Introduction: The Coronavirus disease 2019 (COVID-19) outbreak is a whole Earth health emergency related to a highly pathogenic human coronavirus responsible for severe acute respiratory syndrome (SARS-CoV-2). Despite the fact that the majority of infected patients were managed in outpatient settings, little is known about the clinical characteristics of COVID-19 patients not requiring hospitalization. The aim of our study was to describe the clinical comorbidity and the pharmacological therapies of COVID-19 patients managed in outpatient settings. Materials and Methods: We performed an observational, retrospective analysis of laboratory-confirmed COVID-19 patients managed in outpatient settings in Naples, Italy between 9 March and 1 May 2020. Data were sourced from the prospectively maintained Health Search (HS)/Thales database, shared by 128 primary care physicians (PCPs) in Naples, Italy. The clinical features and pharmacological therapies of COVID-19 patients not requiring hospitalization and managed in outpatient settings have been described. Results: A total of 351 laboratory-confirmed COVID-19 patients (mean age 54 ± 17 years; 193 males) with outpatient management were evaluated. Hypertension was the most prevalent comorbidity (35%). The distribution of cardiovascular comorbidities showed no gender-related differences. A total of 201 patients (57.3%) were treated with at least one experimental drug for COVID-19. Azithromycin, alone (42.78%) or in combination (27.44%), was the most widely used experimental anti-COVID drug in outpatient settings. Low Molecular Weight Heparin and Cortisone were prescribed in 24.87% and 19.4% of the study population, respectively. At multivariate regression model, diabetes (risk ratio (RR): 3.74; 95% CI 1.05 to 13.34; p = 0.04) and hypertension (RR: 1.69; 95% CI 1.05 to 2.7; p = 0.03) were significantly associated with the experimental anti-COVID drug administration. Moreover, only diabetes (RR: 2.43; 95% CI 1.01 to 5.8; p = 0.03) was significantly associated with heparin administration. Conclusions: Our data show a high prevalence of hypertension, more likely treated with renin–angiotensin–aldosterone system (RASS) inhibitors, among COVID-19 patients not requiring hospitalization. Experimental COVID-19 therapies have been prescribed to COVID-19 patients considered at risk for increased venous thromboembolism based on concomitant comorbidities, in particular diabetes and hypertension.

The risk of cardiovascular disease (CVD) is approximately doubled in subjects with hypercholesterolemia compared to those with normal blood cholesterol levels. Monacolin K (MK), the main active substance in rice fermented by the Monascus purpureus, acts on cholesterol metabolism. Rice also contains other bioactive compounds such as γ-oryzanol (OZ) and γ-aminobutyric acid (GABA). In a randomized, placebo-controlled, double-blind trial, the efficacy and tolerability of a food supplement (FS) based on an ingredient standardized to contain monacolins (4.5%), OZ, and GABA were evaluated in subjects with mild dyslipidemia. For the duration of the trial, enrolled subjects (n = 44, each group) received the FS or placebo and were instructed to use an isocaloric diet. Compared to the placebo group, after a 3 months of the FS, the mean low-density lipoprotein cholesterol and mean TC values were reduced by 19.3 and 8.3%, respectively, while the mean high-density lipoprotein cholesterol value increased by 29.3%. On average, the subjects shifted from very high to moderate CVD risk. Glucose metabolism and hepatic and renal parameters did not change after the treatment and no adverse events were reported. Guidelines to handle hypercholesterolemia with food supplements in specific clinical settings are needed to better manage mild dyslipidemia.

Background Atrial fibrillation (AF) is the most common cardiac arrhythmia and is associated with a heavy burden of morbidity and mortality, mainly due to an increased risk of cerebrovascular events and cardiac failure. Oral anticoagulant (OAC) treatment prevents stroke and systemic thromboembolism in patients with AF and its use is strongly recommended in guidelines. However, its use in this patient group remains limited. Primary care physicians (PCPs) have an important role to play in this context. Objective The primary objective was to estimate prevalence and epidemiological features of AF in the primary care setting, focusing on ischaemic and bleeding risk assessment. A secondary objective was to examine the PCPs’ level of adherence to the guidelines for the prevention of thromboembolic risk in these patients. Methods This retrospective, observational study was based on data entered by 128 PCPs into the Health Search (HS) Thales database, identifying patients with a diagnosis of AF at the time of the analysis. Results Out of 167,056 patients analysed, 2,173 (1.3 %) were diagnosed with AF, with 86 % at high risk for ischaemic stroke, according to CHA₂DS₂-VASc (congestive heart failure, hypertension, age ≥75 years [doubled], diabetes, stroke [doubled], vascular disease, age 65–74 years, sex category [female]) stratification. After the diagnosis of AF, 84 % of patients were prescribed OAC treatment. However, at 2 years’ follow-up, only 29.6 % were still being treated with OACs. Conclusion The prevalence of AF in this analysis was consistent with previously reported Italian national epidemiological data. Adherence to the European Society of Cardiology AF guidelines by PCPs was low, despite the high levels of stroke risk. At the end of the observation period less than one-third of patients were still on OAC therapy. Awareness of the benefits of OACs in stroke prevention in AF patients needs to be improved.

Background/Objectives: Irritable Bowel Syndrome (IBS) is a disorder of the gut-brain axis for which the gastroenterologist is most often consulted. Gastrointestinal symptoms and decreased quality of life lead to a considerable burden of disease. The exact causes of IBS are not well understood, and no standard therapy has been established. The primary outcome of the study focused on the improvements of the IBS symptoms assessed through the validated questionnaire IBS-Severity Scoring System (IBS-SSS). Similarly, secondary outcomes geared towards the improvement of the quality of life (IBS-Quality of Life (IBS-QoL) and the Gastrointestinal Quality of Life Index (GIQLI)) and specific IBS symptoms (bloating, abdominal distension, feeling of heaviness, abdominal pain, and flatulence), were assessed through self-administered questionnaires. Intestinal habits (consistency and frequency of depositions) through subject stratification into diarrhoea (IBS-D), constipation (IBS-C), mixed type (IBS-M), as well as the treatment tolerability were also evaluated. Methods: A randomised, placebo-controlled, double-blind, clinical trial was conducted on 156 enrolled IBS patients (79 female and 77 male), aged 18–70 years, randomised (1:1 allocation ratio) to receive either two capsules per day of the food supplement (containing 480 mg of a complex of tannin extracts) or a placebo for 56 days. Linear random intercept mixed models (LMM) were used to analyse all experimental variables Results: Supplementation resulted in a significant improvement (p < 0.05) in the primary outcome IBSS score, with respect to the placebo group, changing the IBS condition going from mild (242.3 ± 89.8) to moderate (148.1 ± 60.6). Similarly, all indicators concerning quality of life, and specific intestinal symptoms resulted in a significant improvement (p < 0.05). Furthermore, the tannin-based treatment showed the ability to modulate the response to different symptomatology such as diarrhoea and constipation, without side effects being reported. Conclusions: The use of a supplement based on chestnut and quebracho tannins presents great application potential in the management of IBS-related disorders, with the peculiarity of resolving opposite symptoms, such as diarrhoea and constipation, indiscriminately.

Preclinical studies have shown that the combination of Cistus × incanus L. and Scutellaria lateriflora L. extracts exerts beneficial effects on oral health against gingivitis. Thus, this study aimed to assess the tolerability of a chewing gum and its efficacy on gingivitis in a double-blind, placebo-controlled clinical trial. Enrolled subjects (n = 60, 18–70 years) were randomized to receive two chewing gums or a placebo daily for 3 months. At baseline (t0) and monthly (t1, t2, and t3) timepoints, the Quantitative Gingival Bleeding Index (QGBI), the Modified Gingival Index (MGI), and the Oral Health 15 items (OH-15)] were employed to assess potential improvements in gingivitis. Pain was self-quantified via the Visual Analogue Scale (VAS), and the Clinical Global Impression Scale for Severity of illness (CGI-S) helped in evaluating the oral general conditions. This study is listed on the ISRCTN registry. At t3, the QGBI, MGI, OH-15, VAS, and CGI-S values decreased in the treated but not in the placebo group (β = 0.6 ± 0.1, t₁₇₆ = 3.680, p < 0.001; β = 0.87 ± 0.21, t₁₁₅ = 4.263, p < 0.001; β = 5.3 ± 2.5, t₁₇₂ = 2.086, p = 0.038; β = 3.16 ± 0.51, t₈₈ = 6.253, p < 0.001; and β = 1.09 ± 0.32, t₈₃ = 3.419, p < 0.001, respectively). A significant improvement in gingival health occurred after a 3-month intervention with the chewing gums containing S. lateriflora and C. incanus extracts.

Background/Objectives: Primary insomnia is characterized by persistent sleeplessness that is not caused by medical, psychological, or environmental factors. It is defined by difficulty initiating or maintaining sleep for at least one month, leading to significant distress or impairment in daily functioning. This randomized, crossover, double-blind, placebo-controlled clinical trial aimed to assess the efficacy and tolerability of a Scutellaria lateriflora L. extract-based food supplement in subjects with mild to moderate primary insomnia. Methods: A total of 66 participants, aged 18–70 years, were randomly allocated into two groups (1:1 allocation ratio) and received either the food supplement (400 mg/day) or a placebo for 56 days, separated by a 28-day washout period. The clinical effectiveness of the food supplement was assessed using the Pittsburgh Sleep Quality Index (PSQI) as the primary outcome measure. Secondary outcomes included sleep-wake cycle parameters (sleep onset latency, sleep efficiency, and total sleep time) and a Visual Analog Scale (VAS). Results: A significant improvement in sleep-wake balance following supplementation with S. lateriflora, as reflected by enhanced scores in both primary and secondary outcomes, was observed. Furthermore, none of the participants reported adverse effects from the food supplement. Conclusions: Overall, these findings suggest that a S. lateriflora extract-based food supplement is a safe and effective strategy for restoring the sleep-wake cycle and improving quality of life in individuals with primary insomnia.