Randomized Double-Blind Multicentre Clinical Trial Comparing the Efficacy of Calcium dobesilate with placebo in the treatment of Chronic Venous Disease

Abstract

Objective. To assess the efficacy of calcium dobesilate on the quality-of-life (QoL) of patients with chronic venous disease (CVD). Design. Randomised, parallel, double blind, placebo-controlled clinical trial. Methods. Patients were recruited from vascular surgery clinics and randomised to 500 mg capsules of calcium dobesilate twice a day for 3 months or placebo. The primary outcome measure was ‘QoL after 3 months’ treatment measured by the specific Chronic Insufficiency Venous International Questionnaire (CIVIQ). Secondary outcomes were QoL at 12 months and assessment of the CVD signs and symptoms. The principal analysis was undertaken on the intention-to-treat (ITT) data. Results. Five hundred and nine patients were recruited (246 to calcium dobesilate and 263 to placebo). The analysis of the ‘QoL after 3 months’ showed no significant differences between groups ( p ¼ 0.07). For secondary outcomes, oedema and symptoms of CVD, there were no significant differences between groups. In a multi-factorial analysis, the ‘QoL at 12 months’ was better in the calcium dobesilate group than in placebo group ( p ¼ 0.02). Conclusions. Treatment with calcium dobesilate was not found to be superior to placebo on the QoL of CVD patients. The sustained effect of calcium dobesilate observed after treatment should be confirmed in future studies. 2007 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.