Comparison of Efficacy Between Thai Herbal Anti-hemorrhoid Formula and Micronized Purified Flavonoid Fraction in Patients with Internal Hemorrhoids

Abstract

Background: Hemorrhoids are a common anorectal condition. In Thai traditional medicine, the Bantaoridsidwangthawan formula (BRF) has been used to treat hemorrhoids. We aimed to evaluate the clinical efficacy and satisfaction of BRF versus Micronized purified flavonoid fraction (MPFF) in patients with internal hemorrhoids grades 1 and 2. Methods: This was a single-blind, randomized control noninferiority trial. Twenty-seven participants were randomly assigned to BRF (n ¼ 13) or MPFF (n ¼ 14). The BRF group received 5 pills 3 times daily for 14 days. The MPFF group received 2 tablets 3 times daily for 4 days, and then 2 tablets 2 times daily for 6 days. The degree of hemorrhoid, bleeding, prolapse, severity of pain, and metabolomic profiling were recorded twice, once at baseline and once after treatment. Results: BRF group had better outcomes compared to that of the MPFF group in terms of hemorrhoid grade and bleeding severity. Both groups had decreased prolapse severity and reported equal satisfaction levels. Twenty-nine potential metabolites associated with anti-inflammatory and antioxidant properties were detected in both groups. Participants in both groups displayed neither abnormal liver nor kidney function. Conclusions: For internal hemorrhoids grades 1 and 2, BRF outperforms MPFF in terms of lowering both hemorrhoid grade and bleeding severity. However, BRF and MPFF there was not a difference between groups in terms of reducing the severity of pain. Further studies should be conducted to better understand the mechanism of action of BRF.