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Ginkgo biloba

Scientific Name(s): Ginkgo biloba L.
Common Name(s): Ginkgo, Ginkyo, Kew tree, Maidenhair tree, Yinhsing (Japanese silver apricot)

Clinical Overview

Use

Ginkgo has been studied extensively in diverse medical conditions. Findings from large trials have been pivotal in evaluating the efficacy of G. biloba extracts; however, there is not enough quality evidence to support the use of ginkgo for any indication. Evidence is lacking to support a protective role in cardiovascular conditions and stroke. Ginkgo's place in therapy for dementia seems limited, and a role in schizophrenia has not been established. Additionally, data do not support enhanced cognitive function resulting from G. biloba use in healthy individuals. Although interest exists in chemotherapeutic applications, safety concerns persist.

Dosing

Standardized ginkgo leaf extracts have been used in clinical trials for cognitive and cardiovascular disorders at daily doses of 120 to 240 mg.

Contraindications

Contraindications have not been established.

Pregnancy/Lactation

Information regarding safety and efficacy in pregnancy and lactation is lacking. Ginkgo should be used with caution during pregnancy, particularly around labor due to risk of prolonged bleeding time, and should be avoided during lactation.

Interactions

At recommended doses, standardized preparations of ginkgo leaf extract are unlikely to exhibit any clinically important interactions.

Adverse Reactions

Severe adverse reactions are rare; possible reactions include headache, dizziness, heart palpitations, and GI and dermatologic reactions. Ginkgo pollen can be strongly allergenic. Contact with the fleshy fruit pulp may cause allergic dermatitis similar to that caused by poison ivy.

Toxicology

Concerns persist regarding the safety of ginkgo leaf extract, based on studies in rodents that suggested increased mitosis and proliferation of tumor cells, as well as the large Ginkgo Evaluation of Memory (GEM) study in which the potential for an increased risk of certain cancers was noted. Consumption of the seeds may induce a toxic syndrome.

Botany

The dioecious ginkgo is the world's oldest living tree species. It has been traced back more than 200 million years to fossils of the Permian geologic period and is the sole survivor of the family Ginkgoaceae. Individual trees may live as long as 1,000 years and grow to a height of approximately 38 m. Ginkgo has characteristic fan-shaped leaves. Male trees older than 20 years blossom in the spring, and adult female trees produce plum-like, yellow-brown drupe that fall in late autumn. The fleshy layer and pulp have a foul, offensive odor and can cause contact dermatitis. The edible inner seed resembles an almond and is sold in Asian markets.USDA 2018, WHO 1999

History

The ginkgo species almost became extinct during the last ice age that began approximately 2 million years ago. The species survived in China, where it was cultivated as a sacred tree, and it still decorates Buddhist temples throughout Asia. Ginkgo preparations have been used for medicinal purposes for more than 1,000 years. Traditional Chinese physicians used ginkgo leaves to treat asthma and chilblains. Roasted ginkgo seeds were consumed in ancient China and Japan and were considered a digestive aid and preventive agent for drunkenness. In the Western world, ginkgo has been used since the 1960s, when technology made it possible to isolate its active compounds. The flavonoids act as free radical scavengers, and the terpenes (ginkgolides) inhibit platelet-activating factor. Ginkgo is one of the most commonly prescribed medications in Europe, but it is not approved for medical use in the United States, where it is sold only as a nutritional supplement.Mohanta 2014, WHO 1999

Chemistry

Reviews of the chemical constituents of ginkgo have been published. Analytical methods, biological standardization, and fingerprinting of ginkgo extracts have been reported.Liu 2015, Ude 2013, van Beek 2009

The main medicinal constituents of ginkgo are found in the leaf. These include flavonoids and several terpene trilactones unique to ginkgo (ginkgolides and bilobalide). The 3 major flavonoids of ginkgo are quercetin, kaempferol, and isorhamnetin. Approximately 40 minor flavonoids have also been identified, including catechins, dehydrocatechins (proanthocyanidins), and flavones (eg, ginkgetin, amentoflavone, bilobetin, sciadopitysin). The major terpene molecules unique to ginkgo are ginkgolides A, B, C, J, and M and bilobalide. Other medicinal constituents of ginkgo include shikimic, vanillic, ascorbic, and p-coumaric acids. Other leaf components include the steroids sitosterol and stigmasterol, polyprenols, benzoic acid derivatives, carbohydrates, straight chain hydrocarbons, alcohol, ketones, and 2-hexenol. There is seasonal variation in active compound content of the leaves, with the highest amounts present in autumn.Liu 2015, Ude 2013, van Beek 2009

The seed portion of ginkgo contains carbohydrate (38%), protein (4%), and less than 2% fat. Ginkgotoxin, amino acids, cyanogenetic glycosides, and long-chain phenols, including anacaric acid, bilobol, and cardanol, are also present. Ginkgolic acid and related alkylphenols from the lipid fraction of the fruit pods have been reviewed. The foul-smelling odor of the fleshy portion of the seedcoat is caused by high concentrations of butanoic and hexanoic acids. 4-O-methylpyridoxine has been isolated from the seeds.Liu 2015, Ude 2013, USDA 2018, van Beek 2009

Uses and Pharmacology

Cancer

Animal and in vitro data

A standardized extract of G. biloba leaves has been examined in several forms of cancer, and numerous mechanisms of action have been proposed based on in vitro studies.Cao 2017, Eli 2006, Li 2002, Liu 2017, Lou 2017, Park 2017, Pretner 2006 Some animal experiments suggest that ginkgo leaf extract reduces the risk of oral cavity, stomach, and colorectal cancer.Ahmed 2017, Chen 2005, Kim 2005, Wang 2000 The deleterious effects of electromagnetic radiation on hippocampal cells were reduced by ginkgo extract given to rats for 1 month,Gevrek 2018 and a protective effect was reported in bleomycin-induced lung fibrosis in rats.Iraz 2006

Conversely, in a mouse colon cancer model, ginkgo exacerbated metastasis to the liver and decreased necrosis and apoptosis of tumor cells.Wang 2017 This is potentially explained by observed carcinogenicity of quercetin in rodents.Wang 2017

Clinical data

Limited clinical studies evaluating use of ginkgo in cancer have produced equivocal findings. Smaller clinical studies have generally reported positive findings,Bonassi 2018, Hauns 2001, Xu 2003 and one epidemiologic study claimed that ginkgolide A and B may be associated with chemoprevention of certain forms of ovarian cancer.Ye 2007 However, in an analysis of cancer as a secondary end point in the 3,069 participants of the GEM study, no protective effect of ginkgo was observed. For site-specific cancers, there were nonsignificant trends towards an increased risk of breast (hazard ratio [HR], 2.15; 95% CI, 0.97 to 4.8; P=0.06) and colorectal (HR, 1.62; 95% CI, 0.92 to 2.87; P=0.1) cancers, and a reduced risk of prostate cancer (HR, 0.71; 95% CI, 0.43 to 1.17; P=0.18).Biggs 2010

Antioxidant effects of G. biloba extract were studied in Chernobyl nuclear accident recovery workers with clastogenic factors evidenced as DNA fragmentation and damage. G. biloba extract was tested on the plasma of salvage personnel; after 2 months of treatment at 120 mg per day, plasma clastogenic factors regressed or completely disappeared.Eli 2006, Emerit 1995 An anticlastogenic effect was demonstrated for ginkgo versus placebo in patients with Graves disease who were receiving radioiodine therapy.Dardano 2007

Cardiovascular disease and stroke

Animal data

Animal studies report efficacy in preventing cardiovascular conditions, and researchers have attempted to explain the mechanisms by which the extract may act.Abdel-Zaher 2017, Jiang 2017, Li 2009, Tang 2017, Wu 2008 Antiplatelet activity has been described, although evidence from controlled studies consistently indicates that ginkgo does not significantly impact hemostasis.Bone 2008

Clinical data

Evidence is lacking to support a protective role in cardiovascular conditions and stroke.

The GEM study (N=3,069 elderly men and women) preplanned an evaluation of cardiovascular outcomes and found no evidence that ginkgo 240 mg/day reduced total or cardiovascular mortality or cardiovascular events.Kuller 2010 A statistically significant positive finding was obtained for ginkgo in peripheral vascular disease; however, the number of events was too small to make any generalizations.Kuller 2010 Similarly, ginkgo did not reduce blood pressure in hypertensive or normotensive participants in the GEM study.Brinkley 2010 A 2009 Cochrane meta-analysis of 14 clinical trials evaluating the role of ginkgo in intermittent claudication found no evidence of a clinically important benefit in patients with peripheral arterial disease; the 2013 update reinforced this conclusion.Nicolaï 2009, Nicolai 2013 The American College of Cardiology Foundation/American Heart Association guidelines for the management of peripheral artery disease (2005/2011) state that the effectiveness of ginkgo in improving walking distance for patients with intermittent claudication is marginal and not well established (level B evidence).Anderson 2013

A Cochrane systematic review of studies to 2005, including 10 trials (N=792) assessing the efficacy of ginkgo, found no convincing evidence to support the use of ginkgo for recovery after stroke or for improvement in neurological deficit at the end of treatment.Zeng 2005

In a double-blind, randomized, placebo-controlled trial (N=102), significantly more patients in the ginkgo group achieved a 50% reduction in 4-month poststroke follow-up National Institutes of Health Stroke Scale (NIHSS) score compared with baseline than those in the placebo group (58.6% vs 18.5%, respectively; P<0.05).Oskouei 2013 In contrast, multivariate regression analysis of the trend of NIHSS scores from admission to follow-up revealed a significant decline in scores for G. biloba when adjusted for age and gender (P<0.05).Oskouei 2013

CNS effects

The widespread use of G. biloba extracts in clinical trials makes data from animal studies largely redundant.

Clinical data

It remains unclear whether ginkgo has a role in reducing the incidence of dementia in elderly patients or protecting against decline in cognitive function.

Results of 2 large clinical trials have been published: the GEM study (N=3,069) and the GuidAge study (N=2,854). The GEM study found no effect of ginkgo in reducing the incidence of dementia or in preventing decline in cognitive impairment among enrolled older adult participants with normal to mild cognitive impairment.DeKosky 2008, Snitz 2009 Similarly, in the GuidAge study, long-term use of standardized ginkgo extract had no effect on the risk of progression to Alzheimer disease compared with placebo.Vellas 2012

In the Impact of Cholinergic Treatment Use (ICTUS) study (N=828), 96.5% of patients received cholinesterase inhibitor therapy alone and 3.5% received ginkgo in combination with cholinesterase inhibitors. Improvements in Mini Mental State Examination (MMSE) score were observed in the combination therapy group; however, changes in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) subscale score and the Activities of Daily Living score were not significantly different. Patients receiving combination therapy were found to have a significantly higher education level (P=0.01) and lower baseline ADAS-Cog score (P<0.01) compared to those receiving cholinesterase inhibitor therapy alone.Canevelli 2014

In a retrospective study, outcomes were compared in 189 patients 80 years or older with Alzheimer disease who had used either donepezil or standardized G. biloba extract (EGb 761) for 12 months. No differences were noted in cognitive decline, as measured by MMSE. Rates of discontinuation because of lack of effect were similar between groups; however, more donepezil patients discontinued because of adverse effects.Rapp 2018

A Cochrane meta-analysis (published in 2009 and including 36 trials) found that results lacked consistent evidence of clinically important effects on dementia or cognitive impairment. Some trials included in the meta-analysis were of small sample size, and treatment duration was less than 3 months in each of the studies.Birks 2009

The effect of G. biloba on cognitive function in healthy individuals was examined in a systematic review and meta-analysis published in 2012, which concluded that no positive effect was evident for memory, executive function, or attention in 13 studies involving more than 2,500 participants.Laws 2012

Multiple other systematic reviews have been published, with many including subgroup analyses.Butler 2018, Cicero 2018 Clinical studies involving commercial industry generally report greater improvements in cognitive and neuropsychiatric measures.Gavrilova 2014, Ihl 2011, Napryeyenko 2007, Savaskan 2018, Von Gunten 2016, Yancheva 2009

A number of guidelines have been published on the use of ginkgo in Alzheimer disease and dementia. The European Federation of Neurological Sciences guidelines on the management of Alzheimer disease (2010) state that there is insufficient evidence to support the use of ginkgo for primary prevention of dementia, and that ginkgo should not be used in the treatment of patients with mild cognitive impairment. Additionally, the guidelines state that there is inconsistent evidence supporting the use of ginkgo in the treatment or prevention of Alzheimer disease.Hort 2010 According to a British Association for Psychopharmacology revised (third) consensus statement (2017), until further evidence is available, ginkgo cannot be recommended for either treatment or prevention of Alzheimer disease.O'Brien 2017

The American Academy of Neurology (AAN) practice parameter for the management of dementia (published in 2001, reaffirmed in 2003) states that some patients with unspecified dementia may benefit from G. biloba; however, evidence-based efficacy data are lacking (practice option recommendation).Doody 2001 The American Association for Geriatric Psychiatry position statement for patients with dementia resulting from Alzheimer disease (2006) does not recommend the general use of ginkgo for Alzheimer disease.Lyketsos 2006 The American Psychiatric Association practice guideline for the treatment of patients with Alzheimer disease and other dementias (2007) does not recommend ginkgo for routine use in treating cognitive and functional loss due to uncertainty regarding safety and efficacy.Rabins 2007

Ginkgo extracts have been studied in clinical trials for conditions including schizophrenia, attention-deficit/hyperactivity disorder (ADHD), dyslexia, autism, anxiety, and migraine, with varying results.D'Andrea 2009, Donfrancesco 2007, Lovera 2007, Niederhofer 2009, Savage 2018, Woelk 2007, Yancheva 2009

As an antioxidant, ginkgo is of interest in schizophrenia. Meta-analyses of quality clinical trials evaluating ginkgo as add-on therapy in chronic schizophrenia have been conducted; G. biloba extract performed better than placebo in the management of total and negative symptoms.Chen 2015, Magalhães 2016, Singh 2010 However, data from a systematic review of herbal and nutritional products for treatment of ADHD in 50 children suggested that ginkgo 80 to 120 mg/day for 6 weeks provided no benefit compared with methylphenidate.Sarris 2011

Guidelines have been published regarding ginkgo's use in major depressive disorder and tardive dyskinesia. AAN guidelines for the treatment of tardive syndromes, including tardive dyskinesia syndrome (2013), conclude that G. biloba extract is probably useful in treatment of tardive dyskinesia syndrome; however, data are limited to inpatients with schizophrenia.Bhidayasiri 2013 For major depressive disorder, the Canadian Network for Mood and Anxiety Treatments clinical guidelines for the management of major depressive disorder in adults (2009) state there is insufficient evidence to provide recommendations regarding use of gingko.Ravindran 2009

The AAN guideline on complementary and alternative medicine in multiple sclerosis (2014) advises that ginkgo is possibly effective for reducing short-term fatigue (low-quality evidence) and is ineffective for improving cognition (high-quality evidence).Yadav 2014

Diabetes

Clinical data

A limited number of small trials evaluating use of ginkgo in diabetes have been conducted. After 3-month ingestion of G. biloba extract in one study (N=20), significant (P<0.001) increases in fasting plasma levels of insulin and C-peptide, and in insulin and C-peptide area under the curve (AUC) were observed after a 2-hour 75 g oral glucose tolerance test. No changes in glucose tolerance were observed.Kudolo 2000 In a follow-up study of type 2 diabetes patients taking oral hypoglycemic agents, ginkgo increased pancreatic beta cell function in response to glucose loading.Kudolo 2001 Over a 3-month period, the pharmacokinetic properties of metformin 500 mg once daily were not affected by coadministration of 120 mg of ginkgo.Kudolo 2006 Ingestion of 120 mg/day of standardized ginkgo extract for 3 months did not produce insulin resistance in nondiabetic and prediabetic populations, nor did it exacerbate the disease in type 2 diabetic subjects.Aziz 2018, Kudolo 2006

Menopause/Sexual dysfunction

Clinical data

Evidence is lacking regarding the role of gingko in the management of menopausal symptoms or sexual function in women.Reid 2014, Wheatley 2004 Clinical trials with small sample sizes have produced varying and equivocal results regarding effects of ginkgo on sexual function.Ashton 2000, Boone 2005, Oh 2006, Ozgoli 2009, Wheatley 2004 In one study (N=99), G. biloba extract had a small but significant facilitatory effect on physiological, but not subjective, sexual arousal compared to placebo. The long-term effects of G. biloba extract on sexual function were then assessed in 68 sexually dysfunctional women randomly assigned to 8 weeks of treatment with G. biloba extract 300 mg/day, placebo, sex therapy alone, or sex therapy in combination with G. biloba extract. G. biloba extract was determined to be no more effective than placebo.Meston 2008 Canadian Society of Obstetricians and Gynaecologists revised clinical practice guidelines on managing menopause (2014) do not recommend ginkgo for reducing menopausal symptoms, based on a lack of evidence supporting clinical benefit.Reid 2014

Migraine

Clinical data

Small studies suggest efficacy in treating migraine; however, methodological limitations (eg, open-label design, multi-ingredient preparations tested) do not allow for extrapolation of the findings.Allais 2013

Ophthalmologic effects

Animal data

Studies in rodents suggest that antioxidant and vascular effects of ginkgo may have a role in glaucomaHirooka 2004, Wimpissinger 2007 and cataractogenesis prevention.Khedr 2018

Clinical data

Limited clinical studies have reported positive findings with G. biloba use in patients with glaucoma.Harris 2018, Kang 2018, Ritch 2005

Osteoporosis

Animal data

In rats with induced osteoporosis given ginkgo for 30 days, bone mineral density was improved.Lucinda 2017

Dental effects

Animal data

Protective effects were observed in a study of rats with induced periodontitis administered G. biloba extract.Freires 2018

Tinnitus

Publication of clinical trial data makes available animal studies of tinnitus less relevant, except to establish a mechanism of action.Dogan 2018, Esen 2018

Clinical data

A Cochrane meta-analysis of 4 clinical trials (N=1,543) conducted up to March 2012 in adults with tinnitus, either as the primary complaint or as a component of cerebral insufficiency, showed no evidence that supplemental ginkgo was effective. In patients with vascular dementia or Alzheimer disease and tinnitus, a small but statistically significant reduction in tinnitus was observed.Hilton 2013 A literature review reports equivocal results,Mahmoudian-Sani 2017 and a small (N=56) clinical study found no effect of ginkgo supplementation on idiopathic sudden sensorineural hearing loss for most outcomes measured, except for speech discrimination.Koo 2016

The American Association of Otolaryngology – Head and Neck Surgery clinical practice guidelines for tinnitus (2014) recommend against the use of ginkgo or other dietary supplements for treating patients with persistent tinnitus (moderate-quality aggregate evidence).Tunkel 2014

Other uses

Limited studies suggest potential applications in hyperuricemia,Zhang 2017 renoprotection,Chávez-Morales 2017, Zhang 2017 and aerobic performance.Sadowska-Krępa 2017

Ginkgo has been evaluated for the prevention of acute mountain sickness, with equivocal results.Leadbetter 2009, Moraga 2007

Dosing

Standardized ginkgo leaf extracts such as EGb 761 have been used in clinical trials for cognitive and cardiovascular disorders at daily doses of 120 to 240 mg.DeKosky 2008, Kuller 2010, Snitz 2009 Extracts are usually standardized to 24% flavones and 6% terpene lactones.DeKosky 2008, Snitz 2009 Ginkgo is commercially available in several doseforms, including teas, liquids, colas, capsules, extracts, tablets, sprays, and bars.

Pharmacokinetic testing of ginkgo doseforms, including capsules, drops, and tablets, has been conducted. When ginkgo is administered orally during fasting, bioavailability is high; food did not change the AUC quantitatively but did increase the time to maximum plasma concentration.Ude 2013, Woelkart 2010

The availability of unregulated or nonstandardized products needs to be considered when using ginkgo.Yadav 2014

Pregnancy / Lactation

Although a systematic review reports that traditional and common use has not indicated substantive risks in pregnancy or lactation, very weak scientific evidence from animal and in vitro studies shows ginkgo leaf has antiplatelet activity, and low-level evidence based on expert opinion shows ginkgo leaf may be an emmenagogue. Ginkgo should be used with caution during pregnancy, particularly around labor due to risk of prolonged bleeding time, and should be avoided during lactation.Dugoua 2006 An animal study of pregnant rats treated with ginkgo 7 to 14 mg/kg/day reported reduced fetal body weights,Pinto 2007 while another study found no evidence of embryotoxicity.Fernandes 2010

Interactions

At recommended doses, standardized preparations of ginkgo leaf extract are unlikely to exhibit any clinically important interactions.Bone 2008, Unger 2013 Caution may be required with use of raw extracts of the leaf with anticoagulants, although evidence from controlled studies consistently indicates that ginkgo does not impact hemostasis.Bone 2008

At higher than recommended dose levels, weak induction of cytochrome P450 (CYP-450) 2C19- and weak inhibition of CYP3A4-mediated metabolism has been observed, as well as a limited effect on drug transporters.Unger 2013 Case reports of treatment failure implicate ginkgo, including in a 41-year-old man receiving antiretroviral therapy with efavirenz and taking a G. biloba 300 mg/day supplementNaccarato 2012; other studies suggest no interaction with raltegravir.Blonk 2012

The availability of unregulated or nonstandardized products, as well as potential interactions of supplements with pharmaceutical medications, must be considered when using ginkgo.Yadav 2014

Adverse Reactions

In large clinical trials using maximum dosages of standardized ginkgo extract 240 mg/day for durations of up to 6 years, reported adverse reactions did not differ from those in placebo groups.Birks 2009, Dekosky 2008, Snitz 2009, Weinmann 2010 A trial evaluating the safety and effectiveness of ginkgo at dosages of 240 mg/day over 22 weeks found no difference in adverse events for ginkgo compared with placebo.Napryeyenko 2009

The effect of ginkgo on platelets is unclear, but evidence from controlled studies consistently indicates that ginkgo does not impact hemostasis.Bone 2008 Case reports of increased bleeding risk exist, but clinical trials have found no effect on platelet function.Bebbington 2005, Rosenblatt 1997, Wolf 2006 Ginkgo should be used with caution in populations with bleeding risks.Page 2016

Severe adverse reactions are rare. Case reports describe headache, dizziness, and heart palpitations, as well as GI and dermatologic reactions. Injectable forms of ginkgo may cause circulatory disturbances, skin allergy, or phlebitis; parenteral ginkgo was withdrawn from the market because of the potential for severe adverse reactions.De Smet 1997 Ginkgo products have been implicated in reports of hepatic injury collected between 2004 and 2013 by 8 US centers in the Drug-induced Liver Injury Network.Navarro 2014 Ginkgo pollen can be strongly allergenic. Contact with the fleshy drupe pulp can cause allergic dermatitis similar to that caused by poison ivy.De Smet 1997 Case reports of seizures associated with ginkgo supplementation existGranger 2001; however, ginkgo extracts have been shown to exhibit both anti- and proconvulsant activity in animal experiments.Jahanshahi 2012, Lee 2012

Toxicology

Data have been reported regarding the carcinogenic potential of G. biloba extract, with increased mitosis and cell proliferation observed in some,Wang 2017 but not all, rodent studies.Fernandes 2010, Grollino 2017

Limited clinical studies have also produced equivocal findings. One study (N=47) reported no increase in liver injury markers or genomic measures (micronucleus frequency, comet assay, c-myc, p53, and ctnnb1 expression profile in lymphocytes).Bonassi 2018 In an analysis of cancer as a secondary end point in the 3,069 participants of the GEM study, no protective effect of ginkgo was observed. For site-specific cancers, there were nonsignificant trends towards an increased risk of breast (HR, 2.15; 95% CI, 0.97 to 4.8; P=0.06) and colorectal (HR, 1.62; 95% CI, 0.92 to 2.87; P=0.1) cancers, and a reduced risk of prostate cancer (HR, 0.71; 95% CI, 0.43 to 1.17; P=0.18).Biggs 2010

Ginkgo seeds have been reported to induce a toxic syndrome ("Gin-nan" food poisoning). Consumption of approximately 50 ginkgo seeds has produced convulsions in a 21-month-old child, and consumption of 70 to 80 seeds induced tonic-clonic seizures and loss of consciousness in a 36-year-old woman.Benjamin 2001, Hasegawa 2006, Miwa 2001 Between 1930 and 1960, 70 reports of poisoning related to ginkgo ingestion revealed a 27% mortality rate, with infants being the most vulnerable. Ginkgotoxin (4-O-methylpyridoxine), found only in the seeds, was considered responsible for this toxicity.De Smet 1997, Newall 1996

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