Page 2 - Fabroven Estudio Clinico

not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame or use framing techniques to enclose any trademark, logo,
means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is
This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies
(either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other
©
COPYRIGHT 2017 EDIZIONI MINERVA MEDICA
KaKKoS eFFICaCy oF RUSCUS, HMC aND VItaMIN C oN VeNoUS SyMPtoMS

are effective in improving patient symptoms and objec- obtained and translated to english if published in anoth-
tively estimated edema of CVDs. However, the efficacy er language. The study selection process (PRISMA flow
of certain VaDs on one or more individual symptoms diagram) is shown in Figure 1. For each rCt included in
may have not been studied in detail or confirmed to jus- the study, raw data (number of patients who developed
tify a high level or grade of recommendation in guide-
lines of CVD.
More recently, the SyM Vein Consensus statement,
developed under the auspices of the european Venous
Forum, attributed leg symptoms to venous disorders
and provided a review on the description and definition,
pathophysiology, scoring, clinical examination and in-
vestigations of venous symptoms. 3
Cyclo 3 Fort (laboratoires Pierre Fabre, Paris,
®
France) is a VaD that combines three active ingredients,
i.e. the saponine Ruscus aculeatus extract, the flavonoid
hesperidin methyl chalcone (HMC) and ascorbic acid.
It has a proven record of effectiveness in improving leg
symptoms in patients with CVD and venous edema. 4, 5
However, the original trials might have been un-
derpowered for some efficacy measures or individu-
al symptoms or had a non-inferiority design, which
formed the rationale of the present investigation. addi-
tionally, consistent evidence from at least two random-
ized controlled trials (RCTs) is required to award a high
level of evidence for each symptom or edema measure.
therefore, the aim of the present systematic review and
meta-analysis was to further study the effectiveness of
VaDs containing Ruscus across the spectrum of defined
venous symptoms.

Evidence acquisition

on November 14 2016, we conducted an up-to-date
th
literature search of two electronic databases (Medline
and Scopus) using the following key-words for Ruscus
extract: Ruscus or Cyclo 3, narrowed down to venous
or vein or post-thrombotic pathology with no language
restrictions. the aim was to identify rCts investigat-
ing the efficacy of Ruscus extract in the treatment of
individual symptoms of CVD or venous edema. this
was followed by a manual search of the reference list
of the relevant articles and known reviews on the topic
of VaDs to identify additional studies. Studies pub-
4-7
or other proprietary information of the Publisher. manufacturers and the authors of the included studies) Figure 1.—PRISMA flow diagram showing the selection process of ran-
lished in an abstract form or having a cross-over design
were not considered. Unpublished data (e.g. from the

were not sought. the full-text article of each rCt was
domized controlled trials for the meta-analysis.

april 2017
INterNatIoNal aNgIology
94