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Efficacy and tolerability of Ginkgo biloba extract EGb 761® in dementia: a systematic review and meta-analysis of randomized placebo-controlled trials

机译:银杏叶提取物EGB761®在痴呆症中的功效和耐受性:随机安慰剂对照试验的系统评价和荟萃分析

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摘要

The objective of this systematic review was to evaluate current evidence for the efficacy of Ginkgo biloba extract EGb 761® in dementia. Seven of 15 randomized, placebocontrolled trials in patients with dementia identified by database searches met all our selection criteria and were included in the meta-analysis. In these trials, patients were treated with 120 mg or 240 mg per day of the defined extract EGb 761 or placebo. Efficacy was assessed using validated tests and rating scales for the cognitive domain, the functional domain (activities of daily living), and global assessment. Tolerability was evaluated by risk differences based on incidences of adverse events and premature discontinuation rates. Of 2,684 outpatients randomized to receive treatment for 22–26 weeks, 2,625 represented the full analysis sets (1,396 for EGb 761 and 1,229 for placebo). Standardized mean differences for change in cognition (−0.52; 95% confidence interval [CI] −0.98, −0.05; P=0.03), activities of daily living (−0.44; 95% CI −0.68, −0.19; P<0.001), and global rating (−0.52; 95% CI −0.92, −0.12; P=0.01) significantly favored EGb 761 compared with placebo. Statistically significant superiority of EGb 761 over placebo was confirmed by responder analyses as well as for patients suffering from dementia with neuropsychiatric symptoms. Treatment-associated risks in terms of relative risks of adverse events and premature withdrawal rates did not differ noticeably between the two treatment groups. In conclusion, meta-analyses confirmed the efficacy and good tolerability of Ginkgo biloba extract EGb 761 in patients with dementia.
机译:该系统评价的目的是评估银杏叶提取物银杏叶提取物761 ®在痴呆症中的有效性的现有证据。通过数据库搜索确定的针对痴呆患者的15项随机安慰剂对照试验中有7项符合我们所有的选择标准,并纳入荟萃分析。在这些试验中,每天用120 mg或240 mg的确定提取物EGb 761或安慰剂治疗患者。使用经验证的测试和认知领域,功能领域(日常生活活动)以及整体评估的等级量表对疗效进行评估。通过基于不良事件发生率和过早停药率的风险差异评估耐受性。在随机分配接受22-26周治疗的2684名门诊患者中,有2625名代表完整的分析集(EGB 761为1396名,安慰剂为1229名)。认知变化的标准化平均差异(-0.52; 95%置信区间[CI] -0.98,-0.05; P = 0.03),日常生活活动(-0.44; 95%CI -0.68,-0.19; P <0.001) ,与安慰剂相比,EGB 761的总体评价(-0.52; 95%CI -0.92,-0.12; P = 0.01)明显偏爱EGb 761。响应者分析以及患有神经精神症状的痴呆患者证实了EGb 761在统计学上优于安慰剂的优势。在两个治疗组之间,就不良事件的相对风险和提早退出率而言,与治疗相关的风险没有显着差异。总之,荟萃分析证实了银杏叶提取物银杏叶提取物EGb 761在痴呆症患者中的疗效和良好的耐受性。

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