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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

OBJECTIVE: The combination of inhaled corticosteroids (ICS) and long-acting beta-agonists (LABAs) is recommended for the treatment of patients with mild-to-severe persistent asthma. However, given the lack of definite and safe therapies, complementary or alternative medicines are frequently used by asthmatic patients in combination with standard treatments. PATIENTS AND METHODS: A group of asthmatic subjects have been enrolled in this multi-center study; after having verified the compliance to their current medical therapy (ICS + LABAs), the subjects have been randomized to receive Casperome® 500 mg/day or no additional treatment for a period of 4 weeks. They were also asked to keep track of the number of inhalations required per day and any adverse events through a daily form. RESULTS: A total of 32 subjects were enrolled in the study. Subjects receiving Casperome® 500 mg/day in addition to the standard ICS + LABAs treatment showed a decrease in the number of inhalations needed compared to patients who did not receive Casperome® therapy. The treatment was well tolerated and only mild-moderate adverse events were registered. CONCLUSIONS: The use of Casperome® 500 mg/day is beneficial for asthmatic patients as it helps reduce the need for inhalation therapy with ICS + LABA. [ABSTRACT FROM AUTHOR]

Objective. Long-term outcome, including school-age function, has been infrequently reported in infants born at ages as young as 23-26 weeks' gestation. The objective of this study is to report outcome on a large cohort of these infants to understand better the risks and factors that affect survival and long-term prognosis. Methods. Records from 1036 infants who were born between January 1, 1986, and December 31, 2000, were analyzed retrospectively by logistic regression to correlate multiple factors with both survival and long-term outcome. A total of 675 surviving infants were analyzed at a mean age of 47.5 months for developmental outcome. A subset of 147 surviving infants who were born before 1991 were followed through school-age years using the University of Vermont Achenbach Child Behavioral Checklist and Teachers Report Form. Longitudinal follow-up was performed comparing 1-year outcome with school-age performance. Results. Gestational age and recent year of birth correlated highly with survival. Maternal nonwhite race, female sex, inborn status, surfactant therapy, single gestation, and secondary sepsis also correlated positively with survival. Normal cranial ultrasound results, absence of chronic lung disease, female sex, cesarean delivery, and increased birth weight correlated favorably with long-term outcome. Infants who were born at 23 weeks were more likely to have severe impairments compared with those who were born at 24-26 weeks. Early follow-up identified most subsequent physical impairments but correlated poorly with school-age function. Conclusions. Survival continues to improve for infants who are born at extremely early gestational ages, but long-term developmental concerns continue to be prevalent. Early outcomes do not reliably predict school-age performance. Strategies that reduce severe intraventricular hemorrhage and chronic lung disease will likely yield the best chances to improve long-term outlook. Pediatrics 2004;113:e1-e6. URL: http://www.pediatrics. org/cgi/content/full/113/1/e1; prematurity, outcome, neurodevelopment, survival, follow-up.

Objective. There are few reports of young adult outcomes of infants born at 23-26 weeks gestation. The objective of this study is to report educational, health, social, and employment outcomes of a large cohort of these infants born during an era when significant advances in neonatal care led to a marked increase in survival. Methods. Medical records of 316 infants who were born between January 1, 1986 and December 31, 1990, were analyzed retrospectively. Two hundred three (64%) infants survived to discharge home, and 5 died following discharge, leaving 198 young adults available for follow-up. One hundred sixty-two (82%) young adults responded to a 27 item telephone questionnaire designed to assess educational, health, social, and employment status at a mean age of 19.3 years. Parents of subjects were interviewed in cases where subjects could not be contacted or had cognitive issues which precluded their responding (19 subjects). Parent social and educational status was previously obtained by response to a phone survey at eight year follow-up and also by phone interview of parents of young adults previously not available for follow-up, but who were located for this report. Results. The only statistically significant differences between the 162 young adult responders and the 36 non-responders were a younger maternal age at delivery (28 ± 6 years vs 25 ± 6 years, respectively, p = 0.015) and race (91% of responders were white compared to 67% of the non-responders, p = 0.001). One hundred forty-three (88%) young adults had graduated from high school. Eighty-four (52%) required educational assistance in the form of special education, a tutor, or an Individual Education Plan (IEP). Ninety-one (56%) were currently enrolled in post-secondary education. These levels of educational achievement closely correspond to the 91% of their mothers who graduated from high school and the 57% who had completed some college level courses, including 30% with either four-year or advanced degrees. Twenty-nine (18%) of the young adults interviewed reported some problems with depression. Thirty subjects admitted to using alcohol socially, 11 reported tobacco use, and 3 admitted to using marijuana. One hundred forty-two have been or are currently employed. Conclusions. The majority of infants born at the lower limits of viability not only have the potential to survive, but with appropriate assistance and resources have the ability to successfully navigate the educational system and eventually be employed as productive members of society. [ABSTRACT FROM AUTHOR]

A study was conducted on patients who had attempted and failed previous in-vitro fertilization (IVF) procedures an average of 3.8 times following the application of assisted hatching with conventional culture systems. The aim of this investigation was to determine if addition of co-culture methodologies could reduce embryonic abnormalities and thus improve the prognosis for pregnancy. The study population consisted of 123 patients, subdivided into three patient categories. Previous IVF results from conventional culture were used to evaluate any potential benefits derived from the present co-culture application. Following co-culture, the rate of blastomere development was increased and the rate of fragmentation decreased. An increased rate of blastomere development was most noticeable in the patients aged < or = 39 years with no male factor as well as the intracytoplasmic sperm injection (ICSI) subgroup. Similarly, the rate of fragmentation was significantly reduced in the aforementioned subgroups. The most pronounced impact of co-culture was on pregnancy and implantation rates. The overall clinical and ongoing pregnancy rates were 38% (47/123) and 36% (44/123) respectively. The corresponding implantation rate was 17% (72/ 412) as shown by embryonic cardiac activity. The ongoing pregnancy rates in the < or = 39 years no male factor, > or = 40 years no male factor and ICSI no age limit patient subgroups were 41% (21/51), 30% (8/27) and 33% (15/45) respectively. The results indicate that addition of co-culture to the IVF procedure for poor-prognosis patients may be advisable. [ABSTRACT FROM AUTHOR]