Double blind randomized placebo-controlled study of the efficacy and safety of proroxan in the complex therapy of generalized anxiety disorder

Abstract

Introduction. The clinical picture of generalized anxiety disorder is characterized by diffuse anxiety, muscle tension and multiple symptoms of hyperactivity of the sympathetic part of the autonomic nervous system. As an alpha-adrenoblocker, proroxan can reduce the hyperactivity of the autonomic nervous system, thereby reducing the severity of anxiety and its somatic symptoms.Aim. To evaluate the efficacy of proroxan in the correction of autonomic disorders in patients with generalized anxiety disorder compared to placebo.Materials and methods. 100 people participated in the study: 50 – in the study group received the SSRI escitalopram, 50 – in the control group received SSRI + placebo. The diagnosis of generalized anxiety disorder was made on the basis of ICD-10 criteria. Psychometric assessment using the Montgomery-Asberg scale was performed (only at the screening visit). Weekly psychometric evaluation was performed using the Hamilton anxiety scale, the SCL-90-R scale to assess somatic manifestations of anxiety, and general clinical impression scales (CGI-S disease severity and CGI-I general improvement).Results. In the course of the study, statistically significant decrease in the mean value of CGI-S scale was observed in both groups, however, more pronounced in the proroxan group (p > 0.05); in the CGI-I scale, more pronounced improvement was observed in the first week of treatment in the proroxan group (p > 0.05). The HAM-A scale also showed a more significant reduction in anxiety in the proroxan group than in the placebo group (p > 0.05). The SCL-90-R SOM scale showed a decrease in the mean value in both groups, more pronounced in the proroxan group, which confirms the effect of the drug on autonomic symptoms of anxiety (p > 0.05).Conclusions. The obtained results confirm the superiority of combination therapy with escitalopram and proroxan in the treatment of generalized anxiety disorder compared to monotherapy. The advantages of proroxan were the absence of sedative effect and, in general, good tolerability, absence of withdrawal syndrome and control of vegetative manifestations of anxiety.