PMID 19017911 Ginkgo biloba for prevention of dementia: a randomized controlled trial 무작위 대조시험(GEM) · JAMA, 2008 75세 이상 3,069명 중앙값 6.1년 - 치매 위험비 1.12(95% CI 0.94~1.33), 발생을 줄이지 못했다.
핵심요약
미국 5개 학술 의료기관에서 2000~2008년에 진행한 무작위 이중맹검 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다. 대조 시험. 인지 정상 2,587명과 경도인지장애 482명, 모두 75세 이상인 지역사회 자원자에게 은행잎 추출물 120 mg을 하루 2회(1,545명) 또는 위약(1,524명)을 주고 6개월마다 치매 발생을 평가했다. 523명이 치매에 걸렸고(위약 246명, 은행잎 277명) 그중 92%가 알츠하이머병 범주였다. 발생률은 100인년당 은행잎 3.3건, 위약 2.9건이었다. 전체 치매 위험비 1.12(95% CI 0.94~1.33, P=.21), 알츠하이머병 1.16(95% CI 0.97~1.39, P=.11), 경도인지장애에서 치매로 진행 1.13(95% CI 0.85~1.50, P=.39). 탈락과 추적 소실은 6.3%로 낮았고 이상반응 양상은 두 군이 비슷했다. 전문에 따르면 미국 국립보건원 산하 기관이 후원한 공공 시험이고, 제조사 Schwabe는 정제와 위약만 기증했다. 제조사 제품(EGb 761)을 썼는데도 효과가 없었다는 점에서 결과의 무게가 크다.
원문 초록 보기
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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트와 아래 전문 인용을 근거로 작성합니다.
전문에서 확인한 내용 보기
시험은 미국 국립보건원 산하 기관(NCCAM, NIA)이 후원했습니다.
"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)"
제조사 Schwabe는 은행잎 정제와 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다.만 기증했습니다.
"Schwabe Pharmaceuticals, Karlsruhe, Germany, donated the G biloba tablets and identical placebos in blister packs for the study."
※ PMC 공개 전문과 기계로 대조한 인용문 (PMC 텍스트 마이닝 허용(공정 이용), 2026-11-07) 정정 공고 있음(내용 미확인): 2008년 JAMA 정정 공고가 있으나 본문을 구하지 못해 내용을 확인하지 못했습니다. 판정은 원 논문 초록에 근거합니다.
원문 보기 ↗ PMID 20040554 Ginkgo biloba for preventing cognitive decline in older adults: a randomized trial 무작위 대조시험(GEM 인지 분석) · JAMA, 2009 GEM 3,069명 - 기억력 연간 감소 속도 0.043 대 0.041, 어느 인지 영역에서도 차이가 없었다.
핵심요약
GEM 시험의 인지 저하 분석. 72~96세 3,069명을 중앙값 6.1년 추적하며 3MSE, ADAS-Cog와 기억·주의·시공간·언어·실행 기능 신경심리 점수의 변화 속도를 비교했다. 연간 z 점수 감소는 기억력 0.043 대 0.041, 주의력 0.043 대 0.048, 시공간 0.107 대 0.118, 언어 0.045 대 0.041, 실행 기능 0.092 대 0.089(은행잎 대 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다.)로 모든 영역에서 차이가 없었다. 3MSE(P=.71)와 ADAS-Cog(P=.97)도 군 간 차이가 없었고, 나이·성별·인종·교육·APOE*E4·경도인지장애 여부에 따른 효과 변화도 없었다.
원문 초록 보기
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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 22959217 Long-term use of standardised Ginkgo biloba extract for the prevention of Alzheimer's disease (GuidAge): a randomised placebo-controlled trial 무작위 대조시험(GuidAge) · Lancet Neurol, 2012 70세 이상 기억력 호소자 2,854명 5년 - 알츠하이머병 위험비 0.84(95% CI 0.60~1.18), 유의하지 않음. 자금은 Ipsen.
핵심요약
프랑스 1차 의료에서 기억력 불편을 스스로 호소한 70세 이상을 모집한 무작위 이중맹검 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다. 대조 시험. 표준화 추출물 EGb 761 120 mg 하루 2회 또는 위약을 주고 5년 추적했다. 2,854명을 배정했고 실제 복용자는 은행잎 1,406명, 위약 1,414명이었다. 알츠하이머병 진단은 61명(100인년당 1.2건) 대 73명(1.4건), 위험비 0.84(95% CI 0.60~1.18, p=0.306)였고 위험 비율은 시간에 따라 일정하지 않았다. 이상반응 발생은 비슷했다. 사망은 76명 대 82명, 뇌졸중은 65명 대 60명(위험비 1.12, 95% CI 0.77~1.63)이었고 다른 출혈성·심혈관 사건도 차이가 없었다. 자금은 Ipsen이 댔다.
원문 초록 보기
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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 23001963 Is Ginkgo biloba a cognitive enhancer in healthy individuals? A meta-analysis 메타분석 · Hum Psychopharmacol, 2012 건강한 사람의 기억력 d=-0.04, 실행 기능 -0.05, 주의력 -0.08 - 모두 유의하지 않고 0에 가깝다.
핵심요약
건강한 사람에서 은행잎이 인지 기능을 높이는지 본 메타분석여러 개별 연구의 결과를 통계적으로 합쳐 하나의 종합 결론을 내는 분석.. 기억력 13건(1,132명), 실행 기능 7건(534명), 주의력 8건(910명)의 무작위 시험 자료를 썼다. 효과크기는 기억력 d=-0.04(95% CI -0.17~0.07), 실행 기능 d=-0.05(95% CI -0.17~0.05), 주의력 d=-0.08(95% CI -0.21~0.02)이었고, 나이·기간·하루 용량·총 용량·표본 크기와 관련이 없었다. 저자들은 표적 인지 기능에서 확인할 수 있는 긍정적 효과가 없다고 결론지었다.
원문 초록 보기
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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 41641880 Ginkgo biloba for cognitive impairment and dementia 코크란 리뷰 · Cochrane Database Syst Rev, 2026 82건 10,613명 - 경도인지장애에는 거의 효과 없음, 치매에는 6개월에 작거나 중간 정도의 이득 가능(확실성 낮음, I²=96%).
핵심요약
인지 저하와 치매에서 은행잎의 이득과 해를 본 코크란치료·예방의 근거를 엄격히 검토·종합하는 국제 연구 네트워크(Cochrane). 체계적 문헌고찰. 2024년 11월 18일까지의 검색으로 무작위 시험 82건(10,613명)을 포함했고, 모든 영역에서 비뚤림 위험이 낮은 시험은 4건이었다. 주관적 인지 호소(3건, 597명)에서는 효과가 불확실했다. 경도인지장애(12건, 1,913명)에서는 6개월 시점 CDR(MD -0.03), ADAS-Cog(MD -0.07, 95% CI -0.67~0.51), 도구적 일상생활 능력(MD -0.05)에 거의 또는 전혀 효과가 없었다(확실성 중간). 치매(13건, 3,288명)에서는 6개월 시점 SKT MD -1.86(95% CI -3.48~-0.24, I²=96%), 일상생활 능력 MD -0.19(95% CI -0.35~-0.03, I²=91%)로 은행잎이 나았고 확실성은 낮음이었다. 전반적 임상 상태의 수치는 초록에 MD -0.06, 95% CI -1.00~-0.20으로 적혀 있어 점추정값이 신뢰구간 밖에 놓이므로 이 도감에서는 인용하지 않는다. 치매에서 이상반응(RR 0.95)과 중대한 이상반응(RR 0.88)은 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다.과 거의 또는 전혀 차이가 없었다.
원문 초록 보기
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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ 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 메타분석(제조사 소속 저자 참여) · World J Biol Psychiatry, 2025 경도 치매 하위군 782명 - 하루 240 mg에서 효과 '중간~큼'. 마지막 저자 소속이 제조사 Dr. Willmar Schwabe.
핵심요약
EGb 761 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다. 대조 시험 4건에서 경도 치매 환자(SKT 총점 9~15) 782명의 자료만 골라 다시 묶은 메타분석여러 개별 연구의 결과를 통계적으로 합쳐 하나의 종합 결론을 내는 분석.. 하루 240 mg이 인지(p=0.04), 전반적 평가(p=0.01), 일상생활 능력(p=0.01), 삶의 질(p=0.02)에서 위약보다 유의하게 나았고 표준화 효과는 중간에서 큰 수준이었다. 이상반응 빈도는 비슷했다(p=0.66). 시험 전체가 아닌 하위군 분석이다. PubMed 기록상 마지막 저자의 소속은 EGb 761 제조사인 Dr. Willmar Schwabe의 통계 부서이며, 이 기록에 이해상충 선언문은 실려 있지 않다.
원문 초록 보기
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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 16375657 A randomized, double-blind, placebo-controlled trial of two doses of Ginkgo biloba extract in dementia of the Alzheimer's type 무작위 대조시험 · Curr Alzheimer Res, 2005 알츠하이머형 치매 513명 26주 - 하루 120 mg·240 mg 모두 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다.과 유의한 차이 없음. 위약군 저하가 적어 결론 유보.
핵심요약
MMSE 10~24점인 경도~중등도 알츠하이머형 치매 외래 환자 513명을 은행잎 추출물 하루 120 mg, 240 mg, 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다.으로 나눠 26주간 본 다기관 무작위 이중맹검 시험. ADAS-cog와 ADCS-CGIC가 주요 결과였다. 전체 표본에서 군 간 유의한 차이는 없었다. 다만 위약군의 인지·기능 저하가 적어 효과를 잡아낼 민감도가 떨어졌을 수 있고, 신경정신 증상이 있는 하위군에서는 은행잎 군의 점수가 유의하게 나았다. 저자들은 효능을 보여주지 못했으며 결론을 낼 수 없는 시험이라고 정리했다.
원문 초록 보기
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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 23744597 Ginkgo biloba for intermittent claudication 코크란 리뷰 · Cochrane Database Syst Rev, 2013 14건 739명 - 보행 거리 증가 64.5 m(CI -1.8~130.7), 임상적으로 의미 있는 이득의 근거 없음.
핵심요약
간헐적 파행 환자의 보행 거리에 은행잎이 미치는 영향을 본 코크란치료·예방의 근거를 엄격히 검토·종합하는 국제 연구 네트워크(Cochrane). 리뷰. 무작위 시험 14건(739명)을 포함했고, 그중 11건(477명)이 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다.과 최대 보행 거리를 비교했다. 효과크기는 3.57 kcal(CI -0.10~7.23, P=0.06)로, 시속 3.2 km 평지 러닝머신에서 64.5 m(CI -1.8~130.7)에 해당한다. 저자들은 출판 비뚤림이 효과크기를 부풀렸을 가능성이 크다고 보았고, 말초동맥질환 환자에게 임상적으로 의미 있는 이득이 있다는 근거가 없다고 결론지었다.
원문 초록 보기
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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 20123670 Does Ginkgo biloba reduce the risk of cardiovascular events? 무작위 대조시험(GEM 심혈관 분석) · Circ Cardiovasc Qual Outcomes, 2010 3,069명 평균 6.1년 - 심혈관 사건·사망이 줄지 않았고 출혈성 뇌졸중은 16건 대 8건(유의하지 않음).
핵심요약
GEM 시험에 미리 계획된 2차 결과인 심혈관 질환을 분석한 논문. 75세 초과 3,069명이 EGb 761 120 mg 하루 2회 또는 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다.을 받았고 평균 6.1년 추적했다. 사망 355건 중 관상동맥심장 근육에 피를 공급하는 혈관. 좁아지면 협심증·심근경색이 생긴다. 질환 사망 87건에 군 간 차이가 없었고, 심근경색(164건), 협심증(207건), 뇌졸중(151건)도 차이가 없었다. 출혈성 뇌졸중은 24건으로 은행잎 16건, 위약 8건이었고 유의하지 않았다. 말초혈관 질환 사건은 35건으로 은행잎 12건(0.8%), 위약 23건(1.5%)이었다(P=0.04). 저자들은 심혈관 질환을 막는 용도로 권할 수 없다고 결론짓고, 말초혈관 결과의 추가 시험을 제안했다.
원문 초록 보기
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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 36383762 Ginkgo biloba for tinnitus 코크란 리뷰 · Cochrane Database Syst Rev, 2022 12건 1,915명 - 이명 중증도 MD -1.35(95% CI -8.26~5.55, 85명), 근거 확실성 매우 낮음으로 이득과 해 모두 불확실.
핵심요약
이명에 대한 은행잎의 효과를 본 코크란치료·예방의 근거를 엄격히 검토·종합하는 국제 연구 네트워크(Cochrane). 체계적 문헌고찰. 2022년 6월 7일까지 검색해 무작위 시험 12건(1,915명)을 포함했고, 11건이 위약유효 성분이 없는 가짜 약(플라시보). 효과 비교의 기준으로 쓴다.과 비교했다. 비뚤림 위험은 전반적으로 높거나 불분명했고 측정 방식이 달라 자료를 묶는 데 한계가 있었다. 3~6개월 Tinnitus Handicap Inventory는 MD -1.35(95% CI -8.26~5.55, 2건, 85명)로 확실성이 매우 낮았다. 출혈이나 발작 같은 중대한 이상반응은 어느 군에서도 보고되지 않았고(4건, 1,154명, 확실성 낮음), 그 밖의 이상반응은 위험비 0.91(95% CI 0.52~1.60, 4건, 1,175명)이었다. 저자들은 이득과 해가 불확실하다고 결론지었다.
원문 초록 보기
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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 21923430 Is there a risk of bleeding associated with standardized Ginkgo biloba extract therapy? A systematic review and meta-analysis 메타분석 · Pharmacotherapy, 2011 무작위 시험 18건 1,985명 - 지혈 지표에서 출혈 위험 증가 근거 없음, 혈액 점도는 감소. 실제 출혈 사건을 센 분석은 아니다.
핵심요약
표준화 은행잎 추출물이 출혈 위험과 관련된 지혈 지표에 미치는 영향을 본 메타분석여러 개별 연구의 결과를 통계적으로 합쳐 하나의 종합 결론을 내는 분석.. 무작위 시험 18건(1,985명)을 포함했고 87%는 치매·말초동맥질환·당뇨병 환자, 13%는 건강한 자원자였다. 혈액 점도는 유의하게 낮아졌지만(WMD -1.03 mPa·s, 95% CI -1.29~-0.78), ADP 유발 혈소판 응집(WMD -0.35%), 피브리노겐(-2.45 mg/dl), aPTT(-0.42초), PT(SMD 0.00)에는 유의한 영향이 없었다. 하루 240 mg 이상 하위군에서 aPTT가 -0.47초 줄었으나 임상적으로 의미 있는 수준은 아니었다. 저자들은 출혈 위험이 더 높다는 근거가 없다고 결론지었다.
원문 초록 보기
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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 26958257 Ginkgo and Warfarin Interaction in a Large Veterans Administration Population 관찰 연구 · AMIA Annu Symp Proc, 2015 미국 재향군인 의무기록 - 와파린과 은행잎을 함께 쓸 때 출혈 사건 위험비 1.38(95% CI 1.20~1.58).
핵심요약
대규모 진료 데이터에서 문장 처리 기법으로 은행잎 복용 정보를 뽑아 와파린 처방 자료와 결합한 분석. 함께 복용할 때 출혈 이상반응 위험비는 1.38(95% CI 1.20~1.58, p<.001)이었다. 저자들은 기존 문헌이 이 상호작용의 존재와 심각성에 대해 엇갈린다고 전제했다. 무작위 시험이 아닌 관찰 자료이고 초록은 환자 수와 교란 요인 처리 내용을 밝히지 않는다.
원문 초록 보기
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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 31306695 Comprehensive HPTLC fingerprinting as a tool for a simplified analysis of purity of ginkgo products 제품 분석 연구 · J Ethnopharmacol, 2019 은행잎 건강기능식품 59개 중 48개에서 혼입물 검출(루틴, 퀘르세틴, 회화나무, 메밀 등).
핵심요약
HPTLC 지문 분석 하나로 은행잎 제품의 진위와 혼입을 함께 판별할 수 있는지 검증한 연구. 저자들은 루틴·퀘르세틴이나 이 성분이 많은 식물 추출물을 섞는 일이 흔하다고 전제했다. 이 방법은 루틴, 퀘르세틴, 회화나무 열매와 꽃봉오리, 메밀 혼입을 검출했고, 분석한 건강기능식품 59개 중 48개에서 혼입물이 하나 이상 나왔다. 루틴·퀘르세틴 한도 시험은 HPLC와 98% 일치했다. 분석 방법을 검증하는 연구라 초록만으로는 이 59개가 시장을 대표하는 표본인지 알 수 없고, 저자 일부의 소속이 CAMAG AG이다.
원문 초록 보기
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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 36304165 Ginkgo biloba leaf extract EGb 761® as a paragon of the product by process concept 리뷰(저자 전원 제조사 소속) · Front Pharmacol, 2022 같은 식물의 추출물도 조성이 크게 달라 한 추출물의 임상 결과를 다른 추출물로 옮길 수 없다. 저자 전원이 EGb 761 제조사 소속.
핵심요약
EGb 761을 예로 들어 기후, 수확 지역, 건조, 추출 용매, 후속 공정이 최종 추출물의 품질과 균일성을 좌우한다고 설명한 리뷰. 저자들은 같은 식물에서 나온 추출물도 조성이 크게 다를 수 있으므로 한 추출물의 약리·독성·임상 결과를 다른 공정의 추출물로 옮겨 적용할 수 없다고 결론지었다. 전문에 따르면 연구비도 Schwabe가 냈고, 이해상충 선언상 저자 전원이 EGb 761 의약품 제조사 Dr. Willmar Schwabe에 고용돼 있어, 자사 제품의 차별성을 주장하는 입장임을 감안해 읽어야 한다.
원문 초록 보기
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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트와 아래 전문 인용을 근거로 작성합니다.
전문에서 확인한 내용 보기
이 리뷰의 연구비는 EGb 761 제조사 Schwabe가 냈습니다.
"The authors declare that this study received funding from Dr. Willmar Schwabe GmbH and Co., KG, Germany."
※ PMC 공개 전문과 기계로 대조한 인용문 (CC BY, 2026-11-07) 원문 보기 ↗ PMID 28055331 Review of Ginkgo biloba-induced toxicity, from experimental studies to human case reports 리뷰(미국 FDA 연구소 저자 포함) · J Environ Sci Health C, 2017 미국 국가독성프로그램 2년 시험에서 생쥐 간 종양 증가, IARC는 은행잎 추출물을 Group 2B로 분류. 동물 근거다.
핵심요약
실험 연구부터 사람 사례까지 은행잎의 독성을 정리한 리뷰. 미국 국가독성프로그램은 은행잎 추출물 한 종을 2년간 위관 투여한 연구에서 간세포암과 간모세포종 증가를 근거로 생쥐에서 발암 활성의 명확한 증거가 있다고 결론지었고, IARC는 은행잎 추출물을 사람에게 발암 가능성이 있는 물질(Group 2B)로 분류했다. 설치류에서 나온 근거이며 사람에게서 발암이 확인됐다는 뜻은 아니다. 저자들은 비교적 큰 임상시험의 부정적 결과도 함께 요약했다.
원문 초록 보기
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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗ PMID 31166961 Incidence of neutropenia in patients with ticlopidine/Ginkgo biloba extract combination drug for vascular events: A post-marketing cohort study 시판 후 조사(한국) · PLoS One, 2019 티클로피딘/은행잎 복합제(Yuclid)의 한국 시판 후 조사 - 3개월 호중구감소증 0.29%. 은행잎의 효능을 시험한 연구는 아니다.
핵심요약
혈관 사건을 막기 위한 항혈소판제로 2008년 승인 이후 쓰이는 티클로피딘/은행잎 추출물 복합제(Yuclid)의 안전성을 본 시판 후 조사. 2009년 3월부터 2015년 10월까지 한국 규정에 따라 89개 병원에서 4,839명을 등록했고 안전성 분석 대상은 4,831명, 3개월 호중구 평가 완료자는 3,150명(65.1%)이었다. 호중구감소증은 9명, 3개월 누적 발생률 0.29%(95% CI 0.13~0.54%)였고 중증은 없었다. 저자들은 티클로피딘 단독의 기존 보고(2.3%)보다 낮을 수 있으나 무작위 시험으로 확인해야 한다고 밝혔다. 대조군이 없는 단일군 조사다.
원문 초록 보기
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. ※ 파이프라인이 API로 수집·저장한 초록 원문 그대로. 한국어 핵심요약은 이 텍스트만을 근거로 작성됩니다.
원문 보기 ↗