Effectiveness and Tolerability of Rectal Ointment and Suppositories Containing Sucralfate for Hemorrhoidal Symptoms: A Prospective, Observational Study

BACKGROUND AND AIMS A high number of topical products are available for the treatment of hemorrhoidal symptoms. Sucralfate-based topical products constitute a new treatment alternative that act as a mechanical barrier to facilitate healing. The aim of this prospective, observational study was to determine patient- and physician-assessed effectiveness and tolerability of rectal ointment and suppositories containing sucralfate for the treatment of hemorrhoidal symptoms in routine clinical practice. METHODS Adult patients with diagnosed, mild-to-moderate, symptomatic non-bleeding hemorrhoids treated with rectal ointment or suppositories containing sucralfate in routine clinical practice were enrolled. Patients were administered treatment twice per day for at least 1 week until symptom resolution and/or for a maximum of 4 weeks. The primary endpoint was patient-assessed effectiveness on a modified symptom severity score (mSSS, range 0 to 14). Physician-assessed effectiveness (9 symptoms, 0 to 5 Likert scale), hemorrhoid grade, and patient satisfaction were also determined. RESULTS Five investigators enrolled 60 patients; mean age was 48.4±16.6 years and 72.4% were female. Pain or pressure sensitivity was reported as the most severe symptom by patients, and pressure sensitivity, discharge, soiling and prolapse by physicians. Mean patient-assessed mSSS at baseline was 6.6±1.9 and was significantly improved overall and in the ointment and suppository groups individually by -4.6±2.0, -4.4±1.8, and -4.8±2.2, respectively (p<0.0001). Investigator-assessed mean baseline symptom score was 18.1±3.9 and improved by -7.1±4.5, -6.9±5.4, and -7.3 ± 3.5, respectively (p<0.0001). Investigator-assessed symptoms of pressure sensitivity, swelling and discharge were improved to the greatest extent. Hemorrhoid grade was improved in 38% of patients at the end of treatment. Compliance with treatment was 97.4% and patient satisfaction with application and onset of action was high (81.3% and 76.2%, respectively). Both the ointment and suppository were well tolerated. CONCLUSIONS The effectiveness of topical ointment or suppository containing sucralfate on patient- and investigator-assessed hemorrhoidal symptoms in real-life clinical practice was demonstrated. Patient satisfaction was high and treatments were well tolerated. Larger controlled trials are warranted to confirm the results.