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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. [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.

Background: Formation of scars after surgical incisions requires the proper appositions of elements contributing to the scarring process. The structural rebuilding of damaged tissues is essential in producing a linear scar. The excess of blood, foreign particles, exuberant sutures, necrotic tissue, possible infective agents, as well as the ongoing inflammatory process may produce a non-linear, sometimes painful keloidal scar. Centella asiatica (CA) extracts have been used topically since ancient times for preventing keloids (i.e. after extensive burns) and for other applications including ulcer healing. The aim of this registry study was to evaluate the effect of supplementation with Centellicum® (Horphag Research Ltd.) on the healing of surgical wounds in subjects with previous hypertrophic or keloid scars, and to identify with ultrasound the collagen components of the scar in order to assess the quality (or linearity) of surgical wounds., Methods: Subjects with history of hypertrophic scars or keloid following previous surgery were included in this registry. Short term antibiotic prophylaxis was used as per surgical standards with cephalosporins for three days maximum after surgery. Only patients receiving abdominal or knee surgery were included. A total of 129 patients were included: 64 in the control group treated only with standard management, and 65 in the active treatment group where CA supplementation with Centellicum® was used at the dose of two 225 mg capsules/day from the 2nd to 6th week after surgery., Results: A total of 64 scars were analyzed within the control group and 65 in the supplement group. The tolerability to Centellicum® was overall good, and no side effects were reported. Compliance to treatment was optimal, with >98% of the CA capsules correctly used. The ultrasound-assessed scar tissue regularity was on average lower in controls than in supplemented subjects (P<0.05). Scars also appeared to be significantly more homogeneous in CA patients than in controls., Conclusions: Supplementation with Centellicum® is safe and does not interfere with other concomitant treatments. It is well tolerated and compliance to treatment is optimal.

This open registry aimed to evaluate the clinical evolution of postpartum varicose veins (VVs), in healthy women after the second pregnancy, how these veins regain shape and competence, and possible treatments. The registry included two groups of women: (1) those who used elastic compression stockings, and (2) who used an oral venotonic agent (Pycnogenol, 100 mg/d). A total of 12 evaluation targets were established. Minor symptoms were scored in an analogue scale line. A visual analogue scale line evaluated the overall satisfaction relative to elastic compression or Pycnogenol. Overall 133 women completed the registry evaluation with at least 3 months of follow-up. The resulting two registry groups were comparable. At 3 and 6 months in the Pycnogenol group the number of veins and incompetent sites were lower. At 6 months there were 13.3% of patients with edema in controls versus 3.2% in the Pycnogenol group. Spider veins decreased in Pycnogenol patients. Cramps and other minor symptoms were less common in the Pycnogenol group. In both groups there was a significant improvement at 6 months with better results in the Pycnogenol group. The need for treatment was limited with a decreased need for sclerotherapy, surgery, and conservative treatments in the Pycnogenol group. The overall satisfaction was higher among Pycnogenol patients, and compliance was optimal. Re-evaluation at 12 months indicated that the variations in VVs and spider vein clusters and the associated symptoms did not change. Most remodeling appeared to happen within 6 months after the pregnancy. It was concluded that the use of Pycnogenol improves signs/symptoms of postpartum VVs, and venous function and shape seem to return faster to prepartum, physiological pattern with its use.

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: Aim of this registry study was the evaluation of the stability of carotid plaques by ultrasound in asymptomatic subjects with high oxidative stress following supplementation with a combination of the extract from bark of Pinus pinaster, Pycnogenol®, with an extract from Centella asiatica leaves, Centellicum®., Methods: 50 patients, mean age 61.5 years, with carotid plaques (<50% stenosis) and high oxidative stress were included in this 3 months registry study. 26 patients received the combination of Pycnogenol® and Centellicum® and standard management, a control group received standard management only. The 2 groups were comparable., Results: The combination of Pycnogenol® and Centellicum® reduced significantly (p<0.05) plaque height and length as well as the number of plaques relative to controls. The plaque stability index, based on the echogenicity in the ultrasound picture of the "white" components of the plaque, increased significantly (p<0.01) in the verum group, no changes were observed in the controls. Plasma free radicals were significantly (p<0.05) decreased by the combination product, whereas the levels of plasma free radicals remained unchanged in the control group. No unwanted effects or abnormal laboratory tests were recorded., Conclusions: This registry study revealed a significant increase in stability of plaques, indicated by an enhanced density of the plaques, following supplementation with the combination of Pycnogenol® and Centellicum®. As size and number of plaques was simultaneously reduced, the combination of the two plant extracts could be a safe option for prevention of cardiovascular events for patients with carotid plaques.

Background: This registry study evaluated low-cost outpatient surgery (mini-S) for venous insufficiency as an alternative to stripping., Methods: 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., Results: 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 (P<0.05). 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 (P<0.05 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 (P<0.05 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 (P<0.05), 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 a <3% (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 (P<0.05). 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)., Conclusions: 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.

The aim of this pilot supplement study was the evaluation of an oak wood extract (Robuvit, Quercus robur [QR], Horphag Research) in an 8-week registry study on lymphatic signs in primary lymphedema. Subjects with primary lymphedema confined to a single leg without skin changes or ulcerations were followed for at least 8 weeks. Lymphedema was mainly present distally (below the knee). Three groups were formed: one group used only the standard management for lymphedema; one used the same management plus 300 mg Robuvit; and one used the standard management plus 600 mg of Robuvit. The three groups were comparable. After 8 weeks the variation in leg volume was on average -6.2% with standard management, -15% in the QR 300 mg group, and -18.9% in the 600 mg group. The edema score was also significantly lower at 8 weeks in the two QR groups. The variation in proteins in the interstitial fluid in comparison with initial values was -14.8% in controls in comparison with -29.9% in QR 300 mg group and -36.9% in QR 600 mg group. Skin flux significantly improved (increased) in the two QR groups. Ultrasound pretibial skin thickness was decreased on average 6% in controls versus 10.3% in the low-dose QR group and 11.8% in the higher dose group. Perimalleolar thickness was decreased 7% in controls and more in the two QR groups. Ankle circumference was decreased 4.4% in controls and more in the two supplement groups. This pilot registry indicates that Robuvit can be effective in the management of primary lymphedema. More patients and longer evaluation periods are needed.