Randomized clinical trial comparing botulinum toxin injections with 0·2 per cent nitroglycerin ointment for chronic anal fissure

Authors: Brisinda, G.; Cadeddu, F.; Brandara, F.; Marniga, G.; Maria, G.

Source: British Journal of Surgery, Volume 94, Number 2, February 2007 , pp. 162-167(6)

Publisher: John Wiley & Sons, Ltd.

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Abstract:

Background:

In recent years treatment of chronic anal fissure has shifted from surgical to medical. This study compared the ability of two non-surgical treatments—botulinum toxin injections and nitroglycerin ointment—to induce healing in patients with idiopathic anal fissure.

Methods:

One hundred adults were assigned randomly to receive treatment with either type A botulinum toxin (30 units Botox® or 90 units Dysport®) injected into the internal anal sphincter or 0·2 per cent nitroglycerin ointment applied three times daily for 8 weeks.

Results:

After 2 months, the fissures were healed in 46 (92 per cent) of 50 patients in the botulinum toxin group and in 35 (70 per cent) of 50 in the nitroglycerin group (P = 0·009). Three patients in the botulinum toxin group and 17 in the nitroglycerin group reported adverse effects (P < 0·001). Those treated with botulinum toxin had mild incontinence to flatus that lasted 3 weeks after treatment but disappeared spontaneously, whereas nitroglycerin treatment was associated with transient, moderate-to-severe headaches. Nineteen patients who did not have a response to the assigned treatment crossed over to the other therapy.

Conclusion:

Although treatment with either topical nitroglycerin or botulinum toxin is effective as an alternative to surgery for patients with chronic anal fissure, botulinum toxin is the more effective option. Copyright © 2007 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

Document Type: Miscellaneous

DOI: http://dx.doi.org/10.1002/bjs.5514

Publication date: 2007-02-01

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