Saw Palmetto

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Note: The archived version of this monograph has been temporarily removed. For an electronic copy of this archived version, please contact the Natural Health Products Directorate (NHPD) at NHPD_DPSN@hc-sc.gc.ca.

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Date: April 15, 2008

Proper name(s): Serenoa repens (W. Bartram) Small (Arecaceae) (USDA 1997)

Common name(s): Saw palmetto (McGuffin 2000; USDA 1997)

Source material(s): Fruit (Mills and Bone 2000; Blumenthal et al. 2000)

Route(s) of administration: Oral

Dosage form(s): Those suited to the allowable route(s) of administration. This monograph is not intended to include food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s): Used in Herbal Medicine to help relieve the urologic symptoms (e.g. weak urine flow, incomplete voiding, frequent daytime and night time urination) associated with mild to moderate benign prostatic hyperplasia (Bradley 2006; Wilt et al. 2002; Blumenthal et al. 2000)

Dose(s):

Subpopulation: Adult males = 19 years

Quantity:

Dried fruit: Preparations equivalent to 1-4 g, per day (Bradley 2006; Blumenthal et al. 2000)

Standardized extract: 320 mg saw palmetto fruit lipidosterolic extract, per day (Bradley 2006; Blumenthal et al. 2000)

See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use: No statement required.

Risk information: Statement(s) to the effect of:

Caution(s) and warning(s):

• Consult a healthcare practitioner if symptoms persist or worsen.
• Consult a health care practitioner prior to use to exclude a diagnosis of prostate cancer (Mills and Bone 2005).

Contraindication(s): No statement required.

Known adverse reaction(s): No statement required.

Non-medicinal ingredients: Must be chosen from the current NHPD List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.

Specifications:

• The finished product must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs.
• The medicinal ingredient may comply with the specifications outlined in the pharmacopoeial monographs listed in Table 1 below.

Table 1: Saw Palmetto monographs published in British, European and US Pharmacopoeias

Pharmacopoeia	Monograph
British Pharmacopoeia	Saw Palmetto Fruit
European Pharmacopoeia	Saw Palmetto Fruit
US Pharmacopoeia	Saw Palmetto, Powdered Saw Palmetto, Saw Palmetto Extract, Saw Palmetto Capsules

References cited:

Blumenthal M, Goldberg A, Brinkmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.

Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (UK): British Herbal Medicine Association; 2006.

McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.

Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.

Mills S, Bone K. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone; 2000.

USDA 1997: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Serenoa repens (W. Bartram) Small. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-04-15]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

Wilt T, Ishani A, Stark G, MacDonald R, Mulrow C, and Lau J. Serenoa repens for benign prostatic hyperplasia. The Cochrane Library 2002;1:1-14.

References reviewed:

Beckert BW, Concannon MJ, Henry SL, Smith DS, Puckett CL. The effect of herbal medicines on platelet function: an in vivo experiment and review of the literature. Plastic and Reconstructive Surgery 2007;120(7):2044-2050.

Bent S, Kane C, Shinohara K, Neuhaus J, Hudes ES, Goldberg H, Avins AL. Saw palmetto for benign prostatic hyperplasia. The New England Journal of Medicine 2006;354(6):557-565.

Bone K. Saw Palmetto: a critical review. The European Journal of Herbal Medicine 1994(1):15-24.

Boyle P, Robertson C, Lowe F, Roehrborn C. Meta-analysis of clinical trials of permixon in the treatment of symptomatic benign prostatic hyperplasia. Urology 2000;55(4):533-539.

Braeckman J. The extract of Serenoa repens in the treatment of benign prostatic hyperplasia: a multicenter open study. Current Therapeutic Research 1994;55(7):776-785.

Brinker F. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2008. [Accessed 2008-04-15]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html

Brinker F. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.

Cheema P, El-Mefty O, Jazieh AR. Intraoperative haemorrhage associated with the use of extract of Saw Palmetto herb: a case report and review of literature. Journal of Internal Medicine 2001;250(2):167-169.

Chitturi S, Farrell GC. Herbal hepatotoxicity: an expanding but poorly defined problem. Journal of Gastroenterology and Hepatology 2000 Oct;15(10):1093-1099.

De Bernardi di Valserra M, Tripodi AS, Contos S, Germogli R. Serenoa repens capsules: a bioequivalence study. Acta Toxicologia Therapeutica 1994;15(1):21-39.

Debruyne F, Koch G, Boyle P, Da Silva FC, Gillenwater JG, Hamdy FC, Perrin P, Teillac P, Vela-Navarrete R, Raynaud JP. Comparison of a phytotherapeutic agent (Permixon) with an alpha-blocker (Tamsulosin) in the treatment of benign prostatic hyperplasia: a 1-year randomized international study. European Urology 2002;41(5):497-507.

Di Silverio F, D'Eramo G, Lubrano C, Flammia GP, Sciarra A, Palma E, Caponera M, Sciarra F. Evidence that Serenoa repens extract displays an antiestrogenic activity in prostatic tissue of benign prostatic hypertrophy patients. European Urology 1992;21(4):309-314.

Di Silverio F, Monti S, Sciarra A, Varasano PA, Martini C, Lanzara S, D'Eramo G, Di Nicola S, Toscano V. Effects of long-term treatment with Serenoa repens (Permixon) on the concentrations and regional distribution of androgens and epidermal growth factor in benign prostatic hyperplasia. Prostate 1998;37(2):77-83.

Ernst E. The risk-benefit profile of commonly used herbal therapies: Ginkgo, St. John's Wort, Ginseng, Echinacea, Saw Palmetto, and Kava. Annals of Internal Medicine 2002;136(1):42-53.

Ernst E. Herbal medications for common ailments in the elderly. Drugs & Aging 1999;15(6):423-428.

Gerber GS. Saw palmetto for the treatment of men with lower urinary tract symptoms. The Journal of Urology 2000;163(5):1408-1412.

Gerber GS, Fitzpatrick JM. The role of a lipido-sterolic extract of Serenoa repens in the management of lower urinary tract symptoms associated with benign prostatic hyperplasia. British Journal of Urology International 2004;94(3):338-344.

Goepel M, Hecker U, Krege S, Rübben H, Michel MC. Saw palmetto extracts potently and noncompetitively inhibit human alpha1-adrenoceptors in vitro. Prostate 1999;38(3):208-215.

Grasso M, Montesano A, Buonaguidi A, Castelli M, Lania C, Rigatti P, Rocco F, Cesana BM, Borghi C. Comparative effects of alfuzosin versus Serenoa repens in the treatment of symptomatic benign prostatic hyperplasia. Archivos españoles de urología 1995;48(1):97-103.

Hoffmann D. Medical Herbalism. Rochester (VT): Healing Arts Press; 2003.

Marks LS, Hess DL, Dorey FJ, Luz Macairan M, Cruz Santos PB, Tyler VE. Tissue effects of saw palmetto and finasteride: use of biopsy cores for in situ quantification of prostatic androgens. Urology 2001;57(5):999-1005.

Yue QY. Herbal drug curbicin and anticoagulant effect with and without warfarin: possibly related to the vitamin E component. Journal of the American Geriatric Society 2001;49(6)838.

Appendix 1: Examples of appropriate dosage preparations and frequencies of use

Dried berry:

• 2-4 g, per day (Bradley 2006)
• 1-2 g, per day (Blumenthal et al. 2000)

Fluidextract: 2-4 g dried equivalent, per day
(1:1, 90% ethanol, 2-4 ml) (Bradley 2006)

Tincture: 1-2 g dried equivalent, 2 times per day
(1:2, 2-4 ml) (Blumenthal et al. 2000)

Standardized extract:

• 320 mg saw palmetto fruit lipidosterolic extract, per day (Bradley 2006)
• 320 mg lipophilic ingredients (extracted with lipophilic solvents such as hexane or ethanol 90% v/v), per day (Blumenthal et al. 2000)