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AIM The aim of this open, pilot supplement registry study was to evaluate the protective, preventive effects of Robuvit® on professional-related fatigue symptoms and on aspects of cognitive functions, professional attitudes and decision-making in healthy nurses under professional stress and with increased oxidative stress. RESULTS In total, 40 subjects, aged 30 - 37, completed the 4-week registry study. A control group of 20 subjects used only the standard management (SM) and one group of 20 subjects took 300 mg Robuvit®. Safety and tolerability of Robuvit® were optimal. The two registry groups were comparable at inclusion. The overall scores of the real daily life & tasks questionnaire after 4 weeks were significantly higher in the Robuvit® group (p

Background: a second wave (W2) of COVID-19 is affecting Italy. Objective: to analyze the ratio between deaths and positive cases in two different 36-day periods of W2. Methods: data were retrieved by the Official Bulletin of the Italian Protezione Civile. The analysis was based on mobile averages. Results: The ratios deaths/positive cases in the first 35-day period form October 9th and November 13th were of 2.45 ± 0.482 and in the second 36-day period from November 14th and December 19th was 2.37 ± 0.416. There is no statistical difference between the periods (p> 0.05). The differences are significant (p

BACKGROUND The aim of this pilot, registry study was to evaluate the prophylactic effects of oral supplementation with Pycnogenol® (150 mg/day) in subjects with previous history of recurrent (urinary tract infections (UTI) in a 2-month open follow-up. METHODS subjects with recurrent-UTIs, defined by: 1) at least three symptomatic UTIs over the past year; 2) two episodes of UTI's in the past six months; 3) symptoms of UTIs with urinalysis without bacterial presence, were included in the study. Pycnogenol® was supplemented at the dose of 150 mg/day for 2 months. RESULTS The two groups of subjects (supplement and controls, each including 25 subjects) were demographically and clinically comparable at baseline. No side effects or tolerability problems were observed. The registry evaluated the number of recurrent UTIs in two months; there was a limited decrease in the rate of recurrent UTIs, in comparison with the period before inclusion of 9.93% in the standard management group in comparison with a more important decrease in the Pycnogenol® group (-50.1%; P

In this preliminary pilot registry study, we investigated the effects of the oral supplementation of a standardized cranberry extract (Anthocran® Phytosome®, Indena) delivered by a lecithin-based system, for the prophylactic management of recurrent-urinary tract infections (R-UTIs). We included 64 otherwise healthy subjects who underwent a surgical procedure and required post-surgical urinary catheterization for high-risk UTIs or a previous history of R-UTIs. Patients were given supplementation with the standardized cranberry extract at the dose of either 120 mg/day (n = 12) or 240 mg/day (n = 12) or assigned to a control group consisting of standard management (SM; n = 18) or nitrofurantoin administration (n = 22) for 4 weeks. After 4 weeks, patients receiving the standardized cranberry supplementation reported to have a more effective reduction in UTI symptoms, as assessed on the visual analogue scale, compared with patients in the SM or nitrofurantoin groups. The occurrence of hematuria and urine bacterial contamination were decreased among patients treated with the supplement compared with controls (p < 0.05). The cranberry extract was also superior to the control management in terms of recurrence of signs/symptoms, with none of the patients in this group suffering from a R-UTI in the 3 months following the study end (p < 0.05). The supplementation showed an optimal safety profile, with no significant adverse events and no drop-outs in the supplement group. This registry shows that this cranberry extract is effective as a supplementary, preventive management in preventing post-operative, post-catheter UTIs; the product has a good tolerability profile.

AIM: The aim of this study was the evaluation of the combination of Pycnogenol® (150 mg/day) and Centella asiatica (Centellicum® 3 x 225 mg/day) (PY-CE) for 8 months in subjects with sequelae of idiopathic interstitial pneumonia (IIP). Recently, post-COVID-19 lung disease is emerging with large numbers of patients left with chronic lung conditions. Considering the antifibrotic activity of the combination PY-CE, we also tested this supplementary management in post-COVID-19 lung patients. RESULTS: 19 subjects with idiopathic interstitial pneumonia (IIP) were included in the study. High Resolution CT scans at inclusion confirmed the presence of lung fibrosis: 10 patients were treated with the Pycnogenol® Centellicum® combination and 9 subjects with standard management (SM) served as controls. Oxidative stress that was very high in all subjects at inclusion, decreased significantly in the supplement group (p

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

BACKGROUND The aim of this registry study was the prospective evaluation of the efficacy of Pycnogenol® in idiopathic fibromyalgia (FM), over 4 weeks in comparison with the standard management (SM). METHODS A SM and a Pycnogenol®+SM group were formed. Pycnogenol® supplementation was used at the dose of 150 mg/day (4 weeks). The study considered the most important/frequent symptoms of FM. RESULTS Fifty patients with idiopathic fibromyalgia were included: 26 in the Pycnogenol® group and 24 served as controls. The two groups were comparable at inclusion. No other disease or condition was present. All subjects were otherwise healthy women (BMI

Background Neck/shoulder, sudden pain, or muscular pain (not associated to structural or bone/joints components), due to fascial or muscular strain is common in active subjects, in non-professional athletes and sports performers. The aim of this supplement registry was the evaluation of a cream based on natural, active ingredients for topical application in supporting the improvement of pain and improving head/neck mobility, possibly minimizing the use of systemic drugs. Methods The cream includes standardized active ingredients of natural origin as an extract of Harpagophytum procumbes, an extract from Boswellia serrata, a CO2 extract of ginger and escin. Subjects were divided into three groups, all using the standard management (SM) in combination with the Sport Cream or in addition to Flector (diclofenac) patch. Results The groups were comparable and homogeneous at the baseline. No side effects or skin tolerability issues were observed with the Sport Cream nor with the SM or diclofenac patches. Subjects receiving sport cream + SM reported a significant improvement in pain, stiffness, altered mobility and altered working capacity, with a reduced need for rescue medication (diclofenac) compared to subjects in the other two groups. Conclusions Finally, subjects receiving sport cream + SM reported a more remarkable decrease in skin temperature in the affected area associated to an improvement in clinical symptoms.

BACKGROUND The aim of this registry study was to evaluate the effects of Robuvit® (extract from oak wood), in otherwise healthy subjects (aged 50 to 65 years) who complained of decreased general vigor. Robuvit® has been shown to be effective in convalescence, chronic fatigue syndrome and post-traumatic stress disorder. METHODS The standard management (SM) for this condition included diet, regular daily routines and regular exercise. All subjects had increased oxidative stress (>350 Carr Units) at inclusion. Two groups, SM and SM+Robuvit® supplementation, were formed. Robuvit® was supplemented at a dose of 300 mg/day for 4 weeks. A visual analogue scale line or vigor visual analogue line score of the most common problems associated with a decrease in vigor was used by all included subjects. RESULTS Forty subjects were included in the study. 20 in the SM group and 20 in the SM + Robuvit® supplement group. All subjects completed the 4-week study; both groups improved with the health program and under SM. No drop-outs and no side effects were recorded; a very good tolerability for the supplement was reported. At 4 weeks, the scores in Robuvit®-supplemented subjects, were significantly higher for all vigor-related items in comparison with the scores of subjects managed with the SM only (P

BACKGROUND The aim of this study was to evaluate the effects of the standardized supplement Robuvit® (oak wood extract) in defined diffuse, minimal lymphatic "retention" (DMLR). METHODS Robuvit® has already been investigated in both primary and secondary (post-surgical, post chemo-radiotherapy) lymphatic insufficiency. This registry included subjects with diffuse, minimal lymphatic "retention" (DMLR). The registry management groups included women with mild-moderate limb swelling using standard management (SM) as controls. A second, comparable group used prevention with Robuvit® at the dosage of 3 cp/day (300 mg/day) for 4 weeks. RESULTS No tolerability problems or side effects were observed with the preventive supplementation. The management groups (34 women in total), including 18 women in Robuvit® and 16 in SM were comparable in age and baseline evaluations. After 4 weeks, in the Robuvit® group, edema scale values derived from ultrasound observations decreased significantly (P

BACKGROUND The aim of this registry study in patients with Parkinson's Disease (PD) in treatment, was to evaluate the effects of Pycnogenol® supplementation on some accessory symptoms and cognitive functions (COFU). METHODS The registry included 43 PD patients who had been diagnosed at least one year before the start of the study. The PD condition was considered mild, with minimal progression. The management for these patients was a monotherapy using carbidopa/levodopa (standard management; SM). Supplementary Pycnogenol® was used at 150 mg/day for 4 weeks. The neurological management was not affected. RESULTS Tolerability and safety were very good; the two registry groups were comparable with comparable symptoms at baseline. The most disabling symptoms were considered tremor, bradychinesia, alterations in COFU, rigidity and speech changes. All symptoms were rated as mild-to-moderate. After 4 weeks, these target symptoms were significantly attenuated with the supplement in comparison with the SM only (P

BACKGROUND This registry study investigated the supplement Pycnogenol® on migraine headache attacks and oxidative stress in otherwise healthy subjects with migraine and moderate headache (MH). METHODS To manage MH, these subjects used only a few drugs (antiemetics, analgesics on demand) and lifestyle changes; only very occasionally they used other, more specific products such as triptans. Study groups: one group used only standard management (SM), basically, management on demand. Oral magnesium and riboflavin (vitamin B2) were used with lipoic acid as they are considered useful to improve MH. Another group used the supplement Pycnogenol® (150 mg/day for 8 weeks) in addition to SM. These two groups were compared to a third (non-parallel, observational) group using topiramate (50 mg/day). If needed, subjects were allowed to use rescue medications. RESULTS Forty-six subjects were included in the study. Twenty-two used the standard management and 24 were supplemented with Pycnogenol® in association with SM. In addition, 21 subjects were treated with topiramate. Safety with Pycnogenol® was very good. The two main management groups and the third non-parallel group had comparable baseline characteristics. The number of migraine attacks were significantly reduced during the observation period with Pycnogenol® (P

BACKGROUND The aim of this supplement registry study was the evaluation of possible benefits of Robuvit® (oak wood extract) as a standardized supplement (in an 8-week registry) in stable, mild, heart failure patients. METHODS All subjects received the standard management (SM) for this condition. Otherwise healthy subjects with mild, initial symptoms (mild shortness of breath and/or angina) and slight limitation during their normal daily activity were included. This corresponds to the New York Heart Association (NYHA) Functional Classification class II. RESULTS Forty subjects were included in the study. The two groups completing 8 weeks were comparable at baseline with 20 subjects managed with SM and 20 subjects supplemented with Robuvit® in addition to SM. Tolerability and compliance were optimal (with more than 95% of the capsules correctly used). The age and symptoms of the supplemented patients and the controls were comparable at baseline. There were no dropouts. At 8 weeks, systolic-diastolic pressure, heart rate, respiratory rate were minimally (non-significantly) lowered with the supplement without differences in controls. Ultrasound-derived ejection fraction was significantly increased in the supplement group (P

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BACKGROUND The aim of this pilot study was the supplementary management of minimal, residual symptoms of systemic Lupus (SLE) with vasculitis (LV) in remission phases, using a natural, anti-inflammatory, antioxidant agent (Pycnogenol®) extracted from French maritime pine bark. Pycnogenol® has a significant clinical anti-inflammatory activity; it is a standardized supplement with a high-safety profile. METHODS Subjects with Lupus vasculitis were included in the study. The standard management (SM) was used in all subjects for 8 weeks; one group added Pycnogenol® (150 mg/day) to SM. RESULTS The two groups completing 8 weeks were comparable at baseline with 12 subjects managed with SM and 14 subjects supplemented with Pycnogenol®. No side effects due to Pycnogenol® were observed; Pycnogenol® was associated with an optimal tolerability. The proportion of patients with photosensitivity, oral ulcers, renal-associated hematuria (minimal), leukopenia, lymphopenia, thrombocytopenia, positive anti-DNA and positive antiphospolipids tests were significantly lower in the Pycnogenol® group (P

BACKGROUND The aim of this pilot registry study was to use a standardized supplement (Lady Prelox®, Horphag Research) - including Pycnogenol®, l-arginine, L-citrulline and rose hip extract - to improve signs and symptoms associated with vaginal dryness in pre and post-menopausal healthy women. A group of women used only a standard management (SM) and a second group added Lady Prelox®. METHODS Four groups of women were included in the study. 34 pre-menopausal and 38 post-menopausal women took Lady Prelox®, four tablets daily for 8 weeks and 33 pre-menopausal women and 35 post-menopausal women served as controls. RESULTS No safety problems were observed with the supplement that was well tolerated. The subgroups of controls and supplemented subjects were comparable in both the pre- and post-menopausal groups. Among pre-menopausal women, results of the female sexual function index (FSFI) were significantly improved with the supplement in comparison with the control subjects' group (P

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

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.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). All subjects took cardioaspirin (Bayer, 100 mg/day).No dropouts, no clinical events were observed in 12 months. The 3 groups had comparable demographic and medical characteristics at baseline. No tolerability problems and no side effects from supplementation were reported. After 12 months, oxidative stress was significantly decreased (P0.05) in both groups taking Pycnogenol®. The evaluation of the number of calcifications1 mm indicated a trend in controls using SM towards a progressive increase in calcifications. At 12 months the decrease in the number of calcifications with the combined supplements (Pycnogenol® and Centellicum®) (group 3) was -9.952% and thus significantly better that in the other two groups (P0.05). Pycnogenol® alone was more effective than SM alone in controlling the variation in calcifications (P0.05). Considering a 34.88% increase in SM subjects, the total absolute difference between SM (34.8%) and the decrease observed in group 3 (-9.95%) was 44.75% (P0.02). This indicates that supplementation with the combined supplements blocks the increase in calcified areas and, possibly, in time may decrease the number of calcified spots.This study shows that there is a significant activity of the complex Pycnogenol®+ Centellicum® in reducing the progressive diffusion of central cardiovascular calcifications-associated with advanced plaques - in a relatively short period of time. Longer studies - focusing also on events - may better evaluate the efficacy of these standardized supplements combination on the evolution of atherosclerosis.

Background In association with standard management, natural pharmaceutical standard (PS) supplements may play an important role in managing and preventing mild-to-moderate symptoms of asthma, a significant health issue that impacts patients and the healthcare system. Quercetin is a natural flavonoid with important biological properties (anti-inflammatory, antihistamine and anti-oxidative actions). Methods In this pilot registry, we evaluated the effects of quercetin formulated with the Phytosome® delivery system (Quercefit™, QFit)+standard management (SM) in otherwise healthy subjects with mild-moderate asthmatic attacks and rhinitis. Subjects used either QFit 1 or 2 tabs/day in association with SM or SM only (control group). After 30 days of management, we evaluated the presence of the main signs/symptoms of asthma according to the GINA classification system also considering the need of rescue medication, nasal drops, the use of inhalers, the rhinitis score and oxidative stress. Results QFit+SM showed superior results compared with SM alone in controlling, preventing and reducing daily and night symptoms, in maintaining higher peak expiratory flow (PEF) and in decreasing PEF variability. The supplementary use of QFit improved additional measures of asthma management, decreasing the use of inhalers, nasal drops, rescue medications and improving the rhinitis score. QFit produced a significantly more evident reduction in oxidative stress compared with SM; Qfit showed a very good safety profile. Conclusions This preliminary supplement, concept registry shows a potential protective and preventive effect of quercetin on attacks frequency and in controlling the most common signs/symptoms of asthma in the milder cases of the disease.

BACKGROUND The aim of this study was to evaluate the regrowth and progression of within-stent neointima after stenting as a model of accelerated atherosclerosis and the potential effects of the combination Pycnogenol® and Centellicum® in 12 months' follow-up. METHODS Progression was defined as the passage from one arterial risk class to next, more advanced risk class in 12 months of follow-up. Each class corresponds to a different risk of cardiovascular events and progression. Three management groups were formed, treated with either standard management (SM), Pycnogenol® 150 mg/day, or a combination of Pycnogenol® 150 mg/day and Centellicum® 450 mg/day. RESULTS No side effects or tolerability problems were observed. 82 subjects with stented arteries in class 2 were evaluated for the passage into class 3 over 12 months. This group included 82 subjects; there were no dropouts. The management subgroups were comparable at baseline. At 12 months 66.7% of subjects in the SM subgroup progressed to class 3, versus 10.7% in the Pycnogenol® group; progression was seen in 6.7% (P

BACKGROUND The aim of this prospective supplement summer registry study was to evaluate the efficacy of Pycnogenol® in controlling symptoms of chronic venous insufficiency (CVI) and microcirculatory parameters: venous hypertension and microangiopathy. Pycnogenol® (Horphag Research) is the standardized extract of the bark of Pinus Pinaster. METHODS During the summer period between June and August 142 patients were split into three groups: 1) Pycnogenol® 150 mg/day; 2) compression stockings; 3) and compression + Pycnogenol®. RESULTS Venous pressure (ambulatory venous pressure, AVP) and refilling time (RT), microcirculatory and clinical measurements were comparable at inclusion. At 8 weeks variations in skin flux (RF), rate of ankle swelling (RAS), skin PO2-PCO2, Analogue Symptomatic Score (ASLS), Venous Disability and severity Scores and local oxidative stress (OS) indicated a statistically significant improvement by Pycnogenol® both as a single supplement and in association with compression in comparison with baseline. Pycnogenol® significantly improved the microcirculation in comparison with compression (P

Background In this study we aimed to evaluate the efficacy of Pycnogenol® supplementation in controlling oxidative stress levels and in reducing the frequency and severity of side effects of levothyroxine (LT4) treatment in patients who had recently started this therapy. Methods The registry included 60 females affected by primary hypothyroidism with multi-nodular goiter. LT4 was administered at the dosage of 100 μg/day.The registry study included only subjects under initial treatment, and followed up for a period of at least 30 days. A group took 150 mg Pycnogenol® daily and another served as control. Results The global occurrence of symptoms during the 30-day period was significantly lower with the supplement (P Conclusions Pycnogenol® may represent a useful tool to reduce LT4- related side effects in patients treated with hormone replacement therapy for hypothyroidism.

BACKGROUND The aim of this study is to evaluate the use of Aspirin, Pycnogenol®, ticlopidine, and sulodexide to reduce the incidence of new RTV (retinal vein thrombosis) after a first episode. Pycnogenol® is an anti-inflammatory, anti-edema, mild antiplatelet-antithrombotic agent. METHODS The registry study evaluated the number of repeated episodes of RVT in 12 months. Possible managements were: standard management (SM); SM + Aspirin (100 mg/once day; if there were no tolerability problems); SM + Pycnogenol (100 mg/day); SM and ticlopidine (200 mg/day); SM + sulodexide (500 ULS/day). The number of subjects age and sex, distribution, the percent of smokers, the vision were comparable at inclusion. RESULTS 307 subjects completed the study, 44 in the SM group, 90 in the Pycnogenol® group, 90 in the aspirin group, 45 in the ticlopidine group and 38 in the sulodexide group. At 12 months, recurrent RVT was documented in 22.7% of controls (SM), 3.3% of Pycnogenol® subjects (P

Background In this pilot non-interference clinical study we evaluated possible interactions between Quercetin Phytosome® (Quercefit™), an innovative delivery form of quercetin, and antiplatelet agents, anticoagulants, and anti-diabetic therapy in otherwise healthy subjects. Methods Interaction with antiplatelet therapy was assessed through the bleeding time (BT) test in 30 patients treated with acetylsalicylic acid, ticlopidine or clopidogrel before and after 10 days of supplementation with Quercetin Phytosome®. Interaction with anticoagulants was evaluated by measuring the International Normalized Ratio (INR) in 20 patients using warfarin or dabigatran before and after 20 days of supplementation with Quercetin Phytosome®. Lastly, glycaemia and glycated hemoglobin were measured in 12 diabetic patients treated with metformin and restricted diet before and after 20 days of supplementation with Quercetin Phytosome®. Results After 10 days of supplementation no significant difference was observed in mean BT in patients treated with acetylsalicylic acid, ticlopidine or clopidogrel at standard dosages. Similarly, after 20 days of supplementation, the INR level among patients assuming warfarin or dabigatran was not statistically different from baseline. Lastly, no statistically significant difference in mean levels of glycaemia and glycated hemoglobin was reported before and after 20 days of complementary administration of Quercetin Phytosome® in diabetic patients treated with metformin and restricted diet. Conclusions Quercetin Phytosome® does not alter the antiplatelet activity of the most common antiplatelet agents, has no impact on the INR values in stable patients treated with warfarin or dabigatran, and does not influence the metabolic control of diabetic patient treated with metformin.

Background The aim of the present observational registry study was to evaluate the efficacy of a thin polycarbonate patch of Pycnogenol® in alleviating symptoms of knee arthrosis, in comparison to the standard management usually applied to treat osteoarthritis (OA). Methods A total of 67 subjects were included in the registry: 34 formed the control group, and 33 entered the active management group in which the Pycnogenol® patch was used. Two Pycnogenol® patches were used every day for three weeks. Each patch contains 110 mg Pycnogenol®. All patients included in this registry suffered from osteoarthritis of the knee. Results Results from this study show that Pycnogenol® patch allows faster improvement in OA symptoms, with a decrease in the use of non-steroidal anti-inflammatory drugs and other painkillers. Pycnogenol® patch significally reduced C reactive protein and ESR. Conclusions Pycnogenol® patch was effective in controlling mild to moderate pain and inflammations and its related symptoms in subjects with knee OA over a period of three weeks.

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. Standardized supplements, used for improving chronic fatigue syndrome (i.e. Robuvit®, Horphag Research Ltd) can also be used to control some of the symptoms associated to PTSD, as well as to control the associated increased oxidative stress, present in many of these patients. The aim of this open registry was to evaluate the effects of supplementary Robuvit® 300 mg/day, added to standard management (SM), in subjects with PTSD over a period of 4 weeks, both on the psychological and the inflammatory level. METHODS Otherwise healthy individuals with a diagnosis of PTSD were included in this registry. A clear main traumatic event occurred with different modalities in all subjects during or just after major earthquakes in Central Italy. SM included exposure therapy and psychotherapy. Supportive psychotherapy was used in all affected subjects. Subjects autonomously decided which group to enter (either SM or SM + Robuvit®), without any pre-defined group allocation or randomization. No placebo was used. RESULTS The two groups were comparable: 18 subjects (11 females; age range 25-49) were included in the SM group, and 16 subjects (8 females; age range 26-52) using SM in combination with Robuvit® supplementation. BMI of all subjects was below 25 kg/m2. After 4 weeks, the percentages of subjects with recurrent memories and dreams, transient walking-dissociative states and reactive flashbacks/hallucinations, alarm reactions and intense emotional distress, emotional numbness, social disinterest and detachment were significantly lower in the subjects treated with Robuvit® (P

Background Infectious mononucleosis (IM) is a common disease of adolescents and young adults, characterized by a specific triad of symptoms represented by fever, sore throat and lymphadenopathy. IM may also affect older adults, with different, more intense signs and symptoms such as fatigue, general malaise, and diffuse body pain. The aim of this four-week-registry study was to evaluate the effects of Robuvit® supplementation on the main consequences of mononucleosis, particularly fatigue, in otherwise healthy adults. Methods All patients enrolled in this registry study experienced an episode of IM characterized by fatigue, a general feeling of unwellness, diffuse body and muscular pain, leukocytosis, and high levels of oxidative stress, at least 2 to 4 weeks prior to inclusion. Fever had already resolved at inclusion. All included patients were positively tested for the Epstein-Barr virus (EBV). Subjects were divided in two groups: those receiving the standard management (SM, N.=26; vitamin B, C, and D, balanced healthy diet, regular sleeping schedule, physical activity, 2 mg copper), and those treated with SM plus Robuvit® (N.=24) supplementation (300 mg/day). Results Supplementation with Robuvit® was safe, overall tolerability was good, and no side effects were reported. All patients completed the four-week treatment. After 4 weeks of treatment, a significant reduction in the rate of symptoms was evident in the Robuvit® group compared to the control group (P Conclusions Supplementation with Robuvit® is safe, well tolerated, and effective in controlling oxidative stress levels and improving fatigue and other symptoms related to IM episodes during the convalescence period.

BACKGROUND The aim of this comparative registry study was to evaluate the supplementation with Pycnogenol® in subjects with Behcet syndrome (BS) with symptoms impairing their quality of life despite being in a remitting phase of the disease. METHODS Thirty-four patients with a confirmed diagnosis of BS were divided into the control group (without supplement) or the active group, in this specific case using Pycnogenol® (Horphag Research LTD) supplement at the daily dose of 150 mg (50 mg tid) for 4 weeks. RESULTS All subjects receiving Pycnogenol® reported a significant decrease in symptoms, such as burning/pain due to dryness and ulcerations (P

BACKGROUND Oxidative stress (OS) plays a substantial role in inflammatory and neurodegenerative diseases, causing cellular damage and mitochondrial dysfunction. OS also contributes to aging and severe neural disorders such as Alzheimer's and Parkinson's diseases. Previous registries have documented a reduction in OS levels with Robuvit® (Horphag Research, Ltd.), an extract from wood of the French oak (Quercus robur) that provides a decrease of OS as well as relief from chronic fatigue syndrome. The aim of the present registry was to investigate the influence of Robuvit® on a group of subjects presenting with mood disorders, oxidative stress, fatigue, and insomnia. METHODS Forty patients were recruited from a selection of patients with high OS levels as assessed with the d-ROMs test. Twenty-two subjects formed the control group following the standard management plan. The remaining 18 subjects formed the Robuvit® supplementation group. They received three capsules of Robuvit® 100 mg per day, for 8 weeks. RESULTS Tolerability to the supplementation with Robuvit® was overall good, and no safety concerns were raised. Mood tests showed a significant general improvement in 13 out of 16 items of the BMIS (P

BACKGROUND The aim of this study was to evaluate the efficacy of Pycnogenol® supplementation in terms of safety and tolerability in the setting of preclinical or borderline, initial symptoms of benign prostatic hyperthrophy (BPH), in otherwise healthy subjects, using Pycnogenol® over a period of 60 days. METHODS Seventy-five healthy men with symptoms and signs of initial BPH were included. The subjects were divided into three groups: 1) control group using only the standard management (SM); 2) a group using SM plus Pycnogenol® 150 mg/day; 3) a group using standard pharmacological management. RESULTS BPH symptoms like emptying, frequency, intermittency, urgency, weak flow, straining, nocturia, were all significantly improved with Pycnogenol® (P

BACKGROUND Post-mastectomy lymphedema is one of the most significant, non-life-threatening complications following breast cancer surgery and radiotherapy. Post-mastectomy post-radiotherapy (PMPR) lymphedema is related to damages to lymphatics and/or veins during/after axillary surgery and radiotherapy. The management of this condition is very challenging; the comprehensive decongestive therapy (CTD), which combines physiotherapy, self-management, and hygiene, and is currently considered the standard management (SM). The aim of this registry study was to evaluate whether the supplementation with Robuvit® as a lymphedema controlling agent added to CTD over a 2-month period could be more effective than CTD alone. METHODS A group of 65 patients with PMPR lymphedema was included in this registry study and followed up for 2 months; 33 were treated with current SM only (control group), and 32 were also supplemented with 600 mg/day of Robuvit® (active treatment group). RESULTS At 1- and 2-month follow-up, the decrease in volume was significantly greater in the supplement group (P

BACKGROUND The aim of this study was to evaluate the efficacy of Robuvit® (French oak extract, Horphag Research) in improving kidney function in subjects with temporary kidney dysfunction (TKD) and increased oxidative stress levels. METHODS Fifty-seven subjects with TKD were included in the registry. Subjects were divided into two goups according to albumin levels in the urine. Plasma free radicals were measured in order to evaluate a possible connection with alterations in kidney function. Robuvit® was used at the dose of three capsules/day (300 mg/day) for 4 weeks. RESULTS Subjects with micro-albuminuria treated with Robuvit® improved significantly more than controls treated with standard management, achieving a full normalization of albumin levels in the urine (P

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). METHODS We selected 50 healthy subjects available to follow the registry plan (age 30-40). No clinical or risk condition were present; no medications were used. Subjects followed a free diet. None used sport supplements (aminoacids or anabolic products). The use of rehydrating drink (Polase) was suggested to all subjects. The only other admitted beverage was Gatorade for use by the control group only. Triathlon total time as well as objective markers of oxidative stress, measured as plasma concentration of free radicals (PFR), and intravascular hemolysis (hemoglobin, serum ferritin, unconjugated bilirubin (UBR) and lactate dehydrogenase (LDH) were measured. RESULTS Fifty subjects were included: 25 using the supplement; 25 subjects did not use the supplement and acted as controls. Routine blood tests were normal at inclusion and after the final triathlon. The two groups were comparable considering men and women performances at inclusion and age distribution. Drinking and training regimens were comparable between the groups. No side effects or tolerance problems were reported; all G3 drinks were used as indicated. The final "measurement" run was not competitive but chronometric. All subjects completed the test. All subjects performances improved with training. The improvements were seen in parallel both in men and women. The improvement was significantly greater with G3 (P

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.

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

Noninvasive, high-resolution, arterial ultrasonic biopsy (UB) was used to evaluate and follow up early arterial wall changes in 356 hyperlipidemic subjects (HLS) in a prospective 4-year follow-up study. UB findings at baseline were classified by severity of vascular damage and ranked to classes I through IV. HLSs were divided at random into a treatment group (low-fat diet and bezafibrate s.v. 400 mg/day) and a control group (low-fat diet). The rate of progression (ROP=percent of subjects progressing to the more advanced UB class) was monitored by UB, repeated every year. In the nontreated HLS, the ROP was higher (p

Study Type – Therapy (RCT) Level of Evidence 1b OBJECTIVE To assess the effects of a complex plant extract (Prelox®, a formulation of pine bark extract and l-arginine aspartate; Horphag Research UK Ltd, London, UK) on erectile dysfunction (ED) in men, as sexual desire typically persists in ageing men, while their erectile and endothelial function gradually declines. PATIENTS AND METHODS In this double-blind, placebo-controlled study we assessed the effects of Prelox in 124 patients (aged 30–50 years) with moderate ED over an investigational period of 6 months. The International Index Of Erectile Function (IIEF) was used to quantify changes in sexual function. RESULTS The erectile domain of the IIEF (questions 1–5 plus 15) improved with Prelox from a baseline mean (sd) score of 15.2 (6.6) to 25.2 (2.1) after 3 months and 27.1 (2.1) after 6 months of treatment. In the placebo group there was an increase from a baseline score of 15.1 (7.0) to 19.1 (3.0) and 19.0 (3.1) after 3 and 6 months, respectively. The effects with Prelox were statistically significant compared with placebo (P < 0.05). Mean (sd) total plasma testosterone levels increased significantly from 15.9 (2.3) to 18.9 (2.6) nmol/L (P < 0.05) after 6 months with Prelox, compared to an increase from 16.9 (2.4) to 17.3 (2.3) nmol/L in the placebo group. CONCLUSION This study shows that Prelox is effective for improving erectile function, and that this effect persists on continuous therapy for up to 6 months. Moreover, there is some evidence that erectile function continues to improve the longer the therapy is used.

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.

A public change to healthier lifestyles with more physical activity and better nutrition, including caloric restriction, is required to address the obesity epidemic. Weight loss can be achieved by caloric restrictions; current research suggests that this may be achieved by consumption of slowly absorbed carbohydrates owing to the resulting prolonged satiety. Our rationale was to prolong the satiety of overweight volunteers by supplementation with a proprietary formulation Glucaffect which delays absorption of carbohydrates. Glucaffect provides potent alpha-glucosidase inhibitors of herbal source such Pycnogenol, Madeglucyl and various others which obstruct absorption of carbohydrates, such as starch. Fifty overweight subjects received either Glucaffect or an inactive control product for eight weeks. Consumption of Glucaffect was found to statistically significantly lower blood-fasting glucose from baseline 145.3 mg/dL to 101.1 mg/dL (-30.4%) and Hba1c from 7.59% to 6.33% as compared to the control group where values decreased only marginally. The weight and the body mass index (BMI) decreased significantly from an average of 88.5 kg (BMI 26.8 kg/m2) to 81.3 kg (BMI 24.5 kg/m2) as compared to the control group. In conclusion, Glucaffect enabled subjects with metabolic syndrome to achieve healthy BMI and blood glucose levels. Glucaffect was well tolerated and no subject dropped out.

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. Subjects who completed five years of treatment were considered in the analysis. Blood parameters, liver and renal function tests, microalbuminuria (in diabetic patients) and cholesterol levels were evaluated to assess the effects of HR treatment. Four groups were studied – group A (98 patients) received oral HR (1500 mg per day), group B (87 diabetic patients with CVI) was treated with 2 g of HR per day, group C (90 controls, including 42 diabetic patients) had no pharmacological treatment and group D (113 patients, including 48 diabetic patients) used elastic stockings. No significant negative changes in blood parameters were recorded at two and five years. Decreases in microalbuminuria and total cholesterol, and an increase in high-density lipoprotein cholesterol were observed in HR-treated patients, particularly in diabetic patients. Minimal (nonsignificant) variations were observed in the groups that did not use HR. In conclusion, HR treatment is safe, and some positive effects from HR on cholesterol levels and microalbuminuria (in diabetic patients) that were previously observed may suggest potential new clinical applications.

This study investigated the efficacy of isotonic bioflavonoid supplementation, OPC-3 on 61 individuals presenting with risk factors meeting the criteria for metabolic syndrome. Subjects were supplemented with a proprietary isotonic bioflavonoid OPC-3 or placebo over 2 months. Plasma oxidative stress status was significantly lowered by 10.1% with OPC-3. All major cardiovascular risk factors were improved with blood pressure, total cholesterol, and fasting blood glucose lowered. OPC-3 significantly improved endothelial function as evaluated by increased vasorelaxation in reactive hyperemia and enhanced diastolic carotid artery flow. Cardiac ultrasound scanning revealed a significant increase of left ventricular ejection fraction. Skin microcirculation was enhanced, and better tissue perfusion led to significantly increased transcutaneous oxygen partial pressure and decreased pCO2. With OPC-3 a dramatic and significant plasma C-reactive protein decrease by 52.1% occurred. Individuals may improve key cardiovascular risk factors by daily supplementation with the bioflavonoid OPC-3 as an important part of a healthier lifestyle.

This independent prospective controlled trial evaluates the efficacy of O-(β-hydroxyethyl)-rutosides (HR) during 5 years of administration against signs and symptoms and further degeneration of microcirculatory disturbances. The protective effect of HR in preventing end-point complications such as venous ulceration is evaluated. This study is based on evaluation of edema and the capillary filtration rate (CFR) in association with a clinical score scale. Patients having a severe degree of chronic venous insufficiency (CVI) and venous microangiopathy and completing at least 5 years of treatment are included. The following 4 groups are considered: group A (patients with CVI but without diabetes mellitus, receiving 1500 mg/d of HR), group B (patients with CVI and diabetes mellitus, receiving 2 g/d of HR), group C (control subjects receiving no pharmacologic or compression treatment), and group D (patients using elastic compression stockings only). All patients received the “best” available treatment. No adverse effects or intolerance is noted, with good compliance (>85%). In group A, there is a statistically significant decrease in the CFR during 5 years of follow-up. In group B, the decrease in the CFR is greater than that in group A. Reductions in edema, swelling, and the CFR during 5 years are notable, and values approach normal levels. During 5 years, HR is effective in treating venous edema and hypertension and in preventing deterioration of the distal venous system. The prevention of ulcerations with HR is another important observation. The effects of HR seem to be partially dose related, and tolerability and compliance are good.