Supplementation with a lecithin-based delivery form of Boswellia serrata extract (Casperome®) controls symptoms of mild irritable bowel syndrome.

OBJECTIVE: Irritable Bowel Syndrome (IBS) is a chronic, gastrointestinal disorder in which abdominal pain or discomfort is associated with defecation or changes in bowel habits. Its multifactorial pathophysiology leads to a variety of available treatments, mainly aimed at controlling symptoms. The management of IBS patients could be optimized by individualized strategies, including non-pharmaceutical approaches. In this study, we evaluated the efficacy and safety of a novel delivery form of Boswellia serrata extracts (BSE) (Casperome®) in patients with IBS. PATIENTS AND METHODS: 71 otherwise healthy subjects with idiopathic IBS were recruited. Participants were assigned to the following management strategies: hyoscine butylbromide; papaverine hydrochloride + A. belladonna extract; supplementation with Casperome®. Predominant IBS symptoms were evaluated at inclusion and at the end of the observational period (4 weeks). The numbers of subjects who needed rescue medication or medical attention/hospital admission were recorded. Adverse events were also evaluated. RESULTS: In all groups, the IBS symptoms investigated, namely abdominal pain, altered bowel movements, meteorism and cramps improved during the observational period. Of note, the number of subjects who needed medical attention significantly decreased only in Casperome®-supplemented group. In addition, Casperome® supplementation was related to a lower incidence of side effects (mainly stypsis). CONCLUSIONS: This preliminary study suggests that Casperome® supplementation could represent a promising alternative approach to manage symptoms associated with IBS in otherwise healthy subjects.

Managing ulcerative colitis in remission phase: usefulness of Casperome®, an innovative lecithin-based delivery system of Boswellia serrata extract.

OBJECTIVE: Boswellia serrata extracts (BSE) have been traditionally used for the treatment of several inflammatory diseases. The aim of this study was to evaluate the efficacy of a novel delivery form of BSE (Casperome®) in Ulcerative Colitis (UC) during minimally symptomatic remission phase. PATIENTS AND METHODS: In this open-label, observational, registry study, informed participants with UC in remission phase (n = 43) freely decided to receive the oral daily Casperome® supplementation (n = 22) or no supplementation (n = 21) for 4 weeks. Several parameters associated with minimally symptomatic UC in remission were evaluated at the inclusion and the end of the study. RESULTS: A significant beneficial effect of Casperome® was observed for all the parameters evaluated, namely: diffuse intestinal pain, evident and occult blood in stools, bowel movements and cramps, watery stools, malaise, anemia, rectal involvement, number of white blood cells as well as need for concomitant drugs and medical attention. Faecal concentration of calprotectin, a marker of bowel inflammation, resulted ameliorated in Casperome® supplemented patients. CONCLUSIONS: Our study showed that Casperome® supplementation attenuates symptoms associated with mild UC in remission, reducing the use of drugs and medical consultations. Therefore, our study suggests that Casperome® supplementation could represent a promising alternative approach to manage minimally symptomatic UC and maintain the remission phase.

Bilberry extracts are not created equal: the role of non anthocyanin fraction. Discovering the "dark side of the force" in a preliminary study.

OBJECTIVE: 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. PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: Our registry study suggests that Mirtoselect® supplementation could represent an effective and safe integrated approach for the treatment of different retinopathies.

Management of functional, hepatic damage after chemotherapy with Liverubin (pharma-standard silymarin).

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). METHODS: 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 (P<0.05) faster with the final values higher in the supplement group. Total bilirubin was reduced with the supplement better than in controls (P<0.05). Direct bilirubin values improved more in the supplement (P<0.05) group. The decrease in SGPT and AST-ASAT was more evident with the supplement (P<0.05). Improvement in controls was more limited. Alkaline phosphatase was significantly lower (than in controls) with Liverubin at 8 weeks (p<0.05). 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 (P<0.05). 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; P<0.05). 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 (P<0.05). Platelets values improved better with Liverubin (P<0.05). 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.

Supplementary management of functional, hepatic damage with Liverubin (pharma-standard Silymarin). A 3-month registry.

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. METHODS: 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. RESULTS: 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 (P<0.05 at 4 weeks) faster and the final blood tests improved more with Liverubin. Total bilirubin was reduced with the supplement (better than in controls; P<0.05). Direct bilirubin values improved more in the supplement group at 3 months (P<0.05). The decrease of SGPT and AST- ASAT was more evident in the supplement group (P<0.05). Alkaline phosphatase value was normalized at in Liverubin patients; values decreased less in controls (P<0.05). Gamma GT decreased more with Liverubin. ESR was decreased in both groups (significantly more with Liverubin: P<0.05). There was a less important decrease in controls at 3 months. The white cell count was also better with the supplement group; P<0.05). 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). 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.

Cranberry supplementation in the prevention of non-severe lower urinary tract infections: a pilot study.

OBJECTIVE: 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. PATIENTS AND METHODS: 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. RESULTS: 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% (p < 0.05). This figure was 15.4% in the control group (p < 0.05; 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 (p < 0.05). 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 (p < 0.05). Three subjects (13.6%) in the cranberry group and 8 (36.3%) in the control group required medical consultation for UTI symptoms (p < 0.05). Urine evaluation was completely negative in 20/22 subjects in the Cranberry group (90.9%) and in 11 control subjects (50.0%; p < 0.005). No adverse events were observed. CONCLUSIONS: 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.

Effects of Pycnogenol® on endothelial dysfunction in borderline hypertensive, hyperlipidemic, and hyperglycemic individuals: the borderline study.

AIM: 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. METHODS: 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. RESULTS: 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% (P<0.05) 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. CONCLUSION: 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.

Beanblock® (standardized dry extract of Phaseolus vulgaris) in mildly overweight subjects: a pilot study.

OBJECTIVE: 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. PATIENTS AND METHODS: 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. RESULTS: 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; p < 0.0001) and a decrease of waist circumference from 94.4 ± 10.3 cm to 88.2 ± 10.0 cm (p < 0.0001). 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; p < 0.0001). Satiety and appetite improved in the supplement group. No side effects were observed and compliance was optimal. CONCLUSIONS: Beanblock®, in association with a health management plan, was useful for weight control in mildly overweight healthy subjects.

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.

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.

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.

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

AIM:he 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.

Topical formulation of heparin is effective in reducing the symptoms of superficial venous thrombosis: a monocenter, observer-blind, placebo-controlled randomized study.

AIM: The aim of the present, randomized, placebo controlled study was to assess the dose-dependent symptom reduction efficacy, safety and tolerability of heparin-spraygel (Viatromb 2.400 IU/g heparin spraygel) in patients with superficial vein thrombosis (SVT) of the lower limbs. METHODS: A number of clinically relevant objectives; time to onset and intensity of symptoms' reduction reflected also by rescue medication consumption were considered and assessed. RESULTS: Pain reduction between the two time-points (days 0 and 7) was significant within both treatment groups (active drug and placebo). However, subjects treated with active drug reported a mean pain reduction (VAS) of 76.21 mm (93.13% decrease); in subjects treated with placebo it was 50.36 (61.35%) mm (P<0.0001). The difference in pain reduction between the active drug and placebo groups was significant (P<0.05). The proportion of responders (subjects with at least 50%reduction in pain (VAS) on day 7 and day 14) was higher within subjects treated with Viatromb (P<0.05). The extension of erythema, evaluated by planimetry indicated a significantly higher reduction (day 0 to 7 and 0 to 14) in Viatromb-treated subjects in comparison with placebo. In the Viatromb group, the reduction in thrombus size was remarkable towards placebo (P<0.05). Reduction of edema and pain (VRS) had comparable time courses. Both investigator's and subject's global assessment of efficacy were significantly better with Viatromb. No adverse events or reactions were reported during the study and the follow up period. CONCLUSION: Viatromb was significantly more effective than placebo in the symptomatic treatment of SVT.

Venoruton®: post thrombotic syndrome. Clinical improvement in venous insufficiency (signs and symptoms) with Venoruton®. A five-year, open-registry, efficacy study.

AIM: This registry evaluation was conducted in post-thrombotic syndrome (PTS) patients (with a minimum five-year follow up). The study evaluated: 1) variations in peripheral edema with an analogue scoring system; 2) ankle circumference at the PTS limb in comparison with the normal contralateral limb. METHODS: The difference was expressed in percent increase in circumference measured at the PTS limb; 3) other end-points were observed in a five-year follow-up that created a specific PTS registry. Subjects could follow a management system including: 1) compression; 2) compression and Venoruton® (1 g/day); 3) compression and Venoruton® (2 g/day). RESULTS: The groups of patients with chronic venous insufficiency (CVI) resulted comparable. The occurrence of a new deep venous thrombosis (DVT) episode was considered a drop out. At five years there were four new DVTs (in 90 patients) in the compression group. There was one case (90 patients included) in the compression and HR (1 g) group and no DVT in group 3. The outcome in groups 2 and 3 was significantly better (0.05) than in group 1. The need for surgery or sclerotherapy (for larger varicose veins), the occurrence of lipodermatosclerosis and ulcerations were significantly lower in the HR groups with a better outcome in the higher dose group (P<0.05). The number of ulcerations were also significantly reduced in the HR groups. The difference in ulcerations was significantly better in the higher dose group in comparison with the other groups (P<0.05). The edema score was significantly reduced at five years in the HR groups (P<0.05) in comparison with the compression group. The higher dose resulted more effective in controlling edema. Both edema score and ankle circumference at five years were significantly lower (P<0.05) in the HR-treated groups with a significant decrease in edema score and ankle circumference in the higher dosage group. CONCLUSION: The study confirms the long-term efficacy of HR in PTS, CVI patients. Controlling signs/symptoms and edema in CVI with HR prevents the most severe complications of CVI including lipodermatosclerosis and venous ulcerations. An early therapeutic program including exercise, risk factor controls, compression an edema-controlling treatment with HR is effective in decreasing the classic complications of PTS syndrome. The important restrictions and difficulties to the use of elastic stockings (in regions with warmer climates) are not applicable to HR that is well tolerated and can be used all the time alone or in association with compression.

Potential role of curcumin phytosome (Meriva) in controlling the evolution of diabetic microangiopathy. A pilot study.

AIM: The aim of the present study was to evaluate the improvement of diabetic microangiopathy in patients suffering from this condition since at least five years, and whose disease was managed without insulin. METHODS: Curcumin, the orange pigment of turmeric, has recently received increasing attention because of its antioxidant properties, mediated by both direct oxygen radical quenching and by induction of anti-oxidant responses via Nrf2 activation. This aspect, combined with the beneficial effects on endothelial function and on tissue and plasma inflammatory status, makes curcumin potentially useful for the management of diabetic microangiopathy. To further evaluate this, Meriva, a lecithinized formulation of curcumin, was administered at the dosage of two tablets/day (1 g Meriva/day) to 25 diabetic patients for four weeks. A comparable group of subjects followed the best possible management for this type of patients. RESULTS: All subjects in the treatment and control group completed the follow-up period; there were no dropouts. In the treatment group, at four weeks, microcirculatory and clinical evaluations indicated a decrease in skin flux (P<0.05) at the surface of the foot, a finding diagnostic of an improvement in microangiopathy, the flux being generally increased in patients affected by diabetic microangiopathy. Also, a significant decrease in the edema score (P<0.05) and a corresponding improvement in the venoarteriolar response (P<0.05) were observed. The PO2 increased at four weeks (P<0.05), as expected from a better oxygen diffusion into the skin due to the decreased edema. These findings were present in all subjects using Meriva, while no clinical or microcirculatory effects were observed in the control group. CONCLUSION: Meriva was, in general, well tolerated, and these preliminary findings suggest the usefulness of this curcumin formulation for the management of diabetic microangiopathy, opening a window of opportunities to be evaluated in more prolonged and larger studies. The molecular mechanisms involved in the beneficial effects of curcumin on microcirculation and edema are also worth investigation.

Pycnogenol® improvements in asthma management.

AIM: The simplification of the management of asthma in the different clinical phases of this common chronic inflammatory disorder is the main goal of therapy. Pycnogenol®, a standardized extract of French maritime pine bark, inhibits expression of 5-lipoxygenase and consequently decreases leukotriene levels in asthmatic patients. Pycnogenol® anti-inflammatory activities may be supportive when taken in addition to inhalation corticosteroid (ICS), putatively allowing for a reduction in dosage and frequency of ICS administration. METHODS: This study evaluated the efficacy of Pycnogenol® during a period of six months for improving allergic (mite in house dust) asthma management in patients with stable, controlled conditions. Pycnogenol® was used at a daily dosage of 100 mg, distributed as 50 mg in the morning at 9 am and again in the evening at 9 pm). An individual patient's asthma condition was graded in five steps based on the daily dosage of inhaled fluticasone propionate with step 1 indicating 0 µg and step 5 the maximum dose of 500 µg ICS twice daily. RESULTS: A total 76 patients were enrolled for this study. The group taking Pycnogenol® in addition to ICS and the group taking only ICS were comparable for age, gender and clinical characteristics including FEV1. The analysis of therapeutic ranking steps showed that 55% of patients taking Pycnogenol® improved as judged by passing to a lower ICS dose step. In comparison, only 6% of patients depending exclusively on ICS progressed to a lower (ICS dose) therapeutic step. No deterioration (passage to a higher ICS therapeutic step) was observed in the Pycnogenol® group, whereas in 18.8% of patients depending exclusively on corticosteroids a deterioration requiring a higher dosage step was observed. The passage to different therapeutic steps was statistical significant between groups (P<0.05). Drop-outs were associated entirely to irregularities in follow-up and not due to medical reasons. No serious adverse events were observed in both groups and tolerability of Pycnogenol® was very good. The levels of asthma control in the 6 interventional months as compared to the same period in the previous year were compared. In the Pycnogenol® group, night-awakenings were less frequent, the number of days with PEF<80% were decreased, days with asthma score >1 were lower, requirement for salbutamol and additional asthma medication less frequent, and consultation of general practitioner and specialist required less commonly. All these parameters were statistical significantly improved in Pycnogenol® + ICS group versus the ICS control group where no considerable changes were observed. Various common signs and symptoms were evaluated by visual analog scale, (dry) cough, severity of chest symptoms, wheezing, dyspnea and daytime symptoms. In the ICS-only group values did not improve while they did improve significantly in the ICS + Pycnogenol® group (P<0.05 vs. ICS only group). A decrease by 15.2% of the specific IgE titer was found in the Pycnogenol® + ICS group, whereas the titer increased by 13.4% in the ICS-only group, while IgG1 and IgG4 remained unchanged in both groups. CONCLUSION: Pycnogenol® administration was effective for better control of signs and symptoms of allergic asthma and reduced the need for medication.

The Cooperative Italian FLIN Study Group: prevalence and clinico-pathological features of colorectal laterally spreading tumors.

BACKGROUND AND STUDY AIMS: Laterally spreading tumors (LSTs) are increasingly recognized as important precursors of colorectal carcinoma. The clinical behavior of these large nonpolypoid lesions is still uncertain. The aim of the present study was to assess prevalence and clinico-pathological features of LSTs in a large Italian cohort of patients. METHODS: The study was a subgroup analysis of a large database of patients undergoing total colonoscopy. The database originated from a multicenter cross-sectional observational study involving 80 centers throughout Italy. RESULTS: Data from 27,400 total colonoscopies were analyzed. Precancerous lesions were detected in 5609 patients. Of these, LSTs were identified in 254 patients (4.5%; 95% confidence interval [CI] 3.5-6.2). Granular-type LSTs (G-LSTs) accounted for 83% of the cases (211/254). LSTs were predominant in the proximal colon (154, 60.6%). A total 231 lesions were endoscopically removed, with histology being available for 242. Neoplasia was confirmed in 225 lesions (93.4%) (143 low grade adenoma, 76 high grade adenoma, and six submucosal cancer). The six cases of submucosally invasive carcinoma were diagnosed in five G-LST and one nongranular LST (NG-LST). The risk of containing advanced histology was not increased in G-LST compared with NG-LST (odds ratio [OR] 1.55, 95%CI 0.73-3.27); it was significantly higher in lesions with large nodules (OR 3.09, 95%CI 1.05-9.04; P = 0.041) or depressed surface (OR 4.27, 95%CI 1.24-14.61; P = 0.021). CONCLUSIONS: LSTs represent approximately 5% of all precancerous colorectal lesions in the Italian population and are prevalent in the proximal colon. These lesions are no more likely to harbor advanced histology than similar-sized polypoid lesions. Large nodularity or depressed surface are risk factors for advanced histology.

Kidney function in metabolic syndrome may be improved with Pycnogenol®.

AIM: We investigated benefits of Pycnogenol(R) as an adjunct to hypotensive medication in metabolic syndrome patients with micro-albuminurea. METHODS: Fifty eight patients were treated with Ramipril and a subgroup received Pycnogenol in addition for six months. Colour Doppler duplex ultrasound was employed for cortical flow measurements. RESULTS: Blood pressure decreased with Ramipril from 188.8/95.2 to 128.2/90.2, with additional Pycnogenol from 189.3/97.2 to 122.2/85.3 (P<0.05). Kidney function improved in both groups, with 24 hour urinary albumin decreasing from 88.8 to 68.9 mg with Ramipril and from 89.3 to 42.2 mg with additional Pycnogenol (P<0.05). In both groups treatment lowered serum creatinine, with combination treatment being significantly more effective. Cortical flow velocities significantly increased with Ramipril from systolic 17.2 +/- 3.1 to 23.8 +/- 2.0 cms-1 and diastolic 4.2+/-2.8 to 2.0+/-3.1 cms-1. The addition of Pycnogenol was more effective, improving cortical flow from systolic 18.2+/-2.2 to 27.2+/-2.9 cms-1 and diastolic 4.1+/-2.2 to 9.8+/-2.1 cms-1 (P>0.05). C-reactive protein (CRP) levels decreased marginally with Ramipril, but significantly with Pycnogenol from 2.17 to 1.62 mg/dL. Pycnogenol significantly lowered fasting blood glucose to 102.3 +/- 11.2 mg/mL and HbA1c to 6.9 +/- 0.3 %. The Pycnogenol group showed a significantly lowered BMI, from baseline 26.5+/-0.9 to 25.0+/-1.2 kgm-2, without reaching statistical significance versus control. Only a limited improvement of blood lipid profile was found in both groups. CONCLUSION: Pycnogenol should be further investigated for kidney function.