title: Parenteral troxerutin and carbazochrome combination in the treatment of post-hemorrhoidectomy status: a randomized, double-blind, placebo-controlled, phase IV study.
abstract: Flavonoids, such as troxerutin, have been shown to be safe and effective agents for the treatment of chronic venous insufficiency. The fixed combination between troxerutin 150 mg and carbazochrome 1.5 mg (Fleboside ampoules) was previously shown to have a good efficacy and safety profile in non-surgical patients with acute uncomplicated hemorrhoids. The purpose of this randomized, double-blind, placebo-controlled study was to investigate the efficacy and tolerability of the active combination in the treatment of post-hemorrhoidectomy patients. 30 patients were randomized to receive one of two treatments: troxerutin 150 mg and carbazochrome 1.5 mg, or placebo, i.m. 3 ml ampoules twice a day for five consecutive days after the surgical procedure, starting from the day of surgery. Efficacy parameters were assessed as follows: at baseline (T1), after the first administration (T2; day of surgery), the second day after the surgical procedure (T3), and the fifth day after the surgical procedure (T4); hemorrhoidal symptoms based on a visual analogue scale (VAS): pain, discharge, bleeding, inflammation, and pruritus; analgesic intake, if any; time to restore a physiological defecation; edema evaluation (based on a four-point scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe); camera pictures taken at T1 and T4 (in selected patients); and blood coagulation tests. Analysis between treatment groups revealed a highly significant difference at T3 and T4 for the total VAS score (p = 0.007 and p = 0.001, respectively) in favor of the active combination treatment. A statistically significant difference was also observed for bleeding and pruritus at T3 and for these two parameters and both inflammation and edema at T4 (p < 0.001) in favor of the active combination group. No adverse events were reported. Neither the active combination nor placebo affected blood coagulation tests. We conclude that intramuscular administration of the fixed combination of troxerutin 150 mg and carbazochrome 1.5 mg is effective, well tolerated and superior to placebo in improving hemorrhoidal and post-surgical symptoms during the five days following surgery.
authors.affiliation: Surgery Unit, University of Chieti-Pescara, Pescara Regional Hospital, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Basile
authors.forename: S
authors.initials: S
authors.lastname: Gidaro
authors.forename: M
authors.initials: M
authors.lastname: Pacella
authors.forename: P M
authors.initials: PM
authors.lastname: Biffignandi
authors.forename: G S
authors.initials: GS
authors.lastname: Gidaro
mesh_terms: D000323:Adrenochrome / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use*; D000328:Adult; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006484:Hemorrhoids / Q000601:surgery*; D006801:Humans; D006896:Hydroxyethylrutoside / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000188:drug therapy*; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D004338:Drug Combinations; D006896:Hydroxyethylrutoside; D014662:Vasoconstrictor Agents; D000323:Adrenochrome; C005865:troxerutin; C073338:carbazochrome