What question did this study set out to answer?

To evaluate the effectiveness of a combination of phlebotonic agents on symptoms and quality of life in patients with chronic venous and lymphatic disease.

February 13, 2026Open Access

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

GAGiampiero AvruscioUniversity of Padua CTCarmen Tirritto SRSonia RagazzoUniversity of Padua

Key Points

To evaluate the effectiveness of a combination of phlebotonic agents on symptoms and quality of life in patients with chronic venous and lymphatic disease.
Conducted a retrospective observational analysis in a real-world clinical setting.
Adult patients received a 30-day treatment with a standardized phlebotonic formulation and compression therapy.
Primary endpoint was health-related quality of life assessed using the CIVIQ-14 questionnaire.
Secondary endpoints included symptom burden changes and limb circumference measurements.
Significant improvements in quality of life as measured by the CIVIQ-14 score (p<0.001).
Reductions in pain, sleep disturbance, and functional limitations were noted.
Significant reductions in ankle and calf circumferences (median reductions of 0.40 cm and 0.50 cm, respectively; p<0.001).
Median symptom burden scores increased significantly from 19.0 to 25.0 (p=0.002).
No adverse events were reported.

Abstract

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<0.001), with reductions in pain, sleep disturbance and functional limitations. Objective measurements showed significant reductions in both ankle and calf circumferences (median reduction: 0.40 cm and 0.50 cm, respectively; p<0.001). Symptom burden scores improved significantly (median increase from 19.0 to 25.0; p=0.002), especially for swelling, heaviness and fatigue. No adverse events were reported. Conclusion: In this real-world setting, a short-term integrative treatment with a phlebotonic formulation combining diosmin, R. aculeatus, M. officinalis and V. vinifera significantly improved QoL, symptom burden and oedema in patients with chronic venous and lymphatic disease. These findings support the therapeutic potential of combined phlebotonic therapy alongside standard care. Download the Plain Language Summary of this article: https://www.drugsincontext.com/plain-language-summaries/plain-language-summary-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-an

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