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Phthalates are ubiquitous pollutants that are currently classified as endocrine disruptor chemicals causing serious health problems. As contaminants of food and beverages, they come into contact with the epithelium of the intestinal tract. In this work, a SPE-HPLC-PDA method for the determination of phthalates in water from plastic bottles was developed and validated according to the food and drug administration (FDA) guidelines. A chromatographic separation was achieved using a mobile phase consisting of ammonium acetate buffer 10 mM pH 5 (line A) and a mixture of methanol and iso-propanol (50:50 v/v, line B) using gradient elution. Several SPE cartridges and different pH values were investigated for this study, evaluating their performance as a function of recovery. Among these parameters, pH 5 combined with the SPE sep pack C18 cartridge showed the best performance. Finally, the proposed method was applied to the analysis of real samples, which confirmed the presence of phthalates. A colonic epithelial cell model was used to evaluate the effects of these phthalates at the concentrations found in water from plastic bottles. In cells exposed to phthalates, the increased expression of factors, which control the signaling pathways necessary for intestinal epithelium homeostasis, inflammatory response, and stress was detected. The proposed method falls fully within the limits imposed by the guidelines with precision (RSD%) below 7.1% and accuracy (BIAS%) within −4.2 and +6.1.

The aim of this study was to evaluate the effects of RobuvitOne group of patients followed the Standard management (SM) and were assigned as controls while the supplementation group followed the SM and additionally took 2 Robuvit® capsules daily for 3 months (200 mg/day).34 subjects with NAFLD were included in the study. The two groups completing 90 days were comparable at baseline with 18 being supplemented with RobuvitRobuvit® improved liver function in NAFLD and prevented progression to liver fibrosis by improving hepatic metabolism in a relatively short period of time. Numerous people are affected by NAFLD, many of them with subclinical symptoms. But to date, there are no specific, definite treatment options. Prolonged evaluations of Robuvit® in a larger group of subjects is suggested.

The aim of this pilot registry study was to assess the preventive effect of an 8-week PycnogenolThe study was based on five types of observations: a. Karnofsky performance scale index; b. oxidative stress markers in plasma (plasma free radicals, PFR); c. the main signs and symptoms, evaluated by a physician; d. face motion and expressions and their symmetry, recorded with a high-speed video camera.A total of 79 patients were included in the study: 39 controls using only standard management (SM) and 40 subjects supplemented with PycnogenolIn conclusion, according to this pilot registry study, Pycnogenol

The aim of this registry study was to evaluate the preventive efficacy of PycnogenolTwo management groups were formed: one using the standard management (SM) and one using SM and PycnogenolForty-five subjects were included in the study, 21 took PycnogenolPycnogenol

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

Intestinal fat absorption shifting (IFAS) can be achieved with a polyglucosamine biopolymer (BP) able to retain most fats in the gut so that they are available to the intestinal microbiota (shift). The aim of this study was to evaluate the effects of the standard management (SM) of asymptomatic cardiovascular disease prevention on intima-media thickness (IMT) in comparison with SM combined with BP.Two groups (SM and SM+3 g BP/day) were compared. They consisted of 86 and 81 subjects respectively treated for 6 months. Anthropometric variables, vital signs, fat mass, lipid profile, oxidative stress, carotid IMT, granulations at the IM layer and near-wall low density bubbles were measured.Seventy-eight cases in the SM group and 81 in the SM+BP group completed the management period. Compliance was optimal (97%) with no side effects. The anthropometric variables, vital signs, fat mass and oxidative stress were significantly lower only in the SM+BP group (P0.05). Cholesterol and triglyceride levels improved with BP use (P0.05). The changes in IMT were reduced significantly (P0.05) in the SM+BP group only. The same was true for intimal granulation/bubbles.The preliminary results suggest that the IFAS caused by BP has a positive effect on IMT and arterial wall structure (thickness and low-density bubbles) even during a short period of management. The intestinal fat shifting and reduction in oxidative stress seem to limit lipid oxidation and deposition on the arterial wall.

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

BACKGROUND The aim of this registry study was to investigate the potential of a new food-grade formulation of the association of Boswellia serrata and Centella asiatica extracts (Boswellia/Centella Phytosome, [BCP]) in combination with standard management (SM) to produce a faster re-expansion of the intervertebral disks in symptomatic subjects with "flattened" disks in the lower spine, due to wrong posture and compression after repeated trauma. METHODS The study was designed as a 3-6 months pilot registry. Three groups of subjects were comparable for characteristics and symptoms at baseline: SM+BCP; SM; SM+glucosamine. RESULTS No side effects were observed. Regarding target measurements at 3 and 6 months, height increased in the BCP group vs. the other two groups. The total spine length improved in the BCP group (P

Back pain (BP) is one of the most common problems seen by general practitioners. The aim of this pilot registry study was to evaluate the effects of PycnogenolThe registry follow-up lasted 3 weeks. Subjects used either SM (standard management), including mild exercise and 3 days of resting or immobilization - or SM+PycnogenolEighty-two subjects were included in the study, 23 took PycnogenolPycnogenol

Simple Summary The dysregulation of Wnt pathways is involved in colorectal carcinogenesis. H2O2 differentially regulates the Wnt/β-Catenin pathway in colorectal cancer (CRC), but the molecular mechanisms remain unclear. Cellular stress might also stimulate APC protein production retaining some functions in N-terminus and lead to cancer progression. The effect of oxidative distress on Wnt/β-catenin signaling in the light of APC functions is unknown. We exposed starved HCT116, SW480 and SW620 CRC cell lines to H2O2-induced short-term oxidative stress. This treatment promoted the activation of β-Catenin and increased cytoplasmic APC. H2O2 regulated gene expression, related to cellular phenotype and stimulated both Wnt/β-Catenin-dependent and -independent signaling. These findings suggest that oxidative distress may influence APC functions in Wnt signaling and open up new perspectives to develop personalized therapeutic approaches for CRC. Abstract Colorectal cancer (CRC) is a multistep process that arises in the colic tissue microenvironment. Oxidative stress plays a role in mediating CRC cell survival and progression, as well as promoting resistance to therapies. CRC progression is associated with Wnt/β-Catenin signaling dysregulation and loss of proper APC functions. Cancer recurrence/relapse has been attributed to altered ROS levels, produced in a cancerous microenvironment. The effect of oxidative distress on Wnt/β-Catenin signaling in the light of APC functions is unclear. This study evaluated the effect of H2O2-induced short-term oxidative stress in HCT116, SW480 and SW620 cells with different phenotypes of APC and β-Catenin. The modulation and relationship of APC with characteristic molecules of Wnt/β-Catenin were assessed in gene and protein expression. Results indicated that CRC cells, even when deprived of growth factors, under acute oxidative distress conditions by H2O2 promote β-Catenin expression and modulate cytoplasmic APC protein. Furthermore, H2O2 induces differential gene expression depending on the cellular phenotype and leading to favor both Wnt/Catenin-dependent and -independent signaling. The exact mechanism by which oxidative distress can affect Wnt signaling functions will require further investigation to reveal new scenarios for the development of therapeutic approaches for CRC, in the light of the conserved functions of APC.

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

To analyze the minimally invasive surgical maneuvers currently performed to remove pancreatic tail, with or without preservation of the spleen, for benign and borderline malignant neoplasms.We described operative steps and technical pitfalls encountered during laparoscopic and robotic distal pancreatectomy. The methodology of research focused on recruitment of evidence-based surgical strategies and critical analysis of modern minimally invasive techniques.Laparoscopic and robotic distal pancreatectomy have gradually accepted by pancreatic surgeons and clinical evidences document its growing interest. The choice of patient positioning, port placement, surgical dissection and operative techniques used for pancreatic parenchymal transection is not codified and changes according to personal preference. The technical variability in minimally invasive approach to pancreatic surgery strongly depends depends on surgeon's training and to limited application of these procedures in single institutions.Pancreatic surgeons worldwide accept laparoscopic and robotic distal pancreatectomy but the best intraoperative praxis is not defined in clinical routine. To date, the pancreatic resection adopts hybrid techniques and the conduction of minimally invasive resection depends to surgeon's experience, patient body habitus and location of pancreatic lesion. Although several technical variations have described, no standardization of the operative minimally invasive surgical method is convincingly built.Laparoscopy, Minimally invasive surgery, Pancreas, Robotic pancreatectomy.Analizzare le manovre chirurgiche mininvasive attualmente in uso e necessarie per asportare la coda del pancreas, con o senza la tecnica di preservazione della milza, nei casi di neoplasie pancreatiche benigne e borderline.riportiamo la descrizione dei tempi operatori e la valutazione delle difficoltà tecniche riscontrate durante la pancreasectomia distale laparoscopica e robotica. Il metodo di ricerca si focalizza sul reclutamento delle strategie chirurgiche più attuali e basate sull’evidenza clinica, oltre che sull’analisi critica delle moderne tecniche mininvasive.La pancreasectomia distale laparoscopica e robotica sono state gradualmente accettate dai chirurghi del pancreas e le evidenze cliniche dimostrano il dilagante interesse scientifico. La scelta della posizione operatoria del paziente, la disposizione dei trocars sulla parete addominale, la scelta delle tecniche operatorie di dissezione e la condotta chirurgica di resezione del parenchima pancreatico non sono state codificate e variano secondo l’esperienza del chirurgo. La variabilità dell’approccio mininvasivo dipende notevolmente dal training del chirurgo e dalle limitate applicazioni della metodica stessa nei singoli centri.In tutto il mondo i chirurgi del pancreas hanno accettato le tecniche di pancreasectomia distale laparoscopica e robotica ma la strategia chirurgica operatoria non è stata codificata nella pratica clinica. Ad oggi la resezione del pancreas viene condotta con tecniche ibride e la variabilità dell’approccio chirurgico mininvasivo dipende in modo significativo dall’esperienza del chirurgo, dall’abitus del paziente e dalla localizzazione della lesione pancreatica. Nonostante le numerose variazioni di tecnica chirurgica finora descritte durante l’intervento di pancreasectomia distale, nessuna standardizzazione del metodo operatorio mininvasivo è stato definito in modo convincente.

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

BACKGROUND To examine the outcome of patients treated with complete mesocolic excision (CME) with central vascular ligation (CVL) after conventional and laparoscopic surgery. METHODS We retrospectively evaluated stage I-IV colon adenocarcinoma patients treated by the same surgeon (L.M.) from 2013 to 2018. Postoperative complications, recurrences and survival are assessed. RESULTS Fifty-one patients (M/F: 24/27) underwent laparoscopic right hemicolectomy with CME (L-CME) or open CME (O-CME) plus CVL. Tumour location was the caecum in 39.2% of cases, the transverse in 23.5%, the hepatic colonic flexure in 21.5%, and the ascending colon in 15.6%. Twenty-four patients underwent L-CME while 27 underwent O-CME. More than 15 harvested lymphnodes are reported in 74.1% of O-CME patients and in 66.7% of L-CME patients (p = 0.562). Postoperative complications occurred in 7 O-CME and 5 L-CME patients, respectively (p = 0.669). Three-year overall survival, including stage IV, was of 75% versus 77.8% for L-CME and O-CME patients, respectively, while for stage I-III, was of 88.9% vs. 80% in L-CME and O-CME, respectively (p = 0.440). The median follow-up was of 2.43 years. CONCLUSION CME with CVL is a meticulous, complex but feasible technique. In our experience, oncological results in terms of recurrences and overall survival, after conventional and laparoscopic CME plus CVL, are comparable. Patients with stage I-III colon adenocarcinoma have a better prognostic trend especially when more than 15 lymphnodes are removed. The respect of oncological radicality and the correct indication to minimally invasive surgery are the undiscussed key outcome variables.

Pancreatic ductal adenocarcinoma is one of the most threatening solid malignancies. Molecular and cellular mediators that activate paracrine signalling also regulate the dynamic interaction between pancreatic cancer cells and nerves. This reciprocal interface leads to perineural invasion (PNI), defined as the ability of cancer cells to invade nerves, similar to vascular and lymphatic metastatic cascade. Targeting PNI in pancreatic cancer might help ameliorate prognosis and pain relief. In this review, the modern knowledge of PNI in pancreatic cancer has been analysed and critically presented. We focused on molecular pathways promoting cancer progression, with particular emphasis on neuropathic pain generation, and we reviewed the current knowledge of pharmacological inhibitors of the PNI axis. PNI represents a common hallmark of PDAC and correlates with recurrence, poor prognosis and pain in pancreatic cancer patients. The interaction among pancreatic cancer cells, immune cells and nerves is biologically relevant in each stage of the disease and stimulates great interest, but the real impact of the administration of novel agents in clinical practice is limited. It is still early days for PNI-targeted treatments, and further advanced studies are needed to understand whether they could be effective tools in the clinical setting.

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

BACKGROUND: The aim of this open supplement study was to evaluate the effects of Pycnogenol® in comparison with controls on symptoms of post-COVID-19 syndrome and in improving endothelial function, microcirculation, inflammatory markers and oxidative stress over 3 months in symptomatic subjects recovering from COVID-19. METHODS: Sixty subjects recovering from symptomatic COVID-19 were included. One group of 30 followed a standard recovery management while 30 comparable subjects received a supplement of 150 mg Pycnogenol® daily (in 3 doses of 50 mg) in addition to standard management. RESULTS: Two groups of selected subjects were comparable at baseline. The groups progressively improved both with the SM (standard management) and with the SM in combination with the supplement. Patients, supplemented with Pycnogenol® showed significantly better improvement compared to the control group patients. No side effects from the supplementation were observed; tolerability was optimal. The progressive evolution over time was visible in all target measurements. Physiological tests. Endothelial function, low in all subjects at inclusion was assessed by flow mediated dilation (FMD) and finger reactive hyperemia in the microcirculation (laser Doppler measurements) after the release of an occluding suprasystolic cuff). It was significantly improved in the Pycnogenol® group after one month and after 3 months (p

Background. Intestinal microbiota dysbiosis may enhance the carcinogenicity of colon cancer (CC) by the proliferation and differentiation of epithelial cells. Oral Fusobacterium nucleatum (Fn) and Porphyromonas gingivalis (Pg) have the ability to invade the gut epithelium, promoting tumor progression. The aim of the study was to assess whether the abundance of these odontopathogenic bacteria was associated with colon cancer. We also investigated how lifestyle factors could influence the oral Fn and Pg abundance and CC. Methods. Thirty-six CC patients were included in the study to assess the Pg and Fn oral and colon tissue abundance by qPCR. Oral health data, food habits and lifestyles were also recorded. Results. Patients had a greater quantity of Fn in the oral cavity than matched CC and adjacent non-neoplastic mucosa (adj t) tissues (p = 0.004 and p &lt, 0.001). Instead, Pg was not significantly detected in colonic tissues. There was an association between the Fn quantity in the oral and CC tissue and a statistically significant relation between the Fn abundance in adenocarcinoma (ADK) and staging (p = 0.016). The statistical analysis revealed a tendency towards a greater Fn quantity in CC (p = 0.073, η2p = 0.12) for high-meat consumers. Conclusion. In our study, Pg was absent in colon tissues but was correlated with the oral inflammation gingival and plaque indices. For the first time, there was evidence that the Fn oral concentration can influence colon tissue concentrations and predict CC prognosis.

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

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

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

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

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

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

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

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

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

BACKGROUND The aim of this pilot study was to evaluate the effects of Pycnogenol® and CA (Centellicum®) on penile fibrosis and on associated signs and symptoms. METHODS A group of 82 subjects with penile nodules and plaques was included in this registry study and followed up for 3 months; 32 were managed with standard management (SM) only. Twenty-four were managed with CA (Centellicum®: 3 capsules/day: 675 mg/day) in association with SM, and 26 subjects were managed with Pycnogenol® (150 mg/day) + CA (Centellicum® at the same dosage as in group 2) and SM. RESULTS Subjects in the 3 groups were comparable, including the distribution of plaques. The occurrence of any previous catheterizations was also comparable. Safety and tolerability were optimal, no subjects had to stop supplementation. The percentage of subjects with improved symptoms evaluated with a Visual Analogue Scale line was significantly higher with both supplements in comparison with SM (P

The cost effectiveness of the laparoscopic right hemicolectomy is still debated, and the current literature does not allow to be drawn certain conclusion. Our study compared direct clinical costs and outcomes for laparoscopic right hemicolectomy with the two most used type of anastomosis, such as ExtraCorporeal Anastomosis (ECA) and IntraCorporeal Anastomosis (ICA).In this retrospective study, all patients who underwent laparoscopic right hemicolectomy with intracorporeal and extracorporeal anastomosis between January 2016 and April 2018 were evaluated. Patients were divided into two groups according to the type of anastomosis: ECA or ICA.Thirty ECA and twenty-nine ICA patients were included in the study. Operative time was significantly longer in ICA group than ECA group (p0.001). No significant differences between the groups were seen in terms of timeto- first flatus, postoperative complications and re-admission rate. ICA group showed a shorter hospitalization (5 vs 6; p0.022). In the ICA group, considering only the surgical tools were more expensive than in ECA (1435.6 € vs 72 €). Nevertheless, the total cost of the two procedures in similar (14451.36 € in ECA group vs 14631.04 € in ICA group).ECA and ICA are comparable in terms of postoperative outcomes. ICA requires much more expensive charges, compared to a minor hospitalization. The ECA seems to be less expensive in terms of surgical supplies but the longer recovery determines an increase in the total cost resulting in a non-inferiority of one compared to the other technique.Cost-analysis, ExtraCorporeal Anastomosis, IntraCorporeal Anastomosis, Laparoscopy, Right Hemicolectomy.Il rapporto costo-efficacia dell’emicolectomia destra laparoscopica è tuttora oggetto di dibattito, ed un’analisi della letteratura attuale non consente di trarre conclusioni certe. Il nostro studio ha l’obiettivo di comparare i costi clinici diretti ed indiretti dell’emicolectomia destra laparoscopica mediante due tipologie di anastomosi: anastomosi extracorporea (Extra Corporeal Anastomosis) ed anastomosi intracorporea (Intra Corporeal Anastomosis).Retrospettivamente, dal Gennaio 2016 ad Aprile 2018, sono stati valutati tutti i pazienti sottoposti ad emicolectomia destra laparoscopica con anastomosi intracorporea ed extracorporea. In base al tipo di anastomosi utilizzata i pazienti sono stati divisi in due gruppi: gruppo ECA e gruppo ICA.Trenta ECA e venti-nove ICA sono stati inclusi nello studio. Il tempo operatorio è risultato significativamente più lungo nel gruppo ICA rispetto al gruppo ECA (p0.001). Non ci sono state significative differenze per quanto riguarda la prima canalizzazione, le complicanze post operatorie ed il tasso di riammissione. I pazienti sottoposti ad anastomosi intracorporea (ICA) hanno avuto tempi di degenza ospedaliera ridotti se comparati ai pazienti sottoposti ad anastomosi extracorporea (5 vs 6; p0.022). Considerando i costi diretti dei soli presidi chirurgici, il gruppo ICA è risultato più dispendioso rispetto al gruppo ECA (1435.6 € vs 72 €). Tuttavia, il costo totale delle due procedure, considerando anche i costi di degenza, (14451.36 € nel gruppo ECA versus 14631.04 € nel gruppo ICA) risultano equivalent.Le anastomosi extracorporea ed intracorporea risultano comparabili in termini di costi clinici ed outcome post-operatorio. L’anastomosi intracorporea (ICA) implica costi più elevati ma una ospedalizzazione minore. L’anastomosi extracorporea sembra essere meno costosa in termini di presidi utilizzati, ma la più lunga degenza ospedaliera media determina un’aumento dei costi totali risultando in una non-inferiorità dell’una o dell’altro tecnica.