Calcium dobesilate versus purified flavonoid fraction of diosmin in the treatment of hemorrhoidal crises: a randomized, controlled study with an initial double-blind, double-dummy period

Abstract Background: Calcium dobesilateand purified, micronizedflavonoid fraction of diosmin, 2 products used in the treatment of chronic venous insufficiencyin the lower limbs, have been shown in open-label, placebo-controlled studiesto improve symptoms of acute hemorrhoidalepisodes. Objective: This study was performed to compare the efficacy and tolerability of calcium dobesilateand purified, micronizedflavonoid fraction of diosminin the treatment of hemorrhoidalcrisis. Methods: Patients with a diagnosis of hemorrhoidalcrisis were randomized to receive 1 of 2 treatments: calcium dobesilateone 500-mg capsule TID for ≥4 weeks or purified, micronizedflavonoid fraction of diosmintwo 500-mg capsules TID for ≥4 weeks. For the first 10 days, patients in both groups were given dummy capsules or tablets to maintain the double-blind provision. Patients underwent physical examination at baseline and after 2 days, 8 days, and 4 weeks of treatment. The following symptoms were assessed using a 4-point scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe): pain, discharge, bleeding, edema, inflammation, pruritus, and anal pressure. Results: A total of 51 patients were treated; 25 received calcium dobesilateand 26 received micronizedflavonoid fraction of diosmin. In both treatment groups, significant improvement was observed in 6 of 7 evaluated symptoms after 2 days of treatment ( P Conclusion: Calcium dobesilate1.5 g/d and purified, micronizedflavonoid fraction of diosmin3 g/d were equally effective and well tolerated in the treatment of signs and symptoms associated with hemorrhoidalcrisis.