Venoruton® vs Daflon®: Evaluation of Effects on Quality of Life in Chronic Venous Insufficiency

Abstract

The aim of this independent study was to investigate differences in efficacy between oxerutins (Venoruton) and 500 mg micronized diosmin + hesperidin (D+H) (Daflon) in patients with chronic venous insufficiency (CVI), evaluating venous-related quality of life (Ve-QOL). A first group of 90 patients with severe venous hypertension (CVI, ankle swelling) was randomized to treatment with oxerutins or D+H. The oxerutins group received oral oxerutins (2 g/day); the D+H group received 3 (500 mg) tablets daily every 8 hours for 8 weeks. A second group of 122 comparable patients was included in a registry following the same study format. The 2 treatments were administered with the same methods and procedures. Clinical conditions were comparable. All patients completing 8 weeks of treatment were included in a registry. Specialists or general practitioners included patients when they considered that clinical conditions were compatible with treatment indications using 1 of the 2 treatments on the basis of their evaluation and experience. When cases were compatible with the registry, the prescribing physician communicated the case to our monitoring center. Patients were evaluated without interfering with their treatment. The main target of evaluation for this study was the change in Ve-QOL (range, 0-100) induced by treatment. A specific Ve-QOL questionnaire was used for this study. Ve-QOL score is a specific expression of the changes in QOL induced by CVI in patients between 35 and 75 years old (defined in our population studies) in which no other significant clinical disease is present (as a confounding factor affecting QOL). Two hundred twelve patients completed the 2 parts of the study. The 2 treatment groups were comparable for age and gender distribution. The mean age was 42 years (SD +/-5.5) in the oxerutins group and 41.5 (SD +/-6) in the D+H group. There were no differences in the severity of CVI between the treatment groups at inclusion. A significant decrease (46.8%, p<0.05) in Ve-QOL score; that is, improvement, was observed in the oxerutins group. The change in Ve-QOL was significantly less in the D+H group (15.5%). In conclusion, CVI, venous microangiopathy, and edema were significantly improved by the treatment with oxerutins; the improvement in QOL was significantly greater in the oxerutins group. The comparison with D+H indicates that oxerutins is comparatively more effective on Ve-QOL and on signs/symptoms of CVI.

Matrix Metalloproteinases as Regulators of Vein Structure and Function: Implications in Chronic Venous Disease

“…Diosmin is a flavonoid and an active ingredient in Daflon-500 that may improve venous tone, microvascular permeability, lymphatic activity, and microcirculatory nutritive flow (Le Devehat et al, 1997). Rutosides enhance endothelial function in patients with CVI (Cesarone et al, 2006). Flavonoids may affect the endothelium and leukocytes and reduce edema and inflammation.…”

Effects of Herbal Supplements on Drug Glucuronidation. Review of Clinical, Animal, andIn VitroStudies

“…In Europe, it is prescribed for treatment of venous insufficiency while in the US, it is marketed as a food supplement [60,61]. A study in rat liver perfusate showed that diosmin was mainly excreted in the bile as a glucuronide conjugate [62].…”

Scientific Opinion on the substantiation of a health claim related to a combination of diosmin, troxerutin and hesperidin and maintenance of normal venous tone pursuant to Article 13(5) of Regulation (EC) No 1924/2006

“…Following an application from Omikron Italia S.r.l, submitted pursuant to Article 13(5) of Regulation (EC) No 1924No /2006 via the Competent Authority of Italy, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to a combination of diosmin, troxerutin and hesperidin and maintenance of normal venous tone.…”

“…EFSA is requested to evaluate the scientific data submitted by the applicant in accordance with Article 16(3) of Regulation (EC) No 1924No /2006. On the basis of that evaluation, EFSA will issue an opinion on the scientific substantiation of a health claim related to a combination of diosmin, troxerutin and hesperidin and maintenance of normal venous tone.…”