Comparative Efficacy and Safety of a Horse Chestnut Formulation vs. Diosmin-Hesperidin in Chronic Venous Insufficiency: Randomized Double-Blind Trial
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; nA = 60) versus a combination of diosmin-hesperidin (Group B; nB = 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 Conclusion: Both regimens were safe and effective, with Group A showing better general performance in relation to Group B.
Authors
- Renato Kaufman (ORCID: https://orcid.org/0000-0002-3393-9415)
- Gustavo Falcão Gama (ORCID: https://orcid.org/0000-0003-1653-8940)
- João Paulo Lima Daher (ORCID: https://orcid.org/0009-0006-6783-4466)
- Aline Levy Sitnoveter
- Tiberiu Ezri
- Spyros G.E. Mezitis
- Marcio Steinbruch
- Mendel Suchmacher
- Mauro Geller (ORCID: https://orcid.org/0000-0002-5108-5054)
- Carlos Pereira Nunes (ORCID: https://orcid.org/0000-0002-8761-312X)
- Carlos Romualdo Barbosa Gama
Publication Details
- Journal
- International Journal of Clinical Medicine
- Published
- 2025-01-01
- DOI
- https://doi.org/10.4236/ijcm.2025.166019
- Citations
- 1
- Primary Topic
- Diagnosis and Treatment of Venous Diseases
- Type
- article
- Field-Weighted Citation Impact
- 2.01