Topical diltiazem ointment versus botulinum toxin A for chronic anal fissure: a double-blind randomized clinical trial: F25


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Abstract

Aim:Topical diltiazem and botulinum toxin A (BTA) arepromising treatments for anal fissure but they have never been compared by randomized trial.Method:One hundred and thirty-four patients with a chronic anal fissure were randomized to receive either diltiazem ointment and a placebo injection (group A) or BTA injection and placebo ointment (group B). Theprimary endpoint was fissure healing at 3 months. Secondary endpoints included the pain score, side effects and cost.Results:At 3 months healing occurred in 32 (43%) patients in group A and 26 (43%) in group B. Reduction of more than 50% in the mean pain score was found in 58 (78%) in group A and 49(82%) in group B. Perianal itching was the only side effec and was reported in 15% of patients in group A (P = 0.012). Theprice of group A was €56.80 and €44.39 in group B.Conclusion:Diltiazem and BTA resulted in equal healing rates. No significant difference in pain reduction was observed. In considering cost BTA might be thepreferred initial choice for chronic anal fissure.

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