Ginkgo biloba for preventing cognitive decline in older adults: a randomized trial.

Ginkgo biloba for preventing cognitive decline in older adults: a randomized trial.
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DOI:
10.1001/jama.2009.1913
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发表时间:
2009-12-23
影响因子:
120.7
通讯作者:
DeKosky, Steven T.
DeKosky, Steven T.
中科院分区:
医学1区
文献类型:
--
作者:
Snitz, Beth E.;O'Meara, Ellen S.;Carlson, Michelle C.;Arnold, Alice M.;Ives, Diane G.;Rapp, Stephen R.;Saxton, Judith;Lopez, Oscar L.;Dunn, Leslie O.;Sink, Kaycee M.;DeKosky, Steven T.

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草药产品银杏叶是经常采取的意图,以改善认知健康的老化。然而,缺乏足够有力的临床试验证据证明其对长期认知功能的影响。确定脑叶G是否减缓了老年人整体或特定领域认知能力下降的速度。银杏记忆评估(GEM)研究是一项随机、双盲、安慰剂对照的临床试验,于2000年至2008年在美国6个学术医疗中心进行,共有3069名年龄在72至96岁之间的社区居民参与,中位随访时间为6.1年。每日两次,每次120毫克的丁香提取物(n=1545)或相同外观的安慰剂(n=1524)。基于个体测试z分数总和的修正迷你精神状态检查(3MSE)、阿尔茨海默病评估量表(ADAS-Cog)的认知子量表以及记忆、注意力、视觉空间构建、语言和执行功能等神经心理学领域随时间的变化率。G - biloba组和安慰剂组在任何领域z分数的年递减率均无差异,包括记忆(0.043;95%置信区间[CI], 0.034-0.051 vs 0.041; 95% CI, 0.032-0.050)、注意力(0.043;95% CI, 0.037-0.050 vs 0.048; 95% CI, 0.041-0.054)、视觉空间能力(0.107;95% CI, 0.097-0.117 vs 0.118; 95% CI, 0.108-0.128)、语言(0.045;95% CI, 0.037-0.054 vs 0.041; 95% CI, 0.033-0.048)和执行功能(0.092;95% CI, 0.086-0.099 vs 0.089;95% ci, 0.082-0.096)。对于3MSE和ADAS-Cog,变化率因基线认知状态(轻度认知障碍)而异,但治疗组之间的变化率没有差异(3MSE, P= 0.71; ADAS-Cog, P= 0.97)。治疗对年龄、性别、种族、受教育程度、APOE*E4等位基因或基线轻度认知障碍的下降率无显著影响(P < 0.05)。与安慰剂相比,在认知正常或有轻度认知障碍的老年人中,每日两次使用120毫克的G biloba并没有减少认知能力下降。clinicaltrials.gov标识符:NCT00010803
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. To determine whether G biloba slows the rates of global or domain-specific cognitive decline in older adults. 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. Twice-daily dose of 120-mg extract of G biloba (n=1545) or identical-appearing placebo (n=1524). 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. 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). 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. clinicaltrials.gov Identifier: NCT00010803
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