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Monograph: Echinacea Angustifolia

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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: (i) Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion. (ii) The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant. (iii) A claim for traditional use must include the term " Herbal Medicine"

Date: 2013-07-10

NHPID Name

Echinacea angustifolia (USDA 2008)

Proper Name(s)

Echinacea angustifolia DC. (Asteraceae) ( USDA 2012 )

Common Name(s)

Source Material

Root and rhizome ( Barnes et al. 2007 , Grieve 1971[1931] )

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:

Dose(s)

Children 2 - 4 years:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 0.17 - 0.5 Grams per day, dried root and rhizome

Children and adolescents 5 - 9 years:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 0.25 - 0.8 Grams per day, dried root and rhizome

Adolescents 10 - 13 years:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 0.5 - 1.5 Grams per day, dried root and rhizome

Adults and adolescents 14 and over:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 1 - 3 Grams per day, dried root and rhizome

  • Adult dose supported by the following references: Barnes et al. 2007; Blumenthal et al. 2000; Bradley 1992
  • Adults includes pregnant and breastfeeding women.
  • Children and adolescent doses were calculated as a proportion of the adult dose (JC 2012).
  • Refer to Appendix 1 for examples of dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.
  • The use of Echinacea angustifolia in children is supported by the following references: McIntyre 2005; Bove 2001; Schilcher 1997.

Duration of use

Consult a health care practitioner for use beyond 8 weeks  (Brinker 2001)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • If symptoms persist or worsen, consult a health care practitioner.
  • If you are taking immunosuppressants, consult a health care practitioner prior to use  (Brinker 2010, Mills and Bone 2005)
  • If you have an autoimmune disorder, consult a health care practitioner prior to use  (Brinker 2010, McGuffin et al. 1997)
  • If you have a progressive systemic disease such as tuberculosis, collagenosis, multiple sclerosis, AIDS and/or HIV infection, consult a health care practitioner prior to use  (Brinker 2010, McGuffin et al. 1997)

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.

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).
  • 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 may comply with the specifications outlined in the following pharmacopoeial monographs: "Narrow-leaved Coneflower Root" of the European Pharmacopoeia (Ph.Eur.) as well as "Echinacea angustifolia", "Powdered Echinacea angustifolia" and "Powdered Echinacea angustifolia Extract" of the United States (USP) Pharmacopoeias.

References cited

  • Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): Pharmaceutical Press.
  • Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
  • Bove M. An Encyclopedia of Natural Healing for Children and Infants. New Canaan (CT): Keats Publishing, Incorporated; 1996
  • Bradley PR, editor. 1992. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (GB): British Herbal Medicine Association.
  • 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
  • Ellingwood F. 1983. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications [Reprint of 1919 original].
  • Felter HW, Lloyd JU. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
  • Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].
  • JC 2012: Justice Canada. Natural Health Products Regulations [Internet]. Ottawa (ON): Justice Canada. Available from: http://laws-lois.justice.gc.ca/eng/regulations/SOR-2003-196/index.html [Current 2012 December 31, Last amended 2008-06-01; Accessed 2013 January 30].
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • McIntyre A. Herbal Treatment of Children - Western and Ayurvedic Perspectives. Toronto (ON): Elsevier Limited; 2005.
  • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
  • Moerman DE . 1998. Native American Ethnobotany. Portland (OR): Timber Press.
  • Schilcher H. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (D): Medpharm Scientific Publishers; 1997.
  • USDA 2012: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [Internet]. Echinacea angustifolia DC. Beltsville (MD): National Germplasm Resources Laboratory. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl [Last updated 2012 March 08; Accessed 2013 January 30].

References reviewed

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  • Barnes J, Anderson LA, Gibbons S, Phillipson JD. 2005. Echinacea species (Echinacea angustifolia (DC.) Hell., Echinacea pallida (Nutt.) Nutt., Echinacea purpurea (L.) Moench): a review of their chemistry, pharmacology and clinical properties. The Journal of Pharmacy and Pharmacology 57(8):929-954.
  • Barnes J, Anderson LA, Philipson JD. 2002. Herbal Medicines: A Guide for Healthcare Professionals, 2nd edition. London (GB): The Pharmaceutical Press.
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  • Gallo M, Sarkar M, Au W, Pietrzak K, Comas B, Smith M, Jaeger TV, Einarson A, Koren G. 2000. Pregnancy outcome following gestational exposure to echinacea: a prospective controlled study. Archives of Internal Medicine 160(20):3141-3143.
  • Gertsch J, Schoop R, Kuenzle U, Suter A. 2004. Echinacea alkylamides modulate TNF-alpha gene expression via cannabinoid receptor CB2 and multiple signal transduction pathways. FEBS Letters 577(3):563-569.
  • Giles JT, Palat CT, Chien SH, Chien SH, Chang ZG, Kennedy DT. 2000. Evaluation of Echinacea for treatment of the common cold. Pharmacotherapy 20(6):690-697.
  • Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications; [Reprint of 1931 Harcourt, Brace & Company publication].
  • Gunning K. 1999. Echinacea in the treatment and prevention of upper respiratory tract infections. The Western Journal of Medicine 171(3):198-200.
  • Haddad PS, Azar GA, Groom S, Boivin M. 2005. Natural health products, modulation of immune function and prevention of chronic diseases. Evidence-Based Complementary and Alternative Medicine 2(4):513-520.
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  • Islam J, Carter R. 2005. Use of Echinacea in upper respiratory tract infection. Southern Medical Journal 98(3):311-318.
  • Kemp DE, Franco KN. 2002. Possible leucopenia associated with long-term use of echinacea. The Journal of the American Board of Family Practice 15(5):417-419.
  • Knight V. 2005. Echinacea treatment for the common cold. Clinical Infectious Diseases 40(6):811-812.
  • Lee AN, Werth VP. 2004. Activation of autoimmunity following use of immunostimulatory herbal supplements. Archives of Dermatology 140:723-727.
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  • Lindenmuth GF, Lindenmuth EB. 2000. The efficacy of echinacea compound herbal tea preparation on the severity and duration of upper respiratory and flu symptoms: a randomized, double-blind, placebo-controlled study. Journal of Alternative and Complementary Medicine 6(4):327-334.
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  • Matthias A, Banbury L, Bone KM, Leach DN, Lehmann RP. 2008. Echinacea alkylamides modulate induced immune responses in T-cells. Fitoterapia 79(1):53-8.
  • Matthias A, Blanchfield JT, Penman KG, Toth I, Lang CS, De Voss JJ, Lehmann RP. 2004. Permeability studies of alkylamides and caffeic acid conjugates from echinacea using a Caco-2 cell monolayer model. Journal of Clinical Pharmacy and Therapeutics 29(1):7-13.
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Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use (for adults only)

Dried root and rhizome:

  • 1 - 3 g, per day (Barnes et al. 2007)
  • 1 g, 3 times per day (Bradley 1992)

Infusion:

  • 1 g dried root and rhizome, several times per day (not to exceed 3 g per day) (Blumenthal et al. 2000)
  • Directions for use: Pour 150 ml of boiling water on dried root and rhizome and steep for at least 10 minutes. Drink between meals (Blumenthal et al. 2000)

Decoction:

  • 1 g dried root and rhizome, 3 times per day (Bradley 1992)
  • Directions for use: Place dried root and rhizome in 150 ml water, bring to a boil, and simmer for 10 minutes (Blumenthal et al. 2000)

Fluid extract:

0.5 - 1 g dried equivalent, 3 times per day (1:1, 45% alcohol, 0.5-1 ml) (Bradley 1992)

Tincture:

0.4 - 1 g dried equivalent, 3 times per day (1:5, 45% alcohol, 2-5 ml) (Bradley 1992)