Efficacy and Safety of Propionibacterium Extract Gel Versus 0.4% Glyceryl Trinitrate Ointment in the Treatment of Chronic Anal Fissure: a Randomised Controlled Trial

Treviso Regional Hospital120 enrolled

Overview

The study compares the efficacy and safety of a Propionibacterium extract gel with 0.4% glyceryl trinitrate ointment in the treatment of chronic anal fissure.

Patients were randomly allocated to a PeG or GTN group and medication was taken every 12 hours for 40 days. Primary outcome was the success rate as measured by a decrease in the REALISE score at 10, 20 and 40 days after starting either treatment. The secondary out-comes were the healing rate, the partial or complete resolution of itching and burning, the rate of complications and adverse events, patients' quality of life and satisfaction at the same time points.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Anal Fissure Chronic Anal Fissure

Interventions

Propionibacterium AcnesDRUG

Application of the gel every 12 hours for 40 days

glyceryl trinitrateDRUG

Application of the gel every 12 hours for 40 days

Eligibility

Medical Language ↔ Plain English

Inclusion Criteria: * Consecutive patients diagnosed with chronic anal fissure aged between 18 and 75 years Exclusion Criteria: * Fecal incontinence * Inflammatory bowel disease * Previous history of anal surgery * Previous or concomitant treatment for anal fissure, sexually transmitted disease, cancer, immune-suppressive treatment * Current pregnancy or breastfeeding * Known allergy to one of the agents contained into the evaluating drugs

Locations (1)

Regional Hospital Treviso

Treviso, Italy

Outcomes

Primary Outcomes

REALISE score

REALISE (scoRing systEm for AnaL fIsSurE), was used to assess pain (minimum score = 0, maximum score = 10)