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Isosorbide dinitrate ointment vs botulinum toxin A ( D ysport ® ) as the primary treatment for chronic anal fissure: a randomized multicentre study
Author(s) -
Berkel A. E. M.,
Rosman C.,
Koop R.,
Duijvendijk P.,
Palen J.,
Klaase J. M.
Publication year - 2014
Publication title -
colorectal disease
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.029
H-Index - 89
eISSN - 1463-1318
pISSN - 1462-8910
DOI - 10.1111/codi.12615
Subject(s) - isosorbide dinitrate , medicine , botulinum toxin , randomized controlled trial , internal anal sphincter , clinical endpoint , anal fissure , surgery , hazard ratio , anesthesia , gastroenterology , confidence interval , anal canal , rectum
Aim 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 ( D ysport ® ) is more effective than ISDN in the primary treatment of chronic anal fissure. Method From A pril 2005 until O ctober 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 D ysport ® ( 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 D ysport ® 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 D ysport ® had fewer side effects than patients treated with ISDN ( P = 0.028). Of the patients with a healed fissure, 28% of the D ysport ® 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). Conclusion 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.