Author(s)

Carlos Romualdo B. Gama¹, Carlos P. Nunes¹, Marcio Steinbruch², Mendel Suchmacher^3*, Gustavo Falcão Gama⁴, Renato Kaufman⁵, Spyros Mezitis⁶, Aline Levy Sitnoveter⁷, Thais Gotfyd Bem Ezri⁸, João Paulo L. Daher⁹, Mauro Geller^1,3,10*

¹Centro Universitário Serra Dos Órgãos, UNIFESO, Teresópolis, Brazil.
²Hospital Israelita Albert Einstein, São Paulo, Brazil.
³Instituto de Pós-Graduação Médica Carlos Chagas, Rio de Janeiro, Brazil.
⁴Centro de Pós-Graduação em Ciências Médicas, Juiz de Fora, Brazil.
⁵Hospital Quinta D’Or, Rio de Janeiro, Brazil.
⁶Weill Cornell Medicine-Presbyterian Hospital, New York, USA.
⁷College of Medicine, University of Central Florida, Orlando, USA.
⁸Board-Certified by the Brazilian Society of Pediatrics, São Paulo, Brazil.
⁹Hospital Universitário Antônio Pedro, Universidade Federal Fluminense (UFF), Niterói, Brazil.
¹⁰Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.

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.

Chronic Venous Insufficiency, Aesculus hippocastanum and Associations, Diosmin-Hesperidin

Gama, C. , Nunes, C. , Steinbruch, M. , Suchmacher, M. , Gama, G. , Kaufman, R. , Mezitis, S. , Sitnoveter, A. , Ezri, T. , Daher, J. and Geller, M. (2025) Comparative Efficacy and Safety of a Horse Chestnut Formulation vs. Diosmin-Hesperidin in Chronic Venous Insufficiency: Randomized Double-Blind Trial. International Journal of Clinical Medicine, 16, 279-292. doi: 10.4236/ijcm.2025.166019.