Robuvit® (French oak wood extract) in the management of functional, temporary hepatic damage. A registry, pilot study.

AIM: The aim of this registry study was to evaluate the evolution of moderate functional hepatic failure (MTHF) using a proprietary new oak wood supplement (Robuvit®) extracted from Quercus Robur. Recent studies have indicated the protective effect of oak wood extracts on liver injury. Quercus wood extracts have shown hepatoprotective effect on initial induced liver-injury. METHODS: This registry included a total of 75 patients with MTHF characterized by: decreased albumin levels; increased total bilirubin, altered hepatic functions enzymes, increased oxidative stress, negative viral hepatitis markers. RESULTS: The two groups (best management in comparison with best management+ Robuvit®) were comparable: 32 Robuvit® patients and 29 comparable controls) completed the 12-week registry. At inclusion, the blood parameter values in the two groups were comparable. At the end of the supplementation period, the increase in albumin levels was significantly (P<0.05 at 12 weeks) faster and higher in the Robuvit® group. The decrease in ALT-SGPT and AST-ASAT was significant in the supplement group (P<0.05 at 4 and 12 weeks); the tests were normalized at 4 and 12 weeks. Controls remained out of the normal range for more than 12 weeks. Alkaline phosphatase was normalized at 4 and 12 weeks in Robuvit® patients; they were decreased, but not normalized in controls at 4 weeks (Robuvit® group's values were significantly better; P<0.05). Values were normalized in controls (significantly higher in comparison with Robuvit®; P<0.05) at 12 weeks. Total bilirubin was normalized in Robuvit® subjects at 4 and 12 weeks. Results were significantly better in comparison with controls (P<0.05). Direct bilirubin values increased more in the Robuvit® group at 4 and 12 weeks (P<0.05). Gamma GT values were normalized at 4 and 12 weeks in the Robuvit® group. There was a less important decrease in controls (P<0.05) without normalization at 12 weeks. Plasma free radicals increased at inclusion showed a significant decrease in Robuvit® subject (at 4 and 12 weeks) with normalization at 12 weeks. Persisting, elevated values in controls were observed even at 12 weeks (P<0.05). ESR and CRP decreased in both groups with a more important decrease in the Robuvit® group (P<0.05). Hepatitis markers were negative when repeated at 4 and 12 weeks. CONCLUSION: Data from this pilot, supplement registry study indicate a significant protective activity of Robuvit®, associated with a very good safety profile, in patients with temporary hepatic failure. The activity of Robuvit® seems to be mediated by its anti-inflammatory activity.

Improvements in edema and microcirculation in chronic venous insufficiency with Pycnogenol® or elastic compression.

BACKGROUND: Chronic venous insufficiency (CVI) is the consequence of venous valve reflux and/or venous flow obstruction and resulting venous hypertension in the lower extremities. The aim of this prospective supplement registry study was to evaluate the efficacy of compression stockings or Pycnogenol® in controlling symptoms and edema in CVI and their efficacy on microcirculatory parameters. METHODS: Two comparable groups of 30 subjects with CVI were observed for 4 months. RESULTS: Elastic compression was less tolerated than Pycnogenol® with 12 subjects being unable to follow the compression routine. No side effects due to supplementation were observed; tolerability of the supplementation was optimal. Ambulatory venous pressure (AVP) and refilling time (RT) at inclusion indicated a significant increase in venous pressure and reflux (refilling time <16 seconds). AVP and RT did not change after 4 months. Microcirculatory and clinical measurements were comparable at inclusion between the 2 groups. After 4 months, skin resting flux (RF) and skin PO2-PCO2 were significantly improved with Pycnogenol® compared to compression (P<0.05). The significant increase in skin PO2 and the decrease in PCO2 after Pycnogenol® intake were ascribed to the decrease in the abnormally high skin resting flux, a sign of better perfusion and skin nutritional supply. Pycnogenol® reduced leg volume, on average by 18.3% in the evening compared to 4.4% of reduction with compression (P<0.05) showing an important effect on edema. The venous Clinical Severity Score (VCSS) and the composite symptom score (CSS) decreased significantly in the Pycnogenol® group compared to compression, indicating a better improvement in microcirculatory perfusion and nutritional supply produced by the supplementation of Pycnogenol® in comparison with compression. Pycnogenol® significantly improved microcirculation and clinical symptoms in comparison with compression. The decrease in local oxidative stress (OS) at the distal perimalleolar region with Pycnogenol® was significant in comparison with compression (P<0.05). A lower local OS is an important metabolic indication of a better capillary perfusion with better nutritional exchanges. At the end of the registry study, four small ulcerations and skin breaks in four limbs (between 3 and 5 mm of maximum diameters) were observed in the compression group. No ulcerations or skin breaks were observed in the Pycnogenol® group. CONCLUSIONS: Pycnogenol® relieved edema, improved microcirculation in CVI patients and reduced stationary, interstitial fluid in comparison with compression. Most symptoms of CVI are associated with interstitial water retention; the presence of extra fluid in limb tissues alters perfusion and nutrient supply. Pycnogenol® supplementation reduced water and fluid accumulation in CVI limbs and improved microcirculation and local oxidative stress thus showing important anti-edema effects.

Pycnogenol® supplementation improves health risk factors in subjects with metabolic syndrome.

This open, controlled study evaluated the effects of 6 month supplementation with Pycnogenol® maritime pine bark extract on health risk factors in subjects with metabolic syndrome. Pycnogenol® was used with the aim of improving risk factors associated with metabolic syndrome, central obesity, elevated triglycerides (TG), low HDL cholesterol, high blood pressure and fasting blood glucose. Sixty-four subjects (range 45-55 years) presenting with all five risk factors of metabolic syndrome were included, and Pycnogenol® was administered for 6 months. A group of 66 equivalent subjects were followed up as controls. In the 6-month study Pycnogenol® supplementation 150 mg/day decreased waist circumference, TG levels, blood pressure and increased the HDL cholesterol levels in subjects. Pycnogenol lowered fasting glucose from baseline 123 ± 8.6 mg/dl to 106.4 ± 5.3 after 3 months and to 105.3 ± 2.5 at the end of the study (p < 0.05 vs controls). Men's waist circumference decreased with Pycnogenol from 106.2 ± 2.2 cm to 98.8 ± 2.3 cm and to 98.3 ± 2.1 after 3 and 6 months. Women's waist decreased from 90.9 ± 1.6 cm to 84.6 ± 2.1 cm and to 83.6 ± 2.2 cm after 3 and 6 months. Both genders waist circumference reduction was significant as compared to controls at both time points. In addition, plasma free radicals decrease in the Pycnogenol group was more effective than in the control group (-34.6%; p < 0.05). In conclusion, this study indicates a role for Pycnogenol® for improving health risk factors in subjects with metabolic syndrome.

A controlled study shows daily intake of 50 mg of French Pine Bark Extract (Pycnogenol®) lowers plasma reactive oxygen metabolites in healthy smokers.

AIM: We investigated a low daily dosage of 50 mg of the antioxidant Pycnogenol for lowering oxidative stress in cigarette smokers who presented with good health. METHODS: A group of 78 smokers were supplemented with 50 mg Pycnogenol over an eight-week period, followed by two weeks cessation. Another 77 smokers took placebo tablets. Plasma reactive oxygen metabolites were detected by d-ROM test and the biological antioxidant potential (BAP) was quantified by photometric analysis of ferric iron reduction to ferrous form. RESULTS: BAP and d-ROM values in the Pycnogenol and placebo group were comparative at trial start. Pycnogenol lowered d-ROM values by 25.3% from baseline 459.4±65 to 342.2±56 Carr units after 2 weeks. At time points 4, 5 and 8 weeks treatment d-ROM values in the Pycnogenol group were significantly lower than in the control group (P<0.05). After cessation of Pycnogenol from week 8 to 10 d-ROM values increased from 288.4±32 to 381.3±39 Carr units. BAP values increased in the Pycnogenol group from baseline 1698±231 to 2349±294 µM after 8 weeks and dropped to 2002±203 µM after two weeks washout period. Values in the control group remained largely unaltered with 1669±311, 1673±229 and 1656±221 µM, at 0, 8 and 10 weeks, respectively. CONCLUSION: A daily dosage of 50 mg Pycnogenol significantly lowers reactive oxygen species as compared to a placebo-treated equivalent control group.

Lady Prelox® improves sexual function in generally healthy women of reproductive age.

AIM: This supplement study evaluates the Female Sexual Function Index (FSFI) of 100 healthy women (37 to 45 years) with moderate sexual dysfunction who underwent a management program of lifestyle, diet, exercise, and stress control. In association with the management program a group of these women also used the supplement Lady Prelox® in tablets (20 mg Pycnogenol® pine bark extract, 200 mg L-arginine, 200 mg L-citrulline and 50 mg Rosvita® rose hip extract) for eight weeks. METHODS: One group of women was supplemented with Lady Prelox® for 8 weeks. The nine-item FSFI questionnaire was used for evaluation of women's sexual function at inclusion (baseline), after four weeks, and after eight weeks of management and supplementation. Variation in oxidative stress was also evaluated by measuring plasma free radicals. RESULTS: Following supplementation with Lady Prelox® the mean total FSFI scores increased from 14.96±2.68 to 28.25±2.35 after four weeks and 33.91±2.7 after eight weeks. Treatment values were significantly higher than in controls (who used only the management plan) with baseline values of 17.92±2.32 and scores of 23.45±1.82 after four weeks and to 23.52±2.20 after eight weeks. Women in the Lady Prelox® group had an initial value of plasma free radicals (PFR) of 398±29 Carr units: this value decreased to 344:28 at 4 weeks (P<0.05) and 332:31 at 8 weeks (P<0.05). Lower changes were observed in controls with an initial value of 389±33, decreasing to 377±32 (P<0.05) at 4 weeks and to 365; 33 (P<0.05) at 8 weeks (value significantly higher in controls not using Lady Prelox®). The supplementation was well tolerated; no unwanted effects occurred and no women had to stop the supplementation. CONCLUSION: The study suggests that supplementation with Lady Prelox significantly improves sexual function across all domains evaluated by the FSFI in healthy women of late reproductive age. The improvement in FSFI is also associated with a significant decrease in oxidative stress.

Evaluation of the effects of supplementation with Pycnogenol® on fitness in normal subjects with the Army Physical Fitness Test and in performances of athletes in the 100-minute triathlon.

AIM: The aim of this registry study was to evaluate the effects of Pycnogenol® (French pine bark extract) on improving physical fitness (PF) in normal individuals using the Army Physical Fitness Test (APFT). The study evaluated the efficacy of Pycnogenol, used as a supplement, in improving training, exercise, recovery and oxidative stress. METHODS: The study was divided into 2 parts. In PART 1 (Pycnogenol 100 mg/day), the APFT was used to assess an improvement in PF during an 8-week preparation and training program. In PART 2 (Pycnogenol 150 mg/day), the study evaluated the effects of Pycnogenol supplementation in athletes in training for a triathlon. RESULTS: PART 1. There was a significant improvement in both males and females in the 2-mile running time within both groups, but the group using Pycnogenol (74 subjects) performed statistically better than controls (73 subjects). The number of push-ups was improved, with Pycnogenol subjects performing better. Sit-ups also improved in the Pycnogenol group. Oxidative stress decreased with exercise in all subjects; in Pycnogenol subjects the results were significantly better. PART 2. In the Pycnogenol group 32 males (37.9; SD 4.4 years) were compliant with the training plan at 4 weeks. In controls there were 22 subjects (37.2;3.5) completing the training plans. The swimming, biking and running scores in both groups improved with training. The Pycnogenol group had more benefits in comparison with controls. The total triathlon time was 89 min 44 s in Pycnogenol subjects versus 96 min 5 s in controls. Controls improved their performing time on average 4.6 minutes in comparison with an improvement of 10.8 minutes in Pycnogenol subjects. A significant decrease in cramps and running and post-running pain was seen in the Pycnogenol group; there were no significant differences in controls. There was an important, significant post-triathlon decrease of PFR one hour after the end of the triathlon with an average of -26.7, whereas PFR in controls increased. In Pycnogenol subjects there was a lower increase on oxidative stress with a faster recovery to almost normal levels (<330 for these subjects). These variations in PFR values were interpreted as a faster metabolic recovery in subjects using Pycnogenol. CONCLUSION: This study opens an interesting new application of the natural supplementation with Pycnogenol that, with proper hydration, good training and nutritional attention may improve training and performances both in normal subjects and in semi-professional athletes performing at high levels in difficult, high-stress sports such as the triathlon.

[Severe intermittent claudication: PGE1 treatment. A 40-week registry, efficacy and costs]. / Claudicatio intermittens severa: trattamento con PGE1. Registry, follow up (40 settimane), efficacia e costi.

AIM: Intermittent claudication (IC) in peripheral vascular disease is characterized by lower limb pain appearing on effort. Treatment with PGE1 has been successfully used to manage IC patients. This registry has evaluated safety and costs of PGE1 in the management of IC. METHODS: In this study a long-term treatment protocol (LTP), a short-term protocol (STP) and an outpatient (OP), "on-demand" treatment have been compared. A treadmill effort test has been used to evaluate walking distance. The follow up for these three protocols was 40 weeks. PGE1 treatment was associated to a risk reduction plan and to an exercise program. RESULTS: The final analysis has included 252 LTP patients, 223 STP patients and 284 OP patients (total 659 valid cases). A group of 171 comparable patients not treated with PGE1 was used for a parallel comparison. Cardiovascular mortality and morbidity has been evaluated in 731 PGE1 patients completing 24 months of follow up. All protocols have been well tolerated. No side effects were observed. The lower cost has been observed for OP patients. In the long term, mortality and morbidity were lower in patients treated with PGE1 in comparison with patients not treated with PGE1. CONCLUSION: Considering costs and results (increase in walking distance) and improvement in Karnofsky scale the STP plan appears to be better than LTP for IC patients. The OP, "on-demand" treatment offers further improvements. This last treatment plan is simpler; the plan allows better timing for exercise. The treatment can be used even in non-specialized centers.

Effects of Robuvit® on the progression of non-alcoholic fatty liver disease.

BACKGROUND: The aim of this study was to evaluate the effects of Robuvit® in preventing the progression of chronic hepatitis (CH) in non-alcoholic fatty liver disease (NAFLD) which encompasses the entire spectrum of fatty liver disease, from isolated steatosis to non-alcoholic steatohepatitis (NASH). METHODS: One 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). RESULTS: 34 subjects with NAFLD were included in the study. The two groups completing 90 days were comparable at baseline with 18 being supplemented with Robuvit® and 16 in the control group. The tolerability was very good, and no side effects were observed with the supplement. Fasting glucose levels were significantly lower after 3 months with Robuvit® (P<0.05) compared to controls. The increased serum aspartate aminotransferase levels (AST), considered the key metabolic value in these patients, decreased significantly with Robuvit® (P<0.05) compared to controls. Serum alanine aminotransferase levels (ALT) also decreased significantly with the supplement compared to controls (P<0.05). Platelet count and albumin levels improved significantly with Robuvit® (P<0.05) in comparison to standard management. No other significant changes were observed. The APRI score (the AST/platelet ratio index) was also decreased with the supplementation compared to controls (P<0.05). A high APRI score provides an estimate of the possibility of the liver to develop fibrosis and eventually cirrhosis. After Robuvit® supplementation, the ultrasound characterization showed a significant decrease in the size of the liver in association with a lower echogenicity, which represents less fibrotic changes due to collagen accumulation. CONCLUSIONS: Robuvit® 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.

Non-arteritic Posterior Ischaemic Optic Neuropathy Treated with Intravenous Prostaglandin E1 and Oral Corticosteroids.

Intravenous prostaglandin E1 and oral corticosteroids were used to treat the ischaemic phase of a non-arteritic posterior ischaemic optic neuropathy with immediate visual improvement. Non-arteritic posterior ischaemic optic neuropathy is a disorder of reduced blood flow to the retrobulbar optic nerve, usually of acute onset. It has been suggested that high-dose steroid therapy given soon after the onset of visual loss can result in significant visual improvement. This treatment, however, is not universally successful. The addition of a potent vasodilator to the corticosteroids could help restore ocular blood flow and improve visual acuity. This paper presents the use of prostaglandin E1 (PGE1), a powerful vasodilator of the microcirculation, to treat non-arteritic posterior ischaemic optic neuropathy. In this case report a 68-year-old white male with hereditary haemochromatosis was seen 8 hours after sudden loss of visual acuity in his left eye (OS) to 4/10. The diagnosis of non-arteritic posterior ischaemic optic neuropathy was made and he was immediately given oral corticosteroids. Intravenous PGE1 was given the next morning, 24 hours after the sudden loss of vision, once ischaemia of the optic nerve was confirmed by colour Doppler imaging. The visual acuity in the OS improved from 4/10 to 11/10 within 1 day. A visual field (VF) post treatment showed a peripheral scotoma without a central scotoma. At 12 months post treatment the vision OS remained 11/10. No complications due to the use of PGE1 were seen. The authors conclude that PGE1 should be considered in addition to steroids in cases of NA-PION to immediately restore blood flow to the optic nerve and improve visual acuity.

Pycnogenol® Supplementation Prevents Recurrent Urinary Tract Infections/Inflammation and Interstitial Cystitis.

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 < 0.05vs. 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.

Arteritic anterior ischemic optic neuropathy treated with intravenous prostaglandin E(1) and steroids.

Arteritic anterior ischemic optic neuropathy (AAION) is an acute ischemia of the posterior ciliary arteries and/or ophthalmic artery due to inflammation. Therapy is immediate intervention with systemic steroids, especially to protect against vision loss in the other eye. The addition of a potent vasodilator to the steroids could help restore ocular blood flow and improve visual acuity. The objective of the current report was to present the use of prostaglandin E(1) (PGE(1)) - a powerful vasodilator of the microcirculation - in the treatment of AAION. Two patients with AAION were treated with intravenous steroids and PGE(1). The visual acuity improved from 4/50 (less than 20/200) to 6/10 (20/35) in one patient and from 1/50 (20/400) to 1/10 (20/200) in the second patient. The visual fields in both patients maintained small central islands of vision. No complications due to the use of PGE(1) were seen. Intravenous PGE(1) should be considered in addition to steroids in cases of AAION to immediately restore blood flow to the optic nerve and improve visual acuity while the steroids reduce the inflammation.

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

BACKGROUND: The aim of this pilot study was the evaluation of primary, idiopathic mucosal dryness (xerostomia or dry mouth) in subjects without cancer. METHODS: A group of non-diabetic subjects and a group of diabetics were managed with standard management (SM) or with SM+Pycnogenol® (150 mg/day) for 2 weeks. RESULTS: In total, 48 subjects were included in the study; 24 diabetics and 24 non-diabetics. 12 diabetics and 12 non-diabetics took Pycnogenol® and 12 diabetics and 12 non-diabetics were followed up with standard management only and served as controls. No side effects and no tolerability problems were observed with Pycnogenol®. The registry groups were comparable for characteristics and symptoms at baseline. All otherwise healthy subjects had a BMI<26 kg/m2. In 2 weeks, salivary flow and oxidative stress improved significantly in both groups of subjects (non-diabetics and diabetics) with 150 mg/day Pycnogenol® (P<0.05), while minimal improvements in salivary flow were seen with SM. The subjective score and the number of mucosal breaks and ulcerations, all minimal (<1 mm in length or diameter), were significantly decreased with Pycnogenol® supplementation (P<0.05) with minimal variations in the SM controls. Finally, the mean lysozyme level in parotid saliva samples was significantly increased in the Pycnogenol® group (P<0.05) both in diabetics and non-diabetics. CONCLUSIONS: Based on these preliminary results, Pycnogenol® could be a new, valid option for the treatment of xerostomia.

Pycnogenol may alleviate adverse effects in oncologic treatment.

AIM: A large variety of adverse reactions are well known to frequently occur during chemotherapy and radiotherapy in oncology. Specific medications exist to target individual side effects. The aim of this study was to explore in a pilot trial whether supplementation with French maritime pine bark extract Pycnogenol could alleviate side effects and improve patient's quality of life. METHODS: Cancer patients who previously underwent surgery and who were in view of their pathology in relatively good condition, both physically and psychologically, were recruited for this study and divided into two groups. These patients received their first cycle of radiotherapy or chemotherapy, which lasted from 10 days up to 1 month. Then one group of patients received 150 mg Pycnogenol, the control group comparable placebo in a single-blinded fashion. The authors studied the occurrence of side effects and made attempts to judge their severity on a semi-quantitative visual analogue scale over a 2 months period starting after patients completed their first cycle of chemo- or radiotherapy, respectively. RESULTS: Twenty five radiotherapy patients receiving Pycnogenol showed a decreased frequency of essentially all investigated side-effects as compared to 21 patients receiving placebo, though in many categories the difference was limited. The most apparent improvements of acute side effects related to decreased soreness and ulceration in the mouth and throat as well as less dryness of the mouth and the eyes. A decreased incidence of nausea /vomiting, diarrhoea, edema and weakness was noticed, which was reflected by semi-quantitative evaluation suggesting that severity was only half or even less pronounced than in the control group. Only one case of deep vein thrombosis occurred in the Pycnogenol group whereas 2 cases of superficial vein thromboses and one case of deep vein thrombosis occurred in the control group (2.9% vs 10%). Thirty four chemotherapy patients were supplemented with Pycnogenol and another 30 patients were in the control group. For all patients this was the first chemotherapy treatment period. The Pycnogenol group presented with a lowered incidence of all investigated side effects as compared to the control group, though in many cases to a limited extent. The most prominent improvements were found for nausea, vomiting, diarrhoea and weight loss. Semi-quantitative evaluation showed that here again symptom severity was half or less pronounced than in the control group. Various further symptoms improved such as cognitive impairment and also cardiotoxicity and neutropenia. Effects on anemia could not be investigated as several patients received erythrocyte transfusion. In the Pycnogenol group one case of superficial vein thrombosis was indentified while 3 cases of superficial vein thromboses and one deep vein thrombosis were detected in the control group (4% vs 19%). In both chemotherapy and radiotherapy patients Pycnogenol lowered the requirement for medication to address side effects. This was reflected by less days of hospitalisation the patients required. The authors did not investigate a possible interference with the anti-neoplastic efficacy of chemo- and radiotherapy. This possibility requires attention in future studies with Pycnogenol. From their previous clinical experience the authors suggest that alleviation of side effects described in this study results from Pycnogenol activities related to endothelial protection, and anti-inflammatory anti-edema activities. CONCLUSION: The results of this pilot trial warrant further prospective studies with larger number of patients to validate benefits more specifically with regard to type of malignancy and treatment regimen.

Lymphatic tissue transplant in lymphedema--a minimally invasive, outpatient, surgical method: a 10-year follow-up pilot study.

Lymphedema is mainly characterized by swelling, fibrosis, and non-pitting edema. The aim of this study was evaluation of the long-term (10 years) effects of autologous lymphatic tissue implant in lymphedema. Lymphatic tissue from 9 patients (harvested form the same patient in areas not affected by lymphedema) was reimplanted into the affected limb, and these patients were followed for 10 years. Lymph nodes were harvested at the neck, axillary, or inguinal space (contralateral limb). Results showed that limb volume was decreased in the treatment group vs. controls. In ultrasound, black, low density, lymphatic spaces were visible in 100% of patients at inclusion but in only 23% of these subjects at 10 years. Thus, this early report proposes a new, minimally invasive method to improve lymphedema. Studies in progress will indicate the role of lymphatic transplant in the management of lymphedema and the best indications for this method.

Treatment of osteoarthritis with Pycnogenol. The SVOS (San Valentino Osteo-arthrosis Study). Evaluation of signs, symptoms, physical performance and vascular aspects.

The aim of this double-blind, placebo-controlled study was to evaluate the efficacy of 100 mg Pycnogenol daily (oral capsules) in a 3 month study in patients with osteoarthritis (OA). OA symptoms were evaluated by WOMAC scores, mobility by recording their walking performance (treadmill). Treatment (77 patients) and placebo group (79) were comparable for age, sex distribution, WOMAC scores, walking distances and use of antiinflammatory drugs. The global WOMAC score decreased by 56% (p < 0.05) in the treatment group versus 9.6% in the placebo group. Walking distance in the treadmill test was prolonged from 68 m at the start to 198 m after 3 months treatment (p < 0.05), under placebo, from 65 m to 88 m (NS). The use of drugs decreased by 58% in the treatment group (p < 0.05) versus 1% under placebo. Gastrointestinal complications decreased by 63% in the treatment group, but only 3% under placebo. Overall, treatment costs were reduced significantly compared with placebo. Foot edema was present in 76% of the patients of the treatment group at inclusion and in 79% of the controls. After 3 months edema decreased in 79% of Pycnogenol patients (p < 0.05) vs 1% in controls. In conclusion, Pycnogenol offers an option for reduction of treatment costs and side effects by sparing antiinflammatory drugs.

Use of polyglucosamine and physical activity to reduce body weight and dyslipidemia in moderately overweight subjects.

AIM: A low molecular weight chitosan (polyglucosamine, PG) was studied in overweight hyperlipemic patients under physical training. A double blind study was conducted in two groups of 30 patients (M/F; from 25 to 59 years). METHODS: Tablets containing PG (2 g/day) or placebo were given for a 4-month period during a physical training (+8 MET-hours/week). Anthropometric measures, caloric intake, blood pressure, LDL and HDL cholesterol, blood glucose and triacylglycerol were measured before and after the treatment. The groups were similar for the caloric intake and expenditure and ended up with positive results in most of the parameters examined. RESULTS: In PG group compared to placebo a more significant (P<0.05, t test) reduction was found for body weight (respectively 6.9+/-1.87 vs 3.0+/-1.61 kg), waist circumference (7.3+/-2.49 vs 3.1+/-4.21 cm), LDL cholesterol (44+/-14.7 vs 12.5+/-12.6 mg/dL), triacylglycerol (52+/-29.3 vs 39+/-15.2 mg/dL); HDL increase was also higher (6+/-3.6 vs and 3+/-4.2 mg/dL). At baseline metabolic syndrome (MS) according to ATP III was present in 15 and 14 patients respectively in the group PG and placebo. CONCLUSIONS: Unexpectedly, at the end of the treatment MS was reduced in 12 cases of the PG group and in 3 cases only of the placebo group (P<0.05). Results indicate that PG may improve the effect of the physical training in moderately overweight patients with dyslipidemia and may be of some help in the treatment of MS.

Deep vein thrombosis: a mininvasive locoregional thrombolytic treatment.

AIM: Locoregional thrombolytic therapy has emerged in the last years as the treatment of choise for iliofemoral deep vein thrombosis, preserving the structural and functional integrity of vein walls. We studied the efficacy and complication rates of direct regional thrombolytic therapy in acute venous thrombosis of lower extremities. METHODS: Between January 2002 and March 2007, 8 selected patients with acute extensive and symptomatic iliofemoral or femoral-popliteal venous thrombosis were treated with flow-direct regional thrombolytic therapy. We used a direct regional infusion of urokinase into the deep venous system ( 100.000 U al presentation, then 75.000 U/ h) from an ipsilateral dorsal foot vein . Simultaneously the superficial venous system was collapsed with elastic limb compression while administering subtherapeutic heparin doses of 300-400 U/h. All patients underwent routine venous duplex imaging at day 1, 2, 30 and after 3, 6 and 12 months. Data including clinical conditions and laboratory values (fibrinogen, hematocrit, haemoglobin, platlets and prothrombin time) were obtained throughout the infusion time. Results. Procedural success was achieved in all patients (100%). Complete recanalization, patency and continence of venous system documented at the echocolorDoppler control, were obtained in 48 hours, with symptom remission. Mean infusion time was 37.5 hours (28-48 hours). Neither major bleeding complications nor pulmonary embolisms occurred during the treatment. At day 30 venous patency and incontinence and long-term symptom resolution were achieved in all patients, as well as at 3, 6 and 12 months. CONCLUSIONS: Loco-regional thrombolytic therapy is safe and effective in selected patients and may become a well-founded alternative in the treatment of acute deep vein thrombosis of lower extremities and in the prevenction of its complications .

Jet-lag: prevention with Pycnogenol. Preliminary report: evaluation in healthy individuals and in hypertensive patients.

This study was conducted with the aim of showing the effects of Pycnogenol on controlling jet-lag symptoms. Oral Pycnogenol, 50 mg tablets 3 times/die, for 7 days starting 2 days prior to the flight was used. The study was divided into two separate parts. In study 1 the most common complaints of patients with jet-lag were evaluated with a rating scale consisting in of a scoring system. In study 2 a brain CT scan was performed after the flight in order to assess minimal brain edema (MBE) in association with typical signs and symptoms, observed in previous published flight studies. Study one included 38 subjects treated with Pycnogenol and 30 controls. The symptomatic jet-lag related total score was significantly lower (indicating a lower level of jet-lag) in the Pycnogenol group. The average duration of any jet lag symptom following the flight was significantly reduced from 39.3 (SD=0.8) hours in controls to an average of 18.2 (SD=3.3) hours in the Pycnogenol group (P<0.05). Study 2 included 34 subjects treated with Pycnogenol and 31 controls. The main observation was the brain CT scan performed within 28 hours after the end of the flight. The difference between the Pycnogenol and the control groups was statistically significant (P<0.05) for all items assessed including the cerebral edema score obtained by CT scan. The short-term memory was significantly altered in the control group and associated to edema and swelling of the lower limbs. The score (and the level of edema) was comparatively higher in a subgroup of hypertensive subjects in the control group. Minor alterations of cardiac function were observed in association with de-stabilisation of blood pressure. Fatigue was also significantly higher in the control group in comparison with the Pycnogenol group. A number of spontaneously reported symptoms was also scored and there was a statistically significant difference (P<0.05) between the Pycnogenol and control groups. In conlusion, Pycnogenol was useful to control jet-lag and minimal brain edema.

Fingerprints and cardiovascular risk. The San Valentino fingerprint vascular screening project (SanVal/FP).

UNLABELLED: Fingerprints (FP), characteristic of humans, are impressions due to skin marks (ridges) on fingertips. Ridges are present on fingers/hands forming curved lines of different sizes/patterns. The point where a line stops or splits is defined typica' (their number/amount constitute identification patterns). FP are permanent and unique. This study compared FP patterns with cardiovascular risk factors: 7 main types of FP were used: 1. Arch: lines form waves from one site to the other side. 2. Tentarch: like arches but with a rising stick in the middle. 3. Loop: lines coming from one site returning in the middle to the same site. 4. Double loop: like loops but with two loops inside: one standing, one hanging. 5. Pocked loop: like the loop but with a small circle in the turning point. 6. Whorl: lines make circles. 7. Mixed figure: composed of different figures. There are two kinds of real typica: A. Ending line; B. Splitting lines (bifurcations). Several combinations may result. Ultrasound evaluation of carotid/femoral arteries in asymptomatic subjects. Arteries were evaluated with high-resolution ultrasound at the bifurcations. Four classes were defined: 1: normal intima-media (IMT) complex; 2: IMT thickening; 3: non-stenosing plaques (<50% stenosis); 4: stenosing plaque (>50%). Subjects in classes 1, 2, 3 were included into the analysis made comparing FP patterns and ultrasound. RESULTS: For each FP pattern: A. the main proportion of subjects with cardiovacular risk factors (91%) had arches (41.2%) and loops (either single, 38.2% or double 11.7% for a total of 49.9%). B. The remaining classes were statistically less important. C. The number of ridges per square mm was comparable in all pattern classes. D. The analysis of typica and other ridges characteristics requires a more elaborated system. Future research must define simple, low cost screening methods for preselection of subjects at higher cardiovascular risk or for exclusion of low risk subjects. The evaluation of fingerprint pattern may be useful to define risk groups.

LINFAVENIX: improvement of signs and symptoms of chronic venous insufficiency and microangiopathy.

The aim of this independent study was to demonstrate the rapidity of the efficacy of an oral venotropic compound (Linfavenix, including natural elements) in patients with chronic venous insufficiency (CVI). Two groups of patients with chronic venous insufficiency (CVI) ankle swelling) were treated with Linfavenix or with below-knee elastic compression. The average ambulatory venous pressure (AVP) at inclusion (both groups)was 56.2 (range 48-55) with a refilling time (RT) shorter than 10 seconds. These parameters indicated a severe level of venous hypertension. There were no significant differences in AVP and RT between the two groups. The two groups of subjects with CVI were comparable; in the Linfavenix group there were 14 patients (age 44.5; sd 4; range 34-55; 7 females); in the elastic compression group there were 12 patients (45.4;5; range 36-56; 7 females). The clinical picture and microcirculatory parameters at inclusion were comparable. RF was comparable at inclusion in the two groups. At two weeks, the differences in RF (between goups) were not significant (the flux decreased in both groups, indicating improvement) while at 4 weeks the difference was larger (but non significant between the two groups) with a significant decrease in RF in the Linfavenix group. The RAS was also comparable at inclusion. Both groups had a significant decrease at 2 and 4 weeks. The decrease produced by Linfavenix after 4 weeks in RF was larger and significant (p<0.05) in comparison with the elastic compression group. Also the differences observed in ASLS were significant in both groups with an important, significant difference in favour of Linfavenix at 4 weeks (op<0.05) visibile as edema reduction. The decrease in edema was relevant in both groups at 2 (p<0.05) and 4 weeks (p<0.05) with a minimal but significant difference (p<0.05) between the Linfavenix and the elastic compression group. These variations in microcirculatory parameters indicate that the treatment with Linfavenix is, in its microcirculatory efficacy, at least comparable than elastic compression with is considered a standard therapeutic option in these patients. A significant level of improvement was reached with Linfavenix, in most patients (10/14) at 2 weeks for RF, at 7 days for the RAS and also at 2 weeks in almost all patients (13/14) considering ASLS and edema. No side effects due to treatment were observed. Compliance and tolerability were very good (no patient had to stop treatment; there were no drop-outs). In conclusion venous microangiopathy and edema were improved by the treatment with Linfavenix (better in comparison with compression) in a few days.