Is Nonmicronized Diosmin 600 mg As Effective As Micronized Diosmin 900 mg Plus Hesperidin 100 mg on Chronic Venous Disease Symptoms? Results of a Noninferiority Study
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Background: Phlebotonics have beneficial effects on some symptoms related to chronic venous disease (CVD) of the lower limbs. The most commonly used one is diosmin, available in a pure semisynthetic form or as a micronized purified flavonoid fraction. . The primary objective of this single-blind, randomized, parallel-group, prospective study was to assess the clinical noninferiority of nonmicronized diosmin 600 mg once daily (D-group) compared to micronized diosmin 900 mg plus hesperidin 100 mg once daily (D/H-group) over a 6-month treatment period. Adult patients with a symptomatic CVD of the lower limbs (C0-C3 grade; 20-60 mm on a 100 mm visual analog scale (VAS)) were included. The primary endpoint was the change (from baseline to last postbaseline value) of the intensity of the lower-limb symptoms on VAS.
Results: 114 patients (mean age, 44.4 years; women, 90.4%) were randomized in the per-protocol analysis (D-group, = 57; D/H-group, = 57; D/H-group, < 0.0001) in the D-group and -22.8 mm ( < 0.0001) in the D-group and -22.8 mm ( < 0.0001) in the D-group and -22.8 mm (.
Conclusion: Nonmicronized diosmin 600 mg was proven to have a noninferior efficacy compared to micronized diosmin 900 mg plus hesperidin 100 mg, associated with greater ease in swallowing the tablet.
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