Kakkos SK, Allaert FA, et al.
International angiology : a journal of the International Union of Angiology. Date of publication 2017 Apr 1;volume 36(2):93-106.
1. Int Angiol. 2017 Apr;36(2):93-106. doi: 10.23736/S0392-9590.17.03815-9.
Efficacy of Ruscus extract, HMC and vitamin C, constituents of Cyclo 3 fort®, on
improving individual venous symptoms and edema: a systematic review and
meta-analysis of randomized double-blind placebo-controlled trials.
Kakkos SK(1), Allaert FA(2)(3).
Author information:
(1)Department of Vascular Surgery, University Hospital of Patras, Patras, Greece
- kakkos@upatras.gr.
(2)Medical Evaluation, University Hospital of Dijon, Dijon, France.
(3)Cen Biotech, Dijon, France.
INTRODUCTION: Venoactive drugs (VADs) are considered an important component of
the medical (conservative) treatment of chronic venous disorders (CVDs).
However, the efficacy of certain VADs on one or more individual leg symptoms may
have not been extensively studied to justify a high level or grade of
recommendation in guidelines on CVD. The aim of the present systematic review
and meta-analysis was to study the effectiveness of VADs containing Ruscus
across the spectrum of defined venous symptoms.
EVIDENCE ACQUISITION: On November 14 2016, a literature search of the databases
MEDLINE and Scopus was performed, supplemented by hand searching, to identify
randomized double-blind placebo-controlled trials on Ruscus extracts in patients
with CVD.
EVIDENCE SYNTHESIS: The main outcome measures were the effects of Ruscus on
individual symptoms and leg edema, which were 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. We identified 10 trials,
mostly with low risk of bias, on 719 patients. On qualitative analysis, Ruscus
significantly improved seven defined leg symptoms, including pain, heaviness,
fatigue, feeling of swelling, cramps, itching and paresthesia compared to
placebo. On quantitative analysis, Ruscus compared with placebo, assessed as a
categorical variable, reduced leg pain (RR=0.35, P=0.01, number needed to treat
[NNT] 5, with no heterogeneity), heaviness (RR=0.26, P<0.00001, NNT=2.4, with a
small amount of heterogeneity), feeling of swelling (RR=0.53, P<0.0001, NNT=4,
with considerable heterogeneity, minimized after sensitivity analysis),
paresthesia (RR=0.27, P<0.0001, NNT=1.8), global symptoms (RR=0.54, P<0.00001,
NNT=4.3) and the total number of venous symptoms (RR 0.41, P=0.002). Similarly,
Ruscus compared to placebo, assessed as a continuous variable reduced pain
(SMD=-0.80, 95% CI: -1.21 to -0.39), heaviness (SMD=-1.23, 95% CI: -1.60 to
-0.86), fatigue (SMD -1.16, 95% CI: -1.71 to -0.61), feeling of swelling
(SMD=-2.27, 95% CI: -3.83 to -0.70), and paresthesia (SMD=-0.86, 95% CI: -1.51
to -0.21). Regarding objective assessments of leg edema, the use of Ruscus
compared with placebo reduced ankle circumference (SMD=-0.74, 95% CI: -1.01 to
-0.47) and leg or foot volume (SMD=-0.61, 95% CI: -0.91 to -0.31). The existing
evidence, where sufficient, was mostly of high quality.
CONCLUSIONS: Based on high quality evidence, Ruscus extracts are highly
effective in reducing symptoms and edema of patients with CVD.
DOI: 10.23736/S0392-9590.17.03815-9
PMID: 28225220 [Indexed for MEDLINE]