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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

  • 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

July 18, 2017

Proper name(s)

Echinacea angustifolia DC. (Asteraceae) (USDA 2012)

Common name(s)

  • Echinacea (McGuffin et al. 2000; McGuffin et al. 1997; Bradley 1992)
  • Narrow-leaf Echinacea (McGuffin et al. 2000; McGuffin et al. 1997; Bradley 1992)
  • Narrow-leaf purple coneflower (McGuffin et al. 2000; McGuffin et al. 1997; Bradley 1992)

Source material(s)

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

Route(s) of administration

Oral

Dosage form(s):

This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Dosage forms by age group:

  • Children 2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/drops (Giacoia et al. 2008; EMEA/CHMP 2006).
  • Children 3-5 years: The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/drops (Giacoia et al. 2008; EMEA/CHMP 2006).
  • Children 6-12 years, Adolescents 13-17 years, and Adults ≥ 18 years: The acceptable dosage forms include, but are not limited to capsules, chewables (e.g., gummies, tablets), liquids, powders, strips or tablets.

Use(s) or Purpose(s)

  • Traditionally used in Herbal Medicine to help relieve the symptoms of upper respiratory tract infections (Barnes et al. 2007; Blumenthal et al. 2000; Ellingwood 1983 [1919]; Felter and Lloyd 1983 [1898]; Grieve 1971 [1931]).
  • Traditionally used in Herbal Medicine to help relieve sore throats (Blumenthal et al. 2000; Moerman 1998).

Note
A claim for traditional use must include the term "Herbal Medicine".

Dose(s)

Table 1: Dose information expressed as "quantity dried equivalent" of Echinacea angustifolia root and rhizome presented as dose per day
Subpopulation Quantity dried equivalent (g/day)
Minimum Maximum

Table 1 Footnotes

Table 1 Footnote 1

Children and adolescent doses were calculated as a proportion of the adult dose (JC 2012). The use of Echinacea angustifolia in children is supported by the following references: McIntyre 2005; Bove 2001; Schilcher 1997.

Return to Table 1 footnote1 referrer

Table 1 Footnote 2

Adult dose supported by the following references: Barnes et al. 2007; Blumenthal et al. 2000; Bradley 1992.

Return to Table 1 footnote2 referrer

Table 1 Footnote 3

Includes pregnant and breastfeeding women.

Return to Table 1 footnote3 referrer

Children Table 1 Footnote1 2-4 y 0.17 0.5
Children and adolescents Table 1 Footnote1 5-9 y 0.25 0.8
Adolescents Table 1 Footnote1 10-14 y 0.5 1.5
Adolescents and adults Table 1 Footnote1 Table 1 Footnote2 Table 1 Footnote3 ≥ 15 y 1.0 3.0

Note

Refer to Appendix 1 for examples of dosage preparations and directions for use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

For use beyond 8 weeks, consult a health care practitioner (Brinker 2001).

Risk information

Caution(s) and warning(s):

  • If symptoms persist or worsen, consult a health care practitioner.
  • 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).
  • If you have an auto-immune disorder, consult a health care practitioner prior to use (Brinker 2010; McGuffin et al. 1997).
  • If you are taking immunosuppressants, consult a health care practitioner prior to use (Brinker 2010; Mills and Bone 2005).

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.

Specifications:

  • The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.
  • The medicinal ingredient may comply with the specifications outlined in the pharmacopoeial monographs listed in Table 2 below.
Table 2: Echinacea angustifolia monographs published in the European (Ph. Eur.) and United States (USP) Pharmacopoeias.
Pharmacopeia Monograph
Ph.Eur. Narrow-leaved Coneflower Root
USP Echinacea angustifolia
Powdered Echinacea angustifolia
Powdered Echinacea angustifolia Extract

References cited:

  • Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): The Pharmaceutical Press.
  • Blumenthal M, Goldberg A, Brinkmann J, editors. 2000. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications.
  • Bove M. 2001. An Encyclopedia of Natural Healing for Children and Infants. New Canaan (CT): Keats Publishing, Incorporated.
  • 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.Next link will take you to another Web siteOnline Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Updated 2010 July 13; Accessed 2013 January 30].
  • Ellingwood F. 1983. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications [Reprint of 1919 original].
  • EMEA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Next link will take you to another Web siteFormulations of choice for the paediatric population. Adopted September 2006. EMEA/CHMP/PEG/194810/2005. [Accessed on 2013 June 29].
  • Felter HW, Lloyd JU. 1983. King’s American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications [Reprint of 1898 original].
  • Giacoia GP, Taylor-Zapata P, Mattison D. Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Formulation Initiative: selected reports from working groups. Clinical Therapeutics 2008; 30(11):2097-2101.
  • Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].
  • JC 2012: Justice Canada. Next link will take you to another Web siteNatural Health Products Regulations [Internet]. Ottawa (ON): Justice Canada.[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. Silver Spring (MD): American Herbal Products Association.
  • McIntyre A. 2005. Herbal Treatment of Children - Western and Ayurvedic Perspectives. Toronto (ON): Elsevier Limited.
  • 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. 1997. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (D): Medpharm Scientific Publishers.
  • 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.
  • Barrett B. 2003. Medicinal properties of echinacea: a critical review. Phytomedicine 10(1):66-86.
  • Barrett BP, Brown RL, Locken K, Maberry R, Bobula JA, D’Alessio D. 2002. Treatment of the common cold with unrefined echinacea: a randomized, double-blind, placebo-controlled trial. Annals of Internal Medicine 137(12):939-946.
  • Barrett B, Brown R, Voland R, Maberry R, Turner R. 2006. Relations among questionnaire and laboratory measures of rhinovirus infection. The European Respiratory Journal 28(2):358-363.
  • Barrett B, Harahan B, Brown D, Zhang Z, Brown R. 2007. Sufficiently important difference for common cold: severity reduction. Annals of Family Medicine 5(3):216-223.
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  • BHP 1996: British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 1996.
  • BHP 1983: British Herbal Pharmacopoeia. Cowling (GB): British Herbal Medical Association; 1983.
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  • Caruso TJ, Gwaltney JM Jr. 2005. Reply to Barton and Hemilä. Clinical Infectious Diseases 41:763-764.
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  • Cohen HA, Varsano I, Kahan E, Sarrell EM, Uziel Y. 2004. Effectiveness of an herbal preparation containing echinacea, propolis, and vitamin C in preventing respiratory tract infections in children: a randomized, double-blind, placebo-controlled, multicenter study. Archives of Pediatrics & Adolescent Medicine 158(3):217-221.
  • Ernst E. 2002. The risk-benefit profile of commonly used herbal therapies: Gingko, St John’s Wort, Ginseng, Echinacea, Saw Palmetto and Kava. Annals of Internal Medicine 136(1):42-53.
  • Felter HW. 1983. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications; [Reprint of 1922 original].
  • Felter HW, Lloyd JU. 1983. King’s American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; [Reprint of 1898 original].
  • Foster S. 1996. Echinacea. The Purple Coneflowers. Austin (TX): Steven Foster.
  • 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-α 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.
  • Hemilä H. 2005. Echinacea, vitamin C, the common cold and blinding. Clinical Infectious Diseases 41(5):762-763.
  • 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.
  • Li T. 1998. Echinacea: cultivation and medicinal value. HortTechnology 8(2):122-129.
  • Linde K, Barrett B, Wölkart K, Bauer B, Melchart D. 2006. Echinacea for preventing and treating the common cold. Cochrane Database of Systematic Reviews. Issue 1. Art. No.: CD000530. DOI: 10.1002/14651858.CD000530.pub2
  • 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.
  • Matthias A, Addison RS, Penman KG, Dickinson RG, Bone KM, Lehmann RP. 2005. Echinacea alkamide disposition and pharmacokinetics in humans after tablet ingestion. Life Sciences 77(16):2019-2029.
  • Matthias A, Banbury L, Bone KM, Leach DN, Lehmann RP. 2008. Echinacea alkylamides modulate induced immune responses in T-cells. Fitoterapia 79(1):53-58.
  • 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.
  • McGregor RL. 1968. The taxonomy of the genus echinacea (compositae). University of Kansas Science Bulletin 48(4):113-142.
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  • Melchart D, Linde K, Worku F, Bauer R, Wagner H. 1994. Immunomodulation with echinacea- a systematic review of controlled clinical trials. Phytomedicine 1:245-254.
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  • Melchart D, Walther E, Linde K, Brandmaier R, Lersch C. 1998. Echinacea root extracts for the prevention of upper respiratory tract infections. Archives of Family Medicine 7(6):541-545.
  • Merali S, Binns S, Paulin-Levasseur M, Ficker C, Smith M, Baum B, Brovelli E, Arnason JT. 2003. Antifungal and anti-inflammatory activity of the Genus Echinacea. Pharmaceutical Biology 41(6):412-420.
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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).

Fluidextract:

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)