Real-world effectiveness of a phlebotonic formulation combining diosmin, Ruscus, Melilotus and Vitis vinifera on symptoms and quality of life in patients with chronic venous and lymphatic disease: results from the VIVEMA Stasis observational study

Background: Chronic venous disease and lymphoedema frequently coexist, leading to significant symptom burden and impaired quality of life (QoL). Phlebotonic agents, such as diosmin, Ruscus aculeatus, Melilotus officinalis and Vitis vinifera, have demonstrated complementary anti-inflammatory, venotonic and lymphokinetic effects. However, real-world evidence on their combined use remains limited. Methods: The VIVEMA Stasis study was a retrospective observational analysis conducted in a real-world clinical setting. Adult patients with lower limb venous and/ or lymphatic oedema received a 30-day treatment with a standardized formulation containing diosmin, R. aculeatus, M. officinalis and V. vinifera extracts, in addition to compression therapy. The primary endpoint was improvement in health-related QoL, assessed using the CIVIQ-14 questionnaire. Secondary endpoints included changes in symptom burden and limb circumference measurements. Results: Fifty-one patients (mean age 54.0 years; 84.3% female) were included. After 30 days, significant improvements were observed in QoL (global CIVIQ-14 score: p