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 dobesilate and purified, micronized flavonoid fraction of diosmin, 2 products used in the treatment of chronic venous insufficiency in the lower limbs, have been shown in open-label, placebo-controlled studies to improve symptoms of acute hemorrhoidal episodes. Objective: This study was performed to compare the efficacy and tolerability of calcium dobesilate and purified, micronized flavonoid fraction of diosmin in the treatment of hemorrhoidal crisis. Methods: Patients with a diagnosis of hemorrhoidal crisis were randomized to receive 1 of 2 treatments: calcium dobesilate one 500-mg capsule TID for ≥4 weeks or purified, micronized flavonoid fraction of diosmin two 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 dobesilate and 26 received micronized flavonoid 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 dobesilate 1.5 g/d and purified, micronized flavonoid fraction of diosmin 3 g/d were equally effective and well tolerated in the treatment of signs and symptoms associated with hemorrhoidal crisis.