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

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F15%3A00059553" target="_blank" >RIV/00023001:_____/15:00059553 - isvavai.cz</a>

Result on the web

<a href="http://www.minervamedica.it/en/journals/international-angiology/article.php?cod=R34Y2015N05A0428" target="_blank" >http://www.minervamedica.it/en/journals/international-angiology/article.php?cod=R34Y2015N05A0428</a>

DOI - Digital Object Identifier

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Result language

angličtina

Original language name

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

Original language description

Aim. The aim was to investigate the effect of micronized purified flavonoid fraction (MPFF; Daflon (R) 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 painheaviness 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.

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

FA - Cardiovascular diseases including cardio-surgery

OECD FORD branch

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Project

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Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2015

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

International angiology

ISSN

0392-9590

e-ISSN

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Volume of the periodical

34

Issue of the periodical within the volume

5

Country of publishing house

IT - ITALY

Number of pages

9

Pages from-to

428-436

UT code for WoS article

000363002100003

EID of the result in the Scopus database

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