RT info:eu-repo/semantics/article
T1 Randomized Double-Blind Multicentre Clinical Trial Comparing the Efficacy of Calcium dobesilate with placebo in the treatment of Chronic Venous Disease
A1 Martínez Zapata, María José
A1 Moreno, Rosa M.
A1 Gich Saladich, Ignasi
A1 Urrutia, Gerard
A1 Bonfill Cosp, Xavier
A1 Vaquero Puerta, Carlos
K1 Insuficiencia crónica venosa
K1 Calcio
AB 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 dobesilatetwice a day for 3 months or placebo. The primary outcome measure was ‘QoL after 3 months’ treatment measured by thespecific Chronic Insufficiency Venous International Questionnaire (CIVIQ). Secondary outcomes were QoL at 12 monthsand 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 andsymptoms of CVD, there were no significant differences between groups. In a multi-factorial analysis, the ‘QoL at 12months’ 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. Thesustained 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.
PB Elsevier
SN 1078-5884
YR 2008
FD 2008
LK http://uvadoc.uva.es/handle/10324/3292
UL http://uvadoc.uva.es/handle/10324/3292
LA eng
NO European Journal Vascular Endovascular Surgery, March 2008, n. 35. p.358-365
NO Producción Científica
DS UVaDOC
RD 27-dic-2024