title: Prospective, randomized, controlled, observer-blinded trial of combined infrared photocoagulation and micronized purified flavonoid fraction versus each alone for the treatment of hemorrhoidal disease.
abstract: BACKGROUND
  Infrared photocoagulation (IRP) is commonly used in the treatment of hemorrhoids, but rectal bleeding can persist after this procedure. Adjuvant therapy may thus be considered for more definitive control of symptoms, particularly bleeding.
  
  
  OBJECTIVE
  The goal of this study was to compare the efficacy of a treatment combining IRP and oral micronized purified flavonoid fraction (MPFF) versus each treatment used alone on bleeding cessation in patients with grades I, II, and III acute internal hemorrhoids.
  
  
  METHODS
  This was a prospective, randomized, controlled, single-blind study. Consecutive outpatients were randomly assigned to a treatment combining MPFF and IRP or to each treatment separately. For each patient, bleeding status was reported at day 0 (day of inclusion) and compared with that at day 5 after treatment by observers blinded to treatment assignment. Follow-up visits were planned at days 7, 30, 60, and 90 of therapy, including monitoring of treatment-related side effects and self-reporting by patients of any problem related to hemorrhoidal disease.
  
  
  RESULTS
  A total of 351 patients (180 women, 171 men) were enrolled in the study. Their mean age was 49.2 years (range, 29-71 years). Hemorrhoids were grade I in 33.6% (118 patients), grade II in 48.7% (171 patients), and grade III in 17.7% (62 patients) of the study population. Patients were randomly assigned to each of the 3 treatment groups (117 patients in each), with no significant difference between groups in the age, sex, or distribution of grade of hemorrhoids. The percentage of patients with no bleeding after 5 days of treatment was higher in the combined treatment group (74.8%) compared with MPFF alone (59.6%; P = 0.023) or with IRP alone (55.6%; P = 0.004). MPFF alone was as effective as IRP alone at stopping bleeding. Patients with grades I and II hemorrhoids responded significantly better (82.5% and 61.7%, respectively) to either treatment than those with grade III hemorrhoids (22.9%; P < 0.001). Of the 216 patients who were followed up for 90 days, 3 had a gastrointestinal adverse event, and 19 had a relapse of bleeding.
  
  
  CONCLUSIONS
  Five days of treatment combining MPFF with IRP significantly reduced bleeding status in these study patients with grades I and II acute internal hemorrhoids compared with each treatment used alone.
authors.affiliation: Gastroenterology Unit, Saint Savvas Hospital, Athens, Greece. dimdim@otenet.gr
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Dimitroulopoulos
authors.forename: Klisthenis
authors.initials: K
authors.lastname: Tsamakidis
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Xinopoulos
authors.forename: Ioannis
authors.initials: I
authors.lastname: Karaitianos
authors.forename: Aikaterini
authors.initials: A
authors.lastname: Fotopoulou
authors.forename: Emmanouil
authors.initials: E
authors.lastname: Paraskevas
mesh_terms: D000284:Administration, Oral; D000287:Administration, Topical; D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D005260:Female; D005419:Flavonoids / Q000008:administration & dosage / Q000627:therapeutic use*; D006471:Gastrointestinal Hemorrhage / Q000150:complications / Q000517:prevention & control / Q000628:therapy; D006484:Hemorrhoids / Q000150:complications / Q000628:therapy*; D006801:Humans; D007259:Infrared Rays / Q000627:therapeutic use*; D008028:Light Coagulation / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016037:Single-Blind Method; D013607:Tablets; D016896:Treatment Outcome
chemical_list: D005419:Flavonoids; D013607:Tablets