Efficacy and Safety of a Butcher’s Broom Preparation (Ruscus aculeatus L. Extract) Compared to Placebo in Patients Suffering from Chronic Venous Insufficiency

Abstract

Extracts from Butcher's broom rhizome (Ruscus aculeatus) have been widely used in the oral treatment of lower leg edema in patients with chronic venous insufficiency. The aim of the present multi-center, double-blind, randomized, placebo-controlled trial was to confirm the efficacy and safety of a ruscus extract (Fagorutin Ruscus Kapseln) according to the latest scientific standards. 166 women suffering from chronic venous insufficiency (Widmer grade I and II, CEAP (Clinical signs, Etiological classification, Anatomic distribution, Pathophysiology) 3-4) were included. The data of 148 patients (30-89 years, 150-182 cm height, 49-97 kg body weight) with a mean disease duration of 14.6 years in the ruscus extract group and 15.1 years in the placebo group were eligible for the intent-to-treat-analysis. The primary parameter was the area under baseline of the leg volume changes over 12 weeks (AUB0-12). Secondary parameters were the changes in circumference of the lower leg and the ankle, changes in subjective symptoms and quality of life, the overall efficacy and tolerability and safety parameters. The study was carried out according to the guidelines for testing drugs for chronic venous insufficiency. There were significant differences between the treatment groups ruscus and placebo for the AUB0-12 (-827 ml x day), for the change of leg volume after 8 and 12 weeks of treatment (-16.5 ml and -20.5 ml), for changes in ankle and leg circumferences after 8 and 12 weeks of treatment, and for the changes in subjective symptoms, heavy tired legs and sensation of tension (week 12). For the changes in the symptoms heavy lower legs, sensation of tension, and tingling sensation a significant positive correlation with the changes in leg volume was shown. Overall assessment of efficacy was significantly better for ruscus extract compared to placebo. Overall tolerability for both treatments was assessed as good and very good. Of all 48 adverse events occurring in both treatment groups, 22 were reported in the ruscus group, one of them was considered to be related to the study medication (unlikely). Considering the study duration of three months it is concluded, that ruscus extract, in the recommended daily dosage according to the German monograph, is a safe and effective treatment for patients suffering from chronic venous insufficiency.

The clinical efficacy of Ruscus Aesculatus extract: is there enough evidence to update the pharmacotherapy guidelines for chronic venous disease?

“…Concerning the clinical efficacy of Ruscus extract, several studies have examined Ruscus aculeatus extract as an active compound of a therapeutic regimen, but few studies focus on Ruscus extract as a unique pharmacological treatment. In a randomized, placebo controlled study performed on a group of 148 patients with chronic venous disease (using solid Ruscus extract only) Vanscheidt (2002) evaluated the results of Ruscus aculeatus extract administration (in capsules containing 4.5 mg of pure roscogenin administered twice daily) over 12 weeks. The primary endpoint of the study was decreased foot and ankle volume.…”

Phytotherapie bei chronisch-venöser Insuffizienz: Wirksamkeit von rotem Weinlaub und von Rosskastanie klinisch belegt

“…Trotzdem gibt es eine klinische Studie mit positivem Resultat für den Mäusedorn-Extrakt [4]. Diese rando- …”

Do modern-day medical herbalists have anything to learn from Anglo-Saxon medical writings?

“…It is recommended for chronic venous disease (Vanscheidt et al, 2002;Frishman and Micozzi, 2005), varicose veins and haemorrhoids (Mills and Bone, 2000), as a diuretic, laxative, haemostatic and anti-inflammatory, with usage in jaundice, obstructed menstruation, oedema and to arrest haemorrhage (Bartram, 1995).…”