Efficacy and tolerability of a red-vine-leaf extract in patients suffering from chronic venous insufficiency--results of a double-blind placebo-controlled study.

OBJECTIVES: The aim of this study was to investigate the effect of a red-vine-leaf extract (AS195, Antistax(®), Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany) on the volume of the leg and clinical symptoms in patients with chronic venous insufficiency (CVI). DESIGN, MATERIALS AND METHODS: A multicentre, randomised, double-blind and placebo-controlled study was carried out with 720 mg AS195 per day over 12 weeks in CVI patients (CEAP Grades 3-4a) and moderate-to-severe clinical symptoms. Efficacy endpoints were changes in limb volume determined by water displacement volumetry, clinical CVI symptoms assessed on a 10-cm visual analogue scale and global efficacy evaluations. RESULTS: The full-analysis set included 248 patients (placebo: n = 122; AS195: n = 126). After 12 weeks, AS195 significantly reduced lower limb volume by a mean of 19.9 standard error (SE) 8.9 ml over placebo (95% confidence interval (CI): -37.5, -2.3; p = 0.0268; analysis of covariance, ANCOVA). The standardised effect size of 0.28 for volume reduction indicates a clinically relevant effect. On Day 84, the symptom of 'pain in the legs' assessed by visual analogue scale decreased in the AS195 group compared with the placebo group: mean difference -6.6 SD 3.3 mm (95% CI: -13.1,-0.1; p = 0.047). Other symptoms showed no significant change. The tolerability of AS195 was similar to that of placebo. CONCLUSIONS: AS195 treatment for 84 days resulted in an approximately 20 ml reduction of limb volume in the active treatment group compared with the placebo group. Patients reported subjective improvement following treatment with AS195 compared with placebo. However, patients' overall rating of efficacy did not correlate well with measured reductions in limb volume. TRIAL REGISTRATION: ClinicalTrials.gov NCT00855179.

Antiinflammatory properties of ambroxol.

Ambroxol is frequently used as mucolytic agent in respiratory diseases associated with increased mucus production like acute or chronic bronchitis. Further, ambroxol is used topically (lozenges) for the treatment of sore throat and pharyngitis associated with common cold. In addition to the effects of ambroxol on mucus regulation and local anaesthetic effects, a wide range of pharmacological antiinflammatory properties of ambroxol have been described in vitro and in vivo, including inhibition or scavenging of oxidative and nitro?sative stress, increase of local defense molecules involved in respiratory virus replication, reduction of proinflammatory cytokines and arachidonic acid meta?bolites, inflammatory cell chemotaxis, and lipid peroxidation of tissues. The present review summarizes the antiinflammatory effects of ambroxol and relates these properties to results from controlled clinical trials in targeted diseases such as chronic bronchitis, chronic obstructive pulmonary disease and sore throat.

Antiviral activity of an extract derived from roots of Eleutherococcus senticosus.

A liquid extract from Eleutherococcus senticosus roots inhibited the productive replication of human rhinovirus (HRV), respiratory syncytial virus (RSV) and influenza A virus in cell cultures infected with these viruses, all of which belong to the RNA type viruses. Analysis of virus production after treatment of the infected cells using plaque-reduction assays showed a strong antiviral activity of the Eleutherococcus extract. In contrast, no effect was detected using the same protocol for cells infected with the DNA viruses, adenovirus (Adeno 5) or herpes simplex type 1 virus (HSV 1). Pre-treatment of cells did not inhibit either virus adsorption or virus replication. The results of the study demonstrate that the Eleutherococcus extract inhibited the replication of all RNA viruses studied so far. This antiviral activity remained stable under the conditions used for drug preparation and storage.

Immunopharmacological in vitro effects of Eleutherococcus senticosus extracts.

The objective of these investigations was to further elucidate the immunopharmacological profile of fluid extracts of Eleutherococcus senticosus and to identify the specific role of its characteristic eleutherosides B and E. An ethanolic dry extract of Eleutherococcus senticosus was used as starting material for the isolation of the eleutherosides B and E. Immunopharmacological studies included expression of major histocompatibility complex class I and II molecules by rat bone marrow-derived mononuclear phagocytes, human lymphocyte marker flow cytometry, and in vitro testing of human lymphocyte functions. In contrast to the isolated eleutherosides B and eleutherosides E and the re-mixed eleutherosides B and E, the whole ethanolic fluid extract of Eleutherococcus senticosus was able to induce and enhance interleukin-1 and interleukin-6 but not interleukin-2 production in vitro. The effective concentration of the whole ethanolic extract ranged from 1.0-0.1 mg/ml for the enhancement of interleuking-1 alpha production and 1.0-0.03 mg/ml for the enhancement of interleukin-6 production. It is concluded that the observed enhancing immunopharmacological activities on acute phase response mediators are best exhibited by the induction with whole ethanolic extracts whereas the species-specific and characteristic eleutherosides B and E are not associated with these activities.