Comparison of topical isosorbide mononitrate, topical diltiazem, and their combination in the treatment of chronic anal fissure

Background/objective: Chronic anal fissure is a painful condition that is associated with an increase in internal anal sphincter pressure. The main aim of this study is to evaluate the efficacy and adverse effects of topical isosorbide 5 mononitrate and topical diltiazem, when administered either as single agents or in combination, in the treatment of anal fissure.

Methods: Patients with chronic anal fissure were enrolled in the study. They were randomized into three groups: Group A (0.2% isosorbide 5 mononitrate users), Group B (2% diltiazem users), and Group C (2%diltiazem + 0.2% isosorbide 5 mononitrate users). Pain was evaluated using a visual analog scale (VAS). Level of strain during defecation was graded on a 4-point scale.

Results: A total of 55 patients were enrolled in the study. The average ages of patients in Groups A, B, and C were 37.94 ± 16.19, 42.83 ± 13.21, 40 ± 13.58 years, respectively. After treatment, pain completely abated in 55.6% of patients in Group A, 27.8% (n = 5) in Group B, and 42.1% (n = 8) in Group C. The decreases in average VAS values prior to and after treatment in Groups A, B, and C were statistically significant (p values 0.0001, 0.001, and 0.0001, respectively). Average strain scores prior to and after treatment were 2.11/0.72 for Group A, 2.17/0.94 for Group B, and 1.95/0.47 for Group C. Strain during defecation prior to and after treatment in Groups A, B, and C was statistically significant (p values 0.001, 0.001, and 0.003, respectively).

Conclusion: Topical diltiazem and a combination of nitrate and diltiazem can be used in the treatment of anal fissure. However, the agents are not significantly superior each other.