Cost-effectiveness analyses for mirtazapine and sertraline in dementia: randomised controlled trial

BACKGROUND Depression is a common and costly comorbidity in dementia. There are very few data on the cost-effectiveness of antidepressants for depression in dementia and their effects on carer outcomes. AIMS To evaluate the cost-effectiveness of sertraline and mirtazapine compared with placebo for depression in dementia. METHOD A pragmatic, multicentre, randomised placebo-controlled trial with a parallel cost-effectiveness analysis (trial registration: ISRCTN88882979 and EudraCT 2006-000105-38). The primary cost-effectiveness analysis compared differences in treatment costs for patients receiving sertraline, mirtazapine or placebo with differences in effectiveness measured by the primary outcome, total Cornell Scale for Depression in Dementia (CSDD) score, over two time periods: 0-13 weeks and 0-39 weeks. The secondary evaluation was a cost-utility analysis using quality-adjusted life years (QALYs) computed from the Euro-Qual (EQ-5D) and societal weights over those same periods. RESULTS There were 339 participants randomised and 326 with costs data (111 placebo, 107 sertraline, 108 mirtazapine). For the primary outcome, decrease in depression, mirtazapine and sertraline were not cost-effective compared with placebo. However, examining secondary outcomes, the time spent by unpaid carers caring for participants in the mirtazapine group was almost half that for patients receiving placebo (6.74 v. 12.27 hours per week) or sertraline (6.74 v. 12.32 hours per week). Informal care costs over 39 weeks were £1510 and £1522 less for the mirtazapine group compared with placebo and sertraline respectively. CONCLUSIONS In terms of reducing depression, mirtazapine and sertraline were not cost-effective for treating depression in dementia. However, mirtazapine does appear likely to have been cost-effective if costing includes the impact on unpaid carers and with quality of life included in the outcome. Unpaid (family) carer costs were lower with mirtazapine than sertraline or placebo. This may have been mediated via the putative ability of mirtazapine to ameliorate sleep disturbances and anxiety. Given the priority and the potential value of supporting family carers of people with dementia, further research is warranted to investigate the potential of mirtazapine to help with behavioural and psychological symptoms in dementia and in supporting carers

Acetic acid guided biopsies in Barrett’s surveillance for neoplasia detection versus non-targeted biopsies (Seattle protocol):a feasibility study for a randomised tandem endoscopy trial. The ABBA study.

<div><p>MiRNAs function in post-transcriptional regulation of gene expression and play very important roles in plant development. <i>Lonicera japonica</i> is one of the important medicinal plants in China. However, few studies on the discovery of conserved and novel miRNAs from <i>L</i>. <i>japonica</i> were reported. In this study, we employed deep sequencing technology to identify miRNAs in leaf and flower tissues of <i>L</i>. <i>japonica</i>. A total of 22.97 million clean reads from flower and leaf tissues were obtained, which generated 146 conserved miRNAs distributed in 20 families and 110 novel miRNAs. Accordingly, 72 differentially expressed miRNAs (P≤0.001) between leaves and flowers and their potential target genes were identified and validated. The qRT-PCR validation showed that majority of the differentially expressed miRNAs showed significant tissue-specific expression in <i>L</i>. <i>japonica</i>. Furthermore, the miRNA-mRNA and mRNA-mRNA regulatory networks were constructed using Cytoscape software. Taken together, this study identified a large number of miRNAs and target genes in <i>L</i>. <i>japonica</i>, which not only provides the first global miRNA expression profiles, but also sheds light on functional genomics research on <i>L</i>. <i>japonica</i> in the future.</p></div

Acetic acid guided biopsies in Barrett’s surveillance for neoplasia detection versus non-targeted biopsies (Seattle protocol):a feasibility study for a randomised tandem endoscopy trial. The ABBA study.

Background and study aims - Barrett’s esophagus is a potentially pre-cancerous condition, affecting 375,000 people in the UK. Patients receive a 2-yearly endoscopy to detect cancerous changes, as early detection and treatment results in better outcomes. Current treatment requires random mapping biopsies along the length of Barrett’s, in addition to biopsy of visible abnormalities. As only 13 % of precancerous changes appear as visible nodules or abnormalities, areas of dysplasia are often missed. Acetic acid chromoendoscopy (AAC) has been shown to improve detection of pre-cancerous and cancerous tissue in observational studies, but no randomized controlled trials (RCTs) have been performed to date. Patients and methods - A “tandem” endoscopy cross-overdesign. Participants will be randomized to endoscopy usingmapping biopsies or AAC, in which dilute acetic acid issprayed onto the surface of the esophagus, highlighting tissuethrough an whitening reaction and enhancing visibilityof areas with cellular changes for biopsy. After 4 to 10weeks, participants will undergo a repeat endoscopy, usingthe second method. Rates of recruitment and retention willbe assessed, in addition to the estimated dysplasia detectionrate, effectiveness of the endoscopist training program,and rates of adverse events (AEs). Qualitative interviewswill explore participant and endoscopist acceptabilityof study design and delivery, and the acceptability ofswitching endoscopic techniques for Barrett's surveillance. Results - Endoscopists’ ability to diagnose dysplasia in Barrett’sesophagus can be improved. AAC may offer a simple,universally applicable, easily-acquired technique to improvedetection, affording patients earlier diagnosis and treatment,reducing endoscopy time and pathology costs. TheABBA study will determine whether a crossover “tandem”endoscopy design is feasible and acceptable to patientsand clinicians and gather outcome data to power a definitivetrial