47 results on '"Marcello CORSI"'
Search Results
2. Chronic venous insufficiency and microangiopathy: supplementation with Pycnogenol® reduces the progression of venous disease in women
- Author
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Maria R. CESARONE, Gianni BELCARO, Umberto CORNELLI, Beatrice FERAGALLI, Claudia SCIPIONE, Valeria SCIPIONE, Mark DUGALL, Morio HOSOI, Roberto COTELLESE, and Marcello CORSI
- Subjects
General Medicine - Published
- 2022
3. Effects of Robuvit® on the progression of non-alcoholic fatty liver disease
- Author
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Gianni BELCARO, David M. COX, M. Rosaria CESARONE, Giuseppe GIZZI, Luciano PELLEGRINI, Claudia SCIPIONE, Valeria SCIPIONE, Mark DUGALL, Shu HU, Marcello CORSI, Beatrice FERAGALLI, and Roberto COTELLESE
- Subjects
Endocrinology, Diabetes and Metabolism ,Gastroenterology ,Internal Medicine - Abstract
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.
- Published
- 2022
4. Soft management of borderline hypertension: blood pressure, endothelial function, oxidative stress. The GSACE-YOMFO registry (Grape Seeds, 2-ACEs, Yoga-Meditation, Fish oil)
- Author
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Gianni BELCARO, David M. COX, M. Rosaria CESARONE, Claudia SCIPIONE, Valeria SCIPIONE, Mark DUGALL, Marcello CORSI, Beatrice FERAGALLI, Roberto COTELLESE, and Elena OLIARO
- Subjects
Oxidative Stress ,Fish Oils ,Meditation ,Taurine ,Yoga ,Hypertension ,Blood Pressure ,Vitis ,Registries ,General Medicine ,Stress, Psychological - Published
- 2022
5. Restless legs syndrome: prevention with Pycnogenol® and improvement of the venoarteriolar response
- Author
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Gianni BELCARO, Peter ROHDEWALD, Maria R. CESARONE, Claudia SCIPIONE, Valeria SCIPIONE, Umberto CORNELLI, Roberta LUZZI, Roberto COTELLESE, Mark DUGALL, Morio HOSOI, Marcello CORSI, and Beatrice FERAGALLI
- Subjects
Flavonoids ,Oxidative Stress ,Plant Extracts ,Restless Legs Syndrome ,Dietary Supplements ,Humans ,General Medicine ,Antioxidants - Abstract
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
- Published
- 2022
6. Prevention of work-related stress, fatigue, loss of cognitive function, improved attention and recovery of stamina with Robuvit® in professionals with increased oxidative stress
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Gianni Belcaro, Umberto Cornelli, Roberto Cotellese, Valeria Scipione, Mark Dugall, Morio Hosoi, Aristide Saggino, B Feragalli, Maria Rosaria Cesarone, Shu Hu, Claudia Scipione, Marcello Corsi, and David Cox
- Subjects
medicine.medical_specialty ,Plant Extracts ,business.industry ,Registry study ,Work related stress ,Cognition ,General Medicine ,medicine.disease_cause ,Hydrolyzable Tannins ,Occupational Stress ,Oxidative Stress ,Tolerability ,Dietary Supplements ,Physical therapy ,Humans ,Medicine ,Registries ,Fatigue symptoms ,business ,Fatigue ,Oxidative stress - Abstract
AIM The aim of this open, pilot supplement registry study was to evaluate the protective, preventive effects of Robuvit® on professional-related fatigue symptoms and on aspects of cognitive functions, professional attitudes and decision-making in healthy nurses under professional stress and with increased oxidative stress. RESULTS In total, 40 subjects, aged 30 - 37, completed the 4-week registry study. A control group of 20 subjects used only the standard management (SM) and one group of 20 subjects took 300 mg Robuvit®. Safety and tolerability of Robuvit® were optimal. The two registry groups were comparable at inclusion. The overall scores of the real daily life & tasks questionnaire after 4 weeks were significantly higher in the Robuvit® group (p
- Published
- 2022
7. Effects of the collagen modulator Centellicum® and spinal elongation exercises on subclinical abdominal aneurysmal dilatation
- Author
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Gianni BELCARO, Maria R. CESARONE, Mark DUGALL, Marcello CORSI, Morio HOSOI, Pietro M. BAVERA, Roberto COTELLESE, Beatrice FERAGALLI, and Edmondo IPPOLITO
- Subjects
Surgery ,Cardiology and Cardiovascular Medicine - Published
- 2022
8. Primary benign back pain: supplementation with Pycnogenol®
- Author
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David COX, Gianni BELCARO, Maria R. CESARONE, Roberto COTELLESE, Mark DUGALL, Beatrice FERAGALLI, Morio HOSOI, Marcello CORSI, and Roberta LUZZI
- Subjects
Flavonoids ,Back Pain ,Plant Extracts ,Dietary Supplements ,Humans ,General Medicine ,Exercise - Abstract
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
- Published
- 2021
9. Pycnogenol® supplementation prevents inflammation and symptoms in recurrent, non-severe urinary infections
- Author
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Maria Rosaria Cesarone, Roberta Luzzi, Roberto Cotellese, Gianni Belcaro, Shu Hu, Mark Dugall, Marcello Corsi, Beatrice Feragalli, Edmondo Ippolito, and Morio Hosoi
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Flavonoids ,Inflammation ,medicine.medical_specialty ,Urinalysis ,medicine.diagnostic_test ,business.industry ,Plant Extracts ,Registry study ,Urinary system ,General Medicine ,medicine.disease_cause ,Tolerability ,Internal medicine ,Dietary Supplements ,Urinary Tract Infections ,medicine ,Humans ,medicine.symptom ,business ,Oxidative stress - Abstract
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
- Published
- 2021
10. Pycnogenol®-Centellicum® supplementation improves lung fibrosis and post-COVID-19 lung healing
- Author
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Maria Rosaria Cesarone, Roberto Cotellese, Umberto Cornelli, Lars Rosenkvist, Ezio Bombardelli, Marcello Corsi, Beatrice Feragalli, Shu Hu, Gianni Belcaro, and Morio Hosoi
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medicine.medical_specialty ,Pulmonary Fibrosis ,medicine.disease_cause ,Gastroenterology ,Idiopathic pulmonary fibrosis ,Fibrosis ,Edema ,Internal medicine ,medicine ,Humans ,Honeycombing ,Idiopathic interstitial pneumonia ,Lung ,Flavonoids ,business.industry ,Plant Extracts ,COVID-19 ,General Medicine ,medicine.disease ,COVID-19 Drug Treatment ,Apposition ,medicine.anatomical_structure ,Dietary Supplements ,medicine.symptom ,business ,Oxidative stress - Abstract
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
- Published
- 2021
11. Preventive effects of Pycnogenol® on cardiovascular risk factors (including endothelial function) and microcirculation in subjects recovering from coronavirus disease 2019 (COVID-19)
- Author
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Carolina Burki, Shu Hu, Morio Hosoi, Umberto Cornelli, David Cox, Valeria Scipione, Marcello Corsi, Gianni Belcaro, Claudia Scipione, Roberto Cotellese, Beatrice Feragalli, and Maria Rosaria Cesarone
- Subjects
medicine.medical_specialty ,Diastole ,Microcirculation ,Post-Acute COVID-19 Syndrome ,Risk Factors ,Internal medicine ,Heart rate ,medicine ,Humans ,Registries ,Reactive hyperemia ,Clotting factor ,Flavonoids ,business.industry ,Interleukin-6 ,Plant Extracts ,COVID-19 ,General Medicine ,COVID-19 Drug Treatment ,Oxidative Stress ,Blood pressure ,Tolerability ,Cardiovascular Diseases ,Heart Disease Risk Factors ,Dietary Supplements ,Cardiology ,business ,Perfusion - Abstract
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
- Published
- 2021
12. Pycnogenol® Supplementation Prevents Recurrent Urinary Tract Infections/Inflammation and Interstitial Cystitis
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Gianni Belcaro, Marcello Corsi, Andrea Ledda, Mark Dugall, Roberta Luzzi, Shu Hu, E. Ippolito, R Cotellese, M. R. Cesarone, Beatrice Feragalli, and M. Hosoi
- Subjects
Abdominal pain ,medicine.medical_specialty ,Article Subject ,Urinary system ,media_common.quotation_subject ,030232 urology & nephrology ,Urination ,Gastroenterology ,03 medical and health sciences ,Other systems of medicine ,0302 clinical medicine ,Internal medicine ,medicine ,In patient ,030212 general & internal medicine ,media_common ,business.industry ,Incidence (epidemiology) ,Interstitial cystitis ,medicine.disease ,Complementary and alternative medicine ,Tolerability ,Infections inflammation ,medicine.symptom ,business ,RZ201-999 ,Research Article - Abstract
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.
- Published
- 2021
13. Thrombo-prophylaxis prevents thrombotic events in home-managed COVID patients. A registry study
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Umberto Cornelli, Maria Rosaria Cesarone, Gianni Belcaro, Roberto Cotellese, Beatrice Feragalli, G.B. Agus, Shu Hu, and Marcello Corsi
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Male ,medicine.medical_specialty ,2019-20 coronavirus outbreak ,Coronavirus disease 2019 (COVID-19) ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Registry study ,MEDLINE ,Body Mass Index ,Polydeoxyribonucleotides ,Medicine ,Humans ,Registries ,Enoxaparin ,Aged ,business.industry ,Anticoagulants ,COVID-19 ,Thrombosis ,General Medicine ,Heparin, Low-Molecular-Weight ,Middle Aged ,Home Care Services ,Case-Control Studies ,Emergency medicine ,Female ,business ,Preliminary Data - Published
- 2020
14. Seven immediate, low-cost management strategies for Covid. Exploiting viral Thermolabity: Possible, immediate solutions
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G Belcaro, Ezio Bombardelli, Roberto Cotellese, Marcello Corsi, Umberto Cornelli, Maria Rosaria Cesarone, Morio Hosoi, Shu Hu, Mark Dugall, Beatrice Feragalli, and Sandeep Shah
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medicine.medical_specialty ,business.industry ,Cost accounting ,Hydroxychloroquine ,social sciences ,General Medicine ,medicine.disease_cause ,humanities ,Clinical research ,Home management ,Pandemic ,medicine ,Intensive care medicine ,business ,medicine.drug ,Coronavirus - Abstract
A ‘war’ consensus document has been produced by a group of clinical research physician on the pandemics with special...
- Published
- 2020
15. Supplementary management with Pycnogenol® in patients with lupus vasculitis in remission phases: a pilot, concept registry study
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Gianni Belcaro, Valeria Scipione, Maria Rosaria Cesarone, Marcello Corsi, Andrea Ledda, Roberto Cotellese, Beatrice Feragalli, Shu Hu, Claudia Scipione, and Morio Hosoi
- Subjects
Adult ,Male ,Vasculitis ,medicine.medical_specialty ,Anemia ,Anti-Inflammatory Agents ,Pilot Projects ,030204 cardiovascular system & hematology ,Severity of Illness Index ,Gastroenterology ,Antioxidants ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Lupus Erythematosus, Systemic ,Lupus vasculitis ,Registries ,030212 general & internal medicine ,Flavonoids ,Lupus erythematosus ,Leukopenia ,Plant Extracts ,business.industry ,medicine.disease ,Rash ,Oxidative Stress ,Treatment Outcome ,Tolerability ,Female ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Serositis - Abstract
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
- Published
- 2020
16. Keloidal penile fibrosis: improvements with Centellicum® (Centella asiatica) and Pycnogenol® supplementation: a pilot registry
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Beatrice Feragalli, Umberto Cornelli, Mark Dugall, Marcello Corsi, Andrea Ledda, Roberto Cotellese, Shu Hu, and Gianni Belcaro
- Subjects
Male ,medicine.medical_specialty ,Penile Diseases ,Visual Analog Scale ,Visual analogue scale ,Urology ,Signs and symptoms ,Pilot Projects ,030204 cardiovascular system & hematology ,Grey scale ,Catheterization ,03 medical and health sciences ,Centella ,0302 clinical medicine ,Erectile Dysfunction ,Penile fibrosis ,Surveys and Questionnaires ,Medicine ,Humans ,Prospective Studies ,Registries ,Sectional area ,Flavonoids ,030219 obstetrics & reproductive medicine ,Plants, Medicinal ,biology ,business.industry ,Plant Extracts ,General Medicine ,Middle Aged ,biology.organism_classification ,Fibrosis ,Tolerability ,Dietary Supplements ,Elasticity Imaging Techniques ,Penile curvature ,Patient Safety ,business ,Penis - Abstract
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
- Published
- 2020
17. Chronic venous insufficiency and venous microangiopathy: management with compression and Pycnogenol®
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Claudia Maione, Roberto Cotellese, Gianni Belcaro, Morio Hosoi, Marcello Corsi, Maria Rosaria Cesarone, Edmondo Ippolito, Valeria Scipione, G.B. Agus, Beatrice Feragalli, Mark Dugall, and Claudia Scipione
- Subjects
Adult ,Male ,medicine.medical_specialty ,Chronic venous insufficiency ,medicine.medical_treatment ,Compression stockings ,030204 cardiovascular system & hematology ,Severity of Illness Index ,Microcirculation ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Severity of illness ,medicine ,Humans ,030212 general & internal medicine ,Prospective Studies ,Registries ,Prospective cohort study ,Flavonoids ,business.industry ,Plant Extracts ,Microangiopathy ,Middle Aged ,medicine.disease ,Combined Modality Therapy ,Oxidative Stress ,Tolerability ,Venous Insufficiency ,Ambulatory ,Chronic Disease ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business ,Stockings, Compression - Abstract
BACKGROUND The aim of this prospective supplement summer registry study was to evaluate the efficacy of Pycnogenol® in controlling symptoms of chronic venous insufficiency (CVI) and microcirculatory parameters: venous hypertension and microangiopathy. Pycnogenol® (Horphag Research) is the standardized extract of the bark of Pinus Pinaster. METHODS During the summer period between June and August 142 patients were split into three groups: 1) Pycnogenol® 150 mg/day; 2) compression stockings; 3) and compression + Pycnogenol®. RESULTS Venous pressure (ambulatory venous pressure, AVP) and refilling time (RT), microcirculatory and clinical measurements were comparable at inclusion. At 8 weeks variations in skin flux (RF), rate of ankle swelling (RAS), skin PO2-PCO2, Analogue Symptomatic Score (ASLS), Venous Disability and severity Scores and local oxidative stress (OS) indicated a statistically significant improvement by Pycnogenol® both as a single supplement and in association with compression in comparison with baseline. Pycnogenol® significantly improved the microcirculation in comparison with compression (P
- Published
- 2019
18. Mononucleosis-related fatigue: supplementary management with Robuvit®
- Author
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Marcello Corsi, Shu Hu, Morio Hosoi, Andrea Ledda, Maria Rosaria Cesarone, Gianni Belcaro, Roberto Cotellese, Beatrice Feragalli, Mark Dugall, and Patrizia Torino-Rodriguez
- Subjects
Adult ,Male ,Vitamin b ,medicine.medical_specialty ,Mononucleosis ,media_common.quotation_subject ,medicine.disease_cause ,Internal medicine ,medicine ,Sore throat ,Humans ,Infectious Mononucleosis ,Registries ,Leukocytosis ,Young adult ,Fatigue ,media_common ,Plant Extracts ,business.industry ,Convalescence ,medicine.disease ,Hydrolyzable Tannins ,Oxidative Stress ,Treatment Outcome ,Tolerability ,Dietary Supplements ,Pediatrics, Perinatology and Child Health ,Female ,medicine.symptom ,business ,Oxidative stress - Abstract
Background Infectious mononucleosis (IM) is a common disease of adolescents and young adults, characterized by a specific triad of symptoms represented by fever, sore throat and lymphadenopathy. IM may also affect older adults, with different, more intense signs and symptoms such as fatigue, general malaise, and diffuse body pain. The aim of this four-week-registry study was to evaluate the effects of Robuvit® supplementation on the main consequences of mononucleosis, particularly fatigue, in otherwise healthy adults. Methods All patients enrolled in this registry study experienced an episode of IM characterized by fatigue, a general feeling of unwellness, diffuse body and muscular pain, leukocytosis, and high levels of oxidative stress, at least 2 to 4 weeks prior to inclusion. Fever had already resolved at inclusion. All included patients were positively tested for the Epstein-Barr virus (EBV). Subjects were divided in two groups: those receiving the standard management (SM, N.=26; vitamin B, C, and D, balanced healthy diet, regular sleeping schedule, physical activity, 2 mg copper), and those treated with SM plus Robuvit® (N.=24) supplementation (300 mg/day). Results Supplementation with Robuvit® was safe, overall tolerability was good, and no side effects were reported. All patients completed the four-week treatment. After 4 weeks of treatment, a significant reduction in the rate of symptoms was evident in the Robuvit® group compared to the control group (P Conclusions Supplementation with Robuvit® is safe, well tolerated, and effective in controlling oxidative stress levels and improving fatigue and other symptoms related to IM episodes during the convalescence period.
- Published
- 2018
19. Behçet syndrome: effects of Pycnogenol® supplementation during regression phases
- Author
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Patrizia Torino-Rodriguez, Maria Rosaria Cesarone, Mark Dugall, Gianni Belcaro, Marcello Corsi, Andrea Ledda, Shu Hu, Beatrice Feragalli, Morio Hosoi, and Roberto Cotellese
- Subjects
Adult ,Male ,medicine.medical_specialty ,Registry study ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,Internal medicine ,Medicine ,Humans ,Registries ,Active group ,Flavonoids ,030219 obstetrics & reproductive medicine ,business.industry ,Plant Extracts ,Behcet Syndrome ,Test response ,030206 dentistry ,Dietary Supplements ,Pathergy ,Quality of Life ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
BACKGROUND The aim of this comparative registry study was to evaluate the supplementation with Pycnogenol® in subjects with Behcet syndrome (BS) with symptoms impairing their quality of life despite being in a remitting phase of the disease. METHODS Thirty-four patients with a confirmed diagnosis of BS were divided into the control group (without supplement) or the active group, in this specific case using Pycnogenol® (Horphag Research LTD) supplement at the daily dose of 150 mg (50 mg tid) for 4 weeks. RESULTS All subjects receiving Pycnogenol® reported a significant decrease in symptoms, such as burning/pain due to dryness and ulcerations (P
- Published
- 2018
20. Benign prostatic hypertrophy: Pycnogenol® supplementation improves prostate symptoms and residual bladder volume
- Author
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Gianni Belcaro, Andrea Ledda, Beatrice Feragalli, Umberto Cornelli, Marcello Corsi, Maria Rosaria Cesarone, and Mark Dugall
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Male ,medicine.medical_specialty ,Pharmacological management ,Urinary Bladder ,Prostatic Hyperplasia ,Urology ,030209 endocrinology & metabolism ,030204 cardiovascular system & hematology ,urologic and male genital diseases ,Muscle hypertrophy ,03 medical and health sciences ,0302 clinical medicine ,Prostate ,Humans ,Medicine ,Nocturia ,Aged ,Flavonoids ,Plant Extracts ,business.industry ,Healthy subjects ,General Medicine ,medicine.anatomical_structure ,Tolerability ,Bladder volume ,medicine.symptom ,business - Abstract
BACKGROUND The aim of this study was to evaluate the efficacy of Pycnogenol® supplementation in terms of safety and tolerability in the setting of preclinical or borderline, initial symptoms of benign prostatic hyperthrophy (BPH), in otherwise healthy subjects, using Pycnogenol® over a period of 60 days. METHODS Seventy-five healthy men with symptoms and signs of initial BPH were included. The subjects were divided into three groups: 1) control group using only the standard management (SM); 2) a group using SM plus Pycnogenol® 150 mg/day; 3) a group using standard pharmacological management. RESULTS BPH symptoms like emptying, frequency, intermittency, urgency, weak flow, straining, nocturia, were all significantly improved with Pycnogenol® (P
- Published
- 2018
21. Pycnogenol® supplementation improves the control of irritable bowel syndrome symptoms
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Marisa Cacchio, Luciano Pellegrini, Roberto Cotellese, Beatrice Feragalli, Marcello Corsi, Gianni Belcaro, and G. Gizzi
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0301 basic medicine ,Adult ,Male ,medicine.medical_specialty ,Papaverine Hydrochloride ,Belladonna extract ,Pain ,Pilot Projects ,Distension ,Gastroenterology ,Irritable Bowel Syndrome ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Abdomen ,Butylscopolammonium Bromide ,medicine ,Pressure ,Humans ,Registries ,Irritable bowel syndrome ,Flavonoids ,Mild pain ,business.industry ,Plant Extracts ,Parasympatholytics ,General Medicine ,Middle Aged ,medicine.disease ,Healthy Volunteers ,Oxidative Stress ,030104 developmental biology ,medicine.anatomical_structure ,Healthy individuals ,Dietary Supplements ,Defecation ,030211 gastroenterology & hepatology ,Female ,business - Abstract
BACKGROUND The aim of this registry was to evaluate the effects of Pycnogenol® on the main symptoms of irritable bowel syndrome (IBS) in otherwise healthy individuals. METHODS This study included 77 healthy individuals with symptoms of IBS. The patients were divided into three groups: group 1 was treated with Buscopan (10 mg when needed), group 2 (Antispasmina col forte; 50 mg papaverine hydrochloride+10 mg belladonna extract when needed) and 3 (Pycnogenol® 150 mg/day) for 3 weeks. RESULTS The number of painful attacks was comparable in all groups after four weeks. Mild pain on manual abdomen pressure was decreased in all groups, with the improvement in the Pycnogenol® group significantly more pronounced that in both control groups (P
- Published
- 2018
22. Management of Varicose Veins and Chronic Venous Insufficiency in a Comparative Registry with Nine Venoactive Products in Comparison with Stockings
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Umberto Cornelli, R Cotellese, G Belcaro, Andrea Ricci, Luciano Pellegrini, Mark Dugall, Cesarone Mr, Morio Hosoi, B.M. Errichi, B. Feragalli, Roberta Luzzi, Andrea Ledda, G. Agus, and Marcello Corsi
- Subjects
medicine.medical_specialty ,Troxerutin ,business.industry ,Chronic venous insufficiency ,Registry study ,Control symptoms ,030204 cardiovascular system & hematology ,medicine.disease ,Symptoms score ,03 medical and health sciences ,0302 clinical medicine ,Tolerability ,Edema ,Anesthesia ,Varicose veins ,Physical therapy ,Medicine ,030212 general & internal medicine ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
The aim of this registry study was to compare products used to control symptoms of CVI. Endpoints of the study were microcirculation, effects on volume changes, and symptoms (analogue scale). Pycnogenol, venoruton, troxerutin, the complex diosmin-hesperidin, Antistax, Mirtoselect (bilberry), escin, and the combination Venoruton-Pycnogenol (VE-PY) were compared with compressions.No safety or tolerability problems were observed. At inclusion, measurements in the groups were comparable: 1,051 patients completed the registry. Best performers: Venoruton, Pycnogenol, and the combination VE-PY produced the best effects on skin flux. These products and the combination VE-PY better improved PO2 and PCO2. The edema score was decreased more effectively with the combination and with Pycnogenol. Venoruton; Antistax also had good results. Considering volumetry, the best performers were the combination PY-VE and the two single products Venoruton and Pycnogenol. Antistax results for edema were also good. The best improvement in symptoms score were obtained with Pycnogenol and compression. A larger decrease in oxidative stress was observed with Pycnogenol, Venoruton, and with the VE-PY combination. Good effects of Antistax were also observed. Parestesias were lower with Pycnogenol and with Antistax. Considering the need for interventions, the best performers were Pycnogenol, VE-PY, and compression. The efficacy of Pycnogenol and the combination are competitive with stockings that do not have the same tolerability in warmer climates. A larger and more prolonged evaluation is suggested to evaluate cost-efficacy (and non-interference with drugs) of these products in the management of CVI. The registry is in progress; other products are in evaluation.
- Published
- 2017
23. Improvements of Venous Tone with Pycnogenol in Chronic Venous Insufficiency: An Ex Vivo Study on Venous Segments
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Marcello Corsi, Gianni Belcaro, Mark Dugall, Morio Hosoi, and Roberta Luzzi
- Subjects
medicine.medical_specialty ,Bypass grafting ,business.industry ,Chronic venous insufficiency ,Control subjects ,medicine.disease ,Article ,Surgery ,Varicose veins ,cardiovascular system ,medicine ,Venous tone ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Ex vivo - Abstract
This study evaluated the stretching and dilatation of venous segments ex vivo in subjects with primary varicose veins in comparison with comparable segments from subjects that used the supplement Pycnogenol (150 mg/d) for 3 months before surgery. Subjects with varicose veins and chronic venous insufficiency voluntarily used Pycnogenol for a period of at least 3 months. The segments of veins removed with surgery (in 30 subjects that had used Pycnogenol and in 10 comparable control subjects that had not used the supplement) were compared with normal, unused vein segments harvested for bypass grafting. The segments were suspended and a weight was attached to the distal part of the veins for 3 minutes and dilated with pressurized water. Digital images were recorded; the veins were measured before and after stretching to evaluate elongation. The manipulation of the vein segment was minimal. Tests were completed within 20 minutes after harvesting the veins. All segments were 4 cm long. The stretching test indicated a significantly higher level of passive elongation in control, varicose segments (2.29; 0.65 mm) in comparison with 1.39; 0.2 mm in vein segments from Pycnogenol-using patients. The dilation test showed an average higher dilation (2.19; 0.3 mm) in control varicose veins in comparison with varicose veins from Pycnogenol-using patients (1.32; 0.7 mm) (p
- Published
- 2014
24. Pycnogenol® and Centella asiatica to prevent asymptomatic atherosclerosis progression in clinical events
- Author
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Umberto Cornelli, Beatrice Feragalli, Marcello Corsi, Andrea Ledda, Luciano Pellegrini, Scoccianti M, Morio Hosoi, Mark Dugall, Edmondo Ippolito, Roberta Luzzi, Gianni Belcaro, and Maria Rosaria Cesarone
- Subjects
Male ,medicine.medical_specialty ,Femoral artery ,030204 cardiovascular system & hematology ,medicine.disease_cause ,Gastroenterology ,Asymptomatic ,Centella ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine.artery ,Humans ,Medicine ,Ultrasonography ,Flavonoids ,biology ,Plant Extracts ,business.industry ,Clinical events ,Ultrasound ,Echogenicity ,Middle Aged ,Atherosclerosis ,biology.organism_classification ,Plaque, Atherosclerotic ,Triterpenes ,Surgery ,Femoral Artery ,Carotid Arteries ,030220 oncology & carcinogenesis ,Dietary Supplements ,Disease Progression ,Platelet aggregation inhibitor ,Female ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Platelet Aggregation Inhibitors ,Oxidative stress - Abstract
BACKGROUND The aim of this study was to evaluate the effect of the nutritional supplements Pycnogenol® and Centella asiatica (CA) on atherosclerosis progression in low-risk, asymptomatic subjects with carotid or femoral stenosing plaques. METHODS The study included subjects aged 45-60 with stenosing atherosclerotic plaques (50-60%) in at least one carotid or common femoral bifurcation. Subjects were allocated into 3 groups. In Group 1 (controls), management was based on education, exercise, diet and lifestyle changes. This same management plan was used in the other two groups: Group 2 used Pycnogenol® (100 mg/day), while Group 3 used Pycnogenol® 100 mg/day plus CA (100 mg/day). The follow-up lasted 4 years. Plaque progression was assessed using the ultrasonic arterial score based on arterial wall morphology, considering plaque characteristics and the number of subjects that had cardiovascular events. Oxidative stress was also measured. RESULTS Of the 413 individuals that were admitted, 391 individuals completed 4 years. Group distribution was comparable. The rate of progression of ultrasound arterial score was significantly lower in the two supplement groups (P
- Published
- 2016
25. Supplementary management of functional, temporary alcoholic hepatic damage with Robuvit® (French oak wood extract)
- Author
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Luciano, Pellegrini, Gianni, Belcaro, Mark, Dugall, Marcello, Corsi, Roberta, Luzzi, and Masayuki, Hosoi
- Subjects
Free Radicals ,Plant Extracts ,Case-Control Studies ,Dietary Supplements ,Humans ,Bilirubin ,Registries ,Middle Aged ,Alkaline Phosphatase ,Liver Diseases, Alcoholic ,Hydrolyzable Tannins ,Liver Failure ,Serum Albumin - Abstract
The aim of this registry study was to evaluate Robuvit® (French oak wood extract) supplementation in the evolution of moderate functional hepatic failure (MTHF) due to alcohol. Recent studies have indicated the protective effect of oak wood (QR) extracts on liver injury. This registry included patients with MTHF characterized by: decreased albumin levels; increased total bilirubin, altered hepatic functions enzymes, increased oxidative stress, negative viral hepatitis markers.The two groups resulted divided into a best management (BM) group and a comparative group (BM + Robuvit®): 23 Robuvit® patients and 21 comparable controls completed the 12-week registry. At inclusion, blood parameters in the two groups were comparable.During the observation period, the increase in albumin levels was significantly (P0.05 at 6 weeks) faster and higher in the Robuvit® group in comparison with controls. The decrease in ALT-SGPT and AST-ASAT were significantly more important in the supplement group (P0.05 at 6 and 12 weeks). Alkaline phosphatase was significantly lower at 6 and 12 weeks in Robuvit® patients; (Robuvit® group's values were significantly better; P0.05). Total bilirubin improved more in Robuvit® subjects at 6 weeks. Results were statistically significant in comparison with controls (P0.05). Also, direct bilirubin values were higher in the Robuvit® group at 6 and 12 weeks (P0.05). Gamma GT values were normalized at 6 and 12 weeks in the Robuvit® group. There was a less important decrease in controls (P0.05) without normalization at 12 weeks. Plasma free radicals, high at inclusion, showed a more significant decrease in Robuvit® subjects (at 6 and 12 weeks), with normalization at 12 weeks. Persisting high values in controls were observed even at 12 weeks (P0.05). Erythrocytes sedimentation rate (ESR) decreased in both groups with a more important decrease in the Robuvit® group (P0.05). Hepatitis markers were negative when repeated at 6 and 12 weeks.In conclusion, observations from this pilot, supplement registry study indicate a significant protective activity of the supplementation with Robuvit®, associated with a very good safety profile, in patients with temporary alcoholic hepatic failure. The activity of Robuvit® seems to be mediated by its anti-inflammatory activity associated to its important action on oxidative stress.
- Published
- 2016
26. 5-Year Control and Treatment of Edema and Increased Capillary Filtration in Venous Hypertension and Diabetic Microangiopathy Using O-(β-Hydroxyethyl)-Rutosides: A Prospective Comparative Clinical Registry
- Author
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Maria Rosaria Cesarone, I. Ruffini, Marcello Corsi, Gianni Belcaro, Andrea Di Renzo, Andrea Ledda, Edmondo Ippolito, M G Grossi, Mark Dugall, Marisa Cacchio, Anna Rita Marino Santarelli, and Andrea Ricci
- Subjects
Adult ,medicine.medical_specialty ,Time Factors ,Chronic venous insufficiency ,Administration, Oral ,Capillary filtration ,Severity of Illness Index ,Drug Administration Schedule ,Group B ,law.invention ,Capillary Permeability ,Randomized controlled trial ,law ,Edema ,Diabetes mellitus ,Varicose veins ,Laser-Doppler Flowmetry ,Humans ,Medicine ,Prospective Studies ,Registries ,Skin ,Dose-Response Relationship, Drug ,business.industry ,Microangiopathy ,Cardiovascular Agents ,Middle Aged ,medicine.disease ,Surgery ,Hydroxyethylrutoside ,Treatment Outcome ,Venous Insufficiency ,Anesthesia ,Chronic Disease ,Patient Compliance ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Blood Gas Monitoring, Transcutaneous ,Venous Pressure ,Blood Flow Velocity ,Diabetic Angiopathies ,Stockings, Compression - Abstract
This independent prospective controlled trial evaluates the efficacy of O-(β-hydroxyethyl)-rutosides (HR) during 5 years of administration against signs and symptoms and further degeneration of microcirculatory disturbances. The protective effect of HR in preventing end-point complications such as venous ulceration is evaluated. This study is based on evaluation of edema and the capillary filtration rate (CFR) in association with a clinical score scale. Patients having a severe degree of chronic venous insufficiency (CVI) and venous microangiopathy and completing at least 5 years of treatment are included. The following 4 groups are considered: group A (patients with CVI but without diabetes mellitus, receiving 1500 mg/d of HR), group B (patients with CVI and diabetes mellitus, receiving 2 g/d of HR), group C (control subjects receiving no pharmacologic or compression treatment), and group D (patients using elastic compression stockings only). All patients received the “best” available treatment. No adverse effects or intolerance is noted, with good compliance (>85%). In group A, there is a statistically significant decrease in the CFR during 5 years of follow-up. In group B, the decrease in the CFR is greater than that in group A. Reductions in edema, swelling, and the CFR during 5 years are notable, and values approach normal levels. During 5 years, HR is effective in treating venous edema and hypertension and in preventing deterioration of the distal venous system. The prevention of ulcerations with HR is another important observation. The effects of HR seem to be partially dose related, and tolerability and compliance are good.
- Published
- 2008
27. Microcirculatory Effects of Viatromb® Spray Gel Heparin in Chronic Venous Insufficiency: Evaluation of TcPO2 and PCO2—A Product Evaluation Study
- Author
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G. Gizzi, Stefano Stuard, Marcello Corsi, Mark Dugall, Andrea Ledda, G. Acerbi, Gianni Belcaro, Andrea Di Renzo, Luciano Pellegrini, Morio Hosoi, Andrea Ricci, S Errichi, G. Vinciguerra, Marisa Cacchio, Maria Rosaria Cesarone, F. Fano, and Edmondo Ippolito
- Subjects
Male ,medicine.medical_treatment ,Elastic compression ,030204 cardiovascular system & hematology ,0302 clinical medicine ,Edema ,Stockings ,030212 general & internal medicine ,Lipodermatosclerosis ,Anticoagulant ,Compression ,Middle Aged ,Varicose veins ,Blood Gas Monitoring ,Cardiology ,Female ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,Stockings, Compression ,Adult ,medicine.medical_specialty ,Transcutaneous ,medicine.drug_class ,Chronic venous insufficiency ,Compression stockings ,Veins ,Venous disease ,Venous microangiopathy ,Anticoagulants ,Blood Gas Monitoring, Transcutaneous ,Chronic Disease ,Gels ,Heparin ,Humans ,Liposomes ,Microcirculation ,Varicose Ulcer ,Venous Insufficiency ,pCO2 ,03 medical and health sciences ,Internal medicine ,medicine ,business.industry ,Microangiopathy ,medicine.disease ,Surgery ,business ,Varices - Abstract
The evolution of microcirculatory methods and the definition of the concept of venous microangiopathy allow the study in a quantitative way of microcirculatory changes produced by pharmacologic treatments at the areas most frequently and severely affected by chronic venous insufficiency (CVI), venous hypertensive microangiopathy, and venous ulcerations. This pilot study compares subjects with CVI, in the area most affected by venous hypertension in a 2-week registry. Elastic compression, compression plus Viatromb® (lyposomal spray gel heparin), Lioton® (gel including heparin), and Viatromb® alone were compared. Subjects were evaluated for laser Doppler flux, transcutaneous partial pressure of oxygen (TcPO2), and partial pressure of carbon dioxide (PCO2) and CVI analogic symptom scale. In the Viatromb® groups (B and D), significant decreases in laser Doppler flux, PCO2, and CVI score were observed. The decrease was proportionally more important in the elastic compression plus Viatromb ® group. Partial pressure of oxygen (PO2) was significantly increased. No significant changes were observed in the Lioton® group. There was a good effect for compression only. These differences are significant, as they can be observed even in small groups (10-15 patients). No treatment side effects were observed, and compliance and tolerability were very good.
- Published
- 2007
28. Superficial venous incompetence: low-cost outpatient minisurgery, sclerotherapy and combined procedure as a management plan. Costs and efficacy. A 20-year, follow-up registry
- Author
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Gianni, Belcaro, Mark, Dugall, Marcello, Corsi, Giovanni B, Agus, and Edmondo, Ippolito
- Subjects
Adult ,Male ,Middle Aged ,Body Mass Index ,Varicose Veins ,Treatment Outcome ,Italy ,Recurrence ,Case-Control Studies ,Outpatients ,Sclerotherapy ,Costs and Cost Analysis ,Humans ,Female ,Saphenous Vein ,Registries ,Ligation ,Follow-Up Studies - Abstract
This registry study evaluated low-cost outpatient surgery (mini-S) for venous insufficiency as an alternative to stripping.This 20-year follow-up is focused on the recurrence of varices and on the long-term efficacy of the mini-S (group 1) in comparison with controls (2, stripping), sclerotherapy (3) or a combination of mini-S+sclerotherapy (4). Costs were compared.At 20-years of follow-up, considering recurrence/development of new varicose veins, 24.05% of the limbs treated with mini-S developed new varices in comparison with 64.4% in group 2, 24.1% in group 3 and 15.4% in group 4 (P0.05). New surgical procedures were needed in 18.9% of mini-S patients vs. 58.5% in group 2, 21.9% in group 3 and 19.7% in group 4 (P0.05 between group 2 and the other groups). Sclerotherapy (in the years following the initial treatment) was used in 37.9% of mini-S patients in comparison with 67.7% of subjects in group 2 patients, 33.1% in group 3 and 22.8% in group 4 (P0.05 between outpatient treatment and group 2). The superficial venous system was incompetent in 21% of mini-S patients in comparison with 38.8% in group 2 (P0.05), 20.7% in group 3 and 17.9% of group 4. At 20 years edema was present in 10.5% of limbs in group 2 in comparison with a3% (range 2.2-2.1%) in the other groups. Edema was more significant after stripping. Ambulatory venous pressure measurements in subgroups was lower in groups 1, 3 and 4 with a lower refilling time (P0.05). The cost of in-hospital, daily surgical treatments were €1978 (covered by the heathcare provider). The cost of mini-S was on average €488 per limb (covered by patients).Outpatients procedures, in particular the mini-S management plan, were cheaper than stripping and more effective at 20-years follow-up. They could be a model for emerging contries with restricted budgets for vein surgery. Also being cheaper more people may have benefits from treatment when/where hospital procedures are not covered by an healthcare provider.
- Published
- 2015
29. Rapid Relief of Signs/Symptoms in Chronic Venous Microangiopathy With Pycnogenol®: A Prospective, Controlled Study
- Author
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G. Vinciguerra, Morio Hosoi, E. Ippolito, Marisa Cacchio, M. R. Cesarone, Andrea Ricci, Mark Dugall, Luciano Pellegrini, Marcello Corsi, G Belcaro, Andrea Ledda, Peter Rohdewald, G. Gizzi, Stefano Stuard, A. Di Renzo, G. Acerbi, and F. Fano
- Subjects
Adult ,Male ,medicine.medical_specialty ,Chronic venous insufficiency ,Administration, Oral ,030204 cardiovascular system & hematology ,Microcirculation ,03 medical and health sciences ,0302 clinical medicine ,Edema ,Laser-Doppler Flowmetry ,medicine ,Humans ,Sign/symptom ,Lymphedema ,030212 general & internal medicine ,Flavonoids ,Leg ,Plant Extracts ,Vascular disease ,business.industry ,Microangiopathy ,Middle Aged ,medicine.disease ,Surgery ,medicine.anatomical_structure ,Venous Insufficiency ,Anesthesia ,Chronic Disease ,Ambulatory ,Female ,Ankle ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Venous Pressure ,Platelet Aggregation Inhibitors - Abstract
The aim of this study was to investigate the clinical efficacy of oral Pycnogenol® (Horphag Research Ltd, UK) in patients with severe chronic venous insufficiency. Patients with severe venous hypertension (chronic venous insufficiency, ankle swelling) and history of venous ulcerations were treated with Pycnogenol. Patients received oral Pycnogenol (50 mg capsules, 3 times daily for a total of 150 mg daily) for 8 weeks. A group of 21 patients was included in the treatment group and 18 equivalent patients were observed as controls (no treatment during the observation period). All 21 patients (age 53 years; range, 42-60 years; M:F=11:10) in the treatment group completed the 8-week study. Also the 18 controls completed the follow-up period. There were no drop-outs. The average ambulatory venous pressure was 59.3 (SD 7.2; range 50-68) with a refilling time shorter than 10 seconds (average 7.6; SD 3). There were no differences in ambulatory venous pressure or refilling time between the treatment and control patients. The duration of the disease—from the first signs/symptoms—was on average 5.7 years (SD 2.1). At 4 and 8 weeks, in all Pycnogenol-treated subjects, microcirculatory and clinical evaluations indicated a progressive decrease in skin flux, indicating an improvement in the level of microangiopathy; a significant decrease in capillary filtration; a significant improvement in the symptomatic score; and a reduction in edema. There were no visible effects in controls. In conclusion, this study confirms the fast clinical efficacy of Pycnogenol in patients with chronic venous insufficiency and venous microangiopathy. The study indicates the significant clinical role of Pycnogenol in the management, treatment and control of this common clinical problem. The treatment may be also useful to prevent ulcerations by controlling the level of venous microangiopathy.
- Published
- 2006
30. HR, 0-(Beta-Hydroxyethyl)-Rutosides; (Venoruton®): Rapid Relief of Signs/Symptoms in Chronic Venous Insufficiency and Microangiopathy: A Prospective, Controlled Study
- Author
-
G. Gizzi, Stefano Stuard, Luciano Pellegrini, G. Vinciguerra, E. Ippolito, Cesarone Mr, Marcello Corsi, Marisa Cacchio, Andrea Ledda, M Dugall, F. Fano, G. Acerbi, G Belcaro, Andrea Ricci, and A. Di Renzo
- Subjects
Adult ,Male ,medicine.medical_specialty ,Chronic venous insufficiency ,Administration, Oral ,030204 cardiovascular system & hematology ,Capillary Permeability ,03 medical and health sciences ,0302 clinical medicine ,Edema ,Laser-Doppler Flowmetry ,medicine ,Humans ,Vasoconstrictor Agents ,Plethysmograph ,Sign/symptom ,Prospective Studies ,030212 general & internal medicine ,Prospective cohort study ,Aged ,Leg ,Dose-Response Relationship, Drug ,business.industry ,Microcirculation ,Microangiopathy ,Middle Aged ,medicine.disease ,Surgery ,Plethysmography ,Hydroxyethylrutoside ,Venous Insufficiency ,Anesthesia ,Ambulatory ,Female ,Powders ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,Varices ,business - Abstract
The aim of this independent study was to demonstrate the rapidity of the clinical action of HR 0-(beta-hydroxyethyl)-rutosides, Venoruton® (Novartis Consumer Health) in patients with chronic venous insufficiency (CVI). Two groups of patients with venous hypertension and microangiopathy were treated with HR (1 or 2 g/day, for 8 weeks). Twelve patients (age 56.4; range 44-66; M:F = 6:6) were included in group 1 (1 g/day) (moderate CVI and microangiopathy); 10 patients (age 57.4; range 42-67; M:F = 5:5) in group 2 (2 g/day) with more severe CVI and microangiopathy. Average ambulatory venous pressure (AVP) was 58.6 (range 50-65) with a refilling time (RT) shorter than 10 seconds. There were no significant differences in AVP and RT between the 2 groups, but the duration of the disease was longer in group 2: 3.5 years (SD 2.0) in group 1 and 6.4 years (SD 3.3) in group 2. All included subjects completed the study and no dropouts were observed. In both dose groups there was a progressive decrease in laser Doppler resting flux (RF), indicating improvement in microangiopathy and a significant decrease in capillary filtration (RAS) associated with a significant improvement in analogue scale line score (ASLS) and edema. Although the effect in the 2 g dose group was more rapid on the microcirculatory parameters with a significant effect on RF and RAS after 4 days (effect of 1 g per day after 8 days and 6 days, respectively), there was no difference in the time to onset of a significant clinical improvement (ie, the ASLS and the edema score): 4 days in both groups. Venous microangiopathy and edema were improved by the treatment with HR within a few days. The effects were visible with both dosages, in both severity groups.
- Published
- 2005
31. Variations in Plasma Free Radicals with Topical Aescin + Essential Phospholipids Gel in Venous Hypertension: New Clinical Data
- Author
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Umberto Cornelli, Marcello Corsi, E. Ippolito, M. R. Cesarone, Mark Dugall, G Belcaro, I. Ruffini, and Andrea Ricci
- Subjects
Adult ,Male ,medicine.medical_specialty ,Free Radicals ,Administration, Topical ,Urology ,Microcirculation ,chemistry.chemical_compound ,Essential phospholipids ,Varicose veins ,Humans ,Medicine ,Tibia ,Venous hypertension ,Aged ,Aescin ,Escin ,Massage ,business.industry ,Microangiopathy ,Middle Aged ,medicine.disease ,Surgery ,Drug Combinations ,Venous Insufficiency ,chemistry ,Phosphatidylcholines ,Female ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Gels ,Venous Pressure - Abstract
The aim of this study was the evaluation of the effects of Aescin + essential phospholipids (AEPL) gel on plasma free radicals (PFRs). In this study, ten patients with venous hypertension, no ulcerations or infections, venous microangiopathy, and varicose veins were treated with topical AEPL applied in a standard protocol. AEPL was applied for 2 weeks, three times daily at the same skin region (perimalleolar internal region at defined distance from the medial malleolus and from the anterior edge of the tibia). In subjects with venous hypertension, PFR values were higher than 420 Carr units. After treatment, the values of PRF decreased to almost normal as an effect of the massage with AEPL gel. The decrease in value was observed in all treatment subjects. A ranking system indicates that the AEPL preparation is active in all subjects who have venous microangiopathy. The decrease in PFR value was greater than 30% in all treatment subjects (p
- Published
- 2004
32. Prevention of Venous Thrombosis in Long-Haul Flights with Flite Tabs: The LONFLIT-FLITE Randomized, Controlled Trial
- Author
-
M. R. Cesarone, G Belcaro, Neil H. Riordan, A. Di Renzo, P Bavera, Andrea Ricci, G. Vinciguerra, Mark Dugall, G. Acerbi, George Geroulakos, I. Ruffini, J. Kenyon, R. Brandolini, Marcello Corsi, Maura Griffin, E. Ippolito, Andrew Nicolaides, Stefano Stuard, and B.M. Errichi
- Subjects
Adult ,Male ,medicine.medical_specialty ,Deep vein ,Capsules ,030204 cardiovascular system & hematology ,Placebo ,Asymptomatic ,Veins ,law.invention ,Fibrin Fibrinogen Degradation Products ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Risk Factors ,law ,medicine ,Edema ,Humans ,Subtilisins ,030212 general & internal medicine ,Vein ,Exercise ,Aged ,Ultrasonography ,Flavonoids ,Venous Thrombosis ,Leg ,Travel ,Plant Extracts ,business.industry ,Fibrinogen ,Middle Aged ,medicine.disease ,Thrombosis ,Surgery ,Drug Combinations ,Venous thrombosis ,medicine.anatomical_structure ,Anesthesia ,Concomitant ,Aerospace Medicine ,Female ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Platelet Aggregation Inhibitors - Abstract
The aim of this study was to evaluate the development of edema, and superficial and deep vein thrombosis (DVT) prophylaxis with an oral profibrinolytic agent (Flite Tabs, 150 mg pinokinase, Aidan, Tempe, AZ, USA) in long-haul flights (7-8 hours), in high-risk subjects. A group of 300 subjects was included; 76 were excluded for several problems including concomitant treat ments ; 204 were randomized into 2 groups (active treatment or placebo) to evaluate the effects of prophylaxis with Flite Tabs. An exercise program was used in both groups. The femoral, popliteal, tibial, and superficial veins were scanned with ultrasound before and within 90 minutes after flights. Of the included subjects, 92 of 103 controls and 94 of 101 treated subjects completed the study. Dropouts were due to connection problems. Age, gender, and risk distribution were comparable in the groups. In the treatment group, no DVT was observed. In the control group, 5 subjects (5.4%) had a DVT and there were 2 superficial thromboses (7 events in 92 subjects; 7.6%). At inclusion, edema was comparable in the 2 groups. After flights there was an increase in score in controls (+12%) in comparison with a decrease (-15%) in the Flite Tabs group (the difference in variation was statistically significant). Intention-to-treat analysis for thrombotic events shows 18 failures in controls (11 lost to follow-up + 7 throm botic events) of 92 subjects (19.6%) in comparison with 7 failures (of 94 subjects, equivalent to 7.4%) in the treatment group (p
- Published
- 2003
33. Comparison of Low-Molecular-Weight Heparin, Administered Primarily at Home, with Unfractionated Heparin, Administered in Hospital, and Subcutaneous Heparin, Administered at Home for Deep-Vein Thrombosis
- Author
-
G Belcaro, Andrew Nicolaides, D. Christopoulos, M.T. De Sanctis, Laurora G, Monique A. Malouf, Antonio Barsotti, Lucrezia Incandela, S. Vasdekis, Marcello Corsi, M. R. Cesarone, and A. Lennox
- Subjects
Male ,0301 basic medicine ,medicine.medical_specialty ,medicine.drug_class ,Injections, Subcutaneous ,Deep vein ,medicine.medical_treatment ,Low molecular weight heparin ,Hemorrhage ,030204 cardiovascular system & hematology ,03 medical and health sciences ,0302 clinical medicine ,Fibrinolytic Agents ,Recurrence ,Ambulatory Care ,Ventilation-Perfusion Ratio ,medicine ,Humans ,International Normalized Ratio ,Ultrasonography, Doppler, Color ,Venous Thrombosis ,Ultrasonography, Doppler, Duplex ,Chemotherapy ,Heparin ,business.industry ,Anticoagulant ,Anticoagulants ,Nadroparin ,Health Care Costs ,Length of Stay ,Middle Aged ,Nadroparin calcium ,medicine.disease ,Thrombosis ,Surgery ,Hospitalization ,Venous thrombosis ,030104 developmental biology ,medicine.anatomical_structure ,Injections, Intravenous ,Female ,Safety ,Pulmonary Embolism ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies ,medicine.drug - Abstract
In this study, 294 patients with acute proximal DVT (deep venous thrombosis) were randomly assigned to receive intravenous standard heparin in the hospital (98 patients) or low-molecular-weight heparin (LMWH) (nadroparin 0.1 mL [equivalent to 100 AXa IU] per kg of body weight subcutaneously twice daily) administered primarily at home (outpatients) or alternatively in hospital (97 patients) or subcutaneous calcium heparin (SCHep) (99 patients, 0.5 mL bid) administered directly at home. The study design allowed outpatients taking LMWH heparin to go home immediately and hospitalized patients taking LMWH to be discharged early. Patients treated with standard heparin or LMWH received the oral anticoagulant starting on the second day, and heparin was discontinued when the therapeutic range (INR 2-3) had been reached. Anticoagulant treatment was maintained for 3 months. Patients treated with SCHep were injected twice daily for 3 months without oral anticoagulants. Patients were evaluated for inclusion and follow-up with color duplex scanning. Venography was not used. In case of suspected pulmonary embolism (PE) a ventilatory-perfusional lung scan was performed. Endpoints of the study were recurrent or extension of DVT, bleeding, the number of days spent in hospital, and costs of treatments. Of the 325 patients included, 294 completed the study. Dropouts totaled 31 (10.5%); six of the 325 included patients (1.8%) died from the related, neoplastic illness. Recurrence or extension of DVT was observed in 6.1% of patients in the LMWH group, in 6.2% in the standard heparin group, and in 7.1% in the SCHep group. Most recurrences (11/17) were in the first month in all groups. Bleedings were all minor, mostly during hospital stay. Hospital stay in patients treated with LMWH was 1.2 ± 1.4 days in comparison with 5.4 ± 1.2 in those treated with standard heparin. There was no hospital stay in the SCHep group. Average treatment costs in 3 months in the standard heparin group (US $2,760) were considered to be 100%; in comparison costs in the LMWH group was 28% of the standard heparin and 8% in the SCHep group. This study indicated that LMWH and SCHep can be used safely and effectively to treat patients with proximal DVT at home at a lower cost.
- Published
- 1999
34. Comparison of the effects of picotamide and aspirin on renal albumin excretion and cutaneous microcirculation in patients with type II diabetes mellitus: a pilot study
- Author
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Massimo Milani, Giuseppe Laurora, Augusto Borzone, Franco Lacerna, and Marcello Corsi
- Subjects
Pharmacology ,medicine.medical_specialty ,Aspirin ,Supine position ,biology ,business.industry ,Microangiopathy ,Urology ,medicine.disease ,Excretion ,Endocrinology ,Internal medicine ,Diabetes mellitus ,biology.protein ,medicine ,Picotamide ,Pharmacology (medical) ,Microalbuminuria ,Thromboxane-A synthase ,business ,medicine.drug - Abstract
We compared the effects of two antiplatelet agents, picotamide, a dual antithromboxane inhibitor, and aspirin, a nonselective cyclooxygenase inhibitor, on microalbuminuria and cutaneous microcirculation in diabetic patients. Twenty patients with type II diabetes mellitus with micro- or macroalbuminuria (urinary albumin excretion rate ⩾ 30 mg/24 h) (8 men, 12 women; mean age, 62 ± 3 years) were enrolled in an open-label, 3-month pilot study and randomly assigned to receive picotamide 300 mg twice daily (10 patients), or aspirin 325 mg/day (10 patients). The 24-hour urinary albumin excretion rate was measured at baseline and after 3 months using a commercial radioimmunoassay kit. Cutaneous microcirculation was assessed at the same time by means of laser-Doppler flowmetry. Supine resting flow (RF) and standing flow (SF) (after 3 minutes in the upright position) were also measured. The arteriovenous response (AVR) was calculated as (RF — SF)/RF × 100. The microangiopathy index (MI) was expressed as the ratio AVR:RF. Urinary albumin excretion rate increased significantly ( P P = not significant). Urinary albumin excretion rate increased in 6 patients in the aspirin group and in 1 patient in the picotamide group ( P P P
- Published
- 1995
35. Acute Branch Retinal Arterial Embolism Successfully Treated with Intravenous Prostaglandin E1
- Author
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Nicola Pescosolido, Marcello Corsi, Robert D Steigerwalt, M. Rosaria Cesarone, and Gianni Belcaro
- Subjects
Male ,Arterial embolism ,Visual acuity ,genetic structures ,Retinal Artery Occlusion ,Vasodilator Agents ,Retinal arterial occlusion ,Embolism ,Visual Acuity ,030204 cardiovascular system & hematology ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Embolus ,Humans ,Medicine ,030212 general & internal medicine ,Alprostadil ,Infusions, Intravenous ,Prostaglandin E1 ,Macular edema ,Aged ,Aged, 80 and over ,business.industry ,medicine.disease ,Arterial occlusion ,eye diseases ,chemistry ,Anesthesia ,Female ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business - Abstract
The purpose of this paper is to report the use of intravenous prostaglandin E1' a potent vasodilator, to rapidly restore blood flow and vision in a patient with an acute branch retinal arterial occlusion. An 82-year-old woman with an acute decrease in the visual acuity of her left eye due to an acute superior temporal branch retinal arterial embolus was treated with 140 μg of intravenous prostaglandin E1. The medicine was repeated the following day. At the onset of the branch arterial occlusion her vision in the left eye was 20/50, the embolus could be seen in the superior temporal branch, and a white retinal edema extended down into the macula. At her first eye examination 4 days after treatment, her visual acuity had returned to 20/20, the retinal embolus was still present, but the white macular edema had disappeared. Intravenous prostaglandin E1 is a safe, potent vasodilator for the peripheral vascular system. If used imme diately to treat acute branch arterial retinal occlusions, it can restore good vision. The authors report the first case of the use of intravenous prostaglandin E1 to treat a spontaneous acute branch retinal arterial embolus.
- Published
- 2003
36. O-(beta-hydroxyethyl)-rutosides systemic and local treatment in chronic venous disease and microangiopathy: an independent prospective comparative study
- Author
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Marcello Corsi, Anna Rita Marino Santarelli, Gianni Belcaro, Andrea Di Renzo, Andrea Ledda, Maria Rosaria Cesarone, Marisa Cacchio, I. Ruffini, M G Grossi, Edmondo Ippolito, Mark Dugall, and Andrea Ricci
- Subjects
Adult ,medicine.medical_specialty ,Time Factors ,Chronic venous insufficiency ,Administration, Oral ,Administration, Cutaneous ,Severity of Illness Index ,Capillary Permeability ,Edema ,Varicose veins ,medicine ,Laser-Doppler Flowmetry ,Humans ,Prospective Studies ,Registries ,Prospective cohort study ,Skin ,business.industry ,Vascular disease ,Microangiopathy ,Cardiovascular Agents ,Middle Aged ,medicine.disease ,Surgery ,Hydroxyethylrutoside ,Treatment Outcome ,Tolerability ,Venous Insufficiency ,Anesthesia ,Ambulatory ,Chronic Disease ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Blood Gas Monitoring, Transcutaneous ,Gels ,Venous Pressure ,Blood Flow Velocity ,Diabetic Angiopathies ,Stockings, Compression - Abstract
O-(β-hydroxyethyl)-rutosides (HR) is used to treat chronic venous disease and signs and symptoms of chronic venous insufficiency (CVI), varicose veins, and deep venous disease. This independent prospective controlled trial (a registry study) evaluates how the efficacy of HR at the local level (perimalleolar region) can be increased by the administration of a topical HR gel. The study is based on evaluation of microcirculatory variables in patients with severe CVI (ambulatory venous pressure, >56 mm Hg) and venous microangiopathy. Patients are treated using 1 of the following 3 regimens: oral treatment with 1-g sachets of HR (2 g/d total) plus topical HR 2% gel applied 3 times daily at the internal perimalleolar region; oral treatment only (same dosage), or light elastic compression stockings. Laser Doppler skin flux at rest, skin flux at the perimalleolar region, and transcutaneous PO2 and PCO2 are measured at baseline and at the end of the treatment period. A comparable group of healthy individuals without treatment is observed for 8 weeks. In the treatment groups, flux is increased, PO2 is decreased, and PCO2 is increased compared with normal skin. At 4 and 8 weeks, the improvement in skin flux (which is decreased by all measurements), the increase in PO 2, and the decrease in PCO2 (indicating microcirculatory improvement) are statistically significantly greater in the combined oral plus topical treatment group (P < .05). No adverse effects, tolerability problems, or compliance issues are noted. These results indicate an important role of HR in the treatment and control of CVI and venous microangiopathy.
- Published
- 2008
37. Topical heparin: New observations
- Author
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A. Di Renzo, M G Grossi, E. Ippolito, S Errichi, Andrea Ledda, F. Fano, Morio Hosoi, Stefano Stuard, Mark Dugall, G. Vinciguerra, Umberto Cornelli, I. Ruffini, G. Gizzi, Marcello Corsi, M. R. Cesarone, Luciano Pellegrini, G Belcaro, Andrea Ricci, Marisa Cacchio, and B.M. Errichi
- Subjects
medicine.medical_specialty ,Superficial vein thrombosis ,medicine.drug_class ,Administration, Topical ,Skin permeability ,030204 cardiovascular system & hematology ,Bioinformatics ,Anticoagulants ,Heparin ,Humans ,Liposomes ,Thrombosis ,Cardiology and Cardiovascular Medicine ,03 medical and health sciences ,0302 clinical medicine ,medicine ,030212 general & internal medicine ,business.industry ,Anticoagulant ,medicine.disease ,Surgery ,Topical ,Skin penetration ,Administration ,medicine.symptom ,business ,Vasoconstriction ,medicine.drug - Abstract
Topical effects of heparins on the skin need deeper investigations. The lack of evidence is mainly due to the lack of large investments in this field. Three main local actions of heparin on the skin can be defined: (a) the anticoagulant action, (b) the microcirculatory-modulatory action determining important control of the microcirculation in case of excessive vasoconstriction or vasodilatation, and (c) the `facilitatory action' on skin permeability allowing other drugs to diffuse better and faster into the skin (producing a therapeutic effect). These aspects have to be evaluated more extensively in both experimental and clinical conditions. Recent experimental studies demonstrate these effects of locally applied heparin. Therefore, key questions on local heparin administration such as skin penetration and the action on the local thrombi have promising answers. These observations suggest important clinical applications for local liposomal heparin. Both the potentials of local applications of heparin, particularly with new formulations, and some new aspects in the management of superficial vein thrombosis (SVT) can focus on locally applied heparin. SVT is an important clinical condition considering its frequency and the potentially heavy use of local heparin in this clinical problem. Results from new studies and observations presented in this issue of Angiology could be a window for suggesting new significant clinical applications and therapeutic solutions.
- Published
- 2007
38. Comparison of Pycnogenol and Daflon in treating chronic venous insufficiency: a prospective controlled study
- Author
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G. Vinciguerra, E. Ippolito, Andrea Ricci, Marcello Corsi, M. R. Cesarone, Luciano Pellegrini, Andrea Ledda, Marisa Cacchio, G Belcaro, Morio Hosoi, Peter Rohdewald, A. Di Renzo, Stefano Stuard, G. Gizzi, F. Fano, Mark Dugall, and G. Acerbi
- Subjects
Adult ,medicine.medical_specialty ,Chronic venous insufficiency ,Diosmin ,Capillary filtration ,030204 cardiovascular system & hematology ,Gastroenterology ,Settore MED/22 - Chirurgia Vascolare ,Varicose Ulcer ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Edema ,Varicose veins ,Humans ,Medicine ,030212 general & internal medicine ,Clinical efficacy ,Flavonoids ,Plant Extracts ,business.industry ,Microangiopathy ,Hematology ,General Medicine ,Middle Aged ,medicine.disease ,Surgery ,Treatment Outcome ,medicine.anatomical_structure ,Venous Insufficiency ,Daflon ,Diosmin and hesperidin ,Pycnogenol® ,Venous disease ,Venous microangiopathy ,Chronic Disease ,Hypertension ,Blood Gas Analysis ,medicine.symptom ,Ankle ,business ,medicine.drug - Abstract
The aim of this study was to investigate the clinical efficacy of oral Pycnogenol® (Horphag Research Ltd., UK) in patients with severe chronic venous insufficiency (CVI) in comparison to the combination of diosmin and hesperidin (Daflon®, Servier, France). A group of 86 patients with severe chronic venous insufficiency (CVI), venous hypertension, ankle swelling) and previous history of venous ulcerations received either oral Pycnogenol (capsules) 150 mg or 300 mg daily for 8 weeks or Daflon, 1000 mg/day. All patients completed the study without dropouts. At the end of the study, microcirculatory results indicated: a progressive decrease of skin flux at rest (RF); a significant decrease in capillary filtration (RAS); an improvement in the symptomatic venous score (ASLS); a reduction in edema; a significant improvement (increase) in pO2 and a decrease in pCO2 in the Pycnogenol group. A significant level of improvement was reached after 4 weeks of treatment in most patients (p < .05) of the Pycnogenol group while clinical improvement was significant only in 6 subjects in the Daflon group. The positive effects of treatment with Pycnogenol after 8 weeks were significantly larger in comparison with the Daflon group. In conclusion, this study confirms the fast clinical efficacy of Pycnogenol in patients with chronic venous insufficiency and venous microangiopathy and its superiority—considering the evaluated parameters—to the combination of diosmin and hesperidin.
- Published
- 2006
39. Circulating endothelial cells in venous blood as a marker of endothelial damage in chronic venous insufficiency: Improvement with Venoruton
- Author
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Marcello Corsi, G. Acerbi, Andrea Ledda, Luciano Pellegrini, Stefano Stuard, Morio Hosoi, Gianni Belcaro, Andrea Ricci, Maria Rosaria Cesarone, G. Vinciguerra, Andrea Di Renzo, Marisa Cacchio, F. Fano, G. Gizzi, Mark Dugall, and Edmondo Ippolito
- Subjects
Male ,Pathology ,medicine.medical_specialty ,Endothelium ,Chronic venous insufficiency ,Endothelial cells ,Venoruton ,Venous disease ,Pharmacology ,Cardiology and Cardiovascular Medicine ,Pharmacology (medical) ,Cell Count ,030204 cardiovascular system & hematology ,Settore MED/22 - Chirurgia Vascolare ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Humans ,Vasoconstrictor Agents ,Medicine ,Distribution (pharmacology) ,030212 general & internal medicine ,Hydroxyethylrutoside ,Vein ,business.industry ,Venous blood ,Middle Aged ,medicine.disease ,Peripheral ,Transplantation ,medicine.anatomical_structure ,Venous Insufficiency ,chemistry ,Blood Circulation ,Chronic Disease ,Female ,Endothelium, Vascular ,business - Abstract
Damage to endothelial cells is common in vascular disorders and in reactions associated with transplantation. An elevated number of circulating endothelial cells indicates the extent of endothelial damage in a variety of disorders. In chronic venous insufficiency (CVI), the number of endothelial cells is abnormally increased, and this can be considered an important indication of endothelial damage. A group of 23 subjects with two levels of CVI (severe and very severe with previous ulcerations) with an increased endothelial cell count (seen by microscopy) was studied and treated for 4 weeks with oral Venoruton (0-[beta-hydroxyethyl]-rutosides) (1 g/day) to evaluate the effects of treatment on the circulating endothelial cells in blood taken from a peripheral leg vein. The controls comprised two groups with comparable age and sex distribution, one of healthy individuals and one of CVI subjects. After 4 weeks, a significant decrease was noted in endothelial cells both in subjects with CVI and in those with very severe CVI with previous ulcerations. This study suggests that endothelial cells may play a significant role in venous disease, being both an indication of severe disease and a further problem in itself. The use of Venoruton appears to decrease the number of circulating endothelial cells. This suggests an important role of this compound in protecting the endothelium and offers new potentially important therapeutic options that are not limited only to venous disease.
- Published
- 2006
40. Prevention of edema and flight microangiopathy with Venoruton (HR), (0-[beta-hydroxyethyl]-rutosides) in patients with varicose veins
- Author
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A. Di Renzo, G. Vinciguerra, Andrea Ricci, Marisa Cacchio, Francesco Cerritelli, Luciano Pellegrini, G. Gizzi, Candiani C, Stefano Stuard, Umberto Cornelli, Marcello Corsi, M. R. Cesarone, Mark Dugall, B.M. Errichi, R. Brandolini, Roberto Adovasio, E. Ippolito, G Belcaro, C. Larnier, Cesarone, Mr, Belcaro, G, Ricci, A, Brandolini, R, Pellegrini, L, Dugali, M, DI RENZO, A, Vinciguerra, G, Gizzi, G, Cornelli, U, Errichi, Bm, Corsi, M, Ippolito, E, Adovasio, Roberto, Cacchio, M, Stuard, S, Larnier, C, Candiani, C, and Cerritelli, F.
- Subjects
Male ,medicine.medical_specialty ,Time Factors ,Chronic venous insufficiency ,030204 cardiovascular system & hematology ,Microcirculation ,Capillary Permeability ,Varicose Veins ,03 medical and health sciences ,0302 clinical medicine ,Edema ,Varicose veins ,medicine ,Humans ,Vasoconstrictor Agents ,030212 general & internal medicine ,Leg ,Travel ,Varix ,business.industry ,Vascular disease ,Microangiopathy ,Middle Aged ,medicine.disease ,Surgery ,Hydroxyethylrutoside ,Treatment Outcome ,Venous Insufficiency ,Anesthesia ,Aerospace Medicine ,Drug Evaluation ,Female ,medicine.symptom ,Ankle ,Cardiology and Cardiovascular Medicine ,business ,Varices ,Aviation - Abstract
The aim of this open study was the evaluation of the effects of HR (Venoruton®) at a dose of 1 g/day on the prevention and control of flight microangiopathy and edema in subjects with varicose veins and moderate chronic venous insufficiency flying for more than 11 hours. Patients with varicose veins, edema, but without initial skin alterations or complications, were included. Measurements of skin laser Doppler (LDF) resting flux (RF) venoarteriolar response (VAR), ankle swelling (RAS), and edema were made within 12 hours before and within 3 hours after the flights. The resulting edema after the flights was evaluated with a composite edema score (analogue scale line). A group of 20 subjects was treated with HR (1 g/day, starting 2 days before the flight and 1 g for every 12 hours on day of travel). Another group of 18 subjects formed the control group. The length of the flights was between 11 and 13 hours; all seats were in coach class. Fifty patients were enrolled and 38 patients were evaluable at the end of the trial. The 2 groups (treatment and control) were comparable for age and sex distribution. The decrease in RF was significant in both groups with a higher flux at the end of the flight in the HR group (p
- Published
- 2005
41. Prevention of recurrent deep venous thrombosis with sulodexide: the SanVal registry
- Author
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A. Felicita, Morio Hosoi, M. Ruffini, M. Scoccianti, R. Brandolini, Marcello Corsi, G Belcaro, A. Di Renzo, A. Ippolito, G. Gizzi, G. Acerbi, R. Marinucci, Lania M, Mark Dugall, G. Vinciguerra, P. Bavera, B. M. Errichi, Andrea Ricci, Luciano Pellegrini, and M. R. Cesarone
- Subjects
Male ,medicine.medical_specialty ,Administration, Oral ,030204 cardiovascular system & hematology ,Recurrent deep vein thrombosis ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,medicine ,Coagulation testing ,Secondary Prevention ,Humans ,030212 general & internal medicine ,Registries ,Glycosaminoglycans ,Ultrasonography ,Venous Thrombosis ,Leg ,business.industry ,Vascular disease ,Incidence (epidemiology) ,Anticoagulants ,Middle Aged ,medicine.disease ,Thrombosis ,Sulodexide ,Surgery ,Clinical trial ,Venous thrombosis ,Female ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies - Abstract
The aim of this study was to evaluate the prevention of recurrent deep vein thrombosis (RDVT) with an oral antithrombotic agent (sulodexide) in moderate to high-risk subjects. A group of 405 patients was included into the multicenter registry. Both compression and an exercise program were used as well as a risk-factors control plan. After diagnosis of DVT, patients were treated with oral anticoagulants for 6 months. At the end of this period a coagulation study was made and patients started treatment with oral sulodexide capsules for a period of 24 months. The femoral, popliteal, tibial, and superficial veins were scanned with high-resolution ultrasound at inclusion; scans were repeated at 6, 12, 18, and 24 months. Of the 405 subjects included into the registry 178 in the control group (mean age 52.2; SD 11; M:F = 90:88) and 189 in the treatment group (mean age 53.2; SD 10.3; M:F = 93:96) completed the analysis period of 24 months. At 6 and 12 months the incidence of R-DVT was lower (p
- Published
- 2004
42. Nomograms used to define the short-term treatment with PGE(1) in patients with intermittent claudication and critical ischemia. The ORACL.E (Occlusion Revascularization in the Atherosclerotic Critical Limb) Study Group. The European Study
- Author
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G Belcaro, Vittorio Bertele, E. Simeone, M. Petrucci, George Geroulakos, M. Cazaubon, Marco Bucci, S. Vasdekis, G.M. Andreozzi, Giuseppe Cipollone, Lucrezia Incandela, G. Ramaswami, Andrew Nicolaides, Andrea Ledda, Laurora G, G. Agus, L. Mezzanotte, E. Ippolito, G. Szendro, M. R. Cesarone, R. Ciccarelli, Umberto Cornelli, P.G. Ferrari, Andrea Ricci, Nicos Labropoulos, San Valentino, R. Venniker, Celia B. Fisher, D. Christopoulos, M.T. De Sanctis, Marcello Corsi, Antonio Barsotti, P. Pomante, Mark Dugall, H. Helmis, Martin Veller, B.M. Errichi, G. Martines, and P. Iacobitti
- Subjects
Male ,medicine.medical_specialty ,medicine.medical_treatment ,Cost-Benefit Analysis ,Vasodilator Agents ,Ischemia ,Pain ,Pilot Projects ,Walking ,030204 cardiovascular system & hematology ,Revascularization ,Drug Costs ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Occlusion ,medicine ,Humans ,030212 general & internal medicine ,Alprostadil ,Aged ,Gangrene ,Leg ,business.industry ,Vascular disease ,Critical limb ischemia ,Intermittent Claudication ,Middle Aged ,medicine.disease ,Intermittent claudication ,Surgery ,Treatment Outcome ,Cardiology ,Female ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,Claudication ,business ,Algorithms - Abstract
Infusional, cyclic PGE 1 treatment is effective in patients with intermittent claudication and critical limb ischemia (CLI). One of the problems related to chronic PGE1 treatment in vascular diseases due to atherosclerosis is to evaluate the variations of clinical condi tions due to treatment in order to establish the number of cycles per year or per period (in severe vascular disease reevaluation of patients should be more frequent) needed to achieve clinical improvement. In a preliminary pilot study a group of 150 patients (mean age 67 ± 12 years) with intermittent claudication (walking range from 0 to 500 m) and a group of 100 patients with CLI (45% with rest pain, and 55% gangrene; mean age 68 ± 11 years) the number of PGE1 cycles according to the short-term protocol (STP) needed to produce significant clinical improvement was preliminarily evaluated. Considering these preliminary observations, the investigators established a research plan useful to produce nomograms indicating the number of cycles of PGE1-STP per year needed to improve the clinical condition (both in intermittent claudication and CLI). A significant clinical improvement was arbitrarily defined as the increase of at least 35% in walking distance (on treadmill) and/or the disappearance of signs and symptoms of critical ischemia in 6 months of treatment in at least 75% of the treated patients. With consideration of the results obtained with the preliminary nomograms a larger validation of the nomograms is now advisable. A cost-effectiveness analysis is also useful to define the efficacy of treatment on the basis of its costs. The publication of this report in two angiological journals (Angeiologie and Angiology) will open the research on nomograms to all centers willing to collaborate to the study. The data are being collected in the ORACL.E database and will be analyzed within 12 months after the publication of this report.
- Published
- 2000
43. Treatment of severe intermittent claudication with PGE1--a short-term vs a long-term infusion plan--a 20 week, European randomized trial--analysis of efficacy and costs
- Author
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S. Vasdekis, D. Christopoulos, Marco Bucci, B.M. Errichi, P. Iacobitti, G Belcaro, Vittorio Bertele, Andrea Ledda, George Geroulakos, G.M. Andreozzi, H. Helmis, E. Simeone, G. Agus, L. Mezzanotte, M. T. DeSanctis, P.G. Ferrari, P. Pomante, Marisa Cacchio, Umberto Cornelli, Cesarone Mr, M. Cazaubon, Marcello Corsi, Lucrezia Incandela, Laurora G, Andrea Ricci, Antonio Barsotti, G. Ramaswami, E. Ippolito, and Andrew Nicolaides
- Subjects
Male ,medicine.medical_specialty ,Time Factors ,Vasodilator Agents ,Main treatment phase ,030204 cardiovascular system & hematology ,law.invention ,03 medical and health sciences ,Walking distance ,0302 clinical medicine ,Randomized controlled trial ,law ,Medicine ,Humans ,030212 general & internal medicine ,Treadmill ,Alprostadil ,Infusions, Intravenous ,Morning ,business.industry ,Intermittent Claudication ,Middle Aged ,Intermittent claudication ,Surgery ,Europe ,Treatment Outcome ,Tolerability ,Anesthesia ,Costs and Cost Analysis ,Exercise Test ,Female ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Claudication - Abstract
The efficacy, safety, and cost of prostaglandin E1 (PGE1) in the treatment of severe inter mittent claudication was studied by comparing a long-term treatment protocol (LTP) with a short-term treatment protocol (STP) in a randomized 20-week study. The study included 109 patients (96 completed the study) with an average total walking distance of 65.5 ±8 m (range 20-109). Phase 1 was a 2-week run-in phase (no treatment) for both protocols. In LTP, phase 2 was the main treatment phase. In the LTP, treatment was performed with 2-hour infusions (60 μg PGE1, 5 days each week for 4 weeks). In phase 3 (4-week interval period) PGE 1 was administered twice a week (same dosage). In phase 4 (monitoring lasting 3 months, from week 9 to 20) no drugs were used. In STP, phase 2 treatment was performed in 2 days by a 2-hour infusion (1st day: morning 20 μg, afternoon 40 μg; 2nd day morning and afternoon 60 μg). The reduced dosage was used only at the first cycle (week 0) to evaluate reduced tolerability or side effects. Full dosage (60 μg bid) was used for all other cycles. The same cycle was repeated at the beginning of weeks 4, 8, and 12. The observation period was between weeks 12 and 20. A treadmill test was performed at inclusion, at the beginning of each phase, and at the end of the 20th week. A similar progressive physical training plan (based on walking) and a reduction in risk factors levels plan was used in both groups. Intention-to-treat analysis indicated an increase in walking distance, which improved at 4 weeks (101.5% in STP vs 78.3% in LTP), at 8 weeks (260.9% STP vs 107.3% LTP), and at 20 weeks (351% STP vs 242% LTP). Comparable increases in pain-free walking distance were observed in the two groups. No serious drug-related side effects were observed. Local, mild adverse reactions were seen in 7% of the treated subjects in the LTP and 5% in the STP. Average cost of LTP was ~6,588 ECU; for STP the average cost was ~1,881 ECU. The cost to achieve an improvement in walking distance of 1 m was 35.6 ECU with the LTP and 9.45 ECU with the STP (26% of the LTP cost; p1 (including infusion and operative costs) was 25% of the total cost for LTP (24.9% for STP). In summary, between-group-analysis favors STP, in terms of walking distance and costs. Results indicate good efficacy and tolerability of PGE1 treatment. With STP less time is spent in infusion and more can be spent in the exercise program. STP reduces costs, speeds up rehabilitation, and may be used in a larger number of nonspecialized units available to follow the protocol.
- Published
- 1998
44. Superficial Vein Thrombosis (SVT), Diffusion of Thrombotic Diseases, and Increased Global Thrombogenicity: SVT as an Important Spy Disease Indicating Environmental Contamination by Estrogens: Introduction
- Author
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Andrea Di Renzo, Andrea Ledda, S Errichi, Marisa Cacchio, M G Grossi, Umberto Cornelli, Edmondo Ippolito, Marcello Corsi, Gianni Belcaro, Maria Rosaria Cesarone, B.M. Errichi, and Angelica Bottari
- Subjects
Pathology ,medicine.medical_specialty ,Superficial vein thrombosis ,Life style ,business.industry ,Thrombogenicity ,Disease ,Environmental exposure ,medicine.disease ,Thrombosis ,Internal medicine ,medicine ,Cardiology ,Cardiology and Cardiovascular Medicine ,business - Published
- 2007
45. Corrections
- Author
-
Marcello Corsi, Franco Lacerna, Giuseppe Laurora, Massimo Milani, and Augusto Borzone
- Subjects
Pharmacology ,Pharmacology (medical) - Published
- 1996
46. Evaluation of the local effects of vitamin E (E-Mousse) on free radicals in diabetic microangiopathy: a randomized, controlled trial
- Author
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Umberto Cornelli, Mark Dugall, Andrea Ricci, R. Brandolini, Marcello Corsi, E. Ippolito, Maura Griffin, G Belcaro, P. Pomante, M. R. Cesarone, P Bavera, G. Acerbi, George Geroulakos, L. Coen, Massimo Milani, A. Di Renzo, and I. Ruffini
- Subjects
Male ,medicine.medical_specialty ,Free Radicals ,Administration, Topical ,medicine.medical_treatment ,Blood sugar ,030204 cardiovascular system & hematology ,Gastroenterology ,law.invention ,Microcirculation ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,Diabetes mellitus ,Laser-Doppler Flowmetry ,medicine ,Humans ,Vitamin E ,030212 general & internal medicine ,Aged ,Skin ,Leg ,Vascular disease ,business.industry ,Middle Aged ,medicine.disease ,Surgery ,Diabetes Mellitus, Type 2 ,Tolerability ,Metabolic control analysis ,Female ,Skin Temperature ,Cardiology and Cardiovascular Medicine ,business ,Diabetic Angiopathies - Abstract
The aims of the study were to evaluate the short-term effects of a new thermosensitive, vitamin E (V-E) mousse on local free radicals (FR) and skin flux in diabetic microangiopathy. A group of 40 patients with diabetic microangiopathy was included. The variation in measure ments of skin FR was evaluated by the D-Rom test. Subjects were between 45 and 65 years with type II diabetes and good metabolic control. E-mousse®, a thermoactive preparation of acetate vitamin E (20%), was applied twice daily on the whole surface of the leg (below knee) and foot for 3 weeks. The contralateral leg was untreated acting as control. Subjects with age between 45 and 65 years with type II diabetes (diagnosed at least 5 years before) and good metabolic control (blood sugar < 180 mg/dL) were included after informed consent. Patients with uncontrolled diabetes, peripheral vascular disease, and severe lower limbs infec tions were excluded. Local free radicals (FR) and laser Doppler flux including the venoarteriolar response (VAR) were evaluated. The tolerability was evaluated by a semiquantitative score. Of the 40 included patients 34 completed the study. The 2 groups were comparable. At 3 weeks there was no decrease in FR in controls; the decrease in the treatment group was 45.3% (p < 0.05). Also in the treatment group RF decreased (p < 0.05) and the VARveno improved from an average of 21% to an average of 38% (p < 0.05). No significant variations were observed in the control group. The variation in symptomatic score was from a total value of 8 to 5 in the control group and from 8 to 1 in the treatment group (p < 0.02). Their tolerability was good. In conclusion local treatment with E-mousse for 3 weeks in diabetic microangiopathy improves skin microcirculation and the metabolic condition as shown by the decrease in FR.
47. Pazienti diabetici di tipo 2, non in terapia insulinica e albumina glicata: una valutazione multidimensionale
- Author
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Ferrario Lucrezia, Schettini Fabrizio, Foglia Emanuela, Avogaro Angelo, Bellia Chiara, Bertuzzi Federico, BonettiGraziella, Ceriello Antonio, Ciaccio Marcello, Corsi Romanelli Massimiliano, Dozio Elena, Falqui Luca, GirelliAngela, Nicolucci Antonio, Perseghin Gianluca, Plebani Mario, Valentini Umberto, Zaninotto Martina, Croce Davide, and Ferrario Lucrezia, Schettini Fabrizio, Foglia Emanuela, Avogaro Angelo, Bellia Chiara, Bertuzzi Federico, BonettiGraziella, Ceriello Antonio, Ciaccio Marcello, Corsi Romanelli Massimiliano, Dozio Elena, Falqui Luca, GirelliAngela, Nicolucci Antonio, Perseghin Gianluca, Plebani Mario, Valentini Umberto, Zaninotto Martina, Croce Davide
- Subjects
diabetes ,glycated albumin - Abstract
Insuline-Naaïve type 2 diabetic patients: a multidimensional evaluation on the role of glycated albuminIntroduction: glycated Albumin (GA) is an innovative glycemic marker, that could be used in the clinical practice, asan add-on strategy, to the traditional glycemic monitoring systems, such as glycated haemoglobin (Hb1Ac) and fastingplasma glucose (FPG). The study aims at presenting the results of a multidimensional analysis conducted in Italy,exploring the main clinical, economic, ethical, social and organizational implications, related to the introduction of GA.Methods: an Health Technology Assessment (HTA) approach was implemented. The analysis considered the ItalianNational Healthcare Service (NHS) perspective, and assumed a 12-month time horizon, focusing on type 2 diabetespatients insulin-naïve, assuming oral therapy. The 9 HTA dimensions (derived from the Core Model developed by theEuropean Network of HTA – EUnetHTA) were deployed, considering scientific evidence, health economics tools andqualitative approaches, through the administration of specific questionnaires to 15 diabetes experts.Results: literature reported better GA safety and efficacy profiles, thus being a predictor of the relative risk for diabetescomplications development, and increasing the therapeutic success after 3 months of therapy (97.0% versus71.6%).From an economic point of view, GA introduction resulted in an economic advantage of 1.06% and in a better trade-off between costs sustained and efficacy gained. Considering a 7-item Likert Scale (ranging from -3 to +3), negativeperceptions emerged with regard to equity aspects (0.13 versus0.72) due to GA limited accessibility, whereas it wouldimprove both patients (2.17 versus1.33) and care givers (1.50 versus0.83) quality of life. In the short term, GArequired training courses and equipment update, whereas, in the long term, it could be considered the preferablesolution from an organizational perspective (0.30 versus0.01).Conclusions: the results of this study demonstrated GA strategic relevance, its economic sustainability and feasibility,as well as the potential clinical pathway improvement.
- Published
- 2019
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