Calcium Dobesilate for Chronic Venous Insufficiency: A Systematic Review

Abstract

Chronic venous insufficiency (CVI) causes much discomfort and sick leave. Many randomized clinical trials (RCTs) have shown a beneficial effect of calcium dobesilate, but consensus is lacking about efficacy and safety. The authors report a meta-analysis of the effectiveness and safety of calcium dobesilate in CVI. Ten RCTs (778 patients) in which calcium dobesilate for CVI was compared with placebo met the inclusion criteria. Only 3 trials (608 patients) were of good methodological quality. Calcium dobesilate significantly improved night cramps and discomfort nearly twice as well as placebo, with the number needed to treat (NNT) being 8 (95% CI 4-50) and 4 (95% CI 3-7), respectively. Frequency of adverse events was not significantly different from placebo. Subgroup analysis found a differential response with respect to disease severity, with greater improvements in pain, heaviness, and malleolar swelling being seen in the severe group than in the mild group. Calcium dobesilate improved paresthesias significantly more than placebo in the severe but not in the mild group and the effect on leg volume was also significantly better in the severe group (-7.2% vs -1.6%). No difference in effect was found for different doses of calcium dobesilate (1,000 or 1,500 mg/day). Sensitivity analyses did not affect the results. Current evidence suggests that calcium dobesilate is more effective than placebo in improving some CVI symptoms, that there is higher efficacy in more severe disease, and that a dose of 1,000 mg/day is as effective and safe as 1,500 mg/day. Further adequately powered trials are needed to further evaluate these hypotheses.

A Randomized, Double-Blind Multicentre Clinical Trial Comparing the Efficacy of Calcium Dobesilate with Placebo in the Treatment of Chronic Venous Disease

“…It acts on the endothelium of capillaries by blocking the hyperpermeability, inhibiting platelet aggregation 6 and increasing red cell flexibility; these mechanisms contribute to an oedema-protective effect. 7 Three metaanalyses 5,8,9 have suggested that calcium dobesilate has more efficacy than placebo relieving oedema and some CVD symptoms. Heterogeneity has been detected among the trials due to the differing criteria in patient selection, stage of the disease, dosage of calcium dobesilate used, and selection of primary and secondary outcomes.…”

Pharmacological Agents in the Treatment of Venous Disease: An Update of the Available Evidence

“…Moreover, there is evidence that venous ulcer healing with compression bandaging may be augmented with Daflon [45]. Significant improvements in symptoms attributable to chronic venous disease have also been reported in patients treated with calcium dobesilate, oxerutins and rutosides [28,40].…”

“…A meta analysis published in 2004 and other randomized studies demonstrated significant improvements in oedema, symptoms and lymphatic drainage in patients treated with calcium dobesilate compared with placebo [40][41][42]. However, the largest randomized study of calcium dobesilate was recently published [43] and 509 patients were randomized to either calcium dobesilate or placebo.…”

Venous leg ulcer: Systemic therapy

“…A meta-analysis identified three RCTs, which demonstrated improvement in pain and other symptoms, more so with severe than mild disease[32] (evidence Level B). However, a meta-analysis in 2008 involving 509 patients failed to show any edema, symptoms, and quality-of-life in patients consuming calcium dobesilate in comparison with placebo[33] (evidence Level A).…”