Estrogen for Alzheimer's disease in women - Randomized, double-blind, placebo-controlled trial
Estrogen for Alzheimer's disease in women - Randomized, double-blind, placebo-controlled trial
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DOI：
10.1212/wnl.54.2.295
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发表时间：
2000-01-25
期刊：
影响因子：
9.9
通讯作者：
Farlow, MR
中科院分区：
文献类型：
--
作者：
Henderson, VW;Paganini-Hill, A;Farlow, MR
背景：AD是痴呆症最常见的原因，女性的发病率是男性的两倍。治疗选择是有限的，但先前的研究结果支持的假设，雌激素治疗可能会改善这种疾病的妇女的症状。研究方法：42名患有AD所致轻度至中度痴呆的女性被纳入一项随机、双盲、安慰剂对照、平行组的无对抗性结合马雌激素（1.25 mg/天）试验，为期16周。结果：40名妇女在4周和36名妇女在16周的结果数据。在第4周和第16周，治疗组之间在主要结局指标（阿尔茨海默病评估量表的认知子量表）、临床医生评定的总体变化印象或非临床评定的功能状态方面没有显著差异或统计学趋势。情绪和认知表现的具体方面的探索性分析也未能证明实质性的群体差异。结论：虽然结论是有限的小样本量和第二类错误的可能性，结果表明，短期雌激素治疗并不能改善大多数妇女与AD的症状。这些发现并没有解决雌激素在AD中可能的长期影响，雌激素和其他治疗方式之间可能的相互作用，或雌激素在预防或延迟这种疾病的发病方面的假定作用。
Background: AD, the most prevalent cause of dementia, affects twice as many women as men. Therapeutic options are limited, but results of prior studies support the hypothesis that estrogen treatment may improve symptoms of women with this disorder. Methods: Forty-two women with mild-to-moderate dementia due to AD were enrolled into a randomized, double-blind, placebo-controlled, parallel-group trial of unopposed conjugated equine estrogens (1.25 mg/day) for 16 weeks. Results: Outcome data were available for 40 women at 4 weeks and 36 women at 16 weeks. At both 4 and 16 weeks, there were no significant differences or statistical trends between treatment groups on the primary outcome measure (the cognitive subscale of the Alzheimer's Disease Assessment Scale), clinician-rated global impression of change, or caregiver-rated functional status. Exploratory analyses of mood and specific aspects of cognitive performance also failed to demonstrate substantial group differences. Conclusions: Although conclusions are limited by small sample size and the possibility of a type II error, results suggest that short-term estrogen therapy does not improve symptoms of most women with AD. These findings do not address possible long-term effects of estrogen in AD, possible interactions between estrogen and other treatment modalities, or putative effects of estrogen in preventing or delaying onset of this disorder.