To mitigate healthcare’s unintended effects, environmental risk data such as ecotoxicity and environmental contamination need to be considered by all stakeholders in the healthcare value chain. As decision-makers and educators, healthcare providers are in a unique position to make healthcare delivery more sustainable. However, current benefit-risk assessments of therapeutic products do not systematically include environmental risk data. The purpose of this paper was to review the literature and regulatory context and propose expanding benefit-risk assessments of therapeutic products to include an evidence-based evaluation of environmental impact to inform decision-making. Our findings indicate that environmental risk assessments need to be broadened to include aspects such as excipients, synergistic effects of contaminants, and risks to humans (e.g., drinking water). Concrete proposals to improve current regulatory guidelines for environmental risk assessment already exist. Open access databases on environmental risk of substances used in products for human consumption are available. The European Union Regulation on Medical Devices provides the basis for evidence-based approach to developing sustainable therapeutic products based on natural substances. Based on this, the here promoted decision scheme for healthcare providers (and other stakeholders) involves comparing the clinical safety and efficacy of therapeutic products; comparing environmental impact data; and then deciding. A case example involving the treatment of patients with gastroesophageal reflux and dyspepsia is presented. We provide suggestions for integrating persistence and ecotoxicity data into clinical practice. Expanding the benefit-risk assessment to include data on environmental impact during clinical decision-making is a way to achieve a healthier outcome for all.

When the protective mechanisms of the gastroesophageal mucosa are overwhelmed by injurious factors, the structural and functional mucosal integrity is compromised, resulting in a wide spectrum of disorders. Poliprotect has recently been shown to be non-inferior to standard-dose omeprazole for the treatment of endoscopy-negative patients with heartburn and/or epigastric pain or burning. Here, we provide preclinical data describing the mechanism of action of the Poliprotect formulation, a 100% natural, biodegradable, and environmental friendly medical device according to EU 2017/745 and containing UVCB (unknown or variable composition, complex-reaction products, or biological materials) substances of botanical and mineral origin, according to the REACH and European Chemical Agency definitions. Different in vitro assays demonstrated the capability of Poliprotect to adhere to mucus-secreting gastric cells and concomitantly deliver a local barrier with buffering and antioxidant activity. In studies conducted in accordance with systems biology principles, we evaluated the effects of this barrier on human gastric cells exposed to acidic stress. Biological functions identified via Ingenuity Pathway Analysis highlighted the product’s ability to create a microenvironment that supports the mucosal structural and functional integrity, promotes healing, and restores a balanced mucosal inflammatory status. Additionally, transepithelial electrical resistance and an Ussing chamber showed the product’s capability of preserving the integrity of the gastric and esophageal epithelial barriers when exposed to an acid solution. Two in vivo models of erosive gastropathy further highlighted its topical protection against ethanol- and drug-induced mucosal injury. Overall, our findings sustain the feasibility of a paradigm shift in therapeutics R&D by depicting a very innovative and desirable mode of interaction with the human body based on the emerging biophysical, rather than the pharmacological properties of these therapeutic agents.

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.

Hemorrhoidal disease (HD) is one of the most common anorectal conditions seen in general practice, but the true prevalence in the general population is not well understood, partly because many patients do not seek treatments. There are many factors which can favour the onset of haemorrhoidal disease. The most common of these are constipation, pregnancy, dietary factors, overweight, obesity, sedentary lifestyles, exertion and sport, heredity. The HD is classified according to their location and degree of prolapse. There are 3 types of haemorrhoids: internal haemorrhoids, external haemorrhoids and mixed haemorrhoids (internal and external). By analyzing the real-word data (RWD) obtained through this survey, it is possible to notice how patients, pharmacists and physicians have reported a very positive effectiveness profile of Neofitoroid BioOintment associated with a very favorable perception of its efficacy and safety profile. In addition, the data indicate that the ointment is widely used both as a monotherapy and in combination with other treatments, underscoring its versatility and clinical relevance across a range of therapeutic contexts. From this point of view, it was observed that all three populations showed a strong concordance and coherence on all items of the questionnaire. The quali-quantitative analyses revealed higher levels of effectiveness , safety and tolerability. A hypothetical parametric distribution (HPD), was used as control, in order to compare RW results to find the significant differences (p<0.05). These findings underscore the treatment’s effectiveness, safety, tolerability, and positive influence on quality of life for patients with hemorrhoids.

Diarrhea continues to be a global health problem as acute diarrhea carries the risk of dehydration, while both acute and chronic diarrhea can significantly affect patients’ quality of life and reduce productivity. The innovative medical device Actitan, which consists of a complex of natural molecules, could be an effective option for the treatment of diarrhea from various causes. The aim of this post-market cross-sectional study was to evaluate the perceived efficacy, safety and usage pattern of the two formulations for adults (Actitan-P) and children (Actitan-F) among patients/child caregivers, physicians and pharmacists. Participants completed online questionnaires with closed multiple-choice questions that were rated on a verbal 5-point Likert scale. These surveys were conducted via the online platform Real World Data, which provides digital questionnaires for patients, doctors and pharmacists. Two separate surveys were conducted for the two formulations, with a total of 2630 participants (1488 participants for Actitan-P and 1142 participants for Actitan-F). Overall, the results indicate a high level of efficacy and safety of the product. In the case of Actitan-F, more than 96% of caregivers rated safety as good or excellent, and over 92% rated efficacy as good or excellent. Actitan-P also received positive feedback: nearly 86% of patients reported good/excellent efficacy, and more than 93% rated safety as good or excellent. These positive evaluations were confirmed by physicians and pharmacists, who also did not report adverse effects. In summary, this study confirms the role of Actitan as a safe and effective option for the treatment of diarrhea of different causes and in different patient groups, including young children.

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.