Tags

Type your tag names separated by a space and hit enter

Efficacy and tolerability of a red-vine-leaf extract in patients suffering from chronic venous insufficiency--results of a double-blind placebo-controlled study.
Eur J Vasc Endovasc Surg. 2011 Apr; 41(4):540-7.EJ

Abstract

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.

Authors+Show Affiliations

Department of Dermatology, University of Bonn, Sigmund-Freud-Strasse 25, 53229 Bonn, Germany. Eberhard.Rabe@ukb.uni-bonn.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21239190

Citation

Rabe, E, et al. "Efficacy and Tolerability of a Red-vine-leaf Extract in Patients Suffering From Chronic Venous Insufficiency--results of a Double-blind Placebo-controlled Study." European Journal of Vascular and Endovascular Surgery : the Official Journal of the European Society for Vascular Surgery, vol. 41, no. 4, 2011, pp. 540-7.
Rabe E, Stücker M, Esperester A, et al. Efficacy and tolerability of a red-vine-leaf extract in patients suffering from chronic venous insufficiency--results of a double-blind placebo-controlled study. Eur J Vasc Endovasc Surg. 2011;41(4):540-7.
Rabe, E., Stücker, M., Esperester, A., Schäfer, E., & Ottillinger, B. (2011). Efficacy and tolerability of a red-vine-leaf extract in patients suffering from chronic venous insufficiency--results of a double-blind placebo-controlled study. European Journal of Vascular and Endovascular Surgery : the Official Journal of the European Society for Vascular Surgery, 41(4), 540-7. https://doi.org/10.1016/j.ejvs.2010.12.003
Rabe E, et al. Efficacy and Tolerability of a Red-vine-leaf Extract in Patients Suffering From Chronic Venous Insufficiency--results of a Double-blind Placebo-controlled Study. Eur J Vasc Endovasc Surg. 2011;41(4):540-7. PubMed PMID: 21239190.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of a red-vine-leaf extract in patients suffering from chronic venous insufficiency--results of a double-blind placebo-controlled study. AU - Rabe,E, AU - Stücker,M, AU - Esperester,A, AU - Schäfer,E, AU - Ottillinger,B, Y1 - 2011/01/15/ PY - 2010/08/15/received PY - 2010/12/04/accepted PY - 2011/1/18/entrez PY - 2011/1/18/pubmed PY - 2011/6/3/medline SP - 540 EP - 7 JF - European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery JO - Eur J Vasc Endovasc Surg VL - 41 IS - 4 N2 - 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. SN - 1532-2165 UR - https://www.unboundmedicine.com/medline/citation/21239190/Efficacy_and_tolerability_of_a_red_vine_leaf_extract_in_patients_suffering_from_chronic_venous_insufficiency__results_of_a_double_blind_placebo_controlled_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1078-5884(10)00755-0 DB - PRIME DP - Unbound Medicine ER -