PMID 19017911 Ginkgo biloba for prevention of dementia: a randomized controlled trial Randomized controlled trial (GEM) · JAMA, 2008 3,069 people aged 75 or older, median 6.1 years - dementia hazard ratio 1.12 (95% CI 0.94 to 1.33); incidence was not reduced.
Key summary
A randomized, double-blind, placeboAn inert dummy treatment used as the comparison baseline.-controlled trial at 5 US academic medical centers from 2000 to 2008. Community volunteers aged 75 or older, 2,587 with normal cognition and 482 with mild cognitive impairment, received 120 mg of ginkgo extract twice daily (1,545) or placebo (1,524) and were assessed every 6 months for dementia. Dementia developed in 523 people (246 on placebo, 277 on ginkgo), 92% of them in the Alzheimer category. Rates were 3.3 per 100 person-years on ginkgo and 2.9 on placebo. Hazard ratios were 1.12 for all-cause dementia (95% CI 0.94 to 1.33, P = .21), 1.16 for Alzheimer's disease (95% CI 0.97 to 1.39, P = .11), and 1.13 for progression from mild cognitive impairment (95% CI 0.85 to 1.50, P = .39). Dropout and loss to follow-up were low at 6.3%, and adverse effect profiles were similar. According to the full text it was a public trial sponsored by US National Institutes of Health institutes, and the manufacturer Schwabe only donated tablets and placebos. That it found no effect even with the manufacturer's own product (EGb 761) gives the result weight.
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CONTEXT: Ginkgo biloba is widely used for its potential effects on memory and cognition. To date, adequately powered clinical trials testing the effect of G. biloba on dementia incidence are lacking. OBJECTIVE: To determine effectiveness of G. biloba vs placebo in reducing the incidence of all-cause dementia and Alzheimer disease (AD) in elderly individuals with normal cognition and those with mild cognitive impairment (MCI). DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo-controlled clinical trial conducted in 5 academic medical centers in the United States between 2000 and 2008 with a median follow-up of 6.1 years. Three thousand sixty-nine community volunteers aged 75 years or older with normal cognition (n = 2587) or MCI (n = 482) at study entry were assessed every 6 months for incident dementia. INTERVENTION: Twice-daily dose of 120-mg extract of G. biloba (n = 1545) or placebo (n = 1524). MAIN OUTCOME MEASURES: Incident dementia and AD determined by expert panel consensus. RESULTS: Five hundred twenty-three individuals developed dementia (246 receiving placebo and 277 receiving G. biloba) with 92% of the dementia cases classified as possible or probable AD, or AD with evidence of vascular disease of the brain. Rates of dropout and loss to follow-up were low (6.3%), and the adverse effect profiles were similar for both groups. The overall dementia rate was 3.3 per 100 person-years in participants assigned to G. biloba and 2.9 per 100 person-years in the placebo group. The hazard ratio (HR) for G. biloba compared with placebo for all-cause dementia was 1.12 (95% confidence interval [CI], 0.94-1.33; P = .21) and for AD, 1.16 (95% CI, 0.97-1.39; P = .11). G. biloba also had no effect on the rate of progression to dementia in participants with MCI (HR, 1.13; 95% CI, 0.85-1.50; P = .39). CONCLUSIONS: In this study, G. biloba at 120 mg twice a day was not effective in reducing either the overall incidence rate of dementia or AD incidence in elderly individuals with normal cognition or those with MCI. Trial Registration clinicaltrials.gov Identifier: NCT00010803. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based on this text and the full-text quotes below.
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The trial was sponsored by US National Institutes of Health institutes (NCCAM, NIA).
"the Ginkgo Evaluation of Memory (GEM) Study, a randomized, double-blind trial sponsored by the National Center for Complementary and Alternative Medicine (NCCAM) and the National Institute on Aging of the National Institutes of Health (NIH)"
The manufacturer Schwabe only donated the ginkgo tablets and matching placeboAn inert dummy treatment used as the comparison baseline.s.
"Schwabe Pharmaceuticals, Karlsruhe, Germany, donated the G biloba tablets and identical placebos in blister packs for the study."
※ Quotes machine-checked against the open full text in PMC (PMC 텍스트 마이닝 허용(공정 이용), 2026-11-07) Correction notice exists (content not confirmed): A 2008 JAMA correction exists. Its text could not be obtained, so its content is unconfirmed. The rating rests on the original abstract.
View original ↗ PMID 20040554 Ginkgo biloba for preventing cognitive decline in older adults: a randomized trial Randomized controlled trial (GEM cognition analysis) · JAMA, 2009 GEM's 3,069 participants - annual memory decline 0.043 versus 0.041, with no difference in any cognitive domain.
Key summary
The cognitive decline analysis of GEM. It followed 3,069 people aged 72 to 96 for a median of 6.1 years, comparing rates of change on the 3MSE, ADAS-Cog, and neuropsychological scores for memory, attention, visuospatial abilities, language, and executive function. Annual z score declines were 0.043 versus 0.041 for memory, 0.043 versus 0.048 for attention, 0.107 versus 0.118 for visuospatial abilities, 0.045 versus 0.041 for language, and 0.092 versus 0.089 for executive function (ginkgo versus placeboAn inert dummy treatment used as the comparison baseline.), with no difference in any domain. The 3MSE (P = .71) and ADAS-Cog (P = .97) showed no group difference, and there was no effect modification by age, sex, race, education, APOE*E4, or baseline mild cognitive impairment.
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CONTEXT: The herbal product Ginkgo biloba is taken frequently with the intention of improving cognitive health in aging. However, evidence from adequately powered clinical trials is lacking regarding its effect on long-term cognitive functioning. OBJECTIVE: To determine whether G. biloba slows the rates of global or domain-specific cognitive decline in older adults. DESIGN, SETTING, AND PARTICIPANTS: The Ginkgo Evaluation of Memory (GEM) study, a randomized, double-blind, placebo-controlled clinical trial of 3069 community-dwelling participants aged 72 to 96 years, conducted in 6 academic medical centers in the United States between 2000 and 2008, with a median follow-up of 6.1 years. INTERVENTION: Twice-daily dose of 120-mg extract of G. biloba (n = 1545) or identical-appearing placebo (n = 1524). MAIN OUTCOME MEASURES: Rates of change over time in the Modified Mini-Mental State Examination (3MSE), in the cognitive subscale of the Alzheimer Disease Assessment Scale (ADAS-Cog), and in neuropsychological domains of memory, attention, visual-spatial construction, language, and executive functions, based on sums of z scores of individual tests. RESULTS: Annual rates of decline in z scores did not differ between G. biloba and placebo groups in any domains, including memory (0.043; 95% confidence interval [CI], 0.034-0.051 vs 0.041; 95% CI, 0.032-0.050), attention (0.043; 95% CI, 0.037-0.050 vs 0.048; 95% CI, 0.041-0.054), visuospatial abilities (0.107; 95% CI, 0.097-0.117 vs 0.118; 95% CI, 0.108-0.128), language (0.045; 95% CI, 0.037-0.054 vs 0.041; 95% CI, 0.033-0.048), and executive functions (0.092; 95% CI, 0.086-0.099 vs 0.089; 95% CI, 0.082-0.096). For the 3MSE and ADAS-Cog, rates of change varied by baseline cognitive status (mild cognitive impairment), but there were no differences in rates of change between treatment groups (for 3MSE, P = .71; for ADAS-Cog, P = .97). There was no significant effect modification of treatment on rate of decline by age, sex, race, education, APOE*E4 allele, or baseline mild cognitive impairment (P > .05). CONCLUSION: Compared with placebo, the use of G. biloba, 120 mg twice daily, did not result in less cognitive decline in older adults with normal cognition or with mild cognitive impairment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00010803. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 22959217 Long-term use of standardised Ginkgo biloba extract for the prevention of Alzheimer's disease (GuidAge): a randomised placebo-controlled trial Randomized controlled trial (GuidAge) · Lancet Neurol, 2012 2,854 people aged 70 or older with memory complaints, 5 years - Alzheimer's hazard ratio 0.84 (95% CI 0.60 to 1.18), not significant. Funded by Ipsen.
Key summary
A randomized, double-blind, placeboAn inert dummy treatment used as the comparison baseline.-controlled trial recruiting people aged 70 or older who reported memory complaints in French primary care. Participants received 120 mg of standardized extract EGb 761 twice daily or placebo and were followed for 5 years. Of 2,854 randomized, 1,406 on ginkgo and 1,414 on placebo took at least one dose. Probable Alzheimer's disease was diagnosed in 61 (1.2 per 100 person-years) versus 73 (1.4), a hazard ratio of 0.84 (95% CI 0.60 to 1.18, p = 0.306), and the risk was not proportional over time. Adverse events were much the same. There were 76 versus 82 deaths and 65 versus 60 strokes (risk ratio 1.12, 95% CI 0.77 to 1.63), and no difference in other hemorrhagic or cardiovascular events. The funder was Ipsen.
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BACKGROUND: Prevention strategies are urgently needed to tackle the growing burden of Alzheimer's disease. We aimed to assess efficacy of long-term use of standardised ginkgo biloba extract for the reduction of incidence of Alzheimer's disease in elderly adults with memory complaints. METHODS: In the randomised, parallel-group, double-blind, placebo-controlled GuidAge clinical trial, we enrolled adults aged 70 years or older who spontaneously reported memory complaints to their primary-care physician in France. We randomly allocated participants in a 1:1 ratio according to a computer-generated sequence to a twice per day dose of 120 mg standardised ginkgo biloba extract (EGb761) or matched placebo. Participants and study investigators and personnel were masked to study group assignment. Participants were followed-up for 5 years by primary-care physicians and in expert memory centres. The primary outcome was conversion to probable Alzheimer's disease in participants who received at least one dose of study drug or placebo, compared by use of the log-rank test. This study is registered with ClinicalTrials.gov, number NCT00276510. FINDINGS: Between March, 2002, and November, 2004, we enrolled and randomly allocated 2854 participants, of whom 1406 received at least one dose of ginkgo biloba extract and 1414 received at least one dose of placebo. By 5 years, 61 participants in the ginkgo group had been diagnosed with probable Alzheimer's disease (1·2 cases per 100 person-years) compared with 73 participants in the placebo group (1·4 cases per 100 person-years; hazard ratio [HR] 0·84, 95% CI 0·60-1·18; p=0·306), but the risk was not proportional over time. Incidence of adverse events was much the same between groups. 76 participants in the ginkgo group died compared with 82 participants in the placebo group (0·94, 0·69-1·28; p=0·68). 65 participants in the ginkgo group had a stroke compared with 60 participants in the placebo group (risk ratio 1·12, 95% CI 0·77-1·63; p=0·57). Incidence of other haemorrhagic or cardiovascular events also did not differ between groups. INTERPRETATION: Long-term use of standardised ginkgo biloba extract in this trial did not reduce the risk of progression to Alzheimer's disease compared with placebo. FUNDING: Ipsen. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 23001963 Is Ginkgo biloba a cognitive enhancer in healthy individuals? A meta-analysis Meta-analysis · Hum Psychopharmacol, 2012 In healthy people, memory d = -0.04, executive function -0.05, attention -0.08 - all non-significant and close to zero.
Key summary
A meta-analysisA statistical synthesis combining results of multiple studies into one conclusion. of whether ginkgo enhances cognition in healthy people, using randomized trial data on memory (13 trials, 1,132 participants), executive function (7, 534), and attention (8, 910). Effect sizes were d = -0.04 for memory (95% CI -0.17 to 0.07), d = -0.05 for executive function (95% CI -0.17 to 0.05), and d = -0.08 for attention (95% CI -0.21 to 0.02), unrelated to age, duration, daily dose, total dose, or sample size. The authors concluded there were no ascertainable positive effects on the targeted cognitive functions.
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OBJECTIVE: We conducted a meta-analysis to examine whether Ginkgo biloba (G. biloba) enhances cognitive function in healthy individuals. METHODS: Scopus, Medline, Google Scholar databases and recent qualitative reviews were searched for studies examining the effects of G. biloba on cognitive function in healthy individuals. We identified randomised controlled trials containing data on memory (K = 13), executive function (K = 7) and attention (K = 8) from which effect sizes could be derived. The analyses provided measures of memory, executive function and attention in 1132, 534 and 910 participants, respectively. RESULTS: Effect sizes were non-significant and close to zero for memory (d = -0.04: 95%CI -0.17 to 0.07), executive function (d = -0.05: 95%CI -0.17 to 0.05) and attention (d = -0.08: 95%CI -0.21 to 0.02). Meta-regressions showed that effect sizes were not related to participant age, duration of the trial, daily dose, total dose or sample size. CONCLUSIONS: We report that G. biloba had no ascertainable positive effects on a range of targeted cognitive functions in healthy individuals. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 41641880 Ginkgo biloba for cognitive impairment and dementia Cochrane review · Cochrane Database Syst Rev, 2026 82 studies, 10,613 participants - little or no effect in mild cognitive impairment; possible small to moderate benefit in dementia at six months (low certainty, I-squared 96%).
Key summary
A CochraneAn international network that rigorously reviews and synthesizes evidence. systematic review of the benefits and harms of ginkgo in cognitive impairment and dementia. With searches updated to 18 November 2024, it included 82 randomized trials (10,613 participants), 4 of them at low risk of bias in all domains. In subjective cognitive complaints (3 studies, 597 participants) the effect was uncertain. In mild cognitive impairment (12 studies, 1,913 participants), there was little or no effect at six months on the CDR (MD -0.03), ADAS-Cog (MD -0.07, 95% CI -0.67 to 0.51), or instrumental daily activities (MD -0.05), with moderate certainty. In dementia (13 studies, 3,288 participants), ginkgo was ahead at six months on the SKT (MD -1.86, 95% CI -3.48 to -0.24, I-squared 96%) and daily activities (MD -0.19, 95% CI -0.35 to -0.03, I-squared 91%), with low certainty. The abstract's figure for global clinical status reads MD -0.06, 95% CI -1.00 to -0.20, which puts the point estimate outside its own interval, so this dossier does not cite it. In dementia, adverse events (RR 0.95) and serious adverse events (RR 0.88) differed little or not at all from placeboAn inert dummy treatment used as the comparison baseline..
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BACKGROUND: Dementia is a neurocognitive disorder that interferes with cognition and independent functioning. Common dementia subtypes include Alzheimer's disease, vascular dementia, and mixed type. Mild cognitive impairment (MCI) is a risk factor for dementia, and subjective cognitive complaints may be the earliest manifestation. Although cholinesterase inhibitors may help reduce some cognitive and behavioral symptoms, there is no established treatment that cures or slows dementia progression. Ginkgo biloba (ginkgo) is a popular herbal preparation that is used to improve brain and circulatory health, and neuroprotective effects are biologically plausible. OBJECTIVES: To assess the benefits and harms of Ginkgo biloba for the treatment of people with cognitive impairment or dementia. SEARCH METHODS: We searched the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE, Embase, four other databases, and two trials registries on 8 December 2022. The search was updated in MEDLINE, Embase, CENTRAL, and the trials registers on 18 November 2024. SELECTION CRITERIA: We included randomized controlled trials (RCTs) comparing ginkgo with placebo, usual treatment, or other treatments for cognitive problems in people with cognitive complaints or diagnoses of MCI or dementia. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, extracted data, and assessed studies for risk of bias. Key outcomes were global clinical status, global cognitive function, activities of daily living (ADLs), adverse events (AEs), and serious adverse events (SAEs) at six months. When clinically appropriate, we pooled data using a random-effects model and expressed treatment effects as mean differences (MDs), standardized mean differences (SMDs), or risk ratios (RRs), each with its 95% confidence interval (CI). We used GRADE methods to assess the certainty of the evidence for each estimate. MAIN RESULTS: We included 82 studies with 10,613 participants; 72 studies with 9783 participants provided extractable data. Four studies were at low risk of bias in all domains. Below we present data for the comparison of ginkgo versus placebo in people with different clinical conditions. Subjective cognitive impairment Three studies (597 participants) compared ginkgo with placebo for people with subjective cognitive complaints. Based on one study that lasted six months, it is uncertain whether ginkgo has any effect on global clinical status measured on a five-point Likert scale (MD 0.00, 95% CI -0.33 to 0.33; P = 1.00; 1 study, 197 participants; very low-certainty evidence). There were no data on cognition or ADLs. One study reported no difference in minor side effects between treatment groups and did not mention SAEs. A larger study lasting three months found that the risk of AEs may be higher with ginkgo versus placebo. It provided very uncertain evidence on the risk of SAEs. Multiple sclerosis and cognitive impairment Two studies (164 participants) tested ginkgo versus placebo over three months in people with multiple sclerosis and cognitive problems. Ginkgo probably has little or no effect on cognition measured on the Perceived Deficits Questionnaire (MD -0.09, 95% CI -0.41 to 0.22; P = 0.55, I² = 0%; 2 studies, 152 participants; moderate-certainty evidence). There were no data on global clinical status or ADLs. The studies suggested no important difference in numbers of AEs between groups, and there was no indication of SAEs due to ginkgo. Mild cognitive impairment Twelve studies (1913 participants) tested ginkgo against placebo in people with MCI. At six months, moderate-certainty evidence suggests that ginkgo probably has little to no effect on global clinical status measured on the Clinical Dementia Rating Scale (MD -0.03, 95% CI -0.06 to 0.01; 3 studies, 631 participants; I² = 0%), cognition measured on the Alzheimer's Disease Assessment Scale - cognition (MD -0.07, 95% CI -0.67 to 0.51; I² = 0%; 2 studies, 508 participants), and ADLs measured on the Instrumental ADL scale (MD -0.05, 95% CI -0.29 to 0.19; 1 study, 350 participants). There may be little or no difference between ginkgo and placebo at up to 12 months in the risk of AEs (RR 0.98, 95% CI 0.77 to 1.24; I² = 58%; 7 studies, 991 participants, 379 events; low-certainty evidence), and there is little or no difference in the risk of SAEs (RR 0.95, 95% CI 0.82 to 1.09; I² = 0%; 3 studies, 714 participants, 327 events; high-certainty evidence). Dementia Thirteen studies (3288 participants) compared ginkgo with placebo for dementia. At six months, low-certainty evidence suggests that people taking ginkgo may have better global clinical status on a six-point Likert scale (lower is better; MD -0.06, 95% CI -1.00 to -0.20; I² = 88%; 5 studies, 1359 participants), better cognition measured by decreases on a short cognitive performance test (Syndrom-Kurztest; MD -1.86, 95% CI -3.48 to -0.24; I² = 96%; 9 studies, 2801 participants), and slightly better ADLs measured on the ADL International Scale (MD -0.19, 95% CI -0.35 to -0.03; I² = 91%; 8 studies, 2571 participants). There is probably little or no difference between ginkgo and placebo in the risk of AEs at up to 12 months (RR 0.95, 95% CI 0.90 to 1.00; I² = 0%; 9 studies, 2746 participants, 1480 events; moderate-certainty evidence). There may be little or no difference in risk of SAEs at six months (RR 0.88, 95% CI 0.58 to 1.33; I² = 0%; 6 studies, 2463 participants, 89 events; low-certainty evidence). AUTHORS' CONCLUSIONS: In people with cognitive complaints, we are unsure whether ginkgo improves global clinical status at six months, and it may be associated with an increased risk of AEs at three months. Ginkgo probably has no benefit at three months for cognition in multiple sclerosis; numeric data on AEs were unavailable, but studies did not suggest concerns. In people with MCI, ginkgo probably has little or no effect at six months on global status, cognition, or ADLS. There may be little or no difference in AEs, and there is little or no difference in SAEs, at up to 12 months. In people with dementia, there may be small to moderate benefits at six months for global status, cognition, and ADLs. There is probably little or no difference in AEs at up to 12 months, and there may be no difference in SAEs. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 39895346 Ginkgo biloba extract EGb 761 is safe and effective in the treatment of mild dementia - a meta-analysis of patient subgroups in randomised controlled trials Meta-analysis (with a manufacturer-affiliated author) · World J Biol Psychiatry, 2025 Subgroup of 782 people with mild dementia - medium to large effects at 240 mg/day. The last author is affiliated with the manufacturer, Dr. Willmar Schwabe.
Key summary
A meta-analysisA statistical synthesis combining results of multiple studies into one conclusion. pooling only the 782 patients with mild dementia (SKT total score 9 to 15) from 4 placeboAn inert dummy treatment used as the comparison baseline.-controlled EGb 761 trials. At 240 mg/day, EGb 761 was significantly better than placebo on cognition (p = 0.04), global assessment (p = 0.01), daily activities (p = 0.01), and quality of life (p = 0.02), with medium to large standardized effects. Adverse event frequency was alike (p = 0.66). This is a subgroup analysis rather than the whole trials. In the PubMed record the last author's affiliation is the biometry division of Dr. Willmar Schwabe, the maker of EGb 761, and the record carries no conflict of interest statement.
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BACKGROUND: Mild dementia is distressing for patients and their relatives. Due to its chronic and progressive nature, healthcare systems are at risk of being overwhelmed by the increasing number of affected patients. Thus, there is a need for safe and well-tolerated treatments that can be initiated at the earliest stages. OBJECTIVES: This meta-analysis of clinical trials aimed to assess the treatment effects of Ginkgo biloba extract EGb 761 in patients with mild dementia. METHODS: Eligible randomised placebo-controlled trials were included in this meta-analysis. Data of patients with mild dementia (defined as the SKT Short Cognitive Performance Test total scores from 9 to 15) were selected. RESULTS: The meta-analysis was performed with pooled data from four eligible trials comprising 782 patients with mild dementia. Treatment with 240 mg EGb 761 daily was significantly superior to placebo in cognition (p = 0.04), global assessment (p = 0.01), activities of daily living (p = 0.01) and quality of life (p = 0.02). Standardised effects were medium to large. The frequency of adverse events was alike in patients treated with EGb 761 and placebo (p = 0.66). CONCLUSIONS: The meta-analysis demonstrates that patients with mild dementia benefit from EGb 761 in terms of cognition, activities of daily living, global assessment and quality of life. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 16375657 A randomized, double-blind, placebo-controlled trial of two doses of Ginkgo biloba extract in dementia of the Alzheimer's type Randomized controlled trial · Curr Alzheimer Res, 2005 513 people with Alzheimer-type dementia, 26 weeks - no significant difference from placeboAn inert dummy treatment used as the comparison baseline. at 120 mg or 240 mg/day. Inconclusive because the placebo group declined little.
Key summary
A multicenter, randomized, double-blind trial of 513 outpatients with mild to moderate Alzheimer-type dementia (MMSE 10 to 24), given ginkgo extract at 120 mg or 240 mg per day or placeboAn inert dummy treatment used as the comparison baseline. for 26 weeks, with the ADAS-cog and ADCS-CGIC as main outcomes. There were no significant between-group differences in the whole sample. The placebo group declined little, however, which may have limited the trial's sensitivity, and a subgroup with neuropsychiatric symptoms scored significantly better on ginkgo. The authors summarized that the trial did not show efficacy and remains inconclusive.
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CONTEXT: Previous studies of Ginkgo biloba extract (GbE) in patients with various forms of cognitive impairment or dementia have shown promising results. OBJECTIVE: To determine the clinical efficacy of GbE in mild to moderate dementia of the Alzheimer type. DESIGN: Randomized, placebo-controlled, double-blind, parallel-group, multicenter trial. SETTING: Outpatient clinics of universities and private research centers specialized in dementia. PATIENTS: 513 outpatients with uncomplicated dementia of the Alzheimer's type scoring 10 to 24 on the Mini-Mental State Examination and less than 4 on the modified Hachinski Ischemic Score, free of other serious illnesses and not requiring continuous treatment with any psychoactive drug. INTERVENTION: 26-week treatment with GbE at daily doses of 120 mg or 240 mg or placebo. MAIN OUTCOMES: Cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog), Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC). RESULTS: There were no significant between-group differences for the whole sample. There was little cognitive and functional decline of the placebo-treated patients, however. For a subgroup of patients with neuropsychiatric symptoms there was a greater decline of placebo-treated patients and significantly better cognitive performance and global assessment scores for the patients on GbE. CONCLUSION: The trial did not show efficacy of GbE, however, the lack of decline of the placebo patients may have compromised the sensitivity of the trial to detect a treatment effect. Thus, the study remains inconclusive with respect to the efficacy of GbE. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 23744597 Ginkgo biloba for intermittent claudication Cochrane review · Cochrane Database Syst Rev, 2013 14 trials, 739 participants - walking distance gain of 64.5 metres (CI -1.8 to 130.7); no evidence of clinically significant benefit.
Key summary
A CochraneAn international network that rigorously reviews and synthesizes evidence. review of ginkgo's effect on walking distance in intermittent claudication, including 14 randomized trials (739 participants), 11 of which (477) compared absolute claudication distance with placeboAn inert dummy treatment used as the comparison baseline.. The effect size was 3.57 kilocalories (CI -0.10 to 7.23, P = 0.06), equivalent to 64.5 metres (CI -1.8 to 130.7) on a flat treadmill at 3.2 km/h. The authors judged that publication bias has likely inflated the effect, and concluded there is no evidence of a clinically significant benefit for people with peripheral arterial disease.
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BACKGROUND: People with intermittent claudication (IC) suffer from pain in the muscles of the leg occurring during exercise which is relieved by a short period of rest. Symptomatic relief can be achieved by (supervised) exercise therapy and pharmacological treatments. Ginkgo biloba is a vasoactive agent and is used to treat IC. OBJECTIVES: To assess the effect of Ginkgo biloba on walking distance in people with intermittent claudication. SEARCH METHODS: For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (March 2013) and CENTRAL (2013, Issue 2). SELECTION CRITERIA: Randomised controlled trials of Ginkgo biloba extract, irrespective of dosage, versus placebo in people with IC. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trials for selection, assessed study quality and extracted data. We extracted number of patients, mean walking distances or times and standard deviations. To standardise walking distance or time, caloric expenditures were used to express the difference between the different treadmill protocols, which were calculated from the speed and incline of the treadmill. MAIN RESULTS: Fourteen trials with a total of 739 participants were included. Eleven trials involving 477 participants compared Ginkgo biloba with placebo and assessed the absolute claudication distance (ACD). Following treatment with Ginkgo biloba at the end of the study the ACD increased with an overall effect size of 3.57 kilocalories (confidence interval (CI) -0.10 to 7.23, P = 0.06), compared with placebo. This translates to an increase of just 64.5 ( CI -1.8 to 130.7) metres on a flat treadmill with an average speed of 3.2 km/h. Publication bias leading to missing data or "negative" trials is likely to have inflated the effect size. AUTHORS' CONCLUSIONS: Overall, there is no evidence that Ginkgo biloba has a clinically significant benefit for patients with peripheral arterial disease. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 20123670 Does Ginkgo biloba reduce the risk of cardiovascular events? Randomized controlled trial (GEM cardiovascular analysis) · Circ Cardiovasc Qual Outcomes, 2010 3,069 participants, mean 6.1 years - no reduction in cardiovascular events or death; hemorrhagic strokes 16 versus 8 (not significant).
Key summary
An analysis of cardiovascular disease, a preplanned secondary outcome of GEM. In all, 3,069 people over 75 received EGb 761 120 mg twice daily or placeboAn inert dummy treatment used as the comparison baseline. for a mean of 6.1 years. Of 355 deaths, the 87 due to coronary heart diseaseDisease caused by narrowing of the arteries that supply the heart. did not differ by group, nor did myocardial infarctionA heart attack - death of heart muscle from blocked blood flow. (164), angina (207), or stroke (151). Of 24 hemorrhagic strokes, 16 were on ginkgo and 8 on placebo, not significant. Of 35 peripheral vascular events, 12 (0.8%) were on ginkgo and 23 (1.5%) on placebo (P = 0.04). The authors concluded ginkgo cannot be recommended for preventing cardiovascular disease and suggested further trials of peripheral vascular outcomes.
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BACKGROUND: Cardiovascular disease (CVD) was a preplanned secondary outcome of the Ginkgo Evaluation of Memory Study. The trial previously reported that Ginkgo biloba had no effect on the primary outcome, incident dementia. METHODS AND RESULTS: The double-blind trial randomly assigned 3069 participants over 75 years of age to 120 mg of G biloba EGb 761 twice daily or placebo. Mean follow-up was 6.1 years. The identification and classification of CVD was based on methods used in the Cardiovascular Health Study. Differences in time to event between G biloba and placebo were evaluated using Cox proportional hazards regression adjusted for age and sex. There were 355 deaths in the study, 87 due to coronary heart disease with no differences between G biloba and placebo. There were no differences in incident myocardial infarction (n=164), angina pectoris (n=207), or stroke (151) between G biloba and placebo. There were 24 hemorrhagic strokes, 16 on G biloba and 8 on placebo (not significant). There were only 35 peripheral vascular disease events, 12 (0.8%) on G biloba and 23 (1.5%) on placebo (P=0.04, exact test). Most of the peripheral vascular disease cases had either vascular surgery or amputation. CONCLUSIONS: There was no evidence that G biloba reduced total or CVD mortality or CVD events. There were more peripheral vascular disease events in the placebo arm. G biloba cannot be recommended for preventing CVD. Further clinical trials of peripheral vascular disease outcomes might be indicated. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00010803. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 36383762 Ginkgo biloba for tinnitus Cochrane review · Cochrane Database Syst Rev, 2022 12 studies, 1,915 participants - tinnitus severity MD -1.35 (95% CI -8.26 to 5.55, 85 participants); very low certainty, so benefits and harms are both uncertain.
Key summary
A CochraneAn international network that rigorously reviews and synthesizes evidence. systematic review of ginkgo for tinnitus. Searching to 7 June 2022, it included 12 randomized trials (1,915 participants), 11 of them against placeboAn inert dummy treatment used as the comparison baseline.. Risk of bias was generally high or unclear, and differing measures limited pooling. The Tinnitus Handicap Inventory at three to six months gave MD -1.35 (95% CI -8.26 to 5.55, 2 studies, 85 participants), with very low certainty. Serious adverse effects such as bleeding or seizures were not reported in either group (4 studies, 1,154 participants, low certainty), and other adverse effects had a risk ratio of 0.91 (95% CI 0.52 to 1.60, 4 studies, 1,175 participants). The authors concluded that benefits and harms are uncertain.
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BACKGROUND: Tinnitus is a symptom defined as the perception of sound in the absence of an external source. In England alone there are an estimated ¾ million general practice consultations every year where the primary complaint is tinnitus, equating to a major burden on healthcare services. Clinical management strategies include education and advice, relaxation therapy, tinnitus retraining therapy (TRT), cognitive behavioural therapy (CBT), sound enrichment using ear-level sound generators or hearing aids, and drug therapies to manage co-morbid symptoms such as insomnia, anxiety or depression. OBJECTIVES: To assess the effects of Ginkgo biloba for tinnitus in adults and children. SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL (2022, Issue 6); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 7 June 2022. SELECTION CRITERIA: Randomised controlled trials (RCTs) recruiting adults and children with acute or chronic subjective tinnitus. We included studies where the intervention involved Ginkgo biloba and this was compared to placebo, no intervention, or education and information. Concurrent use of other medication or other treatment was acceptable if used equally in each group. Where an additional intervention was used equally in both groups, we analysed this as a separate comparison. The review included all courses of Ginkgo biloba, regardless of dose regimens or formulations, and for any duration of treatment. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were tinnitus symptom severity measured as a global score on a multi-item tinnitus questionnaire and serious adverse effects (bleeding, seizures). Our secondary outcomes were tinnitus loudness (change in subjective perception), tinnitus intrusiveness, generalised depression, generalised anxiety, health-related quality of life and other adverse effects (gastrointestinal upset, headache, allergic reaction). We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: This review included 12 studies (with a total of 1915 participants). Eleven studies compared the effects of Ginkgo biloba with placebo and one study compared the effects of Ginkgo biloba with hearing aids to hearing aids alone. All included studies were parallel-group RCTs. In general, risk of bias was high or unclear due to selection bias and poor reporting of allocation concealment and blinding of participants, personnel and outcome assessments. Due to heterogeneity in the outcomes measured and measurement methods used, only limited data pooling was possible. Ginkgo biloba versus placebo When we pooled data from two studies for the primary outcome tinnitus symptom severity, we found that Ginkgo biloba may have little to no effect (Tinnitus Handicap Inventory scores) at three to six months compared to placebo, but the evidence is very uncertain (mean difference (MD) -1.35 (scale 0 to 100), 95% confidence interval (CI) -8.26 to 5.55; 2 studies; 85 participants) (very low-certainty). Ginkgo biloba may result in little to no difference in the risk of bleeding or seizures, with no serious adverse effects reported in either group (4 studies; 1154 participants; low-certainty). For the secondary outcomes, one study found that there may be little to no difference between the effects of Ginkgo biloba and placebo on tinnitus loudness measured with audiometric loudness matching at 12 weeks, but the evidence is very uncertain (MD -4.00 (scale -10 to 140 dB), 95% CI -13.33 to 5.33; 1 study; 73 participants) (very low-certainty). One study found that there may be little to no difference between the effects of Ginkgo biloba and placebo on health-related quality of life measured with the Glasgow Health Status Inventory at three months (MD -0.58 (scale 0 to 100), 95% CI -4.67 to 3.51; 1 study; 60 participants) (low-certainty). Ginkgo biloba may not increase the frequency of other adverse effects (gastrointestinal upset, headache, allergic reaction) at three months compared to placebo (risk ratio 0.91, 95% CI 0.52 to 1.60; 4 studies; 1175 participants) (low-certainty). None of the studies reported the other secondary outcomes of tinnitus intrusiveness or changes in depressive symptoms or depression, anxiety symptoms or generalised anxiety. Gingko biloba with concurrent intervention versus concurrent intervention only One study compared Ginkgo biloba with hearing aids to hearing aids only. It assessed the mean difference in the change in Tinnitus Handicap Inventory scores and tinnitus loudness using a 10-point visual analogue scale (VAS) at three months. The study did not report adverse effects, tinnitus intrusiveness, changes in depressive symptoms or depression, anxiety symptoms or generalised anxiety, or health-related quality of life. This was a single, very small study (22 participants) and for all outcomes the certainty of the evidence was very low. We were unable to draw meaningful conclusions from the numerical results. AUTHORS' CONCLUSIONS: There is uncertainty about the benefits and harms of Ginkgo biloba for the treatment of tinnitus when compared to placebo. We were unable to draw meaningful conclusions regarding the benefits and harms of Ginkgo biloba when used with concurrent intervention (hearing aids). The certainty of the evidence for the reported outcomes, assessed using GRADE, ranged from low to very low. Future research into the effectiveness of Ginkgo biloba in patients with tinnitus should use rigorous methodology. Randomisation and blinding should be of the highest quality, given the subjective nature of tinnitus and the strong likelihood of a placebo response. The CONSORT statement should be used in the design and reporting of future studies. We also recommend the use of validated, patient-centred outcome measures for research in the field of tinnitus. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 21923430 Is there a risk of bleeding associated with standardized Ginkgo biloba extract therapy? A systematic review and meta-analysis Meta-analysis · Pharmacotherapy, 2011 18 randomized trials, 1,985 adults - hemostasis outcomes showed no higher bleeding risk, while blood viscosity fell. This analysis did not count actual bleeding events.
Key summary
A meta-analysisA statistical synthesis combining results of multiple studies into one conclusion. of standardized ginkgo extract's effect on hemostasis measures linked to bleeding risk, covering 18 randomized trials (1,985 adults), 87% of them patients with dementia, peripheral artery disease, or diabetes and 13% healthy volunteers. Blood viscosity fell significantly (WMD -1.03 mPa·s, 95% CI -1.29 to -0.78), but there was no significant effect on ADP-induced platelet aggregation (WMD -0.35%), fibrinogen (-2.45 mg/dl), aPTT (-0.42 sec), or prothrombin time (SMD 0.00). A subgroup at 240 mg/day or more saw aPTT fall by 0.47 sec, not clinically relevant. The authors concluded the outcomes did not indicate a higher bleeding risk.
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STUDY OBJECTIVE: To determine the effect of standardized Ginkgo biloba leaf extracts (GBE) on outcome parameters of hemostasis associated with risk of bleeding. DESIGN: Meta-analysis of 18 randomized controlled trials. SUBJECTS: A total of 1985 adults were enrolled to receive either GBE or placebo; 87% were patients with dementia, peripheral artery disease, or diabetes mellitus; 13% were healthy volunteers. MEASUREMENTS AND MAIN RESULTS: The MEDLINE, EMBASE, Cochrane Library, and SciSearch databases were searched from inception through 2009. The following outcome parameters of hemostasis were assessed: blood flow, blood viscosity, adenosine 5'-diphosphate (ADP)-induced platelet aggregation, fibrinogen concentration, activated partial thromboplastin time (aPTT), and prothrombin time (PT). Reference parameter values were taken into account when assessing clinical relevance of statistically significant treatment effects. The quality and risk of bias of each study were evaluated by using the Jadad score and Cochrane Collaboration tool, respectively. According to the continuous data, the following statistical methods were used: weighted mean difference (WMD), standardized mean difference (SMD), and generic inverse variance (GIV), with 95% confidence intervals (CIs). Random-effects models of effects on baseline change or mean difference showed a positive effect of GBE on blood perfusion, as shown by a significant reduction in blood viscosity (WMD -1.03 mPa•sec, 95% CI -1.29 to -0.78 mPa•sec), but no evidence of any significant effect on ADP-induced platelet aggregation (WMD -0.35%, 95% CI -15.16-14.46%), fibrinogen concentration (GIV -2.45 mg/dl, 95% CI -11.59-6.70 mg/dl), aPTT (GIV -0.42 sec, 95% CI -0.97-0.12 sec), and PT (SMD 0.00, 95% CI -0.09-0.09). Subgroup analyses revealed a statistically significant reduction in aPTT for subgroups receiving high-dose GBE of 240 mg/day or more (GIV -0.47 sec, 95% CI -0.88 to -0.05 sec) and for studies including only patients, not healthy volunteers (GIV -0.61 sec, 95% CI -0.95 to -0.27 sec); however, both findings were not clinically relevant. CONCLUSION: Based on meta-analysis of hemostasis outcomes, comparison of mean difference or baseline change between treatment and placebo groups did not indicate a higher bleeding risk associated with standardized GBE. This finding ultimately contributes to an informed evaluation of GBE use, including patient self-medication. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 26958257 Ginkgo and Warfarin Interaction in a Large Veterans Administration Population Observational study · AMIA Annu Symp Proc, 2015 US Veterans Administration records - bleeding event hazard ratio 1.38 (95% CI 1.20 to 1.58) when ginkgo is used with warfarin.
Key summary
An analysis that used text processing to extract ginkgo use from a large clinical data repository and combined it with warfarin prescription data. Taken concurrently with warfarin, the hazard ratio for a bleeding adverse event was 1.38 (95% CI 1.20 to 1.58, p<.001). The authors note that the existing literature conflicts on the presence and severity of the interaction. These are observational rather than randomized data, and the abstract does not report patient numbers or how confounders were handled.
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Ginkgo biloba is a widely used herbal product that could potentially have a severe interaction with warfarin, which is the most frequently prescribed anticoagulant agent in North America. Literature, however, provides conflicting evidence on the presence and severity of the interaction. In this study, we developed text processing methods to extract the ginkgo usage and combined it with prescription data on warfarin from a very large clinical data respository. Our statistical analysis suggests that taking concurrently with warfarin, gingko does significantly increase patients' risk of a bleeding adverse event (hazard ratio = 1.38, 95%CI: 1.20 to 1.58, p<.001). This study also is the first attempt of using a large medical record databaseto confirm a suspected herb-drug interaction. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 31306695 Comprehensive HPTLC fingerprinting as a tool for a simplified analysis of purity of ginkgo products Product analysis · J Ethnopharmacol, 2019 Adulterants detected in 48 of 59 ginkgo dietary supplements (rutin, quercetin, sophora, buckwheat, and others).
Key summary
A study validating whether a single HPTLC fingerprint analysis can establish both the identity and the adulteration of ginkgo products. The authors start from the premise that adding rutin, quercetin, or plant extracts rich in them is common. The method detected rutin, quercetin, sophora fruit and flower bud, and buckwheat, and 48 of the 59 dietary supplements analysed contained one or more adulterants. Limit tests for rutin and quercetin agreed with HPLC in 98% of cases. Because this study validates a method, the abstract does not show whether the 59 are a representative market sample, and some authors are affiliated with CAMAG AG.
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ETHNOPHARMACOLOGICAL RELEVANCE: Herbal medicinal products based on ginkgo leaf refined dry extract (GBE) are an European development from the Eastern Asia traditionally used species Ginkgo biloba L. Nowadays, ginkgo products have increased the presence in the market, mainly as dietary supplements. Its adulteration with rutin and quercetin or herbal extracts rich in these compounds is a common practice. Tests featuring assays and detection of adulterants need to be performed on top of other existent methods (e.g. identification test). This may increase the costs of evaluating the quality of ginkgo products. AIM OF THE STUDY: To prove that comprehensive HPTLC fingerprinting can provide information beyond identification of ginkgo products, avoiding additional chromatographic tests for detection of adulterations. MATERIALS AND METHODS: The information contained in the fingerprint obtained by HPTLC analysis of flavonoids was used for identification and for detection of adulterants, as well as to verify the limits of rutin and quercetin, which are normally determined by HPLC and used for detection of adulterants. For this purpose, peak profiles were generated from HPTLC chromatogram images. USP-HPLC methods were used for quantification of total flavonoids and testing the limits of rutin and quercetin. HPLC data were used to support the validity of the HPTLC method. An additional reversed phase HPTLC method was developed as a possible confirmatory method for the quercetin limit test. RESULTS: The proposed HPTLC method uses a particular sequence of detections, resulting in a number of images, which are later interpreted in a certain order. It is able to identify ginkgo products, to detect adulterants (rutin, quercetin, sophora fruit and flower bud, and buckwheat), and, using peak profiles generated from the chromatogram images prior to and after derivatisation, to evaluate the limits of rutin and quercetin. Forty-eight out of fifty-nine ginkgo dietary supplements analysed contained one or more adulterants. Furthermore, results of the HPTLC and HPLC limit tests for rutin and quercetin were in agreement in 98% of the cases. Finally, a decision tree showing the sequence of interpretation of the fingerprints obtained with the different detections after a single HPTLC analysis is included to help the analyst to evaluate whether samples have the correct identity and whether they contain or not adulterants. CONCLUSION: A single HPTLC analysis is able to provide information on identity and purity of the products. This simplifies the analytical workflow and reduces the number of analyses prescribed in the USP powdered ginkgo extract monograph. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 36304165 Ginkgo biloba leaf extract EGb 761® as a paragon of the product by process concept Review (all authors employed by the manufacturer) · Front Pharmacol, 2022 Extracts of the same plant can differ greatly, so clinical results from one cannot be transferred to another. All authors work for the maker of EGb 761.
Key summary
A review using EGb 761 as its example to explain how climate, harvest region, drying, extraction solvents, and later process steps shape the quality and uniformity of the final extract. The authors conclude that because extracts of the same plant can differ greatly in composition, pharmacological, toxicological, and clinical results from one extract cannot be applied to extracts made by other processes. According to the full text Schwabe also funded the review, and per the conflict of interest statement all authors are employed by Dr. Willmar Schwabe, the manufacturer of EGb 761 medicinal products, so it should be read as coming from a party with an interest in distinguishing its own product.
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It is an often-neglected fact that extracts derived from the very same plant can differ significantly in their phytochemical composition, and thus also in their pharmacokinetic and pharmacodynamic properties which are the basis for their clinical efficacy and safety. The Ginkgo biloba L. [Ginkgoaceae] special extract EGb 761® is one of the best-studied plant extracts in the world. In the present review, using that extract as a paradigm, we describe insights how climate, the harvest region, processing of the plant material, the drying process, the extraction solvents, and the details of the subsequent process steps substantially impact the quality and uniformity of the final extract. We highlight the importance of regulating active constituent levels and consistent reduction of undesired substances in herbal extracts. This is accomplished by a controlled production process and corresponding analytical specifications. In conclusion, since extracts derived from the same plant can have very different phytochemical compositions, results from pharmacological, toxicological and clinical studies gained with one specific extract cannot be extrapolated to other extracts that were generated using different production processes. We propose that the heterogenous nature of extracts should be meticulously considered when evaluating the efficacy and safety of plant-derived remedies. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based on this text and the full-text quotes below.
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This review was funded by Schwabe, the maker of EGb 761.
"The authors declare that this study received funding from Dr. Willmar Schwabe GmbH and Co., KG, Germany."
※ Quotes machine-checked against the open full text in PMC (CC BY, 2026-11-07) View original ↗ PMID 28055331 Review of Ginkgo biloba-induced toxicity, from experimental studies to human case reports Review (including US FDA research center authors) · J Environ Sci Health C, 2017 A 2-year US National Toxicology Program study found more liver tumors in mice, and IARC classified ginkgo leaf extract as Group 2B. This is animal evidence.
Key summary
A review of ginkgo toxicity from experimental studies to human case reports. The US National Toxicology Program, in 2-year gavage studies of one ginkgo leaf extract, concluded there was clear evidence of carcinogenic activity in mice based on increased hepatocellular carcinoma and hepatoblastoma, and IARC classified ginkgo leaf extract as a possible human carcinogen (Group 2B). This evidence comes from rodents and does not mean cancer has been confirmed in people. The authors also summarize negative results from relatively large clinical trials.
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Ginkgo biloba seeds and leaves have been used as a traditional herbal remedy for thousands of years, and its leaf extract has been consumed as a botanical dietary supplement for decades. Ginkgo biloba extract is a complex mixture with numerous components, including flavonol glycosides and terpene lactones, and is one of the most widely sold botanical dietary supplements worldwide. Concerns about potential health risks for the general population have been raised because of the widespread human exposure to Ginkgo biloba and its potential toxic and carcinogenic activities in rodents. The National Toxicology Program conducted 2-year gavage studies on one Ginkgo biloba leaf extract and concluded that there was clear evidence of carcinogenic activity of this extract in mice based on an increased incidence of hepatocellular carcinoma and hepatoblastoma. Recently, Ginkgo biloba leaf extract has been classified as a possible human carcinogen (Group 2B) by the International Agency for Research on Cancer. This review presents updated information on the toxicological effects from experimental studies both in vitro and in vivo to human case reports (caused by ginkgo seeds or leaves), and also summarizes the negative results from relatively large clinical trials. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 31166961 Incidence of neutropenia in patients with ticlopidine/Ginkgo biloba extract combination drug for vascular events: A post-marketing cohort study Post-marketing surveillance (Korea) · PLoS One, 2019 Korean post-marketing surveillance of a ticlopidine/ginkgo combination drug (Yuclid) - neutropenia 0.29% at 3 months. It did not test ginkgo's efficacy.
Key summary
Post-marketing surveillance of the safety of a ticlopidine/ginkgo extract combination drug (Yuclid), used as an antiplatelet agent for vascular events since its approval in 2008. From March 2009 to October 2015, 4,839 people were enrolled at 89 hospitals under Korean regulations; 4,831 entered the safety analysis and 3,150 (65.1%) completed neutropenia evaluation at 3 months. Neutropenia occurred in 9, a cumulative incidence of 0.29% (95% CI 0.13% to 0.54%), with no severe cases. The authors said this may be lower than the previously reported 2.3% with ticlopidine but needs confirming in randomized trials. It is a single-arm survey with no control group.
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BACKGROUND AND PURPOSE: The ticlopidine/Ginkgo biloba ext. combination drug (Yuclid) is used as an antiplatelet agent for prevention of vascular events since its approval in 2008. The purpose of this study is to explore the safety of ticlopidine/Ginkgo biloba combination, mainly regarding the incidence of neutropenia, through a post-marketing surveillance study. METHODS: From March 2009 to October 2015, a total of 4839 subjects had been enrolled in this study. The enrollments were conducted by 152 doctors of 89 hospitals according to the regulations for post-marketing surveillance programs in Korea. If a subject was administered the drug once, he/she was included in the safety analysis set for any adverse events and bleedings, and the primary safety evaluation regarding neutropenia was conducted in subjects who completed 3-month blood test follow-up. We predefined that 1% reduction in neutropenia incidence by ticlopidine/Ginkgo biloba ext. combination from the previously reported incidence of ticlopidine of 2.3% was clinically meaningful. RESULTS: Among the safety analysis set of 4831 patients (99.8% of the enrolled subjects), 3150 (65.1%) completed evaluation for neutropenia at 3 months which is the primary safety endpoint. The major causes of dropout were no follow-up visit at 3 months (n = 1016) and violation of the follow-up period (n = 503). Nine patients experienced neutropenia (Absolute neutrophil count [ANC] ≤ 1200mm3) and the estimated cumulative incidence at 3 months is 0.29% (95% confidence interval, 0.13%- 0.54%). Severe neutropenia (ANC ≤ 450mm3) did not occur in any patients. CONCLUSIONS: The incidence of neutropenia with addition of Ginkgo biloba ext. to ticlopidine may be lower than the previously reported incidence of neutropenia with ticlopidine, which needs to be confirmed in randomized controlled trials. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
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