Isosorbide dinitrate ointment vs botulinum toxin A (Dysport®) as the primary treatment for chronic anal fissure: a randomized multicentre study. (October 2014)

• Record Type: Journal Article
• Authors: Berkel, A. E. M.; Rosman, C.; Koop, R.; van Duijvendijk, P.; van der Palen, J.; Klaase, J. M.
• Is Part Of: Colorectal disease. Volume 16:Number 10(2014)
• Page Start: O360
• Page End: O366
• Publication Date: 2014-10
• Subjects: Colon (Anatomy) -- Diseases -- Periodicals; Rectum -- Diseases -- Periodicals; 616.34
• DOI: 10.1111/codi.12615
• Languages: English
• ISSNs: 1462-8910

Abstract

<abstract abstract-type="main" id="codi12615-abs-0001"> <title>Abstract</title> <sec id="codi12615-sec-0001" sec-type="section"> <title>Aim</title> <p>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<sup>®</sup>) is more effective than ISDN in the primary treatment of chronic anal fissure.</p> </sec> <sec id="codi12615-sec-0002" sec-type="section"> <title>Method</title> <p>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%) (<italic>n</italic> = 33) or injection with 60 units of Dysport<sup>®</sup> (<italic>n</italic> = 27). The primary end‐point was the percentage of complete fissure healing after 8 weeks.</p> </sec> <sec id="codi12615-sec-0003" sec-type="section"> <title>Results</title> <p>After a median of 9 weeks complete fissure healing was noted in 18 of 27 patients in the Dysport<sup>®</sup> group and in 11 of 33 patients in the ISDN group (<italic>P</italic> = 0.010). Absolute improvement of pain scores after 9 weeks was similar in both groups (<italic>P</italic> = 0.733). Patients treated with Dysport<sup>®</sup> had fewer side effects than patients treated with ISDN (<italic>P</italic> = 0.028). Of the patients with a healed fissure, 28% of the Dysport<sup>®</sup> group and 50% of the ISDN group had a recurrence within 1 year (<italic>P</italic> = 0.286; hazard ratio 2.08; 95% CI = 0.54–7.97).</p> </sec> <sec id="codi12615-sec-0004" sec-type="section"> <title>Conclusion</title> <p>Dysport<sup>®</sup> 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.</p> </sec> </abstract>