ContextNecrotizing enterocolitis (NEC) is the most frequent gastrointestinal emergency in neonates. The microbiome of the preterm gut may regulate the integrity of the intestinal mucosa. Probiotics may positively contribute to mucosal integrity, potentially reducing the risk of NEC in neonates.ObjectiveTo perform an updated systematic review and meta-analysis on the efficacy and safety of probiotics for the prevention of NEC in premature infants.Data SourcesStructured searches were performed in: Medline, Embase, and the Cochrane Central Register of Controlled Trials (all via Ovid, from 2013 to January 2015). Clinical trial registries and electronically available conference materials were also searched. An updated search was conducted June 3, 2016.Study SelectionRandomized trials including infants less than 37 weeks gestational age or less than 2,500 g on probiotic vs. standard therapy.Data ExtractionData extraction of the newly-identified trials with a double check of the previously-identified trials was performed using a standardized data collection tool.ResultsThirteen additional trials (n = 5,033) were found. The incidence of severe NEC (RR 0.53 95% CI [0.42–0.66]) and all-cause mortality (RR 0.79 95% CI [0.68–0.93]) were reduced. No difference was shown in culture-proven sepsis RR 0.88 95% CI [0.77–1.00].LimitationsHeterogeneity of organisms and dosing regimens studied prevent a species-specific treatment recommendation from being made.ConclusionsPreterm infants benefit from probiotics to prevent severe NEC and death.
Background. The relative efficacy and safety of lacosamide as adjunctive therapy compared to other antiepileptic drugs has not been well established.Objective. To determine if lacosamide provides improved efficacy and safety, reduced length of hospital stay and improved quality of life compared with other anti-epileptic therapies for adults with partial-onset seizures.Data Sources. A systematic review of the medical literature using Medline (1946–Week 4, 2012), EMBASE (1980–Week 3, 2012), Cochrane Central Register of Controlled Trials (Issue 1 of 12, January 2012). Additional studies were identified (through to February 7, 2012) by searching bibliographies, the FDA drug approval files, clinical trial registries and major national and international neurology meeting abstracts. No restrictions on publication status or language were applied.Study Selection. Randomized controlled trials of lacosamide in adults with partial-onset seizures were included.Data Extraction. Study selection, extraction and risk of bias assessment were performed independently by two authors. Authors of studies were contacted for missing data.Data Synthesis. All pooled analyses used the random effects model.Results. Three trials (1311 patients) met inclusion criteria. Lacosamide increased the 50% responder rate compared to placebo (RR 1.68 [95% CI 1.36 to 2.08]; I2 = 0%). Discontinuation due to adverse events was statistically significantly higher in the lacosamide arm (RR3.13 [95% CI 1.94 to 5.06]; I2 = 0%). Individual adverse events (ataxia, dizziness, fatigue, and nausea) were also significantly higher in the lacosamide group.Limitations. All dosage arms from the included studies were pooled to make a single pair-wise comparison to placebo. Selective reporting of outcomes was found in all of the included RCTs.Conclusions. Lacosamide as adjunctive therapy in patients with partial-onset seizures increases the 50% responder rate but with significantly more adverse events compared to the placebo.
Objective: A systematic review was conducted to examine the efficacy, tolerability, and acceptability of asenapine compared with other antipsychotics in the treatment of psychotic disorders.Methods: Four databases, 8 trial registries, and conference presentations were searched for randomized clinical trials of asenapine versus any comparator for the treatment of any psychotic illness. Primary outcome measures were changes in the Positive and Negative Syndrome Scale (PANSS) total score and the incidence of withdrawal due to adverse effects. Results: Eight randomized clinical trials, encompassing 3765 patients, that compared asenapine with placebo (n ¼ 5) and olanzapine (n ¼ 3) were included. No differences were found between asenapine and olanzapine in terms of changes to PANSS total or PANSS negative subscale scores. Patients taking asenapine were more likely to experience worsening schizophrenia and/or psychosis than were those taking olanzapine. No differences were found between asenapine and olanzapine in rates of discontinuation due to adverse drug reactions or lack of efficacy, but those taking asenapine had higher rates of withdrawal for any reason than those taking olanzapine. Asenapine caused less clinically significant weight gain or increases in triglycerides than olanzapine and was more likely to cause extrapyramidal symptoms than olanzapine. In comparison to placebo, either no difference or superiority was demonstrated in favour of asenapine on all efficacy measures. Conclusion:The current evidence is limited, as asenapine has been compared only with placebo or olanzapine. In the randomized clinical trials analysed, asenapine was similar or superior to placebo and similar or inferior to olanzapine on most efficacy outcomes. While asenapine demonstrated fewer adverse metabolic outcomes than olanzapine, rates of extrapyramidal symptom-related adverse effects were higher. Abré géObjectif : Une revue systématique a été menée pour examiner l'efficacité, la tolérabilité et l'acceptabilité de l'asénapine comparativement à d'autres antipsychotiques dans le traitement des troubles psychotiques.Mé thodes : Quatre bases de données, 8 registres d'essais et des présentations à des congrès ont étés recherchés pour y repérer des essais cliniques randomisés d'asénapine contre tout comparateur pour le traitement des maladies psychotiques. Les principales mesures des résultats étaient les changements du score total à l'Échelle des symptô mes positifs et négatifs (PANSS) et l'incidence de la cessation en raison d'effets indésirables.
Duloxetine is an orally administered, selective norepinephrine and serotonin reuptake inhibitor (SNRI) class of antidepressant that has been approved for the treatment of major depressive disorder (MDD). Its chemical designation is (+)- (S)-N-methyl--(1-naphthyloxy)-2-thiophenepropylamine. Duloxetine acts through the inhibition of reuptake of serotonin (5- HT) and noradrenalin/norepinephrine (NE) at presynaptic sites. Preclinical and placebo controlled trials of duloxetine have proved that duloxetine is significantly more efficacious in the treatment of major depression. Comparative trials of duloxetine with paroxetine and venlafexine have the almost same efficacy. Similarly, with comparison of SSRI, duloxetine has shown similarity or noninferiority as compare to esitalopram in randomized trials. It is also efficacious in painful physical symptoms associated with depression at dose used for MDD during trials. Duloxetine is generally well-tolerated drug and it has already concluded that incidence of adverse events and drug interactions are less as compare to TCAs, SSRIs and other SNRIs. Duloxetine should be considered as a potential antidepressant effective in short- and long-term treatment of MDD. © 2011 IGJPS. All rights reserved
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