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.