Randomised Prospective Controlled Trial of Topical 2 % Diltiazem Versus Lateral Internal Sphincterotomy for the Treatment of Chronic Fissure in Ano

Abstract

Fissure in ano is a very common disorder of the anorectal region. Internal sphincter hypertonia with decreased relaxation coupled with mucosal ischemia of posterior anal canal are the major pathologies in chronic anal fissure (CAF). Though lateral internal sphincterotomy (LIS) remains the gold standard of treatment for the disease, it is accompanied by the potential complication of incontinence to both flatus and faecal matter. The aim of our study was to explore the role of topical diltiazem as an effective and a safe alternative to sphincterotomy for chronic anal fissure. Ninety patients with CAF were randomly assigned to group A and group B, with 45 patients each. Group A patients received 2 % diltiazem topical application, twice daily, and group B patients underwent LIS. All the patients were reviewed at first, fourth and sixth week after initiation of treatment. Visual analogue scores for pain and healing of fissure by visual inspection were recorded and compared. In group A, 71 % had complete healing of fissure at 6 weeks, with fair amount of pain relief (mean VAS-3.38), and in group B, 96 % showed healing of fissure, with excellent pain relief (mean VAS-1.87). Headache and flushing were noted in two patients in group A while no patients in group B developed incontinence. We conclude that LIS is more effective than topical diltiazem in the treatment of CAF. Topical diltiazem may be employed as an initial conservative treatment option before considering the surgical alternative.

Keywords: Fissure in ano; Lateral sphincterotomy; Pain score; Topical diltiazem.