Department of Psychiatry and Psychotherapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.
Fliedner Klinik Berlin, Charlottenstraße 65, 10117 Berlin, Germany.
Int J Neuropsychopharmacol. 2014 Jun;17(6):859-69. doi: 10.1017/S1461145714000017. Epub 2014 Jan 23.
The anxiolytic efficacy of the orally administered lavender oil preparation Silexan was investigated in generalized anxiety disorder (GAD) in comparison to placebo and paroxetine. In this randomized, double-blind, double-dummy trial 539 adults with GAD according to DSM-5 criteria and a Hamilton Anxiety Scale (HAMA) total score ⩾ 18 points participated and received 160 or 80 mg Silexan, 20 mg paroxetine, or placebo once daily for 10 wk. The primary efficacy endpoint was the HAMA total score reduction between baseline and treatment end. The HAMA total score decreased by 14.1 ± 9.3 points for Silexan 160 mg/d, 12.8 ± 8.7 points for Silexan 80 mg/d, 11.3 ± 8.0 points for paroxetine, and 9.5 ± 9.0 points for placebo (mean ± s.d.). Silexan 160 and 80 mg/d were superior to placebo in reducing the HAMA total score (p < 0.01) whereas paroxetine showed a trend towards significance (p = 0.10) in the full analysis set. The difference between paroxetine and placebo was more pronounced in the analysis of observed cases (HAMA total score reduction: p < 0.01). In the Silexan 160 mg/d group 73/121 patients (60.3%) showed a HAMA total score reduction ⩾ 50% of the baseline value and 56 (46.3%) had a total score <10 points at treatment end, compared to 70/135 (51.9%) and 45 (33.3%) for Silexan 80 mg/d, 57/132 (43.2%) and 45 (34.1%) for paroxetine, and 51/135 (37.8%) and 40 (29.6%) for placebo. In addition, Silexan showed a pronounced antidepressant effect and improved general mental health and health-related quality of life. Incidence densities of adverse events (AEs) were 0.006 AEs/d for Silexan 160 mg/d, 0.008 AEs/d for 80 mg/d, 0.011 AEs/d for paroxetine, and 0.008 AEs/d for placebo. In GAD Silexan is more efficacious than placebo. AE rates for Silexan were comparable to placebo and lower than for the active control paroxetine.
薰衣草油制剂 Silexan 的口服给药在广泛性焦虑症（GAD）中的抗焦虑疗效与安慰剂和帕罗西汀进行了比较。在这项随机、双盲、双模拟试验中，539 名符合 DSM-5 标准和汉密尔顿焦虑量表（HAMA）总分≥18 分的成年人接受了 160 或 80mg Silexan、20mg 帕罗西汀或安慰剂，每日一次，持续 10 周。主要疗效终点是基线至治疗结束时 HAMA 总分的降低。Silexan 160mg/d 组 HAMA 总分降低 14.1±9.3 分，Silexan 80mg/d 组降低 12.8±8.7 分，帕罗西汀组降低 11.3±8.0 分，安慰剂组降低 9.5±9.0 分（均数±标准差）。Silexan 160mg/d 和 80mg/d 组在降低 HAMA 总分方面均优于安慰剂（p<0.01），而帕罗西汀在全分析集（FAS）中显示出有统计学意义的趋势（p=0.10）。在观察病例分析中，帕罗西汀与安慰剂之间的差异更为明显（HAMA 总分降低：p<0.01）。在 Silexan 160mg/d 组中，121 名患者中有 73 名（60.3%）HAMA 总分降低≥基线值的 50%，56 名（46.3%）治疗结束时总分<10 分，而 Silexan 80mg/d 组中分别有 135 名患者中的 70 名（51.9%）和 45 名（33.3%），帕罗西汀组中分别有 132 名患者中的 57 名（43.2%）和 45 名（34.1%），安慰剂组中分别有 135 名患者中的 51 名（37.8%）和 40 名（29.6%）。此外，Silexan 还显示出明显的抗抑郁作用，并改善了整体心理健康和健康相关生活质量。不良事件（AE）发生率密度分别为 Silexan 160mg/d 组 0.006AE/d，80mg/d 组 0.008AE/d，帕罗西汀组 0.011AE/d，安慰剂组 0.008AE/d。在 GAD 中，Silexan 比安慰剂更有效。Silexan 的 AE 发生率与安慰剂相当，低于活性对照药物帕罗西汀。
