Advantage of a micronized flavonoidic fraction (Daflon 500 mg) in comparison with a nonmicronized diosmin.

A randomized, double-blind, multicenter trial was performed to study the pharmacodynamic and clinical activities of Daflon 500 mg,* in comparison with a nonmicronized diosmin. Daflon 500 mg is a micronized purified flavonoidic fraction consisting of 450 mg of diosmin and 50 mg of hesperidin per tablet, which has been micronized in order to ensure a better gastrointestinal absorption. Ninety patients with chronic venous insufficiency of the lower limbs, stabilized for one year, entered the study. They received either two tablets of Daflon 500 mg or an equivalent dose of nonmicronized diosmin in two divided doses each day during two months. The following parameters were studied: functional clinical symptoms in the lower extremities, ankle circumference measurement, strain gauge plethysmographic parameters with 20, 40, and 60 mmHg venous occlusion, and clinical and biochemical acceptability. Statistically significant changes were obtained in both groups of patients in comparison with baseline values. However, the improvements in all clinical symptoms and plethysmographic parameters (maximum increase of venous volume at 60 mmHg and total time for emptying) were significantly better with Daflon 500 mg than with nonmicronized diosmin. The clinical and laboratory acceptability was similar in both groups. However, the percentage of satisfied patients was 95% in the Daflon 500 mg group, versus 80% in the nonmicronized diosmin group (p < 0.01). In conclusion, the pharmacodynamic and clinical activities of Daflon 500 mg are superior to those of an equivalent dose of nonmicronized diosmin and demonstrate the therapeutic advantage of a micronized formulation in the treatment of chronic venous insufficiency.

RCT Entities:   Population Interventions Outcomes