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.

Prevention of recurrent postpartum depression a reasonable option?

Clinical Dilemma: A 27-year-old woman is in the 32nd week of her second pregnancy. After her first childbirth she suffered from postpartum depression (PPD) and was successfully treated with an antidepressant. Since then she has been asymptomatic. Now she asks for consultation whether she should be treated preventively for depression after her upcoming childbirth.

Predicting the success of retrograde stenting for managing ureteral obstruction.

PURPOSE: Retrograde ureteral stenting is often considered the first line option for relieving ureteral obstruction when temporary drainage is indicated. Several retrospective studies have implied that in cases of extrinsic obstruction retrograde ureteral stenting may fail and, therefore, percutaneous nephrostomy drainage is required. We examined the efficacy of retrograde ureteral stenting for resolving ureteral obstruction and identified clinical and radiological parameters predicting failure. MATERIALS AND METHODS: Enrolled in our prospective study were 92 consecutive patients with ureteral obstruction, which was bilateral in 8. Retrograde ureteral stenting was attempted in all cases by the urologist on call. When stent insertion failed, drainage was achieved by percutaneous nephrostomy. Patients were followed at 3-week intervals for 3 months. Each followup visit included a medical interview, blood evaluation, urine culture and ultrasound. Stent malfunction was defined as continuous flank pain manifesting as recurrent episodes of acute renal colic, 1 or more episodes of pyelonephritis, persistent hydronephrosis or elevated creatinine. Preoperative data and outcomes were compared in cases of intrinsic and extrinsic obstruction. Univariate and multivariate analysis was done to identify predictors of the failure of ureteral stent insertion and long-term function. RESULTS: The etiology of obstruction was intrinsic in 61% of patients and extrinsic in 39%. Extrinsic obstruction, which was associated with a greater degree of hydronephrosis, was located more distal. Retrograde ureteral stenting was successful in 94% and 73% of patients with intrinsic and extrinsic obstruction, respectively. At the 3-month followup stent function was maintained in all patients with intrinsic obstruction but in only 56.4% with extrinsic obstruction. On multivariate logistic regression the type of obstruction, level of obstruction and degree of hydronephrosis were the only predictors of stent function at 3 months. Stent diameter and preoperative creatinine had no predictive value. CONCLUSIONS: Retrograde ureteral stenting is a good solution for most acutely obstructed ureters. In patients with extrinsic ureteral obstruction a more distal level of obstruction and higher degree of hydronephrosis are associated with a greater likelihood of stent failure. These patients may be better served by percutaneous drainage.

Neonatal sepsis after prolonged premature rupture of membranes.

The objective of this study was to prospectively evaluate the incidence of neonatal sepsis after prolonged premature rupture of membranes (PROM), to correlate sepsis with gestational age and with the duration of PROM, and to evaluate the necessity for prophylactic antibiotic therapy in neonates born after PROM. Of 12,182 infants, 135 (1.1%) were delivered after PROM with a latency period of > 24 hours. Neonatal sepsis occurred in 11 infants (8.1%), 10 of whom were premature. The only term, septic newborn was a small-for-gestational-age infant. A latency period > 72 hours was not associated with an increased incidence of sepsis. Maternal fever, neonatal signs of infection including leukopenia, leukocytosis, thrombocytopenia, and positive gastric aspirate cultures, were not good predictors of sepsis. Of premature infants with PROM, 15% had sepsis, and thus the administration of prophylactic antibiotic therapy in these cases may be warranted. However, it may be unnecessary to administer prophylactic antibiotics to term, appropriate-for-gestational-age infants born after PROM.