ORIGINAL ARTICLES   

International Angiology 2015 October;34(5):428-36

Copyright © 2015 EDIZIONI MINERVA MEDICA

lingua: Inglese

Analysis of the effects of micronized purified flavonoid fraction versus placebo on symptoms and quality of life in patients suffering from chronic venous disease: from a prospective randomized trial

Rabe E. ¹, Agus G. B. ², Roztocil K. ³

¹ Department of Dermatology, University of Bonn, Bonn, Germany; ² Section of Vascular Surgery and Angiology, Department of Clinical Science and Community Health, University of Milan, Milan, Italy; ³ Department of Cardiology, Institute of Clinical and Experimental Medicine, Prague, Czech Republic

AIM: The aim was to investigate the effect of micronized purified flavonoid fraction (MPFF; Daflon® 500 mg, Laboratoires Servier, France) versus placebo, on pain and quality of life (QoL) in patients with symptomatic chronic venous disease (CVD).
METHODS: A large randomized, double-blind, placebo-controlled, parallel-group study was conducted to evaluate treatment effects on vesperal oedema using water displacement volumetry (WDV). Other criteria were leg pain\heaviness assessed by Visual Analog Scale (VAS) and Quality Of Life Questionnaire (CIVIQ-20). Study treatments were administered once a day for 4 months. The tolerance to the study treatments was assessed based on spontaneously reported adverse events, coded using the MedDRA dictionary. The present post-hoc analysis focuses on the subgroup of symptomatic patients having a baseline VAS>4 cm.
RESULTS: The main study included 1137 patients classified C3 or C4 according to CEAP classification, with 592 in the symptomatic subgroup: 296 randomized to MPFF and 296 to placebo. Patient demographics and medical history were well-balanced at baseline. The main study was inconclusive on WDV for methodological reasons. In the symptomatic subgroup, MPFF treatment was associated with a greater reduction in VAS score than on placebo treatment (between-group difference =-0.5 cm; P=0.031) and greater improvement in CIVIQ score (between-group difference =3.1%; P=0.040).
CONCLUSION: A 4-month treatment with MPFF significantly reduced leg pain/heaviness and improved QOL when compared to placebo and was well tolerated.