Efficacy and Safety of Horse Chestnut Seed Extract (ZO-SA0: Belfemin) for Treatment of Mild Chronic Venous Insufficiency with Lower Limb Oedema in Japanese Patients: A Multicenter, Open-label, Single-arm Study

Abstract

In Europe, herbal medicinal products containing horse chestnut seed extract as an active ingredient are widely used in patients with chronic venous insufficiency (CVI). In Japan, however, no clinical evidence for this drug has been established, and it has not been approved as a drug for CVI in Japan. Accordingly, we conducted a multicenter, open-label, single-arm study to confirm the efficacy and safety of ZO-SA0 (Belfemin) containing horse chestnut seed extract in seventy Japanese patients with mild CVI. After 12  weeks of treatment with the drug, a decrease in lower leg volume and improvement in subjective symptoms were suggested, as in overseas clinical studies, and no safety problems were observed.