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Abstract：
BACKGROUND: Flibanserin, approved for the treatment of hypoactive sexual desire disorder (HSDD) in females, has demonstrated diverse therapeutic and adverse effect (AE) prospects in the extant randomized controlled trials (RCTs). This meta-analysis aimed to characterize the outcomes of flibanserin use in these patients comprehensively.
METHODS: RCTs involving women with HSDD receiving flibanserin in the intervention arm and placebo in the control arm were sought after throughout the electronic databases. The primary outcomes were the changes from baseline in satisfying sexual events (SSE) per month and sexual desire score per month measured using an electronic diary (eDiary).
RESULTS: From 478 initially screened articles, data from 8 RCTs involving 7906 women with HSDD were analyzed. In premenopausal women, flibanserin 100 mg was superior to placebo in improving the number of SSE per month (mean difference, MD 0.69, 95% CI [0.39, 0.99]), eDiary sexual desire score (MD 1.71, 95% CI [0.43, 2.98]), Female Sexual Function Index (FSFI) desire domain (FSFI-d) score (MD 0.30, 95% CI [0.29, 0.31]), FSFI total score (MD 2.51, 95% CI [1.47, 3.55]), Female Sexual Distress Scale-Revised (FSDS-R) Item 13 score (MD -0.30, 95% CI [-0.31, -0.29]), and FSDS-R total score (MD -3.30, 95% CI [-3.37, -3.23]). Compared to placebo, a higher number of premenopausal women using flibanserin 100 mg achieved improvements in the Patient\'s Global Impression of Improvement score (OR 1.93, 95% CI [1.58, 2.36], P < .00001) and responded positively at Patient Benefit Evaluation (PBE) (odds ratio, OR 1.76, 95% CI [1.34, 2.31], P < .0001). Postmenopausal women receiving flibanserin 100 mg also benefited in terms of the number of SSE per month, FSFI-d and total scores, FSDS-R Item 13 and total scores, and PBE response. Although flibanserin use was associated with higher risks of dizziness, fatigue, nausea, somnolence, and insomnia, these adverse events were mild in nature; the serious AEs and severe AEs were comparable between the flibanserin and placebo groups.
CONCLUSIONS: While flibanserin has demonstrated efficacy in the treatment of HSDD in both pre- and postmenopausal women, its therapeutic advantages may be overshadowed by the higher likelihood of AEs.
METHODS: RCTs involving women with HSDD receiving flibanserin in the intervention arm and placebo in the control arm were sought after throughout the electronic databases. The primary outcomes were the changes from baseline in satisfying sexual events (SSE) per month and sexual desire score per month measured using an electronic diary (eDiary).
RESULTS: From 478 initially screened articles, data from 8 RCTs involving 7906 women with HSDD were analyzed. In premenopausal women, flibanserin 100 mg was superior to placebo in improving the number of SSE per month (mean difference, MD 0.69, 95% CI [0.39, 0.99]), eDiary sexual desire score (MD 1.71, 95% CI [0.43, 2.98]), Female Sexual Function Index (FSFI) desire domain (FSFI-d) score (MD 0.30, 95% CI [0.29, 0.31]), FSFI total score (MD 2.51, 95% CI [1.47, 3.55]), Female Sexual Distress Scale-Revised (FSDS-R) Item 13 score (MD -0.30, 95% CI [-0.31, -0.29]), and FSDS-R total score (MD -3.30, 95% CI [-3.37, -3.23]). Compared to placebo, a higher number of premenopausal women using flibanserin 100 mg achieved improvements in the Patient\'s Global Impression of Improvement score (OR 1.93, 95% CI [1.58, 2.36], P < .00001) and responded positively at Patient Benefit Evaluation (PBE) (odds ratio, OR 1.76, 95% CI [1.34, 2.31], P < .0001). Postmenopausal women receiving flibanserin 100 mg also benefited in terms of the number of SSE per month, FSFI-d and total scores, FSDS-R Item 13 and total scores, and PBE response. Although flibanserin use was associated with higher risks of dizziness, fatigue, nausea, somnolence, and insomnia, these adverse events were mild in nature; the serious AEs and severe AEs were comparable between the flibanserin and placebo groups.
CONCLUSIONS: While flibanserin has demonstrated efficacy in the treatment of HSDD in both pre- and postmenopausal women, its therapeutic advantages may be overshadowed by the higher likelihood of AEs.
摘要：
背景：Flibanserin，批准用于治疗女性性欲减退障碍（HSDD），在现有的随机对照试验（RCTs）中已经证明了不同的治疗和不良反应（AE）前景。这项荟萃分析旨在全面描述这些患者使用氟班色林的结果。
方法：在整个电子数据库中寻找涉及HSDD女性的RCTs，这些女性在干预组接受氟班色林，在对照组接受安慰剂。主要结果是使用电子日记（eDiary）测量的每月满足性事件（SSE）和每月性欲得分的基线变化。
结果：从478篇最初筛选的文章中，我们分析了8项RCT的数据,涉及7906例HSDD女性.在绝经前的女性中，氟班色林100mg在改善每月SSE的数量方面优于安慰剂（平均差异，MD0.69，95%CI[0.39，0.99])，eDiary性欲评分（MD1.71，95%CI[0.43，2.98]），女性性功能指数(FSFI)欲望域(FSFI-d)评分(MD0.30,95%CI[0.29,0.31]),FSFI总分（MD2.51，95%CI[1.47，3.55]），女性性困扰量表修订（FSDS-R）项目13得分（MD-0.30，95％CI[-0.31，-0.29]），和FSDS-R总分（MD-3.30，95%CI[-3.37，-3.23]）。与安慰剂相比，使用氟班色林100mg的绝经前妇女获得患者总体改善评分的改善（OR1.93,95%CI[1.58,2.36]，P<.00001)，并在患者获益评估(PBE)时反应积极(比值比，或1.76，95%CI[1.34，2.31]，P<.0001)。接受氟班色林100毫克的绝经后妇女也受益于每月SSE的数量，FSFI-d和总分，FSDS-R项目13和总分，和PBE响应。尽管使用氟班色林与较高的头晕风险相关，疲劳,恶心,嗜睡,失眠，这些不良事件性质轻微;氟班色林组和安慰剂组的严重AE和严重AE具有可比性.
结论：虽然氟班色林在绝经前和绝经后妇女中都显示出治疗HSDD的疗效，其治疗优势可能被较高的AE可能性所掩盖.
方法：在整个电子数据库中寻找涉及HSDD女性的RCTs，这些女性在干预组接受氟班色林，在对照组接受安慰剂。主要结果是使用电子日记（eDiary）测量的每月满足性事件（SSE）和每月性欲得分的基线变化。
结果：从478篇最初筛选的文章中，我们分析了8项RCT的数据,涉及7906例HSDD女性.在绝经前的女性中，氟班色林100mg在改善每月SSE的数量方面优于安慰剂（平均差异，MD0.69，95%CI[0.39，0.99])，eDiary性欲评分（MD1.71，95%CI[0.43，2.98]），女性性功能指数(FSFI)欲望域(FSFI-d)评分(MD0.30,95%CI[0.29,0.31]),FSFI总分（MD2.51，95%CI[1.47，3.55]），女性性困扰量表修订（FSDS-R）项目13得分（MD-0.30，95％CI[-0.31，-0.29]），和FSDS-R总分（MD-3.30，95%CI[-3.37，-3.23]）。与安慰剂相比，使用氟班色林100mg的绝经前妇女获得患者总体改善评分的改善（OR1.93,95%CI[1.58,2.36]，P<.00001)，并在患者获益评估(PBE)时反应积极(比值比，或1.76，95%CI[1.34，2.31]，P<.0001)。接受氟班色林100毫克的绝经后妇女也受益于每月SSE的数量，FSFI-d和总分，FSDS-R项目13和总分，和PBE响应。尽管使用氟班色林与较高的头晕风险相关，疲劳,恶心,嗜睡,失眠，这些不良事件性质轻微;氟班色林组和安慰剂组的严重AE和严重AE具有可比性.
结论：虽然氟班色林在绝经前和绝经后妇女中都显示出治疗HSDD的疗效，其治疗优势可能被较高的AE可能性所掩盖.
