Silexan does not cause withdrawal symptoms even when abruptly discontinued

Gastpar, Markus; Müller, Wernér E.G.; Volz, Hans-Peter; Möller, Hans‐Jürgen; Schläfke, Sandra; Dienel, Angelika; Kasper, Siegfried

doi:10.1080/13651501.2017.1301488

Cited by 13 publications

(4 citation statements)

References 7 publications

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“…In addition to the original publications presenting the results of the three trials above [14–16], the MEDLINE search retrieved a total of 14 other publications. Four described randomised, controlled trials with Silexan in other psychiatric indications [13, 17–19], and three covered non-clinical studies with Silexan [10, 12, 20]. Retrieved publications also included a contraceptives interaction study [21] and a case report [22].…”

Section: Methodsmentioning

confidence: 99%

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

Möller

Volz

Dienel

et al. 2017

Eur Arch Psychiatry Clin Neurosci

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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.

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Section: Methodsmentioning

confidence: 99%

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

Möller

Volz

Dienel

et al. 2017

Eur Arch Psychiatry Clin Neurosci

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“…The herbal product does, however, not interfere with activities of daily living [ 34 ], including driving performance [ 45 ], and has neither a sedating effect nor a potential for abuse [ 57 , 58 ]. Silexan does also not cause withdrawal symptoms even when discontinued abruptly [ 19 ] and does not interact with oral contraceptives [ 28 ], which is an important finding since an appreciable proportion of patients affected by anxiety disorders and subthreshold anxiety are young female patients [ 60 ]. Generally, therapeutic doses of Silexan did not show any interaction potential with activities of cytochrome P450 enzymes CYP1A2, 2C9, 2C19, 2D6, and 3A4 [ 16 ].…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Silexan in patients with anxiety disorders: a meta-analysis of randomized, placebo-controlled trials

Dold

Bartova

Volz

et al. 2023

Eur Arch Psychiatry Clin Neurosci

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Introduction We report on a meta-analysis of Silexan, a proprietary active substance produced from Lavandula angustifolia, in subthreshold anxiety, mixed anxiety and depressive disorder (MADD), and generalized anxiety disorder (GAD). Methods The present analyses are based on all currently completed 5 double-blind, randomized, placebo-controlled trials investigating Silexan in adult out-patients who received Silexan 1 × 80 mg/day or placebo for ten weeks according to random assignment (n = 1213). Efficacy was assessed based on the Hamilton Anxiety Rating Scale (HAMA), several anxiety self-rating scales, the Clinical Global Impression (CGI) scale, and the Short Form-36 (SF-36) health status questionnaire. Results After ten weeks’ treatment, Silexan was significantly superior to placebo in reducing the HAMA total score (including the psychic and somatic anxiety sub-scores) and self-rated anxiety. Based on a ≥ 50% HAMA total score reduction, the responder rate ratio was 1.34 favoring Silexan, and the rate ratio of subjects much or very much improved according to the CGI was 1.51. Silexan was also significantly superior in improving the physical and mental health summary scores of the SF-36. There were no significant between-group differences concerning the occurrence of adverse events (AEs), serious AEs, and premature withdrawal due to AEs. Conclusions This meta-analysis demonstrates that Silexan exerts significant anxiolytic effects in subthreshold anxiety, GAD and MADD that were consistently reflected in investigator ratings and patient-reported outcomes, including improvement of health-related life-quality, while showing favorable tolerability and safety.

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“…On the other hand, reducing the dosage to 80 mg/day resulted in less pronounced beneficial effects, indicating that this dosage may represent the lower end of the therapeutic range for Silexan in treating GAD [197]. Furthermore, withdrawal symptoms and dependency associated with silexan use have not been observed, indicating that silexan can be safely discontinued without tapering even after long-term treatment [198]. While emerging evidence suggests that Silexan exhibits a robust and clinically significant anxiolytic effect, further research is needed to explore its broader potential [199].…”

Section: Lavender Oilmentioning

confidence: 99%

An Alternative Approach in the Treatment of Anxiety Disorders: Current Directions

Antos,

Zackiewicz,

Tomaszek

et al. 2024

Preprint

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Anxiety disorders significantly reduce patients' quality of life. Current pharmacological treatments, primarily benzodiazepines and antidepressants, are associated with numerous side effects. Consequently, there is a continual search for alternative methods to traditional therapies that are less burdensome for patients and broaden their therapeutic options. In this review, we examined recent evidence on alternative treatments for anxiety disorders, including physical activity, mindfulness, VR technology, biofeedback, herbal remedies, and transcranial magnetic stimulation (TMS), cryotherapy, hyperbaric therapy, vagus nerve stimulation, MDMA, electroconvulsive therapy (ECT), and eye movement desensitization and reprocessing (EMDR) therapy. Our objective was to determine the role of these selected alternative methods in the treatment of anxiety disorders. Alternative treatments significantly expand the options available to patients and clinicians, with many serving as adjuncts to traditional therapies. Among the methods presented, mindfulness has the most significant therapeutic potential.

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Silexan does not cause withdrawal symptoms even when abruptly discontinued

Abstract: Values assessed for the silexan groups indicate the absence of a dependency potential of this preparation.

Cited by 13 publications

References 7 publications

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

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

Efficacy of Silexan in patients with anxiety disorders: a meta-analysis of randomized, placebo-controlled trials

An Alternative Approach in the Treatment of Anxiety Disorders: Current Directions

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