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
Autor: | Marcio Steinbruch, Carlos Nunes, Romualdo Gama, Renato Kaufman, Gustavo Gama, Mendel Suchmacher Neto, Rafael Nigri, Natasha Cytrynbaum, Lisa Brauer Oliveira, Isabelle Bertaina, François Verrière, Mauro Geller |
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Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: | |
Zdroj: | International Journal of Vascular Medicine, Vol 2020 (2020) |
Druh dokumentu: | article |
ISSN: | 2090-2824 2090-2832 |
DOI: | 10.1155/2020/4237204 |
Popis: | 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. Patients and Methods. 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, n=57; D/H-group, n=57). Symptoms significantly improved in both groups with adjusted mean VAS changes of -24.9 mm (p |
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