E Rabe1, K A Jaeger, M Bulitta, F Pannier. 1. Department of Dermatology, University of Bonn, Sigmund-Freud-Str. 25, D-53105 Bonn, Germany. Eberhard.Rabe@ukb.uni-bonn.de
Abstract
OBJECTIVE: To test the efficacy of calcium dobesilate (CaD) in chronic venous insufficiency (CVI). METHOD: Double-blind, parallel groups, placebo-controlled, multicentre trial in adult patients with symptomatic CVI and pitting oedema. Wearing of compression stockings Class II was admitted. During treatment period of eight weeks, the patients received CaD 3 × 500 mg/day or placebo. The leg volume calculation was based on a truncated cone model. RESULTS: A total of 256 patients was randomized to treatment (dobesilate: n = 132, placebo: n = 124); the demographic and anamnestic data at admission were comparable in the two therapeutic groups. The volume of the lower calf diminished in the dobesilate group at the end of the active treatment period by -64.72 ± 111.93 cm³ (mean ± SD), independent of the concomitant usage of compression stockings versus placebo +0.8 ± 152.98 cm³ (P = 0.0002). The symptoms of pain, discomfort, heavy legs, tired legs, tingling, itching and cramps, as well as the global assessments by investigators and patients, also improved significantly (P < 0.05) better in the dobesilate group at the end of the treatment. The observed adverse events correspond to the known profile. CONCLUSION: Dobesilate reduces leg oedema and improves the symptoms of objectively diagnosed CVI, independent of the concomitant usage of compression stockings.
RCT Entities:
OBJECTIVE: To test the efficacy of calcium dobesilate (CaD) in chronic venous insufficiency (CVI). METHOD: Double-blind, parallel groups, placebo-controlled, multicentre trial in adult patients with symptomatic CVI and pitting oedema. Wearing of compression stockings Class II was admitted. During treatment period of eight weeks, the patients received CaD 3 × 500 mg/day or placebo. The leg volume calculation was based on a truncated cone model. RESULTS: A total of 256 patients was randomized to treatment (dobesilate: n = 132, placebo: n = 124); the demographic and anamnestic data at admission were comparable in the two therapeutic groups. The volume of the lower calf diminished in the dobesilate group at the end of the active treatment period by -64.72 ± 111.93 cm³ (mean ± SD), independent of the concomitant usage of compression stockings versus placebo +0.8 ± 152.98 cm³ (P = 0.0002). The symptoms of pain, discomfort, heavy legs, tired legs, tingling, itching and cramps, as well as the global assessments by investigators and patients, also improved significantly (P < 0.05) better in the dobesilate group at the end of the treatment. The observed adverse events correspond to the known profile. CONCLUSION:Dobesilate reduces leg oedema and improves the symptoms of objectively diagnosed CVI, independent of the concomitant usage of compression stockings.
Authors: Maria José Martinez-Zapata; Robin W M Vernooij; Sonia Maria Uriona Tuma; Airton T Stein; Rosa M Moreno; Emilio Vargas; Dolors Capellà; Xavier Bonfill Cosp Journal: Cochrane Database Syst Rev Date: 2016-04-06
Authors: Sinan Demirtas; Ahmet Caliskan; Orkut Guclu; Suleyman Yazici; Oguz Karahan; Celal Yavuz; Binali Mavitas Journal: Med Sci Monit Basic Res Date: 2013-09-27
Authors: Maria José Martinez-Zapata; Robin Wm Vernooij; Daniel Simancas-Racines; Sonia Maria Uriona Tuma; Airton T Stein; Rosa Maria M Moreno Carriles; Emilio Vargas; Xavier Bonfill Cosp Journal: Cochrane Database Syst Rev Date: 2020-11-03