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Monograph: Bilberry - Oral

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Note: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicant's discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.

Date: 2010-06-08

NHPID Name

Vaccinium myrtillus (USDA 2008)

Proper Name(s)

Vaccinium myrtillus L. (Ericaceae) ( USDA 2008 )

Common Name(s)

Bilberry ( McGuffin et al. 2000 )

Source Material

Fruit ( Blumenthal et al. 2000 )

Route Of Administration

Oral ( Blumenthal et al. 2000 )

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)

Adults:

Progression of disorders of the eye; Relieve symptoms related to non-complicated CVI
Preparation: All Standardised Extracts

Dose(s): 12 - 75 Grams per day, fruit 36 Percent Anthocyanosides
Relief of diarrhoea; Antioxidant
Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 1.8 - 75 Grams per day, dried fruit

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

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Progression of disorders of the eye; Relieve symptoms related to non-complicated CVI:
    Consult a health care practitioner if symptoms worsen.
  • Relief of diarrhoea:
    Consult a health care practitioner if symptoms persist or worsen

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 medicinal ingredient may comply with the specifications outlined in the following pharmacopoeial monographs: 'Dried Bilberry' in BP, 'Bilberry Fruit, Dried' and 'Fresh Bilberry Fruit Dry Extract, Refined and Standardised' in Ph. Eur., 'Powdered Bilberry Extract' in USP

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.
  • Blumenthal M, Hall T, Goldberg A, Kunz T, Kinda K, editors. 2003. The ABC Clinical Guide to Herbs. Austin (TX): American Botanical Council
  • BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
  • European Pharmacopoeia, 6th edition. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).; 2008
  • Felter HW, Lloyd JU. 1983. King's American Dispensatory, Volume 2, 18th edition. Sandy (OR): Eclectic Medical Publications [Reprint of 1898 original].
  • Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
  • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
  • Morazzoni P, Bombardelli E. 1996. Vaccinium myrtillus L. Fitoterapia 67(1):3-29.
  • Upton R, editor. 2001. American Herbal Pharmacopoeia and Therapeutic Compendium: Bilberry Fruit Vaccinium mysrtillus L.: Standards of Analysis, Quality Control and Therapeutics. Santa Cruz (CA): American Herbal Pharmacopoeia
  • USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • USP 32 : United States Pharmacopeial Convention. 2009. United States Pharmacopeia and the National Formulary (USP 32 - NF 27). Rockville (MD): The United States Pharmacopeial Convention.

References reviewed

  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Canter PH, Ernst E. 2004. Anthocyanosides of Vaccinium myritillus (bilberry) for night vision - a systematic review of placebo-controled trials. Survey of Opthalmology 49(1):38-50.
  • Jang YP, Zhou J, Nakanishi K, Sparrow JR. 2005. Anthocyanins protect against A2E photooxidation and membrane permeabilization in retinal pigment epithelial cells. Photochemistry and Photobiology 81(3):529-536.
  • Lee J, Lee HK, Kim Y, Hong YJ, Choe CM, You TW and Seong J. 2005. Purified high-dose anthocyanoside oligomer improves nocturnal vision and clinical symptoms in myopia subjects. British Journal of Nutrition 93:895-899.
  • Levy Y, Glovinski Y. 1998. The effect of anthocyanosides on night vision. Eye 12:967-969.
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
  • Muth ER, Laurent JM and Purcell Jasper. 2000. The effect of bilberry nutritional supplementation on night vision acuity and contrast sensitivity. Alternative Medecine Review 5:164-73.
  • Sparrow JR, Vollmer-Snarr HR, Zhou J, Jang PY, Jockusch. 2003. A2E-epoxides damage DNA in retinal pigment epithelial cells. Journal of Biological Chemistry 278(20):18207-18213.
  • Steigwalt RD Jr, Gianni B, Paolo M, Bombardelli E, Burki C, Schönlau F. 2008. Effects of Mirtogenol® on ocular blood flow and intraocular hypertension in asymptomatic subjects. Molecular Vision 14:1288-1292.
  • Zadok D, Levy Y, Glovinski Y. 1999. The effect of anthocyanosides in multiple oral dose on night vision. Eye 13:734-736.

Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use

ORAL:

Dried fruit:

  • 20 - 60 g, per day (ESCOP 2003)
  • 4 g, per day (Grieve 1971 [1931])

Decoction:

5 - 10 g dried fruit, 4-6 times per day (Blumenthal et al. 2000)

Directions for use:

Place crushed dried fruit in 150 ml of cold water. Bring to a boil for approximately 10 minutes. Strain while hot. Drink cold several times per day (Blumenthal et al. 2000)

Fluid extract:

  • 2 - 4 g dried equivalent, 3 times per day (1:1, 2-4 ml) (Blumenthal et al. 2000)
  • 3-6 g dried equivalent, per day (1:1, 3-6 ml) (Mills and Bone 2000)
  • 1.8-7.4 g dried equivalent, per day (1:1, 1.8-7.4 ml (0.5-2 drachms)) (Grieve 1971 [1931])

Cold macerate:

5 - 10 g dried fruit, 4 - 6 times per day (Blumenthal et al. 2000)

Directions for use:

Soak crushed dried fruit in 150 ml cold water for 2 hours, allowing the fruit to swell. Drink cold several times per day (Blumenthal et al. 2000).