No abstract

Despite the routine application of septoplasty in clinical practice, the current body of evidence does not support firm conclusions on its effectiveness.

BackgroundSeptoplasty, i.e., surgical correction of the deviated nasal septum, is the most common ear, nose and throat (ENT) operation in adults. Currently the main indication to perform septoplasty is nasal obstruction. However, the effectiveness of septoplasty for nasal obstruction in adults with a deviated nasal septum remains uncertain. Scientific evidence is scarce and inconclusive, and internationally accepted guidelines are lacking. Moreover, there is no consensus on whether or not septoplasty should be combined with concurrent turbinate surgery. The objective of the current ongoing trial is to study the effectiveness of septoplasty (with or without concurrent turbinate surgery) as compared to non-surgical management for nasal obstruction in adults with a deviated nasal septum, both in terms of subjective (health-related quality of life) as well as objective (nasal patency) outcome measures.Methods/DesignThe study is designed as a pragmatic, multicenter, parallel-group, randomized controlled trial. A total of 200 adults will be enrolled with nasal obstruction based on a deviated nasal septum and an indication for septoplasty according to current medical practice in the Netherlands. Participants will be randomized to either septoplasty (with or without concurrent turbinate surgery as originally indicated by the otorhinolaryngologist) or a non-surgical watchful waiting strategy. Follow-up visits will be scheduled at 0, 3, 6, 12, and 24 months. During each follow-up visit, health-related quality of life questionnaires will be administered and measurements of four-phase rhinomanometry and peak nasal inspiratory flow will be performed. Costs will be studied using a patient-based diary. Effects of septoplasty on health-related quality of life (primary outcome) and nasal patency will be calculated as mean differences with 95 % confidence intervals. Subgroup analyses according to gender, age, and severity of the septal deviation will be performed. All analyses will be performed on an intention-to-treat basis.DiscussionWith the results of this study we aim to contribute to the development of evidence-based guidelines regarding indications for septoplasty.Trial registrationNederlands Trial Register/Dutch Trial Registry (www.trialregister.nl), trial identifying number: NTR3868. Registered on 21 February 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-1031-4) contains supplementary material, which is available to authorized users.

To determine which factors predict development of chronic suppurative otitis media (CSOM) in children. Design: Case-control study, with univariate and multivariate logistic regression analysis applied to determine which factors independently predict CSOM. Subjects: Prognostic factors for CSOM were identified in (1) 100 children with CSOM and 161 controls aged 1 to 12 years and (2) 83 children who developed CSOM in the presence of a tympanostomy tube and 136 children with tympanostomy tubes who did not develop CSOM. Results: Independent predictors for CSOM were previous tympanostomy tube insertion (odds ratio [OR], 121.4 [95% confidence interval {CI}, 38.9-379.3]); having had more than 3 upper respiratory tract infections in the past 6 months (OR, 12.2 [95% CI, 3.5-42.3]); having parents

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged as a new human pathogen in late 2019 and it has infected over 100 million people in less than a year. There is a clear need for effective antiviral drugs to complement current preventive measures, including vaccines. In this study, we demonstrate that berberine and obatoclax, two broad-spectrum antiviral compounds, are effective against multiple isolates of SARS-CoV-2. Berberine, a plant-derived alkaloid, inhibited SARS-CoV-2 at low micromolar concentrations and obatoclax, which was originally developed as an anti-apoptotic protein antagonist, was effective at sub-micromolar concentrations. Time-of-addition studies indicated that berberine acts on the late stage of the viral life cycle. In agreement, berberine mildly affected viral RNA synthesis, but it strongly reduced infectious viral titers, leading to an increase in the particle-to-pfu ratio. In contrast, obatoclax acted at the early stage of the infection, which is in line with its activity to neutralize the acidic environment in endosomes. We assessed infection of primary human nasal epithelial cells that were cultured on an air-liquid interface and found that SARS-CoV-2 infection induced and repressed expression of specific sets of cytokines and chemokines. Moreover, both obatoclax and berberine inhibited SARS-CoV-2 replication in these primary target cells. We propose berberine and obatoclax as potential antiviral drugs against SARS-CoV-2 that could be considered for further efficacy testing.