Abstract

Objective of the research: to investigate the efficacy and safety of Afobazole in the treatment of adult patients with anxiety disorders and metabolic syndrome X. The study included 60 adult patients (18–65 years) (36 men, 24 women), whose clinical picture revealed mild and moderate forms of neurotic disorders observed in the therapeutic hospital and outpatient service. The main group (30 people) and control group (30 people) were formed on the basis of representativeness by gender and age (χ2emp <χ2krit, p ≤ 0.01). The sample consisted of patients who signed a written informed consent to participate in the study. The average age of the patients in the control group was 44.81 ± 2.17, in the main group ­– 45.13 ± 2.34 (p < 0.01); the average age of onset of mental disorders in the main group was 33.2 ± 3.1 years; in the control group it was 34.1 ± 3.4 years (p < 0.05); the average duration of psychopathological symptoms in the main group was 5.6 ± 0.6 months, in the control group – 5.8 ± 0.3 months (p < 0.05). The duration of treatment equaled 1 month of active therapy (later, the patients were transferred to maintenance therapy outside this study). Afobazole containing 0.01 g of active substance per tablet was used for treatment. The drug was prescribed 3 times a day (morning, afternoon and evening); the dose of the drug was increased: 1–1–2 (number of tablets per administration). There were changes in psychometric scaling, i.e. a significant decrease in state (by 57.2 and 42.9%; p ≤ 0.001) and trait (by 23.8 and 23.3%; p ≤ 0, 01) anxiety on the Spielberger–Khanin scale in the main and control groups at the end of treatment. In all groups of patients, we noted complete recovery (38.4%) or a significant improvement (37.9%); for most patients with mild manifestations, complete recovery was observed in 92% of cases. Among patients with moderate manifestations, a good response was recorded in 75% of cases; for the rest, moderate and minimal effects were observed, respectively. The changes in the severity as compared with baseline values were significantly positive (p < 0.05) already after 7 days of Afobazole therapy; similar changes were noted in the indicators of the overall effectiveness of therapy. No positive changes after Afobazole therapy were observed in 3.3% of cases, deterioration was registered in 3.3% of cases, while in the control group these values were 6.6% and 3.3%, respectively. The changes in somatic indicators also had positive trends in the control and main groups – SBP reduced by 11.0% and 18.0%, respectively (p ≤ 0.05); DBP – by 4.4% and 14.9% (p ≤ 0.05). The therapeutic effect of Afobazole is the reduction of viscero-vegetative manifestations of anxiety disorders, including relief of breathing, normalization of blood pressure and heart rate, reduction of muscle tension and pain, sweating and dizziness.

Highlights

  • There were changes in psychometric scaling, i.e. a significant decrease in state and trait anxiety on the Spielberger–Khanin scale in the main and control groups at the end of treatment

  • In the control and main groups – SBP reduced by 11.0% and 18.0%, respectively (p ≤ 0.05); DBP – by 4.4% and 14.9% (p ≤ 0.05)

  • In the main and control groups at the end of treatment, changes in psychometric scaling were noted, i.e. significant decrease in state and trait anxiety by the Spielberger-Khanin scale

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Summary

Introduction

There were changes in psychometric scaling, i.e. a significant decrease in state (by 57.2 and 42.9%; p ≤ 0.001) and trait (by 23.8 and 23.3%; p ≤ 0, 01) anxiety on the Spielberger–Khanin scale in the main and control groups at the end of treatment. Мета роботи: дослідити ефективність і безпеку препарату Афобазолу при терапії дорослих пацієнтів з тривожними розладами та метаболічним синдромом Х.

Results
Conclusion

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