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.

Hyperthermia to normal human skin in vivo upregulates heat shock proteins 27, 60, 72i and 90.

This study was performed to test the hypothesis that expression of heat shock proteins (HSPs) exhibits a spatially selective response within intact human skin following in vivo exposure to thermal stress. This response is believed to protect cells and tissues from further damage. Using Western blotting and immunohistochemistry, we studied the expression of a range of HSPs in normal human skin of 5 subjects prior to and following heating in vivo. The skin was heated to 41 +/- 0.5 degrees C for 1 h and biopsies were taken at 4, 8 and 24 h and from control, untreated skin. HSPs 27, 60, 72i, 90, 110 and heat shock constitutive (HSC)70 were expressed in normal skin, but the extent and distribution of these HSPs showed considerable variation. HSP27, 60 and 72i were found predominantly in the epidermis, whereas HSC70 showed weak epidermal staining but strong dermal expression. Heating the skin in vivo resulted in an increased skin content of HSP27, 60, 72i and 90, with maximal increase at 24 h following hyperthermia, while the skin content of HSC70 and HSP110 were unchanged. Significant increases in the content of HSP72i and HSP90 had occurred by 4 h following hyperthermia, with a mean +/-SEM of 206 +/- 50% and 197 +/- 38% of the control, untreated values, respectively (p<0.05). These findings indicate the complexity of HSP dynamics in human skin, and suggest that heating within the experimental range may protect the skin from further stresses for at least 24 h.

Tooth morphology and archaeology: a problem solving exercise.

A knowledge of tooth morphology is often a valuable aid in forensic science but another less well-known application is the analysis of skeletal remains from archaeological sites, particularly when these involve children. This article describes one such case.