Safety of phosphatidylserine containing omega3 fatty acids in ADHD children: a double-blind placebo-controlled trial followed by an open-label extension.

OBJECTIVE: To evaluate the safety of phosphatidylserine (PS) enriched with omega3 fatty acids, mainly eicosapentaenoic (PS-Omega3) in children with attention-deficit hyperactivity disorder (ADHD). METHODS: Two hundred children diagnosed with ADHD were randomised to receive either PS-Omega3 (300mg PS-Omega3/day) or placebo for 15 weeks. One hundred and fifty children continued into an open-label extension for an additional 15 weeks in which they all consumed PS-Omega3 (150mg PS-Omega3/day). Standard blood biochemical and haematological safety parameters, blood pressure, heart rate, weight and height were evaluated. Adverse events and the Side Effect Rating Scale were also assessed. RESULTS: One hundred and sixty-two participants completed the double-blind phase. No significant differences were noted between the two study groups in any of the safety parameters evaluated. One hundred and forty participants completed the open-label phase. At the end of this phase, no significant changes from baseline were observed in any of the studied parameters among participants who consumed PS-Omega3 for 30 weeks. CONCLUSIONS: Study results demonstrate that consumption of PS-Omega3 by children with ADHD, as indicated in a 30-week evaluation period, is safe and well tolerated, without any negative effect on body weight or growth.

The effect of phosphatidylserine containing Omega3 fatty-acids on attention-deficit hyperactivity disorder symptoms in children: a double-blind placebo-controlled trial, followed by an open-label extension.

OBJECTIVE: To study the efficacy and safety of phosphatidylserine (PS) containing Omega3 long-chain polyunsaturated fatty acids attached to its backbone (PS-Omega3) in reducing attention-deficit/ hyperactivity disorder (ADHD) symptoms in children. METHOD: A 15-week, double-blind, placebo-controlled phase followed by an open-label extension of additional 15 weeks. Two hundred ADHD children were randomized to receive either PS-Omega3 or placebo, out of them, 150 children continued into the extension. Efficacy was assessed using Conners' parent and teacher rating scales (CRS-P,T), Strengths and Difficulties Questionnaire (SDQ), and Child Health Questionnaire (CHQ). Safety evaluation included adverse events monitoring. RESULTS: The key finding of the double-blind phase was the significant reduction in the Global:Restless/impulsive subscale of CRS-P and the significant improvement in Parent impact-emotional (PE) subscale of the CHQ, both in the PS-Omega3 group. Exploratory subgroup analysis of children with a more pronounced hyperactive/impulsive behavior, as well as mood and behavior-dysregulation, revealed a significant reduction in the ADHD-Index and hyperactive components. Data from the open-label extension indicated sustained efficacy for children who continued to receive PS-Omega3. Children that switched to PS-Omega3 treatment from placebo showed a significant reduction in subscales scores of both CRS-P and the CRS-T, as compare to baseline scores. The treatment was well tolerated. CONCLUSIONS: The results of this 30-week study suggest that PS-Omega3 may reduce ADHD symptoms in children. Preliminary analysis suggests that this treatment may be especially effective in a subgroup of hyperactive-impulsive, emotionally and behaviorally-dysregulated ADHD children.

Parenchymal trafficking of pleural mesothelial cells in idiopathic pulmonary fibrosis.

Idiopathic pulmonary fibrosis (IPF) is characterised by myofibroblast proliferation leading to architectural destruction. Neither the origin nor the continued proliferation of myofibroblasts is well understood. Explanted human IPF lungs were stained by immunohistochemistry for calretinin, a marker of pleural mesothelial cells (PMCs). Chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF) lungs acted as controls. The number of PMCs per 100 nucleated cells and per photomicrograph was estimated along with the Ashcroft score of fibrosis. Mouse PMCs expressing green fluorescent protein (GFP) or labelled with nanoparticles were injected into the pleural space of mice given intranasal transforming growth factor (TGF)-ß1. Mouse lungs were lavaged and examined for the presence of GFP, smooth muscle α-actin (α-SMA) and calretinin. Calretinin-positive PMCs were found throughout IPF lungs, but not in COPD or CF lungs. The number of PMCs correlated with the Ashcroft score. In mice, nanoparticle-laden PMCs were recoverable by bronchoalveolar lavage, depending on the TGF-ß1 dose. Fluorescent staining showed α-SMA expression in GFP-expressing PMCs, with co-localisation of GFP and α-SMA. PMCs can traffic through the lung and show myofibroblast phenotypic markers. PMCs are present in IPF lungs, and their number correlates with IPF severity. Since IPF presumably begins subpleurally, PMCs could play a pathogenetic role via mesothelial-mesenchymal transition.

Morphometry of the adult human earlobe: a study of 547 subjects and clinical application.

The purpose of this study was to define the factors that influence earlobe length and to establish a standard for adult earlobe length by sex and age. The study sample consisted of 547 adult subjects older than 20 years of age. A randomized, prospective design was used. Patients with malignancies, previous surgery or trauma to the earlobe, or congenital earlobe anomalies were excluded. The following variables were studied: sex; age; ethnic origin; skin complexion; height, weight, and body mass index; and piercing. Pearson's correlation, analysis of variance, t test, and multiple regression analysis were used for the statistical analysis. There were 383 women (70 percent) and 164 men (30 percent) aged 20 to 80 years. The average length of the left earlobe was 1.97 cm (SD, 0.42 cm), and that of the right earlobe, 2.01 cm (SD, 0.42 cm) (p < 0.0001). A post hoc test revealed a statistically significant difference among the three age groups (20 to 40 years, 40 to 60 years, and >60 years) in both men and women. Pendulous earlobes were significantly longer and less symmetrical than nonpendulous ones by t test. In men, nonpierced left earlobes were longer than pierced lobes; in women, there was no significant difference between pierced and nonpierced ears. Pearson's correlation tests for weight, height, and body mass index showed that only weight had a significant effect on earlobe length, and only in women. Analysis of variance for ethnic origin and skin color revealed a longer left earlobe in Ashkenazi and Sephardic Jews compared with Ethiopian, Asian, and American Jews and Arabs and a short earlobe in blacks compared with dark and fair-skinned people. On multiple regression analysis, sex and age were the only factors that contributed to earlobe length. A table of average earlobe length by age was formulated on the basis of the authors' findings. These data, together with the knowledge that earlobe length changes little in women over 40, that earlobes are not symmetrical, and that right and left nonpendulous earlobes are symmetrical in individual patients and shorter than pendulous earlobes, can assist the plastic surgeon in deciding on the proper time for loboplasty. The preferable technique is creating a nonpendulous earlobe to minimize the chances of further elongation with time.

The leukocyte adhesiveness/aggregation test as an inflammation-related, plasma-dependent agglutination phenomenon.

The leukocyte adhesiveness/aggregation test (LAAT) is a non-specific marker of inflammation. In the present study, we examined the expression of the CD11b/CD18 as well as the CD62L antigens on the surface of peripheral blood leukocytes in 84 patients with various inflammatory conditions and 60 controls by using whole blood flow cytometry. We also conducted several in vitro experiments in order to explain the mechanism of the leukocyte adhesiveness/aggregation. A significant (r= -0.36, p<0.001) negative correlation was found between the expression of CD62L on the surface of peripheral blood polymorphonuclears and the state of LAA. There was no correlation between the availability of the CD11b/CD18 antigen and the adhesive state of these cells. In a series of in vitro experiments, we could show that it is possible to significantly reduce the number of aggregated leukocytes in the peripheral blood by using dilutions with buffer but not with plasma. There is no change in the degree of aggregation following incubation at low temperature in the presence of an aerobic metabolism blocker or following incubation with a divalent ion chelator. Additionally, white blood cells could be seen to adhere to protein-rich areas in the peripheral slides. We assume that the state of LAA in the peripheral blood as revealed by the LAA test is more a plasma factor-dependent agglutination than a firm aggregation phenomenon. Factors other than the leukocyte integrins or selectins should be sought as being responsible for this LAA phenomenon.

"Hook effect" in complete hydatidiform molar pregnancy: a falsely low level of beta-HCG.

BACKGROUND: In some cases of gestational trophoblastic disease, a large amount of serum beta-hCG may lead to the high-dose "hook effect" with falsely low serum levels, creating misdiagnosis or delay in diagnosis and therapeutic hazards to the patient. CASES: In two cases of the hook effect in complete hydatidiform mole, ultrasonographic scan showed intrauterine echogenic material, whereas diluted serum specimens gave very high levels of beta-hCG (1,600,000 and 2,225,000 mIU/mL). CONCLUSION: The possibility of a method-dependent hook effect must be considered. Early recognition of falsely low values of beta-hCG can allow correction to the true values by various methods, such as serum dilution before the radioimmunometric method.

[Value of determining prostate specific antigen in follow-up of prostatic cancer].

The value of measuring serum prostate specific antigen (PSA) in monitoring cases of prostatic cancer was studied in 239 patients. 30 patients with benign prostatic hyperplasia served as controls. The patients were treated by radical prostatectomy, radiotherapy or chemotherapy. In the controls PSA levels were elevated in 60%, indicating that PSA measurement is not specific for prostatic cancer. Among 35 patients before and after radical prostatectomy, in those without disease progression, PSA levels were repeatedly low, but were elevated in all with progression. Among 25 patients after radiation and in 28 before and after radiation, low PSA levels were found in all those, without disease progression. High PSA levels, or a rise in levels after irradiation, preceded local growth or metastatic spread. In the 95 patients with metastatic spread who received hormone-and/or chemo-therapy, low PSA levels following initiation of treatment, were a favorable prognostic indicator, with a sensitivity of 100%. High levels, or a rise of levels after initiation of treatment indicated disease progression. The rise in PSA levels preceded clinical evidence of progression by 0 to 30 months. We conclude that serum PSA is a valuable marker for following patients with prostatic cancer.

Does mca contribute to the follow-up of breast-cancer patients by ca-15-3.

Mucin-like carcinoma-associated antigen (MCA) and CA 15-3 tumor markers were randomly assayed in 234 consecutive breast cancer patients. It was found that 45 patients (19.2%) had elevated MCA levels (cut-off level >14 U/ml) and normal CA 15-3 levels (cut off level >30 U/ml). In 14 of these 45 patients (31.1%), overt metastases were detected, although five had started their follow-up with no evidence of disease. In these five patients, the median lead time was nine months. In our limited experience, it was found that measuring MCA levels in the serum in the presence of normal CA15-3 levels contributes to early detection and monitoring of recurrences in follow-up of breast cancer patients.