Birks Jacqueline, Grimley Evans John
Centre for Statistics in Medicine, University of Oxford, Wolfson College, Linton Road, Oxford, UK, OX2 6UD.
Cochrane Database Syst Rev. 2009 Jan 21(1):CD003120. doi: 10.1002/14651858.CD003120.pub3.
Extracts of the leaves of the maidenhair tree, Ginkgo biloba, have long been used in China as a traditional medicine for various disorders of health. A standardized extract is widely prescribed for the treatment of a range of conditions including memory and concentration problems, confusion, depression, anxiety, dizziness, tinnitus and headache. The mechanisms of action are thought to reflect the action of several components of the extract and include increasing blood supply by dilating blood vessels, reducing blood viscosity, modification of neurotransmitter systems, and reducing the density of oxygen free radicals.
To assess the efficacy and safety of Ginkgo biloba for dementia or cognitive decline.
The Specialized Register of the Cochrane Dementia and Cognitive Improvement Group (CDCIG), The Cochrane Library, MEDLINE, EMBASE, PsycINFO, CINAHL and LILACS were searched on 20 September 2007 using the terms: ginkgo*, tanakan, EGB-761, EGB761, "EGB 761" and gingko*. The CDCIG Specialized Register contains records from all major health care databases (The Cochrane Library, MEDLINE, EMBASE, PsycINFO, CINAHL, LILACS) as well as from many trials databases and grey literature sources.
Randomized, double-blind studies, in which extracts of Ginkgo biloba at any strength and over any period were compared with placebo for their effects on people with acquired cognitive impairment, including dementia, of any degree of severity.
Data were extracted from the published reports of the included studies, pooled where appropriate and the treatment effects or the risks and benefits estimated.
36 trials were included but most were small and of duration less than three months. Nine trials were of six months duration (2016 patients). These longer trials were the more recent trials and generally were of adequate size, and conducted to a reasonable standard. Most trials tested the same standardised preparation of Ginkgo biloba, EGb 761, at different doses, which are classified as high or low. The results from the more recent trials showed inconsistent results for cognition, activities of daily living, mood, depression and carer burden. Of the four most recent trials to report results three found no difference between Ginkgo biloba and placebo, and one found very large treatment effects in favour of Ginkgo biloba.There are no significant differences between Ginkgo biloba and placebo in the proportion of participants experiencing adverse events.A subgroup analysis including only patients diagnosed with Alzheimer's disease (925 patients from nine trials) also showed no consistent pattern of any benefit associated with Ginkgo biloba.
AUTHORS' CONCLUSIONS: Ginkgo biloba appears to be safe in use with no excess side effects compared with placebo. Many of the early trials used unsatisfactory methods, were small, and publication bias cannot be excluded. The evidence that Ginkgo biloba has predictable and clinically significant benefit for people with dementia or cognitive impairment is inconsistent and unreliable.
银杏叶提取物在中国长期以来一直被用作治疗各种健康问题的传统药物。一种标准化提取物被广泛用于治疗一系列病症,包括记忆力和注意力问题、意识模糊、抑郁、焦虑、头晕、耳鸣和头痛。其作用机制被认为反映了提取物中几种成分的作用,包括通过扩张血管增加血液供应、降低血液粘度、调节神经递质系统以及降低氧自由基密度。
评估银杏叶对痴呆或认知功能衰退的疗效和安全性。
2007年9月20日,使用以下检索词在Cochrane痴呆与认知改善小组(CDCIG)的专业注册库、Cochrane图书馆、MEDLINE、EMBASE、PsycINFO、CINAHL和LILACS中进行检索:ginkgo*、tanakan、EGB - 761、EGB761、“EGB 761”和gingko*。CDCIG专业注册库包含来自所有主要医疗保健数据库(Cochrane图书馆、MEDLINE、EMBASE、PsycINFO、CINAHL、LILACS)以及许多试验数据库和灰色文献来源的记录。
随机、双盲研究,其中将任何强度和任何疗程的银杏叶提取物与安慰剂对任何严重程度的获得性认知障碍(包括痴呆)患者的影响进行比较。
从纳入研究的已发表报告中提取数据,在适当情况下进行汇总,并估计治疗效果或风险与益处。
纳入了36项试验,但大多数试验规模较小且持续时间少于三个月。9项试验持续时间为6个月(2016名患者)。这些较长时间的试验是较新的试验,一般规模足够且按照合理标准进行。大多数试验测试了相同的标准化银杏叶制剂Egb 761,不同剂量分为高剂量或低剂量。较新试验的结果显示,在认知、日常生活活动、情绪、抑郁和照料者负担方面结果不一致。在报告结果的四项最新试验中,三项试验发现银杏叶与安慰剂之间无差异,一项试验发现银杏叶有非常大的治疗效果。在经历不良事件的参与者比例方面,银杏叶与安慰剂之间无显著差异。一项仅包括被诊断为阿尔茨海默病患者的亚组分析(来自9项试验的925名患者)也未显示出与银杏叶相关的任何益处的一致模式。
与安慰剂相比,银杏叶似乎使用安全,无过多副作用。许多早期试验方法不令人满意,规模较小,且不能排除发表偏倚。银杏叶对痴呆或认知障碍患者具有可预测且临床上显著益处的证据不一致且不可靠。