CrossRefPubMedPubMedCentral Barry MJ, Meleth S, Lee JY, et al. Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial. JAMA. 2011;306(12):1344–51.CrossRefPubMedPubMedCentral
14.
Zurück zum Zitat Braeckman J, Denis L, de Leval J, et al. A double-blind, placebo-controlled study of the plant extract Serenoa repens in the treatment of benign hyperplasia of the prostate. Eur J Clin Res. 1997;9:247–59. Braeckman J, Denis L, de Leval J, et al. A double-blind, placebo-controlled study of the plant extract Serenoa repens in the treatment of benign hyperplasia of the prostate. Eur J Clin Res. 1997;9:247–59.
15.
Zurück zum Zitat Willetts KE, Clements MS, Champion S, et al. Serenoa repens extract for benign prostate hyperplasia: a randomized controlled trial. BJU Int. 2003;92:267–70.CrossRefPubMed Willetts KE, Clements MS, Champion S, et al. Serenoa repens extract for benign prostate hyperplasia: a randomized controlled trial. BJU Int. 2003;92:267–70.CrossRefPubMed
16.
Zurück zum Zitat Bent S, Kane C, Shinohara K, et al. Saw palmetto for benign prostatic hyperplasia. N Engl J Med. 2006;354(6):557–66.CrossRefPubMed Bent S, Kane C, Shinohara K, et al. Saw palmetto for benign prostatic hyperplasia. N Engl J Med. 2006;354(6):557–66.CrossRefPubMed
17.
18.
Zurück zum Zitat Boccafoschi C, Annoscia S. Confronto fra estratto di Serenoa repens e placebo mediante prova clinical controllata in pazienti con adenomatosi prostatica. Urologia. 1983;50:1257–68. Boccafoschi C, Annoscia S. Confronto fra estratto di Serenoa repens e placebo mediante prova clinical controllata in pazienti con adenomatosi prostatica. Urologia. 1983;50:1257–68.
19.
Zurück zum Zitat Emili E, Lo Cigno M, Petrone U. Risultati clinici su un nuovo farmaco nella terapia dell’ipertrofia della prostata (Permixon). Urologia. 1983;50:1042–8. Emili E, Lo Cigno M, Petrone U. Risultati clinici su un nuovo farmaco nella terapia dell’ipertrofia della prostata (Permixon). Urologia. 1983;50:1042–8.
20.
Zurück zum Zitat Mandressi A, Tarallo U, Maggioni A, et al. Terapia medica dell’adenoma prostatico: Confronto della efficacia dell’estratto di Serenoa repens (Permixon) versus l’estratto di pigeum africanum e placebo. Urologia. 1983;50:752–7. Mandressi A, Tarallo U, Maggioni A, et al. Terapia medica dell’adenoma prostatico: Confronto della efficacia dell’estratto di Serenoa repens (Permixon) versus l’estratto di pigeum africanum e placebo. Urologia. 1983;50:752–7.
21.
Zurück zum Zitat Champault G, Patel JC, Bonnard AM. A double-blind trial of an extract of the plant Serenoa repens in benign prostatic hyperplasia. Br J Clin Pharmacol. 1984;18(3):461–2.CrossRefPubMedPubMedCentral Champault G, Patel JC, Bonnard AM. A double-blind trial of an extract of the plant Serenoa repens in benign prostatic hyperplasia. Br J Clin Pharmacol. 1984;18(3):461–2.CrossRefPubMedPubMedCentral
22.
Zurück zum Zitat Tasca A, Barulli M, Cavazzana A, et al. Trattamento della sintomatologia ostruttiva da adenoma prostatico con estratto di Serenoa repens. Minerva Urol Nefrol. 1985;37:87–91.PubMed Tasca A, Barulli M, Cavazzana A, et al. Trattamento della sintomatologia ostruttiva da adenoma prostatico con estratto di Serenoa repens. Minerva Urol Nefrol. 1985;37:87–91.PubMed
23.
Zurück zum Zitat Reece Smith H, Memon A, Smart CJ, et al. The value of permixon in benign prostatic hypertrophy. Br J Urol. 1986;58:36–40.CrossRefPubMed Reece Smith H, Memon A, Smart CJ, et al. The value of permixon in benign prostatic hypertrophy. Br J Urol. 1986;58:36–40.CrossRefPubMed
24.
Zurück zum Zitat Descotes JL, Rambeaud JJ, Deschaseaux P, et al. Placebo-controlled evaluation of the efficacy and tolerability of permixon in benign prostatic hyperplasia after exclusion of placebo responders. Clin Drug Investig. 1995;9(5):291–7.CrossRef Descotes JL, Rambeaud JJ, Deschaseaux P, et al. Placebo-controlled evaluation of the efficacy and tolerability of permixon in benign prostatic hyperplasia after exclusion of placebo responders. Clin Drug Investig. 1995;9(5):291–7.CrossRef
25.
Zurück zum Zitat Bauer HW, Casarosa C, Cosci M, et al. Sabalfrucht-Extrakt zur Behandlung der benignen Prostatahyperplasie. MMW Fortschr Med. 1999;141(25):62.PubMed Bauer HW, Casarosa C, Cosci M, et al. Sabalfrucht-Extrakt zur Behandlung der benignen Prostatahyperplasie. MMW Fortschr Med. 1999;141(25):62.PubMed
26.
Zurück zum Zitat Stepanov VN, Siniakova LA, Sarrazin B, et al. Efficacy and tolerability of the lipidosterolic extract of Serenoa repens (Permixon) in benign prostatic hyperplasia: a double-blind comparison of two dosage regimens. Adv Ther. 1999;16(5):231–41.PubMed Stepanov VN, Siniakova LA, Sarrazin B, et al. Efficacy and tolerability of the lipidosterolic extract of Serenoa repens (Permixon) in benign prostatic hyperplasia: a double-blind comparison of two dosage regimens. Adv Ther. 1999;16(5):231–41.PubMed
27.
Zurück zum Zitat 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;29:231–40.CrossRefPubMed 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;29:231–40.CrossRefPubMed
28.
Zurück zum Zitat Debruyne F, Koch G, Boyle P, et al. Comparaison d’un produit de phytothérapie (Permixon) et d’un alpha-bloquant (tamsulosine) dans le traitement de l’hypertrophie bénigne de la prostate: étude internationale randomisée d’une durée de 12 mois. Prog Urol. 2002;12:384–94.PubMed Debruyne F, Koch G, Boyle P, et al. Comparaison d’un produit de phytothérapie (Permixon) et d’un alpha-bloquant (tamsulosine) dans le traitement de l’hypertrophie bénigne de la prostate: étude internationale randomisée d’une durée de 12 mois. Prog Urol. 2002;12:384–94.PubMed
29.
Zurück zum Zitat Glemain P, Coulange C, Billebaud T, et al. Tamsulosine avec ou sans Serrenoa repens dans l’hypertrophie bénigne de la prostate: l’essai OCOS. Prog Urol. 2002;12:395–403.PubMed Glemain P, Coulange C, Billebaud T, et al. Tamsulosine avec ou sans Serrenoa repens dans l’hypertrophie bénigne de la prostate: l’essai OCOS. Prog Urol. 2002;12:395–403.PubMed
30.
Zurück zum Zitat Oelke M, Madersbacher S. Primary and secondary prevention of benign prostatic hyperplasia: current knowledge and implications for clinical management. Urologe. 2011;50(10):1257–64.CrossRefPubMed Oelke M, Madersbacher S. Primary and secondary prevention of benign prostatic hyperplasia: current knowledge and implications for clinical management. Urologe. 2011;50(10):1257–64.CrossRefPubMed
31.
Zurück zum Zitat MacDonald R, Tacklind JW, Rutks I, et al. Serenoa repens monotherapy for benign prostatic hyperplasia (BPH): an updated Cochrane systematic review. BJU Int. 2012;109(12):1756–61.CrossRefPubMedPubMedCentral MacDonald R, Tacklind JW, Rutks I, et al. Serenoa repens monotherapy for benign prostatic hyperplasia (BPH): an updated Cochrane systematic review. BJU Int. 2012;109(12):1756–61.CrossRefPubMedPubMedCentral
32.
Zurück zum Zitat Wang JY, Liu M, Zhang YG, et al. Relationship between lower urinary tract symptoms and objective measures of benign prostatic hyperplasia: a Chinese survey. Chin Med J. 2008;121(20):2042–5.PubMed Wang JY, Liu M, Zhang YG, et al. Relationship between lower urinary tract symptoms and objective measures of benign prostatic hyperplasia: a Chinese survey. Chin Med J. 2008;121(20):2042–5.PubMed
33.
Zurück zum Zitat European Union herbal monograph on Serenoa repens (W. Bartram) Small, fructus, EMA/HMPC/280079/2013, Committee on Herbal Medicinal Products (HMPC), London, 24 November 2015, (2015). European Union herbal monograph on Serenoa repens (W. Bartram) Small, fructus, EMA/HMPC/280079/2013, Committee on Herbal Medicinal Products (HMPC), London, 24 November 2015, (2015).
34.
Zurück zum Zitat Vaughan CP, Johnson TM 2nd, Haukka J, et al. The fluctuation of nocturia in men with lower urinary tract symptoms allocated to placebo during a 12-month randomized, controlled trial. J Urol. 2014;191(4):1040–4.CrossRefPubMed Vaughan CP, Johnson TM 2nd, Haukka J, et al. The fluctuation of nocturia in men with lower urinary tract symptoms allocated to placebo during a 12-month randomized, controlled trial. J Urol. 2014;191(4):1040–4.CrossRefPubMed
35.
Zurück zum Zitat Pöyhönen A, Häkkinen JT, Koskimäki J, et al. Natural course of lower urinary tract symptoms in men not requiring treatment – a 5‑year longitudinal population-based study. Urology. 2014;83(2):411–5.CrossRefPubMed Pöyhönen A, Häkkinen JT, Koskimäki J, et al. Natural course of lower urinary tract symptoms in men not requiring treatment – a 5‑year longitudinal population-based study. Urology. 2014;83(2):411–5.CrossRefPubMed
36.
37.
Zurück zum Zitat Avins AL, Lee JY, Meyers CM, et al. Safety and toxicity of saw palmetto in the CAMUS trial. J Urol. 2013;189(4):1415–20.CrossRefPubMed Avins AL, Lee JY, Meyers CM, et al. Safety and toxicity of saw palmetto in the CAMUS trial. J Urol. 2013;189(4):1415–20.CrossRefPubMed
38.
Zurück zum Zitat Aliaev Iu G, Vinarov AZ, Demidko Iu L, et al. The results of the 10-year study of efficacy and safety of Serenoa repens extract in patients at risk of progression of benign prostatic hyperplasia. Urologiia. 2013;4(4):32–6. Aliaev Iu G, Vinarov AZ, Demidko Iu L, et al. The results of the 10-year study of efficacy and safety of Serenoa repens extract in patients at risk of progression of benign prostatic hyperplasia. Urologiia. 2013;4(4):32–6.
Metadaten
Titel
Randomized double-blind controlled clinical trials with herbal preparations of Serenoa repens fruits in treatment of lower urinary tract symptoms
An overview
verfasst von
Rainer C. Görne
Tankred Wegener
Olaf Kelber
Björn Feistel
Jürgen Reichling
Publikationsdatum
01.05.2017
Verlag
Springer Vienna
Erschienen in
Wiener Medizinische Wochenschrift / Ausgabe 7-8/2017
Print ISSN: 0043-5341
Elektronische ISSN: 1563-258X
DOI
https://doi.org/10.1007/s10354-016-0526-2

Weitere Artikel der Ausgabe 7-8/2017

Wiener Medizinische Wochenschrift 7-8/2017 Zur Ausgabe