Diltiazem gel 2% en el tratamiento de la fisura anal crónica: eficacia, seguridad y recurrencia

Resumen

INTRODUCTION. In recent years, the medical treatment of chronic anal fissure has consolidated as the choice in clinical practice as a result of the failure of conventional treatment and morbidity associated to surgical sphincterotomy. OBJECTIVE. To evaluate the efficacy, safety and recurrence of topical diltiazem in the treatment of chronic anal fissure. PATIENTS AND METHOD. We studied patients diagnosed with chronic anal fissure referred to our hospital from other hospitals of the Community of Madrid, to treatment, during the period April 2008 to March 2012 (4 years). Of the 195 patients referred for treatment, 163 accepted to enter the study. Inclusion criteria: age greater 18 and less than 65 years, manometry with hypertensive internal anal sphincter and signed informed consent. We used a formulation of diltiazem gel 2% in 3 applications daily for 8 weeks. There were clinical and extent of pain by visual analog scale (VAS) at the end of the second, fourth, sixth and eighth weeks. We compared the groups with and without response to diltiazem by the ¯2 test and Student. RESULTS. We excluded 22 patients, which could not be contacted for follow-up. We analyzed 141 patients (62 men) with a mean age of 47.58 (19-65) years. Posterior anal localization in 91%, anterior in 7% and 2% side. All had pain,105 bleeding and 132 patients, pruritus. At the end of 8 weeks of treatment 65.2% (92 patients) cured, with a morbidity of 13.5%, of which almost half the patients (7.8%) discontinued the treatment due to adverse effects. Of the 92 patients who improved with treatment, 49 patients (53.2%) improved after two weeks of treatmentdid, 25 patients (27.2%) after 4 weeks, 14 patients (15.2%) after 6 weeks and only 4.3% (4 cases) after the eighth week, with a statistically significant difference (p <0.005) among responders at two and four weeks, compared to sixth and eighth week of initiation of treatment. There were no significant differences between groups with and without response to diltiazem related to age, sex, location, bleeding or itching. After a mean follow up of 26 (5-48) months, we have not been able to contact 22 (15.6%) patients (patients lost). A 23.4% (19 patients) presente a recurrence. The median time to recurrence after successful completion of treatment was 4.5 (2.5 to 32)months. CONCLUSIONS. Diltiazem 2% gel is an effective drug in the treatment of chronic anal fissure, in selected cases. His response is early and sustained over time. No major side effects were observed with an acceptable compliance, avoiding the morbidity associated to sphincterotomy. Treatment should not be continued beyond the fourth week, because most patients experience improvement earlier. Although recurrences are relatively common, they often respond to repeated medical treatment.