Troxerutin-carbazochrome combination versus placebo in the treatment of posthemorrhoidectomy symptoms: a single-center, randomized, double-blind, placebo-controlled study

Background: Flavonoids, such as troxerutin, have been shown to be safe and effective agents for the treatment of chronic venous insufficiency. The fixed combination of troxerutin 150 mg plus carbazochrome (an oxidation product of epinephrine that enhances the microcirculatory tone) 1.5 mg has been shown to have a good efficacy and tolerability profile in nonsurgical patients with acute, uncomplicated hemorrhoids. A previous pilot study we carried out in 30 posthemorrhoidectomy patients showed that this combination was also effective and well tolerated in improving posthemorrhoidectomy symptoms.Objective: This study compared the efficacy and tolerability of troxerutin-carbazochrome active combination with placebo in the treatment of posthemorrhoidectomy symptoms.Methods: In this single-center, randomized, double-blind, placebo-controlled study, patients scheduled for hemorrhoidectomy were randomized to receive 1 of 2 treatments: troxerutin 150 mg plus carbazochrome 1.5 mg active combination or placebo IM in 3-mL ampules BID for 5 consecutive days after surgery, starting on the day of surgery. Efficacy parameters were assessed at baseline (T1), after the first administration (T2; day of surgery), day 2 after surgery (T3), and day 5 after surgery (T4). Efficacy parameters assessed included hemorrhoidal symptoms based on a visual analog scale (VAS): pain, discharge, bleeding, inflammation, and pruritus; edema; analgesic intake, if any; time to restore physiologic defecation; photographs taken at T1 and T4 (in selected patients; not included here); and standard blood coagulation tests.Results: Sixty patients were enrolled (33 males, 27 females; mean age, 45.6 ± 7.4 years). Analysis between treatment groups revealed significant differences in mean total VAS scores at T3 and T4 (P = 0.01 and P = 0.001, respectively) in favor of the active-combination group. Statistically significant between-group differences in scores for bleeding and pruritus at T3 and for bleeding, pruritus, and edema at T4 in favor of the active-combination group also were found (P < 0.001 for all). No severe adverse events were reported in either group. Blood coagulation test results were unaffected in both groups.Conclusions: IM administration of troxerutin 150 mg plus carbazochrome 1.5 mg combination was effective, well tolerated, and superior to placebo in improving hemorrhoidal and postsurgical signs and symptoms in 5 days of treatment in this study population.