Efficacy of escin combined with micronized purified flavonoid fraction in controlling bleeding and preventing recurrence of acute internal hemorrhoids: a randomized controlled trial.

Abstract

Purpose: Recurrence after initial control of acute internal hemorrhoidal bleeding remains a common and clinically relevant challenge. Escin, a venotonic and anti-inflammatory compound, may augment the therapeutic effects of micronized purified flavonoid fraction (MPFF). This study aimed to evaluate whether the addition of escin to MPFF reduces recurrence of acute internal hemorrhoidal bleeding.

Methods: In this double-blind randomized controlled trial, adults with grade 1 or 2 acute bleeding internal hemorrhoids received MPFF 3,000 mg/day for 7 days in combination with either escin 120 mg/day or a matched placebo. Patients who achieved hemostasis subsequently continued MPFF 1,000 mg/day with escin or placebo for 2 months. The primary endpoint was recurrence within 90 days, defined clinically and confirmed by proctoscopy. Secondary outcomes included time to hemostasis, the Short Health Scale for Hemorrhoids (SHSHD), and safety outcomes.

Results: Among the 108 patients who achieved hemostasis, recurrence occurred in 0% vs. 7.84% at 1 month and 7.02% vs. 23.52% at 3 months in the escin and placebo groups, respectively. Combination therapy was associated with a significantly reduced risk of recurrence (hazard ratio, 3.95; P=0.009). Time to bleeding cessation was shorter in the escin group (median, 2 days vs. 4 days; P<0.001). Improvement in SHSHD scores was greater with escin. No adverse events were observed in either group.

Conclusion: The combination of escin and MPFF reduces recurrence and accelerates symptom resolution in acute internal hemorrhoidal bleeding, with a favorable safety profile.

Trial registration: ClinicalTrials.gov identifier: NCT06748014.