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Monograph: Pygeum - Prunus Africana (Under consultation)

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.

Date

December 8, 2015

Proper Name(s)

Prunus africana (Hook.f.) Kalkman (Rosaceae) (USDA 2009)

Common Name(s)

  • Pygeum (USDA 2009)
  • Red stinkwood (Godfrey et al. 2010)

Source Material(s)

  • Stem bark (Godfrey et al. 2010; Mills and Bone 2005)
  • Trunk bark (Godfrey et al. 2010; Mills and Bone 2005)

Route(s) 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:

Helps reduce the urologic symptoms (e.g. weak urine flow, incomplete voiding, frequent daytime and nighttime urination) associated with benign prostatic hyperplasia (Wilt et al. 2002; Ishani et al. 2000; Chatelain et al. 1999; Breza et al. 1998; Carani et al. 1991; Barlet et al. 1990).

Dose(s)

Subpopulation

Adult Males (≥ 18 years)

Quantities

Products making a claim for symptoms of benign prostatic hyperplasia

All standardized extracts

75 ≥ 200 mg of extract per day standardized to 12-14% phytosterols (Wilt et al. 2002; Ishani et al. 2000; Chatelain et al. 1999; Breza et al. 1998; Carani et al. 1991; Barlet et al. 1990).

All other products (safety only)

Valid only for Class II and III applications for supporting safety in adults

Dry, powder, tincture, fluid extract, decoction

Up to 4 g dried pygeum bark per day1

Potency (optional): Up to 14% phytosterols; not to exceed 28 mg phytosterols per day (Wilt et al. 2002; Ishani et al. 2000; Chatelain et al. 1999; Breza et al. 1998; Carani et al. 1991; Barlet et al. 1990)

1Note
Maximum daily dose of the crude material is based on a conservative extrapolation of the dose supported in the available evidence

Duration of Use

No statement required.

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s)

Products making a claim for symptoms of benign prostatic hyperplasia
  • If symptoms persist or worsen, consult a health care practitioner.
  • To exclude the diagnosis of prostate cancer, consult a health care practitioner prior to use (Goldman and Ausiello 2004).
Products for adults (i.e. including women):Valid only for Class II and III applications

If pregnant or breastfeeding, consult a health care practitioner prior to use.

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

Non Medicinal Ingredients

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

Storage Condition(s)

No statement required.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.
  • Please note that this organism, one of its parts, or the organism or part from which this ingredient is derived, is considered at risk and is listed in Appendix II of CITES. Details are available at the Next link will take you to another Web site following location.

References Cited

Barlet A, Albrecht J, Aubert A, Fischer M, Grof F, Grothuesmann HG, Masson JC, Mazeman E, Mermon R, Reichelt H. 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. Wiener Klinische Wochenschrrift 1990;102(22):667-73.

Breza J, Dzurny O, Borowka A, Hanus T, Petrik R, Blane G, Chadha-Boreham H. Efficacy and acceptability of tadenan (Pygeum africanum extract) in the treatment of benign prostatic hyperplasia (BPH): a multicentre trial in central Europe. Current Medical Research and Opinion 1998;14(3):127-39.

Carani C, Salvioli V, Scuteri A, Borelli A, Baldini A, Granata AR, Marrama P. Urological and sexual evaluation of treatment of benign prostatic disease using Pygeum africanum at high doses. Archivio italiano di urologia, nefrologia, andrologia 1991 Sep;63(3):341-5

Chatelain C, Autet W, Brackman F. Comparison of once and twice daily dosage forms of Pygeum africanum extract in patients with benign prostatic hyperplasia: a randomized, double-blind study, with long-term open label extension. Urology 1999 Sep;54(3):473-8.

Godfrey A, Saunders PR, with Barlow K, Gilbert C, Gowan M, Smith F. Principles and Practices of Naturopathic Botanical Medicine. Volume 1: Botanical Medicine Monographs. Toronto (ON): CCNM Press; 2010.

Goldman L, Ausiello D. Cecil Textbook of Medicine. 22nd edition. Philadelphia (PA): Saunders; 2004.

Ishani A, MacDonald R, Nelson D, Rutks I, Wilt TJ. Pygeum africanum for the treatment of patients with benign prostatic hyperplasia: a systematic review and quantitative meta-analysis. American Journal of Medicine 2000;109: 654-66

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

USDA 2009: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Next link will take you to another Web site Germplasm Resources Information Network (GRIN)). [Internet]. National Germplasm Resources Laboratory, Beltsville (MD). [Prunus africana (Hook.f.) Last updated 2011 Mar 03; Accessed 2014 June 9].

Wilt T, Ishani A, MacDonald R, Rutks I, Stark G. Pygeum africanum for benign prostatic hyperplasia (review). Cochrane Database of Systematic Reviews 2002;(1):CD001044

References Reviewed

Brinker, F. 2009. Next link will take you to another Web site Updates and Additions for Herb Contradictions and Drug Interactions, 3rd ed. With extensive appendices addressing influences on phase i, ii & iii metabolism [Accessed 2013-Aug-14].

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

Kadu C, Parich A, Schueler S, Konrad H, Muluvi G, Eyog-Matig O, Muchugi A, Williams V, Ramamonjisoa L, Kapinga C, Foahom B, Katsvanga C, Hafashimana D, Obama C, Vinceti B, Schumacher R, Geburek T. Bioactive constituents in Prunus africana: Geographical variation throughout Africa and associations with environmental and genetic parameters. Phytochemistry 2012;83:70-78