title: Clinical acceptability study of micronized purified flavonoid fraction 1000 mg tablets versus 500 mg tablets in patients suffering acute hemorrhoidal disease.
abstract: To compare the clinical acceptability of micronized purified flavonoid fraction (MPFF) 1000 mg with MPFF 500 mg tablets, administered at the same daily dose in patients suffering non-complicated acute hemorrhoids.
  
  
  
  MPFF is an established treatment for hemorrhoidal disease.
  
  
  
  This was a double-blind, multi-center, randomized study. Patients took either MPFF 1000 mg or 500 mg tablets for 7 days (daily dose; 3 g over 4 days followed by 2 g over 3 days). Adverse events were recorded in a patient diary. On day 7, anal pain and bleeding were assessed (visual analog scale [VAS] and Dimitroulopoulos scale, respectively).
  
  
  
  Patients (162) were randomized to MPFF 1000 mg (79) and MPFF 500 mg (83). No serious adverse events (AEs) occurred; 10 emergent AEs were considered treatment-related (6 for MPFF 1000 mg and 4 for 500 mg). Both regimens were associated with significant reduction in anal pain (VAS); -2.37 cm MPFF 1000 mg (P < 0.001) and -2.17 cm 500 mg (P < 0.001), with a slight trend in favor of MPFF 1000 mg (mean global reduction -2.27 cm, P < 0.001). Bleeding improved significantly in both groups of patients, 56% of patients on MPFF 1000 mg versus 61% on MPFF 500 mg. Bleeding ceased after treatment in 47% patients on MPFF 1000 mg versus 54% on 500 mg.
  
  
  
  After 7 days of treatment with MPFF at the same daily dose, both regimens reduced anal pain and bleeding. MPFF 1000 mg had a comparable safety profile to MPFF 500 mg, with the advantage of fewer tablets. Key limitations: Safety study.
authors.affiliation: a State Scientific Center of Coloproctology, Ministry of Health of Russian Federation , Moscow , Russia.
authors.forename: Yuri
authors.initials: Y
authors.lastname: Shelygin
authors.affiliation: b Institute for Digestive Diseases, Clinical Center of Serbia , Belgrade , Serbia.
authors.forename: Zoran
authors.initials: Z
authors.lastname: Krivokapic
authors.affiliation: a State Scientific Center of Coloproctology, Ministry of Health of Russian Federation , Moscow , Russia.
authors.forename: S A
authors.initials: SA
authors.lastname: Frolov
authors.affiliation: a State Scientific Center of Coloproctology, Ministry of Health of Russian Federation , Moscow , Russia.
authors.forename: I V
authors.initials: IV
authors.lastname: Kostarev
authors.affiliation: c Burdenko General Military Clinical Hospital, Consultative Diagnostic Centre , Moscow , Russia.
authors.forename: V L
authors.initials: VL
authors.lastname: Astashov
authors.affiliation: d City Clinical Hospital No. 9, Saint-Petersburg Scientific Practical Centre of Coloproctology , Saint-Petersburg , Russia.
authors.forename: S V
authors.initials: SV
authors.lastname: Vasiliev
authors.affiliation: e Lipetsk Regional Clinical Hospital , Department of Coloproctology 6A , Lipetsk , Russia.
authors.forename: A V
authors.initials: AV
authors.lastname: Lakhin
authors.affiliation: f City Clinical Hospital No. 24, Moscow City Centre of Coloproctology , Moscow , Russia.
authors.forename: G V
authors.initials: GV
authors.lastname: Rodoman
authors.affiliation: g ZAO Medical Scientific Productive Establishment Dvizhenie , Volgograd.
authors.forename: A O
authors.initials: AO
authors.lastname: Soloviev
authors.affiliation: h National Pirogov Medical Surgical Centre, Phlebology Service , Moscow , Russia.
authors.forename: Y M
authors.initials: YM
authors.lastname: Stoyko
authors.affiliation: i Railway Clinical Hospital on Rostov-Glavniy Railway Station , 1st Surgery Department , Rostov-on-Don , Russia.
authors.forename: A G
authors.initials: AG
authors.lastname: Khitaryan
authors.affiliation: f City Clinical Hospital No. 24, Moscow City Centre of Coloproctology , Moscow , Russia.
authors.forename: I A
authors.initials: IA
authors.lastname: Nechay
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D005419:Flavonoids / Q000008:administration & dosage / Q000627:therapeutic use*; D006470:Hemorrhage / Q000188:drug therapy; D006484:Hemorrhoids / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013607:Tablets
chemical_list: D005419:Flavonoids; D013607:Tablets
keywords: Acceptability; Anal pain; Bleeding; Hemorrhoidal disease; MPFF