Evidence map›Paper›PMID 29150713›Full record

SynthesisEuropean archives of psychiatry and clinical neuroscience2019

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

Hans-Jürgen Möller, Hans-Peter Volz, Angelika Dienel, Sandra Schläfke, Siegfried Kasper

Open access · hybridAbstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in European archives of psychiatry and clinical neuroscience, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 4 pooled it
4.0field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 4 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
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  5. Trial
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  13. Plant Extracts for Sleep Disturbances: A Systematic Review.Evidence-based complementary and alternative medicine : eCAM · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 2 countries.

Hans-Jürgen MöllerClinic and Polyclinic for Psychiatry and Psychotherapy, Ludwig Maximilian University, Munich, Germany.
Hans-Peter VolzHospital for Psychiatry, Psychotherapy and Psychosomatic Medicine Schloss Werneck, Werneck, Germany.
Angelika DienelDepartment of Clinical Research 1, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.
Sandra SchläfkeDepartment of Biostatistics, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.
Siegfried KasperDepartment of Psychiatry and Psychotherapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. sci-biolpsy@meduniwien.ac.at.ORCID http://orcid.org/0000-0001-8278-191X
Dr Willmar Schwabe (Germany) · DEBDH-Klinik Hessisch Oldendorf · DELudwig-Maximilians-Universität München · DEMedical University of Vienna · AT

Funding

Dr. Willmar Schwabe GmbH & Co. KG n.a.
6 · The paper itself

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.

Indexed as

Treatment OutcomeAnxietyAnxiety DisordersHumansLavandulaOils, VolatilePhytotherapyPlant OilsRandomized Controlled Trials as Topiclavender oilOils, VolatilePlant OilsLavender oilMeta-analysisSilexanSubthreshold anxietyTreatment efficacy

Identifiers

PMID29150713
PMCPMC6726711
OpenAlexW2770656902

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.