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Behavior and symptom change among women treated with placebo for sexual dysfunction.

机译:接受安慰剂治疗的性功能障碍妇女的行为和症状变化。

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INTRODUCTION: In clinical trials of drug treatments for women's sexual dysfunction, placebo responses have often been substantial. However, little is known about the clinical significance, specificity, predictors, and potential mechanisms of placebo response in sexual dysfunction. AIM: We aimed to determine the nature and predictors of sexual function outcomes in women treated with placebo for female sexual arousal disorder (FSAD). METHODS: We conducted a secondary analysis of data from the placebo arm of a 12-week, multisite, randomized controlled pharmaceutical trial for FSAD (N=50). We analyzed the magnitude, domain specificity, and clinical significance of sexual function scores at baseline, 4, 8, and 12 weeks (post-treatment). We examined longitudinal change in sexual function outcomes as a function of several baseline variables (e.g., age, symptom-related distress) and in relation to changes in sexual behavior frequency during the trial. MAIN OUTCOME MEASURE: Female Sexual Function Index total score. RESULTS: The magnitude of change at post-treatment was clinically significant in approximately one-third of placebo recipients. Effect sizes were similar across multiple aspects of sexual function. Symptom improvement was strongly related to the frequency of satisfying sexual encounters during treatment. However, the relationship between sexual encounter frequency and outcome varied significantly between participants. CONCLUSIONS: A substantial number of women experienced clinically significant improvement in sexual function during treatment with placebo. Changes in sexual behavior during the trial, more so than participant age or symptom severity at baseline, appeared to be an important determinant of outcome. Contextual and procedural aspects of the clinical trial may have influenced outcomes in the absence of an active drug treatment.
机译:简介:在针对女性性功能障碍的药物治疗的临床试验中,安慰剂的反应通常是很严重的。然而,人们对性功能障碍中安慰剂反应的临床意义,特异性,预测因素和潜在机制了解甚少。目的:我们旨在确定使用安慰剂治疗女性性唤起障碍(FSAD)的女性的性功能结果的性质和预测因子。方法:我们对一项为期12周的多中心,FSAD(N = 50)随机对照药物试验的安慰剂组的数据进行了二次分析。我们分析了基线,第4、8和12周(治疗后)性功能评分的大小,领域特异性和临床意义。我们研究了性功能预后的纵向变化与几个基线变量(例如年龄,症状相关的困扰)的关系以及试验期间性行为频率的变化。主要观察指标:女性性功能指数总得分。结果:大约三分之一的安慰剂接受者在治疗后的变化幅度具有临床意义。在性功能的多个方面,效果大小相似。症状的改善与治疗期间满足性接触的频率密切相关。然而,参与者之间性接触频率与结果之间的关系差异很大。结论:大量妇女在安慰剂治疗期间性功能临床上显着改善。试验期间性行为的变化,而不是参与者年龄或基线症状严重程度的变化,似乎是决定结局的重要因素。在缺乏有效药物治疗的情况下,临床试验的上下文和程序方面可能会影响结果。

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