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INTERNATIONAL ANGIOLOGY

Rivista di Angiologia


Official Journal of the International Union of Angiology, the International Union of Phlebology and the Central European Vascular Forum
Indexed/Abstracted in: BIOSIS Previews, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
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International Angiology 2018 Jan 31

DOI: 10.23736/S0392-9590.18.03975-5

Copyright © 2018 EDIZIONI MINERVA MEDICA

lingua: Inglese

Efficacy of micronized purified flavonoid fraction (Daflon®) on improving individual symptoms, signs and quality of life in patients with chronic venous disease: a systematic review and meta-analysis of randomized double-blind placebo-controlled trials

Stavros KAKKOS 1 , Andrew NICOLAIDES 2

1 Department of Vascular Surgery, University Hospital of Patras, Patras, Greece; 2 Imperial College London, London, UK and University of Nicosia Medical School, Cyprus, Greece


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INTRODUCTION: The use of a venoactive drug is considered an important component of medical treatment of chronic venous disease (CVD), although the efficacy of certain VADs on one or more individual leg symptoms or signs may have not been extensively studied to justify a strong recommendation in guidelines on CVD. The aim of this systematic review and metaanalysis was to study the effectiveness of the micronized purified flavonoid fraction (MPFF, Daflon®) across the spectrum of defined venous symptoms, signs, quality of life (QoL) and treatment assessment by the physician.
EVIDENCE ACQUISITION: On September 9, 2017, a systematic review of the databases MEDLINE, Scopus and Cochrane Central was performed, supplemented by hand searching, to identify randomized doubleblind placebocontrolled trials on MPFF in patients with CVD.
EVIDENCE SYNTHESIS: The main outcome measures were the individual and global symptoms, leg edema and redness, skin changes, QoL and evaluation of the overall effectiveness of the treatment by the physician. The effectiveness of MPFF compared with placebo was expressed as risk ratio (RR) or standardized mean difference (SMD) with 95% confidence interval (CI). Trial quality of evidence was graded using the GRADE system.
RESULTS: We identified 7 trials, mostly with low risk of bias, involving 1,692 patients. On qualitative analysis, MPFF significantly improved nine defined leg symptoms, including pain, heaviness, feeling of swelling, cramps, paresthesia, burning sensation, and pruritus (itching), but also functional discomfort compared with placebo, leg redness, skin changes and QoL. On quantitative analysis, MPFF compared with placebo, assessed as a categorical variable, reduced leg pain (RR 0.53, p=0.0001, NNT=4.2), heaviness (RR 0.35, p<0.00001, NNT=2.0), feeling of swelling (RR 0.39, p<0.00001, NNT=3.1), cramps (RR 0.51, p=0.02, NNT =4.8), paresthesia (RR 0.45, p=0.03, NNT=3.5), and functional discomfort (RR 0.41, p=0.0004, NNT =3.0). Similarly, MPFF compared with placebo, assessed as a continuous variable reduced pain (SMD 0.25, 95% CI 0.38 to 0.11), heaviness (SMD 0.80, 95% CI 1.05 to 0.54), feeling of swelling (SMD 0.99, 95% CI 1.25 to 0.73), burning sensation (SMD 0.46, 95% CI 0.78 to 0.14), cramps (SMD 0.46, 95% CI 0.78 to 0.14), and functional discomfort (SMD 0.87, 95% CI 1.13 to 0.61). Regarding objective assessments of leg edema, the use of MPFF compared with placebo reduced ankle circumference (SMD 0.59, 95% CI 1.15 to 0.02), and leg redness (SMD 0.32, 95% CI 0.56 to 0.07, RR 0.50, p=0.03, NNT =3.6), improved skin changes (RR 0.18, p=0.0003, NNT=1.6) and quality of life (SMD 0.21, 95% CI 0.37 to 0.04) and was associated with clinical improvement as assessed by the physician (RR 0.28, p<0.00001, NNT =2.5). Heterogeneity was mostly minimal. The existing evidence where sufficient was mostly of high quality.
CONCLUSIONS: Based on high quality evidence, MPFF is highly effective in improving leg symptoms, edema and quality of life in patients with CVD.


KEY WORDS: Micronized purified flavonoid fraction - Daflon - Chronic venous disease

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Publication History

Article first published online: January 31, 2018
Manuscript accepted: January 29, 2018
Manuscript received: January 23, 2018

Per citare questo articolo

Kakkos S, Nicolaides A. Efficacy of micronized purified flavonoid fraction (Daflon®) on improving individual symptoms, signs and quality of life in patients with chronic venous disease: a systematic review and meta-analysis of randomized double-blind placebo-controlled trials. Int Angiol 2018 Jan 31. DOI: 10.23736/S0392-9590.18.03975-5

Corresponding author e-mail

kakkos@upatras.gr