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.

Improvements to diagnostic techniques, medical surveillance and screening have allowed early detection of small asymptomatic thyroid lesions, although incidence of large thyroid cancers has increased. The role of environmental, lifestyle, medical and hormonal factors in thyroid cancer development remain under discussion. The aim of this study was to define associations between environmental, lifestyle, medical history and hormonal factors and thyroid tumors. This retrospective cross-sectional population-based study evaluated 246 patients admitted to the ‘SS. Annunziata’ Hospital in Chieti (Italy) for total thyroidectomy or lobectomy. Twenty-eight variables were collected using questionnaires and clinical records. Logistic regression analysis was used to analyze associations between these patient variables and thyroid histology, to identify novel risk factors, and to generate a multivariate model for thyroid tumour risk assessment. Univariate logistic regression analysis showed significant difference in median age for goiter versus thyroid tumour (Odds Ratio [OR]: 0.980; 95% Confidence Interval [CI], 0.962-0.998; P=0.033). Multivariate logistic regression analysis showed hyperthyroidism significantly associated with lower risk of thyroid tumour (hyperthyroidism versus hypothyroidism: OR: 0.174; 95% CI, 0.044-0.694; euthyroidism vs. hypothyroidism: OR: 1.760; 95% CI, 0.678-4.560; P<0.001). These data are supported by significant association with the respective thyroid treatments (in therapy: OR: 0.242; 95% CI, 0.128-0.458; P<0.001). Higher risk of thyroid tumour was significantly associated with single nodule versus multinodular lesions (uninodular: OR: 4.910; 95% CI, 2.240-10.800; P<0.001). Our results suggest that hyperthyroidism and the presence of multinodular lesions represent conditions infrequently associated with thyroid tumors. Mariangela Mazzone1, Maria Carmela Di Marcantonio1, Emira D'Amico2, Luisa Stellin3,4, Margherita Legnini2,5, Alberto D’Aulerio1,5, Luca Napolitano2,5, Roberto Cotellese2,5, Raffaella Muraro1, Anna Chiara Frigo6 and Gabriella Mincione1* 1Department of Innovative Technologies in Medicine and Dentistry, ‘G. d’Annunzio’ University of Chieti-Pescara, Italy 2Department of Medical, Oral and Biotechnological Sciences, ‘G. d’Annunzio’ University of Chieti-Pescara, Italy 3Department of Medicine and Aging Sciences, G. d’Annunzio’ University of Chieti-Pescara, Italy 4Division of Emergency Surgery, ‘SS Annunziata’ Hospital, Italy 5Division of General Surgery, ‘SS Annunziata’ Hospital, Italy 6Department of Cardiac-Thoracic-Vascular Sciences, University of Padua, Italy

Background: Gastrointestinal (GI) tract metastatic melanoma is an extremely rare entity. Only 2-4 % of patients with metastatic melanoma present repetition to GI tract organs. Among them, biliary tract metastases are among the rarest, and the small intestine, colon and stomach represent the most common sites of recurrence. Surgical treatment of these lesions could be indicated in symptomatic cases or in patients with isolated metastases with a curative intent.

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

OBJECTIVE:Oncological treatments are associated with toxicities that may decrease compliance to treatment in most genitourinary cancer patients. Supplementation with pharmaceutical-standardized supplement may be a supplementary method to control the side effects after chemo- and radiotherapy and the increased oxidative stress associated to treatments. This registry study evaluated a natural combination of supplements containing curcumin, cordyceps, and astaxanthin (Oncotris™) used as supplementary management in genitourinary cancer patients who had undergone oncological therapy. PATIENTS AND METHODS:Patients with genitourinary cancers (prostate or bladder malignancies) who had undergone and completed cancer treatments (radiotherapy, chemotherapy or intravesical immunotherapy with increased oxidative stress and residual symptoms) were recruited in this registry, supplement study. Registry subjects (n = 61) freely decided to follow either a standard management (SM) (control group = 35) or SM plus oral daily supplementation (supplement group = 26). Evaluation of severity of treatment-related residual side effects, blood count test, prostate-specific antigen (PSA) test and plasma free radicals (oxidative stress) were performed at inclusion and at the end of the observational period (6 weeks). RESULTS:Two patients dropped out during the registry. Therefore, the analysis included 59 participants: 26 individuals in the supplementation group and 33 in the control group. In the supplement group, the intensity of signs and symptoms (treatment-related) and residual side effects significantly decreased at 6 weeks: minimal changes were observed in controls. Supplementation with Oncotris™ was associated with a significant improvement in blood cell count and with a decreased level of plasmatic PSA and oxidative stress. CONCLUSIONS:Naturally-derived supplements, specifically Oncotris™ (patent pending), could support the body to overcome the treatment-related toxicities - and the relative oxidative stress in cancer patients.

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.

OBJECTIVE: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.PATIENTS AND METHODS: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.RESULTS: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.CONCLUSIONS:These preliminary results indicate the efficacy and safety of Movardol® supplementation in the management of moderate knee OA.

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.

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.

Adipogenesis is a continuous process even in adult adipose tissue for the presence of preadipocytes that, when subjected to appropriate stimuli can proliferate and differentiate. ChREBP, the essential transcription factor for lipogenesis, is expressed in all tissues, but mainly in lipogenic organs. In this study, we focused on ChREBP expression during preadipocytes differentiation. Since it was found that cyanidin-3 reduces body weight in mice even in the presence of a high-fat diet, by decreasing levels of blood glucose and by improving insulin sensitivity, we studied the effect of this substance on adipogenic differentiation. For this purpose we used preadipocytes obtained from subcutaneous and visceral human adipose explant tissue, characterized and stimulated to differentiate in selective media. On cytofluorimetric analysis these cells showed mesenchymal markers (CD29, CD90, CD44), whereas they were negative for hematopoietic markers (CD45, CD10, CD117,CD31). ChREBP expression levels were quantified by immunoelectron-microscopy and western blotting analysis. In this report we show that ChREBP is expressed in preadipocytes (both nuclear and cytoplasmic compartments); the cytoplasmic level of ChREBP increased by 50 percent on day seven of differentiation into mature adipocytes. Cyanidin reduced differentiation by 20 percent (as evaluated by red oil O staining) and the expression of ChREBP. In addition, cyanidin-treated cells showed abnormal morphology, a square shape with irregular size, probably due to the fact that cyanidin may interfere with the extracellular matrix. These findings suggest that dietary cyanidin, may have inhibitory effects on adipogenesis.

AIM The aim of this study was to evaluate the long-term efficacy of the sclerosing agent Atossisclerol in the treatment of benign, ecolucent, thyroid cysts. METHODS Two groups of cysts, one between 1 and 3 cm and a group smaller than 0.99 mm in maximum diameter (range 0.6-0.99) were considered in the inclusion plan. The localization of the cysts was at lobar level. A limited quantity of Atossisclerol (0.5 to 2%) was injected. RESULTS No side effects were noted. After 5 years in the group treated with the sclerosing agent 93% of the cysts were completely disappeared (vs 60% in controls). However the initial target cyst at 5 and years was completely cured in most patients (>80%) treated with the sclerosing agent; at 10 years more than 90% of the original, sclerosed target cysts were not visible. Another control of most of these patients (53/68) at 15 years indicated that sclerosis of the cyst is safe and allow a better occlusion/obliteration (in almost all patients) of the cyst in comparison with aspiration only (slow recurrence in some 25% of the cysts). CONCLUSION The sclerosing agent can be re-injected in the same patients without significant reaction or clinical problems or immunological reactions.

Background Liver resection is a curative treatment for hepatocellular carcinoma (HCC) [1]. Its role for the elderly remains undefined. In addition to surgery, percutaneous procedures have recently been proposed [2,3]. The choice of surgical and non-surgical therapy closely depends on the liver functional reserve and pre-existing co-morbidities.

Background: Surgery is the treatment of choice for localized Gastrointestinal stromal tumors (GIST). Complete resection, tumor size and biological behavior are the most important factors predicting good prognosis. GIST measuring 2 cm and larger should be treated aggressively, while for tumor smaller then 2 cm it is still under evaluation the role of surgery, the efficacy of chemotherapy and the benefits of follow-up with radiological surveillance.Methods: We present the experience of managing GIST in our Institute. The clinical-pathologicapl arameters, the histopathological behavior and the outcome of patients that underwent to surgery were examined.Results: This is a retrospective study of 9 patients with diagnosis of GIST observed from January 2000 to February 2009. The median age was 62 years (range: 45 to 74 years). The GIST size was in media 42 mm (range: 14 to 70 mm). Complete resection with microscopically tumor-free margins was archivied in all cases (2 with laparoscopic approach, 1 using video-assisted techniques). In one patient that undergo to hepatic primary tumor resection, the biopsy of 15 mm nodule of the stomach wall has showed GIST lesion. No evidence of recurrence was observed during the median follow-up of 55 months.Conclusions: Our patient'cohort showed a variation in the clinical presentation but not in the disease stages. All GISTs have been completely resected and in according to the benign biological behaviour was not required chemotherapy. However, all patients have been enrolled in follow-up program. Results of ongoing trials will established the role of a multidisciplinary approach for GIST therapy.

AimColorectal cancer is a disease of elderly people, since over 70% of cases occur in patients aged 65 years or older, and is a major cause of morbidity and mortality.The purpose of this study is to evaluate the outcome of surgical treatment in this population referred to our institution.