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

In brief

Sucralfate formulation healed 79% of chronic anal fissures by four weeks

In a single-center randomized trial of 82 adults, 79% using 3% topical sucralfate had healed fissures by four weeks, compared with 48% using nitroglycerin. Pain relief and quality-of-life gains were similar, and recurrence rates did not differ; the small trial leaves longer-term effectiveness uncertain.

Journal
The American journal of gastroenterology (Q1)
Published
6 November 2026
Study design
Randomized controlled trial
Evidence level
Level 1, High (CEBM 1b)
Authors
Varut Lohsiriwat, Navarat Gosoom, Pornraksa Ovartchaiyapong
PMID
42993576
DOI
10.14309/ajg.0000000000004248

Why clinicians should know about it

  • Picked for Gastroenterology (paper of the day, 8 November 2026): Sucralfate superior to nitroglycerin for fissure healing

Abstract

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.

Abstract as published, via PubMed.

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For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.