A randomized trial of botulinum toxin vs lidocain pomade for chronic anal fissure.

PURPOSE: As lateral sphincterotomy and anal dilatation causes complications, a reversible chemical sphincterotomy method has been recently proposed as an alternative treatment in patients with anal fissure. In this study, the effect of botulinum toxin causing temporary paralysis in internal anal sphincter was compared with that of lidocaine in patients with chronic anal fissure.

METHOD: A total of 62 outpatients were randomly assigned to receive botulinum toxin or lidocaine pomade. The patients were evaluated before and after two months of treatment with physical examination and anal manometry. Pain and nocturnal pain were scored.

RESULTS: In an evaluation period of two months, in 24 of 34 patients of botulinum group (70.58%), and in six of 28 patients of lidocaine group (21.42%) showed complete epithelization (p = 0.006). All patients who had previously reported nocturnal pain became symptom free in botulinum group and in four patients of lidocaine group. Pain following defecation disappeared in 24 patients of botulinum group and in 20 patients of control group (p = 0.959). There was no adverse effect in both groups. While resting anal pressure and maximum voluntary pressure were significantly low in botulinum toxin group, both parameters did not change in lidocaine group.

CONCLUSIONS: Botulinum toxin is a reliable and effective method for patients with chronic anal fissure. It can be applied easily without any anesthesia and instrumentation. It is cheaper in comparison with surgical methods and it can be a good alternative treatment in patients with risk of incontinence.