HR (Venoruton1000, Paroven, 0-[beta-hydroxyethyl]-rutosides) vs. Daflon 500 in Chronic Venous Disease and Microangiopathy: An Independent Prospective, Controlled, Randomized Trial

Abstract

Objectives: The aim of this study was to demonstrate whether and how HR (Venoruton1000, Paroven, 0-[beta-hydroxyethyl]-rutosides) and Daflon (diosmin, 500 mg) were comparatively effective in improving the microcirculation in venous hypertension and microangiopathy. Methods: A group of 90 patients with severe venous hypertension due to chronic venous insufficiency, ankle swelling, and lipodermatosclerosis were included. After informed consent, patients were randomized into a Venoruton and a Daflon (DF) group: patients in the Venoruton group received oral HR (2 g/day for 8 weeks); those in the Daflon group received three 500-mg tablets daily every 8 hours. The two groups were comparable for age and sex distribution. The mean age was 41 years (SD ± 11) in the Venoruton group (46 patients) and 41.3 (SD ± 12) in the DF group (44 patients). Results: There were no differences in microcirculatory parameters between the Venoruton and DF treatment groups at inclusion. There was no significant change between inclusion and measurements at 8 weeks in the DF group. In comparison, a significant decrease ( P < .05) in RF (resting skin flux) and RAS (rate of ankle swelling) was observed in the Venoruton group ( P < .00 1). The decrease in capillary filtration was associated with improvement in signs and symptoms (measured by an analogue scale line) ( P < .05). Symptomatic improvement was clinically and statistically significant and important only in the Venoruton group. No side effects and no drop-outs were observed. Conclusion: Venous microangiopathy was improved by the treatment with Venoruton. The comparison with Daflon indicates that HR is comparatively more effective both on microcirculatory parameters and on signs and symptoms.