Reviewed: Vanscheidt W, Jost V, Wolna P, et al. Efficacy and safety of a butcher’s broom preparation (Ruscus aculeatus L. extract) compared to placebo in patients suffering from chronic venous insufficiency. Arzneimittelforschung 2002;52(4):243-50.
Chronic venous insufficiency (CVI) is a condition characterized by inadequate venous return in the lower leg and foot. This causes symptoms such as congested veins of the foot and lower leg, edema, pain, itching, eczema, hyper- or depigmentation of the skin, and the sensation of tired, heavy legs. Traditionally, CVI has been treated with compression therapy (support stockings). For patients who cannot tolerate consistent compression therapy, use of herbal medicines, such as extracts of horse chestnut (Aesculus hippocastanum L., Hippocastanaceae) seed, is a new and promising alternative. Butcher’s broom (Ruscus aculeatus L., Liliaceae) extracts were classified as herbal edema protectants by the German Commission E.
The main active ingredients in the rhizome of the butcher’s broom (BB) plant are the steroid saponins, ruscin and ruscoside. The current study evaluated BB extract to determine whether it would be effective and well tolerated for treating CVI. This multi-center, double-blind, randomized trial included 148 Caucasian women aged 30—89 years with CVI; the severity of their CVI was grade I or II, according to the Widmer classification system (these grades are equivalent to 3—4 in CEAP, another classification system). The average duration of CVI was approximately 15 years. All of the subjects had been told previously to use compression therapy, but either refused to try it, could not tolerate it, or were noncompliant with the recommended treatment.
The herbal treatment used in this study was an extract of BB rhizome (Fagorutin® Ruscus Kapseln, GlaxoSmithKline Consumer Healthcare GmbH, Herrenberg, Germany). The daily dosage of BB extract was 72—75 mg dry extract from BB rhizome; this is the recommended dosage according to the Commission E monograph. No standardization to active constituents such as ruscgenins is given in the paper.
The study began with a two-week placebo run-in period. The subjects were then randomly assigned to take either BB extract (77 women) or placebo (71 women) for a 12-week treatment period. Some subjects in both groups had major deviations from the study protocol and therefore their data were not used in the final analysis. The final numbers of subjects with usable data were 56 women in the BB extract group and 54 in the placebo group.
The efficacy of the BB extract was evaluated by measuring leg volume (indicative of edema), ankle circumference, lower leg circumference, and four subjective symptoms. These subjective symptoms were tingling, pain, sensation of tension, and sensation of heavy, tired legs. Measurements were taken and symptoms were rated after 4, 8, and 12 weeks of treatment.
The results showed that all parameters improved over time in the BB group. In contrast, baseline values were maintained in general for all parameters in the placebo group. Significant differences between BB and placebo groups were found for volume changes of the lower leg after 8 and 12 weeks of treatment, ankle circumference after 4, 8, and 12 weeks, and lower leg circumference after 8 and 12 weeks (P < 0.001). Two symptoms, heavy, tired legs and sensation of tension, were significantly reduced in the BB group compared with the placebo group after 12 weeks (P < 0.001).
The global efficacy of treatment was rated by the investigator as very good, good, moderate, or bad; the difference between groups was significant (P = 0.0498). Ratings of quality of life were not significantly changed in either group from baseline to 12 weeks. However, the authors conclude that "improvement of life quality may well be presumed for these patients" (i.e., BB group) because of the significant differences between the groups for several symptoms (heavy, tired legs and sensation of tension). The authors also note that improvements in quality of life may be less noticeable in patients with milder CVI (such as the study patients) than in patients with severe CVI.
Adverse events were reported by 17 BB-group patients (22 events) and 20 placebo-group patients (26 events). Only one event (calf cramps) in the BB group was assessed as possibly related to the treatment, and even for this event, a link to the treatment was considered unlikely. Patients in the BB group rated the tolerability of the treatment as either very good (76.8%) or good (23.2%); ratings in the placebo group were similar.
The mechanism of action of BB extract appears to be a toning effect on the veins. This toning effect apparently results from postsynaptic activation of the alpha1- and alpha2-receptors of the smooth muscle and also from increased presynaptic noradrenaline release. Previous studies reported that BB extract had a much stronger effect on vein tone than did horse chestnuts or witch hazel (Hamamelis virginiana L., Hamamelidaceae).
The authors conclude that BB extract was well tolerated and effective for CVI of Widmer grades I and II. "All considered, the therapeutic effect of ruscus extract, i.e. Rusci aculeati rhizoma et radices [BB exract], as was well-established for centuries in the pharmacopoeia of the Mediterranean countries, is now clinically established by its scientifically proven pharmacodynamic properties and clinical actions," the authors write.
–Christina Chase, MS, RD