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Therapeutic effects of Silexan on somatic symptoms and physical health in patients with anxiety disorders: A meta‐analysis
Brain and Behavior ( IF 2.6 ) Pub Date : 2021-02-27 , DOI: 10.1002/brb3.1997 Roland von Känel 1 , Siegfried Kasper 2 , Guido Bondolfi 3 , Edith Holsboer-Trachsler 4 , Josef Hättenschwiler 5 , Martin Hatzinger 6 , Christian Imboden 7 , Ellen Heitlinger 8 , Erich Seifritz 9
Brain and Behavior ( IF 2.6 ) Pub Date : 2021-02-27 , DOI: 10.1002/brb3.1997 Roland von Känel 1 , Siegfried Kasper 2 , Guido Bondolfi 3 , Edith Holsboer-Trachsler 4 , Josef Hättenschwiler 5 , Martin Hatzinger 6 , Christian Imboden 7 , Ellen Heitlinger 8 , Erich Seifritz 9
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A meta‐analysis was performed to examine therapeutic effects of Silexan on somatic symptoms, including insomnia/fatigue, and physical health in patients with anxiety disorders. Five randomized, placebo‐controlled trials were included in this analysis: The efficacy of Silexan (80 mg/day) was investigated in patients with subthreshold anxiety disorders (three trials) and in patients with generalized anxiety disorder (two trials). Silexan was superior to placebo in terms of the mean change from baseline in the Hamilton Anxiety Rating Scale (HAMA) subscore somatic anxiety at week 10 with a standardized mean difference of −0.31 [95% Cl: −0.52 to −0.10, p = .004]. Treatment effects of silexan on somatic anxiety were independent of gender and age. Statistically significant differences were also shown for single HAMA items somatic muscular, cardiovascular, respiratory, and genitourinary symptoms, indicating clinical relevance with small to medium effects of Silexan. Similar clinically meaningful effects of Silexan on SF‐36 physical health, including reduced bodily pain and improved general health, and on insomnia complaints and fatigue, were demonstrated. In this meta‐analysis including all placebo‐controlled clinical trials in patients with anxiety disorders to date, statistically significant and clinically meaningful advantages of Silexan over placebo treatment were found in improving somatic symptoms and physical health.
中文翻译：
Silexan对焦虑症患者的躯体症状和身体健康的治疗作用：一项荟萃分析
进行荟萃分析以检查西来森对焦虑症患者的躯体症状（包括失眠/疲劳）和身体健康的治疗效果。该分析包括五项随机，安慰剂对照试验：在阈下焦虑症患者（三项试验）和广泛性焦虑症患者（两项试验）中研究了Silexan（80毫克/天）的疗效。在第10周汉密尔顿焦虑评分量表（HAMA）评分的躯体性焦虑相对于基线的平均变化方面，Silexan优于安慰剂，其标准化平均差异为-0.31 [95％Cl：-0.52至-0.10，p = .004]。西莱克森对躯体焦虑症的治疗效果与性别和年龄无关。在单项HAMA项目中，躯体肌肉，心血管，呼吸道和泌尿生殖系统症状也显示出统计学上的显着差异，表明与西来森的中小效应在临床上具有相关性。西莱克森对SF‐36身体健康具有类似的临床意义的影响，包括减轻身体疼痛和改善总体健康，以及对失眠症和疲劳的影响。在这项荟萃分析中，包括迄今为止对焦虑症患者进行的所有安慰剂对照临床试验，发现西莱森优于安慰剂治疗在改善躯体症状和身体健康方面具有统计学上的显着和临床意义的优势。
更新日期：2021-04-11
中文翻译：
Silexan对焦虑症患者的躯体症状和身体健康的治疗作用：一项荟萃分析
进行荟萃分析以检查西来森对焦虑症患者的躯体症状（包括失眠/疲劳）和身体健康的治疗效果。该分析包括五项随机，安慰剂对照试验：在阈下焦虑症患者（三项试验）和广泛性焦虑症患者（两项试验）中研究了Silexan（80毫克/天）的疗效。在第10周汉密尔顿焦虑评分量表（HAMA）评分的躯体性焦虑相对于基线的平均变化方面，Silexan优于安慰剂，其标准化平均差异为-0.31 [95％Cl：-0.52至-0.10，p = .004]。西莱克森对躯体焦虑症的治疗效果与性别和年龄无关。在单项HAMA项目中，躯体肌肉，心血管，呼吸道和泌尿生殖系统症状也显示出统计学上的显着差异，表明与西来森的中小效应在临床上具有相关性。西莱克森对SF‐36身体健康具有类似的临床意义的影响，包括减轻身体疼痛和改善总体健康，以及对失眠症和疲劳的影响。在这项荟萃分析中，包括迄今为止对焦虑症患者进行的所有安慰剂对照临床试验，发现西莱森优于安慰剂治疗在改善躯体症状和身体健康方面具有统计学上的显着和临床意义的优势。
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