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Monograph - Elder Sambucus (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 16, 2014

Proper Name(s) amd Common Name(s)

Proper name(s) Common name(s) References
Sambucus nigra L. subsp. nigra
[Adoxaceae (Caprifoliaceae)]
  • European elder
  • Black elder
McGuffin et al. 2000; USDA 2014a
Sambucus nigra L. subsp. canadensis (L.) R. Bolli
[Adoxaceae (Caprifoliaceae)]
  • American elder
  • Canadian elder
USDA 2014b; McGuffin et al. 2000
Note
Sambucus nigra is a taxonomic synonym of Sambucus nigra L. subsp. nigra.
Sambucus canadensis is a taxonomic synonym of Sambucus nigra subsp. canadensis.

Source Material(s)

  • Flower (Godfrey and Saunders 2010; EMEA 2008; Hoffman 2003)
  • Fruit (berry) (Godfrey and Saunders 2010; Hoffman 2003)

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

Adults ≥ 18 years

Flower
  • (Traditionally) used in Herbal Medicine to promote sweating (diaphoretic), to help relieve fever (in cases of common colds, flus) (Godfrey and Saunders 2010; Bone 2003; Hoffman 2003; WHO 2002; BHC 1992; BHP 1983; Grieve 1931; Sayre 1917; Felter and Lloyd 1898).
  • (Traditionally) used in Herbal Medicine to help relieve symptoms of colds and flus (such as coughs, sore throat and catarrh of the upper respiratory tract) (Godfrey and Saunders 2010; Barnes et al. 2007; Bone 2003; Hoffman 2003; WHO 2002; BHP 1983; Grieve 1931).
  • Used in Herbal Medicine to help relieve nasal congestion and discharge associated with sinusitis, hay fever/allergic rhinitis (Godfrey and Saunders 2010; Barnes et al. 2007; Bone 2003; Hoffman 2003).
  • (Traditionally) used in Herbal Medicine as a diuretic (Winston and Kuhn 2008; Barnes et al. 2007; Williamson 2003; BHC 1992; Felter 1922; Culbreth 1927; Fyfe 1903).
  • (Traditionally) used in Herbal Medicine as an alterative to help remove accumulated waste products via the kidneys, skin and mucus membranes (Williamson 2003; Tilgner 1999; Felter 1922; Culbreth 1921; Fyfe 1903; Felter and Lloyd 1898).
Fruit (berry)
  • (Traditionally) used in Herbal Medicine to promote sweating (diaphoretic), to help relieve fever (in cases of common colds, flus) (Winston and Kuhn 2008; Hoffman 2003; Shook 1992; Grieve 1931; Remington et al. 1918).
  • (Traditionally) used in Herbal Medicine to help relieve symptoms of colds and flus (such as coughs, sore throat and catarrh of the upper respiratory tract) (Winston and Kuhn 2008; Hoffman 2003; Tillotson 2001; Shook 1992).
  • (Traditionally) used in Herbal Medicine to help relieve joint pain associated with conditions such as arthritis (Godfrey and Saunders 2010; Hoffman 2003; Tilgner 1999; Grieve 1931; Remington et al. 1918).
  • (Traditionally) used in Herbal Medicine as a diuretic (Hoffman 2003; Shook 1992; Fyfe 1903).
  • (Traditionally) used in Herbal Medicine as an alterative to help remove accumulated waste products via the kidneys, skin and mucus membranes (Tilgner 1999; Shook 1992; Grieve 1931; Remington et al. 1918; Fyfe 1903).
  • Provides antioxidants (Youdim et al. 2004; Abuja et al. 1998).

Children and adolescents

Flower and/or Fruit (berry)
  • (Traditionally) used in Herbal Medicine to promote sweating (diaphoretic), to help relieve fever (in cases of common colds, flus) (Godfrey and Saunders 2010; Winston and Kuhn 2008; Bone 2003; Hoffman 2003; WHO 2002; Shook 1992; BHC 1992; BHP 1983; Grieve 1931; Remington et al. 1918; Sayre 1917; Felter et Lloyd 1898).
  • (Traditionally) used in Herbal Medicine to help relieve symptoms of colds and flus (such as coughs, sore throat and catarrh of the upper respiratory tract) (Godfrey and Saunders 2010; Winston and Kuhn 2008; Barnes et al. 2007; Bone 2003; Hoffman 2003; WHO 2002; Tillotson 2001; Shook 1992; BHP 1983; Grieve 1931).
Flower

Used in Herbal Medicine to help relieve nasal congestion and discharge associated with sinusitis, hay fever/allergic rhinitis (Godfrey and Saunders 2010; Barnes et al. 2007; Bone 2003; Hoffman 2003).

Note

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

Dose

Sub population

Adults (≥ 18 years), Adolescents (14-17 years), Adolescents (10-13 years), Children (5-9 years), Children (2-4 years)

Quantity(ies)

Flower

Table 1: Dosing information for Flower. Preparations: Dry, Powder, Non standardized ethanolic extracts (tincture, fluid extract)

Use(s) or purpose(s) Subpopulations Dried flowers (g/day)
Minimum Maximum

Table 2 footnotes

Table 2 footnote 1

Children and adolescent doses were calculated as a proportion of the adult dose (JC 2008). The use of Elder spp. in children and adolescents is supported by the following references: McIntyre 2005; Bove 2001; Gladstar 1999.

Return to table 2 footnote 1 referrer

Footnote 2

Adult dose supported by the following references: Winston and Kuhn 2008; Bone 2003; WHO 2002; BHC 1992; Fyfe 1903.

Return to table 2 footnote 2 referrer

Diaphoretic; Symptoms of colds and flus; Sinusitis, hay fever Children1 2-4 y 0.25 2.5
5-9 y 0.375 3.75
Adolescents1 10-13 y 0.75 7.5
14-17 y 1.5 15
Diaphoretic; Symptoms of colds and flus; Sinusitis, hay fever; Diuretic; Alterative Adults2 ≥ 18 y 1.5 15

Table 2: Dosing information for Flower. Preparation: Infusion

Use(s) or purpose(s) Subpopulations Dried flowers (g/day)
Minimum Maximum

Table 3 footnotes

Table 3 footnote 1

Children and adolescent doses were calculated as a proportion of the adult dose (JC 2008). The use of Elder spp. in children and adolescents is supported by the following references: McIntyre 2005; Bove 2001; Gladstar 1999.

Return to table 3 footnote 1 referrer

Footnote 2

Adult dose supported by the following references: Winston and Kuhn 2008; Bone 2003; WHO 2002; BHC 1992

Return to table 3 footnote 2 referrer

Diaphoretic; Symptoms of colds and flus; Sinusitis, hay fever Children1 2-4 y 1 2.5
5-9 y 1.5 3.75
Adolescents1 10-13 y 3 7.5
14-17 y 6 15
Diaphoretic; Symptoms of colds and flus; Sinusitis, hay fever; Diuretic; Alterative Adults2 ≥ 18 y 6 15
Fruit (berry)

Table 3: Dosing information for ripe Fruit (berry). Preparations: Dry, Powder, Non standardized ethanolic extracts (tincture, fluid extract)

Use(s) or purpose(s) Subpopulations Dried, ripe berries (g/day)
Minimum Maximum

Table 4 footnotes

Table 4 footnote 1

Children and adolescent doses were calculated as a proportion of the adult dose (JC 2008). The use of Sambucus spp. in children and adolescents is supported by the following references: McIntyre 2005; Bove 2001; Gladstar 1999.

Return to table 4 footnote 1 referrer

Footnote 2

Adult dose supported by the following references: Winston and Kuhn 2008; Bone 2003; WHO 2002; BHC 1992; Fyfe 1903.

Return to table 4 footnote 2 referrer

Footnote 3

Adult dose supported by the following reference: Winston and Kuhn 2008.

Return to table 4 footnote 3 referrer

Diaphoretic; Symptoms of colds and flus Children1 2-4 y 0.217 3
5-9 y 0.325 4.5
Adolescents1 10-13 y 0.65 9
14-17 y 1.3 18
Diaphoretic; Alterative; Diuretic; Symptoms of colds and flus; Joint pain Adults2 ≥ 18 y 1.3 18
Antioxidants Adults3 ≥ 18 y - 18

Directions for use

Statement(s) to the effect of
  • Pour 250 ml of boiling water over dried flowers, steep 10 minutes.
  • For use as a diaphoretic: Drink hot (Felter 1922).
  • For use as diuretic and/or alterative: Drink cold (Felter 1922).

Duration of Use

Statement(s) to the effect of
Diuretic
For occasional use only (APhA 2002; CPhA 2002).
All other products
No statement required.

Risk Information

Statement(s) to the effect of

Caution(s) and Warning(s)

All products
If you are pregnant or breastfeeding, consult a health care practitioner prior to use.
Diaphoretic; Symptoms of colds, flus; Sinusitis, hay-fever; Joint pain
If symptoms persist or worsen, consult a health care practitioner.

Contraindication(s)

No statement required.

Known adverse reaction(s)

All products
  • Hypersensitivity (e.g. allergy) can occur, in which case, discontinue use (Forster-Waldl et al. 2003).
  • Discontinue use in case of gastrointestinal upsets, such as abdominal cramps, nausea, vomiting, diarrhea (EMA 2014; Winston and Kuhn 2008; Barnes et al. 2007; Hoffman 2003; Tilgner 1999; Grieve 1931).
Products without diuretic claim

Diuretic effect may occur (Bradley 1992; Winston and Kuhn 2008; Barnes et al. 2007; Hoffman 2003).

Non Medicinal Ingredients

Must be chosen from the current NNHPD 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 NNHPD "Quality of Natural Health Products Guide".
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.

References Cited

Abuja PM, Murkovic M., Pfannhauser W. Antioxidant and Prooxidant Activities of Elderberry (Sambucus nigra) Extract in Low-Density Lipoprotein Oxidation. Journal of Agricultural and Food Chemistry 1998;46(10):4091-4096.

APhA 2002: Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 13th edition. Washington (DC): American Pharmaceutical Association; 2002.

Artz S.A., Paes I.C., Faloon W.W. Hypokalemia-induced hepatic coma in cirrhosis. Occurrence despite neomycin therapy. Gastroenterology 1966; 51(6):1046.

Barnes J, Anderson LA, Philipson JD. Herbal Medicines. 3rd edition. London (GB): The Pharmaceutical Press; 2007.

BHC 1992: Bradley PR, editor. British Herbal Compendium Volume 1: A Handbook of Scientific Information on Widely Used Plant Drugs-Companion to Volume 1 of the British Herbal Pharmaocopeia. Bournemouth (GB): British Herbal Medicine Association; 1992.

BHP 1983: British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association; 1983.

Bone K. A Clinical Guide to Blending Liquid Herbs: Herbal Formulations for the Individual Patient. St. Louis (MI): Churchill Livingstone; 2003.

Bove M. An Encyclopedia of Natural Healing for Children and Infants. 2nd edition. Toronto (ON): McGraw-Hill; 2001.

Carlsen J.E., Kober L., Torp-Pedersen C., Johansen P. Relation between dose of bendrofluazide, antihypertensive effect and adverse biochemical effects. British Medical Journal 1990; 300(6730): 975.

CPhA 2002: Canadian Pharmacists Association. Patient Self-Care. Helping Patients Make Therapeutic Choices. Ottawa (ON): Canadian Pharmacists Association; 2002.

Culbreth DMR. Next link will take you to another Web site A Manual of Materia Medica and Pharmacology. [Internet] 7th edition; 1927. Abridged and edited; herbs and botanicals in use today. Scanned by Michael Moore, director, The Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2014 August 15].

EMA 2014: Next link will take you to another Web site  EMA/HMPC/44208/2012 Assessment report on Sambucus nigra L., fructus. London (GB): European Medicines Agency: Committee on Herbal Medicinal Products (HMPC). [Accessed 2014 August 15].

EMEA 2008: EMEA/HMPC/283166/2007 Next link will take you to another Web site Community herbal monograph on Sambucus nigra L., flos. Final. 3 July 2008. London (GB): European Medicines Agency: Committee on Herbal Medicinal Products (HMPC). [Accessed 2014 August 15].

Felter HW. The Eclectic MateriaMedica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1922 original].

Felter HW, Lloyd JU. King's American Dispensatory. Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].

Förster-Waldl E, Marchetii M, Schöll I, Focke M, Radauer C, Kinaciyan T., Nentwich I, Jäger S, Schmid ER, Boltz-Nitulescu G, Scheiner O, Jensen-Jarolim E. Type I allergy to elderberry (Sambucus nigra) is elicited by a 33.2 kDa allergen with significant homology to ribosomal inactivating proteins. Clinical and Experimental Allergy. 2003;33(2):1703-1710.

Fyfe JW. Next link will take you to another Web site The Essentials of Modern Materia Medica and Therapeutics. [Internet] Eclectic Manual #6; 1903. Abridged; herbal material only. Scanned by Michael Moore, director, The Southwest School of Botanical Medicine, Bisbee (AZ).[ Accessed 2014 August 15].

Gladstar R. Herbal Remedies for Children's Health. North Adams (MA):Storey Publishing; 1999

Godfrey A, Saunders PR, 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.

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Hoffmann D. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press; 2003.

McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce. 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.

McIntyre A. Herbal Treatment of Children: Western and Ayurvedic Perspectives. Toronto (ON): Elsevier Limited; 2005.

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

Mujais S.K., Katz A.L. Potassium deficiency in the Kidney: Physiology and Pathophysiology, Seldin D.W., Giebisch G (Eds), Lippincott Williams and Wilkins, 2000. P1615.

Remington JP, Woods HC, editors. Next link will take you to another Web site The Dispensatory of the United States of America [Internet] 20th edition; 1918.. Abridged; botanicals only. Scanned by Michael Moore, director, The Southwest School of Botanical Medicine, Bisbee (AZ).[ Accessed 2014 August 15].

Sayre LE. Next link will take you to another Web site A Manuel of Organic MateriaMedica and Pharmacognosy [Internet] 4th edition.. Philadelphia (PA): P. Blakiston's Son &Co.; 1917.Scanned by Michael Moore, director, The Southwest School of Botanical Medicine, Bisbee (AZ).[Accessed 2014 August 15].

Shook EE. Advanced Treatise in Herbology. Banning (CA): Enos Publishing Co; 1992

Tilgner S. Herbal Medicine from the Heart of the Earth. Creswell (OR): Wise Acre Press; 1999.

Tillotson AK. The One Earth Herbal Sourcebook. New York (NY): Kensington Publishing Corp.; 2001.

USDA 2014a: 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). [Sambucus nigra L. Last updated 1996 December 9; Accessed 2014 August 15].

USDA 2014b: 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). [Sambucus nigra L. subsp. canadensis (L.) Bolli. Last updated 20134 March 4; Accessed 2014 August 15].

WHO 2002: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 2. Geneva (CH): World Health Organization; 2002.

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Youdim KAU, Martin A, Josepha JA. Incorporation of the elderberry anthocyanins by endothelial cells increases protection against oxidative stress. Free Radical Biology and Medicine 2000;29(1):51-60.

References Reviewed

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