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We investigated the efficacy of orally and topically applied Pycnogenol® for the management of acute hemorrhoidal attacks in a controlled, randomized study with 84 subjects. Within less than 48 h of onset of an acute attack, patients were enrolled and signs and symptoms were scored. This evaluation was repeated after seven days' treatment and again seven days following treatment cessation. The decrease in scores was significantly more pronounced in the Pycnogenol®-treated groups than in the control group given placebo (p < 0.05), showing the efficacy of Pycnogenol® for relieving signs and symptoms of acute external hemorrhoids. In a group of patients given topical (0.5%) Pycnogenol® in addition to oral Pycnogenol® the improvement in symptoms set in significantly faster and was more pronounced. The most prominent symptom, hemorrhoidal bleeding, was completely absent in all patients treated with Pycnogenol® for seven days and also at the 14 days follow-up. In contrast, bleedings were still observed in the control group during the two weeks follow-up. This study indicates that Pycnogenol®, both in oral and in topical form, is effective for controlling this common, disabling health problem. The application of Pycnogenol® eases the management of acute hemorrhoidal attacks and help avoid bleedings. Copyright © 2009 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Sulfaminoheparosans (SAHs) are biotechnologically derived heparin analogs composed of sulfated glucuronic acid/iduronic acid and glucosamine. Though structurally and functionally similar to heparin (UFH), SAHs are resistant to digestion by heparinase-I. To test the hypothesis that SAHs inhibit heparinase-I, studies were undertaken to determine the effect of two derivatives of SAH with MWs of 6 kDa (Bio-6) and 20 kDa (Bio-20), respectively on the depolymerization of heparin using a defined system containing UFH (10 mg/ml), 0.1 M CaCl2, graded amounts of Bio-6 and Bio-20 (5.0 - 0.62 mg/ml) and heparinase-I (0.1 U/ml). Heparinase-I digested both UFH and enoxaparin into lower MW oligosaccharides (MW= 3-5 kDa). Both Bio-6 and Bio-20 concentration dependently inhibited heparinase-I resulting in the decreased generation of the lower MW oligosaccharides. Inhibition of the depolymerization of heparin was stronger than that of enoxaparin. On a gravimetric basis, Bio-20 was a stronger inhibitor than Bio-6. Functional studies using the activated clotting time in whole blood and the activated partial thromboplastin time (APTT) in citrated plasma confirmed these observations. Similar results were obtained with other LMWHs such as dalteparin, tinzaparin and fraxiparin. These results suggest that SAH derivatives are capable of inhibiting heparin digesting enzymes such as heparinase-I and that additional studies are warranted to investigate the modulatory actions of SAHs on other heparin digesting enzymes such as heparinase-II, heparinase-III and heparanases. [ABSTRACT FROM AUTHOR]

Background: Centellicum ® , a standardized Centella Asiatica extract, has been used orally for fibrosis and scar prevention. The main aim of this 2-month registry pilot study was the reduction of visible, significant scars and keloids after suturing traumatic wounds with irregular edges (lacerations), using Centellicum ® ., Methods: The effects of oral Centellicum ® (450 mg/day; 2 capsules) and a standard management (SM) on wound healing were compared with the effects of a control group that used only the standard management., Results: Forty-eight otherwise healthy male subjects with lacerations requiring suturing were included in the study. 25 took Centellicum ® in addition to the standard management and 24 followed the standard management only. No side effects were observed with the supplement. Centellicum ® supplementation showed very good tolerability and compliance with 98% of the capsules correctly used. The two groups of otherwise healthy male subjects with lacerations were considered comparable at inclusion and there were no dropouts. No infections were observed. At 60 days, the scar dimensions were significantly smaller in the supplemented group (P<0.05). The elevation of the scar above the surrounding, non-affected skin, was also significantly reduced in the Centellicum ® group compared to controls (P<0.05). Local pain levels were significantly lower (P<0.05) in the supplement group at 60 days. Additionally, the scar redness score was significantly lower in the supplement group compared to controls (P<0.05) by the end of the study. The incidence of initial keloid formation was significantly lower in the supplemented subjects at 60 days, as determined by finger-point pressure palpation and high-resolution ultrasound (P<0.05). Skin flux, as measured by laser Doppler flowmetry (indicating hypervascularization due to local inflammation) was lower (P<0.05) with Centellicum ® at the end of the study. Inflammation, assessed via thermography (hot spots on the healing skin) was less visible and reduced in most areas in the supplement group (P<0.05) in comparison with the control group. Plasma oxidative stress was significantly lower in the Centellicum ® group at the end of the study (P<0.05)., Conclusions: Oral Centellicum ® intake over 2 months improved healing of lacerations and reduced scarring, fibrosis and keloids at the level of the lesions. A larger study setup with more patients and with a prolonged study duration is needed to confirm these initial results.

Background: The aim of this supplement registry study was to evaluate the efficacy of Pycnogenol ® in controlling signs and symptoms of chronic venous insufficiency (CVI), diabetic microangiopathy and microcirculatory parameters - in diabetic patients with CVI and microangiopathy. These CVI patients are eligible for medical procedures as their incompetent superficial veins can be treated with repeated sclerotherapy and or local surgery according to needs., Methods: During this registry study, only non-interventional managements were used. The effects of the use of elastic compression with standard management (SM) was compared to Pycnogenol ® intake (150 mg/day) and SM, without using elastic compression for 8 weeks., Results: Fifty-eight diabetic patients with CVI completed the study with 28 subjects supplemented with Pycnogenol ® and 30 in the control group. The two groups completing 8 weeks were comparable at baseline. After 8 weeks, no side effects were observed; the compliance was optimal with >98.5% of the supplement capsules correctly used. The tolerability to stockings was lower (73% of stockings were not fully used for the whole day). There were no dropouts. Venous pressures were comparable in the two groups at baseline. Microcirculatory and clinical measurements of the patients were comparable at inclusion. After 8 weeks, the differences between Pycnogenol ® and elastic compression were statistically significant for skin resting flux (RF), rate of ankle swelling (RAS), transcutaneous PO2 and PCO2 indicating a significant improvement in microcirculatory perfusion with Pycnogenol ® in comparison with elastic compression. In parallel, clinical symptoms assessed by the Composite Symptom Score (CSS), the venous Clinical severity Score (VCSS) and the Venous Disability Score (VDS), were significantly lower in the Pycnogenol ® group than in the compression group, indicating a significant clinical effect of Pycnogenol ® compared to elastic compression (P<0.05). Pycnogenol ® showed important antioxidant properties and lowered oxidative stress as seen also in previous studies., Conclusions: This registry study confirms the clinical and microcirculatory efficacy of Pycnogenol ® in CVI in diabetics. The study indicates the significant supplementary, clinical role of Pycnogenol ® in the management of this common clinical condition over a short period of time, possibly preventing ulcerations.

This article was published in Volume 69, issue 1 of publishing year 2023, with a mistake in Table I. The correct Table I is the one included in this erratum.

Background: The aim of this pilot registry study was to evaluate the efficacy of Robuvit ® (oak wood extract) on residual fatigue due to convalescence in otherwise healthy subjects within one month after surgery and chemotherapy for colon cancer. Robuvit ® has been clinically tested in subjects with fatigue (chronic fatigue syndrome), post-traumatic stress disorder, convalescence and burnout., Methods: One group of patients followed the standard management (SM) and was designated as control group while the supplementation group followed the SM and additionally took two Robuvit ® capsules daily for six weeks (200 mg/day).The main study endpoints were the Karnofsky performance scale index, handgrip strength in kg, fitness test score on a treadmill, self-assessed work ability, fatigue score, oxidative stress and carcinoembryonic antigen (CEA) plasma levels. In addition, the mood of the patients was assessed using the 'brief mood introspection scale', BMIS., Results: Fifty-one subjects with fatigue linked to convalescence within 1 month after chemotherapy for colon cancer completed the study, 29 in the Robuvit ® group and 22 as controls. The two management groups were comparable for age and sex distribution. The main investigation parameters were also comparable at inclusion. No side effects or tolerability problems were observed in the six weeks of follow-up. Occasional use of painkillers, antinausea medication or anti-inflammatory agents was accepted. After six weeks, Robuvit ® supplementation significantly improved the Karnofsky performance scale index compared to controls. Hand grip strength (dynamometry), treadmill fitness test score and the self-assessed work ability were significantly improved with Robuvit ® as well. The fatigue score after six weeks was significantly improved with Robuvit ® (P<0.05) in comparison with SM controls. Mood was significantly improved after 6 weeks in the Robuvit ® patients compared to the control group. The examined study parameters improved in the patients of the control group as well, during a normal postchemotherapy convalescence, but in a lesser extend when compared to the supplementation group. Oxidative stress was high at inclusion in both groups. The decrease in oxidative stress - as plasma free radicals - was significantly higher with the supplementation (P<0.05). CEA values were within the normal values from inclusion and in the 6 weeks of the registry in all subjects., Conclusions: In conclusion, Robuvit ® helps to reduce fatigue after chemotherapy and improves strength, performance, fitness, work ability and mood in these patients, without exposing them to the risk of side effects.

Background: Intestinal fat absorption shifting (IFAS) can be obtained in hyperlipidemic subjects with polyglucosamine biopolymer (BP) able to segregate most metabolic fats in the gut, making them unavailable for intestinal interaction (shift). The aim of this study was to evaluate the effects of a SM (standard management) for hyperlipidemia in asymptomatic subjects for primary cardiovascular prevention focusing on arterial wall morphology (IMT thickness) in comparison to SM associated to the administration of the BP., Methods: Two groups of comparable subjects (SM and SM+oral BP, 3 g/day) were considered; subjects were managed - in a supplement, pilot registry - for a year. Weight, fat mass, lipid profile, oxidative stress, IMT (carotids), the presence of granulations at the internal arterial layers and "near wall low density 'bubbles' were observed and compared at 1 year of management. A non-parallel, comparable group of subjects (102) using a statin for the same conditions was used as a reference population., Results: Two hundred eighty-four subjects completed one year (140 in the SM group and 144 in the SM+BP group). Compliance was optimal with (96.3% of the table correctly used) with no side effects. BMI, fat mass and oxidative stress decreased more in the SM+BP group (P<0.05). Cholesterol and triglycerides levels were significantly improved with BP (P<0.05). IMT measurements were significantly decreased (P<0.05) in the SM+BP group (as for the intimal granulation/bubbles) with minimal variations in the comparative SM group. In the statin group, the lipid profile was modified (P<0.05) but not the IMT and the rate of drop outs was higher (15.7%); these patients stopped the management; in 23% of these subjects muscular pain not seen with BP, was observed., Conclusions: These results indicate positive effects of IFAS due to BP on IMT and arterial wall morphology and weight after 12 months. Fat shifting at intestinal level and the reduction of oxidative stress limit lipid oxidation/deposition into the arterial wall.

Background: 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., Methods: 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 ® in addition. Safety and tolerability of Robuvit ® were optimal. The two registry groups were comparable at inclusion., Results: The overall scores of the real daily life and tasks questionnaire after 4 weeks were significantly higher in the Robuvit ® group (P<0.05) as compared to controls. It increased from 4.3±0.4 at baseline to 6.78±0.8 after 4 weeks of Robuvit ® intake and from 4.2±0.5 to 5.12±1.0 in the control group. The supplementation significantly improved the subjective perception of fatigue in comparison with controls (P<0.05). A practical professional score evaluation provided an indication of professional attitude and stamina, in difficult, stressful working conditions under continuous pressure. The results showed that after 4-week supplementation, all assessed parameters improved significantly and the difference with controls was statistically significant (P<0.05). Furthermore, oxidative stress as plasma free radicals decreased significantly in the Robuvit ® group (P<0.05) but not in the control group., Conclusions: Robuvit ® supplementation appears to improve most symptoms related to work-induced fatigue, stress and cognitive function and supports stamina. Further evaluations need to be planned according to the concept of this pilot registry in a field that requires more attention.

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<0.05 vs. controls). The rate of ankle swelling (RAS) by strain gauge decreased significantly in the supplemented group (P<0.05) in comparison with controls showing an improvement of the capillary filtration rate. At inclusion, the kidney cortical flow velocity indicated a decrease in perfusion (lower systolic and diastolic flow velocity) in all patients. Kidney cortical flow velocity increased significantly with the supplement (P<0.05) in comparison with controls with improvement in systolic velocity and in diastolic component. High sensitivity CRP (hs-CRP) and Il-6 plasma levels decreased progressively over 3 months with a significant more pronounced decrease in the supplement group (P<0.05). The number of patients with normal plasma IL-6 levels at the end of the study was higher (P<0.05) with the supplement. ESR followed the same pattern with a progressive and a more significant decrease in the supplemented subjects (P<0.02). Oxidative stress decreased significantly in the supplemented group (P<0.05) compared with the control group. Systolic blood pressure was significantly lower in the supplemented group (P<0.05) at the end of the study. Finally, the scores of Quality-of-life, mood and fatigue questionnaire and the Karnofsky Scale Performance Index significantly improved in the supplement group (P<0.05) compared to controls after 1 and 3 months. All other blood parameters (including platelets and clotting factors) were within normal values at the end of the study., Conclusions: In conclusion, Pycnogenol ® may offer a significant option for managing some of the signs and symptoms associated with post-COVID-19 syndrome. This pilot evaluation offers some potential rationale for the use of Pycnogenol ® in this condition that will have significant importance in the coming years.

Background: The aim of this study was to evaluate the combination of Pycnogenol ® (150 mg/day) (Horphag Research, London, UK) and Centella asiatica (Centellicum ® 3×225 mg/day; Horphag Research) (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., Methods: Nineteen 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<0.05). The Karnofsky Performance Scale Index significantly improved in the supplement group in comparison with controls (P<0.05). The symptoms (fatigue, muscular pain, dyspnea) were significantly lower after 8 months in supplemented patients (P<0.05) as compared with controls., Results: At the end of the study, the small cystic lesions (honeycombing) and traction bronchiectasis were stable or in partial regression in 4 subjects in the supplemented group (vs. none in the control group) with a significant improvement in tissue edema in the supplemented subjects. On ultrasound lung scans the white (more echogenic) fibrotic component at inclusion was 18.5±2.2% in the images in controls vs. 19.4±2.7% in the supplement group. At the end of the study, there was no improvement in controls (18.9±2.5%) vs. a significant improvement in supplemented subjects (16.2±2.1%; P<0.05). In addition, 18 subjects with post-COVID-19 lung disease were included in the study; 10 patients were treated with the Pycnogenol ® Centellicum ® combination and evaluated after 4 weeks; 8 patients served as controls. Preliminary results show that symptoms associated with post-COVID-19 lung disease after 4 weeks were significantly improved with the supplement combination (P<0.05). Oxidative stress and the Karnofsky Performance Scale Index were significantly improved in the supplements group as compared with controls (P<0.05)., Conclusions: According to these observations, Pycnogenol ® controls and decreases edema and Centellicum ® by modulating the apposition of collagen, slows down the development of irregular cicatrization, the keloidal scarring and fibrosis. More time is needed to evaluate this effect in a larger number of post-COVID-19 patients with lung disease. This disease has affected millions of subjects worldwide, leaving severe consequences. Pycnogenol ® and Centellicum ® may improve the residual clinical picture in post-COVID-19 lung disease (PCL) patients and may reduce the number of subjects evolving into lung fibrosis. The evolution from edema to fibrosis seems to be slower or attenuated with this supplement combination both in Idiopathic pulmonary fibrosis (IPF) and in PCL patients.

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

Background: This study evaluates the effects of training (on running distance measured with a Cooper test) in 3 weeks in non-professional athletes using PycnoRacer®, a fitness drink (FD) including Pycnogenol® during the training period., Methods: Pycnogenol® has been used in preclinical conditions and prevention. PycnoRacer® is a liquid combination of Pycnogenol® (15 mg), L-leucine (0.6 g), L-arginine (0.3 g), L-isoleucine (0.3 g), and L-valine (0.3 g). Two comparable groups (one using the FD) were formed: 60 training athletes were requested to drink one bottle 4 times/day, while 65 controls did not use PycnoRacer® or other comparable sports drinks. All subjects had a strong athletic background and advanced knowledge of the procedures of the tests. Two daily training sessions were completed. The sessions consisted in warming up and running a Cooper test., Results: 125 subjects completed the three weeks according to plans. There were nine dropouts due to logistical or working problems. Subjects using the FD improved on average by 18.83% (range 12-23%) in their running distance with training. The difference with controls was significant (P<0.05) at 3 weeks (controls improved on average by 8.9%; range 3-17.4%). The difference between the two groups was on average 9.93% (P<0.05). A comparable increase in VO2max was observed in the groups. In the FD group the increase was on average by 10.05 mL/kg/min compared to 4.95 mL/kg/min in controls, with a difference of 5.1 mL/kg/min (P<0.05). A VAS score showed comparable values. Lower values (concerning muscular pain and cramps) were observed in FD subjects (P<0.05) at the end of the 3 weeks of training. The level of plasma free radicals (PFR) values after the last Cooper test was significantly lower at 3 weeks in the FD group (P<0.05). No intolerance problem was observed by subjects using the FD., Conclusions: In conclusion, the use of PycnoRacer® improved training, running distance, VO2max and PFR decreasing muscular pain and cramps.

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.

Background: Short-term treatment of overweight and obesity with polyglucosamine (PG) was found to be more effective than placebo and orlistat in double-blind clinical studies. Objective: The aim of the study was to compare the efficacy of long-term (12-mo) treatment of weight loss with PG and placebo (PL). Methods: This was a double-blind randomized study in 100 participants of both sexes with a body mass index (in kg/m 2 ) >30 to <35. One group of 50 participants was treated for 1 y with PG at 1.6 g/d and a similar group received PL. PG is a combination of low-molecular-weight chitosan with organic acids. Participants were instructed to reduce their caloric intake by 10% and increase the physical activity level by 9 metabolic equivalent task hours/wk. Dietary compliance was checked every 3 mo by using a weekly questionnaire [food intake assessment (FIA)] based on 25 different food servings. Body weight (BW), waist circumference (WC), blood pressure (BP), glucose, lipids, and high-sensitivity C-reactive protein (hs-CRP) were also monitored. Results: Ninety-seven participants completed the study (49 in the PG group, 48 in the PL group). The decrease in calories was similar in both groups, as was the change in number of food servings ( P > 0.05, ANOVA). Decreases in BW and WC were 8.0 kg and 10.2 cm, respectively, in the PL group, whereas they were 12.1 kg and 13.3 cm in the PG group ( P < 0.001, ANOVA). The decrease in BP, plasma lipids, glucose, and hs-CRP was more evident in the group treated with PG ( P < 0.05, ANOVA). The intake of lipids was found to correlate directly with hs-CRP, with the exception of extra-virgin olive oil. Conclusions: PG was found to be more effective than PL in reducing BW, WC, glucose, BP, plasma lipids, and hs-CRP in moderately obese individuals undergoing a 10% caloric reduction and a slight increase in physical activity. Dietary monitoring with the use of an FIA was an effective tool in supporting dietary compliance. This trial was registered at clinicaltrials.gov as U111111292405 (WHO).

This registry study evaluated echogenicity of carotid-femoral plaques in asymptomatic subjects with increased oxidative stress and risk factors (mild hypertension, hypercholesterolemia). Supplementation with the combination Pycnogenol-CA (centella asiatica) on the echogenicity of plaques was assessed at 6 months (79 subjects). A standard management (SM) plan was used in all subjects (control of risk factors, lifestyle changes); 36 subjects used the supplements +SM; 43 SM only. The groups were comparable. High-resolution ultrasound evaluated echogenicity and plaque structure. Pycnogenol (150 mg/day) and CA (Centellicum, 450 mg/day) were used. At 6 months, cholesterol was reduced ( p  < 0.05) in both groups (difference between groups not significant). At 6 months, plasma free radicals were decreased with the supplements (17.64%; p  < 0.05; vs <2% in controls). The plaque stability index increased from 11.22;2.3 to 22.4;1.1 ( p  < 0.05) with the supplements; no significant changes were seen in controls. Plaque echogenicity (% of "whiter" component in images) increased with supplementation from 16.7;1.7% to 34.2;2% ( p  < 0.05); no variations were observed in controls. The maximum plaque height decreased ( p  < 0.05) with the supplements. No significant variations were observed in controls. Plaque length was decreased ( p  < 0.05) in the supplement group with no changes in controls. The number of plaques (carotid, femoral bifurcations) decreased with supplementation; no significant changes were observed in controls. No adverse events, tolerability problems, or variations in routine blood tests were recorded. The combination Pycnogenol-CA appears to improve echogenicity and stability of complex plaques in 6 months.

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<0.05) in comparison with controls suggesting a beneficial effect of Pycnogenol® with a significant difference in favor of the combination (P<0.05). There was a reduction in plaques progression in the supplement groups with the best effects obtained by the combination, considering maximum plaque thickness and length and echogenicity (grey scale median) (P<0.05). Plaques became generally dense (more echogenic) achieving a mixed echogenicity. The occurrence of anginal events was less than 3% in the two supplement groups (in comparison with 6.25% in controls) (P<0.05) with the best results obtained by the combination (P<0.05). The occurrence in myocardial infarctions was significantly lower for the combination (P<0.05). Minor transient ischemic attacks were also less frequent with the supplements with the best results observed with the combination (P<0.05). Events in controls - requiring hospital admission - were globally seen in 16.4% of subjects (minor events) in comparison with 8.9% of subjects using Pycnogenol® and only 3.3% of patients using the combination. At 4 years, oxidative stress in the supplement groups was lower than in controls (P<0.05, with no significant difference between groups 2 and 3)., Conclusions: Pycnogenol® and the combination of Pycnogenol® plus CA reduce the progression of arterial plaques and the progression to clinical stages. The reduction in plaques and clinical progression was associated with a reduction in oxidative stress. The results justify a larger study to define the efficacy of the combination of Pycnogenol® plus CA as a prophylaxis in preclinical atherosclerosis.

Background: Antioxidants (AOs) represent the main barrier of defense against damaging aggression due to reactive species, in particular by reactive oxygen species (ROS). The plasma AO capacity is a measure of physiological, environmental, and nutritional factors (exposure to ROS and antioxidant supplementation) determining the redox status in humans and can underline the oxidative stress (OS) conditions in the progression/development of many diseases. Moreover, changes in AO plasma content after supplementation may provide information on the absorption and bioavailability of nutritional compounds and efficacy of AO therapy., Aim: The aim of the study was a comparison between the common BAP (Biological Antioxidant Potential) test, used for the evaluation of the antioxidant capacity, and the innovative PAT (Plasma Antioxidant Test) and to assess both the in vitro interferences of phosphates on the iron reduction and the interference of the plasmatic concentration of phosphates in relation to the plasma antioxidant capacity measured with the two methods., Methods: Thirty-six apparently healthy volunteers were involved in the study for the comparison of the two methods., Results: BAP test and PAT performed on 36 plasma samples demonstrated that plasma antioxidant capacity dosage using the BAP test resulted in overestimated levels in relation to plasma phosphate. Increased BAP values due to phosphates correspond to increased differences between BAP and PAT value (correlation coefficient R = 0.812, p = 0.001)., Conclusions: PAT can be considered an innovative and predictable method for the measure of the antioxidant power of plasma.