Effect of Micronized Purified Flavonoid Fraction (MPFF) in Indian patients with Grade I-II Hemorrhoids: the IMPACT HD Study
A recently published IMPACT-HD (Integrating Proctoscopic Assessment With Patient Experience of Micronized Purified Flavonoid Fraction in Treatment of Grade I–II Hemorrhoids) study has shown effective improvements in clinical signs on proctoscopic assessment (redness, swelling, and bleeding) and in quality of life (QoL), following the administration of Micronized Purified Flavonoid Fraction (MPFF) in Indian patients with Grade I-II hemorrhoids.
These findings, published in the September 2025 issue of the Journal of Surgery, support MPFF as a safe, non-invasive first-line therapy for the management of Hemorrhoidal Disease (HD).
Hemorrhoidal disease (HD) is common and distressing anorectal condition, a frequent cause of patient visits to both primary care and specialist clinics, impacting their comfort, daily activities, and quality of life. The true incidence of HD is challenging to determine, as many affected individuals are reluctant to seek medical care and also hesitant to undergo invasive procedures or surgery. Micronized Purified Flavonoid Fraction (MPFF) offers a pharmacological approach that directly addresses the underlying pathophysiological pathway of HD and or adjunct to invasive interventions as well.
To evaluate the clinical efficacy and patient-reported outcomes of Micronised Purified Flavonoid Fraction (MPFF) in the management of early-grade hemorrhoids, an open-label, prospective, single-center, observational study was conducted, enrolling 12 adults (≥18 years) having Grade I–II hemorrhoids with acute rectal bleeding (<2 days), confirmed on proctoscopy. All participants received MPFF in the form of Daflon 1000 mg tablets. The dosing regimen was in accordance with standard prescribing practices for acute hemorrhoidal episodes: 3 tablets daily for the first four days, followed by 2 tablets daily for the subsequent three days. Based on the patient’s clinical response, treatment could be optionally continued at a dose of one tablet daily until Day 21, with assessments carried out at days 0, 3, 7, 10, 14, and 21 for both physician-reported clinical parameters on proctoscopy and patient reported Quality Of Life (QoL) scores.
The primary outcome was patient-reported QoL measured using HEMO-FISS-QoL score. Secondary outcomes were physician-reported clinical parameters like redness, swelling, bleeding, discharge, tenderness, prolapse, and overall improvement assessed using proctoscopy.
The findings from the study include:
Graph 1: Proctoscopic Examination: Change in Redness and Swelling till the End of the Study
2. Quality of life (QOL) Assessment (HEMO-FISS-QoL score): By Day 21, patients showed substantial improvements across all domains. Overall QoL score decreased from 45.51 ± 8.01 at baseline to 2.80 ± 1.84 at Day 21 (mean change −42.70 ± 7.57; p < 0.05), suggesting significant improvement in QoL.
Conclusion: MPFF administration was associated with a progressive reduction in proctoscopic inflammation and significant improvements in QoL. These findings suggest that MPFF may be a valuable adjunct in conservative management of HD, offering both objective mucosal healing and subjective symptomatic benefits in patients with Grade I-II hemorrhoids
Reference: Porwal A (2025) Integrating Proctoscopic Assessment With Patient Experience of Micronized Purified Flavonoid Fraction in Treatment of Grade I–II Hemorrhoids: the IMPACT-HD. J Surg 10: 11435 https://doi.org/10.29011/2575-9760.011435
