3% Sucralfate-Containing Topical Formulation Versus 0.2% Topical Nitroglycerin for Chronic Anal Fissure: A Double-Blind Randomized Controlled Trial

OBJECTIVES: Chronic anal fissure is associated with elevated resting anal pressure and impaired tissue healing. Promoting fissure healing with the mucoprotective agent sucralfate could be an alternative pharmacologic approach to medical sphincterotomy. We aimed to evaluate the efficacy of topical sucralfate versus topical nitroglycerin for chronic anal fissure. METHODS: This single-center, double-blind, randomized controlled trial enrolled adult with chronic anal fissure. Participants were randomly assigned in a 1:1 ratio to receive either 3% sucralfate-containing topical formulation or 0.2% nitroglycerin ointment, applied onto the fissure twice daily. The primary outcome was fissure healing at 2 weeks. Secondary outcomes included healing at 4 weeks, changes in pain score and quality-of-life score, and recurrence. RESULTS: This study included 82 patients (42 in the sucralfate-containing formulation group) with a median age of 46 years and median fissure symptom duration of 8 weeks. Patients' demographics were comparable between groups. At 2 weeks, fissure healing occurred in 21 of 42 patients (50%) in the sucralfate-containing formulation group and 9 of 40 (23%) in the nitroglycerin group (P=0.010; RR 2.22; 95% CI 1.16-4.26). At 4 weeks, healing occurred in 33 of 42 patients (79%) and 19 of 40 (48%), respectively (P=0.004; RR 1.65; 95% CI 1.15-2.38). Pain reduction and quality-of-life improvement were comparable between groups. Recurrence occurred in 5 of 27 patients (19%) in the sucralfate-containing formulation group and 4 of 17 (24%) in the nitroglycerin group (P=0.716). CONCLUSION: Sucralfate-containing formulation was superior to nitroglycerin in achieving fissure healing at 2 and 4 weeks.