Pycnogenol® Supplementation Prevents Recurrent Urinary Tract Infections/Inflammation and Interstitial Cystitis.

This open pilot registry study aimed to evaluate and compare the prophylactic effects of Pycnogenol® or cranberry extract in subjects with previous, recurrent urinary tract infections (UTI) or interstitial cystitis (IC). Methods. Inclusion criteria were recurrent UTI or IC. One subject group was supplemented with 150 mg/day Pycnogenol®, another with 400 mg/day cranberry extract, and a group served as a control in a 2-month open follow-up. Results. 64 subjects with recurrent UTI/IC completed the study. The 3 groups of subjects were comparable at baseline. All subjects had significant symptoms (minor pain, stranguria, repeated need for urination, and lower, anterior abdominal pain) at inclusion. In the course of the study, the subjects reported no tolerability problems or side effects. The incidence of UTI symptoms, in comparison with the period before inclusion in the standard management (SM) group, decreased significantly; there was a more pronounced decrease in the rate of recurrent infections in the Pycnogenol® group (p < 0.05). The improvement in patients supplemented with Pycnogenol® was significantly superior to the effects of cranberry. At the end of the study, all subjects in the Pycnogenol® group were infection-free (p < 0.05vs. cranberry). Significantly, more subjects were completely symptom-free after 2 months of management with Pycnogenol® (20/22) than with SM (18/22) and cranberry (16/20). Conclusions. This pilot registry suggests that 60 days of Pycnogenol® supplementation possibly decrease the occurrence of UTIs and IC without side effects and with an efficacy superior to cranberry.

Effectiveness of a novel boswellic acids delivery form (Casperome®) in the management of grade II ankle sprains due to sport trauma - a registry study.

OBJECTIVE: In this study, we evaluated a novel delivery form of boswellic acids (Casperome®) in the management of signs and symptoms associated with ankle sprain grade II due to sport trauma. PATIENTS AND METHODS: In this supplement registry study, 72 otherwise healthy subjects with grade II ankle sprain induced by sport activities were advised to either follow a standard management (SM, 37 subjects) for the condition or the SM with the additional daily intake of 1 tablet containing 250 mg Casperome® (35 subjects). Subjects were allowed to use rescue medications (ketoprofen tablets, 25 mg/tablet), and their intake was measured at the end of the management period of 7 days. Each individual was subjected to several non-invasive examinations (self-reported pain at rest and under moderate exercise, range of active and passive movement, presence of local hematomas by ultrasonography) at the following time periods: at inclusion, to evaluate the basal conditions of the subject before the beginning of the study, at day 3 and at the end of the week to evaluate the response differences between the two groups. Additionally, a blood sample from the Casperome® treated subjects (34 out of 35 subjects) was taken at day 7 and analyzed for the systemic concentration of boswellic acids. RESULTS: The 72 individuals recruited in this study spontaneously decided which management to follow, either SM (n=37) or SM+Casperome® (n=35). Supplementation with Casperome® 250 mg/day showed beneficial effects in the reduction of signs and symptoms of ankle sprains evaluated at day 3 and day 7, and was shown to induce measurable plasma level of boswellic acids. Moreover, the supplementary use of Casperome® was well-tolerated and devoid of side effects. CONCLUSIONS: Our pilot registry study showed the effectiveness of Casperome® supplementation in improving recovery after ankle sprain of mild severity (grade II), suggesting a potentially beneficial role in relieving the trauma associated with sport activities and in decreasing the use of rescue drugs.

Management of Varicose Veins and Chronic Venous Insufficiency in a Comparative Registry with Nine Venoactive Products in Comparison with Stockings.

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 PO 2 and PCO 2 . 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.

Robuvit® (Quercus robur extract) supplementation in subjects with chronic fatigue syndrome and increased oxidative stress. A pilot registry study.

AIM: The aim of this registry study was to evaluate the effects of supplementation with Robuvit® (French Quercus robur extract) capsules in subjects with Chronic Fatigue Syndrome (CFS) associated with an increased oxidative stress. Robuvit is a wood extract from Quercus robur (Horphag Research) used to improve liver dysfunction and chronic fatigue. After excluding any disease, subjects observed a defined management plan to improve CFS. Signs/symptoms had been present for more than 6 months in association with an increase in oxidative stress (measured as plasma free radicals). Blood tests were within normal values. METHODS: The registry study included 38 CFS subjects and 42 comparable controls. There were no dropouts in the 4 weeks of follow-up; the subjects were evaluated for a further period of 6 months. The management plan included: improved/increased sleep; reduction/abolition in smoking and alcohol or any other agent that may have affected them; control of diet, increase in dietary proteins; good hydration; rest (1/2-1 h/day) and exercise (at least 30 min/day); planned relaxation time; increased time in open spaces. In the Robuvit® supplementation group 300 mg/day of Robuvit® was used. RESULTS: Symptoms improved in both groups with a significantly more important improvement in the supplement group (P<0.05). The single items in the Multidimensional Assessment of Fatigue (MAF) questionnaire were statistically better improved (P<0.05) in the supplement group. A parallel improvement in oxidative stress was observed in the supplemented subjects. In the follow up, at 6 months no organic disease was discovered or disease markers found. CONCLUSION: This preliminary registry indicates that supplementation with Robuvit® improves CFS in otherwise healthy subjects with no presence of clinical disease or risk conditions. The effects of Robuvit® in CFS may be partially mediated by a clear reduction of plasma free radicals and oxidative stress.

Pycnogenol® and Centella asiatica in the management of asymptomatic atherosclerosis progression.

AIM: 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. METHODS: 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. RESULTS: 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; P<0.05). All treatment groups had a significantly lower event rate (P<0.05) in comparison with controls. Considering treatments groups 2, 3, 5, 6 had a lower number (P<0.05) 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 (P<0.05). In groups 2 to 6 the need for risk factor management was lower than in controls (P<0.05). 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) (P<0.002). The most important reduction (higher that in all groups; P<0.05) 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 (P<0.001). CONCLUSION: 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.

Improvement of common cold with Pycnogenol®: a Winter registry study.

AIM: 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. METHODS: 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. RESULTS: 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. CONCLUSION: In this pilot registry, Pycnogenol® appears to decrease symptoms of cold and shorten its course also preventing some complications.

Improvement in signs and symptoms in psoriasis patients with Pycnogenol® supplementation.

AIM: The aim of the study was the evaluation of supplementation with Pycnogenol®, French maritime pine bark extract (registered trademark of Horphag Research Ltd.) to improve the effects of the management of psoriasis and reduce the need for treatments. METHODS: Patients (age range 30-45) with moderate/severe plaque psoriasis were included in a 12-week registry study that did not interfere with 'standard management'. The minimum Psoriasis Area Severity Index (PASI) score at inclusion was 10. Subjects with 10-29% (grade 2) and 30-49% (grade 3) of involved area were included. Oxidative stress (plasma free radicals) was measured. Patient-reported measures included the Dermatology Life Quality Index (DLQI). The supplement was used at a dosage of 150 mg/day (50 mg three times daily). RESULTS: The two registry groups (standard management and standard management+supplementation) were comparable. Dropouts were due to logistical problems. Single PASI items were evaluated: a decrease in the affected body area in boths groups was observed. The decrease in affected areas was more pronounced in the Pycnogenol group in all body regions. The severity score (erythema, induration, desquamation) improved more significantly with Pycnogenol. Considering the water content of skin in all areas, the increase was higher with Pycnogenol. The quantity of exfoliating cells (score from -5 to +5) was significantly reduced in both groups, with a better action using Pycnogenol. Skin moisture improved with treatment in all subjects, with better effects using Pycnogenol. Using a modified (12 items) DLQI indicating how much psoriasis had affected the patient's life in the previous week, Pycnogenol-supplemented subjects performed better for each single parameter in comparison with standard management. Improvement in the treatment time (-32% in comparison with standard management) and costs (decreased on average 36.4% in comparison with standard management) were observed in the supplement group. A decrease in consumption of other drugs was observed with the supplement. Oxidative stress was significantly lower in the supplement group at 12 weeks. CONCLUSION: These results indicate the efficacy of Pycnogenol supplementation in improving control of the most common clinical aspects of psoriasis and in reducing oxidative stress. Further studies may indicate the possible systemic or local use of Pycnogenol and its role in controlling side effects and costs of standard management.

Robuvit® (French oak wood extract) in the management of functional, temporary hepatic damage. A registry, pilot study.

AIM: The aim of this registry study was to evaluate the evolution of moderate functional hepatic failure (MTHF) using a proprietary new oak wood supplement (Robuvit®) extracted from Quercus Robur. Recent studies have indicated the protective effect of oak wood extracts on liver injury. Quercus wood extracts have shown hepatoprotective effect on initial induced liver-injury. METHODS: This registry included a total of 75 patients with MTHF characterized by: decreased albumin levels; increased total bilirubin, altered hepatic functions enzymes, increased oxidative stress, negative viral hepatitis markers. RESULTS: The two groups (best management in comparison with best management+ Robuvit®) were comparable: 32 Robuvit® patients and 29 comparable controls) completed the 12-week registry. At inclusion, the blood parameter values in the two groups were comparable. At the end of the supplementation period, the increase in albumin levels was significantly (P<0.05 at 12 weeks) faster and higher in the Robuvit® group. The decrease in ALT-SGPT and AST-ASAT was significant in the supplement group (P<0.05 at 4 and 12 weeks); the tests were normalized at 4 and 12 weeks. Controls remained out of the normal range for more than 12 weeks. Alkaline phosphatase was normalized at 4 and 12 weeks in Robuvit® patients; they were decreased, but not normalized in controls at 4 weeks (Robuvit® group's values were significantly better; P<0.05). Values were normalized in controls (significantly higher in comparison with Robuvit®; P<0.05) at 12 weeks. Total bilirubin was normalized in Robuvit® subjects at 4 and 12 weeks. Results were significantly better in comparison with controls (P<0.05). Direct bilirubin values increased more in the Robuvit® group at 4 and 12 weeks (P<0.05). Gamma GT values were normalized at 4 and 12 weeks in the Robuvit® group. There was a less important decrease in controls (P<0.05) without normalization at 12 weeks. Plasma free radicals increased at inclusion showed a significant decrease in Robuvit® subject (at 4 and 12 weeks) with normalization at 12 weeks. Persisting, elevated values in controls were observed even at 12 weeks (P<0.05). ESR and CRP decreased in both groups with a more important decrease in the Robuvit® group (P<0.05). Hepatitis markers were negative when repeated at 4 and 12 weeks. CONCLUSION: Data from this pilot, supplement registry study indicate a significant protective activity of Robuvit®, associated with a very good safety profile, in patients with temporary hepatic failure. The activity of Robuvit® seems to be mediated by its anti-inflammatory activity.

Pycnogenol® in postpartum symptomatic hemorrhoids.

AIM: The aim of this registry study was to evaluate the efficacy of Pycnogenol® (Horphag Research Ltd.), a standardized extract from the French maritime pine bark, to control signs/symptoms and prevent complications associated with hemorrhoids in the months after delivery in healthy women. METHODS: Women with hemorrhoids after their second pregnancy were included within the third month after pregnancy. Pycnogenol dosage was 150 mg/day for 6 months. Symptoms for 4th and 3rd degree hemorrhoids were evaluated. RESULTS: The registry groups were comparable. For 4th degree hemorrhoids, main symptoms were reduced after 6 months in all patients, but the group using Pycnogenol in addition to standard best management showed more improvement. In patients with 3rd degree hemorrhoids, symptoms were reduced in both management groups at 6 months; with Pycnogenol the reduction in symptoms scores was significantly better. At 6 months 18/24 subjects (75%) in the Pycnogenol group were symptom-free in comparison with 14/25 (56%) in controls. In the 4th degree hemorrhoid group, 7/10 patients (70%) in the Pycnogenol group were symptom-free at 6 months in comparison with 4/11 subjects (36%) in the best management group. No significant side effects were observed. CONCLUSION: Pycnogenol appears to positively affect hemorrhoid signs and symptoms in the months after pregnancy.

Improved management of primary chronic fatigue syndrome with the supplement French oak wood extract (Robuvit®): a pilot, registry evaluation.

AIM: The aim of this supplement study was to evaluate French oak wood extract (Robuvit®, Horphag Research Ltd) used as a supplement in association with a defined management plan for chronic fatigue syndrome (CFS) in healthy subjects with CFS, a condition that has, so far, no specific treatment or management standards. METHODS: Robuvit® is a new proprietary and exclusive extract of oak wood with important antoxidant actions. The dosage of the supplementation was 200 mg/day for at least 6 months. The CFS questionnaire and the Brief Mood Introspection Scale (BMIS) questionnaire were used to evaluate mood variations associated with CFS patients. The CFS form includes an analogue scale to record the variations of single symptoms with a score range of 0-10. At inclusion into the registry study, at least 5 symptoms were present. All subjects (age range 35-44; BMI range 24-26) with CFS were tested for oxidative stress: 61 out of 91 subjects had an increased value of oxidative stress. The BMIS scale evaluating mood changes in time was also used. The evaluation was repeated at 3 and 6 months. RESULTS: Out of 91 eligible subjects with CFS, 48 subjects (31 with increased oxidative stress) were accepted as part of the supplement registry study using Robuvit; 43 (30 with increased oxidative stress) were accepted as controls using only the management plan. In the Robuvit® group there were 3 drop outs; also 3 controls were lost. Oxidative stress was increased in 64.58% of subjects that used Robuvit and in 69.7% of controls. The average values of oxidative stress were expressed for the whole group. The average follow up was 199.3;9.2 days in the Robuvit group and 202.2;5.5 in the control group with a minimum of 6 months. Considering variations in oxidative stress, there was no significant average change in controls, but a significant decrease from the initial values was observed in Robuvit subjects after 3 and 6 months. The CFS questionnaire variations in score indicated that there was a significant improvement for most symptoms after 3 and 6 months in the Robuvit group. Positive variations were also present in controls, indicating the positive effect of an increased attention to CFS. The improvement in signs/symptoms was significantly more valuable in subjects using the oak wood extract considering the main 8 symptoms and the accessory symptoms. Considering the BMIS variations, the totals for positive and negative items were significantly more favourable for Robuvit subjects. Overall mood evaluation in the oak wood extract group improved from an inclusion average of -6.93;2.1 to +4.32;2.6 at 6 months; in contrast it changed from -6.5;2.5 to -3.4;1.5 in controls. No side effects were observed during the supplementation with Robuvit. The compliance was optimal with 93% of the capsules correctly used. CONCLUSION: This promising pilot supplement registry study indicates a new opportunity of management for these difficult and often neglected patients. Correlation between oxidative stress and CFS have to be better explored.

Meriva®+Glucosamine versus Condroitin+Glucosamine in patients with knee osteoarthritis: an observational study.

OBJECTIVE: 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. PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

FlexiQule (Boswellia extract) in the supplementary management of osteoarthritis: a supplement registry.

UNLABELLED: 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. METHODS: 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 Index >25, metabolic disorders, surgery within three months prior to inclusion, oncological condition or inability to walk. RESULTS: 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 (P<0.05) in the Boswellia group in comparison with a variation from 75.3;5.2 to 79.4;3.3 (P<0.05) in the SM. The effects of the supplement were significantly higher (P<0.05). The WOMAC Score was decreased significantly more in the supplement+SM group in comparison with controls considering pain, stiffness and physical functions (P<0.05). Social/emotional functions improved better with the supplement (P<0.05). Both groups improved their walking distance at 4 weeks. The improvement was higher (P<0.05) in the Boswellia group. The need for other drugs or tests during the registry period was reduced more in the supplement group (P<0.05). CONCLUSION: 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.

Liverubin (standardized silymarin) in the supplementary management of functional, temporary hepatic damage. A pilot, registry, study.

AIM: 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. METHODS: 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. RESULTS: 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 (P<0.05 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 (P<0.05). Direct bilirubin values improved more in the supplement group at 4 weeks (P<0.05). The decrease of ALT-SGPT and AST-ASAT was more evident in the supplement group (P<0.05). Improvement in controls was more limited. Alkaline phosphatase value was normalized at 4 weeks in Liverubin patients; values decreased less in controls (P<0.05). Gamma GT decreased and were normal at 4 weeks with Liverubin. ESR was decreased in both groups (significantly more in the Liverubin group: P<0.05). 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; P<0.05). 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 (P<0.05 in comparison with normal range). Platelets values improved in the Liverubin group (P<0.05) 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). CONCLUSION: 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.

Evaluation of the effects of supplementation with Pycnogenol® on fitness in normal subjects with the Army Physical Fitness Test and in performances of athletes in the 100-minute triathlon.

AIM: The aim of this registry study was to evaluate the effects of Pycnogenol® (French pine bark extract) on improving physical fitness (PF) in normal individuals using the Army Physical Fitness Test (APFT). The study evaluated the efficacy of Pycnogenol, used as a supplement, in improving training, exercise, recovery and oxidative stress. METHODS: The study was divided into 2 parts. In PART 1 (Pycnogenol 100 mg/day), the APFT was used to assess an improvement in PF during an 8-week preparation and training program. In PART 2 (Pycnogenol 150 mg/day), the study evaluated the effects of Pycnogenol supplementation in athletes in training for a triathlon. RESULTS: PART 1. There was a significant improvement in both males and females in the 2-mile running time within both groups, but the group using Pycnogenol (74 subjects) performed statistically better than controls (73 subjects). The number of push-ups was improved, with Pycnogenol subjects performing better. Sit-ups also improved in the Pycnogenol group. Oxidative stress decreased with exercise in all subjects; in Pycnogenol subjects the results were significantly better. PART 2. In the Pycnogenol group 32 males (37.9; SD 4.4 years) were compliant with the training plan at 4 weeks. In controls there were 22 subjects (37.2;3.5) completing the training plans. The swimming, biking and running scores in both groups improved with training. The Pycnogenol group had more benefits in comparison with controls. The total triathlon time was 89 min 44 s in Pycnogenol subjects versus 96 min 5 s in controls. Controls improved their performing time on average 4.6 minutes in comparison with an improvement of 10.8 minutes in Pycnogenol subjects. A significant decrease in cramps and running and post-running pain was seen in the Pycnogenol group; there were no significant differences in controls. There was an important, significant post-triathlon decrease of PFR one hour after the end of the triathlon with an average of -26.7, whereas PFR in controls increased. In Pycnogenol subjects there was a lower increase on oxidative stress with a faster recovery to almost normal levels (<330 for these subjects). These variations in PFR values were interpreted as a faster metabolic recovery in subjects using Pycnogenol. CONCLUSION: This study opens an interesting new application of the natural supplementation with Pycnogenol that, with proper hydration, good training and nutritional attention may improve training and performances both in normal subjects and in semi-professional athletes performing at high levels in difficult, high-stress sports such as the triathlon.

Lady Prelox® improves sexual function in generally healthy women of reproductive age.

AIM: This supplement study evaluates the Female Sexual Function Index (FSFI) of 100 healthy women (37 to 45 years) with moderate sexual dysfunction who underwent a management program of lifestyle, diet, exercise, and stress control. In association with the management program a group of these women also used the supplement Lady Prelox® in tablets (20 mg Pycnogenol® pine bark extract, 200 mg L-arginine, 200 mg L-citrulline and 50 mg Rosvita® rose hip extract) for eight weeks. METHODS: One group of women was supplemented with Lady Prelox® for 8 weeks. The nine-item FSFI questionnaire was used for evaluation of women's sexual function at inclusion (baseline), after four weeks, and after eight weeks of management and supplementation. Variation in oxidative stress was also evaluated by measuring plasma free radicals. RESULTS: Following supplementation with Lady Prelox® the mean total FSFI scores increased from 14.96±2.68 to 28.25±2.35 after four weeks and 33.91±2.7 after eight weeks. Treatment values were significantly higher than in controls (who used only the management plan) with baseline values of 17.92±2.32 and scores of 23.45±1.82 after four weeks and to 23.52±2.20 after eight weeks. Women in the Lady Prelox® group had an initial value of plasma free radicals (PFR) of 398±29 Carr units: this value decreased to 344:28 at 4 weeks (P<0.05) and 332:31 at 8 weeks (P<0.05). Lower changes were observed in controls with an initial value of 389±33, decreasing to 377±32 (P<0.05) at 4 weeks and to 365; 33 (P<0.05) at 8 weeks (value significantly higher in controls not using Lady Prelox®). The supplementation was well tolerated; no unwanted effects occurred and no women had to stop the supplementation. CONCLUSION: The study suggests that supplementation with Lady Prelox significantly improves sexual function across all domains evaluated by the FSFI in healthy women of late reproductive age. The improvement in FSFI is also associated with a significant decrease in oxidative stress.

A controlled study shows daily intake of 50 mg of French Pine Bark Extract (Pycnogenol®) lowers plasma reactive oxygen metabolites in healthy smokers.

AIM: We investigated a low daily dosage of 50 mg of the antioxidant Pycnogenol for lowering oxidative stress in cigarette smokers who presented with good health. METHODS: A group of 78 smokers were supplemented with 50 mg Pycnogenol over an eight-week period, followed by two weeks cessation. Another 77 smokers took placebo tablets. Plasma reactive oxygen metabolites were detected by d-ROM test and the biological antioxidant potential (BAP) was quantified by photometric analysis of ferric iron reduction to ferrous form. RESULTS: BAP and d-ROM values in the Pycnogenol and placebo group were comparative at trial start. Pycnogenol lowered d-ROM values by 25.3% from baseline 459.4±65 to 342.2±56 Carr units after 2 weeks. At time points 4, 5 and 8 weeks treatment d-ROM values in the Pycnogenol group were significantly lower than in the control group (P<0.05). After cessation of Pycnogenol from week 8 to 10 d-ROM values increased from 288.4±32 to 381.3±39 Carr units. BAP values increased in the Pycnogenol group from baseline 1698±231 to 2349±294 µM after 8 weeks and dropped to 2002±203 µM after two weeks washout period. Values in the control group remained largely unaltered with 1669±311, 1673±229 and 1656±221 µM, at 0, 8 and 10 weeks, respectively. CONCLUSION: A daily dosage of 50 mg Pycnogenol significantly lowers reactive oxygen species as compared to a placebo-treated equivalent control group.

Pycnogenol® supplementation improves health risk factors in subjects with metabolic syndrome.

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.

Lady Prelox® improves sexual function in post-menopausal women.

AIM: The aim of this pilot, single-blinded study was to evaluate the efficacy of a proprietary, dietary supplement Lady Prelox® for supporting and improving sexual function in generally healthy, post-menopausal women. METHODS: The Lady Prelox® and placebo control groups were comparable at inclusion with regard to the total Female Sexual Function Index (FSFI) score, as well as for the six individual FSFI domains, with 40 women (50.1 ± 3.1 years) and 43 women (51.2 ± 2.3 years), respectively. RESULTS: At baseline the women in the verum group presented with a mean total FSFI score of 44.6 ± 24.1 which increased significantly already after four weeks treatment with Lady Prelox® to 70.9 ± 18.5 and further increased to 71.7 ± 23.9 after completion of the eight-week trial period. In the control group the mean total FSFI was 44.1 ± 22.8 at inclusion and non-significantly increased to 45 ± 21.4 after four weeks and 47.4 ± 21.8 after eight weeks, respectively. The treatment with Lady Prelox® was comparatively significantly more effective than placebo after both four and eight weeks of treatment (P<0.05). The individual six FSFI domains related to desire, arousal, lubrication, orgasm, satisfaction and pain did all respond favourably to treatment with Lady Prelox®; however, with only marginable higher scores in the placebo group. Four women in each group dropped out because of inabilities to attend scheduled check-ups. No adverse effects were reported. CONCLUSION: This study opens an interesting perspective for women experiencing moderate sexual function impairment and suggests a promising new treatment option. Further studies with larger numbers of women, including also premenopausal and perimenopausal women are warranted.

Meriva®, a lecithinized curcumin delivery system, in diabetic microangiopathy and retinopathy.

BACKGROUND: In the present study, the improvement of diabetic microangiopathy and retinopathy was evaluated in 38 diabetic patients treated with a novel curcumin phospholipids delivery form (Meriva®). METHODS: Diabetes was diagnosed at least 5 years before inclusion and all patients had signs of retinal oedema and of peripheral microangiopathy. Meriva® was administered at the dosage of 2 tablets/day (each tablet containing 500 mg Meriva® corresponding to 100 mg curcumin) for a period of at least 4 weeks in addition to the standard management plan, while a comparable group of subjects (n = 39) followed the standard management plan alone. RESULTS: All subjects (treatment and controls) completed the follow-up period, there were no dropouts and Meriva® showed an optimal tolerability. At 4 weeks, microcirculatory and clinical evaluations indicated an improvement of microangiopathy. In terms of peripheral microangiopathy, in the Meriva® group, there was a significant improvement in the venoarteriolar response (p<0.05) and a decrease in the score of peripheral oedema (p<0.05), a sign typically associated with the failure of the venoarteriolar response. At the retinal level, high-resolution, duplex scanning, used to measure retinal flow, showed improvements in the Meriva® treated patients. The evaluation of retinal oedema (Steigerwalt's scale) showed an improvement associated with improved visual acuity (Snellen scale). There were no clinical or microcirculatory effects in controls. CONCLUSION: These preliminary observations, indicate the value of curcumin, when administered in a bioavailable form as with Meriva®, in the management of diabetic microangiopathy and retinopathy.

Product evaluation of Ureadin Rx Db (ISDIN) for prevention and treatment of mild-to-moderate xerosis of the foot in diabetic patients. Prevention of skin lesions due to microangiopathy.

UNLABELLED: The aim of this pilot, registry study was to evaluate a dermatological solution Ureadin Rx Db (ISDIN) including urea in a water-lipid-based foam delivery system in diabetic subjects with microangiopathy and with mild-to-moderate xerosis of the foot. The product was applied to the whole surface of the foot and particularly on the affected areas and pressure/contact zones, at least twice daily for 4 weeks. Skin breaks, ulcerations, infection, investigator and patients' questionnaire, microcirculatory measurements, skin thickness (ultrasound), laser Doppler flux and other parameters were observed and evaluated at inclusion and 4 weeks. RESULTS: The evaluation in skin breaks indicated a decrease in breaks in the Ureadin group vs controls (p<0.05) with the development of one ulcer in controls. There was a significant difference in favour of the Ureadin group in both the Investigator global assessment and in the subjects' assessment questionanire (p<0.05). At 4 weeks PO2 was improved in the Ureadin group (p<0.05) and PCO2 was significantly better (p<0.05) in the Ureadin group. Skin thickness was increased (p<0.05) in the Ureadin group (no change in controls) indicating a better hydration of the more superficial skin layers. Skin flux and the venoarteriolar response were better improved in the Ureadin group. Considering new skin lesions at 4 weeks there were no Class A lesions in the Ureadin group vs. 4 lesions in 26 patients (15.38%; p<0.05) in the control group. There was also a Class B lesion (3.84%; p<0.05) in controls. Diabetic control was good (as before inclusion and did not change at 4 weeks). Therefore the clinical and microcirculatory changes were very possibly due only to local management and not to a systemic improvement in the management of diabetes.