Comparison between topical 5-ASA versus combined oral and topical 5-ASA for the treatment of ulcerative proctitis.

Comparison between combined oral and topical 5-ASA versus topical 5-ASA for the treatment of ulcerative proctitis

Clinical trial without control group, with parallel groups, triple-blinded, randomized, phase 2 on 64 patients. Block method was used for randomization.

In this study, all patients over 15 years of age referred to Amir al-Momenin Hospital in Arak with the diagnosis of ulcerative colitis in colonoscopy and histopathology and relevant tests are included in the study. The patients of the first group were given mesalazine suppositories, and the patients of the second group were given oral mesalazine along with mesalazine suppositories, and the patients were followed up for 6 months. Finally, laboratory criteria, severity of disease activity and response to treatment are examined in two groups.

Inclusion criteria: people over 15 years of age who have been diagnosed with ulcerative proctitis through colonoscopy and histology at Amirul Mominin Hospital in Arak during 1398-1402 Exclusion criteria: patients with sensitivity to salicylate, active peptic disease, proven coagulation problem, significant liver, kidney or heart disease, pregnant or lactating women, as well as patients whose previous treatment with 5-ASA has not been effective or undergoing maintenance treatment with compounds 5 -ASA.

The first intervention group: patients treated with mesalazine suppositories at the rate of one gram per day for 6 months The second intervention group: patients treated with oral mesalazine at the rate of 3 grams per day along with mesalazine suppositories of 1 gram per day for 6 months.

Severity of disease activity, response to treatment and laboratory criteria

Randomization has been done based on the 6 permutation block method taken from Randomization.org and the patients have been divided into two groups A (local treatment) and B (local and oral combination).

The study is a triple-blind type. The patients do not know about the assignment of the groups, and the doctor and also the data analyst do not know about the assignment of the study groups. Pharmaceuticals are provided by a third party who is a pharmacy staff, and the researcher himself is informed of the medicinal contents according to the code on the package.