Selenium is an antioxidant trace element. Patients with diabetes are shown to have increased oxidative stress together with decreased selenium concentrations. Whether raising serum selenium will improve blood glucose management in diabetes is largely unknown. In this randomized, double-blind placebo-controlled trial, we assessed the effects of selenium on blood glucose, lipid profile, and oxidative stress in 60 patients with type 2 diabetes. Selenium 200 µg/d or placebo was administered orally for 3 months. Serum concentrations of fasting plasma glucose, glycosylated hemoglobin A1c (HbA1c), insulin, and lipid profile, as well as ferric-reducing ability of plasma and thiobarbituric acid-reactive substances were determined in the fasting state at baseline and after 3 months. Mean (SD) serum selenium at baseline was 42.69 (29.47) µg/L and 47.11 (42.86) µg/L in selenium and placebo groups, respectively. At endpoint, selenium concentration reached to 71.98 (45.08) µg/L in selenium recipients compared with 45.38 (46.45) µg/L in placebo recipients (P<0.01). Between-group comparison showed that fasting plasma glucose, glycosylated hemoglobin A1c, and high-density lipoprotein cholesterol were statistically significantly higher in the selenium recipient arm. Other endpoints changes during the course of trial were not statistically different across the 2 treatment arms. This study suggests that selenium supplementation in patients with type 2 diabetes may be associated with adverse effects on blood glucose homeostasis, even when plasma selenium concentration is raised from deficient status to the optimal concentration of antioxidant activity. Until results of further studies become available, indiscriminate use of selenium supplements in patients with type 2 diabetes warrants caution.
Oral atorvastatin 40 mg/day was not associated with therapeutic benefit when given to patients with baseline PASI scores less than 12 who were also treated with standard topical therapies. Additional trials are needed to elucidate the place of statins for the treatment of psoriasis. A larger follow-up study, as well as testing atorvastatin in patients with more intensive disease characterized by high PASI scores, is needed. Studies using higher atorvastatin doses or dose-ranging studies should also be performed.
The results of this open-label study suggest a promise of duloxetine in the treatment of youth with ADHD. Further controlled studies with larger samples are required to evaluate the efficacy of duloxetine in children and adolescents with ADHD.
Objective:Adverse drug reactions (ADRs) are known as a cause of hospital admission. We have carried out a prospective study to characterize and assess the frequency, probability, preventability, and severity of ADRs, which lead to hospital admission in children.Methods:In a prospective observational study, a cohort of children admitted to a tertiary pediatric hospital was randomly screened to assess ADR as the cause of admission from June 2014 to January 2015. ADRs causing admissions were detected based on patients’ records, interviewing their parents, and confirmation by medical team. The probability of the ADRs was assessed based on WHO criteria and Naranjo tool. The preventability assessment was performed using Schumock and Thornton questionnaire.Findings:Of the 658 evaluated emergency admissions, 27 were caused by an ADR giving an incidence of 4.1%. Among ADRs, 37.1% were estimated to be preventable. Antibiotics were the most common medication class which caused hospital admission.Conclusion:Pediatric pharmacotherapy still needs evidence-based strategies to improve child care including education, monitoring, planning for medications after ADR occurrence, and implementing preventive measures when applicable.
New onset diabetes mellitus is frequently observed following hematopoietic stem cell transplantation (HSCT) and is associated with adverse transplantation outcomes. However, the outcomes of patients with preexisting diabetes mellitus undergoing HSCT are largely unknown. We aimed to explore the impact of preexisting diabetes on transplantation outcomes in HSCT. In a retrospective study, medical charts of 34 HSCT recipients with diabetes mellitus undergoing allogeneic or autologous transplantation were reviewed and compared with 71 HSCT recipients without diabetes. Primary outcome was overall survival. Secondary outcomes included hematopoietic recovery, length of hospital stay, febrile neutropenia, acute and chronic graft-versus-host disease (GVHD), primary disease recurrence, and non-relapse mortality (NRM). On univariate analysis, there was no difference in transplantation outcomes in recipients with diabetes compared with recipients without diabetes. However, after adjusting for potential covariates, multivariate analysis demonstrated that having diabetes before HSCT significantly predicted outcome and decreased overall survival (hazard ratio 0.51, 95% confidence interval: 0.27-0.97, p value: 0.04). This study suggests that patients with diabetes mellitus undergoing allogeneic or autologous HSCT may have inferior survival rates and warrant further attention.
BackgroundMetabolic and cardiovascular side effects have been noted with the use of second generation antipsychotics (SGAs) and mood stabilizers. Since Omega-3 fatty acids have been known to prevent some cardiovascular risks, this preliminary study was designed to evaluate the cardiovascular benefits of omega-3 when added to the combinations of olanzapine with mood stabilizers.MethodsThis study was a randomized, double-blind, placebo-controlled, within-subject trial in adult psychiatric patients who were receiving olanzapine combined with lithium (Li) or valproate sodium (VPA). Omega-3 as fish oil with less than 1 g/day of EPA/DHA or its placebo was added to patients’ olanzapine and mood stabilizer regimens for 6 weeks. Metabolic parameters including anthropometric variables, lipid profile, metabolic syndrome indices, C-reactive protein, fibrinogen and lipoprotein (a) [(Lp) (a)] were assessed for participants.ResultsForty one participants completed this study; 20 patients received omega-3 and 21 patients received placebo, added to their regimen of SGA and mood stabilizer. Omega-3 addition did not modulate anthropometric, metabolic syndrome and lipid parameter changes in 6 weeks. However, fibrinogen levels significantly decreased, Lp (a) did not increase and non-high-density lipoprotein cholesterol (non-HDL-C) did not go beyond its target level after omega-3 supplementation. Additionally, a significant inter-group effect was noted for Lp(a).ConclusionsThis study suggests that use of short-term omega-3 supplementation added to a combined regimen of olanzapine and mood stabilizer may have a small modulating effect on some cardiovascular risk factors. Trials in longer periods of time and with larger number of patients are needed to further evaluate the effects of omega-3 supplements on preventing cardiovascular risk factors.This trial is registered at irct.ir and its Identifier is as following: IRCT138712231764N1
Objective:The aim of the current study was to determine various aspects of methylphenidate adverse reactions in children with attention deficit-hyperactivity disorder (ADHD) in Iran.Methods:During the 6 months period, all children under methylphenidate treatment alone or along with other agents attending a university-affiliated psychology clinic were screened regarding all subjective and objective adverse drug reactions (ADRs) of methylphenidate. Causality and seriousness of detected ADRs were assessed by relevant World Health Organization definitions. The Schumock and Thornton questionnaire was used to determine preventability of ADRs.Findings:Seventy-one patients including 25 girls and 46 boys with ADHD under methylphenidate treatment were enrolled within the study period. All (100%) ADHD children under methylphenidate treatment developed at least one ADR. Anorexia (74.3%), irritability (57.1%), and insomnia (47.2%) were the most frequent methylphenidate-related adverse reactions. Except for one, all other detected ADRs were determined to be mild. In addition, no ADR was considered to be preventable and serious.Conclusion:Our data suggested that although methylphenidate related adverse reactions were common in children with ADHD, but they were mainly mild and nonserious.
Objective:One of the main problems facing public health providers and administrators in many countries is ensuring the rational use of high-cost drugs. In this regard, on-going process of medication use evaluation can be considered as a useful tool. In this study, we evaluated certain usage aspects of a highly-cost medication, that is, recombinant growth hormone (GH).Methods:This cross-sectional study conducted from August 2012 to August 2014. Children receiving GH ± gonadotropin releasing hormone (GnRH) analogs were included in the study. A researcher-designed checklist was developed to evaluate the GH utilization in these patients. Baseline demographic characteristics and background clinical and growth data, as well as any aspects of drug therapy including indications, dosing, monitoring, and discontinuation were collected from the patients' medical records.Findings:Seventy children receiving GH entered the study, of which 23 patients (32.85%) received GH and GnRH analogs simultaneously. At the baseline, 67 children (95.7%) had GH stimulation test, whereas serum insulin-like growth factor-1 (IGF-1) levels were measured in 63 (90%) patients. Sixty-seven patients (95.71%) had thyroid function test, whereas bone age was determined in 68 children (97.14%). The mean ± standard deviation of GH dose for idiopathic short stature, GH deficiency, Turner's syndrome and born small for gestational age in our study was 0.22 ± 0.025 mg/kg/week, 0.23 ± 0.04 mg/kg/week, 0.22 ± 0.015 mg/kg/week, and 0.23 ± 0.02 mg/kg/week, respectively. Height and weight of all patients were followed every 3–6 months, regularly. Thirty patients were treated with GH for at least 1 year, of which thyroid hormones and IGF-1 levels were measured annually in 25 (83.33%) and 26 (86.66%) patients, respectively; while bone age was evaluated in 13 (43.33%) children, annually. GH treatment was discontinued in 15 patients (21.42%), while financial problem was the major reason.Conclusion:Diagnostic tests and monitoring of height, weight, IGF-1 level and thyroid function was properly performed in this setting. However, a number of patients with ISS and Turner's syndrome were under-dosed.
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