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1.
J Trauma Stress ; 33(4): 410-419, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32667076

RESUMO

Given the extensive research on posttraumatic stress disorder (PTSD) treatment, a single, updatable repository of data from PTSD treatment studies would be useful for clinical, research, and policy stakeholders. To meet this need, we established a preliminary dataset of abstracted PTSD trial data, which serve as the basis for the PTSD Trials Standardized Data Repository (PTSD-Repository), maintained by the National Center for PTSD (NCPTSD). We followed systematic review methods to identify published randomized controlled trials (RCTs) of PTSD interventions. We consulted with a panel of experts to determine a priori inclusion criteria, ensure that we captured all relevant studies, and identify variables for abstraction. We searched multiple databases for materials published from 1980 to 2018 and reviewed reference lists of relevant systematic reviews and clinical practice guidelines. In total, 318 RCTs of PTSD interventions that enrolled almost 25,000 participants were included. We abstracted 337 variables across all studies, including study, participant, and intervention characteristics as well as results. In the present paper, we describe our methods and define data elements included in the data tables. We explain coding challenges, identify inconsistencies in reporting across study types, and discuss ways stakeholders can use PTSD-Repository data to enhance research, education, and policy. The abstracted data are currently publicly available on the NCPTSD website and can be used for future systematic reviews and identifying research gaps and as an information resource for clinicians, patients, and family members.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto , Sistema de Registros , Transtornos de Estresse Pós-Traumáticos/terapia , Adulto , Humanos , Pesquisa
2.
Int Urogynecol J ; 30(10): 1603-1617, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31346670

RESUMO

INTRODUCTION: Overactive bladder (OAB) is a common condition, increasing with age and affecting quality of life. While numerous OAB drugs are available, persistence is low. We evaluated evidence published since 2012 to determine if newer drugs provided better efficacy and harm profiles. METHODS: We searched MEDLINE and the Cochrane Library from 2012 to September 2018 using terms for included drugs and requested information from manufacturers of included drugs. We performed dual review of all systematic review processes, evaluated study quality, and conducted meta-analyses using random effects models. RESULTS: In addition to 31 older studies, we included 20 trials published since 2012 (N = 16,478; 4 good, 11 fair, and 5 poor quality). Where statistical differences were found, they were clinically small (reductions of < 0.5 episodes/day). Solifenacin plus mirabegron improved efficacy outcomes over monotherapy with either drug, but significantly increased constipation compared with solifenacin and dry mouth compared with mirabegron. Solifenacin reduced incontinence over mirabegron and tolterodine and urgency episodes over tolterodine. Mirabegron did not differ from tolterodine in efficacy but had significantly lower incidence of dry mouth than solifenacin or tolterodine. Fesoterodine showed significant improvements but also anticholinergic effects vs. tolterodine. Oxybutynin, solifenacin, and tolterodine had similar efficacy, but dry mouth led to greater discontinuation with oxybutynin. Blurred vision, cardiac arrhythmia, and dizziness were uncommon. CONCLUSION: New evidence confirms small, but clinically uncertain, differences among monotherapies and also between combination and monotherapy, regardless of statistical significance. While drugs mainly differed in incidence of dry mouth or constipation, none provided improved efficacy without increased harms.


Assuntos
Bexiga Urinária Hiperativa/tratamento farmacológico , Agentes Urológicos/uso terapêutico , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
3.
J Child Neurol ; 34(5): 237-247, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30674203

RESUMO

Sleep problems are common in children, especially those with neurodevelopmental disorders, and can lead to consequences in behavior, functioning, and quality of life. We systematically reviewed the efficacy and harms of pharmacologic treatments for sleep disorders in children and adolescents. We searched MEDLINE, Cochrane library databases, and PsycINFO through June 2018. We included 22 placebo-controlled randomized controlled trials (1-13 weeks' duration), involving 1758 children (mean age 8.2 years). Single randomized controlled trials of zolpidem and eszopiclone in children with attention-deficit/hyperactivity disorder (ADHD) showed no improvement in sleep or ADHD ratings. Clinical Global Impression Improvement/Severity scores significantly improved with zolpidem ( P = .03 and P = .006, respectively). A single, small randomized controlled trial of diphenhydramine reported small improvements in sleep outcomes (8-10 minutes' better sleep latency and duration) after 1 week. In 19 randomized controlled trials, melatonin significantly improved sleep latency (median 28 minutes; range 11-51 minutes), sleep duration (median 33 minutes; range 14-68 minutes), and wake time after sleep onset (range 12-43 minutes), but not number of awakenings per night (range 0-2.7). Function and behavior improvement varied. Improvement in sleep was greatest in children with autism or other neurodevelopmental disorders, and smaller in adolescents and children with chronic delayed sleep onset. Adverse events were infrequent with melatonin, but more frequent than placebo in children taking eszopiclone or zolpidem. These findings show that melatonin was useful in improving some sleep outcomes in the short term, particularly those with comorbid ASD and neurodevelopmental disorders. Other drugs and outcomes are inadequately studied.


Assuntos
Transtornos do Sono-Vigília/tratamento farmacológico , Adolescente , Criança , Humanos , Transtornos do Neurodesenvolvimento/complicações , Transtornos do Neurodesenvolvimento/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto , Transtornos do Sono-Vigília/complicações
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