Comparison of the effectiveness of combination gel (diltigel 2% -urea-colchicine) with diltigel 2% in the treatment of acute anal fissures

Abstract

One of the solutions for the treatment of anal fissure is to use diltiazem gel, which relaxes the muscles of the anal sphincter and by strengthening the blood flow, the recovery process begins. In addition to the beneficial effects of this gel, its use is prohibited for people who take calcium channel blocking drugs and patients receiving blood pressure control drugs. On the other hand, in 30% of cases, this drug leads to headache, dizziness and acute allergic reactions such as severe itching, which makes the treatment process difficult. Researchers have turned to using drugs that can minimize the side effects of the mentioned gel. Purpose: Therefore, the present study was designed with the aim of comparing the effectiveness of combined gel (diltiazem-urea-colchicine) with Diltigel in the treatment of acute anal fissures. Materials and methods: This study is a randomized clinical trial that was conducted in Tabriz University of Medical Sciences with the participation of 80 patients with acute fissure. Patients were randomly divided into two groups. Patients in the Diltigel group used the mentioned gel once every twelve hours externally. For the patients of the other group (the main group of the study), the mentioned gel was prepared by the pharmacist in the form of a combination of 30 grams of Diltigel 2%, 67 grams of urea and 3 grams of Medacin (colchicine) and was prescribed twice a day and externally. The duration of the study was 8 weeks. Then, the patients were examined in the second week (face-to-face visit), fourth (telephone follow-up), sixth week (telephone follow-up) and eighth week (face-to-face visit). The intensity of pain, bleeding and itching for each patient was checked at the mentioned times and recorded in the data collection form of each person. The amount of bleeding and itching was also asked from the patients during the follow-up period. Results: According to the findings of our study, the intensity of pain during the follow-up period was significantly lower in the intervention group than in the control group. Also, the trend of intra-group changes in the intervention group was significantly associated with a decrease in pain intensity, while the trend of changes in pain intensity in the control group was without statistically significant changes. Comparing the number of itching after the intervention (in all visits) in the intervention group was significantly less than the itching in the control group patients. Also, the intra-group changes in the intervention group showed a significant reduction in itching, while the reduction in itching in the control group was without significant changes in the intra-group comparison. Comparing the number of people with bleeding after the intervention (in all visits) in the intervention group was significantly less than the patients in the control group. Also, the intra-group changes in the intervention group showed a significant decrease in people with bleeding, while the decrease of people with bleeding in the control group was without significant changes in the intra-group comparison.