Use of mesoglycan in the acute phase of hemorrhoidal disease, the aCute HaemORrhoidal MEsoglycan Study (CHORMES): A double-blind, randomized controlled trial.

Abstract

Hemorrhoidal disease is a common condition with significant clinical and socioeconomic impact. Mesoglycan, with endothelial-protective, antithrombotic, and profibrinolytic properties, has shown potential benefits in postoperative hemorrhoidal disease management. The aCute HaemORrhoidal MEsoglycan Study trial was designed to evaluate the efficacy and safety of mesoglycan in the acute phase of hemorrhoidal disease. This multicenter, randomized, double-blind, placebo-controlled phase 2 trial enrolled adults with symptomatic grade II to III hemorrhoidal disease. Participants were randomly assigned (1:1) to receive oral mesoglycan or placebo for 40 days, followed by a 30-day telephone follow-up. The primary endpoint was the change in the Hemorrhoidal Disease Symptom Score from baseline to day 40. Analyses were performed on modified intention-to-treat and modified per-protocol populations. Fifty-two patients were randomized (26 mesoglycan, 26 placebo), and 48 completed the study. In the modified intention-to-treat population (n = 47), mesoglycan resulted in a significantly greater reduction in Hemorrhoidal Disease Symptom Score compared with placebo (-7.5 ± 5.9 vs -3.9 ± 5.4; P = .027). Improvements were consistent across sensitivity analyses and more pronounced in patients with grade III hemorrhoidal disease (P = .042). Symptom-specific analysis showed significant reductions in itching (P = .0048), pain (P = .0246), and swelling/prolapse (P = .0418) in the mesoglycan group. Pain relief (visual analog scale) was sustained only in the mesoglycan arm. Bleeding improved significantly in the grade III subgroup (P = .03). Treatment adherence exceeded 97% in both arms. No treatment-related serious adverse events were observed. Mesoglycan demonstrated clinically meaningful and statistically significant improvements in acute hemorrhoidal disease symptoms, with a favorable safety profile and excellent adherence. Its mechanism of action allows for sustained benefits beyond mere symptomatic relief.