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

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

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.

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