Schwabe Pharmaceuticals’ proprietary lavender oil, marketed in Europe as Silexan and available over the counter in the US as “CalmAid” from Nature’s Way (see TCPR August 2020) has gained attention as a promising alternative to more traditional pharmacotherapies for anxiety and comorbid depression. This trial compares the antidepressant efficacy of Silexan against a first-line selective serotonin reuptake inhibitor in cases of mild to moderate major depressive disorder (MDD).
Researchers enrolled 498 outpatient adults with mild or moderate MDD in Germany and Poland. Two-thirds of the participants were female, and all but five were White. Participants were randomized to Silexan 80 mg/day (the marketed dose) plus placebo, sertraline 50 mg/day plus placebo, or placebo alone. The primary outcome was the change from baseline to week 8 on the 60-point Montgomery-Åsberg Depression Scale (MADRS). The trial utilized other standardized tools, including the Patient Health Questionnaire (PHQ-9) and Beck’s Depression Inventory (BDI-II), as secondary outcome measures. The study was funded by Schwabe.
The Silexan group and the sertraline group outperformed placebo by 2.17 points and 2.59 MADRS points, respectively, at week 8 (95% confidence interval 0.58–3.76, p=0.008; and 1.02–4.17, p<0.001). The Silexan, sertraline, and placebo response rates were 53.5%, 54%, and 41.5%, respectively. Remission rates were 44.4%, 45.2%, and 36.2%, respectively. Silexan and sertraline statistically separated from placebo. The number needed to treat for Silexan was nine versus eight for sertraline. Side effects of Silexan were limited to burping.
CARLAT TAKE
This industry-funded trial pitted half of the maximum Silexan dose against 50 mg of sertraline and placebo, and they fared similarly. It would be nice to know how 80–160 mg of Silexan fares when pitted against 50–200 mg of sertraline. That said, for both anxiety and mild or moderate MDD, Silexan is an evidence-based option for those interested in an alternative to traditional pharmaceuticals.
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