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Volume 14
Issue 17
10.3390/jcm14176069
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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

A Substance-Based Medical Device for Managing Hemorrhoidal Disease: Output from a Cross-Sectional Survey

by
Roberto Cioeta
1,*,
Paola Muti
2,3,
Marta Rigoni
2,3,
Roberta La Salvia
1,
Elena Gabriele
1,
Andrea Cossu
1 and
Emiliano Giovagnoni
1
1
Aboca SpA, 52037 Sansepolcro, Italy
2
Department of Biomedical, Surgical and Dental Sciences, University of Milan, 20122 Milan, Italy
3
Istituto di Ricovero e Cura a Carattere Scientifico I.R.C.C.S. Multimedica, 20099 Milan, Italy
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2025, 14(17), 6069; https://doi.org/10.3390/jcm14176069 (registering DOI)
Submission received: 25 June 2025 / Revised: 3 August 2025 / Accepted: 7 August 2025 / Published: 27 August 2025
(This article belongs to the Special Issue Clinical Innovations in Digestive Disease Diagnosis and Treatment)
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Abstract

Background: Hemorrhoidal disease (HD) is a common anorectal condition characterized by symptoms such as bleeding, pain, discomfort and itching. While often underdiagnosed due to patient reluctance to seek care, HD significantly impacts quality of life (QoL). Conservative treatments are preferred for low-grade HD, with increasing interest in natural substance-based therapies. Materials and Methods: A large-scale survey was conducted using a digital platform to collect real-world data (RWD) from patients, pharmacists and physicians. The research assessed perceived effectiveness, safety, tolerability, quality of life (QoL) and usage patterns of NeoFitoroid BioOintment. Quantitative analysis was also performed using a global score (GS) based on Likert scale ratings and their distribution. Results: A total of 2618 participants were included. A strong concordance across the three participating cohorts in the answers provided for all items of the questionnaire was observed. The descriptive analysis revealed high grades of effectiveness, safety and tolerability. Indeed, over 90% of respondents rated the product as “good” or “excellent” in terms of effectiveness and safety. Conclusions: These findings underscore the treatment’s effectiveness, safety, tolerability and positive influence on QoL in HD patients.
Keywords: hemorrhoidal disease; real-word evidence, RWE; natural substance-based medical device; safety; effectiveness hemorrhoidal disease; real-word evidence, RWE; natural substance-based medical device; safety; effectiveness
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MDPI and ACS Style

Cioeta, R.; Muti, P.; Rigoni, M.; La Salvia, R.; Gabriele, E.; Cossu, A.; Giovagnoni, E. A Substance-Based Medical Device for Managing Hemorrhoidal Disease: Output from a Cross-Sectional Survey. J. Clin. Med. 2025, 14, 6069. https://doi.org/10.3390/jcm14176069

AMA Style

Cioeta R, Muti P, Rigoni M, La Salvia R, Gabriele E, Cossu A, Giovagnoni E. A Substance-Based Medical Device for Managing Hemorrhoidal Disease: Output from a Cross-Sectional Survey. Journal of Clinical Medicine. 2025; 14(17):6069. https://doi.org/10.3390/jcm14176069

Chicago/Turabian Style

Cioeta, Roberto, Paola Muti, Marta Rigoni, Roberta La Salvia, Elena Gabriele, Andrea Cossu, and Emiliano Giovagnoni. 2025. "A Substance-Based Medical Device for Managing Hemorrhoidal Disease: Output from a Cross-Sectional Survey" Journal of Clinical Medicine 14, no. 17: 6069. https://doi.org/10.3390/jcm14176069

APA Style

Cioeta, R., Muti, P., Rigoni, M., La Salvia, R., Gabriele, E., Cossu, A., & Giovagnoni, E. (2025). A Substance-Based Medical Device for Managing Hemorrhoidal Disease: Output from a Cross-Sectional Survey. Journal of Clinical Medicine, 14(17), 6069. https://doi.org/10.3390/jcm14176069

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