Objective / Purpose: This open-label, randomized comparative clinical study evaluated the efficacy and tolerability of the newly reformulated Acidosalus® hemorrhoidal suppositories in patients with Grade I–III haemorrhoidal disease, compared to Bioapifit® anti-haemorrhoidal ointment as an established comparator. Materials and methods: Acodosalus suppositories are applied rectally once a day (before bedtime) for 10 consecutive days. Bioapifit ointment applied externally three times a day onto clean perianal area and rectally once a day for 10 consecutive days. Symptoms (pain, defecation discomfort, bleeding severity, anal itching, and overall subjective discomfort) were assessed at baseline, Day 3, Day 5, and Day 10 of treatment using a standardized rating scale. Results: Symptom improvement was observed in both groups, with no statistically significant differences between treatments at any time point (all p0.05). Ten days of the application of Acidosalus suppositories resulted in 89.6% reduction of pain, 91.3% defecation discomfort, 100% of bleeding, 91.7% of itching while overall subjective discomfort was reduced for 89.6% with clinical cure rate of 82.5%. In the end of the treatment Bioapifit ointment performed slightly but not significantly better with decrease of initial values between 97.5% and 100% with clinical cure rate of 82.5%. Comparison with historical data from a previous clinical study using the older Acidosalus® formulation demonstrated a highly similar clinical performance profile, confirming continuity of therapeutic effect. Conclusion / Discussion: By Day 10, Overall subjective discomfort reduction reached 89.6% and 97.5% in Acidosalus and Bioapifit group, respectively with no statistically significant difference between them. Both treatments were well tolerated, with no adverse events. The new Acidosalus® formulation maintained clinical efficacy which is slightly but not significantly better for all time points.
Oreščanin et al. (Sat,) studied this question.