Title:Safety and Efficacy of Proctosoll Allevia in the Management of Haemorrhoidal Disease in Adults: A Prospective Randomized Clinical Trial
VOLUME: 15 ISSUE: 2
Author(s):Alessandro Sturiale*, Gaetano Gallo, Luigi Brusciano, Concetta Cacace, Danilo Cafaro, Felipe Celedon Porzio and Gabriele Naldini
Affiliation:Proctology and Pelvic Floor Clinical Centre, Cisanello University Hospital, Pisa, Department of Medical and Surgical Sciences, University of Catanzaro, Catanzaro, Department of Medical, Surgical, Neurologic, Metabolic and Aging Sciences, General, Mininvasive and Obesity Surgery Unit, University of Campania "Luigi Vanvitelli" Naples, Proctology and Pelvic Floor Clinical Centre, General Surgery, Pisa, Proctology and Pelvic Floor Clinical Centre, Cisanello University Hospital, Pisa, Proctology and Pelvic Floor Clinical Centre, Cisanello University Hospital, Pisa, Proctology and Pelvic Floor Clinical Centre, Cisanello University Hospital, Pisa
Keywords:Cortisone-free cream, hemorrhoidal prolapse, hemorrhoids, Proctosoll Allevia®, safety and efficacy, randomized
clinical trial.
Abstract:
Introduction: Hemorrhoidal Disease (HD) is a very common anorectal disorder that affects
millions of people around the world and represents a major medical and socioeconomic problem.
The aim of the present study was to assess the safety and efficacy of Proctosoll Allevia® in patients
affected by symptomatic HD in comparison with the results obtained from a control group.
Materials and Methods: From January to February 2019, all the patients referred to the outpatient
clinic of Rajalakshmi Hospital, who were complaining of first or second degree hemorrhoidal symptoms,
were enrolled in the study. They were randomly assigned to either of the 2 arms. Group 1: patients
were treated with the Proctosoll Allevia® and were under a controlled diet. Group 2: patients
were only under a controlled diet without any treatment - control group.
Results: A total of 51 subjects were screened and 45 (13 F- 32 M) enrolled in the study. All the patients
treated with topical application of the cream showed a statistically significant improvement of
symptoms within 14 days from the beginning of the therapy if compared to patients who were treated
only with a controlled diet. No major adverse events associated with the use of the new product were
recorded.
Conclusion: The treatment of I-II degree symptomatic HD with Proctosoll Allevia® has demonstrated
to be promising with a good profile of tolerability, safety and efficacy.
