To provide a comprehensive meta-analysis on the efficacy of psychological and medical treatments for binge-eating disorder (BED), including those targeting weight loss. Through a systematic search before March 2018, 81 published and unpublished randomized-controlled trials (RCTs), totaling 7,515 individuals with BED (Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition [DSM-IV] and Fifth Edition [DSM-5]), were retrieved and analyzed using random-effect modeling. In RCTs with inactive control groups, psychotherapy, mostly consisting of cognitive-behavioral therapy, showed large-size effects for the reduction of binge-eating episodes and abstinence from binge eating, followed by structured self-help treatment with medium-to-large effects when compared with wait-list. Pharmacotherapy and pharmacological weight loss treatment mostly outperformed pill placebo conditions with small effects on binge-eating outcome. These results were confirmed for the most common treatments of cognitive-behavioral therapy, self-help treatment based on cognitive-behavioral therapy, and lisdexamfetamine. In RCTs with active control groups, there was limited evidence for the superiority of one treatment category or treatment. In a few studies, psychotherapy outperformed behavioral weight loss treatment in short- and long-term binge-eating outcome and led to lower longer-term abstinence than self-help treatment, while combined treatment revealed no additive effect on binge-eating outcome over time. Overall study quality was heterogeneous and the quality of evidence for binge-eating outcome was generally very low. This comprehensive meta-analysis demonstrated the efficacy of psychotherapy, structured self-help treatment, and pharmacotherapy for patients with BED. More high quality research on treatments for BED is warranted, with a focus on long-term maintenance of therapeutic gains, comparative efficacy, mechanisms through which treatments work, and complex models of care. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

A diagnosis of celiac disease is made based on clinical, genetic, serologic, and duodenal morphology features. Recent pediatric guidelines, based largely on retrospective data, propose omitting biopsy analysis for patients with concentrations of IgA against tissue transglutaminase (IgA-TTG) >10-fold the upper limit of normal (ULN) and if further criteria are met. A retrospective study concluded that measurements of IgA-TTG and total IgA, or IgA-TTG and IgG against deamidated gliadin (IgG-DGL) could identify patients with and without celiac disease. Patients were assigned to categories of no celiac disease, celiac disease, or biopsy required, based entirely on antibody assays. We aimed to validate the positive and negative predictive values (PPV and NPV) of these diagnostic procedures. We performed a prospective study of 898 children undergoing duodenal biopsy analysis to confirm or rule out celiac disease at 13 centers in Europe. We compared findings from serologic analysis with findings from biopsy analyses, follow-up data, and diagnoses made by the pediatric gastroenterologists (celiac disease, no celiac disease, or no final diagnosis). Assays to measure IgA-TTG, IgG-DGL, and endomysium antibodies were performed by blinded researchers, and tissue sections were analyzed by local and blinded reference pathologists. We validated 2 procedures for diagnosis: total-IgA and IgA-TTG (the TTG-IgA procedure), as well as IgG-DGL with IgA-TTG (TTG-DGL procedure). Patients were assigned to categories of no celiac disease if all assays found antibody concentrations 10-fold the ULN. All other cases were considered to require biopsy analysis. ULN values were calculated using the cutoff levels suggested by the test kit manufacturers. HLA typing was performed for 449 participants. We used models that considered how specificity values change with prevalence to extrapolate the PPV and NPV to populations with lower prevalence of celiac disease. Of the participants, 592 were found to have celiac disease, 345 were found not to have celiac disease, and 24 had no final diagnosis. The TTG-IgA procedure identified patients with celiac disease with a PPV of 0.988 and an NPV of 0.934; the TTG-DGL procedure identified patients with celiac disease with a PPV of 0.988 and an NPV of 0.958. Based on our extrapolation model, we estimated that the PPV and NPV would remain >0.95 even at a disease prevalence as low as 4%. Tests for endomysium antibodies and HLA type did not increase the PPV of samples with levels of IgA-TTG ≥10-fold the ULN. Notably, 4.2% of pathologists disagreed in their analyses of duodenal morphology—a rate comparable to the error rate for serologic assays. In a prospective study, we validated the TTG-IgA procedure and the TTG-DGL procedure in identification of pediatric patients with or without celiac disease, without biopsy. German Clinical Trials Registry no.: DRKS00003854.

A daily injection of low-molecular-weight heparin (LMWH) is often prescribed to women with unexplained recurrent pregnancy loss (RPL), although evidence suggesting a benefit is questionable. To determine whether LMWH increases ongoing pregnancy and live-birth rates in women with unexplained RPL. Controlled, multicenter trial with randomization using minimization conducted from 2006 to 2013. (ClinicalTrials.gov: NCT00400387) 14 university hospitals and perinatal care centers in Germany and Austria. 449 women with at least 2 consecutive early miscarriages or 1 late miscarriage were included during 5 to 8 weeks' gestation after a viable pregnancy was confirmed by ultrasonography. Women in the control group received multivitamin pills, and the intervention group received vitamins and 5000 IU of dalteparin–sodium for up to 24 weeks' gestation. Primary outcome was ongoing pregnancy at 24 weeks' gestation. Secondary outcomes included the live-birth rate and late pregnancy complications. At 24 weeks' gestation, 191 of 220 pregnancies (86.8%) and 188 of 214 pregnancies (87.9%) were intact in the intervention and control groups, respectively (absolute difference, −1.1 percentage points [95% CI, −7.4 to 5.3 percentage points]). The live-birth rates were 86.0% (185 of 215 women) and 86.7% (183 of 211 women) in the intervention and control groups, respectively (absolute difference, −0.7 percentage point [CI, −7.3 to 5.9 percentage points]). There were 3 intrauterine fetal deaths (1 woman had used LMWH); 9 cases of preeclampsia or the hemolysis, elevated liver enzyme level, and low platelet count (HELLP) syndrome (3 women had used LMWH); and 11 cases of intrauterine growth restriction or placental insufficiency (5 women had used LMWH). Placebo injections were not used, and neither trial staff nor patients were blinded. Daily LMWH injections do not increase ongoing pregnancy or live-birth rates in women with unexplained RPL. Given the burden of the injections, they are not recommended for preventing miscarriage. Pfizer Pharma.

We performed a meta-analysis of randomized controlled trials comparing low-molecular-weight heparin (LMWH) vs no LMWH in women with inherited thrombophilia and prior late (≥10 weeks) or recurrent early (<10 weeks) pregnancy loss. Eight trials and 483 patients met our inclusion criteria. There was no significant difference in livebirth rates with the use of LMWH compared with no LMWH (relative risk, 0.81; 95% confidence interval, 0.55-1.19; P = .28), suggesting no benefit of LMWH in preventing recurrent pregnancy loss in women with inherited thrombophilia.

Objective: Long‐term effectiveness is a critical aspect of the clinical utility of a treatment; however, a meta‐analytic evaluation of psychological and medical treatments for binge‐eating disorder (BED), including weight loss treatments, is outstanding. This meta‐analysis sought to provide a comprehensive evaluation of the long‐term effectiveness in diverse treatments for BED regarding a range of clinically relevant outcomes.Method: Based on a systematic search up to February 2018, 114 published and unpublished randomized‐controlled (RCTs), nonrandomized, and uncontrolled treatment studies, totaling 8,862 individuals with BED (DSM‐IV, DSM‐5), were identified and analyzed using within‐group random‐effect modeling.Results: Effectiveness (regarding binge‐eating episodes and abstinence, eating disorder and general psychopathology) up to 12 months following treatment was demonstrated for psychotherapy, structured self‐help treatment, and combined treatment, while the results regarding body weight reduction were inconsistent. These results were confirmed in sensitivity analyses with RCTs on the most common treatments—cognitive‐behavioral therapy and self‐help treatment based on this approach. Follow‐up intervals longer than 12 months were rarely reported, mostly supporting the long‐term effectiveness of psychotherapy. Few follow‐up data were available for pharmacotherapy, and behavioral and self‐help weight loss treatment, while follow‐up data were lacking for pharmacological and surgical weight loss treatment. Study quality varied widely.Discussion: This comprehensive meta‐analysis demonstrated the medium‐term effectiveness of psychotherapy, structured self‐help treatment, and combined treatment for patients with BED, and supported the long‐term effectiveness of psychotherapy. The results were derived from uncontrolled comparisons over time. Further long‐term high quality research on psychological and medical treatments for BED is required.

Introduction: Spinal cord injury (SCI) including permanent paraplegia constitutes a common complication after repair of thoracoabdominal aortic aneurysms. The staged-repair concept promises to provide protection by inducing arteriogenesis so that the collateral network can provide a robust blood supply to the spinal cord after intervention. Minimally invasive staged segmental artery coil embolisation (MIS ² ACE) has been proved recently to be a feasible enhanced approach to staged repair. Methods and analysis: This randomised controlled trial uses a multicentre, multinational, parallel group design, where 500 patients will be randomised in a 1:1 ratio to standard aneurysm repair or to MIS ² ACE in 1–3 sessions followed by repair. Before randomisation, physicians document whether open or endovascular repair is planned. The primary endpoint is successful aneurysm repair without substantial SCI 30 days after aneurysm repair. Secondary endpoints include any form of SCI, mortality (up to 1 year), length of stay in the intensive care unit, costs and quality-adjusted life years. A generalised linear mixed model will be used with the logit link function and randomisation arm, mode of repair (open or endovascular repair), the Crawford type and the European System for Cardiac Operative Risk Evaluation (euroSCORE) II as fixed effects and the centre as a random effect. Safety endpoints include kidney failure, respiratory failure and embolic events (also from debris). A qualitative study will explore patient perceptions. Ethics and dissemination: This trial has been approved by the lead Ethics Committee from the University of Leipzig (435/17-ek) and will be reviewed by each of the Ethics Committees at the trial sites. A dedicated project is coordinating communication and dissemination of the trial. Trial registration number: NCT03434314.