[Correction of autonomic nervous system disorders: results from an observational study].

OBJECTIVE

To evaluate the efficacy and safety of Prospekta in real-world clinical settings for the treatment of autonomic nervous system (ANS) disorders in patients presenting with asthenia.

MATERIAL AND

METHODS

This observational study included 425 patients, comprising individuals of both sexes aged 18 to 55 years (mean age 38.4±10.8 years), who reported symptoms associated with ANS disorders and fatigue. Participants received Prospekta, administered as 1 tablet twice daily for 4 weeks. The severity of ANS disorders was evaluated using the 4DSQ (Four Dimensional Symptom Questionnaire) somatoform disorder scale. Quality of life was measured employing the EQ-5D-3L questionnaire. The mean Clinical Global Impression - Improvement (CGI-I) score, along with the nature and frequency of adverse events during treatment, their severity, relationship to Prospekta, and outcomes, were comprehensively recorded.

RESULTS

Patients were categorized into three groups based on their initial level of somatization. A statistically significant reduction in the mean 4DSQ score was noted across all groups, with the most significant improvement observed in Group 3 (characterized by a severely elevated level of somatization) (p<0.001). Additionally, an improvement in quality of life, as assessed by the EQ-5D-3L questionnaire, was statistically significant. A positive correlation was identified between the decrease in somatization severity and reductions in both blood pressure and heart rate.

CONCLUSION

The use of Prospekta in patients with ANS disorders and asthenia results in a significant decrease in somatization, which corresponds with normalization of cardiovascular function and improvements in quality of life.