Efficacy and safety of topical diltiazem 2% in anal fissure

Objectives

To evaluate the effectiveness and safety of 2% diltiazem ointment in the treatment of anal fissure. To analyse the relationship between healing and diagnosis, and duration of the treatment, and the number of applications.

Methods

A prospective observational study of all patients diagnosed with anal fissure that began treatment with topical diltiazem between January and June in 2007. Diltiazem ointment was prepared in the Pharmacy Service. Effectiveness and safety were assessed by a telephone survey conducted with each patient after 8 weeks of treatment, adding it to the patient's clinical records. The variables that were analysed were healing, adverse effects, diagnosis, duration of treatment, and number of applications, among others. Follow-up was carried out for up to 1 year until complete healing of the fissure. The data analysis was carried out by descriptive statistics, crosstabs, and x².

Results

A total of 70 patients were included in the study and anal fissure healed in 48.6% of them. Healing occurred in 54.5% of patients with anal fissure and in 33.3% of patients with anal fissure and haemorrhoids. Some adverse effects occurred in 30% of patients. Therapy was abandoned due to adverse reactions for 5.7%. The fissure was cured for 60% of patients who underwent treatment for a month or more. More than twice-daily applications did not lead to improved healing. There were no significant statistical differences in these results.

Conclusions

Despite not having found statistical differences between the analysed variables, treatment of anal fissures with 2% diltiazem ointment has avoided surgery in nearly 50% of patients, with few adverse effects.