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Monograph: Saw palmetto, liposterolic extract

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and label for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Note: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicant's discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.

Date: 2010-12-23

NHPID Name

Saw palmetto liposterolic extract (USDA 2008)

Proper Name(s)

Serenoa repens (W. Bartram) Small (Arecaceae) ( USDA 1997 )

Common Name(s)

Saw palmetto liposterolic extract ( USDA 2008 )

Source Material

Fruit ( Blumenthal et al. 2000 , Mills and Bone 2000 , USP 32 )

Route Of Administration

Oral

Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

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  (Croom and Chan 2010, Bradley 2006, Wilt et al. 2002, Blumenthal et al. 2000, USP 32)

Dose(s)

Adult males:

Preparation: Dry standardised

Dose(s): 100 - 400 Milligrams per day, saw palmetto fruit lipidosterolic extract 70-95 Percent Fatty acids
Directions For Use: Take with food to minimize gastric disturbance (DerMarderosian and Beutler 2009, USP 32)


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 is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Consult a health care practitioner if symptoms persist.
  • Consult a health care practitioner if symptoms worsen.
  • Consult a health care practitioner prior to use to exclude a diagnosis of prostate cancer  (Mills and Bone 2005, USP 32)

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
No statement is required

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database and must meet the limitations outlined in the database.

Storage Conditions

Store in a tightly closed, light-resistant container in a cool, dry place (USP 32, WHO 2002).

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • Acceptable lipophilic extraction methods of the dried saw palmetto fruit (Croom and Chan 2010, USP Verified 2010, derMarderosian and Beutler 2009) are as follows: N-hexane, Supercritical carbon dioxide, 90 % ethanol.
  • Note: Information detailed in this section is not to be submitted with the compendial PLA, although it may be requested at Health Canada's discretion.
  • 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 Saw Palmetto Fruit monograph published in the British Pharmacopoeia, the Saw Palmetto Fruit monograph published in the European Pharmacopoeia, the Saw Palmetto monograph published in the US Pharmacopeia, Powdered Saw Palmetto monograph published in the US Pharmacopeia, or the Saw Palmetto Extract monograph published in the US Pharmacopeia.

References cited

  • Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
  • BP 2009: British Pharmacopoeia Commission. 2008. British Pharmacopoeia 2009. Volume III. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA).
  • 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.
  • Croom EM, Chan M. Saw palmetto. Dans: Coates PM, Betz JM, Blackman MR, Cragg GM, Levine M, Moss J, White JD, editors. Encyclopedia of Dietary Supplements. Second Edition. New York (NY): Informa Healthcare; 2010. p. 700-710.
  • derMarderosian A, Beutler JA, editors. The Review of Natural Products. [Saw Palmetto: Issue date June 2009; Updated July 2009]. St Louis (MO): Facts and Comparisons, Wolters Kluwer Health; Printed in 2008 and Updated to November 2010.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
  • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
  • Ph.Eur. 2007: European Pharmacopoeia Commission. European Pharmacopoeia. 6th edition, Volume 2. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM); 2007.
  • USDA 1997: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). "Serenoa repens (W. Bartram) Small". Last updated May 1997. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2010-12-02]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • USP 32: United States Pharmacopeial Convention. United States Pharmacopeia and the National Formulary (USP 32 - NF 27). Rockville (MD): The United States Pharmacopeial Convention; 2009.
  • USP Verified 2010: U.S. Pharmacopeia Verified Dietary Supplements. Saw Palmetto [Accessed 2010-11-26]. The United States Pharmacopeial Convention; 2010. Available at: http://www.usp.org/USPVerified/dietarySupplements/sawpalmetto.html?USP_Print
  • WHO 2002: World Health Organization. WHO Monographs on Selected Medicinal Plants. Volume 2. "Fructus Serenoae Repentis". Geneva (CH): World Health Organization; 2002.
  • Wilt T, Ishani A, Stark G, MacDonald R, Mulrow C, Lau J. Serenoa repens for benign prostatic hyperplasia. Cochrane Database Syst Rev 2000; (2): CD001423.
  • Wilt T, Ishani A, Stark G, MacDonald R, Mulrow C, 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. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Brinker F. 2010. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Updated 2010 July 13; Accessed 2013 January 30]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • 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. Herbal medications for common ailments in the elderly. Drugs & Aging 1999;15(6):423-428.
  • 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.
  • 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.
  • Gerber GS. Saw palmetto for the treatment of men with lower urinary tract symptoms. The Journal of Urology 2000;163(5):1408-1412.
  • 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. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
  • Khwaja TA, Friedman EP. Pharmaceutical grade saw palmetto. United States Patent 6039950. Los Angeles (CA): University of Southern California and Irvine (CA): Pharmaprint Inc. 2000. [Accessed 2010-10-19]. Available at: http://www.freepatentsonline.com/6039950.html
  • 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.
  • Sorenson WR, Sullivan D. 2007. Determination of campesterol, stigmasterol, and beta sitosterol in saw palmetto raw materials and dietary supplements by gas chromatography: collaborative study. Journal of the Association of Official Analytical Chemists [AOAC] International 90(3):670-678
  • Tacklind J, MacDonald R, Rutks I, Wilt TJ. Serenoa repens for benign prostatic hyperplasia. Cochrane Database of Systematic Reviews 2009, Issue 2. Art. No.: CD001423. DOI: 10.1002/14651858.CD001423.pub2
  • 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 dosage preparations and frequencies of use taken verbatim from the cited references

Fluid extract:

2-4 g dried equivalent, per day BPC 1934 (1:1, 90% ethanol, 2-4 ml) (BHP 1983) (Bradley 2006)

Soft native extract (lipophilic extract):

  • 10:1-14:1 (w/w) (contains ~85-95% fatty acids): 160 mg, twice daily (Blumenthal et al. 2000)
  • extracts standardized to 85% to 95% fatty acids (derMarderosian and Beutler 2009)

Dry normalized extract:

  • 4:1 (w/w) (contains ~ 25% fatty acids): 400 mg, twice daily (Blumenthal et al. 2000)
  • extracts standardized to 25% (derMarderosian and Beutler 2009)

Standardized extract:

  • Clinical Trial Preparations: Liposterolic Extract (LESP)— 320 mg orally once daily or 160 mg twice daily (liquid or solid), with an approximate 10:1 herb to extract ratio (HER), standardized to 70 to 95% free fatty acids which corresponds to about 3 grams of dried fruits daily. All doses should be taken with food to minimize gastric disturbances (USP Verified 2010).
  • Saw Palmetto Extract: Saw Palmetto extract is obtained from comminuted Saw Palmetto by extraction with hydroalcoholic mixtures or solvent hexane, or by supercritical extraction with carbon dioxide. The ratio of starting crude plant material to Extract is between 8.0:1 and 14.3:1. The Extract contains not less than 70.0 percent and not more than 95.0 percent of fatty acids and not less than 0.2 percent and not more than 0.5 percent of sterols, calculated on an anhydrous basis (USP 32).
  • Typical dosages of standardized extracts range from 100 to 400 mg given twice daily (derMarderosian and Beutler 2009).
  • 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)