Publications by authors named "Beatrice Feragalli"

73 Publications

Low Sensitivity of Admission Lung US Compared to Chest CT for Diagnosis of Lung Involvement in a Cohort of 82 Patients with COVID-19 Pneumonia.

Medicina (Kaunas) 2021 Mar 4;57(3). Epub 2021 Mar 4.

Unit of Interventional and Diagnostic Ultrasound of Internal Medicine, Department of Medical Sciences, IRCCS Fondazione Casa Sollievo della Sofferenza, 71013 San Giovanni Rotondo, Italy.

: 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). : 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. : 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%). : 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).
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http://dx.doi.org/10.3390/medicina57030236DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8001137PMC
March 2021

Idiopathic myalgic pain (fibromyalgia): supportive management and prevention with Pycnogenol®.

Panminerva Med 2021 Mar;63(1):46-50

IRVINE3 Labs & San Valentino Vascular Screening Project, Department of Medical, Oral and Biotechnological Sciences, Ch-Pe University, Pescara, Italy.

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<26), not using any drug. All subjects had an elevated level of oxidative stress (OS) at inclusion. All routine blood tests - and all inflammatory and rheumatic tests - were within the normal range at inclusion and at the end of the study. No safety or tolerability problems were observed. The percentage of patients using NSAIDs (non-steroidal anti-inflammatory drugs) as rescue medications in the observation period was significantly higher in the SM management group (P<0.05) in comparison with the supplement group. The percentage of patients using corticosteroids as rescue medication was significantly higher in the SM group (P<0.05). The percentage of subjects with the symptoms/complaints decreased significantly, considering each symptom, with Pycnogenol after 4 weeks in comparison with the SM (P<0.05).

Conclusions: Pycnogenol supplementation appears to control and reduce the intensity of common symptoms and complaints - especially pain-related - associated with FM. Pycnogenol could be a 'soft', safe supplementation and prevention method to manage the symptoms of most of these patients, even for longer periods, reducing the need for drugs.
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http://dx.doi.org/10.23736/S0031-0808.20.03955-5DOI Listing
March 2021

Coronavirus Disease 2019 (COVID-19) in Italy: Double Reading of Chest CT Examination.

Biology (Basel) 2021 Jan 25;10(2). Epub 2021 Jan 25.

Department of Precision Medicine, Università degli Studi della Campania Luigi Vanvitelli, 80121 Naples, Italy.

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 29-93 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 к 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 (-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.
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http://dx.doi.org/10.3390/biology10020089DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7911408PMC
January 2021

COVID-19 pneumonia: computer-aided quantification of healthy lung parenchyma, emphysema, ground glass and consolidation on chest computed tomography (CT).

Radiol Med 2021 Apr 18;126(4):553-560. Epub 2020 Nov 18.

Division of Radiodiagnostic, Università Degli Studi Della Campania Luigi Vanvitelli, Naples, Italy.

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.
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http://dx.doi.org/10.1007/s11547-020-01305-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7673247PMC
April 2021

Coronavirus disease 2019 (COVID-19) in Italy: features on chest computed tomography using a structured report system.

Sci Rep 2020 10 14;10(1):17236. Epub 2020 Oct 14.

Division of Radiodiagnostic, "Università Degli Studi Della Campania Luigi Vanvitelli", Naples, Italy.

To assess the use of a structured report in the Chest Computed Tomography (CT) reporting of patients with suspicious viral pneumonia by COVID-19 and the evaluation of the main CT patterns. This study included 134 patients (43 women and 91 men; 68.8 years of mean age, range 29-93 years) with suspicious COVID-19 viral infection evaluated by reverse transcription real-time fluorescence polymerase chain reaction (RT-PCR) test. All patients underwent CT examinations at the time of admission. CT images were reviewed by two radiologists who identified COVID-19 CT patterns using a structured reports. Temporal difference mean value between RT-PCRs and CT scan was 0.18 days ± 2.0 days. CT findings were positive for viral pneumonia in 94.0% patients while COVID-19 was diagnosed at RT-PCR in 77.6% patients. Time mean value to complete the structured report by radiologist was 8.5 min ± 2.4 min. The disease on chest CT predominantly affected multiple lobes and the main CT feature was ground glass opacity (GGO) with or without consolidation (96.8%). GGO was predominantly bilateral (89.3%), peripheral (80.3%), multifocal/patching (70.5%). Consolidation disease was predominantly bilateral (83.9%) with prevalent peripheral (87.1%) and segmental (47.3%) distribution. Additional CT signs were the crazy-paving pattern in 75.4% of patients, the septal thickening in 37.3% of patients, the air bronchogram sign in 39.7% and the "reversed halo" sign in 23.8%. Less frequent characteristics at CT regard discrete pulmonary nodules, increased trunk diameter of the pulmonary artery, pleural effusion and pericardium effusion (7.9%, 6.3%, 14.3% and 16.7%, respectively). Barotrauma sign was absent in all the patients. High percentage (54.8%) of the patients had mediastinal lymphadenopathy. Using a Chest CT structured report, with a standardized language, we identified that the cardinal hallmarks of COVID-19 infection were bilateral, peripheral and multifocal/patching GGO and bilateral consolidation with peripheral and segmental distribution.
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http://dx.doi.org/10.1038/s41598-020-73788-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7566610PMC
October 2020

Clinical and laboratory data, radiological structured report findings and quantitative evaluation of lung involvement on baseline chest CT in COVID-19 patients to predict prognosis.

Radiol Med 2021 Jan 12;126(1):29-39. Epub 2020 Oct 12.

Division of Radiodiagnostic, "Azienda Ospedaliero-Universitaria Careggi", Firenze, Italy.

Objective: To evaluate by means of regression models the relationships between baseline clinical and laboratory data and lung involvement on baseline chest CT and to quantify the thoracic disease using an artificial intelligence tool and a visual scoring system to predict prognosis in patients with COVID-19 pneumonia.

Materials And Methods: This study included 103 (41 women and 62 men; 68.8 years of mean age-range, 29-93 years) with suspicious COVID-19 viral infection evaluated by reverse transcription real-time fluorescence polymerase chain reaction (RT-PCR) test. All patients underwent CT examinations at the time of admission in addition to clinical and laboratory findings recording. All chest CT examinations were reviewed using a structured report. Moreover, using an artificial intelligence tool we performed an automatic segmentation on CT images based on Hounsfield unit to calculate residual healthy lung parenchyma, ground-glass opacities (GGO), consolidations and emphysema volumes for both right and left lungs. Two expert radiologists, in consensus, attributed at the CT pulmonary disease involvement a severity score using a scale of 5 levels; the score was attributed for GGO and consolidation for each lung, and then, an overall radiological severity visual score was obtained summing the single score. Univariate and multivariate regression analysis was performed.

Results: Symptoms and comorbidities did not show differences statistically significant in terms of patient outcome. Instead, SpO2 was significantly lower in patients hospitalized in critical conditions or died while age, HS CRP, leukocyte count, neutrophils, LDH, d-dimer, troponin, creatinine and azotemia, ALT, AST and bilirubin values were significantly higher. GGO and consolidations were the main CT patterns (a variable combination of GGO and consolidations was found in 87.8% of patients). CT COVID-19 disease was prevalently bilateral (77.6%) with peripheral distribution (74.5%) and multiple lobes localizations (52.0%). Consolidation, emphysema and residual healthy lung parenchyma volumes showed statistically significant differences in the three groups of patients based on outcome (patients discharged at home, patients hospitalized in stable conditions and patient hospitalized in critical conditions or died) while GGO volume did not affect the patient's outcome. Moreover, the overall radiological severity visual score (cutoff ≥ 8) was a predictor of patient outcome. The highest value of R-squared (R = 0.93) was obtained by the model that combines clinical/laboratory findings at CT volumes. The highest accuracy was obtained by clinical/laboratory and CT findings model with a sensitivity, specificity and accuracy, respectively, of 88%, 78% and 81% to predict discharged/stable patients versus critical/died patients.

Conclusion: In conclusion, both CT visual score and computerized software-based quantification of the consolidation, emphysema and residual healthy lung parenchyma on chest CT images were independent predictors of outcome in patients with COVID-19 pneumonia.
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http://dx.doi.org/10.1007/s11547-020-01293-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7549421PMC
January 2021

Chest CT Computerized Aided Quantification of PNEUMONIA Lesions in COVID-19 Infection: A Comparison among Three Commercial Software.

Int J Environ Res Public Health 2020 09 22;17(18). Epub 2020 Sep 22.

Division of Radiodiagnostic, Azienda Ospedaliero-Universitaria Careggi, 50139 Firenze, Italy.

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.
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http://dx.doi.org/10.3390/ijerph17186914DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7558768PMC
September 2020

Supplementation with a new food grade delivery system of Boswellia and Centella in the intervertebral discs registry: the Sager study.

Panminerva Med 2020 Sep 8. Epub 2020 Sep 8.

Indena SpA, Milan, Italy.

Background: The aim of this registry study was to investigate the potential of a new food-grade formulation of the association of Boswellia serrata and Centella asiatica extracts (Boswellia/Centella Phytosome, [BCP]) in combination with standard management (SM) to produce a faster re-expansion of the intervertebral disks in symptomatic subjects with "flattened" disks in the lower spine, due to wrong posture and compression after repeated trauma.

Methods: The study was designed as a 3-6 months pilot registry. Three groups of subjects were comparable for characteristics and symptoms at baseline: SM+BCP; SM; SM+glucosamine.

Results: No side effects were observed. Regarding target measurements at 3 and 6 months, height increased in the BCP group vs. the other two groups. The total spine length improved in the BCP group (P<0.05); in particular at 6 months the increase was doubled with BCP. SM was effective in producing elongation but the association with BCP made spinal elongation faster, more effective, with a better expansion of the intervertebral disks. Regarding ultrasound measurements, BCP was able to significantly ameliorate the posterior disk space (P<0.05) and decreased disk density more than the other groups of the study. Signs/symptoms and mobility were improved with BCP (P<0.05), while rescue medications decreased. The loss of working days was reduced with all managements (significantly more in BCP group than in the other two).

Conclusions: The relative effects on spinal elongation, disk space, signs/symptoms of BCP appeared to double the efficacy of SM, improving symptoms associated to a very good tolerability of BCP.
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http://dx.doi.org/10.23736/S0031-0808.20.04028-8DOI Listing
September 2020

A sport cream (Harpago-Boswellia-ginger-escin) for localized neck/shoulder pain.

Minerva Med 2021 Apr 3;112(2):255-260. Epub 2020 Sep 3.

Irvine3 Labs, Department of Medical, Oral and Biotechnological Sciences, Chieti-Pescara University, IAPSS, Pescara, Italy.

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.
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http://dx.doi.org/10.23736/S0026-4806.20.06819-6DOI Listing
April 2021

Exploring the concept of vigor and dys-vigor in men of 50-65 years: effects of Robuvit®.

Panminerva Med 2020 Sep;62(3):131-134

IRVINE3 Labs, Department of Medical Oral and Biotechnological Sciences, Chieti-Pescara University, IAPSS, Pescara, Italy.

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<0.05). In parallel, oxidative stress (plasma free radicals expressed in Carr units) was statistically lower (P<0.05) in Robuvit®-supplemented subjects than in SM only after 4 weeks.

Conclusions: The concept of vigor, partially associated with premature aging, decreased level of activity and exercise, a sedentary lifestyle, appears to be a quantifiable entity. Robuvit® supplementation - previously shown to be effective in chronic fatigue syndrome, convalescence, post-mononucleosis, PTSD or in liver failure - improves vigor; further evaluations need to be planned according to the concept of this pilot registry.
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http://dx.doi.org/10.23736/S0031-0808.19.03795-9DOI Listing
September 2020

Artificial Saliva in Diabetic Xerostomia (ASDIX): Double Blind Trial of Aldiamed Versus Placebo.

J Clin Med 2020 Jul 11;9(7). Epub 2020 Jul 11.

Department of Medical, Oral and Biotechnological Sciences, University "G. d'Annunzio" of Chieti-Pescara, 66100 Chieti, Italy.

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.
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http://dx.doi.org/10.3390/jcm9072196DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7408818PMC
July 2020

Fatigue due to mild heart failure: effects of Robuvit® in a concept, pilot registry study.

Minerva Cardioangiol 2020 Jun;68(3):216-223

Irvine3 labs & PAP/PEA Screening Project and the International Irvine Network, Department SMO Biotec and Cardiology School, G. D'Annunzio University, Chieti-Pescara, Pescara, Italy.

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<0.05) while there were minimal, non-significant differences in controls. Walking distance on treadmill was also significantly increased in the supplement group (P<0.05) and significantly less in controls. The microcirculation (laser Doppler parameters and transcutaneous PO2, PCO2) improved significantly in the Robuvit® group (P<0.05) in comparison with the non-supplemented controls. Oxidative stress was significantly decreased (P<0.05) with the supplement while there were minimal, non-significant changes in controls.

Conclusions: In conclusion in this pilot, supplement registry Robuvit® seems to help and improve patients with mild heart failure and should be considered for larger studies.
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http://dx.doi.org/10.23736/S0026-4725.19.05029-1DOI Listing
June 2020

Hangover and fatigue: effects of Robuvit® supplementation. A pilot registry study.

Minerva Cardioangiol 2020 Jun;68(3):203-208

Irvine3 Labs, Department of Medical and Oral Sciences and Biotechnologies, Chieti-Pescara University, Pescara, Italy.

Background: The aim of this open registry study was to evaluate the effects of Robuvit® in subjects with hangover after acute alcohol consumption also measuring changes in levels of oxidative stress. A group using standard management (SM) and a group using SM and Robuvit® 300 mg/day for 3 days were compared.

Methods: Nineteen male subjects with hangover were included in the SM group and 22 in the Robuvit® + SM group.

Results: The groups were comparable at baseline. No side effects were observed. Fatigue scores - as the main observable symptom in these subjects, in both groups - were significantly lower in the group using Robuvit® (P<0.05) than in the control group after 24 hours. The scores of other symptoms like weakness, thirst, headache, muscle aches and body pain were significantly lower at 24 hours (P<0.05) with the supplement than in the control group. The scores of residual gastrointestinal symptoms (nausea, vomiting and stomach pain) were also significantly lower at 24 hours with Robuvit® (P<0.05). Sleep and rest were significantly better with Robuvit® (P<0.05). Sensory symptoms and cognitive functions were also significantly better with supplementation in comparison with SM only (P<0.05). Finally, scores of mood, concentration, depression, anxiety, irritability were significantly lower (P<0.05) with Robuvit® though these symptoms need a more specific and complete evaluation. Signs of sympathetic activity, tremor, sweating, increased heart rate improved significantly better with the supplement at 24 hours (P<0.05). Oxidative stress was increased at inclusion in all subjects; in the Robuvit® group, oxidative stress decreased significantly (P<0.05) at 24 hours; in controls (SM) oxidative stress showed minimal changes at 24 hours and it remained elevated above normal values (>330 CU). Most symptoms almost disappeared at 24 hours in the Robuvit® group. Significant symptoms were still observed in 11 out of 19 subjects in the SM group in comparison with four of 22 subjects using the supplementation with Robuvit® (P<0.05). Blood tests were normal in all subjects (hematocrit and kidney and liver functional test at 24 hours).

Conclusions: In conclusion, Robuvit® supplementation appears to improve hangover and relieved symptoms faster. More studies are needed to confirm this association between acute alcohol consumption and a possible hepatic dysfunction.
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http://dx.doi.org/10.23736/S0026-4725.19.05028-XDOI Listing
June 2020

Prevention of diffuse, minimal lymphatic "retention" with Robuvit®: a concept, supplement registry study.

Minerva Cardioangiol 2020 Jun;68(3):197-202

IRVINE3 Labs, Department of Medical, Oral and Biotechnological Sciences, Chieti-Pescara University, IAPSS, Pescara, Italy.

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<0.05) at all measurement's sites, from the proximal (inguinal) level to the more distal (ankle-foot) level. No significant changes in edema were observed in control subjects. Generally, in areas with higher level of edema (distal areas at the foot and ankle), the edema decrease was larger than in more proximal, ultrasound measurement sites.

Conclusions: Preventive Robuvit® supplementation appears to be safe and effective in controlling DMLR in subjects without significant or apparent clinical conditions. This preventive, concept study should be extended to a larger population for more meaningful observations.
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http://dx.doi.org/10.23736/S0026-4725.19.05026-6DOI Listing
June 2020

Supplementary management with Pycnogenol® in patients with lupus vasculitis in remission phases: a pilot, concept registry study.

Minerva Cardioangiol 2020 Apr;68(2):146-152

IRVINE3 Labs, Department of Medical, Oral and Biotechnological Sciences, Chieti-Pescara University, Pescara, Italy.

Background: The aim of this pilot study was the supplementary management of minimal, residual symptoms of systemic Lupus (SLE) with vasculitis (LV) in remission phases, using a natural, anti-inflammatory, antioxidant agent (Pycnogenol®) extracted from French maritime pine bark. Pycnogenol® has a significant clinical anti-inflammatory activity; it is a standardized supplement with a high-safety profile.

Methods: Subjects with Lupus vasculitis were included in the study. The standard management (SM) was used in all subjects for 8 weeks; one group added Pycnogenol® (150 mg/day) to SM.

Results: The two groups completing 8 weeks were comparable at baseline with 12 subjects managed with SM and 14 subjects supplemented with Pycnogenol®. No side effects due to Pycnogenol® were observed; Pycnogenol® was associated with an optimal tolerability. The proportion of patients with photosensitivity, oral ulcers, renal-associated hematuria (minimal), leukopenia, lymphopenia, thrombocytopenia, positive anti-DNA and positive antiphospolipids tests were significantly lower in the Pycnogenol® group (P<0.05) at 8 weeks in comparison with controls. No difference in activity between SM and supplementation was observed for rash, serositis, anemia, neurological symptoms (all mild at inclusion) and anti-Smith. Considering additional clinical parameters such as the need for corticosteroids, peripheral ischemia, oxidative stress, the effects of Pycnogenol® appeared to be superior to SM alone (P<0.05). The decrease in oxidative stress was significantly higher with Pycnogenol® (P<0.05) compared to SM. This is particularly interesting as it has not been observed before in LV. Considering microvascular parameters, the number of subjects with 'cold' hypoperfused thermographic areas was significantly lower in the supplement group (P<0.05) and distal flux (laser Doppler) was higher with the supplement (P<0.05) at 8 weeks.

Conclusions: This pilot registry indicates that Pycnogenol® can be safely used in subjects with LV with mild symptoms (in remission) possibly avoiding some drug treatments that may cause side effects. A larger study in progress is evaluating the effects of Pycnogenol® on recurrent symptoms in subjects in remission.
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http://dx.doi.org/10.23736/S0026-4725.19.05027-8DOI Listing
April 2020

Keloidal penile fibrosis: improvements with Centellicum® (Centella asiatica) and Pycnogenol® supplementation: a pilot registry.

Panminerva Med 2020 Mar;62(1):13-18

Irvine3 Labs and IAPSS (International Agency For Pharma Standard Supplements), University of Chieti-Pescara, Pescara, Italy.

Background: The aim of this pilot study was to evaluate the effects of Pycnogenol® and CA (Centellicum®) on penile fibrosis and on associated signs and symptoms.

Methods: A group of 82 subjects with penile nodules and plaques was included in this registry study and followed up for 3 months; 32 were managed with standard management (SM) only. Twenty-four were managed with CA (Centellicum®: 3 capsules/day: 675 mg/day) in association with SM, and 26 subjects were managed with Pycnogenol® (150 mg/day) + CA (Centellicum® at the same dosage as in group 2) and SM.

Results: Subjects in the 3 groups were comparable, including the distribution of plaques. The occurrence of any previous catheterizations was also comparable. Safety and tolerability were optimal, no subjects had to stop supplementation. The percentage of subjects with improved symptoms evaluated with a Visual Analogue Scale line was significantly higher with both supplements in comparison with SM (P<0.05). The combined management with Pycnogenol® and Centellicum® was superior to the other 2 managements (P<0.05). Erectile function assessed by the Index of Erectile Fuction questionnaire (IIEF) was significantly higher with the combination Pycnogenol®+Centellicum (P<0.05). The number of plaques and microplaques, the average total sectional area of the plaques in each subject and the grey scale median were all better improved with the combination. Both supplementations were superior to SM at 12 weeks (P<0.05). Oxidative stress resulted significantly better (P<0.05) with the combination. All blood tests were normal at inclusion and at 12 weeks. The minimal, penile curvature at baseline was reduced in both the supplement groups at 12 weeks more than in the SM group (P<0.05).

Conclusions: In conclusion Centellicum and Pycnogenol® appear to improve penile fibrosis reducing the keloidal aspects of penile plaques.
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http://dx.doi.org/10.23736/S0031-0808.18.03572-3DOI Listing
March 2020

Prevention of vaginal dryness in perimenopausal women. Supplementation with Lady Prelox®.

Minerva Ginecol 2019 Dec;71(6):434-441

IRVINE3 Labs & Pap/Pea Screening Project and the International Irvine Network, Pescara, Italy.

Background: The aim of this pilot registry study was to use a standardized supplement (Lady Prelox®, Horphag Research) - including Pycnogenol®, l-arginine, L-citrulline and rose hip extract - to improve signs and symptoms associated with vaginal dryness in pre and post-menopausal healthy women. A group of women used only a standard management (SM) and a second group added Lady Prelox®.

Methods: Four groups of women were included in the study. 34 pre-menopausal and 38 post-menopausal women took Lady Prelox®, four tablets daily for 8 weeks and 33 pre-menopausal women and 35 post-menopausal women served as controls.

Results: No safety problems were observed with the supplement that was well tolerated. The subgroups of controls and supplemented subjects were comparable in both the pre- and post-menopausal groups. Among pre-menopausal women, results of the female sexual function index (FSFI) were significantly improved with the supplement in comparison with the control subjects' group (P<0.05). The results of the FSFI questionnaire for post-menopausal women indicated a significant improvement at 8 weeks with Lady Prelox® (P<0.05) in comparison with controls. Preclinical items (vaginal dryness, pain/discomfort during intercourse, mucus, minimal infections, presence of candida and oxidative stress) were significantly improved (P<0.05) with Lady Prelox®) in comparison to minimal changes with the SM group. These measurements included all women.

Conclusions: The effects of the supplementation with Lady Prelox® on vaginal dryness were significant. The supplement was well accepted and revealed no side effects or tolerability problems. Further studies are evaluating the effects of Lady Prelox® on other aspects of the menopausal transition that may alter the quality of life of most women in advanced age. A gentle approach with suitable dietary supplementation, represents a promising option for addressing common challenges that women experience in such conditions.
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http://dx.doi.org/10.23736/S0026-4784.19.04466-6DOI Listing
December 2019

Xerostomia: prevention with Pycnogenol® supplementation: a pilot study.

Minerva Stomatol 2019 Dec;68(6):303-307

Irvine3 Labs, Department of Medical and Oral Sciences and Biotechnologies, G. d'Annunzio University, Pescara, Italy.

Background: The aim of this pilot study was the evaluation of primary, idiopathic mucosal dryness (xerostomia or dry mouth) in subjects without cancer.

Methods: A group of non-diabetic subjects and a group of diabetics were managed with standard management (SM) or with SM+Pycnogenol® (150 mg/day) for 2 weeks.

Results: In total, 48 subjects were included in the study; 24 diabetics and 24 non-diabetics. 12 diabetics and 12 non-diabetics took Pycnogenol® and 12 diabetics and 12 non-diabetics were followed up with standard management only and served as controls. No side effects and no tolerability problems were observed with Pycnogenol®. The registry groups were comparable for characteristics and symptoms at baseline. All otherwise healthy subjects had a BMI<26 kg/m2. In 2 weeks, salivary flow and oxidative stress improved significantly in both groups of subjects (non-diabetics and diabetics) with 150 mg/day Pycnogenol® (P<0.05), while minimal improvements in salivary flow were seen with SM. The subjective score and the number of mucosal breaks and ulcerations, all minimal (<1 mm in length or diameter), were significantly decreased with Pycnogenol® supplementation (P<0.05) with minimal variations in the SM controls. Finally, the mean lysozyme level in parotid saliva samples was significantly increased in the Pycnogenol® group (P<0.05) both in diabetics and non-diabetics.

Conclusions: Based on these preliminary results, Pycnogenol® could be a new, valid option for the treatment of xerostomia.
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http://dx.doi.org/10.23736/S0026-4970.19.04311-5DOI Listing
December 2019

PycnoRacer®, a fitness drink including Pycnogenol®, improves recovery and training in the Cooper test.

Panminerva Med 2019 Dec;61(4):457-463

IRVINE3 Labs, Pescara, Italy.

Background: This study evaluates the effects of training (on running distance measured with a Cooper test) in 3 weeks in non-professional athletes using PycnoRacer®, a fitness drink (FD) including Pycnogenol® during the training period.

Methods: Pycnogenol® has been used in preclinical conditions and prevention. PycnoRacer® is a liquid combination of Pycnogenol® (15 mg), L-leucine (0.6 g), L-arginine (0.3 g), L-isoleucine (0.3 g), and L-valine (0.3 g). Two comparable groups (one using the FD) were formed: 60 training athletes were requested to drink one bottle 4 times/day, while 65 controls did not use PycnoRacer® or other comparable sports drinks. All subjects had a strong athletic background and advanced knowledge of the procedures of the tests. Two daily training sessions were completed. The sessions consisted in warming up and running a Cooper test.

Results: 125 subjects completed the three weeks according to plans. There were nine dropouts due to logistical or working problems. Subjects using the FD improved on average by 18.83% (range 12-23%) in their running distance with training. The difference with controls was significant (P<0.05) at 3 weeks (controls improved on average by 8.9%; range 3-17.4%). The difference between the two groups was on average 9.93% (P<0.05). A comparable increase in VO2max was observed in the groups. In the FD group the increase was on average by 10.05 mL/kg/min compared to 4.95 mL/kg/min in controls, with a difference of 5.1 mL/kg/min (P<0.05). A VAS score showed comparable values. Lower values (concerning muscular pain and cramps) were observed in FD subjects (P<0.05) at the end of the 3 weeks of training. The level of plasma free radicals (PFR) values after the last Cooper test was significantly lower at 3 weeks in the FD group (P<0.05). No intolerance problem was observed by subjects using the FD.

Conclusions: In conclusion, the use of PycnoRacer® improved training, running distance, VO2max and PFR decreasing muscular pain and cramps.
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http://dx.doi.org/10.23736/S0031-0808.19.03639-5DOI Listing
December 2019

Supplementary management with Pycnogenol® in Parkinson's disease to prevent cognitive impairment.

J Neurosurg Sci 2020 Jun 20;64(3):258-262. Epub 2020 Jan 20.

Irvine3 Labs & San Valentino Vascular Screening Project, Chieti, Italy.

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<0.05). Particularly the COFU score was significantly higher (P<0.05) with the supplement. No interference between the main neurological management and the supplement was observed. Oxidative stress (plasma free radicals), high in both registry groups at inclusion, was significantly lower in the supplement group at 4 weeks (P<0.05). The main PD-associated items (cognitive aspects, motory and postural aspects) considered the most common and disturbing problems were evaluated and scored (0 to 4) with a visual scale line. At 4 weeks, the scores for all items were lower in the supplement group in comparison with the control, SM group. Peripheral edema was present in all patients at inclusion. The edema was minimal at inclusion (at the ankle-foot level with pretibial extension) and present in all subjects. It changed in two SM subjects and was still present at 4 weeks in 19 out 22 of the SM patients. In the supplemented patients, edema (present at inclusion in all subjects), was visible in 4 subjects out of 21 (19%) at 4 weeks.

Conclusions: Pycnogenol® supplementation may help in selected patients with PD - under stable neurological treatment - to improve some signs and symptoms and some aspects associated with COFU. Studies are in progress on a larger population sample and with new evaluation methods.
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http://dx.doi.org/10.23736/S0390-5616.19.04839-2DOI Listing
June 2020

Transthoracic ultrasound sign in severe asthmatic patients: a lack of "gliding sign" mimic pneumothorax.

BJR Case Rep 2019 Dec 15;5(4):20190030. Epub 2019 Nov 15.

Unit of Interventional and Diagnostic Ultrasound of Internal Medicine IRCCS Fondazione Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.

Transthoracic ultrasound (TUS) is a validate complementary technique widely used in everyday medical practice. TUS is the gold-standard for studying pleural effusion and for echo-guided thoracentesis, moreover, it is employed in detection of pleural and pulmonary lesions adherent to pleural surface and their ccho-guided percutaneous needle biopsy (PTNB). We used TUS technique to study severe asthma patients. We found that several patterns are constant in these patients. One of these patterns, . lack of gliding sign, mimic pneumothorax (PNX). In this study, we attempted an echographic approach to asthma, trying to lay the first stone for the individuation of common ultrasound patterns in this disease.
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http://dx.doi.org/10.1259/bjrcr.20190030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6945254PMC
December 2019

Pycnogenol®+Centellicum®, post-stent evaluation: prevention of neointima and plaque re-growth.

Minerva Cardioangiol 2019 Dec;67(6):450-455

Irvine3 Labs, Department of Medical and Oral Sciences, and Biotechnologies, G. D'Annunzio University, Pescara, Italy.

Background: The aim of this study was to evaluate the regrowth and progression of within-stent neointima after stenting as a model of accelerated atherosclerosis and the potential effects of the combination Pycnogenol® and Centellicum® in 12 months' follow-up.

Methods: Progression was defined as the passage from one arterial risk class to next, more advanced risk class in 12 months of follow-up. Each class corresponds to a different risk of cardiovascular events and progression. Three management groups were formed, treated with either standard management (SM), Pycnogenol® 150 mg/day, or a combination of Pycnogenol® 150 mg/day and Centellicum® 450 mg/day.

Results: No side effects or tolerability problems were observed. 82 subjects with stented arteries in class 2 were evaluated for the passage into class 3 over 12 months. This group included 82 subjects; there were no dropouts. The management subgroups were comparable at baseline. At 12 months 66.7% of subjects in the SM subgroup progressed to class 3, versus 10.7% in the Pycnogenol® group; progression was seen in 6.7% (P<0.05) of subjects supplemented with the combination. In the second section of the registry study (78 subjects with stented arteries in class 3) we evaluated the percentage of patients passing into class 4. At 12 months 53.6% of subjects using the SM progressed versus 26.9% in the subgroup using Pycnogenol® (P<0.05) and 11.5% in the Pycnogenol®+Centellicum® group (P<0.05). Across all 160 subjects in the three management groups, progression of the stented artery at 12 months was seen in 59.6% of subjects in the SM group versus 18.5% (P<0.05) in the group managed with Pycnogenol® only. The Pycnogenol®+Centellicum® combination further decreased progression down to 8.9% (P<0.05). Oxidative stress was significantly reduced (P<0.05) in the two supplement groups.

Conclusions: In conclusion, the combination Pycnogenol®+Centellicum® appears to reduce the rate of progression of the neointima after stenting.
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http://dx.doi.org/10.23736/S0026-4725.19.05048-5DOI Listing
December 2019

Management of mild, primary Raynaud Syndrome: supplementation with Pycnogenol®.

Minerva Cardioangiol 2019 Oct;67(5):392-398

IRVINE3 Labs, IAPSS, Nicolaides's Lab, Chieti, Italy.

Background: Raynaud syndrome (RS) is associated with vasospasm of the hand and fingers as a response to cold or stress. RS may cause discomfort and color changes (pallor, cyanosis, erythema, as single symptoms, but usually in combination, localized to one or more fingers). The aim of this 4-week registry study was the evaluation of subjects with mild, primary RS and their treatment with a standard management (SM) plan in comparison with SM associated with supplementation with Pycnogenol®.

Methods: A group of 67 females with mild, primary RS was included. All subjects were working in shops with refrigerators. No skin lesions were present. The age range was between 30 and 40; the vasospastic changes were symmetrical; no other physical findings were present.

Results: The two groups, receiving standard management (N.=33) or SM+Pycnogenol®, 100 mg/day, (N.=34) were comparable at inclusion. Considering the main symptoms, the decrease in coldness, burning pain, paresthesias and irregular color changes was more significant with Pycnogenol® (P<0.05) at 4 weeks. At thermography, low temperature areas and discrepancies in temperature and color were decreased with Pycnogenol® more than in controls (P<0.05). In the Pycnogenol® group, one subject (2.94%) decided to use drug treatment (PGE1) in 4 weeks in comparison with 5 controls (15.15%). The lowest finger temperature improved from 20.3° C at inclusion to 26.4° C at 4 weeks (+30.04%) with Pycnogenol® in comparison with lower values (from 20.5 to 23.1 [+12.7%] in controls [P<0.05]). The fingertip skin flux increased significantly (+ 1.55 flux units) with Pycnogenol® (P<0.05), in controls just by +0.14 (ns). Supplementation with Pycnogenol® decreased oxidative stress and increased transcutaneous oxygen pressure (TcPO2) more than in controls. Compliance and tolerability were optimal.

Conclusions: This pilot registry study suggests that Pycnogenol® may be used with significant advantages in primary, mild RS. Subjects using Pycnogenol® may control their symptoms and may avoid the need for more complex and, potentially dangerous or expensive treatments.
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http://dx.doi.org/10.23736/S0026-4725.19.04991-0DOI Listing
October 2019

Central cardiovascular calcifications: supplementation with Pycnogenol® and Centellicum®: variations over 12 months.

Minerva Cardioangiol 2020 Feb 15;68(1):22-26. Epub 2019 Oct 15.

IRVINE3 Labs, Department of Medical Oral and Biotechnological Sciences, Chieti-Pescara University, IAPSS, Pescara, Italy.

Background: This 'concept' registry study evaluated the efficacy of Pycnogenol® and the combination Pycnogenol® and Centella Asiatica (Centellicum®) in controlling over 12 months the increasing number of arterial/cardiac calcifications in subjects with asymptomatic atherosclerosis.

Methods: The study included 3 groups of 30 males with asymptomatic coronary calcifications. Group one was followed with standard management (SM); group 2 used SM and Pycnogenol® (150 mg/day); group 3 used the combination Pycnogenol® (150 mg/day) + Centellicum® (450 mg/day). All subjects took cardioaspirin (Bayer, 100 mg/day).

Results: No dropouts, no clinical events were observed in 12 months. The 3 groups had comparable demographic and medical characteristics at baseline. No tolerability problems and no side effects from supplementation were reported. After 12 months, oxidative stress was significantly decreased (P<0.05) in both groups taking Pycnogenol®. The evaluation of the number of calcifications >1 mm indicated a trend in controls using SM towards a progressive increase in calcifications. At 12 months the decrease in the number of calcifications with the combined supplements (Pycnogenol® and Centellicum®) (group 3) was -9.952% and thus significantly better that in the other two groups (P<0.05). Pycnogenol® alone was more effective than SM alone in controlling the variation in calcifications (P<0.05). Considering a 34.88% increase in SM subjects, the total absolute difference between SM (34.8%) and the decrease observed in group 3 (-9.95%) was 44.75% (P<0.02). This indicates that supplementation with the combined supplements blocks the increase in calcified areas and, possibly, in time may decrease the number of calcified spots.

Conclusions: This study shows that there is a significant activity of the complex Pycnogenol®+ Centellicum® in reducing the progressive diffusion of central cardiovascular calcifications-associated with advanced plaques - in a relatively short period of time. Longer studies - focusing also on events - may better evaluate the efficacy of these standardized supplements combination on the evolution of atherosclerosis.
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http://dx.doi.org/10.23736/S0026-4725.19.05052-7DOI Listing
February 2020

Delayed progression of atherosclerosis and cardiovascular events in asymptomatic patients with atherosclerotic plaques: 3-year prevention with the supplementation with Pycnogenol®+Centellicum®.

Minerva Cardioangiol 2020 Feb 11;68(1):15-21. Epub 2019 Oct 11.

DSMO-Biotec, Chieti-Pescara University, Chieti, Italy.

Background: The aim of this study was the evaluation of the progression of atherosclerosis and the occurrence of cardiovascular events in asymptomatic patients with atherosclerotic plaques (Class IV and V) and arterial wall atherosclerotic lesions and intima-media thickening (IMT).

Methods: Progression of atherosclerotic lesions, oxidative stress and IMT were measured in a 3-year concept, pilot registry study. All subjects were followed with standard management (SM) - including diet and exercise - to control cardiovascular risk factors.The target measurements were: the rate of progression of the atherosclerotic lesions (the passage of subjects from one atherosclerotic class to the next class); the occurrence of "hard" cardiovascular events (i.e. myocardial infarction or strokes; angina was not considered a "hard" event). The study included 3 groups: 1) SM): 2) subjects using cardioaspirin (100 mg/day) and SM; 3) subjects following SM, taking cardioaspirin and supplemented with Pycnogenol® (150 mg/day)+Centellicum® (450 mg/day).

Results: The groups were comparable for age and baseline evaluations. 54 subjects completed the 3 year study with standard management only, 74 with aspirin and 56 with aspirin and Pycnogenol®+Centellicum®. The BMI of all subjects was <26. No side effects and no tolerability problems were observed with the supplements. Progression was defined by the passage of the atherosclerotic lesions from one class to the next more advanced class. Progression in the supplement group was observed in 5.3% of the subjects in comparison with a progression >20% in the other groups (P<0.05). In comparison with the SM group and the cardioaspirin group the rate of 'hard' cardiovascular events, requiring hospital admissions were <4% with the combined supplement in comparison with a value >12% in the other two groups (22.22% event rate in the SM group). The reduction produced by the aspirin only was significantly lower (P<0.05) in comparison with supplemented patients. Antiplatelet management appears to reduce a significant number of events (P<0.05) without a real effect on progression of atherosclerotic lesions. The additional parameters of carotid IMT and oxidative stress were also lower (P<0.05) with the supplements.

Conclusions: In conclusion, this study indicates that the combined supplementation with Pycnogenol®+Centelicum® appears to control both the progression of atherosclerosis and the occurrence of cardiovascular events in this 3 year study. Larger studies, in a wider population with more complex and less standardized conditions may be needed.
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http://dx.doi.org/10.23736/S0026-4725.19.05051-5DOI Listing
February 2020

Supplementary prevention and management of asthma with quercetin phytosome: a pilot registry.

Minerva Med 2019 Dec 27;110(6):524-529. Epub 2019 Sep 27.

IRVINE3 Labs, Department of Medical, Oral and Biotechnological Sciences, University of Chieti-Pescara, Chieti, Italy.

Background: In association with standard management, natural pharmaceutical standard (PS) supplements may play an important role in managing and preventing mild-to-moderate symptoms of asthma, a significant health issue that impacts patients and the healthcare system. Quercetin is a natural flavonoid with important biological properties (anti-inflammatory, antihistamine and anti-oxidative actions).

Methods: In this pilot registry, we evaluated the effects of quercetin formulated with the Phytosome® delivery system (Quercefit™, QFit)+standard management (SM) in otherwise healthy subjects with mild-moderate asthmatic attacks and rhinitis. Subjects used either QFit 1 or 2 tabs/day in association with SM or SM only (control group). After 30 days of management, we evaluated the presence of the main signs/symptoms of asthma according to the GINA classification system also considering the need of rescue medication, nasal drops, the use of inhalers, the rhinitis score and oxidative stress.

Results: QFit+SM showed superior results compared with SM alone in controlling, preventing and reducing daily and night symptoms, in maintaining higher peak expiratory flow (PEF) and in decreasing PEF variability. The supplementary use of QFit improved additional measures of asthma management, decreasing the use of inhalers, nasal drops, rescue medications and improving the rhinitis score. QFit produced a significantly more evident reduction in oxidative stress compared with SM; Qfit showed a very good safety profile.

Conclusions: This preliminary supplement, concept registry shows a potential protective and preventive effect of quercetin on attacks frequency and in controlling the most common signs/symptoms of asthma in the milder cases of the disease.
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http://dx.doi.org/10.23736/S0026-4806.19.06319-5DOI Listing
December 2019

Ultrasound and interstitial lung disease: use and limitations.

Radiol Med 2020 01 21;125(1):66-67. Epub 2019 Sep 21.

Department of Medical Science, Chieti-Pescara University, Chieti, Italy.

The Connective Tissue Diseases (CTDs)-related Interstitial Lung Disease (ILD) early diagnosis by Transthoracic Ultrasound (TUS) still arises several issues. Gutierrez et al. clearly underlined the current role of ultrasound artifacts for ILD definition according to some Authors. In this Letter to the Editor, we would like to highlight the proper role of TUS and its pitfalls.
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http://dx.doi.org/10.1007/s11547-019-01084-yDOI Listing
January 2020