Scientific Evidence

Background/Objectives: Irritable Bowel Syndrome (IBS) is a widely prevalent chronic disorder of brain–gut interaction which represents a clinical challenge due to its complex underlying causes and the lack of a standardized treatment approach. This cross-sectional research collected real-world data (RWD) on the effectiveness, safety, and usage pattern of a natural substance-based medical device, Colilen IBS, indicated for the treatment of IBS. Methods: Surveys were conducted both in Italy and Germany with 6101 participants, including 4425 patients, 1014 pharmacists, and 662 physicians using a structured GxP web platform that allows voluntary participants to share their experiences with the device. The validated platform was designed to comply with post-market surveillance requirements of EU Regulation 2017/745. Statistical analyses included descriptive evaluations of responses to gauge overall effectiveness and safety of the device. Results: The effectiveness reported with the medical device was judged extreme or great by 79.2% of patients, with 89.2% of whom observed symptom improvement within one month. Both safety and tolerability were rated extreme or great by 90.7% of patients. Healthcare professionals reported a similar rate on the overall effectiveness, with 94.9% of pharmacists and 95.9% of physicians indicating it extreme or great. Similarly, the safety profile was corroborated by nearly all pharmacists (97.0%) and physicians (98.2%) reporting extreme or great satisfaction with both safety and tolerability of the medical device. Conclusions: This research provides RWD supporting the effectiveness and safety of the product for treating IBS. The strong coherence among patients, pharmacists, and physicians in positively rating the device’s performance suggests that this medical device represents a therapeutic option that effectively addresses patient needs while minimizing safety concerns. Continuous RWD collection is essential, as it offers insights into real-world practice and ensures ongoing confirmation of the product’s safety and effectiveness. Ultimately, this will advance IBS patient care by integrating real-world evidence into clinical management.

Background/Objectives: Metabolic syndrome (MetS) and even closely related metabolic and anthropometric alterations require timely intervention to reduce associated risks. Neo-Policaptil^® Gel Retard has shown potential in managing both established MetS and early imbalances. To further characterize its real-world impact, a large post-marketing survey was conducted to assess perceived effectiveness, safety, quality of life (QoL), and patterns of use. Methods: Between December 2021 and May 2025, patients/child caregivers, pharmacists, and physicians completed online questionnaires via a dedicated web platform. Patients reported their direct experience, while healthcare professionals (HCPs) provided observations on patient use. Results: The survey included 2204 patients, 57 child caregivers, 455 physicians, and 387 pharmacists. Overall, 97.7% of patients reported an improvement in their condition. Most physicians (94.3%) and pharmacists (89.1%) rated the overall effectiveness of the product as “good” or “excellent”. The safety profile was judged “good” or “excellent” by 84.4% of patients and by over 93% of HCPs. The product was mainly used as monotherapy or in combination with dietary measures and/or physical exercise. Conclusions: These findings underscore the product’s effectiveness, safety, tolerability, and positive influence on QoL in both adults and children affected by MetS or by related metabolic and anthropometric imbalances.

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.