RESUMEN
A meta-analysis was performed to examine therapeutic effects of Silexan on somatic symptoms, including insomnia/fatigue, and physical health in patients with anxiety disorders. Five randomized, placebo-controlled trials were included in this analysis: The efficacy of Silexan (80 mg/day) was investigated in patients with subthreshold anxiety disorders (three trials) and in patients with generalized anxiety disorder (two trials). Silexan was superior to placebo in terms of the mean change from baseline in the Hamilton Anxiety Rating Scale (HAMA) subscore somatic anxiety at week 10 with a standardized mean difference of -0.31 [95% Cl: -0.52 to -0.10, p = .004]. Treatment effects of silexan on somatic anxiety were independent of gender and age. Statistically significant differences were also shown for single HAMA items somatic muscular, cardiovascular, respiratory, and genitourinary symptoms, indicating clinical relevance with small to medium effects of Silexan. Similar clinically meaningful effects of Silexan on SF-36 physical health, including reduced bodily pain and improved general health, and on insomnia complaints and fatigue, were demonstrated. In this meta-analysis including all placebo-controlled clinical trials in patients with anxiety disorders to date, statistically significant and clinically meaningful advantages of Silexan over placebo treatment were found in improving somatic symptoms and physical health.