MEBO versus topical Diltiazem versus a combination of both ointments in the treatment of acute anal fissure: a randomized clinical trial protocol

Mohamad Hadi El Charif, Samer Doughan, Rawya Kredly, Sara Kassas, Rayan Azab, Eman Sbaity, Mohamad Hadi El Charif, Samer Doughan, Rawya Kredly, Sara Kassas, Rayan Azab, Eman Sbaity

Abstract

Background: Anal fissure is a common complication of the anorectal region and one of the most reported causes of anal pain. Acute anal fissure can be cured by surgery or medical treatment. There is an increase in the use of topical therapy for the treatment of anal fissures. A common topical drug used is Diltiazem (DTZ), a calcium-channel blocker, which relaxes the anal sphincter and thus promotes healing of the anal fissure. Moist exposed burn ointment (MEBO) is an ointment that is effective for the treatment of burns and wound healing and is becoming popular in the treatment of anal fissures.

Methods: This is a 1:1:1 randomized, controlled, parallel design, with endpoint measures of change in pain score, wound healing, defecation strain score and patient's global impression of improvement. The study will be conducted at AUBMC over a 10-week period. Patients will be randomized to three treatment arms: MEBO, Diltiazem, and a combination of MEBO and Diltiazem ointments.

Discussion: The results of this study will allow physicians to assess the efficacy and safety of MEBO in the treatment of acute anal fissure, and also in comparison to Diltiazem. This trial will generate evidence-based conclusions regarding the use of a herbal/natural-based product (MEBO ointment) for the treatment of anal fissures.

Trial registration: ClinicalTrials.gov Identifier NCT04153032 . Clinical Trial Registration Date: 06-NOVEMBER-2019.

Keywords: Anal fissure; Diltiazem ointment; Herbal; Mebo ointment; Natural; Randomized clinical trial.

Conflict of interest statement

Eman Sbaity has received a research grant from Gulf Pharmaceutical Industries – Julphar. Rawya Kredly and Rayan Azab are the involved funder’s representatives from Gulf Pharmaceutical Industries – Julphar. The role of the funders is to provide the funding and the interventional medications MEBO ointment as well as providing/covering the cost of Diltiazem ointment. The funders have absolutely no role nor are they involved in study design or study conduct (the collection, management, analysis or interpretation of the data) or in writing the final manuscript/report or in the decision to submit the report for publication.

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