Clinical acceptability study of micronized purified flavonoid fraction 1000 mg tablets versus 500 mg tablets in patients suffering acute hemorrhoidal disease

Abstract

Objective: To compare the clinical acceptability of micronized purified flavonoid fraction (MPFF) 1000 mg with MPFF 500 mg tablets, administered at the same daily dose in patients suffering non-complicated acute hemorrhoids.

Background: MPFF is an established treatment for hemorrhoidal disease.

Methods: This was a double-blind, multi-center, randomized study. Patients took either MPFF 1000 mg or 500 mg tablets for 7 days (daily dose; 3 g over 4 days followed by 2 g over 3 days). Adverse events were recorded in a patient diary. On day 7, anal pain and bleeding were assessed (visual analog scale [VAS] and Dimitroulopoulos scale, respectively).

Results: Patients (162) were randomized to MPFF 1000 mg (79) and MPFF 500 mg (83). No serious adverse events (AEs) occurred; 10 emergent AEs were considered treatment-related (6 for MPFF 1000 mg and 4 for 500 mg). Both regimens were associated with significant reduction in anal pain (VAS); −2.37 cm MPFF 1000 mg (P < 0.001) and −2.17 cm 500 mg (P < 0.001), with a slight trend in favor of MPFF 1000 mg (mean global reduction −2.27 cm, P < 0.001). Bleeding improved significantly in both groups of patients, 56% of patients on MPFF 1000 mg versus 61% on MPFF 500 mg. Bleeding ceased after treatment in 47% patients on MPFF 1000 mg versus 54% on 500 mg.

Conclusion: After 7 days of treatment with MPFF at the same daily dose, both regimens reduced anal pain and bleeding. MPFF 1000 mg had a comparable safety profile to MPFF 500 mg, with the advantage of fewer tablets.

Key limitations: Safety study.

Keywords:

• Acceptability
• Anal pain
• Bleeding
• Hemorrhoidal disease
• MPFF

Transparency

Declaration of funding

Funding for the study and manuscript preparation was provided by Laboratoires Servier.

Y.S. and Z.K. were national coordinators.

Declaration of financial/other relationships

Y.S. and Z.K. have disclosed receiving consulting fees/remuneration for participation in advisory boards from Servier. S.A.F., I.V.K., V.L.A., S.V.V., A.V.L., G.V.R., A.O.S., Y.M.S., A.G.K., and I.A.N. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The authors would like to thank Arnaud Maggioli MD of Sevier for his role in medical writing coordination and management of this publication.