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Meta-Analysis
. 2019 Mar;269(2):183-193.
doi: 10.1007/s00406-017-0852-4. Epub 2017 Nov 17.

Efficacy of Silexan in subthreshold anxiety: meta-analysis of randomised, placebo-controlled trials

Hans-Jürgen Möller  1 , Hans-Peter Volz  2 , Angelika Dienel  3 , Sandra Schläfke  4 , Siegfried Kasper  5
Affiliations
Meta-Analysis

Efficacy of Silexan in subthreshold anxiety: meta-analysis of randomised, placebo-controlled trials

Hans-Jürgen Möller et al. Eur Arch Psychiatry Clin Neurosci. 2019 Mar.

Abstract

Subthreshold psychiatric disorders do not fully meet the diagnostic criteria of syndromal disorders but may be associated with comparable disability. To investigate the anxiolytic effect of Silexan, an active substance from lavender oil for oral administration, in patients with subthreshold anxiety, a meta-analysis that included all published trials with Silexan in this indication was performed. Three randomised, placebo-controlled trials in subthreshold anxiety disorders (anxiety disorder not otherwise specified, restlessness and agitation, mixed anxiety and depressive disorder) were included. Eligible participants with a baseline Hamilton Anxiety Rating Scale (HAMA) total score ≥ 18 points received 1 × 80 mg/day Silexan or placebo for 10 weeks. Outcomes included the HAMA, the Pittsburgh Sleep Quality Index, the Zung Self-rating Anxiety Scale, the Clinical Global Impressions questionnaire and the SF-36 health status inventory. Data were analysed using meta-analysis based on pooled raw data of individual patients (random effects models). A total of 697 patients were assessed for efficacy. Silexan was superior to placebo in reducing the HAMA total score during 10 weeks' treatment [mean value difference, 95% confidence interval: 3.83 (1.28; 6.37) points]. Superiority was comparably pronounced for psychic and somatic anxiety as well as for observer- and self-rated anxiety. Silexan had a beneficial effect on sleep (secondary to the anxiolytic effect) without causing sedation and improved the patients' health-related quality of life. Adverse event incidence in both treatment groups was comparable [risk ratio: 1.06 (0.85; 1.33)]. Silexan has a significant and clinically meaningful anxiolytic effect in subthreshold anxiety. The results cannot be generalised to other lavender oil products.

Keywords: Lavender oil; Meta-analysis; Silexan; Subthreshold anxiety; Treatment efficacy.

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Conflict of interest statement

Hans-Jürgen Möller has received grant/research support, consulting fees and honoraria within the last years from AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen Cilag, Lundbeck, MSD, Novartis, Organon, Otsuka, Pfizer, Schwabe, Sepracor, Servier, and Wyeth. Hans-Peter Volz has served as a consultant or on advisory boards for Astra/Zeneca, Eli Lilly, Lundbeck, Pfizer, Schwabe, Janssen, Otsuka, Merz, Wyeth, neuraxpharm and has served on speakers’ bureaus for Astra/Zeneca, Eli Lilly, Lundbeck, Schwabe, Janssen, Merz, Wyeth, Lichtwer, Steigerwald, Hormosan, neuraxpharm and Bristol-Myers Squibb. Angelika Dienel and Sandra Schläfke are employees of Dr. Willmar Schwabe GmbH & Co. KG, manufacturer of Silexan. Siegfried Kasper received grants/research support, consulting fees and/or honoraria within the last 3 years from Angelini, AOP Orphan Pharmaceuticals AG, AstraZeneca, Eli Lilly, Janssen, KRKA-Pharma, Lundbeck, Neuraxpharm, Pfizer, Pierre Fabre, Schwabe and Servier.

Figures

Fig. 1
Fig. 1
Hamilton Anxiety Rating Scale total score—change between baseline and treatment end (SD standard deviation, MD mean value difference, CI confidence interval, W weight)
Fig. 2
Fig. 2
Anxiety self-rating (studies A and B: Zung Anxiety Self-rating Scale total score; study C: Hospital Anxiety and Depression Scale, anxiety subscore)—change between baseline and treatment end (SD standard deviation, SMD standardised mean value difference, CI confidence interval, W weight)
Fig. 3
Fig. 3
Clinical Global Impressions, item 2, change from project admission—assessment at treatment end (SD standard deviation, MD mean value difference, CI confidence interval, W weight)
Fig. 4
Fig. 4
Analysis of response—number of patients with a Hamilton Anxiety Rating Scale total score reduction by at least 50% between baseline and treatment end (RR risk ratio, CI confidence interval, W weight)
Fig. 5
Fig. 5
Analysis of remission—number of patients with a Hamilton Anxiety Rating Scale total score < 10 points at treatment end (RR risk ratio, CI confidence interval, W weight)
Fig. 6
Fig. 6
Number of patients with any adverse events (RR risk ratio, CI confidence interval, W weight)
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