Efficacy and safety of EHO-85-based hydrogel for anal fissure treatment: a pilot open-label clinical trial.

Background Anal fissure (AF) is the most common cause of severe anorectal pain in adults, with an overall annual incidence of 0.1%. The primary objective of this pilot trial was to evaluate the safety and efficacy of an Olea europaea leaf extract (OELE)-based hydrogel (EHO-85), as a supportive treatment for acute AF episodes. Methods Prospective, open-label, pilot study (May to October 2022). Adult patients with AF were recruited from three centers in Bulgaria and one in Romania. Patients were allocated 1:1 to each treatment using a computer-generated-based system and received either EHO-85 or customary supportive therapy (CST) for 60 days. The primary endpoint was the time to bleeding disappearance. Results 42 patients were included by web-based allocation to receive EHO-85 (n=21) or CST (n=21). All patients completed the 60 days' study. Patients reporting bleeding absence were significantly higher in the EHO-85 group at days 7 (p=0.032) and 15 (p=0.006). From day 29 or 36, no bleeding at defecation was reported in the EHO-85 and CST groups, respectively. On day 60, all subjects were bleeding-free. No adverse events were reported. Conclusion EHO-85 was feasible to deliver and showed efficacy, safety, and apparent superiority in promoting and speeding up the healing process. In a future definitive trial, the sample size and diversity may be increased, and new objective methods may be considered. Implications in clinical practice It highlights the combined wound-healing properties of EHO-85 as a promising noninvasive, cost-effective, and easy-to-apply alternative to current CSTs for AF wound repair. [ABSTRACT FROM AUTHOR]