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Drugs and Health Products

NATURAL HEALTH PRODUCT - Dandelion (Taraxacum Officinale)

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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

May 21, 2013

Proper name(s)

Taraxacum officinale F.H. Wigg. (Asteraceae) (USDA 2012; McGuffin et al. 2000)

Common name(s)

Dandelion (USDA 2012; McGuffin et al. 2000; Wiersema and León 1999)

Lion’s tooth (USDA 2012; McGuffin et al. 2000; Wiersema and León 1999)

Source material(s)

  • Leaf1(BHP 1996)
  • Root2(BHP 1996)
  • Whole plant3 (Blumenthal et al. 1998; BHP 1996)

Notes

  1. Collected before flowering(BHC 1996)
  2. Collected in the autumn(BHC 1996)
  3. Collected while flowering(Blumenthal et al. 1998; BHC 1996)

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:

LEAF
  • Traditionally used in Herbal Medicine to increase the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor urinary complaints (EMA 2009).
  • (Traditionally) used in Herbal Medicine as a diuretic (Mills and Bone 2005; Hoffmann 2003; BHC 1992; BHP 1983).
  • (Traditionally) used in Herbal Medicine as a laxative (aperient) (Mills and Bone 2005; Hoffmann 2003; BHP 1983).
  • (Traditionally) used in Herbal Medicine to help increase bile flow (choleretic) (Godfrey et al. 2010; Mills and Bone 2005; Hoffmann 2003; BHC 1992; BHP 1983).
  • (Traditionally) used in Herbal Medicine to help treat digestive disturbances (dyspepsia) (Godfrey et al. 2010; Mills and Bone 2005; BHC 1992; Grieve 1971 [1931]).
ROOT
  • (Traditionally) used in Herbal Medicine as an alterative to help relieve dermatological conditions (Blumenthal et al. 2000; Ellingwood 1983 [1919]; Felter and Lloyd 1983 [1898]), such as eczema (Wichtl 2004).
  • (Traditionally) used in Herbal Medicine as a diuretic (Mills and Bone 2005; Hoffmann 2003; Ellingwood 1983 [1919]; BHP 1983; Wren 1907).
  • (Traditionally) used in Herbal Medicine as a laxative (aperient) (Godfrey et al. 2010; Mills and Bone 2005; Hoffmann 2003; BHC 1996; BHP 1983).
  • (Traditionally) used in Herbal Medicine to help increase bile flow (cholagogue and choleretic) (Hoffmann 2003; BHC 1992; BHP 1983; Ellingwood 1983 [1919]).
  • (Traditionally) used in Herbal Medicine to help stimulate appetite (Godfrey et al. 2010; EMA 2009ESCOP 2003; BHC 1992; Grieve 1971 [1931]).
  • (Traditionally) used in Herbal Medicine to help treat digestive disturbances (dyspepsia) (Godfrey et al. 2010; Mills and Bone 2005; BHC 1992; Grieve 1971 [1931]).
WHOLE PLANT
  • Used in Herbal Medicine as a diuretic (WHO 2007; Witchl 2004; Blumenthal et al. 1998; BHC 1992).
  • Used in Herbal Medicine to help increase bile flow (cholagogue and choleretic) (WHO 2007; Witchl 2004; Blumenthal et al. 1998; BHC 1992).
  • (Traditionally) used in Herbal Medicine to help stimulate appetite (EMA 2009; WHO 2007; Witchl 2004; Blumenthal et al. 1998; BHC 1992).
  • (Traditionally) used in Herbal Medicine to help treat digestive disturbances (dyspepsia) (EMA 2009; WHO 2007; Witchl 2004; Blumenthal et al. 1998; BHC 1992).
  • Traditionally used in Herbal Medicine to increase the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor urinary complaints (EMA 2009).

Dose(s)

Statement(s) to the effect of

Subpopulation(s)

  • Adults (≥ 19 years)
  • Adolescents (12-18 years)

Quantity(ies)

LEAF

Preparations equivalent to 1.2-30 g dried leaf, per day (Mills and Bone 2005; Hoffmann 2003; Blumenthal et al. 2000, 1998; BHC 1992; BHP 1983)

ROOT

Preparations equivalent to 1.5-24 g dried root, per day (Mills and Bone 2005; Hoffmann 2003; BHC 1992; BHP 1983)

WHOLE PLANT

Preparations equivalent to 3-30 g dried whole plant, per day (EMA 2009; WHO 2007; Witchl 2004; Blumenthal et al. 2000, 1998).

Directions for use

Flushing of urinary tract

To ensure an increase of the amount of urine, adequate fluid intake is required during treatment (EMA 2009).

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

Duration of use

Diuretic

For occasional use only (APhA 2002; CPhA 2002)

Flushing of the urinary tract, indigestion, or loss of appetite

If symptoms persist beyond 2 weeks, consult a health care practitioner (EMA 2009).

Risk information

Statement(s) to the effect of:

Caution(s) and warning(s)

All products

If you have liver or gall bladder diseases, and/or intestinal obstruction, consult a health care practitioner prior to use (Godfrey et al. 2010; EMA 2009; ESCOP 2003; Brinker 2001; BHC 1992).

Constipation, urinary retention, indigestion, or loss of appetite

If symptoms persist or worsen, consult a health care practitioner.

Contraindication(s)

Preparations equivalent to ≥ 10 g per day dried leaf and/or dried root

If you have heart disease, high or low blood pressure, kidney or liver disorder, diabetes or edema (swelling of hands, face and feet) or are taking products containing diuretics, do not use this product(EMA 2009; Hunt et al. 2005; Green et al. 2002; Mujais and Katz 2000; Carlsen et al. 1990; Kuller et al. 1986; Artz et al. 1966).

Known adverse reaction(s)

No statement required.

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.

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 Natural Health Products Ingredients Database (NHPID). In addition, the medicinal ingredient may comply with the specifications outlined in in the DANDELION HERB WITH ROOT or the DANDELION ROOT monograph published in the European Pharmacopoeia (Ph.Eur. 2013).

References cited

  • 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 SA, Paes IC, Faloon WW. Hypokalemia-induced hepatic coma in cirrhosis. Occurrence despite neomycin therapy. Gastroenterology 1966;51(6):1046-1053.
  • BHP 1996: British Herbal Pharmacopoeia. Bournemouth (GB): The British Herbal Medicine Association; 1996.
  • BHP 1983: British Herbal Pharmacopoeia. Cowling (GB): British Herbal Medical Association; 1983.
  • Blumenthal M, editor. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council in cooperation with Integrative Medicine Communications; 1998.
  • Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
  • BHC 1992: Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (GB): British Herbal Medicine Association; 1992.
  • Brinker F. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
  • Carlsen JE, Køber L, Torp-Pedersen C, Johansen P. Relation between dose of bendrofluazide, antihypertensive effect, and adverse biochemical effects. British Medical Journal 1990;300(6730):975-978.
  • CPhA 2002: Canadian Pharmacists Association. Patient Self-Care. Helping Patients Make Therapeutic Choices. Ottawa (ON): Canadian Pharmacists Association; 2002.
  • Ellingwood F. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1919 original].
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products. 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
  • EMA 2009a: Next link will take you to another Web site European Medicines Agency, Science Medicines Health, 12 November 2009. EMA/HMPC/212895/2008. Committee on Herbal Medicinal Products (HMPC) Community herbal monograph on Taraxacum officinale Weber ex Wigg., radix cum herba. Final. [Accessed 2012 November 9]
  • EMA 2009b: Next link will take you to another Web site European Medicines Agency, Science Medicines Health, 12 November 2009, EMA/HMPC/579636/2008 Committee on Herbal Medicinal Products (HMPC). Community herbal monograph on Taraxacum officinale Weber ex Wigg., folium. Final. [Accessed 2012 November 9]
  • Felter HW, Lloyd JU. King’s American Dispensatory, Volume 2, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
  • Goksu E, Eken C, Karadeniz O, Kucukyilmaz O, Firt report of hypoglycemia secondary to dandelion (Taraxacum officinale) ingestion. The American Journal of Emergency Medicine 2010;28:111.e1-111.e2
  • Green DM, Ropper AH, Kronmal RA, Psaty BM, Burke GL. Serum potassium level and dietary potassium intake as risk factors for stroke. Neurology 2002;59(3):314-320.
  • Grieve M. A Modern Herbal, Volume 1. New York (NY): Dover Publications; 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
  • Hoffmann D. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press; 2003.
  • Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith Jr. SC, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B. American College of Cardiology, American Heart Association Task Force on Practice Guidelines, American College of Chest Physicians, International Society for Heart and Lung Transplantation, Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation 2005;112(12):e154-235.
  • Kuller LH, Hulley SB, Cohen JD, Neaton J. Unexpected effects of treating hypertension in men with electrocardiographic abnormalities: a critical analysis. Circulation 1986;73(1):114-123.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce. 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
  • Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
  • Mujais SK, Katz AL. Potassium deficiency. In: Seldin & Giebisch’s The Kidney: Physiology and Pathophysiology. Lippincott Williams and Wilkins; 2000. p1615.
  • USDA 2012: Next link will take you to another Web site United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN).. National Germplasm Resources Laboratory, Beltsville (MD). [Taraxacum officinale F.H. Wigg: Last updated: 23-May-2012; Accessed 2012 October 5].
  • WHO 2007: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 3. Geneva (CH): World Health Organization; 2007.
  • Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis. 3rd edition. Stuttgart (DE): Medpharm Scientific Publishers; 2004.
  • Wiersema J, León B. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC; 1999.
  • Wren RC. Potter’s Cyclopedia of Botanical Drugs and Preparations. London (GB): Potter and Clark; 1907.

References reviewed

  • Barnes J, Anderson LA, Philipson JD. Herbal Medicines. 3rd edition. London (GB): The Pharmaceutical Press; 2007.
  • Barnes J, Anderson LA, Philipson JD. Herbal Medicines: A Guide for Healthcare Professionals, 2nd edition. London (GB): The Pharmaceutical Press; 2002.
  • Bisset NG, Wichtl M, editors. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 2nd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2001.
  • Brinker 2010: Next link will take you to another Web site Brinker F. Final updates and additions for Herb Contraindications and Drug Interactions 3rd edition, including extensive Appendices addressing common problematic conditions, medications and nutritional supplements, and influences on Phase I, II & III metabolism with new appendix on botanicals as complementary adjuncts with drugs. Sandy (OR): Eclectic Medical Publications. [Updated July 13, 2010; Accessed 2012 October 17].
  • Clare BA, Conroy RS, Spelman K. The Diuretic Effect in Human Subjects of an Extract of Taraxacum officinale Folium over a Single Day. The Journal of Alternative and Complementary Medicine 2009;15(8):929-934.
  • Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1922 original].
  • Schütz K, Carle R, Schieber A. Taraxacum – A review on its phytochemical and pharmacological profile. Journal of Ethnopharmacology 2006;107:313-323.
  • Swanston-Flatt SK, Day C, Flatt PR, Gould BJ, Baily CJ. Glycaemic effects of traditional European plant treatments for diabetes. Studies in normal and streptozotocin diabetic mice. Diabetes Research 1989;10(2):69-73.
  • Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (GB): C.W. Daniel Company Limited; 1988.

Appendix 1

Examples of appropriate dosage preparations and frequencies of use

LEAF

Dried leaf

  • 12-30 g, per day (Mills and Bone 2005)
  • 4-10 g, thrice daily/three times daily(Blumenthal et al. 1998; BHC 1992; BHP 1983)

Infusion

  • 12-30 g dried leaf, per day (Mills and Bone 2005)
  • 4-10 g dried leaf, thrice daily/three times daily (BHC 1992; BHP 1983)

Fluid extract

  • [6-11.5 g dried equivalent, per day]
    6-11.5 ml (1:1) (Mills and Bone 2005)
  • [4-10 g dried equivalent, 3 times per day]
    4-10 ml, three times daily (1:1, 25% ethanol) (Blumenthal et al. 2000)
  • [4-10 g dried equivalent, 3 times per day]
    4-10 ml, thrice daily (1:1, 25% alcohol) (BHP 1983)

Tincture

  • [1.2-3 g dried equivalent, per day]
    6-15 ml (1:5) (Mills and Bone 2005)
  • [1-2 g dried equivalent, 3 times per day]
    5-10 ml (1:5, 40% alcohol) (Hoffmann 2003)
  • [0.4-1 g dried equivalent, 3 times per day]
    2-5 ml, three times daily (1:5, 25% ethanol) (BHC 1992)
ROOT

Dried root

  • 6-24 g, per day (Mills and Bone 2005)
  • 3-5 g, 3 times per day (BHC 1992)
  • 2-8 g, thrice daily (BHP 1983)

Infusion or decoction

  • 6-24 g dried root, per day (Mills and Bone 2005)
  • 3-5 g dried root, 3 times per day (BHC 1992)
  • 2-8 g, thrice daily (BHP 1983)

Fluid extract

  • [2-8 g dried equivalent, 3 times per day]
    2-8 ml, thrice daily (1:1, 30% alcohol) (BHP 1983)

Tincture

  • [1.5-3 g dried equivalent, per day]
    (1:2, 3-6 ml) (Mills and Bone 2005)
  • [3-6 g dried equivalent, per day]
    (1:5, 15-30 ml) (Mills and Bone 2005)
  • [0.5-1 g dried equivalent, 3 times per day]
    (1:5, 60% alcohol, 2.5-5 ml) (Hoffmann 2003)
  • [1-2 g dried equivalent, 3 times per day]
    5-10 ml, three times daily (1:5, 25% ethanol) (BHC 1992)
  • [1-2 g dried equivalent, 3 times per day]
    5-10 ml, three times per day (1:5, 45% alcohol) (BHP 1983)
Root and aerial part(Blumenthal et al. 2000)

Unless otherwise prescribed
3-4 g of cut or powdered root and herb three times daily.

Decoction
Boil 3-4 g cut or powdered root and herb in 150 ml water. (Ed. Note: The decoction instructions in the German Standard License monograph are as follows: Boil 1-2 teaspoonfuls (2.4-4.4 g) and strain after 15 minutes, twice daily in the morning and evening.)

Infusion
Steep 1 tablespoon cut root and herb in 150 ml water.

Dry native extract
4:1 (w/w): 0.75-1 g.

Fluid extract
1:1 (g/ml): 3-4 ml.

Tincture
10-15 drops, three times daily. (Ed. Note: The Commission E-recommended tincture dosage of 10-15 drops, three times daily, does not correlate closely with the Commission E daily dosage of 3-4 g dried root and herb. No justification can be found in the literature for such a low tincture dosage, in drops as opposed to milliliters. Most herbal references recommend 5-10 ml, three times daily, which relates to the Commission E daily dosage of 3-4 g dried root.)