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Original Article   

Minerva Gastroenterology 2022 May 05

DOI: 10.23736/S2724-5985.22.03173-4

Copyright © 2022 EDIZIONI MINERVA MEDICA

language: English

Safety and efficacy of Oryza sativa topical treatment in subjects with hemorrhoidal disease: a randomized, double blind, clinical trial

Alessandro STURIALE 1 , Lisa FRALLEONE 1, Danilo CAFARO 2, Gaetano GALLO 3, Luigi BRUSCIANO 4, Felipe CELEDON PORZIO 5, Sreedhara VENKATARATNAIAH SETTY 6, Gabriele NALDINI 1

1 Proctology and Pelvic Floor Clinical Centre, Cisanello University Hospital, Pisa, Italy; 2 Proctology surgery, Tropea Hospital, Vibo Valentia, Italy; 3 Department of Medical and Surgical Sciences, University of Catanzaro, Catanzaro, Italy; 4 Division of General, Oncologic, Mininvasive and Bariatric Surgery, University of Campania Luigi Vanvitelli, Naples, Italy; 5 Cirugia Coloproctologica, Hospital de la Fuerza Aerea de Chile, Santiago de Chile, Chile; 6 SPARSH Hospital, Bangalore, Karnataka, India


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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 is to assess the safety and efficacy of a topical medical device (Lenoid™) 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 (Lenoid™) was found safe and effective in improving clinical signs and symptoms in patients with grade I-II HD.


KEY WORDS: Hemorrhoids; Oryza sativa; topical treatment

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