[note: all Kasper-authored studies aside from Woelk & Schläfke2010, who are Schwabe employees] …We found Silexan to be substantially superior to placebo in ameliorating anxiety symptoms independently of diagnosis (Hedges g = 0.67; 95% confidence interval [CI], 0.16–1.67) (Figure 1). Interestingly, there was a tendency for greater clinical effect when analyzing separately generalized anxiety disorder patients in comparison with all other diagnosis (Hedges g = 0.50; 95% CI, 0.02–0.97 vs Hedges g = 0.87; 95% CI, −0.16–1.90). In addition, we found Silexan to be superior to placebo and as effective as active comparator group (lorazepam) in the pooled analysis.
Figure 1: Forest plot of effect sizes (Hedges g) for active versus placebo group. CI, Confidence interval.
The other study limitation was the small number of studies, which may also compromise external validity. Regarding each study individually, we ought to underscore the lack of blinding assessment, the small samples, and the heterogeneity regarding eligibility criteria as main limitations to our final analysis.
Our results point toward a positive association between Silexan and amelioration of anxiety symptoms mainly regarding generalized anxiety disorder patients. Notwithstanding, given the relatively small number of trials published to date, further trials with greater sample sizes and more standardized experimental protocols will aid to clarify the precise effects of this promising therapeutic tool in clinical psychiatry.