Comparative Efficacy and Safety of a Horse Chestnut Formulation vs. Diosmin-Hesperidin in Chronic Venous Insufficiency: Randomized Double-Blind Trial

Abstract

Background: Chronic venous insufficiency (CVI) is a prevalent and incurable condition that can be managed through both medical and surgical interventions. Objective: To compare the safety and efficacy of a combination of Aesculus hippocastanum , Polygonum acre , Smilax papyracea , and rutin (Group A; n A = 60) versus a combination of diosmin-hesperidin (Group B; n B = 60), over a 90-day treatment period, in patients with symptoms consistent with CVI. Methods: Efficacy and safety were assessed using both self-paired and comparative study designs. Study endpoints included: 1) Severity of venous symptoms measured by the Visual Analogue Scale (VAS), 2) Quality of life via the CIVIQ-20 score, 3) Physician’s assessment score, 4) Patient’s self-assessment score, and 5) Ease of swallowing the pharmaceutical form, assessed by VAS. Safety profiles were also evaluated. Results: The Group A combination was statistically non-inferior to the Group B combination across all study endpoints, including venous symptom severity, quality of life, and both physician and patient assessments. Group A’s formulation was reported to perform better on quality-of-life (CIVIQ-20 score-Visit 3) (p < 0.05) and was easier to swallow (p < 0.05). Both treatments were well tolerated. Conclusion: Both regimens were safe and effective, with Group A showing better general performance in relation to Group B.