Effectiveness and safety of calcium dobesilate in treating chronic venous insufficiency: randomized,double-blind,placebo-controlled trial

Abstract

Objective: To determine whether calcium dobesilate is effective in reducing chronic venous insufficiency-related peripheral oedema.

Methods: Randomized, double-blind, placebo-controlled, multicentre, parallel-group study in 253 consecutive outpatients with chronic venous insufficiency (CEAP C3-C4). The patients were treated for four weeks with either calcium dobesilate (CaD) 500 mg three times a day or matching placebo. The primary outcome measure was the reduction in lower leg volume. The leg volume calculation was based on a truncated cone model

Results: Active drug treatment resulted in a median reduction of the leg volume of 25.5 ± 33.6 ml/l tissue. The difference in the median change of the leg volume between the treatment groups at week 4 was -12.2 ml/l tissue (95 % CI -21.6 to -2.8; P =0.01). In contrast with the placebo, the effects of CaD were independent of the duration of CVI and most pronounced in more severely diseased patients. Safety variables did not differ significantly between groups.

Conclusions: Calcium dobesilate is an effective and well tolerated treatment for chronic venous insufficiency.