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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.
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).
Adult Males (≥ 18 years)
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).
Valid only for Class II and III applications for supporting safety in adults
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)
Maximum daily dose of the crude material is based on a conservative extrapolation of the dose supported in the available evidence
If pregnant or breastfeeding, consult a health care practitioner prior to use.
No statement required.
No statement required.
Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.
No statement required.
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. 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
Brinker, F. 2009. 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