Efficacy of Escitalopram for Hot Flashes in Healthy Menopausal Women A Randomized Controlled Trial
Efficacy of Escitalopram for Hot Flashes in Healthy Menopausal Women A Randomized Controlled Trial
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DOI：
10.1001/jama.2010.2016
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发表时间：
2011-01-19
影响因子：
120.7
通讯作者：
LaCroix, Andrea Z.
中科院分区：
文献类型：
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作者：
Freeman, Ellen W.;Guthrie, Katherine A.;LaCroix, Andrea Z.
背景：对雌激素和黄体酮治疗绝经期症状相关风险的担忧，导致其使用减少，并增加了对经证实对潮热有效的非激素治疗的兴趣。目的观察选择性5 -羟色胺再摄取抑制剂艾司西酞普兰（escitalopram） 10 ~ 20mg /d治疗绝经期潮热的疗效和耐受性。设计、环境和患者一项多中心、8周、随机、双盲、安慰剂对照、平行组试验，在2009年7月至2010年6月期间纳入205名妇女（95名非裔美国人，102名白人，8名其他）。妇女接受10 - 20mg /d的艾司西酞普兰或匹配的安慰剂治疗，持续8周。主要结局指标主要结局是在第4周和第8周通过前瞻性每日日记评估潮热的频率和严重程度。次要结果是潮热症状，记录在每日日记中，以及临床改善（定义为潮热频率>=较基线减少50%）。结果基线时平均（SD）每日热闪频率为9.78次（5.60次）。在一项改进的意向治疗分析中，包括所有提供潮热日记数据的随机参与者，在第8周服用艾西酞普兰的女性中，潮热频率减少的平均差异为1.41 （95% CI, 0.13-2.69）
Context Concerns regarding the risks associated with estrogen and progesterone to manage menopausal symptoms have resulted in its declining use and increased interest in nonhormonal treatments with demonstrated efficacy for hot flashes.Objective To determine the efficacy and tolerability of 10 to 20 mg/d escitalopram, a selective serotonin reuptake inhibitor, in alleviating the frequency, severity, and bother of menopausal hot flashes.Design, Setting, and Patients A multicenter, 8-week, randomized, double-blind, placebo-controlled, parallel group trial that enrolled 205 women (95 African American; 102 white; 8 other) between July 2009 and June 2010.Intervention Women received 10 to 20 mg/d of escitalopram or a matching placebo for 8 weeks.Main Outcome Measures Primary outcomes were the frequency and severity of hot flashes assessed by prospective daily diaries at weeks 4 and 8. Secondary outcomes were hot flash bother, recorded on daily diaries, and clinical improvement (defined as hot flash frequency >= 50% decrease from baseline).Results Mean (SD) daily hot flash frequency was 9.78 (5.60) at baseline. In a modified intent-to-treat analysis that included all randomized participants who provided hot flash diary data, the mean difference in hot flash frequency reduction was 1.41 (95% CI, 0.13-2.69) fewer hot flashes per day at week 8 among women taking escitalopram (P