A pilot study on the efficacy and safety of preoperative micronized purified flavonoid fraction treatment and sucralfate-based rectal ointment on patients with grade II to IV hemorrhoidal disease

BACKGROUND: Hemorrhoidal disease (HD) is a chronic and extremely common condition that negatively impacts patients’ quality of life. The aim of the present study was to evaluate the changes in symptom severity and the need for further interventions following treatment with the oral micronized purified flavonoid fraction (MPFF) and a topical rectal ointment containing 3% sucralfate and herbal extracts (calendula, witch hazel leaf, chamomile). METHODS: A consecutive series of patients aged 18 to 75 with symptomatic II to IV-degree HD classified according to the Goligher classification were prospectively enrolled between September and December 2023. All patients were proposed a hypothetical surgical strategy at time 0 (T0) based on clinical presentation. At T1 (60 days), 7 days before any subsequent procedure, a different colorectal surgeon from the one who conducted the initial assessment performed a reassessment. All enrolled patients underwent medical therapy with a 500 mg MPFF twice daily and rectal ointment twice daily for a duration of 60 days, in addition to conservative therapy. The primary outcome was the change in symptom severity from T0 to T1, assessed using the Hemorrhoidal Disease Symptom Score (HDSS), Short Health Scale HD (SHS-HD) and Vaizey incontinence score. Secondary outcomes included the rate of downgrading intervention. RESULTS: The present study included 34 patients (15 [44.1%] female) with a median age of 46.5 years (IQR 30-66). Both HDSS and SHS statistically improved from a median value of 11 and 16 at T0 to 2 and 1 at T1, respectively (P<0.00001). In 12 out of 34 (35.3%) of patients, the second colorectal surgeon considered a less invasive treatment due to the downstaging of symptoms. CONCLUSIONS: Combined local and systemic treatment with MPFF and sucralfate-based rectal ointment for HD patients showed clinical advantages both in terms of reducing the severity of the disease and allowing a less invasive treatment in certain cases.