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Francesco Di Pierro,1 Pietro Putignano,2 Tarcisio Ferrara,3 Carmela Raiola,4 Giuliana Rapacioli,5 Nicola Villanova6 1Scientific Department, Velleja Research, Milan, Italy; 2Outpatient Diabetic Clinic, University Hospital San Gerardo, Monza, Italy; 3District 63, Cava de’ Tirreni-Costa d’Amalfi, Salerno, Italy; 4Outpatient Clinic “Ordine di Malta”, Naples, Italy; 5AIOR, Piacenza, Italy; 6Metabolic Disorders, S. Orsola Malpighi Hospital, Bologna, Italy Background: Berberis aristata, because of its berberine content, and Monascus purpureus fermented rice, because of the presence of monacolins (naturally derived statins), are widely investigated food-grade ingredients used to formulate cholesterol-lowering supplements. Although they are extensively used, berberine is poorly absorbed and monacolins are poorly chemically characterized, not standardized, and possibly contaminated with toxic compounds. Silymarin is reported to enhance berberine absorption, while Monakopure™-K20 (MK-20) is a highly standardized red yeast rice containing monacolins K and KA in the ratio of 1:1 but not secondary monacolins, dehydromonacolins, or citrinin.Aim: The effects of a cholesterol-lowering supplement (Berberol®K) containing berberine, silymarin, and MK-20 (BSM) in patients with dyslipidemia were clinically analyzed.Methods: The clinical role of BSM in naïve and in statin-intolerant patients was retrospectively evaluated and the effects observed were compared with those obtained in patients without treatment or treated with lovastatin.Results: Total cholesterol, low density lipoprotein, and triglyceride levels were approximately 4%, 6%, and 11% lower, respectively, and the creatine phosphokinase increase was reduced in patients treated with BSM compared to those treated with lovastatin. Similar results were also obtained in statin-intolerant subjects where BSM was administered as add-on therapy to ezetimibe or fenofibrate. Conclusion: BSM is a food supplement potentially useful 1) as a primary intervention in low-cardiovascular-risk subjects with dyslipidemia; 2) as add-on therapy in mildly statin-intolerant patients; and 3) in dyslipidemic patients with a negative perception of statins who prefer a treatment seen as natural. Keywords: berberine, Berberol®K, silymarin, P-glycoprotein, cholesterol, triglycerides, Monascus purpureus, Monakopure™-K20

Francesco Di Pierro,1 Iaele Bellone,2 Giuliana Rapacioli,3 Pietro Putignano4 1Scientific Department, Velleja Research, Milan, Italy; 2ASL TO1, Turin, Italy; 3AIOR, Pontenure, Province of Piacenza, Italy; 4University Hospital San Gerardo, Monza, Italy Background: Statin intolerance is a medical condition often leading patients to nonadherence to the prescribed therapy or to a relevant reduction of the statin dosage. Both situations determine a totally or partially uncontrolled lipid profile, and these conditions unquestionably increase the risk of cardiovascular events. Methods: We enrolled hypercholesterolemic, type 2 diabetic patients complaining of intolerance to statins. Some of them had reduced the statin dose ‘until the disappearance of symptoms’; others had opted for treatment with ezetimibe; and yet others were not undergoing any treatment at all. All patients of the three groups were then given a fixed combination of berberine and silymarin (Berberol®), known from previous papers to be able to control both lipidic and glycemic profiles. Results: The tested product both as a single therapy and as add-on therapy to low-dose statin or to ezetimibe reduced triglycerides, low-density lipoprotein cholesterol, fasting blood glucose, and glycosylated hemoglobin in a significant manner without inducing toxicity conditions that might be somehow ascribed to a statin-intolerant condition. Conclusion: Our study demonstrates that use of Berberol®, administered as a single or add-on therapy in statin-intolerant subjects affected by diabetes and hypercholesterolemia is a safe and effective tool capable of improving the patients' lipidic and glycemic profiles. Keywords: berberine, silymarin, Berberol®, ezetimibe, cholesterol, type 2 diabetes

Francesco Di Pierro,1 Mario Gatti,2 Giuliana Rapacioli,3 Leandro Ivaldi4 1Velleja Research, Milan, 2Gastroenterology Department, Giussano Hospital, Monza-Brianza, 3AIOR, Piacenza, 4Digestive Endoscopic Department, Ceva Hospital, Ceva, Cuneo, Italy Background: The purpose of this study was to compare the efficacy of alginic acid alone versus alginic acid combined with low doses of pure glycyrrhetinic acid and bilberry anthocyanosides as an addon to conventional proton pump inhibitor therapy in relieving symptoms associated with nonerosive reflux disease. Methods: This prospective, randomized, 8-week, open-label trial was conducted at two centers. Sixty-three patients with persistent symptoms of gastroesophageal reflux disease and normal upper gastrointestinal endoscopy were eligible for the study. Patients in group A (n = 31) were treated with pantoprazole and a formula (Mirgeal®) containing alginic acid and low doses of pure glycyrrhetinic acid + standardized Vaccinium myrtillus extract for 4 weeks, then crossed over to the multi-ingredient formula for a further 4 weeks. Patients in group B (n = 32) were treated pantoprazole and alginic acid alone twice daily, then crossed over to alginic acid twice daily for a further 4 weeks. Efficacy was assessed by medical evaluation of a symptom relief score, estimated using a visual analog scale (0–10). Side effects, tolerability, and compliance were also assessed. Results: Of the 63 patients enrolled in the study, 58 (29 in group A and 29 in group B) completed the 8-week trial. The baseline characteristics were comparable between the two groups. During the study, significant differences were recorded in symptom scores for both groups. In group A, symptoms of chest pain, heartburn, and abdominal swelling were less serious than in group B. Treatment A was better tolerated, did not induce hypertension, and had fewer side effects than treatment B. No significant differences in compliance were found between the two groups. Conclusion: Use of low doses of pure glycyrrhetinic acid + bilberry anthocyanosides, together with alginic acid as addon therapy, substantially improves symptoms in patients with nonerosive reflux disease without increasing side effects or worsening tolerability or compliance. Keywords: proton pump inhibitors, alginic acid, glycyrrhetinic acid, anthocyanosides, nonerosive reflux disease, gastroesophageal reflux disease

Francesco Di Pierro,1 Giuliana Rapacioli,2 Eleonora Adriana Di Maio,3 Giovanni Appendino,4 Federico Franceschi,5 Stefano Togni5 1Velleja Research, 2Associazione Italiana Omeopatia di Risonanza, 3Presidio Ospedaliero Riunito Ciriè-Lanzo, 4Università degli Studi del Piemonte Orientale, 5Indena SpA, Milan, Italy Abstract: In addition to its anti-inflammatory activity, Meriva®, a proprietary lecithin formulation of curcumin, has been anecdotally reported to decrease acute pain in patients with various chronic diseases. Given that curcumin can desensitize transient receptor potential A1, a nociceptor seemingly also mediating the analgesic effect of acetaminophen, as well as inhibiting and downregulating the expression of cyclo-oxygenase 2, the selective target of nimesulide, a nonsteroidal anti-inflammatory agent, we carried out a pilot comparative study of the acute pain-relieving properties of these three agents. At a dose of 2 g (corresponding to 400 mg of curcumin), Meriva showed clear analgesic activity, comparable with that of a standard dose (1 g) of acetaminophen, but lower than that of a therapeutic (100 mg) dose of nimesulide. The analgesic activity of lower (1.5 g) doses of Meriva was less satisfactory, and the onset of activity was longer than that of nimesulide for both doses. On the other hand, gastric tolerability was significantly better than that of nimesulide and comparable with that of acetaminophen. Taken together, our results show that the preclinical analgesic properties of curcumin have clinical relevance, at least at a dose of 2 g as the Meriva formulation. While this dose is significantly higher than that used to relieve chronic inflammatory conditions (1–1.2 g/day), its pain-relieving activity could benefit from the general downregulation of the inflammatory response induced by curcumin, considering that the transient receptor potential channel-mediated mechanisms of analgesia are magnified by attenuation of inflammation. In patients on treatment with Meriva, this would also translate into better control of acute pain, providing a rationale for the analgesic properties associated with this curcumin formulation. Keywords: curcumin phytosome, Meriva®, acute pain, acetaminophen, nimesulide, tolerability

OBJECTIVE: This randomized, controlled study aims to evaluate the tolerability and the efficacy of curcumin in overweight subjects affected from metabolic syndrome, with a focus on impaired glucose intolerance and android-type fat accumulation. PATIENTS AND METHODS: Forty-four subjects, selected among those who after 30 days of diet and intervention lifestyle have shown a weight loss < 2%, have been treated for further 30 days either with curcumin complexed with phosphatidylserine in phytosome form or with pure phosphatidylserine. Outcomes concerning anthropometric measurements and body composition were analyzed at enrollment and after 30 and 60 days. RESULTS: Curcumin administration increased weight loss from 1.88 to 4.91%, enhanced percentage reduction of body fat (from 0.70 to 8.43%), increased waistline reduction (from 2.36 to 4.14%), improved hip circumference reduction from 0.74 to 2.51% and enhanced reduction of BMI (from 2.10 to 6.43%) (p < 0.01 for all comparisons). Phosphatidylserine did not show any statistical significant effect. Tolerability was very good for both treatments, and no drop-out was reported. CONCLUSIONS: Although preliminary, our findings suggest that a bioavailable form of curcumin is well-tolerated and can positively influence weight management in overweight people. [ABSTRACT FROM AUTHOR]

Background: Streptococcus salivarius K12 has been shown to inhibit the growth of Streptococcus pyogenes due to bacteriocins release. Because of its ability to colonize the oral cavity, we have tested the strain K12 for its efficacy in preventing streptococcal pharyngitis and/or tonsillitis in adults., Methods: Forty adults with a diagnosis of recurrent oral streptococcal pharyngitis were enrolled in the study. Twenty of these subjects took for 90 days a tablet containing Streptococcus salivarius K12 (Bactoblis®). The other 20 subjects served as untreated controls. A 6-month follow-up was included to evaluate any persistent protective role., Results: The 20 adults who completed the 90-day course of Bactoblis® showed a reduction in their episodes of streptococcal pharyngeal infection (about 80%). The 90 days treatment was also associated with an approximately 60% reduction in the incidence of reported pharyngitis in the 6-month period following use of the product. The product was well tolerated by the subjects with no treatment-related side effects or drop-outs reported., Conclusion: Prophylactic administration of Streptococcus salivarius K12 to adults having a history of recurrent oral streptococcal pathology reduced the number of episodes of streptococcal pharyngeal infections and/or tonsillitis.

Echinacea preparations are extensively used for the prevention and the management of the common cold. Despite this popularity, the clinical studies on Echinacea have produced mixed results, possibly in part because of the poor characterization of the extracts investigated and the use of different species and/or plant parts for the preparations investigated in the various trials. To address this issue, Polinacea, a highly standardized extract from a well-defined botanical source (roots of Echinacea angustifolia) with a specific phytochemical profile (presence of the complex polysaccharide IDN5405, the phenylethanoid echinacoside, and substantial lack of alkamides) was developed. We have studied whether Polinacea could enhance the immune response subsequent to the influenza vaccination, and whether the use of this preparation could translate into a decreased morbidity from influenza. The preliminary results were encouraging, and suggest that Polinacea could be used for improving the immune response to influenza vaccine.

Electric field measurements of skin potential and electrical currents are physiological indicators of electrodermal activity (EDA) and have been associated with a variety of sensory, cognitive and emotional stimuli. The aim of this study was to investigate the EDA at some hand acupoints before, during and after a physical exercise. EDA of eight points located at the corner of fingernails of hands was measured in 10 healthy young volunteers before, during and after a 14-min acute exercise in a bicycle ergometer. In pre-exercise resting state the parameters were stable and similar between the 8 different tested points, while during exercise a significant increase of current (from 1000-2000 to 4000-8000 nA) was observed, with the maximal values related to the point located on the ulnar side of the little finger, at the base of the nail, corresponding to the Shao chong (HT9) of heart meridian., (Copyright 2010 Elsevier Ltd. All rights reserved.)