title: Isosorbide dinitrate ointment vs botulinum toxin A (Dysport) as the primary treatment for chronic anal fissure: a randomized multicentre study.
abstract: OBJECTIVE
  Nitric oxide donors, such as isosorbide dinitrate ointment (ISDN), are considered as first-choice agents in the treatment of chronic anal fissure. Injection with botulinum toxin A in the internal anal sphincter is often used as a second-line therapy, although it may give better results and fewer side effects than nitric oxide donors. The aim of this randomized clinical trial was to investigate whether botulinum toxin A (Dysport) is more effective than ISDN in the primary treatment of chronic anal fissure.
  
  
  METHODS
  From April 2005 until October 2009, 60 patients (32 men) with a median age of 42 (25-82) years were randomized to receive either ISDN 10 mg/ml (1%) (n = 33) or injection with 60 units of Dysport (n = 27). The primary end-point was the percentage of complete fissure healing after 8 weeks.
  
  
  RESULTS
  After a median of 9 weeks complete fissure healing was noted in 18 of 27 patients in the Dysport group and in 11 of 33 patients in the ISDN group (P = 0.010). Absolute improvement of pain scores after 9 weeks was similar in both groups (P = 0.733). Patients treated with Dysport had fewer side effects than patients treated with ISDN (P = 0.028). Of the patients with a healed fissure, 28% of the Dysport group and 50% of the ISDN group had a recurrence within 1 year (P = 0.286; hazard ratio 2.08; 95% CI = 0.54-7.97).
  
  
  CONCLUSIONS
  Dysport is more effective than ISDN ointment and has fewer side effects in the primary treatment of chronic anal fissure. The recurrence rate within 1 year in both treatment groups is high.
authors.affiliation: Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: A E M
authors.initials: AE
authors.lastname: Berkel
authors.forename: C
authors.initials: C
authors.lastname: Rosman
authors.forename: R
authors.initials: R
authors.lastname: Koop
authors.forename: P
authors.initials: P
authors.lastname: van Duijvendijk
authors.forename: J
authors.initials: J
authors.lastname: van der Palen
authors.forename: J M
authors.initials: JM
authors.lastname: Klaase
mesh_terms: D065087:Acetylcholine Release Inhibitors / Q000627:therapeutic use*; D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001003:Anal Canal; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D002908:Chronic Disease; D005260:Female; D005401:Fissure in Ano / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007273:Injections, Intramuscular; D007548:Isosorbide Dinitrate / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020030:Nitric Oxide Donors / Q000627:therapeutic use*; D009824:Ointments; D010146:Pain / Q000209:etiology; D012008:Recurrence
chemical_list: D065087:Acetylcholine Release Inhibitors; D020030:Nitric Oxide Donors; D009824:Ointments; D019274:Botulinum Toxins, Type A; C542869:abobotulinumtoxinA; D007548:Isosorbide Dinitrate
keywords: Anal fissure; Dysport; ISDN; botulinum toxin A; isosorbide dinitrate ointment