[Use of Detravenol in treatment of chronic venous insufficiency of lower limbs]. / Primenenie preparata Detravenol pri lechenii khronicheskoi venoznoi nedostatochnosti nizhnikh konechnostei.

AIM: The purpose of this study was to prove that Detravenol is not inferior by clinical efficacy to Detralex® in the course administration in patients presenting with chronic venous insufficiency of the lower extremities caused by lower limb varicose veins. PATIENTS AND METHODS: Ours was a prospective randomized open-liable comparative trial aimed at determining efficacy and safety of the two drugs in parallel groups with active control. The trial enrolled a total of 106 patients with chronic venous insufficiency of the lower extremities secondary to lower limb varicose veins. The patients took the drug during 60 days twice daily. The primary outcome measure of efficacy was reduction of the malleolar circumference upon completion of treatment as compared with the baseline values, with the secondary outcome measures being the dynamics of parameters according to the Venous Clinical Severity Score (VCSS), CIVIQ-2 quality of life questionnaire, and the findings of ultrasonographic duplex scanning. RESULTS: The obtained findings demonstrated efficacy of therapy with the use of Detravenol in treatment of patients with chronic venous insufficiency of the lower limbs. The 60-day therapy with the study drug resulted in decreased oedema of the lower extremities: the malleolar circumference reduced averagely by 4%, the composite index of the venous clinical severity score diminished averagely by 50%, and the subjective measure of quality of life increased. Patients taking the study drug demonstrated positive dynamics according to the findings of ultrasonographic duplex scanning, with no serious adverse events during the trial observed. CONCLUSION: By the primary outcome measure of efficacy (reduction of the malleolar circumference) therapy using the investigational drug proved to be not inferior to therapy with the comparator drug. By the secondary outcome measures the compared therapies appeared equally effective. The study drug and the comparator were found to have a similar safety profile.

The linguistic validation of Russian version of Dutch four-dimensional symptoms questionnaire (4DSQ) for assessing distress, depression, anxiety and somatization in patients with borderline psychosomatic disorders.

BACKGROUND: The four-dimensional symptom questionnaire (4DSQ) is an originally Dutch self-report questionnaire that has been developed in primary care to distinguish non-specific general distress from depression, anxiety and somatization. In order to produce the appropriate translated Russian version the process of linguistic validation has been initiated. This process has been done according to the "Linguistic Validation Manual for Health Outcome Assessments" developed by MAPI institute. OBJECTIVE: To produce the appropriate Russian version of the 4DSQ that is conceptually and linguistically equivalent to the original questionnaire. METHODS: The original Dutch version of the 4DSQ was translated by one translator into Russian. The validated English version of the 4DSQ was translated by another translator into Russian without mutual consultation. The consensus version was created based on two translated versions. After that the back translation was performed to Dutch, some changes were implemented to the consensus Russian version and the second target version was developed based on these results. The second target version was sent to an appropriate group of reviewers. Based on their comments, the second target version was updated. After wards this version was tested in patients during cognitive interview. The study protocol was approved by the Independent Interdisciplinary Ethics Committee on Ethical Review for Clinical Studies, and in compliance with the Helsinki Declaration and ICH-GCP guidelines and local regulations. Enrolled patients provided written informed consent. RESULTS: After the process of forward and backward translation, consultant and developer's comments, clinicians and cognitive review the final version of Russian 4DSQ was developed for assessment of distress, depression, anxiety and somatization. CONCLUSION: The Russian 4DSQ as a result of translation procedures and cognitive interviews linguistically corresponds to the original Dutch 4DSQ and could be assessed in psychometric validation for the further using in general practice.

[The multicenter non-interventional, prospective observational program on the study of practical use of teraligen in patients diagnosed with autonomic disorder (START2): a local Russian experience with the use of the Russian version of The Four-Dimensional Symptom Questionnaire (4DSQ). An intermediate analysis].

AIM: To develop a new instrument able to identify pathological states and assess their changes during medication treatment. We aimed to study the typical practice of using alimemazine (teraligen) in patients with the diagnosis of autonomic nervous system disorder and to test the Russian version of @The Four-Dimensional Symptom Questionnaire@ (4DSQ) for measuring distress, depression, anxiety and somatization. MATERIAL AND METHODS: We examined 3053 patients (mean age 42.09 ± 11.71 years) who received teraligen in doses gradually increasing from 5 to 15 mg per day. The observational program was carried out in over 600 outpatient clinics of the Russian Federation. The 4DSQ was administered before treatment and 4 weeks after treatment. The Clinical Global Impression (CGI) scale was used before, during (after 2 weeks) and after (4 weeks) treatment with teraligen. RESULTS AND CONCLUSION: There was a significant improvement of patient's state assessed both by physicians (CGI scale) and by patients (96 and 98%, respectively). The 4DSQ was sensitive to the parameters of response to treatment with teraligen: parameters obtained at baseline and 4 weeks after the beginning of treatment differed significantly demonstrating a significant decrease in distress, anxiety and somatization.

[The primary screening of patients with autonomic disorders in outpatient clinics in Russia (START1) using the Russian version of The Four-Dimensional Symptom Questionnaire (4DSQ)].

OBJECTIVE: To develop an effective diagnostic algorithm for detection of a mental component in the state of patients diagnosed with autonomic nervous system disorder. MATERIAL AND METHODS: In the frames of START1 epidemiological study, we examined 6633 patients with autonomic nervous system disorders (ICD-10 G.90.8 and G90.9) and somatoform disorders (F45) including 18,8% patients who got a referral to a psychiatrist. A linguistically validated Russian version of The Dutch Four-Dimensional Symptoms Questionnaire (4DSQ) was tested in domain subpopulations. RESULTS: In subpopulations of anxiety and depression, more than 26% of the patients got a referral to a psychiatrist that indirectly supported the assumption on the conformity of 4DSQ to the purposes of primary screening of four-dimensional disorders in the general population of patients with autonomic nervous system disorders. CONCLUSION: The linguistically validated Russian version of 4DSQ enabled to formalize the description of clinical profile of these patients. Cluster analysis of the results allowed to single out two superdomains by the pairwise combination somatization with distress (SDis) and anxiety with depression (ADep). The detection of superdomain SDis appears to be a population specific characteristic of autonomic nervous system disorders in the Russian Federation.

[The Four-Dimensional Symptom Questionnaire (4DSQ) to assess distress, depression, anxiety and somatization in autonomic and borderline psychosomatic disorders].

OBJECTIVE: Autonomic nervous system disorders are a frequent reason that makes patients to seek medical advice from general physicians and neurologists in outpatient clinics. The Dutch Four-Dimensional Symptoms Questionnaire (4DSQ) used for measuring distress, depression, anxiety and somatization is an adequate tool for identifying psychogenic factors for the development of autonomic disorders. An aim of the study was to localize the questionnaire to the Russian population. MATERIAL AND METHODS: The questionnaire was translated and the Russian version was subsequently psychometrically validated. The statistical analysis conducted for the verification of compatibility of the Russian version with the Dutch version was based on the survey of 243 patients. RESULTS: All elements of the Russian version measured the same parameters of the Dutch 4DSQ. Some differences were identified. CONCLUSION: The analysis has confirmed the possibility of using the questionnaire in the Russian-speaking population using higher threshold values: +2 points for distress and anxiety, +4 points for somatization.