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The aim of this study was to evaluate the effects of RobuvitOne group of patients followed the Standard management (SM) and were assigned as controls while the supplementation group followed the SM and additionally took 2 Robuvit® capsules daily for 3 months (200 mg/day).34 subjects with NAFLD were included in the study. The two groups completing 90 days were comparable at baseline with 18 being supplemented with RobuvitRobuvit® improved liver function in NAFLD and prevented progression to liver fibrosis by improving hepatic metabolism in a relatively short period of time. Numerous people are affected by NAFLD, many of them with subclinical symptoms. But to date, there are no specific, definite treatment options. Prolonged evaluations of Robuvit® in a larger group of subjects is suggested.

The aim of this pilot registry study was to assess the preventive effect of an 8-week PycnogenolThe study was based on five types of observations: a. Karnofsky performance scale index; b. oxidative stress markers in plasma (plasma free radicals, PFR); c. the main signs and symptoms, evaluated by a physician; d. face motion and expressions and their symmetry, recorded with a high-speed video camera.A total of 79 patients were included in the study: 39 controls using only standard management (SM) and 40 subjects supplemented with PycnogenolIn conclusion, according to this pilot registry study, Pycnogenol

The aim of this registry study was to evaluate the preventive efficacy of PycnogenolTwo management groups were formed: one using the standard management (SM) and one using SM and PycnogenolForty-five subjects were included in the study, 21 took PycnogenolPycnogenol

Intestinal fat absorption shifting (IFAS) can be achieved with a polyglucosamine biopolymer (BP) able to retain most fats in the gut so that they are available to the intestinal microbiota (shift). The aim of this study was to evaluate the effects of the standard management (SM) of asymptomatic cardiovascular disease prevention on intima-media thickness (IMT) in comparison with SM combined with BP.Two groups (SM and SM+3 g BP/day) were compared. They consisted of 86 and 81 subjects respectively treated for 6 months. Anthropometric variables, vital signs, fat mass, lipid profile, oxidative stress, carotid IMT, granulations at the IM layer and near-wall low density bubbles were measured.Seventy-eight cases in the SM group and 81 in the SM+BP group completed the management period. Compliance was optimal (97%) with no side effects. The anthropometric variables, vital signs, fat mass and oxidative stress were significantly lower only in the SM+BP group (P0.05). Cholesterol and triglyceride levels improved with BP use (P0.05). The changes in IMT were reduced significantly (P0.05) in the SM+BP group only. The same was true for intimal granulation/bubbles.The preliminary results suggest that the IFAS caused by BP has a positive effect on IMT and arterial wall structure (thickness and low-density bubbles) even during a short period of management. The intestinal fat shifting and reduction in oxidative stress seem to limit lipid oxidation and deposition on the arterial wall.

Objective: To calculate by means of a computer-aided tool the volumes of healthy residual lung parenchyma, of emphysema, of ground glass opacity (GGO) and of consolidation on chest computed tomography (CT) in patients with suspected viral pneumonia by COVID-19. Materials and methods: This study included 116 patients that for suspected COVID-19 infection were subjected to the reverse transcription real-time fluorescence polymerase chain reaction (RT-PCR) test. A computer-aided tool was used to calculate on chest CT images healthy residual lung parenchyma, emphysema, GGO and consolidation volumes for both right and left lung. Expert radiologists, in consensus, assessed the CT images using a structured report and attributed a radiological severity score at the disease pulmonary involvement using a scale of five levels. Nonparametric test was performed to assess differences statistically significant among groups. Results: GGO was the most represented feature in suspected CT by COVID-19 infection; it is present in 102/109 (93.6%) patients with a volume percentage value of 19.50% and a median value of 0.64 L, while the emphysema and consolidation volumes were low (0.01 L and 0.03 L, respectively). Among quantified volume, only GGO volume had a difference statistically significant between the group of patients with suspected versus non-suspected CT for COVID-19 (p < < 0.01). There were differences statistically significant among the groups based on radiological severity score in terms of healthy residual parenchyma volume, of GGO volume and of consolidations volume (p < < 0.001). Conclusion: We demonstrated that, using a computer-aided tool, the COVID-19 pneumonia was mirrored with a percentage median value of GGO of 19.50% and that only GGO volume had a difference significant between the patients with suspected or non-suspected CT for COVID-19 infection.

Back pain (BP) is one of the most common problems seen by general practitioners. The aim of this pilot registry study was to evaluate the effects of PycnogenolThe registry follow-up lasted 3 weeks. Subjects used either SM (standard management), including mild exercise and 3 days of resting or immobilization - or SM+PycnogenolEighty-two subjects were included in the study, 23 took PycnogenolPycnogenol

BACKGROUND The aim of this pilot, registry study was to evaluate the prophylactic effects of oral supplementation with Pycnogenol® (150 mg/day) in subjects with previous history of recurrent (urinary tract infections (UTI) in a 2-month open follow-up. METHODS subjects with recurrent-UTIs, defined by: 1) at least three symptomatic UTIs over the past year; 2) two episodes of UTI's in the past six months; 3) symptoms of UTIs with urinalysis without bacterial presence, were included in the study. Pycnogenol® was supplemented at the dose of 150 mg/day for 2 months. RESULTS The two groups of subjects (supplement and controls, each including 25 subjects) were demographically and clinically comparable at baseline. No side effects or tolerability problems were observed. The registry evaluated the number of recurrent UTIs in two months; there was a limited decrease in the rate of recurrent UTIs, in comparison with the period before inclusion of 9.93% in the standard management group in comparison with a more important decrease in the Pycnogenol® group (-50.1%; P

In this preliminary pilot registry study, we investigated the effects of the oral supplementation of a standardized cranberry extract (Anthocran® Phytosome®, Indena) delivered by a lecithin-based system, for the prophylactic management of recurrent-urinary tract infections (R-UTIs). We included 64 otherwise healthy subjects who underwent a surgical procedure and required post-surgical urinary catheterization for high-risk UTIs or a previous history of R-UTIs. Patients were given supplementation with the standardized cranberry extract at the dose of either 120 mg/day (n = 12) or 240 mg/day (n = 12) or assigned to a control group consisting of standard management (SM; n = 18) or nitrofurantoin administration (n = 22) for 4 weeks. After 4 weeks, patients receiving the standardized cranberry supplementation reported to have a more effective reduction in UTI symptoms, as assessed on the visual analogue scale, compared with patients in the SM or nitrofurantoin groups. The occurrence of hematuria and urine bacterial contamination were decreased among patients treated with the supplement compared with controls (p < 0.05). The cranberry extract was also superior to the control management in terms of recurrence of signs/symptoms, with none of the patients in this group suffering from a R-UTI in the 3 months following the study end (p < 0.05). The supplementation showed an optimal safety profile, with no significant adverse events and no drop-outs in the supplement group. This registry shows that this cranberry extract is effective as a supplementary, preventive management in preventing post-operative, post-catheter UTIs; the product has a good tolerability profile.

AIM: The aim of this study was the evaluation of the combination of Pycnogenol® (150 mg/day) and Centella asiatica (Centellicum® 3 x 225 mg/day) (PY-CE) for 8 months in subjects with sequelae of idiopathic interstitial pneumonia (IIP). Recently, post-COVID-19 lung disease is emerging with large numbers of patients left with chronic lung conditions. Considering the antifibrotic activity of the combination PY-CE, we also tested this supplementary management in post-COVID-19 lung patients. RESULTS: 19 subjects with idiopathic interstitial pneumonia (IIP) were included in the study. High Resolution CT scans at inclusion confirmed the presence of lung fibrosis: 10 patients were treated with the Pycnogenol® Centellicum® combination and 9 subjects with standard management (SM) served as controls. Oxidative stress that was very high in all subjects at inclusion, decreased significantly in the supplement group (p

BACKGROUND: The aim of this open supplement study was to evaluate the effects of Pycnogenol® in comparison with controls on symptoms of post-COVID-19 syndrome and in improving endothelial function, microcirculation, inflammatory markers and oxidative stress over 3 months in symptomatic subjects recovering from COVID-19. METHODS: Sixty subjects recovering from symptomatic COVID-19 were included. One group of 30 followed a standard recovery management while 30 comparable subjects received a supplement of 150 mg Pycnogenol® daily (in 3 doses of 50 mg) in addition to standard management. RESULTS: Two groups of selected subjects were comparable at baseline. The groups progressively improved both with the SM (standard management) and with the SM in combination with the supplement. Patients, supplemented with Pycnogenol® showed significantly better improvement compared to the control group patients. No side effects from the supplementation were observed; tolerability was optimal. The progressive evolution over time was visible in all target measurements. Physiological tests. Endothelial function, low in all subjects at inclusion was assessed by flow mediated dilation (FMD) and finger reactive hyperemia in the microcirculation (laser Doppler measurements) after the release of an occluding suprasystolic cuff). It was significantly improved in the Pycnogenol® group after one month and after 3 months (p

Background and Objectives: The potential role of lung ultrasound (LUS) in characterizing lung involvement in Coronavirus disease 2019 (COVID-19) is still debated. The aim of the study was to estimate sensitivity of admission LUS for the detection of SARS-CoV-2 lung involvement using Chest-CT (Computed Tomography) as reference standard in order to assess LUS usefulness in ruling out COVID-19 pneumonia in the Emergency Department (ED). Methods: Eighty-two patients with confirmed COVID-19 and signs of lung involvement on Chest-CT were consecutively admitted to our hospital and recruited in the study. Chest-CT and LUS examination were concurrently performed within the first 6–12h from admission. Sensitivity of LUS was calculated using CT findings as a reference standard. Results: Global LUS sensitivity in detecting COVID-19 pulmonary lesions was 52%. LUS sensitivity ranged from 8% in case of focal and sporadic ground-glass opacities (mild disease), to 52% for a crazy-paving pattern (moderate disease) and up to 100% in case of extensive subpleural consolidations (severe disease), although LUS was not always able to detect all the consolidations assessed at Chest-CT. LUS sensitivity was higher in detecting a typical Chest-CT pattern (60%) and abnormalities showing a middle-lower zone predominance (79%). Conclusions: As admission LUS may result falsely negative in most cases, it should not be considered as a reliable imaging tool in ruling out COVID-19 pneumonia in patients presenting in ED. It may at least represent an expanded clinical evaluation that needs integration with other diagnostic tests (e.g., nasopharyngeal swab, Chest-CT).

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

BACKGROUND The aim of this registry study was the prospective evaluation of the efficacy of Pycnogenol® in idiopathic fibromyalgia (FM), over 4 weeks in comparison with the standard management (SM). METHODS A SM and a Pycnogenol®+SM group were formed. Pycnogenol® supplementation was used at the dose of 150 mg/day (4 weeks). The study considered the most important/frequent symptoms of FM. RESULTS Fifty patients with idiopathic fibromyalgia were included: 26 in the Pycnogenol® group and 24 served as controls. The two groups were comparable at inclusion. No other disease or condition was present. All subjects were otherwise healthy women (BMI

To assess the performance of the second reading of chest compute tomography (CT) examinations by expert radiologists in patients with discordance between the reverse transcription real-time fluorescence polymerase chain reaction (RT-PCR) test for COVID-19 viral pneumonia and the CT report. Three hundred and seventy-eight patients were included in this retrospective study (121 women and 257 men, 71 years median age, with a range of 29&ndash, 93 years) and subjected to RT-PCR tests for suspicious COVID-19 infection. All patients were subjected to CT examination in order to evaluate the pulmonary disease involvement by COVID-19. CT images were reviewed first by two radiologists who identified COVID-19 typical CT patterns and then reanalyzed by another two radiologists using a CT structured report for COVID-19 diagnosis. Weighted k values were used to evaluate the inter-reader agreement. The median temporal window between RT-PCRs execution and CT scan was zero days with a range of (&minus, 9, 11) days. The RT-PCR test was positive in 328/378 (86.8%). Discordance between RT-PCR and CT findings for viral pneumonia was revealed in 60 cases. The second reading changed the CT diagnosis in 16/60 (26.7%) cases contributing to an increase the concordance with the RT-PCR. Among these 60 cases, eight were false negative with positive RT-PCR, and 36 were false positive with negative RT-PCR. Sensitivity, specificity, positive predictive value and negative predictive value of CT were respectively of 97.3%, 53.8%, 89.0%, and 88.4%. Double reading of CT scans and expert second readers could increase the diagnostic confidence of radiological interpretation in COVID-19 patients.

This open pilot registry study aimed to evaluate and compare the prophylactic effects of Pycnogenol® or cranberry extract in subjects with previous, recurrent urinary tract infections (UTI) or interstitial cystitis (IC). Methods. Inclusion criteria were recurrent UTI or IC. One subject group was supplemented with 150 mg/day Pycnogenol®, another with 400 mg/day cranberry extract, and a group served as a control in a 2-month open follow-up. Results. 64 subjects with recurrent UTI/IC completed the study. The 3 groups of subjects were comparable at baseline. All subjects had significant symptoms (minor pain, stranguria, repeated need for urination, and lower, anterior abdominal pain) at inclusion. In the course of the study, the subjects reported no tolerability problems or side effects. The incidence of UTI symptoms, in comparison with the period before inclusion in the standard management (SM) group, decreased significantly; there was a more pronounced decrease in the rate of recurrent infections in the Pycnogenol® group ( p < 0.05 ). The improvement in patients supplemented with Pycnogenol® was significantly superior to the effects of cranberry. At the end of the study, all subjects in the Pycnogenol® group were infection-free ( p < 0.05 vs. cranberry). Significantly, more subjects were completely symptom-free after 2 months of management with Pycnogenol® (20/22) than with SM (18/22) and cranberry (16/20). Conclusions. This pilot registry suggests that 60 days of Pycnogenol® supplementation possibly decrease the occurrence of UTIs and IC without side effects and with an efficacy superior to cranberry.

Purpose: To compare different commercial software in the quantification of Pneumonia Lesions in COVID-19 infection and to stratify the patients based on the disease severity using on chest computed tomography (CT) images. Materials and methods: We retrospectively examined 162 patients with confirmed COVID-19 infection by reverse transcriptase-polymerase chain reaction (RT-PCR) test. All cases were evaluated separately by radiologists (visually) and by using three computer software programs: (1) Thoracic VCAR software, GE Healthcare, United States, (2) Myrian, Intrasense, France, (3) InferRead, InferVision Europe, Wiesbaden, Germany. The degree of lesions was visually scored by the radiologist using a score on 5 levels (none, mild, moderate, severe, and critic). The parameters obtained using the computer tools included healthy residual lung parenchyma, ground-glass opacity area, and consolidation volume. Intraclass coefficient (ICC), Spearman correlation analysis, and non-parametric tests were performed. Results: Thoracic VCAR software was not able to perform volumes segmentation in 26/162 (16.0%) cases, Myrian software in 12/162 (7.4%) patients while InferRead software in 61/162 (37.7%) patients. A great variability (ICC ranged for 0.17 to 0.51) was detected among the quantitative measurements of the residual healthy lung parenchyma volume, GGO, and consolidations volumes calculated by different computer tools. The overall radiological severity score was moderately correlated with the residual healthy lung parenchyma volume obtained by ThoracicVCAR or Myrian software, with the GGO area obtained by the ThoracicVCAR tool and with consolidation volume obtained by Myrian software. Quantified volumes by InferRead software had a low correlation with the overall radiological severity score. Conclusions: Computer-aided pneumonia quantification could be an easy and feasible way to stratify COVID-19 cases according to severity, however, a great variability among quantitative measurements provided by computer tools should be considered.

Background Neck/shoulder, sudden pain, or muscular pain (not associated to structural or bone/joints components), due to fascial or muscular strain is common in active subjects, in non-professional athletes and sports performers. The aim of this supplement registry was the evaluation of a cream based on natural, active ingredients for topical application in supporting the improvement of pain and improving head/neck mobility, possibly minimizing the use of systemic drugs. Methods The cream includes standardized active ingredients of natural origin as an extract of Harpagophytum procumbes, an extract from Boswellia serrata, a CO2 extract of ginger and escin. Subjects were divided into three groups, all using the standard management (SM) in combination with the Sport Cream or in addition to Flector (diclofenac) patch. Results The groups were comparable and homogeneous at the baseline. No side effects or skin tolerability issues were observed with the Sport Cream nor with the SM or diclofenac patches. Subjects receiving sport cream + SM reported a significant improvement in pain, stiffness, altered mobility and altered working capacity, with a reduced need for rescue medication (diclofenac) compared to subjects in the other two groups. Conclusions Finally, subjects receiving sport cream + SM reported a more remarkable decrease in skin temperature in the affected area associated to an improvement in clinical symptoms.

Xerostomia is a symptom frequently present in patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM). In the present trial, the activity of an artificial saliva (aldiamed&reg, spray) in comparison to a placebo spray were used to evaluate the xerostomia and the saliva antioxidant capacity (SAT). Sixty patients of both genders with T1DM or T2DM were randomized into two groups of 30 subjects each. The experiment was a double-blind study approved by the Ethics Committee of the &ldquo, G. d&rsquo, Annunzio University&rdquo, of Chieti and Pescara. Moreover, measurements of the stimulated saliva flow rate and the ultrasonography of the submandibular and parotid glands were performed at both the study time points. The results demonstrated statistically significant differences between the treatments in terms of the xerostomia average score. Specifically, the values were at baseline and after 30 days 2.9 &plusmn, 1.31 and 3.0 &plusmn, 1.44 and 1.4 &plusmn, 1.48 and 2.4 &plusmn, 0.99 for aldiamed&reg, spray and the placebo, respectively. Meanwhile, no statistically significant differences were shown between the two groups for the other variables, such as the salivary flow rate, the antioxidant capacity of the saliva, and the ultrasonography of the major salivary glands.

BACKGROUND The aim of this registry study was to evaluate the effects of Robuvit® (extract from oak wood), in otherwise healthy subjects (aged 50 to 65 years) who complained of decreased general vigor. Robuvit® has been shown to be effective in convalescence, chronic fatigue syndrome and post-traumatic stress disorder. METHODS The standard management (SM) for this condition included diet, regular daily routines and regular exercise. All subjects had increased oxidative stress (>350 Carr Units) at inclusion. Two groups, SM and SM+Robuvit® supplementation, were formed. Robuvit® was supplemented at a dose of 300 mg/day for 4 weeks. A visual analogue scale line or vigor visual analogue line score of the most common problems associated with a decrease in vigor was used by all included subjects. RESULTS Forty subjects were included in the study. 20 in the SM group and 20 in the SM + Robuvit® supplement group. All subjects completed the 4-week study; both groups improved with the health program and under SM. No drop-outs and no side effects were recorded; a very good tolerability for the supplement was reported. At 4 weeks, the scores in Robuvit®-supplemented subjects, were significantly higher for all vigor-related items in comparison with the scores of subjects managed with the SM only (P

BACKGROUND The aim of this study was to evaluate the effects of the standardized supplement Robuvit® (oak wood extract) in defined diffuse, minimal lymphatic "retention" (DMLR). METHODS Robuvit® has already been investigated in both primary and secondary (post-surgical, post chemo-radiotherapy) lymphatic insufficiency. This registry included subjects with diffuse, minimal lymphatic "retention" (DMLR). The registry management groups included women with mild-moderate limb swelling using standard management (SM) as controls. A second, comparable group used prevention with Robuvit® at the dosage of 3 cp/day (300 mg/day) for 4 weeks. RESULTS No tolerability problems or side effects were observed with the preventive supplementation. The management groups (34 women in total), including 18 women in Robuvit® and 16 in SM were comparable in age and baseline evaluations. After 4 weeks, in the Robuvit® group, edema scale values derived from ultrasound observations decreased significantly (P

BACKGROUND The aim of this registry study in patients with Parkinson's Disease (PD) in treatment, was to evaluate the effects of Pycnogenol® supplementation on some accessory symptoms and cognitive functions (COFU). METHODS The registry included 43 PD patients who had been diagnosed at least one year before the start of the study. The PD condition was considered mild, with minimal progression. The management for these patients was a monotherapy using carbidopa/levodopa (standard management; SM). Supplementary Pycnogenol® was used at 150 mg/day for 4 weeks. The neurological management was not affected. RESULTS Tolerability and safety were very good; the two registry groups were comparable with comparable symptoms at baseline. The most disabling symptoms were considered tremor, bradychinesia, alterations in COFU, rigidity and speech changes. All symptoms were rated as mild-to-moderate. After 4 weeks, these target symptoms were significantly attenuated with the supplement in comparison with the SM only (P

BACKGROUND The aim of this supplement registry study was the evaluation of possible benefits of Robuvit® (oak wood extract) as a standardized supplement (in an 8-week registry) in stable, mild, heart failure patients. METHODS All subjects received the standard management (SM) for this condition. Otherwise healthy subjects with mild, initial symptoms (mild shortness of breath and/or angina) and slight limitation during their normal daily activity were included. This corresponds to the New York Heart Association (NYHA) Functional Classification class II. RESULTS Forty subjects were included in the study. The two groups completing 8 weeks were comparable at baseline with 20 subjects managed with SM and 20 subjects supplemented with Robuvit® in addition to SM. Tolerability and compliance were optimal (with more than 95% of the capsules correctly used). The age and symptoms of the supplemented patients and the controls were comparable at baseline. There were no dropouts. At 8 weeks, systolic-diastolic pressure, heart rate, respiratory rate were minimally (non-significantly) lowered with the supplement without differences in controls. Ultrasound-derived ejection fraction was significantly increased in the supplement group (P

Xerostomia is a symptom frequently present in patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM). In the present trial, the activity of an artificial saliva (aldiamed® spray) in comparison to a placebo spray were used to evaluate the xerostomia and the saliva antioxidant capacity (SAT). Sixty patients of both genders with T1DM or T2DM were randomized into two groups of 30 subjects each. The experiment was a double-blind study approved by the Ethics Committee of the “G. d’Annunzio University” of Chieti and Pescara. Moreover, measurements of the stimulated saliva flow rate and the ultrasonography of the submandibular and parotid glands were performed at both the study time points. The results demonstrated statistically significant differences between the treatments in terms of the xerostomia average score. Specifically, the values were at baseline and after 30 days 2.9 ± 1.31 and 3.0 ± 1.44 and 1.4 ± 1.48 and 2.4 ± 0.99 for aldiamed® spray and the placebo, respectively. Meanwhile, no statistically significant differences were shown between the two groups for the other variables, such as the salivary flow rate, the antioxidant capacity of the saliva, and the ultrasonography of the major salivary glands.

A ‘war’ consensus document has been produced by a group of clinical research physician on the pandemics with special...