Abstract
BackgroundAnal 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.MethodsThis 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.DiscussionThe 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 registrationClinicalTrials.gov Identifier NCT04153032. Clinical Trial Registration Date: 06-NOVEMBER-2019.
Highlights
Anal fissure is a common complication of the anorectal region and one of the most reported causes of anal pain
In the absence of data comparing Moist exposed burn ointment (MEBO) to other topical agents, and since there is no single standard of care, we propose to conduct a comparative randomized clinical study
Aims of the study The main aim of this study is to evaluate the efficacy and adverse effects of MEBO Ointment and Topical DTZ ointment, when administered as single agents, or as a combination, in the treatment of acute anal fissure
Summary
Anal fissure is a common complication of the anorectal region and one of the most reported causes of anal pain. 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 calciumchannel blocker, which relaxes the anal sphincter and promotes healing of the anal fissure. Anal fissure is one of the most common anorectal complications encountered in practice [1] that represents a common cause of intense anal pain [2]. Anal fissure is linked to reduced quality of life and loss of working hours [2]. It occurs in all age groups, and is prevalent in men and women [3]. A minority of patients experience additional symptoms such as swelling, prolapse, pruritus, and discharge [6]
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