Pycnogenol® improves cognitive function in post-stroke patients: a 6 month-study.

Background: This pilot study in post-stroke patients evaluated the effects of supplementation with Pycnogenol on alterations in cognitive functions (COFU) over a period of 6 months, starting 4 weeks after the stroke.

Methods: The effects of supplementation - possibly acting on residual brain edema, on global cognitive function, attention and on mental performance - were studied. A control group used standard management (SM) and the other group added Pycnogenol, 150 mg daily to SM.

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

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.

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

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

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

G3 sports supplement in short triathlon: improvements in training, performance, recovery and oxidative stress.

Background: This registry study evaluated the effects of G3 Sports supplement drink (G3) on performance and endurance in triathlon in amateur athletes in a period of 2 weeks of training. G3 is composed of a proprietary fruit juice blend high in carotenoid compounds as well as 100 mg of standardized French oak (Quercus robur) wood extract, Robuvit®, per 50 mL bottle. The antioxidant and anti-inflammatory actions of the compounds in G3 may improve training efficiency (decreasing post-triathlon muscular pain, cramps and improve recovery time) and decrease post-training plasma free radicals (PFR).

Supplementation with Robuvit® in post-traumatic stress disorders associated to high oxidative stress.

Background: Post-traumatic stress disorder (PTSD) is associated to recurrent, obsessive recollection of severe traumatic events. This condition is still not completely understood. Elective treatment of PTSD is psychotherapy.

Analysis of oxidative stress during the menstrual cycle.

Background: Few data concerning the oxidative stress (OS) in plasma during the entire menstrual cycle of eumenorrheic women are available.

Methods: OS was assessed in 20 healthy volunteers during the phase of the menstrual cycle by determining the plasmatic hydroperoxides levels (d-ROMs test). The assessment was performed every three days, starting from the first day (t1) up the end of the menstrual phase (t27).

A controlled study of a lecithinized delivery system of curcumin (Meriva®) to alleviate the adverse effects of cancer treatment.

A proprietary lecithin delivery system of curcumin (Meriva) was evaluated in a controlled study to assess its efficacy in alleviating the side effects of cancer chemo- and radiotherapy in 160 patients undergoing these treatments. In both cases, a semi-quantitative evaluation of the side effects was carried out using a visual analogue scale, assessing also the plasma free radical status in all patients. Results showed that lecithinized curcumin might alleviate the burden of side effects associated to chemo- and radiotherapy, suggesting that the anecdotal use of various preparations of curcumin as a supportive agent for cancer treatment is well worth a systematic investigation in larger scale clinical trials.

Evaluation of oxidative stress after treatment with low estrogen contraceptive either alone or associated with specific antioxidant therapy.

Background: The aim of the study is to analyze the effect of low estrogen contraceptives (OC) on oxidative stress (OS) and concomitantly also the changes produced by different treatments using physiological modulators (PMs) with antioxidant action.

Study Design: Sixty-four female volunteers using a low estrogen OC regimen were analyzed for their OS status through the reactive oxygen metabolites-derived compounds (d-ROMs) test, during 5 different cycles (Cycle I to V). Three experiments were performed.

Assessment of the activity of an oral contraceptive on the levels of oxidative stress and changes in oxidative stress after co-treatment with two different types of physiological modulators with antioxidant action.

Background: The aims of this research were to document the nature of oxidative stress (OS) while taking an estrogen/progestagen-combined oral contraceptive (OC) and to evaluate the action of two different products composed of a combination of antioxidant, vitamins and natural products in physiological quantity and classified as antioxidant/food supplement. For this reason, the two products are classified as physiological modulators (PM), able to restore the balance between antioxidants and reactive oxygen species in the organism.

Study Design: The Reactive Oxygen Metabolites-derived compound test, a photometric assay that measures the hydroperoxides levels in biological fluids, was used to determine the OS.

Efficacy and safety of Meriva®, a curcumin-phosphatidylcholine complex, during extended administration in osteoarthritis patients.

In a previous three-month study of Meriva, a proprietary curcumin-phosphatidylcholine phytosome complex, decreased joint pain and improvement in joint function were observed in 50 osteoarthritis (OA) patients. Since OA is a chronic condition requiring prolonged treatment, the long-term efficacy and safety of Meriva were investigated in a longer (eight months) study involving 100 OA patients. The clinical end points (Western Ontario and McMaster Universities [WOMAC] score, Karnofsky Performance Scale Index, and treadmill walking performance) were complemented by the evaluation of a series of inflammatory markers (interleukin [IL]-1beta, IL-6, soluble CD40 ligand [sCD40L], soluble vascular cell adhesion molecule (sVCAM)-1, and erythrocyte sedimentation rate [ESR]).

Kidney flow and function in hypertension: protective effects of pycnogenol in hypertensive participants--a controlled study.

This study evaluated the effects of Pycnogenol as an adjunct to angiotensin-converting enzyme (ACE)-inhibitor ramipril treatment of hypertensive patients presenting with early signs of renal function problems. One group of 26 patients was medicated with 10 mg ramipril per day only; a second group of 29 patients took Pycnogenol in addition to the ACE inhibitor over a period of 6 months. At trial end, a lowered systolic and diastolic blood pressure was found in both groups, with a significant further reduction of diastolic pressure in the group given Pycnogenol in addition to ramipril.

Pycnogenol treatment of acute hemorrhoidal episodes.

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.

Pycnogenol improves microcirculation, retinal edema, and visual acuity in early diabetic retinopathy.

Purpose: The growing numbers of diabetes cases in the developed world are followed by increasing numbers of people diagnosed with diabetic complications. Diabetic microangiopathies in the eye lead to the development of retinopathy involving gradual loss of vision. Previous studies with Pycnogenol showed effectiveness for stopping progression of preproliferative stages of retinopathy.

Five-year treatment of chronic venous insufficiency with O-(β-hydroxyethyl)-rutosides: safety aspects.

Chronic venous insufficiency (CVI), and related signs and symptoms of venous and diabetic microangiopathy, can be effectively treated with O-(β-hydroxyethyl)-rutosides (HR). The aim of the present independent registry study was to evaluate HR in a long-term (five-year) period of administration that examined the tolerability and safety of HR. Patients with severe CVI and venous microangiopathy were included in the registry.

5-Year control and treatment of edema and increased capillary filtration in venous hypertension and diabetic microangiopathy using O-(beta-hydroxyethyl)-rutosides: a prospective comparative clinical registry.

This independent prospective controlled trial evaluates the efficacy of O-(beta-hydroxyethyl)-rutosides (HR) during 5 years of administration against signs and symptoms and further degeneration of microcirculatory disturbances. The protective effect of HR in preventing end-point complications such as venous ulceration is evaluated. This study is based on evaluation of edema and the capillary filtration rate (CFR) in association with a clinical score scale.

O-(beta-hydroxyethyl)-rutosides systemic and local treatment in chronic venous disease and microangiopathy: an independent prospective comparative study.

O-(beta-hydroxyethyl)-rutosides (HR) is used to treat chronic venous disease and signs and symptoms of chronic venous insufficiency (CVI), varicose veins, and deep venous disease. This independent prospective controlled trial (a registry study) evaluates how the efficacy of HR at the local level (perimalleolar region) can be increased by the administration of a topical HR gel. The study is based on evaluation of microcirculatory variables in patients with severe CVI (ambulatory venous pressure, > 56 mm Hg) and venous microangiopathy.

Improvement of microcirculation and healing of venous hypertension and ulcers with Crystacide: evaluation with a microcirculatory model, including free radicals, laser doppler flux, and PO2/PCO2 measurements.

In 32 patients with chronic venous insufficiency and venous hypertension associated with ulcerations, the effects of the local application of a hydrogen peroxide cream (Crystacide) applied onto the skin was evaluated using a complex, proportional, microcirculatory model to assess and quantify venous microangiopathy after local treatment. A comparative group treated without Crystacide was included. Laser Doppler flowmetry was used to assess skin perfusion (flux and venoarteriolar response) in association with transcutaneous PO2 and PCO2 measurements.

Local heparin, superficial vein thrombosis.

Local, topical effects of heparins on the skin still need deeper investigations. The lack of evidence is mainly due to the lack of large investments in this field. Three main local actions of heparin on the skin can be defined: (1) the anticoagulant action, (2) the microcirculatory-modulatory action determining important control of the microcirculation in case of excessive vasoconstriction or vasodilatation, and (3) the "facilitatory action" on skin permeability, allowing other drugs to diffuse better and faster into the skin (producing a therapeutic effect).

Microcirculatory effects of Viatromb spray gel heparin in chronic venous insufficiency: evaluation of TcPO2 and PCO2--a product evaluation study.

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.

Prevention of influenza episodes with colostrum compared with vaccination in healthy and high-risk cardiovascular subjects: the epidemiologic study in San Valentino.

The efficacy of a 2-month treatment with oral colostrum in the prevention of flu episodes compared with antiinfluenza vaccination was evaluated. Groups included healthy subjects without prophylaxis and those receiving both vaccination and colostrum. After 3 months of follow-up, the number of days with flu was 3 times higher in the non-colostrum subjects.

Control of edema in hypertensive subjects treated with calcium antagonist (nifedipine) or angiotensin-converting enzyme inhibitors with Pycnogenol.

The presence of edema in different phases and stages of essential hypertension may be due to antihypertensive treatment. Some drugs may cause edema by inducing vasodilatation, increasing the capillary exchange surface and capillary filtration. Pycnogenol has an important anti-edema effect in diabetic microangiopathy and chronic venous insufficiency.

Circulating endothelial cells in venous blood as a marker of endothelial damage in chronic venous insufficiency: improvement with venoruton.

Damage to endothelial cells is common in vascular disorders and in reactions associated with transplantation. An elevated number of circulating endothelial cells indicates the extent of endothelial damage in a variety of disorders. In chronic venous insufficiency (CVI), the number of endothelial cells is abnormally increased, and this can be considered an important indication of endothelial damage.

The LONFLIT4--Concorde Deep Venous Thrombosis and Edema Study: prevention with travel stockings.

Background: The LONFLIT1+2 studies have established that in high risk subjects after long flights (> 10 hours) the incidence of deep venous thrombosis (DVT) is between 4% and 6%. The LONFLIT4 study was designed to evaluate the control of edema and DVT in low-medium risk subjects. The aim of this study was to evaluate edema and its control with specific stockings (ankle pressure between 20 and 30 mm Hg) in long-haul flights.