Berrocal, Felix, Etropolska, Zlatka, Armova, Mariya, Dimitrov, Stefan, Yanev, Petar, and Petrisor, Diana
Aim: The aim of this multicenter, comparative clinical study was to evaluate the safety and efficacy of EHO-85 in adult patients diagnosed with anal fissures. Method: The efficacy and safety of a topical treatment containing Olea europaea leaf extract versus standard of care (e.g., hyaluronic acid-based products) were assessed in 42 adults in a 1:1 ratio in this multicenter, comparative clinical study. Each subject received the prescribed treatment three times per day for 42 days. The time to complete healing - bleeding disappearance - was used to assess efficacy using an observational method. The effectiveness of EHO-85 was measured in terms of time to pain reduction (VAS) and discomfort diminution (Likert Scale). SF-36 was used to assess the impact of anal fissures on patients' quality of life. Results / Discussion: Improvement or remission of bleeding symptoms while taking EHO-85 was statistically significant at Days 7 (p=0.032) and 15 (p=0.006). EHO-85 patients reported statistically significant pain symptom relief or reduction at Day 3, Day 4, Day 5, Day 6, Day 7, and Day 15 (p=0.017, p=0.014, p=0.024, p=0.09, p=0.002, p=0.008, and p=0.001). Starting on Day 6, the subjects reported, during EHO-85 administration, discomfort improving or disappearing (p=0.042). In both the EHO-85 arm and the SoC arm, there are statistically significant differences in the subjects' assessments of quality of life from Day 1 to Day 42. Conclusion: EHO-85 administered in adult patients showed that the clinical symptoms associated with anal fissures were reduced or solved when compared to day 1. EHO-85 has a good safety profile as there were no adverse events registered during the study, or clinical symptoms progression. [ABSTRACT FROM AUTHOR]