Silexan, a special active substance produced from Lavandula angustifolia, is efficacious in subsyndromal anxiety at a dose of 80 mg/day, but its effective dosage in generalized anxiety disorder (GAD) has yet to be defined. In two double-blind, placebo-controlled trials, daily doses of 10, 40, 80, and 160 mg silexan were administered for 10 weeks. A total of 925 adults with GAD according to Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria and a Hamilton Anxiety Scale (HAMA) total score of at least 18 points were analyzed for efficacy. We assessed the change versus baseline for the HAMA and the Covi Anxiety Scale, the Clinical Global Impressions scale, the Sheehan Disability Scale, and the SF-36 health status questionnaire using analysis of variance and covariance. Silexan 160 mg/day was superior to placebo for all efficacy outcomes investigated, with responder rates exceeding 60% on the basis of HAMA and Clinical Global Impressions criteria. For the 80 mg/day dosage, superiority over placebo could be shown in one trial as well as in the pooled analysis. The risk of adverse events under silexan was similar to placebo for all dosages investigated. In GAD silexan 160 mg/day is efficacious whereas 80 mg/day may represent the lower end of the therapeutic range. Daily doses up to 160 mg were well tolerated.

中文翻译：

---

Silexan在广泛性焦虑症中的作用：在汇总数据集中研究治疗剂量范围。

Silexan是从Lavandula angustifolia生产的一种特殊活性物质，在症状下的焦虑症中有效，剂量为80 mg / day，但其在广泛性焦虑症（GAD）中的有效剂量尚未确定。在两项双盲，安慰剂对照试验中，每天服用10、40、80和160 mg西力生的剂量为10周。根据精神障碍诊断和统计手册（DSM）标准以及汉密尔顿焦虑量表（HAMA）总分至少18分对总共925名GAD成人进行了疗效分析。我们使用方差和协方差分析评估了HAMA和Covi焦虑量表，临床总体印象量表，Sheehan残疾量表以及SF-36健康状况调查表相对于基线的变化。在所有调查的疗效结果中，Silexan 160 mg / day均优于安慰剂，根据HAMA和《临床总体印象》标准，应答率超过60％。对于80毫克/天的剂量，一项试验以及汇总分析均显示出优于安慰剂的优越性。在所有研究剂量下，西莱克森下发生不良事件的风险与安慰剂相似。在GAD中，西利克森160 mg /天有效，而80 mg /天可能代表治疗范围的下限。每天耐受高达160 mg的剂量。在所有研究剂量下，西莱克森下发生不良事件的风险与安慰剂相似。在GAD中，西利克森160 mg /天有效，而80 mg /天可能代表治疗范围的下限。每天耐受高达160 mg的剂量。在所有研究剂量下，西莱克森下发生不良事件的风险与安慰剂相似。在GAD中，西利克森160 mg /天有效，而80 mg /天可能代表治疗范围的下限。每天耐受高达160 mg的剂量。