Sertraline to treat hot flashes: a randomized controlled, double-blind, crossover trial in a general population

Sertraline to treat hot flashes: a randomized controlled, double-blind, crossover trial in a general population
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DOI:
10.1097/01.gme.0000196595.82452.ca
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发表时间:
2006-07-01
影响因子:
2.7
通讯作者:
Senf, Janet
Senf, Janet
中科院分区:
医学3区
文献类型:
--
作者:
Gordon, Paul R.;Kerwin, James P.;Senf, Janet

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目的:评价选择性5-羟色胺再摄取抑制剂(SSRI)(舍曲林)在一般女性人群中减少潮热的有效性。设计:在西南城市环境中进行双盲、安慰剂对照、交叉试验。共有102名年龄在40岁到65岁之间的女性被招募,她们正在经历潮热,并且没有接受任何激素治疗。在基线潮热数据收集1周后,研究参与者被随机接受安慰剂或活性药物(舍曲林50 mg)治疗4周。这一干预之后是1周的洗涤,并交叉到相反的治疗4周。测量潮热的次数和严重程度。结果:102名女性参与了研究。在提供基准数据之前,有5人退出了。在剩下的97人中,52人被随机分成先服用活性药物,45人先服用安慰剂。在完成所有10周的研究之前,有10人退出了研究,剩下46人在活性药物第一组,41人在安慰剂第一组。基线时,平均报告的潮热次数为每周45.6次(SD=29.6),范围为2至148次。在研究的舍曲林阶段,女性每周潮热的次数比服用安慰剂的女性少5次(P=0.002)。潮热的严重程度没有显著差异,但在舍曲林阶段潮热评分(数字x平均严重度)显著改善。结论:舍曲林与安慰剂相比减少了潮热的次数,改善了潮热评分,可能是一种可以接受的替代治疗方法。
Objective: To evaluate the effectiveness of a selective serotonin reuptake inhibitor (SSRI) (sertraline) in decreasing hot flashes in a general population of women.Design: A double-blind, placebo-controilcd, crossover trial was conducted in a Southwestern urban setting. A total of 102 women aged 40 to 65 who were experiencing hot flashes and not taking any hormone therapy were recruited. After 1 week of baseline hot flash data collection, study participants were randomized to receive placebo or active drug (sertraline 50 mg) for 4 weeks. This intervention was followed by a 1-week washout and cross over to the opposite treatment for 4 weeks. The number and severity of hot flashes were measured.Results: One hundred two women were enrolled in the study. Five dropped out before providing baseline data. Of the 97 remaining, 52 were randomized to active drug first and 45 to placebo first. Ten dropped out of the study before completing all 10 weeks, leaving 46 in the active drug-first arm and 41 in the placebo-first arm. At baseline, the mean number of hot flashes reported was 45.6 per week (SD = 29.6), ranging from 2 to 148. During the sertraline phase of the study, women experienced five fewer hot flashes per week than they did on the placebo (P = 0.002). The severity of hot flashes was not significantly different; however, the hot flash score (number x average severity) was significantly improved during the sertraline phase.Conclusion: Sertraline reduced the number of hot flashes and improved the hot flash score relative to placebo and may be an acceptable alternative treatment for women experiencing hot flashes.