Emotion dysregulation, impulsivity and anger rumination in borderline personality disorder: the role of amygdala and insula.

Borderline Personality Disorder (BPD) is a severe mental disorder, characterized by deficits in emotion regulation, interpersonal dysfunctions, dissociation and impulsivity. Brain abnormalities have been generally explored; however, the specific contribution of different limbic structures to BPD symptomatology is not described. The aim of this study is to cover this gap, exploring functional and structural alterations of amygdala and insula and to highlight their contribution to neuropsychiatric symptoms. Twenty-eight BPD patients (23.7 ± 3.42 years; 6 M/22F) and twenty-eight matched healthy controls underwent a brain MR protocol (1.5 T, including a 3D T1-weighted sequence and resting-state fMRI) and a complete neuropsychiatric assessment. Volumetry, cortical thickness and functional connectivity of amygdala and insula were evaluated, along with correlations with the neuropsychiatric scales. BPD patients showed a lower cortical thickness of the left insula (p = 0.027) that negatively correlated with the Anger Rumination Scale (p = 0.019; r = - 0.450). A focused analysis on female patients showed a significant reduction of right amygdala volumes in BPD (p = 0.037), that correlate with Difficulties in Emotion Regulation Scale (p = 0.031; r = - 0.415), Beck Depression Inventory (p = 0.009; r = - 0.50) and Ruminative Response Scale (p = 0.045; r = - 0.389). Reduced functional connectivity was found in BPD between amygdala and frontal pole, precuneus and temporal pole. This functional connectivity alterations correlated with Anger Rumination Scale (p = .009; r = - 0.491) and Barratt Impulsiveness Scale (p = 0.020; r = - 0.447). Amygdala and insula are altered in BPD patients, and these two limbic structures are implicated in specific neuropsychiatric symptoms, such as difficulty in emotion regulation, depression, anger and depressive rumination.

Post-operative morbidity in Crohn's disease: what is the impact of patient-, disease- and surgery-related factors?

PURPOSE: Over 50% of patients suffering from Crohn's disease (CD) require surgery in their lifetime. Predictors/risk factors of post-operative morbidity and mortality in CD are poorly investigated. We aimed to assess the risk factors of post-operative morbidity/mortality in CD. METHODS: We performed a retrospective cohort study in which all CD patients operated and followed up at our tertiary Inflammatory Bowel Disease Centre from 2014 to 2019 were enrolled. For each patient, we evaluated patient-dependent, disease-dependent and surgery-dependent variables. All patients underwent small bowel and/or colic resections. RESULTS: Of the 165 operated patients, forty-two (25.5%) developed post-operative complications (major complication rate = 9.8%) including wound infection (12.1%), respiratory complications (4.8%), prolonged ileum (4.2%), anastomotic leak (3.6%), urinary infections (3%), abdominal abscess (2.4%), anastomotic bleeding (3.6%), abdominal bleeding (1.2%) and obstruction (0.6%). Two subjects (1.2%) required re-operation within 30 days, and one died. A surgery duration < 141 min was predictive of a better post-operative outcome (sensitivity 80.9%, specificity 43.1%, PPV 32.7%, NPV 86.9%). The multivariable analysis showed stricturing/fistulizing behaviour (OR 3.7, 95% CI 1.6-6.4, p = 0.02), need for total parenteral nutrition (OR 4.1, 95% CI 2.4-9.2, p = 0.01), pre-operative bowel cleansing (OR 0.6, 95% CI 0.41-0.83, p = 0.01) and surgery duration < 141 min (OR 0.2, 95% CI 0.08-0.7, p = 0.03) as the only risk factors associated with post-operative morbidities. CONCLUSIONS: About 25% of CD patients develop post-operative complications. Several patient-related, disease-related and surgery-related factors should be considered risk factors for post-operative morbidity. The recognition of these factors, as well as a multidisciplinary approach to the pre-operative management of CD, could reduce post-operative complications.

Structural basis for the coiled-coil architecture of human CtIP.

The DNA repair factor CtIP has a critical function in double-strand break (DSB) repair by homologous recombination, promoting the assembly of the repair apparatus at DNA ends and participating in DNA-end resection. However, the molecular mechanisms of CtIP function in DSB repair remain unclear. Here, we present an atomic model for the three-dimensional architecture of human CtIP, derived from a multi-disciplinary approach that includes X-ray crystallography, small-angle X-ray scattering (SAXS) and diffracted X-ray tracking (DXT). Our data show that CtIP adopts an extended dimer-of-dimers structure, in agreement with a role in bridging distant sites on chromosomal DNA during the recombinational repair. The zinc-binding motif in the CtIP N-terminus alters dynamically the coiled-coil structure, with functional implications for the long-range interactions of CtIP with DNA. Our results provide a structural basis for the three-dimensional arrangement of chains in the CtIP tetramer, a key aspect of CtIP function in DNA DSB repair.

Natural history of SARS-CoV-2 infection in healthcare workers in Northern Italy.

At present, the time-frame used for the quarantine of individuals with coronavirus disease 2019 (COVID-19) is the entire duration of symptoms plus 14 days after symptom recovery; however, no data have been reported specifically for healthcare workers (HCWs). In the study population of 142 HCWs with COVID-19, the mean time for viral clearance was 31.8 days. Asymptomatic subjects cleared the virus more quickly than symptomatic subjects (22 vs 34.2 days; P<0.0001). The presence of fever at the time of diagnosis was associated with a longer time to viral clearance (relative risk 11.45, 95% confidence interval 8.66-14.25; P<0.0001). These findings may have a significant impact on healthcare strategies for the future management of the COVID-19 pandemic.

Factors affecting respiratory system compliance in anaesthetised mechanically ventilated healthy dogs: a retrospective study.

OBJECTIVES: To determine the influence of several factors on respiratory system compliance in volume-controlled mechanically ventilated healthy anaesthetised dogs. MATERIALS AND METHODS: Review of 100 dogs anaesthetised for elective surgeries between 2015 and 2016. Dogs were mechanically ventilated with a respiratory rate adjusted to maintain normocapnia and a fraction of inspired oxygen of 50%. Body weight, body condition score, age, thoracic shape, time in spontaneous ventilation before volume-controlled ventilation, time with a fraction of inspired oxygen of 100% until starting mechanical ventilation, type of surgery and patient position were recorded. Respiratory system compliance, expressed per kg of bodyweight, was recorded every 15 minutes following initiation of volume-controlled ventilation. RESULTS: Baseline respiratory system compliance was 1.3 ± 0.3 mL/cmH2 O/kg and was reduced by high body condition score and barrel-shaped thorax but not by age, type of surgery or patient position, time in spontaneous ventilation nor time with a fraction of inspired oxygen of 100%. CLINICAL SIGNIFICANCE: Respiratory system compliance is lower in overweight and barrel-chested dogs and should be taken into account during monitoring of lung function and ventilation management under general anaesthesia.

Comparison of the Hepatotoxic Potential of Two Treatments for Autosomal-Dominant Polycystic Kidney DiseaseUsing Quantitative Systems Toxicology Modeling.

PURPOSE: Autosomal-dominant polycystic kidney disease (ADPKD) is an orphan disease with few current treatment options. The vasopressin V2 receptor antagonist tolvaptan is approved in multiple countries for the treatment of ADPKD, however its use is associated with clinically significant drug-induced liver injury. METHODS: In prior studies, the potential for hepatotoxicity of tolvaptan was correctly predicted using DILIsym®, a quantitative systems toxicology (QST) mathematical model of drug-induced liver injury. In the current study, we evaluated lixivaptan, another proposed ADPKD treatment and vasopressin V2 receptor antagonist, using DILIsym®. Simulations were conducted that assessed the potential for lixivaptan and its three main metabolites to cause hepatotoxicity due to three injury mechanisms: bile acid accumulation, mitochondrial dysfunction, and oxidative stress generation. Results of these simulations were compared to previously published DILIsym results for tolvaptan. RESULTS: No ALT elevations were predicted to occur at the proposed clinical dose for lixivaptan, in contrast to previously published simulation results for tolvaptan. As such, lixivaptan was predicted to have a markedly lower risk of hepatotoxicity compared to tolvaptan with respect to the hepatotoxicity mechanisms represented in DILIsym. CONCLUSIONS: These results demonstrate the potential for using QST methods to differentiate drugs in the same class for their potential to cause hepatotoxicity.

Carcaça e componentes não carcaça de cordeiros terminados em confinamento com caroço de algodão na dieta / Carcass and non carcass components of lambs finished in feedlot with cottonseed on the diet

O objetivo deste estudo foi avaliar as características de carcaça e dos componentes não carcaça de cordeiros terminados em confinamento, com diferentes proporções de caroço de algodão na dieta. Foram utilizados 45 cordeiros, machos, não castrados, da raça Ile de France. Os tratamentos foram constituídos por níveis de inclusão de caroço de algodão na matéria seca (MS) da dieta total (0%; 10%; 20%; 30% ou 40%), sendo a dieta composta por silagem de milho (Zea mays L.), grão de milho triturado (Zea mays L.), farelo de soja (Glycine max L.), caroço de algodão (Gossypium hirsutum L.), calcário calcítico e sal mineral, em proporção de volumoso:concentrado de 40:60. Os animais foram abatidos com peso de abate preestabelecido. O peso de carcaça quente e o peso de carcaça fria, bem como o índice de quebra ao resfriamento, o índice de compacidade, a conformação e o estado de engorduramento da carcaça, não foram influenciados (P>0,05) pelo nível de inclusão de caroço de algodão na dieta. As características de rendimento de carcaça quente e rendimento de carcaça fria diminuíram linearmente (P≤0,05) à medida que se incluiu caroço de algodão na dieta. Com relação à medida de espessura de gordura de cobertura, pode-se observar que houve comportamento quadrático crescente e, em relação à variável área de olho de lombo, o comportamento observado foi o linear decrescente. Quanto às proporções dos cortes comerciais da carcaça, o peso de perna diminuiu linearmente (P≤0,05) enquanto a porcentagem de perna foi influenciada de forma quadrática (P≤0,05) pela inclusão de caroço de algodão nas dietas. O trato gastrointestinal cheio e o conteúdo do trato gastrointestinal aumentam linearmente (P≤0,05) com o incremento do nível de inclusão de caroço de algodão na dieta. Algumas das características de carcaça e dos componentes não carcaça tiveram influência negativa da elevação do teor de fibra e de lipídios da dieta à medida que se incluiu caroço de algodão na dieta total.(AU)

The objective of this study was to evaluate the carcass and non carcass components characteristics of lambs finished in feedlot with different proportions of cottonseed on the diet. Forty five lambs, non castrated males, from Ile de France race. The treatments were constituted by levels of inclusion of cottonseed on dry matter (DM) of the total diet (0%; 10%; 20%; 30% or 40%), being the diet composed by corn silage (Zea mays L.), ground corn grain (Zea mays L.), soybean meal (Glycine max L.), cottonseed (Gossypiumhirsutum L.), limestone and mineral salt in a roughage: concentrate proportion of 40:60. The animals were slaughtered with a pre- established slaughter weight. The hot and cold carcass weight, as well as the carcass chilling index, the compactness index, the conformation and the fattening state of the carcass were not influenced (P> 0.05) by the level of inclusion of cottonseed on the diet. The hot and cold carcass yield decreased linearly (P≤ 0.05) as the cottonseed was included on the diet. Regarding the subcutaneous fat thickness it is possible to observe that there was a crescent quadratic behavior and in relation to the rib eye area variable, the behavior observed was linear decrescent. Regarding the proportions of the commercial cuts of the carcass, the leg weight decreased linearly (P≤ 0.05) while the percentage of leg was quadratic influenced (P≤ 0.05) by the inclusion of cottonseed on the diets. The full gastrointestinal tract and the gastrointestinal tract content increased linearly (P≤ 0.05) with the increase on the level of inclusion of cottonseed on the diet. Some of the carcass and non carcass components characteristics had negative influence of level fiber content and dietary lipids as it included cottonseed in the total diet.(AU)

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

The aim of this registry study was to compare products used to control symptoms of CVI. Endpoints of the study were microcirculation, effects on volume changes, and symptoms (analogue scale). Pycnogenol, venoruton, troxerutin, the complex diosmin-hesperidin, Antistax, Mirtoselect (bilberry), escin, and the combination Venoruton-Pycnogenol (VE-PY) were compared with compressions. No safety or tolerability problems were observed. At inclusion, measurements in the groups were comparable: 1,051 patients completed the registry. Best performers : Venoruton, Pycnogenol, and the combination VE-PY produced the best effects on skin flux. These products and the combination VE-PY better improved PO 2 and PCO 2 . The edema score was decreased more effectively with the combination and with Pycnogenol. Venoruton; Antistax also had good results. Considering volumetry, the best performers were the combination PY-VE and the two single products Venoruton and Pycnogenol. Antistax results for edema were also good. The best improvement in symptoms score were obtained with Pycnogenol and compression. A larger decrease in oxidative stress was observed with Pycnogenol, Venoruton, and with the VE-PY combination. Good effects of Antistax were also observed. Parestesias were lower with Pycnogenol and with Antistax. Considering the need for interventions, the best performers were Pycnogenol, VE-PY, and compression. The efficacy of Pycnogenol and the combination are competitive with stockings that do not have the same tolerability in warmer climates. A larger and more prolonged evaluation is suggested to evaluate cost-efficacy (and non-interference with drugs) of these products in the management of CVI. The registry is in progress; other products are in evaluation.

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.

A novel lecithin based delivery form of Boswellic acids (Casperome®) for the management of osteo-muscular pain: a registry study in young rugby players.

OBJECTIVE: Several experimental studies and clinical trials support the potential of Boswellia serrata extracts (BSE) for the treatment of various inflammatory diseases. The aim of this registry study was to assess the safety and the efficacy of a novel lecithin-based delivery form of Boswellia serrata extract (Casperome®) in the supportive management of osteo-muscular pain. PATIENTS AND METHODS: 52 healthy young rugby players with acute knee pain and inflammation were recruited. Informed participants freely decided to follow either a standard management (SM) to control joint pain (control group = 27) or SM associated with oral daily supplementation with Casperome® (supplement group =25). Parameters associated with osteo-muscular pain and inflammation, and measurements of joint health and functions were assessed at the inclusion and after a 4-week supplementation. RESULTS: A significant beneficial effect of Casperome® vs SM alone was observed for all the parameters evaluated, namely: local pain on effort; pain-free walking distance (treadmill test); minimal joint effusion; structural damage (joint, tendons, muscles) and intramuscular hematomas; thermal imaging of the anterior knee; Visual Analog Scale for Pain (VAS Pain); need for concomitant drugs and medical attention; measurement of inflammatory biomarkers. CONCLUSIONS: Our registry study suggests that Casperome® supplementation could represent an effective and safe, integrated approach for the treatment of osteo-muscular pain and inflammation.

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.

The coming of age of the mitochondria-ER contact: a matter of thickness.

The sites of near-contact between the mitochondrion and the endoplasmic reticulum (ER) have earned a lot of attention due to their key role in the maintenance of lipid and calcium (Ca(2+)) homeostasis, in the initiation of autophagy and mitochondrial division, and in sensing metabolic shifts. At these sites, typically called MAMs (mitochondria-associated ER membranes) or MERCs (mitochondria-ER contacts), the organelles juxtapose at a distance that can range from ~10 to ~50 nm. The multifunctional role of this subcellular compartment is puzzling; further, recent studies have shown that mitochondria-ER contacts are highly plastic structures that remodel upon metabolic transitions and that their activity in controlling lipid homeostasis could be involved in Alzheimer's disease pathogenesis. This review aims at integrating the functions of this subcellular compartment to its most characterizing and unexplored structural parameter, their 'thickness': that is, the width of the cleft that separates the cytosolic face of the outer mitochondrial membrane from that of the ER. We describe and discuss the reasons why the thickness of a MERC should be considered a regulated structural parameter of the cell that defines and controls its function. Further, we propose a MERC classification that will help organize the expanding field of MERCs biology and of their role in cell physiology and human disease.

Long-term Clinical Outcome and Functional Status After Arterial Reconstruction in Upper Extremity Injury.

OBJECTIVE/BACKGROUND: To analyse long term outcome, including functional status and prognostic factors, in patients who have undergone arterial repair of civilian upper limb injury. Retrospective data analysis of prospectively collected data was performed. METHODS: This was a retrospective data analysis of prospectively collected data. Records of all patients who had undergone repair of traumatic arterial lesions in the upper limb between 1989 and 2010 were reviewed, and clinical follow up was performed. End points were: long term patency, measured by color Doppler ultrasound; vascular re-intervention; limb salvage rate; and long term functional status using the Disabilities of Arm, Shoulder, and Hand (DASH) questionnaire. The DASH questionnaire is an instrument used to identify a patient's disabilities, in which everyday activities are assessed by 30 questions. The DASH answers are summarized and, using a conversion formula, lead to a score between 0 (full recovery) and 100 (severe disability). The DASH questionnaire was sent to all German-speaking individuals for data supplementation after completion of a clinical follow up study. RESULTS: A total of 117 arterial repairs were performed in 108 patients (87 men, median age 35.7 years). Blunt trauma was the predominant cause of injury (n = 96; 82%). Accompanying nerve lesions (n = 39; 36%) and/or orthopedic injuries (n = 65; 60%) were present in 84 patients (78%). After a median follow up time of 5.3 years (range 0.5-19.7 years), 65 patients (60%) were re-investigated: long-term patency was 97%. The DASH questionnaire was answered by 57 patients (53%). Functional impairment was frequently seen, and determined by neurological injury (including neurological lesions, median DASH score was 40.3 [range 3.5-69.8] vs. 0.8 [range 0-5.8] without; p < .001) and ischemia at time of injury (median DASH score with ischemia 4.2 [range 0-16.9] vs. 0.0 [0-1.7] without; p < .04). CONCLUSION: Favorable long term patency rates after arterial repair in upper extremity injuries can be achieved. Long term functional impairment is a significant problem and determined by associated neurological injury, as well as ischemia at time of injury.

Minimal asbestos exposure in germline BAP1 heterozygous mice is associated with deregulated inflammatory response and increased risk of mesothelioma.

Germline BAP1 mutations predispose to several cancers, in particular malignant mesothelioma. Mesothelioma is an aggressive malignancy generally associated with professional exposure to asbestos. However, to date, we found that none of the mesothelioma patients carrying germline BAP1 mutations were professionally exposed to asbestos. We hypothesized that germline BAP1 mutations might influence the asbestos-induced inflammatory response that is linked to asbestos carcinogenesis, thereby increasing the risk of developing mesothelioma after minimal exposure. Using a BAP1(+/-) mouse model, we found that, compared with their wild-type littermates, BAP1(+/-) mice exposed to low-dose asbestos fibers showed significant alterations of the peritoneal inflammatory response, including significantly higher levels of pro-tumorigenic alternatively polarized M2 macrophages, and lower levels of several chemokines and cytokines. Consistent with these data, BAP1(+/-) mice had a significantly higher incidence of mesothelioma after exposure to very low doses of asbestos, doses that rarely induced mesothelioma in wild-type mice. Our findings suggest that minimal exposure to carcinogenic fibers may significantly increase the risk of malignant mesothelioma in genetically predisposed individuals carrying germline BAP1 mutations, possibly via alterations of the inflammatory response.

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.

Phyto-relief CC: prevention of cold episodes. Control of signs/symptoms and complications.

The aim of this supplement, registry study was to evaluate the effects of the use of standardized, oral supplement (Phyto-Relief CC, Alchem). Phyto-Relief CC includes anti-inflammatory, anti-oxidant and anti- edema natural compounds. Increased salivation produced by ginger is useful in the prevention of cold episodes and on signs and symptoms associated to the episodes by increasing saliva and its content (i.e. lysozyme). Main targets of the study were the evaluation of the occurrence of episodes and the reduction of signs/symptoms, the reduction of days of disease, the reduction in the use of other treatments and the control of cold-related complications. RESULTS: The two resulting registry groups were comparable. There were 5 full episodes (lasting at least 3 days) of cold in 61 registry subjects (8.1%) in comparison with 17 cases in 63 subjects (26.98%) in controls. Phyto-Relief CC subjects - even in this time-limited and small study population registry - had 30.1% of the episodes of the control group with a reduction of 69.88% of the cold episodes (p<0.0221). Also in the following, continuation, third week only 3 episodes of cold were recorded in the Phyto- Relief CC group vs 6 (50% reduction) observed in controls. All the other chosen parameters were better in the supplement group (p<0.05). Affected days (2.9;1.1 vs 4.6; 1.2 in controls), lost working days (0.58;0.5 vs 1.02;0.43 in controls. The use of any other OTC product, nasal drops, aspirin, Vit C, antihistamines, aerosols, the number of complications after 4 days were better in the Phyto-Relief CC group. Disease 'extension' (to >4 days), particularly tracheal and bronchial extension were significantly less frequent (p<0.05) with the supplement. No safety or tolerability problem was observed. In conclusion this preliminary study shows that Phyto-Relief CC may help the evolution of cold if used early, when initial symptoms could be identified. More specific evaluations and larger prevention studies are needed.

Management of osteoarthritis (OA) with the pharma-standard supplement FlexiQule (Boswellia): a 12-week registry.

This registry study assessed the pharma-standard supplement FlexiQule (Boswellia extract in capsules) in the management of symptoms associated to osteoarthritis (OA) also managed with the 'standard management' (SM) in comparison with a group of patients managed only with SM. The 12- week registry included patients with symptomatic knee arthrosis. They were able to walk on a treadmill for a walking test and to complete the WOMAC questionnaire. RESULTS: 32 patients used the supplement and 34 acted as controls (SM). No safety problems were observed. At 12 weeks, the Karnofsky scale was significantly improved in both groups: the variation was higher (p<0.05) in the supplement group. The WOMAC score was decreased significantly more in the supplement+SM group in comparison with controls considering pain, stiffness and physical functions (p<0.05). For social and emotional functions the decrease in score was also more evident in the supplement group (p<0.05). Both groups improved in pain-free and total walking distance at 12 weeks. Pain-free walking distance (treadmill) was higher (p<0.05) with the supplement (from 93.4;11.6 m to 271.3;19.3 m) than in controls (from 90.5;13.5 m to 158.3;22.3)(p<0.05). The improvement in total walking distance was also higher in the supplement group (p<0.05) (from 164.3;23.2 to 322.3;22.3 m) in comparison with the SM- only group ( from 158.3;18,4 to 240.2;19.3 m). The need for concomitant drugs and medical attention during the registry was reduced more in the supplement group (p<0.05). In conclusion the difference between SM and the Flexiqule+SM was in favor of the management with the supplement for all target measurements. The product is safe and well tolerated.

Supplementary management of benign prostatic hypertrophy with Prostaquil. An 8-week registry.

The aim of this registry was to evaluate the management of initial symptoms of benign prostatic hyperthrophy (BPH) in otherwise healthy subjects, using Prostaquil® (Alchem) in a 8-week registry. Prostaquil was used at the dosage of 200 mg/day. The product includes Pygeum extract (100 mg) and Saw palmetto oil (35 mg). The two resulting groups standard management and supplement) were comparable. RESULTS: No side effects or comparability problems were observed and compliance was optimal with more than 95% of the capsules correctly used. Empting, frequency, intermittency, urgency, weak flow, straining, nocturia were all significantly improved with Prostaquil (p<0.05) and the improvement - globally and evaluating any single item - was significantly superior to the one observed in controls (p<0.05). Quality of life with the supplement was also significantly better in comparison with controls (p<0.05). The residual vescical volume was 94.7;5,8 ml in the supplement group at inclusion and decreased to 39.3;5 ml (p<0.05) at 8 weeks. This decrease was equivalent to a reduction of 58.5%(vs a decrease of 27.9% in controls)(p<0.05; ANOVA). In conclusion, the most common symptoms of BPH are controlled by Prostaquil a new standardized supplement including Pygeum.