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Peruvian Maca/Ginseng – Health Canada Product Monograph

SOURCE- HEALTH CANADA: Compendium of Medicinal Ingredients Nomenclature

Drugs and natural health products

Monograph: Peruvian Maca/Ginseng

The purpose of this monograph is to serve as a guide for industry in the preparation of licence applications (MMDLs) and labels for the purpose of obtaining a product market authorization. It is not intended to be an in-depth study of the medicinal ingredient. Note: (i) Parentheses contain optional pieces of information — they do not need to be included in the DLMM or on the product label. (ii) The forward slash (/) indicates that the terms or statements are synonymous. The applicant may use any of the terms or statements indicated.

Date: 2013-03-06

Name of NHPID

Lepidium meyenii (USDA)

Proper name(s)

Lepidium meyenii Walp. (1843) (Brassicaceae)

Common name(s)

  • Peruvian ginseng
  • Maca

Material of origin

  • Hypocotile
  • Root

 

Route of administration

Oral

Dosage form(s)

  • Foods or food-like dosage forms such as bars, chewing gum or beverages are excluded from this monograph.
  • Acceptable dosage forms include, but are not limited to, strips, capsules, tablets, chewable dosage forms (e.g., tablets, gummies), liquids or powders.

Recommended use(s) or purpose(s)

Statement(s) specifying the following:

  • Provides antioxidants
  • Helps maintain a healthy mood balance during menopause
  • Helps support the emotional aspects of sexual health

Dose(s)

Adults:

Antioxidant
Preparation: Dry, powder, decoction and infusion + all unstandardized extracts

Dose(s): not to exceed 3 Grams per day, dried root/hypocotyl or equivalent

Mood balance
Preparation: Dry, powder, decoction and infusion + all unstandardized extracts

Dose(s): 2 – 3.5 Grams per day, dried hypocotyl root/equivalent

Sexual health
Preparation: Dry, powder, decoction and infusion + all unstandardized extracts

Dose(s): 3 – 3.5 Grams per day, dried hypocotyl root/equivalent

Duration of use

  • For products providing Doses equal to or greater than 3 Grams per day:
    For women during or after menopause only: For use beyond 6 weeks, consult a health care practitioner
  • For products providing 0.6 – 3 Grams per day:
    For use beyond 3 months, consult a health care practitioner

Mention of risks

Statement(s) specifying the following:

Precaution(s) and warning(s):

  • If you are pregnant or breastfeeding, consult a health care practitioner before using it.
  • Doses equal to or greater than 0.6 Grams per day:
    If you have hypertension, consult a health care practitioner before using it
  • Doses equal to or greater than 0.6 Grams per day:
    If you are taking blood thinners, consult a health care practitioner before using them
  • Doses equal to or greater than 0.6 Grams per day:
    If you are taking antidepressants, consult a health care practitioner before using them
  • Sexual health:
    If you have a psychological disorder or illness, such as frequent anxiety or depression, consult a health care practitioner before using it

 

Contraindication(s):
Statement not required

 

Known adverse reaction(s):
Statement not required

 

Non-medicinal ingredients

Must be selected from the current Natural Health Products Ingredient Database and must meet the restrictions defined in the database.

 

Specifications

  • Finished product specifications must be established in accordance with the requirements outlined in the NHPD’s Natural Health Product Quality Reference Guide.
  • The medicinal ingredient must comply with the requirements set out in the Natural Health Products Ingredient Database (NHPID).
  • The medicinal ingredient must comply with the requirements set out in the Natural Health Products Ingredient Database (NHPID).

 

References cited

  • Brooks NA, Wilcox G, Walker KZ, Ashton JF, Cox MB, Stojanovska L. Beneficial effects of Lepidium meyenii (Maca) on physiological symptoms and measures of sexual dysfunction in postmenopausal women are not related to estrogen or androgen content. Menopause 2008;15(6):1157-1162.
  • Brotto LA. The DSM diagnostic criteria for hypoactive sexual desire disorder in women. Archives of Sexual Behavior 2010;39(2):221-239.
  • Dording CM, Fsher L, Papakostas G, Farabaugh A, Sonawalla S, Fava M, Mischoulon D. A double-blind, randomized, pilot dose-finding study of maca root (L. meyenii) for the management of SSRI-induced sexual dysfunction. CNS Neuroscience Therapy and Therapeutics 2008;14(3):182-191.
  • Gonzales GF, Cordova A, Vega K, Chung A, Villena A, Gonez C, Costillo S. Effect of Lepidium meyenii (Maca) on sexual desire and its absent relationship with serum testosterone levels in adult healthy men. Andrologia 2002;34(6):367-372.
  • Gonzales GF, Gonzales-Castaneda GC. The Methyltetrahydro- {beta} -Carbolines in Maca (Lepidium meyenii). Evidence Based Complementary Alternative Medicine 2009;6(3):315-316.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce. 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
  • Meissner, Kapczynski, Mscisz, Lutomski. Use of Gelatinized Maca (Lepidium peruvianum) in Early Postmenopausal Women – a Pilot Study. International Journal of Biomedical Sciences 2005;1(1):33-45.
  • Meissner, Reich-Bilinska, Kedzia. Therapeutic Effects of Pre-Gelatinized Maca (Lepidium peruvianum Chacon) used as a non-hormonal alternative to HRT in perimenopausal women – Clinical Pilot study. International Journal of Biomedical Sciences 2006;2(2):143-159.
  • NS 2012. Natural Standard. Maca (Lepidium meyenii) Copyright 2012 [Internet] . [Consulté le 18 avril 2012] . Available at: http://www.naturalstandard.com.
  • Shin BC, Lee MS, Yang EJ, Lim H-S, Ernst E. Maca (L. meyenii) for improving sexual function: a systematic review. BMC Complementary and Alternative Medicine 2010;10(44):1-6.
  • USDA 2011: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. National Germplasm Resources Laboratory, Beltsville, MD. [Lepidium meyenii Walp. Last updated 2011 June 25; Accessed April 24, 2012]. Available at: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • Valentova K, Stejskal D, Bartek J, Dvoráckova S, Kren V, Ulrichova J, Simanek V. Maca (Lepidium meyenii) and yacon (Smallanthus sonchifolius) in combination with silymarin as food supplements: in vivo safety assessment. Food and Chemical Toxicology 2008;46(3):1006-1013.
  • Vecera R, Orolin J, Skottova N, Kazdova L, Oliyarnik O, Ulrichova J, Simaner V. The Influence of Maca (Lepidium meyenii) on Antioxidant Status, Lipid and Glucose Metabolism in Rat. Plant Foods for Human Nutrition 2007;62(2):59-63.
  • Zenico T, Cicero AF, Valmorri L, Merculiali M, Bercovich E. Subjective effects of Lepidium meyenii (Maca) extract on well-being and sexual performances in patients with mild erectile dysfunction: a randomized, double-blind clinical trial. Andologia 2009;41(2):95-99.

 

References reviewed

  • Baldwin DS. Depression and sexual dysfunction. British Medical Bulletin 2001;57:81-99.
  • EFSA Compendium of botanicals that have been reported to contain toxic, addictive, psychotropic or other substances of concern; European Food Safety Authority. Parma, Italy. EFSA Journal 2009, 7(9): 281. [Consulté le 19 avril 2012]. Available at: http://www.efsa.europa.eu/en/supporting/doc/280rax1.pdf
  • Gonzales GF, Cordova A, Gonzales C, Chung A, Vega K, Villena A. Lepidium meyenii (Maca) improved semen parameters in adult men. Asian Journal of Andrology 2001;3(4):301-303.
  • Gonzales GF, Cordova A, Vega K, Chung A, Villena A, Gonez C. Effect of Lepidium meyenii (Maca), a root with aphrodisiac and fertility-enhancing properties, on serum reproductive hormone levels in adult healthy men. Journal of Endocrinology 2003;176(1):163-168.
  • Herraiz T, Galisteo J. Tetrahydro-beta-carboline alkaloids occur in fruits and fruit juices. Activity as antioxidants and radical scavengers. Journal of Agriculture and Food Chemistry 2003;51(24):7156-7161.
  • Laumann, Paik, Rosen. Sexual Dysfunction in the United States: Prevalence and Predictors. Journal of the American Medical Association 1999;281(6):537-544.
  • McCollom MM, Villinski JR, McPhail KL, Craker LE, Gafner S. Analysis of macamides in samples of Maca (Lepidium meyenii) by HPLC-UV-MS/MS. Phytochemical Analysis 2005;16(6):463-469.
  • McKay D. Nutrients and botanicals for erectile dysfunction: Examining the evidence. Alternative medicine review 2004;9(1):4-16.
  • Mehta K, Gala J, Bhasake S, Naik S, Modak M, Thakur H, Deo N, Miller S. Comparison of glucosamine sulfate and a polyherbal supplement for the relief of osteoarthritis of the knee. BMC Complementary and Alternative Medicine 2007;7(34):1-13.
  • Health Passports 2011: Maca [Internet] . Montreal (QC): Totalmedia Inc.; 2011. [Consulté le 9 juillet 2012] . Available at: http://www.passeportsante.net/fr/Solutions/PlantesSupplements/Fiche.aspx?doc=maca_ps
  • Piacente S, Carbone V, Plaza A, Zampelli A, Pizza C. Investigation of the tuber constituents of maca (Lepidium meyenii Walp.). Journal of Agriculture and Food Chemistry 2002;50:5621-5625.
  • Sandoval M, Okuhama NN, Angeles MF, Melchor VV, Condezo AL, Lao L, Miller JSM. Antioxidant activity of the cruciferous vegetable Maca (Lepidemium meyenii). Food Chemistry 2002;79(2):207-213.
  • Schumacher M et al. Novel perspectives for progesterone in hormone replacement therapy, with special reference to the nervous system. Endocrine Reviews 2007;28(4): 387-439.
  • Sloley BD, Urichuk LJ, Morley P, Durkin J, Shan JJ, Pang PK, Coutts RT. Identification of kaempferol as a monoamine oxidase inhibitor and potential neuroprotectant in extracts of Ginkgo biloba leaves. Journal of Pharmacy and Pharmacology 2000;52(4):451-459.
  • Stone M, Ibarra A, Roller M, Zangara A, Stevenson A. A pilot investigation into the effect of maca supplementation on physical activity and sexual desire in sportsmen. Journal of Ethnopharmacology 2009;126(3):574-576.
  • Valentova K, Buckiova D, Kren V, Peknicova J, Ulrichova J, Simanek V. The in vitro biological activity of Lepidium meyenii extracts. Cell Biology and Toxicology 2006;22(2):91-99.
  • Valentova K, Ulrichova J. Smallanthus sonchifolius and Lepidum meyenii – Prospective Andean crops for the prevention of chronic diseases. Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia 2003;147(2):119-130.
  • Zheng BL, He K, Kim CH, Rogers L, Shao Y, Huang ZY, Lu Y, Yan SJ, Qien LC, Zheng QY. Effect of a lipidic extract from Lepidium meyenii on sexual behavior in mice and rats. Urology 2000;55(4):598-602.

 

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