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Phytotherapy for benign prostatic hyperplasia

Published online by Cambridge University Press:  02 January 2007

Timothy J Wilt*
Affiliation:
Minneapolis VA Center for Chronic Diseases Outcomes Research, 1 Veterans Drive (111-0), Minneapolis, MN 55417, USA
Areef Ishani
Affiliation:
Minneapolis VA Center for Chronic Diseases Outcomes Research, 1 Veterans Drive (111-0), Minneapolis, MN 55417, USA
Indulis Rutks
Affiliation:
Minneapolis VA Center for Chronic Diseases Outcomes Research, 1 Veterans Drive (111-0), Minneapolis, MN 55417, USA
Roderick MacDonald
Affiliation:
Minneapolis VA Center for Chronic Diseases Outcomes Research, 1 Veterans Drive (111-0), Minneapolis, MN 55417, USA
*
*Corresponding author: Email wilt.timothy@minneapolis.va.gov
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Abstract

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Objective

To systematically review the existing evidence regarding the efficacy and safety of phytotherapeutic compounds used to treat men with symptomatic benign prostatic hyperplasia (BPH).

Design

Randomized trials were identified searching MEDLINE (1966–1997), EMBASE, Phytodok, the Cochrane Library, bibliographies of identified trials and review articles, and contact with relevant authors and drug companies. The studies were included if men had symptomatic benign prostatic hyperplasia, the intervention was a phytotherapeutic preparation alone or combined, a control group received placebo or other pharmacologic therapies for BPH, and the treatment duration was at least 30 days. Key data were extracted independently by two investigators.

Results

A total of 44 studies of six phytotherapeutic agents (Serenoa repens, Hypoxis rooperi, Secale cereale, Pygeum africanum, Urtica dioica, Curcubita pepo) met inclusion criteria and were reviewed. Many studies did not report results in a method allowing meta-analysis. Serenoa repens, extracted from the saw palmetto, is the most widely used phytotherapeutic agent for BPH. A total of 18 trials involving 2939 men were reviewed. Compared with men receiving placebo, men taking Serenoa repens reported greater improvement of urinary tract symptoms and flow measures. Serenoa repens decreased nocturia (weighted mean difference (WMD)=−0.76 times per evening; 95% CI=−1.22 to −0.32; n=10 studies) and improved peak urine flow (WMD=1.93 ml s−1; 95% CI=0.72 to 3.14, n=8 studies). Men treated with Serenoa repens rated greater improvement of their urinary tract symptoms versus men taking placebo (risk ratio of improvement=1.72; 95% CI=1.21 to 2.44, n=8 studies). Improvement in symptoms of BPH was comparable to men receiving the finasteride. Hypoxis rooperi (n=4 studies, 519 men) was also demonstrated to be effective in improving symptom scores and flow measures compared with placebo. For the two studies reporting the International Prostate Symptom Score, the WMD was −4.9 IPSS points (95% CI=−6.3 to −3.5, n=2 studies) and the WMD for peak urine flow was 3.91 ml s−1 (95% CI=0.91 to 6.90, n=4 studies). Secale cereale (n=4 studies, 444 men) was found to modestly improve overall urological symptoms. Pygeum africanum (n=17 studies, 900 men) may be a useful treatment option for BPH. However, review of the literature has found inadequate reporting of outcomes which currently limit the ability to estimate its safety and efficacy. The studies involving Urtica dioica and Curcubita pepo are limited although these agents may be effective combined with other plant extracts such as Serenoa and Pygeum. Adverse events due to phytotherapies were reported to be generally mild and infrequent.

Conclusions

Randomized studies of Serenoa repens, alone or in combination with other plant extracts, have provided the strongest evidence for efficacy and tolerability in treatment of BPH in comparison with other phytotherapies. Serenoa repens appears to be a useful option for improving lower urinary tract symptoms and flow measures. Hypoxis rooperi and Secale cereale also appear to improve BPH symptoms although the evidence is less strong for these products. Pygeum africanum has been studied extensively but inadequate reporting of outcomes limits the ability to conclusively recommend it. There is no convincing evidence supporting the use of Urtica dioica or Curcubita pepo alone for treatment of BPH. Overall, phytotherapies are less costly, well tolerated and adverse events are generally mild and infrequent. Future randomized controlled trials using standardized preparations of phytotherapeutic agents with longer study durations are needed to determine their long-term effectiveness in the treatment of BPH.

Type
Research Article
Copyright
Copyright © CABI Publishing 2000

References

1Lowe, FC, Ku, JC. Phytotherapy in treatment of benign prostatic hyperplasia: a critical review. Urology 1996; 48: 1220.Google Scholar
2Int. Med. World Report, 02 1998, Vol. 13, No. 3, 8 pp.Google Scholar
3Ernst, E.Harmless herbs? A review of the recent literature. Am. J. Med. 1998; 104: 170–8.Google Scholar
4Di Silverio, F, Flammia, GP, Sciarra, A, Caponera, M, Mauro, M, Buscarini, M, et al. Plant extracts in benign prostatic hyperplasia. Minerva Urol. Nefrol. 1993; 45: 143–9.Google Scholar
5Bales, G, Christiano, AP, Kirsh, E, Gerber, GS. Phytotherapeutic agents in the treatment of lower urinary tract symptoms: a demographic analysis of awareness and use at the University of Chicago. Urology 1999; 54: 8689.Google Scholar
6Lowe, FC, Dreikorn, K, Borkowski, A, Braeckman, J, Denis, L, Ferrari, P et al. Review of recent placebo-controlled trials utilizing phytotherapeutic agents for treatment of BPH. Prostate 1998; 37: 187–93.Google Scholar
7Fitzpatrick, JM. Phytotherapy for treatment of benign prostatic hyperplasia: case not proven. Urology 1999; 53: 462–4.Google Scholar
8Mulrow, CD. Rationale for systematic reviews. BMJ 1994; 309: 597–9.Google Scholar
9Dreikorn, K, Richter, R. Conservative nonhormonal treatment of patients with benign prostatic hyperplasia. In: Ackerman, R, Schroeder, FH, eds. New Developments in Biosciences 5, Prostatic Hyperplasia.Berlin: Walter de Gruyter & Co,1989; 109–31.Google Scholar
10Marwick, C.Growing use of medicinal botanicals forces assessment by drug regulators. JAMA 1995; 273: 607–9.Google Scholar
11McGuire, E. Detrusor response to obstruction. NIH Publication No. 87-2881, Department of Health and Human Services, Rockville, MD, 1987: 221.Google Scholar
12Di Silverio, F, D'Eramo, G, Lubrano, C, Flammia, GP, Sciarra, A, Palma, E, et al. Evidence that Serenoa repens extract displays an antiestrogenic activity in prostatic tissue of benign prostatic hypertrophy patients. Eur. Urol. 1992; 2: 309–14.Google Scholar
13Wilt, TJ, Ishani, A, Stark, G, MacDonald, R, Lau, J, Mulrow, C.Saw palmetto extracts for treatment of benign prostatic hyperplasia: a systematic review. JAMA 1998; 280: 1604–9.Google Scholar
14Boccafoschi, C, Annoscia, S.Confronto fra estratto di Serenoa repens e placebo mediate prova clinica controllata in pazienti con adenomatosi prostatica. Urologia 1983; 50: 1257–68.Google Scholar
15Braeckman, J, Denis, L, de Lavel, J, Keuppens, F, Cornet, A, De Bruyne, R, 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.Google Scholar
16Carbin, BE, Larsson, B, Lindahl, O.Treatment of benign prostatic hyperplasia with phytosterols. Br. J. Urol. 1990; 66: 639–41.Google Scholar
17Carraro, JC, Raynaud, JP, Koch, G, Chisholm, GD, Di Silverio, F, Teillac, P, et al. . Comparison of phytotherapy (Permixon) with finasteride in the treatment of benign prostate hyperplasia: a randomized international study of 1098 patients. Prostate 1996; 29: 231–40.Google Scholar
18Champault, 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: 461–2.Google Scholar
19Cukier, J, Ducassou, J, Le Guillou, M, Leriche, A, Lobel, B, Toubol, J.Permixon versus placebo; resultats d'une étude multicentrique. C. R. Therapeut. Pharmacol. Clin. 1985; 4: 1521.Google Scholar
20Descotes, JL, Rambeaud, JJ, Deschaseaux, P, Faure, G.Placebo-controlled evaluation of the efficacy and tolerability of Permixon in benign prostatic hyperplasia after the exclusion of placebo responders. Clin. Drug Invest. 1995; 5: 291–7.Google Scholar
21Emili, E, Lo Cigno, M, Petrone, U.Risultati clinici su un nuovo farmaco nella terapia dell'ipertofia della prostata (Permixon). Urologia 1983; 50: 1042–8.Google Scholar
22Gabric, V, Miskic, H.Behandlung des benignen prostata-adenoms und der chronischen prostatatitis. Therapiewoche 1987; 37: 1775–88.Google Scholar
23Lobelenz, J.Extractum Sabal fructus bei benigner prostatahyperplasie (BPH). Klinische prufung im stadium I und II. Therapeutikon 1992; 6: 34–7.Google Scholar
24Mandressi, S, Tarallo, U, Maggioni, A, Tombolini, P, Rocco, F, Quadraccia, S.Terapia medica dell'adenoma prostatico: confronto della efficacia dell'estratto di Serenoa repens (Permixon®) versus l'estratto di. Pygeum Africanum e placebo. Valutazione in doppio cieco. Urologia 1983; 50: 752–8.Google Scholar
25Mattei, FM, Capone, M, Acconcia, A.Medikamentose therapie der benignen prostatahyperplasie mit einem extrakt der sagepalme. TW Urol. Nephrol. 1990; 2: 346–50.Google Scholar
26Metzker, H, Kieser, M, Hölscher, U.Wirksamkeit eines Sabal–Urtica-kombinationspräparats bei der behandlung der benignen prostatahyperplasie (BPH). Urologe B 1996; 36: 292300.Google Scholar
27Pannunzio, E, D'Ascenzo, R, Giardinetti, F, Civili, P, Persichelli, E. Serenoa repens vs. gestonorone caproato nel trattamento dell'ipertofia prostatica benigna: Studio randomizzato. Urologia 1986; 53: 696705.Google Scholar
28Reece Smith, H, Memon, A, Smart, CJ, Dewbury, K.The value of permixon in benign prostatic hypertrophy. Br. J. Urol. 1986; 58: 3640.Google Scholar
29Roveda, S, Colombo, P.Sperimentazione clinica controllata sulla bioequivalenza terapeutica e sulla tollerabilita dei prodotti a base di Serenoa repens in capsule da 160 mg o capsule rettali da 640 mg. Arch. Med. Intern. 1994; 46: 6175.Google Scholar
30Sokeland, J, Albrecht, J.Kombination aus Sabal und Urticaestrakt vs. finasterid bei BPH (Stad. I bis II nach Alken); Vergleich der therapeutischen wirksamkeit in einer einjahrigen doppelblindstudie. Urologe A 1997; 36: 327–33.Google Scholar
31Tasca, A, Barulli, M, Cavazzana, A, Zattoni, F, Artibani, W, Pagano, F.Trattamento della sintomatologia ostruttiva da adenoma prostatico con estratto di Serenoa repens. Studio clinico in doppio cieco vs. placebo. Minerva Urol. Nefrol. 1985; 37: 8791.Google Scholar
32Boyle, P, Gould, AL, Roehrborn, CG. Prostate volume predicts outcome of treatment of benign prostatic hyperplasia with finasteride: A meta-analysis of randomized clinical trials. Urology 1996; 48: 398405.Google Scholar
33McConnell, JD, Bruskewitz, R, Walsh, P, Andriole, G, Lieber, M, Holtgrewe, L et al. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. N. Engl. J. Med. 1998; 338: 557–63.Google Scholar
34Berges, RR, Windeler, J, Trampisch, HJ, Senge, TH. Randomised, placebo-controlled, double-blind clinical trial of β-sitosterol in patients with benign prostatic hyperplasia. Lancet 1995; 345: 1529–32.Google Scholar
35Fischer, A, Jurincic-Winkler, CD, Klippel, KF. Conservative treatment of benign prostatic hyperplasia with high-dosage β-sitosterol (65 mg): results of a placebo-controlled double-blind study. Uroscop 1993; 1: 1220.Google Scholar
36Kadow, C, Abrams, PH. A double-blind trial of the effect of beta-sitosteryl glucoside (WA184) in the treatment of benign prostatic hyperplasia. Eur. Urol. 1986; 12: 187–9.Google Scholar
37Klippel, KF, Hiltl, DM, Schipp, B.A multicentric, placebo-controlled, double-blind clinical trial of β-sitosterol (phytosterol) for the treatment of benign prostatic hyperplasia. Br. J. Urol. 1997; 80: 427–32.Google Scholar
38 AB Cernelle. Engleholm, Sweden.Google Scholar
39Ruyan, D, Cernitin American. Personal communication, 19 February 1999.Google Scholar
40Buck, AC. Phytotherapy for the prostate. Br. J. Urol. 1996; 78: 325–6.Google Scholar
41Ito, R, Ishii, M, Yamashita, S.Antiprostatic hypertrophic action of Cernilton pollen-extract. Pharmacometrics 1986; 31: 111.Google Scholar
42Kimura, M, Kimura, I, Nakase, K, Sonobe, T, Mori, E.Micturition activity of pollen extract: contractile effects on bladder and inhibitory effects on urethral smooth muscle of mouse and pig. Planta Med. 1986; 2: 148–51.Google Scholar
43Nakase, S, Takenaka, K, Hamanaka, T, Kimura, M.Effects of Cernilton pollen-extract on the urethral smooth muscle and diaphragmatic neuromuscular specimen. Folio Pharmacol. Jpn. 1988; 91: 385–92.Google Scholar
44Becker, H, Ebeling, L.Konservative therapie der benignen prostata-hyperplasie (BPH) mit Cernilton®N: ergebnisse einer plazebokontrollierten doppleblindstudie. Urologe B 1988; 28: 301–6.Google Scholar
45Buck, AC, Cox, R, Rees, RWM, Ebeling, L, John, A.Treatment of outflow tract obstruction due to benign prostatic hyperplasia with the pollen-extract, Cernilton: a double-blind, placebo-controlled study. Br. J. Urol. 1990; 66: 398404.Google Scholar
46Dutkiewicz, S.Usefulness of Cernilton in the treatment of benign prostatic hyperplasia. Int. Urol. Nephrol. 1984; 28: 4953.Google Scholar
47Maekawa, M, Kishimoto, T, Yasumoto, R, Wada, S, Harada, T, Ohara, T.Clinical evaluation of Cernilton on benign prostatic hypertrophy: a multiple center double-blind study with Paraprost. Hinyo Kiyo 1981; 27: 317–26.Google Scholar
48Andro, MC, Riffaud, JP. Pygeum africanum for the treatment of patients with benign prostatic hyperplasia: a review of 25 years of published experience. Curr. Ther. Res. 1995; 56: 796817.Google Scholar
49Barlet, A, Albrecht, J, Aubert, A, Fischer, M, Grof, F, Grothuesmann, HG et al. Efficacy of Pygeum africanum extract in the medical therapy of urination disorders due to benign prostatic hyperplasia: evaluation of objective and subjective parameters. A placebo-controlled double-blind multicenter study. Wien. Klin. Wochenschr. 1990; 102: 667–73.Google Scholar
50Barth, H. Non hormonal treatment of benign prostatic hypertrophy. Clinical evaluation of the active extract of Pygeum africanum. Proceedings of Symposium on Benign Prostatic Hypertrophy, Paris. 1981; 45–8.Google Scholar
51Bassi, P, Artibani, W, De Luca, V, Zattoni, F, Lembo, A.Standardized extract of Pygeum africanum in the treatment of benign prostatic hypertrophy. Controlled clinical study versus placebo. Minerva Urol. Nefrol. 1987; 39: 4550.Google Scholar
52Blitz, M, Garbit, JL, Masson, JC. Etude controlee de l'efficacite d'un traitemente medical sur des sujets consultant pour la premiere fois pour un adenome de la prostate. Lyon Mediterr. Med. 1985; 21: 11.Google Scholar
53Bongi, G.II Tadenan nella terapia dell'adenoma prostatico. Studio anatomo-clinico. Minerva Urol. 1972; 24: 124–38.Google Scholar
54Donkervoort, T, Sterling, A, van Ness, J, Donker, PJ. A clinical and urodynamic study of Tadenan in the treatment of benign prostatic hypertrophy. Eur. Urol. 1977; 3: 218–25.Google Scholar
55Dufour, B, Choquenet, C, Revol, M, Faure, G, Jorest, R.Controlled study of the effects of Pygeum africanum extract on the functional symptoms of prostatic adenoma. Ann. Urol. 1984; 18: 193–5.Google Scholar
56Frasseto, G, Bertoglio, S, Mancuso, S, Ervo, R, Mereta, F.Studio sull'efficacia e sulla tollerabilita del Tadenan 50 in pazienti affeti da ipertrofia prostatica. Prog. Med. 1986; 42: 4953.Google Scholar
57Gagliardi, V, Apicella, F, Pino, P, Falchi, M.Terapia medica dell'ipertrofia prostatica. Sperimentazione clinica controllata. Arch. Ital. Urol. Nefrol. Andrologia 1983; 55: 5169.Google Scholar
58Giacobini, S, von Heland, M, de Natale, G, Gentile, V, Bracci, U.Valutazione clinica e morfo-funzionale del trattamento a doppio cieco con placebo. Tadenan 50 e Tadenan 50 associato a Farlutal nei pazienti con ipertrofia prostatica benigna. Antologia Med. Ital. 1986; 6: 110.Google Scholar
59Krzeski, T, Kazon, M, Borkowski, A, Witeska, A, Kuczera, J.Combined extracts of Urtica dioica and Pygeum africanum in the treatment of benign prostatic hyperplasia: Double-blind comparison of two doses. Clin. Ther. 1993; 15: 1011–20.Google Scholar
60Maver, A.Medical treatment of fibroadenomatous hypertrophy of the prostate with a new plant substance. Minerva Med. 1972; 63: 2126–36.Google Scholar
61Ranno, S, Minaldi, G, Viscusi, G, Di Marco, G, Consoli, C.Efficacia e tollerabilita del trattamento dell' adenoma prostatico con Tadenan 50. Prog. Med. 1986; 42: 165–9.Google Scholar
62Rigatti, P, Zennaro, F, Fraschini, O, Oxilia, A.L'impegio del Tadenan nell'adenoma prostatico. Ricerca clinica controllata. Atti Accad. Med. Lomb. 1983; 38: 14.Google Scholar
63Rizzo, M, Tosto, A, Paoletti, MC, Raugei, A, Favini, P, Nicolucci, A.Terapia medica dell'adenoma della prostata: Valutazione clinica comparativa tra estratto di Pygeum africanum ad alte dosi e placebo. Farmacia Terapia 1985; 2: 105–10.Google Scholar
64Englemann, U, Boos, G, Kres, H.Therapie der benignen Prostatahyperplasie mit Bazoton liquidum. Urologe B 1996; 36: 287–91.Google Scholar
65Vontobel, HP, Herzog, R, Rutihauser, G, Kres, H.Results of a double-blind study on the effectiveness of ERU (extractum radicis Urticae) capsules in conservative treatment of benign prostatic hyperplasia. Urologe A 1985; 24: 4951.Google Scholar
66McKinney, DE. Re: Saw palmetto for Benign Prostatic Hyperplasia. JAMA 1999; 281:1699.Google Scholar