Monograph: Ginkgo Biloba
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Date:
2023-01-27
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.
NHPID name
Ginkgo biloba ( Germplasm Resources Information Network Taxonomy )Proper name(s)
Ginkgo biloba ( USDA 2008 )Common name(s)
- Baiguo ( Unavailable )
- Ginkgo ( USDA 2008 , McGuffin et al. 2000 , WHO 1999 )
- Ginkgo biloba ( USDA 2008 )
- Icho ( Unavailable )
- Maidenhair tree ( USDA 2008 , McGuffin et al. 2000 , WHO 1999 )
Source material
Leaf ( Birks et al. 2007 )Route Of administration
OralDosage 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:
- Helps to enhance cognitive function and memory in adults.
- Helps to enhance cognitive function in adults. (Cieza et al. 2003, Santos et al. 2003, Mix and Crews 2002, Stough et al. 2001, Kennedy et al. 2000, Mix and Crews 2000)
- Helps to enhance memory in adults. (Santos et al. 2003, Stough et al. 2001, Kennedy et al. 2000, Mix and Crews 2000)
- Helps to support peripheral circulation. (Boelsma et al. 2004, Mehlsen et al. 2002, Pittler and Ernst 2000)
Dose(s)
Adults:
Dose(s):
1 Day per day
Duration of use
- For products providing 9.01 - 12 Grams per day : Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 4 weeks. (Cieza et al. 2003)
- For products providing 6 - 9 Grams per day : Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 6 weeks. (Elsabagh et al. 2005, Mix and Crews 2002, Mix and Crews 2000)
- For products providing 4 - 5.99 Grams per day : Consult a health care practitioner/health care provider/health care professional/doctor/physician, for use beyond 8 months. (Santos et al. 2003, Le Bars et al. 1997, Grassel 1992)
Risk information
Statement(s) to the effect of:
Caution(s) and Warning(s):- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding. (Blumenthal et al. 2000, WHO 1999)
- Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are taking medications for diabetes, high blood pressure or seizures. (Brinker 2010)
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: 'Ginkgo Leaf' published in the British Pharmacopoeia, 'Ginkgo Leaf (Ginkgonis folium)' published in the European Pharmacopoeia, or 'Ginkgo', 'Powdered Ginkgo Extract', 'Ginkgo Capsules' and 'Ginkgo Tablets' published in the USP.
References cited
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Bent S, Goldberg H, Padula A, Avins AL. Spontaneous bleeding associated with ginkgo biloba: a case report and systematic review of the literature. Journal of General Internal Medicine 2005;20(7):657-661.
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Birks J, Grimley EV, Van Dongen M. Ginkgo biloba for cognitive impairment and dementia (Review). Oxfordshire (UK): The Cochrane Database of Systematic Reviews; 2007, Issue 2. Art. No.: CD003120. DOI: 10.1002/14651858.CD003120.pub2
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Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
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Boelsma E, Lamers RJ, Hendriks HF, Van Nesselrooij JH, Roza L. Evidence of the regulatory effect of Ginkgo biloba extract on skin blood flow and study of its effects on urinary metabolites in healthy humans. Planta Medica 2004;70(11):1052-1057.
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BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
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Brinker F. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2010. [Accessed 2015 June 4]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
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Cieza A, Maier P, Pöppel E. Effects of Ginkgo biloba on mental functioning in healthy volunteers. Archives of Medical Research 2003;34(5):373-381.
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Crews WD, Harrison DW, Griffin ML, Falwell KD, Crist T, Longest L, Hehemann L, Rey ST. The neuropsychological efficacy of Ginkgo preparations in healthy and cognitively intact adults: a comprehensive review. HerbalGram: The Journal of the American Botanical Council 2005;67:43-62.
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Elsabagh S, Hartley DE, Ali O, Williamson EM, File SE. Differential cognitive effects of Ginkgo biloba after acute and chronic treatment in healthy young volunteers. Psychopharmacology 2005;179(2):437-446.
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European Pharmacopoeia, 6th edition. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).; 2008
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Grässel E. [Effect of Ginkgo-biloba extract on mental performance. Double-blind study using computerized measurement conditions in patients with cerebral insufficiency]. Fortschritte der Medizin 1992;110(5):73-76 (in German).
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Kennedy DO, Scholey AB, Wesnes KA. The dose-dependent cognitive effects of acute administration of Ginkgo biloba to healthy young volunteers. Psychopharmacology 2000;151(4):416-423.
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Le Bars PL, Katz MM, Berman N, Itil TM, Freedman AM, Schatzberg AF. A placebo-controlled, double-blind, randomized trial of an extract of Ginkgo biloba for dementia. North American EGb Study Group. The Journal of the American Medical Association 1997;278(16):1327-1332.
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McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
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Mehlsen J, Drabaek H, Wiinberg N, Winther K. Effects of a Ginkgo biloba extract on forearm haemodynamics in healthy volunteers. Clinical Physiology and Functional Imaging 2002;22(6):375-378.
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Mix JA, Crews WD. A double-blind, placebo-controlled, randomized trial of Ginkgo biloba extract EGb 761 in a sample of cognitively intact older adults: neuropsychological findings. Human Psychopharmacology: Clinical and Experimental 2002;17(6):267-277.
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Mix JA, Crews WD. An examination of the efficacy of Ginkgo biloba extract EGb761 on the neuropsychologic functioning of cognitively intact older adults. Journal of Alternative and Complementary Medicine 2000;6(3):219-229.
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Moulton PL, Boyko LN, Fitzpatrick JL, Petros TV. The effect of Ginkgo biloba on memory in healthy male volunteers. Physiology and Behavior 2001;73(4):659-665.
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Pittler MH, Ernst E. Ginkgo biloba extract for the treatment of intermittent claudication: a meta-analysis of randomized trials. The American Journal of Medicine 2000;108(4):276-281.
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Santos RF, Galduróz JC, Barbieri A, Castiglioni ML, Ytaya LY, Bueno OF. Cognitive performance, SPECT, and blood viscosity in elderly non-demented people using Ginkgo biloba. Pharmacopsychiatry 2003;36(4):127-133.
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Stough C, Clarke J, Lloyd J, Nathan PJ. Neuropsychological changes after 30-day Ginkgo biloba administration in healthy participants. The International Journal of Neuropsychopharmacology 2001;4(2):131-134.
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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
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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.
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WHO 1999: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 1. Geneva (CH): World Health Organization; 1999.
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Carlson JJ, Farquhar JW, DiNucci E, Ausserer L, Zehnder J, Miller D, Berra K, Hagerty L, Haskell WL. Safety and efficacy of a ginkgo biloba-containing dietary supplement on cognitive function, quality of life, and platelet function in healthy, cognitively intact older adults. Journal of the American Dietetic Association 2007;107(3):422-432.
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Gerhardt G, Rogalla K, Jaeger J. [Drug therapy of disorders of cerebral performance. Randomized comparative study of dihydroergotoxine and Ginkgo biloba extract]. Fortschritte der Medizin 1990;108(19):384-388 (in German).
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Greenblatt DJ, von Moltke LL, Luo Y, Perloff ES, Horan KA, Bruce A, Reynolds RC, Harmatz JS, Avula B, Khan IA, Goldman P. Ginkgo biloba does not alter clearance of flurbiprofen, a cytochrome P450-2C9 substrate. Journal of Clinical Pharmacology 2006;46(2):214-221.
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Appendix 1: Examples of dosage preparations, frequencies of use and directions for use
Leaf:
Standardized extract:
- Dried extract equivalent to 4 g dried leaf, per day (50:1, 80 mg) (Santos et al. 2003)
- Dried extract equivalent to 3-4 g dried leaf, 2 to 3 times per day (50:1, 60-80 mg) (Elsbagh et al. 2005; Boelsma et al. 2004; Cieza et al. 2003; Mehlsen et al. 2002; Mix and Crews 2002; Moulton et al. 2001; Stough et al. 2001; Kennedy et al. 2000; Mix and Crews 2000; Pittler and Ernst 2000)