Safety and efficacy of topical drug-free cream in subjects with hemorrhoidal disease: a randomized, double blind, clinical trial

Background: Hemorrhoidal disease (HD) is one of the most common anorectal benign disorder affecting millions of people around the world. Grade I-II HD are generally treated with a conservative approach with topical products such as creams and ointments considered a safe and effective option to treat mild symptoms. The aim of the present study was to assess the safety and efficacy of a topical medical device (Lenoid™; International Health Science [IHS] - Biofarma Group, Mereto di Tomba, Udine, Italy) in patients affected by symptomatic HD. Methods: This study is a randomized, double blind, placebo-controlled, 2-weeks clinical trial. Patients affected by I-II grade symptomatic HD were enrolled in the study and then randomly assigned to Lenoid™ arm (LA) or placebo arm (PA), respectively. Patients were evaluated before and after intervention through clinical examination and disease-specific questionnaires assessing symptoms such as pain, tenesmus, pruritus and anal discharge. Results: A total of 68 patients were screened and 60 (30 in each group) were enrolled into the study. All patients belonging to LA showed a statistically significant improvement of each symptom after 7 and 14 days of treatment when compared to PA (P<0.001). Furthermore, subjective improvement of change in overall assessment of disease was observed in the LA but not in the PA. No serious adverse events were recorded. Conclusions: The tested product was found safe and effective in improving clinical signs and symptoms in patients with grade I-II HD.