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Background: Several mortality waves (between 1 to 5) have been observed over time in the 47 European countries. Material and Methods: The data on mortality rate shown on the WHO dashboard were used, and twelve LEEDELS variables (life expectancy, ecological, economic, demographic and lifestyle) during the period between March 2020 and September 2021. WMVs (weighted median values) were used to calculate the mortality rates and their respective waves. The partition model was used to identify which LEEDELS variables correlated with the mortality rates (predictors). Results: In the partition model four LEEDELS predictors were considered relevant: number of cars per 103 inhabitants, GDP, percentage of population over 65 years old, and life expectancy. The remaining eight LEEDELS variables (total population aged over 65 years old, population density, urban population, education expenditure, number of hospital beds, particulate matter, number of mobile phones, and number of internet connections) were irrelevant. The analysis revealed four pathways (from P1 to P4), which limit or increase the WMVs respectively. The P3 pathway was shown to be at the highest risk of death while P1 was more protective. Conclusions: High GDP, a high percentage of the population over 65 years of age and life expectancy are crucial for WMV containment, represented by P1. The pathway P3, characterized by high GDP, low percentage of population over 65 is at higher risk. Population density, particulate matter, number of hospital beds and expenditure on education, cell phone x 103 inhabitants were not found to be causal variables.

Background: in the 47 European countries the vaccination against COVID-19 started between December 2020 and January 2021. However, the first wave (W1) was controlled without any vaccine administration Objective: to analyze the effect of vaccines on COVID-19 deaths rates, comparing the W1 with last wave (W2) Methods: deaths rates from March 2, 2020, up to May 10, 2021, were recorded from WHO dashboard The same was for the vaccine doses administered up to the May 9-11, 2021. The trends of the deaths during W1 were followed for 5 weeks after the peak (6 values), while for the W2 the last 6 weeks from April 5 to May 10, 2021 were considered. Results: the vaccination coverage was between

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

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&reg, 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 &ldquo, G. d&rsquo, Annunzio University&rdquo, 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 &plusmn, 1.31 and 3.0 &plusmn, 1.44 and 1.4 &plusmn, 1.48 and 2.4 &plusmn, 0.99 for aldiamed&reg, 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.

A ‘war’ consensus document has been produced by a group of clinical research physician on the pandemics with special...

The objective of this clinical study is to evaluate possible interactions between antiplatelet agents, anticoagulants, thyroid hormone replacement therapy and a formulation of curcumin (Meriva®) that resulted effective for the complementary treatment of osteoarthritis.Interaction between antiplatelet agents and Meriva® was evaluated by measuring anti-platelet activity with the in-vivo bleeding-time (BT) in patients assuming acetylsalicylic acid or ticlopidine or clopidogrel from at least 2 years. The BT was evaluated before and after 10 days of supplementation with Meriva®. The interaction between anticoagulants and Meriva® was evaluated in patients using warfarin or dabigatran for previous venous thrombosis. The INR level was evaluated before and after 10 days of supplementation with the curcumin formulation. Thyroid function tests in hypothyroid patients using LT4 replacement therapy (Eutirox®) were evaluated before and after 15 days of supplementation with Meriva®. Similarly, levels of glycemia and glycated hemoglobin were evaluated in diabetic patients in treatment with metformin, before and after 10 days of supplementation with the studied product.After 10 days of supplementation with Meriva® the average BT value was not significantly different for patients assuming acetylsalicylic acid, ticlopidine or clopidogrel at standard dosages. Similarly, after 10 days of Meriva® treatment, the INR level in the two groups of patients assuming warfarin or dabigatran was not statistically different from that observed at baseline. In the analyzed patients assuming LT4 or metformin, no interactions between the therapy and Meriva® were observed.Results from this non-interaction clinical study suggest that Meriva® does not interfere with the antiplatelet activity of the most common antiplatelet agents nor alters the INR values in stable patients assuming warfarin or dabigatran. Similarly, dosages of LT4 or metformin do not need to be adjusted in case of complementary treatment with Meriva®.

Supplementation with Mirtogenol® improves the retinal microcirculation and reduces intraocular pressure (IOP) in ocular hypertension, when administrated either alone or in association with an ophthalmic solution (latanoprost). In this study, microcirculatory parameters (perfusion of the circle of Zinn-Haller and retinal circulation) and oxidative stress were tested to assess the effects of Mirtogenol® plus traditional antihypertensive drugs in patients with elevated IOP.88 otherwise healthy patients with increased IOP were followed-up in a supplement registry for 12 weeks. Three groups received; (a) dorzolamide-timolol plus Mirtogenol®; (b) latanoprost drops plus Mirtogenol® or (c) latanoprost only. Oral supplementation consisted of two tablets/day of Mirtogenol® (80 mg of bilberry extract, Mirtoselect® plus 40 mg of Pycnogenol®). IOP, retinal blood flow, perfusion of the circle of Zinn-Haller, and oxidative stress were measured during the registry period.The three study groups were comparable; IOP and ocular blood flow velocity at inclusion were also comparable. Over the study period the decrease in IOP and the improvements in retinal microcirculation were statistically significant for all management groups, with a marginally more evident benefit in Mirtogenol®+latanosprost-treated patients. At 12 weeks, the altered perfusion at the circle of Zinn-Haller was improved in all groups; patients using Mirtogenol® showed a better perfusional pattern compared with subjects using only latanoprost. A reduction in oxidative stress was observed in supplemented subjects at the end of the study period; no significant change was seen in non-supplemented patients. All managements were well-tolerated without side effects.Supplementation with Mirtogenol®, in addition to local ophthalmic treatments, is safe and may contribute as a supplementary management to reach a normal IOP and ocular microcirculatory parameters.

The aim of this registry study was to compare products used to control symptoms of CVI. Endpoints of the study were microcirculation, effects on volume changes, and symptoms (analogue scale). Pycnogenol, venoruton, troxerutin, the complex diosmin-hesperidin, Antistax, Mirtoselect (bilberry), escin, and the combination Venoruton-Pycnogenol (VE-PY) were compared with compressions.No safety or tolerability problems were observed. At inclusion, measurements in the groups were comparable: 1,051 patients completed the registry. Best performers: Venoruton, Pycnogenol, and the combination VE-PY produced the best effects on skin flux. These products and the combination VE-PY better improved PO2 and PCO2. The edema score was decreased more effectively with the combination and with Pycnogenol. Venoruton; Antistax also had good results. Considering volumetry, the best performers were the combination PY-VE and the two single products Venoruton and Pycnogenol. Antistax results for edema were also good. The best improvement in symptoms score were obtained with Pycnogenol and compression. A larger decrease in oxidative stress was observed with Pycnogenol, Venoruton, and with the VE-PY combination. Good effects of Antistax were also observed. Parestesias were lower with Pycnogenol and with Antistax. Considering the need for interventions, the best performers were Pycnogenol, VE-PY, and compression. The efficacy of Pycnogenol and the combination are competitive with stockings that do not have the same tolerability in warmer climates. A larger and more prolonged evaluation is suggested to evaluate cost-efficacy (and non-interference with drugs) of these products in the management of CVI. The registry is in progress; other products are in evaluation.

Recently, cranberry extracts have been tested as a nutritional supplementation in the prevention of lower urinary tract symptoms (LUTS) as well as recurrent urinary tract infections (UTIs) in subjects at risk, with mixed results. However, evidence of efficacy should be considered only for well-characterized and standardized products in a more selected study population. Moreover, the efficacy of these interventions in elderly must be further investigated. The aim of this pilot, registry study was to evaluate the prophylactic effects of an oral supplementation containing a highly concentrated and standardized cranberry extract reproducing the natural total profile of cranberry fruits, in elderly men with benign prostatic hyperplasia (BPH), suffering from recurrent UTIs, over a 2-months follow-up.43 men (age65 years) enrolled in this study freely decided to receive either a standard management (SM) only (n = 21) or SM associated with an oral supplementation (n = 23). Supplementation consisted in a daily administration of one capsule containing cranberry extract (Anthocran®) for 60 consecutive days. The clinical effectiveness in the prevention of UTIs was determined by the number of UTIs in the two months before the inclusion in the registry and during the supplementation period, and the number of symptom-free subjects during the registry period. Safety considerations were also performed.In the supplemented group, the mean number of UTI episodes reported during the registry (0.8 ± 0.5) significantly decreased compared with inclusion time (3.2 ± 1.3), p-value = 0.0001. No significant changes were observed in control, SM-only group. Importantly, the cranberry oral supplementation was superior over SM at reducing the mean number of UTIs (p-value = 0.0062).These results suggest that cranberry supplementation could be an effective and safe approach, within an SM program, for the prevention of recurrent UTIs in elderly men suffering from BPH avoiding some antibiotic treatments.

Knee Osteoarthritis (OA) is a chronic disease caused by the deterioration of cartilage in joints, which results in activation of the inflammatory response, pain, and impaired movement. Complementary therapies, particularly supplementation, in the management of moderate/severe knee OA have been gaining attention. This registry study aimed at evaluating the synergistic effect of Movardol®, a supplementation containing active ingredients with recognized anti-inflammatory activities on symptoms and levels of circulating biomarkers of knee OA.54 subjects with symptomatic, moderate knee OA freely decided to follow either a standard management (SM) (n = 26) or SM plus oral supplementation with Movardol® (n = 28). Movardol® supplementation containing N-acetyl-D-glucosamine, ginger, and Boswellia Serrata extract was taken at the following dosage: 3 tablets/day for one week and then 2 tablets/day. Several parameters were assessed at inclusion and after 1, 3 and 6 months: functional impairment by the Karnofsky Performance Scale Index; pain, stiffness, physical, social and emotional functions by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC); total and pain-free walking distance; circulating biomarkers of inflammation and oxidative stress.Significant improvements in the functional outcomes and pain-free walking distance were observed after 1, 3 and 6 months in OA patients supplemented with Movardol®. Moreover, all the signs/symptoms of disease assessed by the WOMAC tended to regress over a 6-month period in patients following SM+supplementation. Inflammatory markers and plasmatic content of reactive oxygen species decreased over 6 months, in supplemented patients. Movardol® supplementation resulted to be safe and well tolerated, also showing the beneficial effect in term of a decrease in pharmacological and non-pharmacological treatments and, consequently, reduction in management costs.These preliminary results indicate the efficacy and safety of Movardol® supplementation in the management of moderate knee OA.

Impairment of the peripheral microcirculation in diabetic patients often leads to severe complications in the lower extremities, such as foot infections and ulcerations. In this study, a novel aescin-based formulation has been evaluated as a potential approach to prevent skin breaks and ulcerations by improving the peripheral microcirculation and skin hydration.In this registry study, 63 patients with moderate diabetic microangiopathy were recruited. Informed participants freely decided to follow either a standard management (SM) to prevent diabetic foot diseases (n = 31) or SM associated with topical application of the aescin-based cream (n = 32). Peripheral microcirculatory parameters such as resting skin flux, venoarteriolar response and transcutaneous gas tension were evaluated at inclusion and after 8 weeks. In addition, several skin parameters of the foot area, such as integrity (as number of skin breaks/patients), hydration and content of dead cells were assessed at the defined observational study periods.Improvements in cutaneous peripheral microcirculation parameters were observed at 8 weeks in both groups; however, a remarkable and significant beneficial effect resulted to be exerted by the aescin-based cream treatment. In fact, the microcirculatory parameters evaluated significantly improved in the standard management + aescin-based cream group, compared with baseline and with the standard management group. Similar findings were reported for skin parameters of the foot area.The topical formulation containing aescin could represent a valid approach to manage skin wounds and prevent skin ulcerations in patients affected by moderate diabetic microangiopathy.

Several experimental studies and clinical trials support the potential of bilberry (Vaccinium myrtillus L) extracts in promoting eye health and circulation. Many active ingredients have been isolated from the berries and leaves of the bilberry plant. However, anthocyanins represent the most widely studied bioactive compounds in this plant.The aim of this registry, supplement study was to evaluate the effects of Mirtoselect® (standardized in 36% anthocyanins and obtained by an industrial extraction process that preserves the full range of the non-anthocyanin components, mainly natural sugars and polyphenols) in different types of retinal vasculopathies. In total, 140 patients with different types of retinopathy spontaneously decided to join one of the following groups: standard management (SM) only (n=38); SM associated with Mirtoselect® supplementation (n=47); SM associated with a generic bilberry extract supplementation (n=55). Retinal circulatory parameters and flow measurements of the retinal vessels were evaluated at the inclusion and after 6-months supplementation.Overall, significant improvements in several retinal circulatory parameters such as retinal blood flow velocity, with respect to the values at inclusion, were observed in both supplementation groups, especially in Mirtoselect® supplementation group. However, at 6 months, inter-group comparison revealed a statistical advantage in all tested parameters for Mirtoselect® supplementation groups. No side effects or tolerability concerns were reported.Our registry study suggests that Mirtoselect® supplementation could represent an effective and safe integrated approach for the treatment of different retinopathies.

Endoscopic laser-Doppler flowmetry was used to evaluate the mucosal skin blood flow in the terminal part of the sigmoid colon in 7 patients with ulcerative colitis and in 8 normals subjects. In total, 229 observations were made. A MUSK (mucosal-skin blood) flow index was obtained that was able to differentiate the normal from abnormal mucosa and areas with different endoscopic characteristics.

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

This 12-month product registry study evaluated the effects of supplementation with French pine bark extract (Pycnogenol(®)) on cognitive function, attention, and mental performance in healthy subjects with high oxidative stress.Healthy subjects (age range 55-70) were screened - within a cardiovascular screening program - for oxidative stress. Out of 150 subjects, high oxidative stress was present in 44; the use of the supplement Pycnogenol(®) was suggested (100 mg/day). These subjects decided to use Pycnogenol(®) and accepted to be evaluated by assessing cognitive functions. A group of subjects with comparable oxidative stress was followed as a reference. IQ Code (Informant Questionnaire on Cognitive Decline in the Elderly), daily tasks, cognitive function, oxidative stress and the short Blessed tests (SBT) were used (in defined scales) to evaluate cognitive functions (COFU).As for the IQ Code, at 12 months there was a significantlty total lower score in Pycnogenol(®) patients and also a lower value (P0.05) for 14 out of 16 items in the questionnaire. Daily tasks: all items were improved (P0.05) with supplementation in comparison with controls. The improvement was seen for all 12 items (P0.05) with the supplement. Cognitive function values (visual scale line) indicated a significant improvement (P0.05) in all elements present in the questionnaire with the 12-month supplementation (no significant variations in controls). Oxidative stress was comparable in both groups at inclusion. It was significantly decreased with Pycnogenol(®) (-28.07%; P0.05) at 12 months; there was no decrease in controls. The short blessed test (SBT) value was significantly increased in controls (P0.05); but significantly decreased in the Pycnogenol(®) group (P0.05). Values for supplemented patients at 12 months were almost within the normal range (21 out or 38 were below the normal value of 4). Tolerability and compliance for Pycnogenol(®) were optimal with97% of the doses of the supplement correctly used. No side effects were observed, recorded or described.Pycnogenol(®) supplementation for 12 months appears to improve cognitive function and oxidative stress in normal subjects between 55 and 70 years of age.

The aim of this registry study was the evaluation of possible benefits of a supplement including CoenzymeQ10 and a grape seed combination (MiraQule C, Alchem) in stable, moderate, heart failure patients.The mean age of the 18 supplemented patients was 60.1;2 years (the age of the 22 controls was 61.1;2.2). The two groups were comparable. There were no dropouts in the two groups. In the 8 weeks of the registry, all supplemented patients remained in the NYHA class while 7 out of 22 in controls increased the level of heart failure passing into Class III. Systolic- diastolic pressure, heart rate, respiratory rate were minimally (non significantly lowered) with the supplement without differences controls. Ultrasound-derived ejection fraction was increased by supplementation (median of 2.7%) in the CoQ10 group (p0.05) while there were minimal, non- significant differences in controls. Walking distance on treadmill was also significantly increased with the supplement (p0.05) and only marginally in controls. The microcirculation (laser Doppler parameters and transcutaneous PO2, PCO2) improved significantly in the MQ-C group (p0.05) and only marginally in controls. Oxidative stress was significantly decreased (p0.05) with the CoQ10 preparation while there were minimal. Non-significant changes were observed in in controls. Tolerability and compliance were optimal (with more than 95% of the capsules correctly used). In conclusion in this supplement registry Miraqule-C seem to help patients with moderate heart failure and should be considered for larger studies.

This registry study assessed the pharma-standard supplement FlexiQule (Boswellia extract in capsules) in the management of symptoms associated to osteoarthritis (OA) also managed with the 'standard management' (SM) in comparison with a group of patients managed only with SM. The 12- week registry included patients with symptomatic knee arthrosis. They were able to walk on a treadmill for a walking test and to complete the WOMAC questionnaire.32 patients used the supplement and 34 acted as controls (SM). No safety problems were observed. At 12 weeks, the Karnofsky scale was significantly improved in both groups: the variation was higher (p0.05) in the supplement group. The WOMAC score was decreased significantly more in the supplement+SM group in comparison with controls considering pain, stiffness and physical functions (p0.05). For social and emotional functions the decrease in score was also more evident in the supplement group (p0.05). Both groups improved in pain-free and total walking distance at 12 weeks. Pain-free walking distance (treadmill) was higher (p0.05) with the supplement (from 93.4;11.6 m to 271.3;19.3 m) than in controls (from 90.5;13.5 m to 158.3;22.3)(p0.05). The improvement in total walking distance was also higher in the supplement group (p0.05) (from 164.3;23.2 to 322.3;22.3 m) in comparison with the SM- only group ( from 158.3;18,4 to 240.2;19.3 m). The need for concomitant drugs and medical attention during the registry was reduced more in the supplement group (p0.05). In conclusion the difference between SM and the Flexiqule+SM was in favor of the management with the supplement for all target measurements. The product is safe and well tolerated.

Mild, temporary hepatic failure (MTHF) after chemotherapy is a common clinical problem; in case of repeated episodes MTHF may cause chronic impairment. This registry has evaluated post- chemotherapy (PC)-MTHF in subjects using Liverubin (standardized Silymarin) for 8 weeks (3 capsules/day).PC-MTHF was evaluated in a registry study. Hepatitis markers were negative at inclusion and at end-registry. In the final registry there were results concerning 18 Liverubin-supplemented patients and 19 controls completing the 8-week period. Signs/symptoms. The distribution of the most common symptoms and signs with ultrasound scans were comparable. Symptoms were mostly minimal or subclinical. Most symptoms observed at inclusion were completely disappeared or greatly attenuated after 8 weeks. The improvement produced by Liverubin induced a better and faster disappearance of symptoms. The results of the blood tests (at inclusion and at 8 weeks showed the increase in albumin, significantly (P0.05) faster with the final values higher in the supplement group. Total bilirubin was reduced with the supplement better than in controls (P0.05). Direct bilirubin values improved more in the supplement (P0.05) group. The decrease in SGPT and AST-ASAT was more evident with the supplement (P0.05). Improvement in controls was more limited. Alkaline phosphatase was significantly lower (than in controls) with Liverubin at 8 weeks (p0.05). Gamma GT also decreased more and faster with the supplement. The ESR (erythrocytes sedimentation rate) was decreased in both groups, more in the Liverubin group (P0.05). There was a more limited decrease in controls with persisting higher values at 8 weeks. The white cell count was also better at 3 months (with a larger decrease with the supplement; P0.05). Oxidative stress. Plasma free radicals (PFR) were elevated in both groups at inclusion. A more significant decrease in the supplement group was observed at 8 weeks. Persisting elevation in values was seen in controls (P0.05). Platelets values improved better with Liverubin (P0.05). Safety and tolerability were optimal (no side effect was registered). In conclusion, results from this pilot registry indicate a significant activity of Liverubin associated with a very good safety profile, in patients with post-chemotherapy hepatic failure. The recovery of hepatic function is faster and more effective with Liverubin in comparison with the best "standard" management.

The aim of this registry was to evaluate the management of initial symptoms of benign prostatic hyperthrophy (BPH) in otherwise healthy subjects, using Prostaquil® (Alchem) in a 8-week registry. Prostaquil was used at the dosage of 200 mg/day. The product includes Pygeum extract (100 mg) and Saw palmetto oil (35 mg). The two resulting groups standard management and supplement) were comparable.No side effects or comparability problems were observed and compliance was optimal with more than 95% of the capsules correctly used. Empting, frequency, intermittency, urgency, weak flow, straining, nocturia were all significantly improved with Prostaquil (p0.05) and the improvement - globally and evaluating any single item - was significantly superior to the one observed in controls (p0.05). Quality of life with the supplement was also significantly better in comparison with controls (p0.05). The residual vescical volume was 94.7;5,8 ml in the supplement group at inclusion and decreased to 39.3;5 ml (p0.05) at 8 weeks. This decrease was equivalent to a reduction of 58.5%(vs a decrease of 27.9% in controls)(p0.05; ANOVA). In conclusion, the most common symptoms of BPH are controlled by Prostaquil a new standardized supplement including Pygeum.

This case report (supplement registry study) evaluated subjects with painful 'stress' arthritis of the hand mainly localized at the joints. The patients received a suggestion to follow a rehabilitation plan (standard management; SM). A second group also used the same SM in association with the oral, pharma-standard supplement FlexiQule (Alchem) a new standardized, phytosomal preparation manufactured from the Boswellia plant, which can be used for self-management in inflammatory conditions (150 mg / 3 times daily). The two resulting registry groups included 12 subjects using SM+Flexiqule and and 11 controls (SM only). The groups were comparable. Serology showed no significant alterations: only ESR was slightly elevated (minimal elevation). After 2 weeks, the ESR was normal in the supplement group and mildly elevated in controls (p0.05%). The decrease in hypertermic areas was greater/faster (p0.05) in the supplement group. The identification of a working stress and the localization to the dominant hand was comparable in both groups. At 2 weeks, the decrease in pain was significantly faster and more important with the supplement (p0.05). The hand became more usable in time and the score was better with the supplement (p0.05). No supplemented patient had to use other drugs, while in the control group 3 subjects eventually used NSAIDs to control pain and stiffness and one used corticosteroids. In conclusion, the natural extract Flexiqule was effective in controlling work-related stress arthritis (without inflammaìtory signs) over a 2 weeks period, better than only Standard Management. More prolonged and larger studies are needed.

The aim of this supplement, registry study was to evaluate the effects of the use of standardized, oral supplement (Phyto-Relief CC, Alchem). Phyto-Relief CC includes anti-inflammatory, anti-oxidant and anti- edema natural compounds. Increased salivation produced by ginger is useful in the prevention of cold episodes and on signs and symptoms associated to the episodes by increasing saliva and its content (i.e. lysozyme). Main targets of the study were the evaluation of the occurrence of episodes and the reduction of signs/symptoms, the reduction of days of disease, the reduction in the use of other treatments and the control of cold-related complications.The two resulting registry groups were comparable. There were 5 full episodes (lasting at least 3 days) of cold in 61 registry subjects (8.1%) in comparison with 17 cases in 63 subjects (26.98%) in controls. Phyto-Relief CC subjects - even in this time-limited and small study population registry - had 30.1% of the episodes of the control group with a reduction of 69.88% of the cold episodes (p0.0221). Also in the following, continuation, third week only 3 episodes of cold were recorded in the Phyto- Relief CC group vs 6 (50% reduction) observed in controls. All the other chosen parameters were better in the supplement group (p0.05). Affected days (2.9;1.1 vs 4.6; 1.2 in controls), lost working days (0.58;0.5 vs 1.02;0.43 in controls. The use of any other OTC product, nasal drops, aspirin, Vit C, antihistamines, aerosols, the number of complications after 4 days were better in the Phyto-Relief CC group. Disease 'extension' (to4 days), particularly tracheal and bronchial extension were significantly less frequent (p0.05) with the supplement. No safety or tolerability problem was observed. In conclusion this preliminary study shows that Phyto-Relief CC may help the evolution of cold if used early, when initial symptoms could be identified. More specific evaluations and larger prevention studies are needed.

The aim of this registry study was to evaluate the effects of supplementation with Robuvit® (Quercus robur wood extract, or "QR") on performance and endurance in triathlon by evaluating amateur athletes in a period of 2 weeks of training. Supplementation with QR may improve training efficiency (by decreasing post-triathlon, muscular pain, cramps and by improving recovery time). Robuvit® should decrease post-training plasma free radicals (PFR).Sixty-one subjects (age range 30-40) were included in the study. Subjects followed a free diet. An isotonic saline drink was suggested to all subjects.After 2 weeks there were 27 subjects using the supplement and 27 without supplementation. The groups were comparable. All subjects improved in training considering the 3 events (swim, biking, run). The improvement was greater with Robuvit® (P0.05) for the swim and biking (P0.05); the running time decreased by 12.32% in subjects using Robuvit® (3.6% in controls; P0.05). The improvement the total triathlon time was -10.56% with Robuvit® in comparison to -3.41% in controls.no side effects or tolerance problems were reported; all QR capsules were used as indicated.In conclusion, the -10.56% shorter total trioathlon time was considered as very good improvement, considering that for this type of athletes being almost at the top of their form it is difficult to improve even further without severe training. Training was considered better (on an analogue scale) in the QR group (P0.05). Postrun muscular pain, cramps, localized pain, straining and the recovery time, were all considered better with QR (P0.05). Plasma free radical (PFR) values 1 hour after the final run were, on average,16.98% higher in controls (P0.05), indicating a higher level of oxidative stress. Higher levels of PFR are associated with a slower recovery. All routine blood tests were normal at inclusion and after the final triathlon. After the final test run triathlon athletes using QR had a lower increase of UBR and LDH (indicator of hemolysis). These two tests were significantly increased in controls (P0.05) but not in the Robuvit® group. Robuvit® supplementation improved training, results and decreased hemolysis.

Mild, temporary hepatic failure (MTHF) is a common clinical problem; in case of repeated episodes MTHF may cause chronic liver impairment. This registry has evaluated MTHF in subjects using Liverubin (standardized Silymarin) for 8 weeks.MTHF was evaluated in a registry study. In all subjects viral hepatitis markers were negative at inclusion. Different possible causes of MTHF had been considered. In these subjects alcohol was not a main factor. The registry included MTHF patients with decreased albumin levels, increased total bilirubin, altered hepatic function enzymes, increased oxidative stress. Two management groups were created: a standard management (SM) group and a SM+Liverubin group; 32 Liverubin patients and 33 SM subjects completed the registry. Liverubin was used at the dosage of two tablets (each equivalent to 140 mg) daily.Distribution of symptoms, blood test values and ultrasound results were comparable. Symptoms observed at inclusion disappeared at 3 months in both groups. The increase in albumin levels was significantly (P0.05 at 4 weeks) faster and the final blood tests improved more with Liverubin. Total bilirubin was reduced with the supplement (better than in controls; P0.05). Direct bilirubin values improved more in the supplement group at 3 months (P0.05). The decrease of SGPT and AST- ASAT was more evident in the supplement group (P0.05). Alkaline phosphatase value was normalized at in Liverubin patients; values decreased less in controls (P0.05). Gamma GT decreased more with Liverubin. ESR was decreased in both groups (significantly more with Liverubin: P0.05). There was a less important decrease in controls at 3 months. The white cell count was also better with the supplement group; P0.05). Plasma free radicals - significantly elevated in both groups at inclusion - decreased more with the supplement at 3 months. All other blood tests (including hematocrit, renal function tests) were within the normal range at inclusion and at 3 months in both groups. Hepatitis markers were negative at inclusion and at end-registry. Safety and tolerability were optimal (no side effect was registered).In conclusion, data from this pilot, registry study indicate a significant activity of Liverubin associated with a very good safety profile, in patients with temporary hepatic failure. The recovery of hepatic function is faster and more effective with Liverubin compared to the best "standard" management.

Mild, temporary hepatic failure (MTHF) may be completely asymptomatic or cause minimal signs and symptoms. This common clinical problem is very diffuse and, in case of repeated episodes may cause a chronic impairment in liver function. The aim of this registry was to evaluate the evolution of MTHF in subjects using Liverubin (a new standardized Silymarin preparation) over a 4-week period.Patients with MTHF were observed in a registry study. In all subjects viral hepatitis markers were negative at inclusion. Different possible causes of MTHF had been considered, documented or excluded. The role of alcohol was mainly as a "facilitator" and not definitely determinant as a single factor in causing the MTHF episode. The registry included patients with MTHF characterized by: decreased albumin levels; increased total bilirubin; altered hepatic functions enzymes; increased oxidative stress. Two management groups were created: a. standard management (SM) only; b: SM and Liverubin; 25 Liverubin patients and 23 SM subjects completed the registry. The average follow-up period was 32.2;1.3 days in the supplement group and 32.1;2 days in controls.The distribution of symptoms and ultrasound results were comparable. Most symptoms observed at inclusion were disappeared or attenuated at 4 weeks in both groups. At inclusion, the values in the two groups were comparable. The increase in albumin levels was significantly (P0.05 at 4 weeks) faster and the final values were higher in the Liverubin group. Total bilirubin was reduced in the supplement group better than in controls (P0.05). Direct bilirubin values improved more in the supplement group at 4 weeks (P0.05). The decrease of ALT-SGPT and AST-ASAT was more evident in the supplement group (P0.05). Improvement in controls was more limited. Alkaline phosphatase value was normalized at 4 weeks in Liverubin patients; values decreased less in controls (P0.05). Gamma GT decreased and were normal at 4 weeks with Liverubin. ESR was decreased in both groups (significantly more in the Liverubin group: P0.05). There was a less important decrease in controls without normalization at 4 weeks. The white cell count was also better at 4 weeks in the supplement group; P0.05). Plasma free radicals were significantly elevated in both groups at inclusion. A more significant decrease in the supplement group was observed at 4 weeks. Persisting, elevated values were seen in controls (P0.05 in comparison with normal range). Platelets values improved in the Liverubin group (P0.05) better than in controls. All other blood tests values (including hematocrit, renal function tests) were within the normal range at inclusion and at 4 weeks in both groups. Hepatitis markers were negative at inclusion and at 4 weeks. Compliance. Ninety-six percent of the Liverubin capsules were correctly used. Safety and tolerability were optimal (no side effect was registered).In conclusion, data from this pilot, registry study indicate a significant activity of Liverubin associated with a very good safety profile, in patients with temporary hepatic failure. The recovery of hepatic function is faster and more effective with Liverubin compared to the best "standard" management.

The aim of the present pilot, registry study was an assessment in a supplement study of FlexiQule (standardized Boswellia extract) capsules in the supplementary management of patients with symptomatic knee osteoarthritis (OA) also treated with the "standard management" (SM) in comparison with a group of patients only managed with SM.This 4-week study included patients with symptomatic knee arthrosis (X-ray). Registry subjects were able to perform a treadmill walking test and to understand questions from the WOMAC questionnaire. Exclusion criteria were conditions requiring drug treatment, Body Mass Index25, metabolic disorders, surgery within three months prior to inclusion, oncological condition or inability to walk.Twenty-seven registry subjects using the supplement+SM and 28 using only SM completed the registry; at inclusion, the two groups were comparable including Karnofsky scale, WOMAC Score and the Treadmill Test. Of the subjects completing the registry 24 preferred to use the combination SM and the supplement. Safety evaluation: no problems - indicating the suspension of the supplementation ‑ were observed. Routine blood tests were normal at inclusion and did not significantly vary at 4 weeks. The Karnofski Scale at 4 weeks was improved in both groups: from 74.3;3.1 to 88.9;5.3 (P0.05) in the Boswellia group in comparison with a variation from 75.3;5.2 to 79.4;3.3 (P0.05) in the SM. The effects of the supplement were significantly higher (P0.05). The WOMAC Score was decreased significantly more in the supplement+SM group in comparison with controls considering pain, stiffness and physical functions (P0.05). Social/emotional functions improved better with the supplement (P0.05). Both groups improved their walking distance at 4 weeks. The improvement was higher (P0.05) in the Boswellia group. The need for other drugs or tests during the registry period was reduced more in the supplement group (P0.05).The difference between SM and the supplementation associated to SM was significant) in favor of the supplementation with Boswellia for all target measurements evaluated in the registry at 4 weeks.

The aim of the study was to evaluate the effect of the nutritional supplements Pycnogenol® and total triterpenic fraction of Centella asiatica (TTFCA) on atherosclerosis progression in low-risk asymptomatic subjects with carotid or femoral stenosing plaques.This was an observational pilot, substudy of the San Valentino epidemiological cardiovascular study. The study included 824 subjects aged 45-60 without any conventional risk factors who had a stenosing atherosclerotic plaque (50-60%) in at least one carotid or common femoral bifurcation, allocated into 6 groups: Group 1 (Controls): management was based on education, exercise, diet and lifestyle changes. This same management plan was used in all other groups; group 2: Pycnogenol® 50 mg/day; group 3: Pycnogenol® 100 mg/day; group 4: Aspirin® 100 mg/day or ticlopidine 250 mg/day if intolerant to aspirin; group 5: Aspirin® 100 mg/day and Pycnogenol® 100 mg/day; group 6: Pycnogenol® 100 mg/day plus TTFCA 100 mg/day. The follow-up lasted 42 months. Plaque progression was assessed using the ultrasonic arterial score based on the arterial wall morphology and the number of plaques that progressed and on the number of subjects that had cardiovascular events. A secondary endpoint was to evaluate the changes in oxidative stress at baseline and at 42 months.The ultrasonic score increased significantly in groups 1, 2, and 4 (1%) but not in groups 3, 5 and 6 (1%) suggesting a beneficial effect of Pycnogenol® 100 mg. Considering the percent of patients that progressed from class V (asymptomatic) to VI (symptomatic) there was a progression of plaques in 48.09% of controls. In the Pycnogenol® 100 (group 3, 10.4%) and in the Aspirin®+ Pycnogenol® (group 5, 10.68%) progression was half of what observed with antiplatelet agent (group 4, 20.93%); in the TTFCA+ Pycnogenol®group (group 6) progression was 7.4 times lower than in controls; 3.22 times lower than in the antiplatelet agents group (4). Events (hospital admission, specialized care) were observed in 16.03% of controls; there were 8.83% of subjects with events with Pycnogenol® 50 mg and 8% in group 3 (Pycnogenol® 100 mg). In group 4 (antiplatelets), 8.52% of subjects had events; in group 5, 6.87% of subjects had events and in group 6 (TTFCA+ Pycnogenol®) only 4.41% had events (this was the lowest event rate; P0.05). All treatment groups had a significantly lower event rate (P0.05) in comparison with controls. Considering treatments groups 2, 3, 5, 6 had a lower number (P0.05) of subjects in need of cardiovascular management in comparison with controls. The need for risk factor management was higher in controls and lower in group 6 (P0.05). In groups 2 to 6 the need for risk factor management was lower than in controls (P0.05). Including all events (hospital admission, need for treatment or for risk management) 51.9% of controls were involved. In the other groups there was a reduction (from a -9.28% reduction in group 2 to a -26% in group 6) (P0.002). The most important reduction (higher that in all groups; P0.05) was in group 6. At 42 months, oxidative stress in all the Pycnogenol® groups was less than in the control group. In the combined group of Pycnogenol® and TTFCA the oxidative stress was less than with Pycnogenol® alone (P0.001).Pycnogenol® and the combination of Pycnogenol® +TTFCA appear to reduce the progression of subclinical arterial plaques and the progression to clinical stages. The reduction in plaque and clinical progression was associated with a reduction in oxidative stress. The results justify a large, randomized, controlled study to demonstrate the efficacy of the combined Pycnogenol® and TTFCA prophylactic therapy in preclinical atherosclerosis.

The aim of this study was to investigate the clinical efficacy of oral Pycnogenol® (Horphag Research Ltd, UK) in patients with severe chronic venous insufficiency. Patients with severe venous hypertension (chronic venous insufficiency, ankle swelling) and history of venous ulcerations were treated with Pycnogenol. Patients received oral Pycnogenol (50 mg capsules, 3 times daily for a total of 150 mg daily) for 8 weeks. A group of 21 patients was included in the treatment group and 18 equivalent patients were observed as controls (no treatment during the observation period). All 21 patients (age 53 years; range, 42-60 years; M:F=11:10) in the treatment group completed the 8-week study. Also the 18 controls completed the follow-up period. There were no drop-outs. The average ambulatory venous pressure was 59.3 (SD 7.2; range 50-68) with a refilling time shorter than 10 seconds (average 7.6; SD 3). There were no differences in ambulatory venous pressure or refilling time between the treatment and control patients. The duration of the disease—from the first signs/symptoms—was on average 5.7 years (SD 2.1). At 4 and 8 weeks, in all Pycnogenol-treated subjects, microcirculatory and clinical evaluations indicated a progressive decrease in skin flux, indicating an improvement in the level of microangiopathy; a significant decrease in capillary filtration; a significant improvement in the symptomatic score; and a reduction in edema. There were no visible effects in controls. In conclusion, this study confirms the fast clinical efficacy of Pycnogenol in patients with chronic venous insufficiency and venous microangiopathy. The study indicates the significant clinical role of Pycnogenol in the management, treatment and control of this common clinical problem. The treatment may be also useful to prevent ulcerations by controlling the level of venous microangiopathy.

The aim of this study was to assess the preventive action of Pycnogenol® (Horphag Research Ltd, UK) on cramps and muscular pain in different groups of subjects and patients. The study included a 5-week observation period (4 weeks treatment and one follow-up week after the suspension of treatment) to evaluate the efficacy of Pycnogenol after its withdrawal. Four 50 mg capsules (total dose 200 mg/day) were prescribed with suggestion to drink at least 1.5 liters of water every day. In the first part of the study 66 healthy subjects completed a 5-week follow-up period. The difference between number of cramps attacks recorded within the 2 weeks before inclusion and the number of episodes during the fourth (p

A medicated plaster containing diclofenac epolamine (DHEP) and heparin has been recently proposed for the treatment of local trauma (ie, ankle sprains) accompanied by a clinically significant edema and/or hematoma formation, based on the combined antiinflammatory, hemorheologic, and antiedema properties of diclofenac and heparin. The aim of this study was therefore to compare the effects of a combined DHEP/heparin and DHEP alone in 2 clinical experimental models of microangiopathy, in order to provide a pharmacologic rationale for association of diclofenac and heparin. The microcirculation was evaluated by measuring cutaneous blood flow (laser Doppler) and transcutaneous oxygen and carbon dioxide pressures (TcPO2 and TcPCO2) in 10 healthy volunteers before and after producing 2 microcirculatory models of microangiopathy: the models were based on reactive hyperemia (RH) and on local histamine injection, which both produce a significant increase in skin flux and alterations of TcPO2 and TcPCO2. The area of the study was the distal medial leg, treated with placebo, DHEP alone (Flector Tissugel), and DHEP/heparin (Flector Tissugel Heparin). The plasters were applied before producing the microcirculatory models to evaluate the efficacy of DHEP and DHEP/heparin in controlling and limiting vasodilatation and development of microangiopathy. A significant increase in cutaneous flux was obtained with both models. The application of DHEP partially limited the increase in flux and in TcPCO2, as well as the decrease in TcPO2 (which were considered signs of microangiopathy), but the combination DHEP/heparin was significantly more effective than DHEP alone. The inclusion of heparin in the plaster thus improved the control of the microcirculation achieved with diclofenac alone, when an experimental model of venous/arterial hyperemia and microangiopathy was used. In conclusion, DHEP in association with heparin modulates microcirculatory changes better than DHEP alone. It should be interesting to investigate the product in comparable clinical conditions in which it may be useful to act pharmacologically both on inflammation and microcirculatory disturbances that delay the recovery of patients.

The aim of this study was to evaluate the prevention of edema during long-haul flights with an oral, anti-edema and antithrombotic agent (Pycnogenol®, Horphag, Research Management SA, Geneva, Switzerland) in asymptomatic subjects. The assessment of edema was performed by evaluating an analogue scale, the rate of ankle swelling by strain-gauge derived rate of ankle swelling (RAS), and by assessing the ankle circumference variation. The study included 211 subjects; 169 completed the study (88 in the control group and 81 in the Pycnogenol® group). There were no important differences between the two groups (comparable for age, gender, weight, body mass index, and pattern distribution). The edema score, the RAS, and the circumference at inclusion were also comparable. After the flight in those treated with Pycnogenol®, the edema score was increased only by 17.9% (vs. an increase of 58.3% in the control group) (p® group (age 44.5; SD 8) and in 23 in the control group (age 45; SD 9) was increased on average by 91% in the control group and 36% in the Pycnogenol® group (p® group (11% in the control group; p® on edema during long flights when considering subjective and objective data. No unwanted effects were observed.

Shock waves (SW) are used to control pain in different clinical conditions (eg, painful knee, elbow, and shoulder, etc). The effects of SWs may be due to cellular “stunning” (particularly nervous components). It may also be the consequence of unknown metabolic actions on tissues, which may include changes in cellular permeability, the liberation of proteins and mediators locally acting on pain and nerve endings. The aim of this study was to evaluate the reduction in pain and the improvement in microcirculation induced by SW treatment in a 2-week study in patients with chronic limb ischemia (CLI). Of the 32 patients with CLI, 30 (20 with rest pain only, 10 with necrosis) completed the study. The treatment was well tolerated. Foot radiographs performed before and after treatment indicate no bone damage after treatment. Foot (tibial arteries) blood pressure was unchanged after 2 weeks. The increase in laser Doppler flux was significant (p2) increased (p2) decreased (p

The aim of this independent study was to demonstrate the rapidity of the clinical action of HR 0-(beta-hydroxyethyl)-rutosides, Venoruton® (Novartis Consumer Health) in patients with chronic venous insufficiency (CVI). Two groups of patients with venous hypertension and microangiopathy were treated with HR (1 or 2 g/day, for 8 weeks). Twelve patients (age 56.4; range 44-66; M:F = 6:6) were included in group 1 (1 g/day) (moderate CVI and microangiopathy); 10 patients (age 57.4; range 42-67; M:F = 5:5) in group 2 (2 g/day) with more severe CVI and microangiopathy. Average ambulatory venous pressure (AVP) was 58.6 (range 50-65) with a refilling time (RT) shorter than 10 seconds. There were no significant differences in AVP and RT between the 2 groups, but the duration of the disease was longer in group 2: 3.5 years (SD 2.0) in group 1 and 6.4 years (SD 3.3) in group 2. All included subjects completed the study and no dropouts were observed. In both dose groups there was a progressive decrease in laser Doppler resting flux (RF), indicating improvement in microangiopathy and a significant decrease in capillary filtration (RAS) associated with a significant improvement in analogue scale line score (ASLS) and edema. Although the effect in the 2 g dose group was more rapid on the microcirculatory parameters with a significant effect on RF and RAS after 4 days (effect of 1 g per day after 8 days and 6 days, respectively), there was no difference in the time to onset of a significant clinical improvement (ie, the ASLS and the edema score): 4 days in both groups. Venous microangiopathy and edema were improved by the treatment with HR within a few days. The effects were visible with both dosages, in both severity groups.

The aim of this study was the evaluation of the effects of Aescin + essential phospholipids (AEPL) gel on plasma free radicals (PFRs). In this study, ten patients with venous hypertension, no ulcerations or infections, venous microangiopathy, and varicose veins were treated with topical AEPL applied in a standard protocol. AEPL was applied for 2 weeks, three times daily at the same skin region (perimalleolar internal region at defined distance from the medial malleolus and from the anterior edge of the tibia). In subjects with venous hypertension, PFR values were higher than 420 Carr units. After treatment, the values of PRF decreased to almost normal as an effect of the massage with AEPL gel. The decrease in value was observed in all treatment subjects. A ranking system indicates that the AEPL preparation is active in all subjects who have venous microangiopathy. The decrease in PFR value was greater than 30% in all treatment subjects (p

The aim of this efficacy study was to evaluate the effects of topical aescin + essential phospholipids gel in a histamine model of acute microangiopathy, comparable to microangiopathy observed in chronic venous disease.

The aim of this study was to evaluate the development of edema, and superficial and deep vein thrombosis (DVT) prophylaxis with an oral profibrinolytic agent (Flite Tabs, 150 mg pinokinase, Aidan, Tempe, AZ, USA) in long-haul flights (7-8 hours), in high-risk subjects. A group of 300 subjects was included; 76 were excluded for several problems including concomitant treat ments ; 204 were randomized into 2 groups (active treatment or placebo) to evaluate the effects of prophylaxis with Flite Tabs. An exercise program was used in both groups. The femoral, popliteal, tibial, and superficial veins were scanned with ultrasound before and within 90 minutes after flights. Of the included subjects, 92 of 103 controls and 94 of 101 treated subjects completed the study. Dropouts were due to connection problems. Age, gender, and risk distribution were comparable in the groups. In the treatment group, no DVT was observed. In the control group, 5 subjects (5.4%) had a DVT and there were 2 superficial thromboses (7 events in 92 subjects; 7.6%). At inclusion, edema was comparable in the 2 groups. After flights there was an increase in score in controls (+12%) in comparison with a decrease (-15%) in the Flite Tabs group (the difference in variation was statistically significant). Intention-to-treat analysis for thrombotic events shows 18 failures in controls (11 lost to follow-up + 7 throm botic events) of 92 subjects (19.6%) in comparison with 7 failures (of 94 subjects, equivalent to 7.4%) in the treatment group (p

The study compared, by a prospective, randomized method, 6 treatment options: A: Sclero therapy ; B: High-dose sclerotherapy; C: Multiple ligations; D: Stab avulsion; E: Foam-sclero therapy ; F: Surgery (ligation) followed by sclerotherapy. Results were analyzed 10 years after inclusion and initial treatment. Endpoints of the study were variations in ambulatory venous pressure (AVP), refilling time (RT), presence of duplex-reflux, and number of recurrent or new incompetent venous sites. The number of patients, limbs, and treated venous segments were comparable in the 6 treatment groups, also comparable for age and sex distribution. The occur rence of new varicose veins at 5 years varied from 34% for group F (surgery + sclero) and ligation (C) to 44% for the foam + sclero group (E) and 48% for group A (dose 1 sclero). At 10 years the occurrence of new veins varied from 37% in F to 56% in A. At inclusion AVP was comparable in the different groups. At 10 years the decrease in AVP and the increase in RT (indicating decrease in reflux), was generally comparable in the different groups. Also at 10 years the number of new points of major incompetence was comparable in all treatment groups. These results indicate that, when correctly performed, all treatments may be similarly effective. "Standard," low-dose sclerotherapy appears to be less effective than high-dose sclero and foam-sclerotherapy which may obtain, in selected subjects, results comparable to surgery.

In 20 patients with chronic venous insufficiency and venous hypertension associated with ulcerations, the effects of a new compound, applied onto the skin (Crystacide) were assessed in a randomized, controlled study. Duplex scanning was used to assess the presence of venous obstruction and incompetence, and microcirculatory methods were used to assess and quantify venous microangiopathy and to follow up subjects after local treatment with Crystacide. Laser Doppler flowmetry (LDF) was used to assess skin perfusion in association with transcutaneous (tc) partial pressure of oxygen (PO2) measurements. Local plasma free radicals (PFR) were evaluated in the area surrounding the venous ulcer, with the D-Rom test. Crystacide was applied around and on the ulcer for 10 days. Crystacide was more effective than the control treatment: PO2 was increased, PFR and LDF were decreased (flux increase is associated with venous hypertension), and the ulcer area was significantly smaller at 10 days in the Crystacide group in comparison with the placebo group (p < 0.05). In conclusion, in venous ulcerations, local treatment with Crystacide (10 days) improves the microcirculation and decreases skin free radicals improving healing.

Cranberry extracts have been tested as a nutritional supplementation in the prevention of recurrent lower-urinary tract infections (R-UTIs), with mixed results. This pilot, registry study evaluates the prophylactic effects of oral supplementation with a new well-standardized cranberry extract in patients with R-UTI, over a 2-month follow-up.All subjects were suggested to take one capsule containing a cranberry extract (Anthocran™) for 60 days and were also given lifestyle advice. Clinical outcomes were compared between patients on cranberry extracts and those who don't take this supplementation.In total, 22 subjects completed the study in each of the two groups. In the cranberry group, the reduction in the frequency of UTI episodes during the study period compared with the two months before the inclusion was 73.3% (p0.05). This figure was 15.4% in the control group (p0.05; p = 0.012 vs cranberry group). Seven (31.8%) subjects in the cranberry group were symptom-free; no patient was symptom-free in the control group (p0.05). The mean duration of UTI episodes was 2.5 ± 1.3 days in the cranberry group, compared with 3.6 ± 1.7 days in subjects not on cranberry (p0.05). Three subjects (13.6%) in the cranberry group and 8 (36.3%) in the control group required medical consultation for UTI symptoms (p0.05). Urine evaluation was completely negative in 20/22 subjects in the Cranberry group (90.9%) and in 11 control subjects (50.0%; p0.005). No adverse events were observed.These preliminary results, obtained in a field-practice setting, indicates the effectiveness and safety of a well-standardized cranberry extract in the prevention of R-UTI.

Osteoarthritis (OA) is a major cause of physical disability and impaired quality of life. Non-steroidal anti-inflammatory drugs are the most used treatment for OA, but they are frequently associated to adverse events. Alternative therapies are under investigation for the treatment of OA. Meriva® is a lecithin delivery form of curcumin, a powerful promoter of anti-oxidant response studied in a number of conditions related to chronic inflammation and pain.This 4-month observational study, conducted in a 'real-life' scenario, compares the association of Meriva and glucosamine (n=63) with chondroitin sulphate+glucosamine (n=61) in 124 patients with grade 1-2 OA of the knee.Patients treated with Meriva+glucosamine had significantly higher Karnofsky Index and WOMAC score (both in the physical and emotional domains), compared to those in the chondroitin+glucosamine group. Noteworthy, the walking distance at the treadmill test after 1 month was also significantly higher in the meriva+glucosamine group; this advantage was sustained until the end of the study. Although the need for concomitant drugs and medical attention decreased in both groups, this reduction was more evident for patients treated with Meriva+glucosamine.Taken together, the results of this study shows that the 4-month administration of the association of Meriva and glucosamine can result in a faster onset of action and improved outcomes than the administration of an association of chondroitin sulphate and glucosamine in patients with OA.

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/m2) >30 to 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 aimed to evaluate the use of Pycnogenol® (pine bark extract), an anti-inflammatory, anti-oxidant and anti-edema natural compound, on symptoms of common cold. Main targets were the evaluation in otherwise healthy subjects of signs/symptoms, the reduction in days of disease, and the prevention of complications.All subjects used the "best management" for colds and one group added Pycnogenol® capsules (50 mg, bid/die) from day zero. The resulting registry groups were comparable. A total of 70 subjects used Pycnogenol® and 76 acted as controls.The number of days with a perceived cold affecting the patients was reduced in the supplement group (3.1;0.4 days) in comparison with controls (4.2;0.2). Lost working days were significantly decreased in the supplement group (0.55;0.3 versus 0.67;0.3 in controls). The need to use any other compound (on demand basis; OTC products) to manage symptoms and the occurrence of any clinically significant complications were significantly lower in the Pycnogenol® group. The most frequent complications were the extension of the cold to a period longer than 4 days, a tracheal extension and a bronchial involvement. Pycnogenol® was significantly effective in reducing the number of complications. The daily evolution of the "pillar cold signs" indicates a significantly faster resolution in the supplement group. With supplementation the decrease in symptom scores appears to be significantly more important. Pycnogenol® supplementation appears to make regression faster for all symptoms in comparison with controls.In this pilot registry, Pycnogenol® appears to decrease symptoms of cold and shorten its course also preventing some complications.

This registry study aimed to evaluate the effects of supplementation with pycnogenol on altered endothelial function (EF) in borderline hypertensive, hyperlipidemic and hyperglycemic subjects without atherosclerotic changes in their main arteries and no coronary artery disease.Flow mediated dilatation (FMD) and endothelium-independent (EID) dilatation were measured with brachial ultrasound after occlusion. Also, after occlusion, laser Doppler (LDF) flux and distal straingauge flow were measured. Oxidative stress (oxstress) was evaluated at 8 and 12 weeks. 93 subjects with borderline symptoms were enrolled into the study: 32 hypertensives, 31 hyperlipidemics, 30 hyperglycemics. All participants were instructed to follow the best available management to control their symptoms. In addition to best management, half of the subjects in each group used 150 mg/day Pycnogenol(®). 31 normal subjects were included as control.After 12 weeks metabolic values and blood pressure were back to normal in all subjects. Values were slightly better under Pycnogenol(®). FMD increased after 8 weeks from an average 5.3;3.4% to 8.2;2.2% with a further increase to 8.8;3.1% (P0.05) at 12 weeks. No effects were found in controls and normal subjects. EID of normal subjects was consistently higher with 26%. LDF skin flux increased with Pycnogenol(®) at 8 weeks and 12 weeks. The final flux increase was not different from normal values. In controls flux after occlusion was not improved at 8 weeks; there was a significant but minor increase at 12 weeks. Flux increases were superior in all Pycnogenol(®) subjects. In Pycnogenol(®) subjects, limb flow after occlusion increased at 8 weeks with a further increase at 12 weeks. In controls inclusion flow after occlusion was comparable at 8 and 12 weeks. Oxidative stress was significantly decreased in Pycnogenol(®) subjects at 8 and 12 weeks. Minor differences were observed in controls.This open registry study indicates that Pycnogenol(®) improves EF in preclinical, borderline subjects in a macro-microcirculatory model. This observation may suggest an important preventive possibility for borderline hypertensive, hyperglycemic and hyperlipidemic subjects.

This study evaluates the efficacy of Beanblock®, a standardized extract of Phaseolus vulgaris L., on weight control in healthy overweight subjects on a weight management plan that combined lifestyle and dietary advice.Sixty overweight (BMI 25-30 kg/m2) healthy subjects were enroled. All subjects were instructed to follow a weight management plan, accompanied by dietary advice. Thirty subjects used Beanblock® for at least 12 weeks (50 mg tablets, two times daily). The remaining 30 subjects did not receive any supplementation (management-only). The main endpoints were changes in body weight and waist circumference, with plasmatic oxidative stress, satiey and appetite being also evaluated.At week 12, the supplementation with Beanblock® was associated with a reduction in body weight (from 82.8 ± 9.1 kg to 78.8 ± 8.9 kg; p0.0001) and a decrease of waist circumference from 94.4 ± 10.3 cm to 88.2 ± 10.0 cm (p0.0001). Conversely, only marginal changes were observed in the control group. Oxidative stress was also significantly decreased with Beanblock® (from 380.4 ± 14.8 to 340.7 ± 14.8 Carr Units; p0.0001). Satiety and appetite improved in the supplement group. No side effects were observed and compliance was optimal.Beanblock®, in association with a health management plan, was useful for weight control in mildly overweight healthy subjects.

The aim of this supplement registry was to evaluate the efficacy of the Pycnogenol® in improving cochlear flow and symptoms in a 6-month follow-up for patients with Meniere's disease (MD), tinnitus and cochlear hypoperfusion.Main signs/symptoms were considered: Spontaneous vertigo, positional vertigo, hearing loss, tinnitus, pressure in the ear, unsteady gait, associated clinical problems, alterations in daily life. All subjects were managed with the best available management (BM); one group used the supplement Pycnogenol (150 mg/day). Cochlear flow and tinnitus were also evaluated. Out of 120 patients incuded in the registry, 55 used Pycnogenol and 52 (controls) were managed only with BM.There was a more significant improvement in all registry items at 3 and 6 months in the Pycnogenol group (P0.05). The number of lost working days was lower in the Pycnogenol group. At 3 months, 45.4% of subjects using Pycnogenol were completely asymptomatic in comparison with 23.07% of controls. At 6 months 87.3% of the Pycnogenol subjects were asymptomatic compared with 34.6% of controls. Cochlear flow velocity was significantly better (higher flow, higher diastolic component) in the Pycnogenol group (P0.05). The subjective tinnitus scale decreased in both groups (P0.05); the decrease was more significant in Pycnogenol subjects (P0.05) at 3 and 6 months.Symptoms of Meniere's disease, flow at cochlear level and tinnitus improved in Pycnogenol subjects in comparison with best management.

The involvement of the microcirculation in diabetic microangiopathy (DM) causes of severe incapacitation and ulceration. DM is characterized by a diffuse increase in flux, reduction in venoarteriolar response, associated with increased permeability resulting in edema and altered function of microlymphatics. In DM, skin PO2 is decreased and CO2 increased. In this condition capillary exchanges are altered and nutritional alterations eventually lead to skin lesions and ulcers. The aim of this randomized, placebo-controlled study was to evaluate the effect of local (foot) treatment with Essaven gel (EG) in 35 subjects with DM and neuropathy and localized, small (