Antibiotics for acute maxillary sinusitis in adults.

BACKGROUND: Sinusitis is one of the most common diagnoses among adults in ambulatory care, accounting for 15% to 21% of all adult outpatient antibiotic prescriptions. However, the role of antibiotics for sinusitis is controversial. OBJECTIVES: To assess the effects of antibiotics in adults with acute maxillary sinusitis by comparing antibiotics with placebo, antibiotics from different classes and the side effects of different treatments. SEARCH METHODS: We searched CENTRAL 2013, Issue 2, MEDLINE (1946 to March week 3, 2013), EMBASE (1974 to March 2013), SIGLE (OpenSIGLE, later OpenGrey (accessed 15 January 2013)), reference lists of the identified trials and systematic reviews of placebo-controlled studies. We also searched for ongoing trials via ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP). We imposed no language or publication restrictions. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing antibiotics with placebo or antibiotics from different classes for acute maxillary sinusitis in adults. We included trials with clinically diagnosed acute sinusitis, confirmed or not by imaging or bacterial culture. DATA COLLECTION AND ANALYSIS: Two review authors independently screened search results, extracted data and assessed trial quality. We calculated risk ratios (RRs) for differences between intervention and control groups in whether the treatment failed or not. All measures are presented with 95% confidence intervals (CIs). We conducted the meta-analyses using either the fixed-effect or random-effects model. In meta-analyses of the placebo-controlled studies, we combined data across antibiotic classes. Primary outcomes were clinical failure rates at 7 to 15 days and 16 to 60 days follow-up. We used GRADEpro to assess the quality of the evidence. MAIN RESULTS: We included 63 studies in this updated review; nine placebo-controlled studies involving 1915 participants (seven of the studies clearly conducted in primary care settings) and 54 studies comparing different classes of antibiotics (10 different comparisons). Five studies at low risk of bias comparing penicillin or amoxicillin to placebo provided information on the main outcome: clinical failure rate at 7 to 15 days follow-up, defined as a lack of full recovery or improvement, for participants with symptoms lasting at least seven days. In these studies antibiotics decreased the risk of clinical failure (pooled RR of 0.66, 95% CI 0.47 to 0.94, 1084 participants randomised, 1058 evaluated, moderate quality evidence). However, the clinical benefit was small. Cure or improvement rates were high in both the placebo group (86%) and the antibiotic group (91%) in these five studies. When clinical failure was defined as a lack of full recovery (n = five studies), results were similar: antibiotics decreased the risk of failure (pooled RR of 0.73, 95% CI 0.63 to 0.85, high quality evidence) at 7 to 15 days follow-up.Adverse effects in seven of the nine placebo-controlled studies (comparing penicillin, amoxicillin, azithromycin or moxicillin to placebo) were more common in antibiotic than in placebo groups (median of difference between groups 10.5%, range 2% to 23%). However, drop-outs due to adverse effects were rare in both groups: 1.5% in antibiotic groups and 1% in control groups.In the 10 head-to-head comparisons, none of the antibiotic preparations were superior to another. However, amoxicillin-clavulanate had significantly more drop-outs due to adverse effects than cephalosporins and macrolides. AUTHORS' CONCLUSIONS: There is moderate evidence that antibiotics provide a small benefit for clinical outcomes in immunocompetent primary care patients with uncomplicated acute sinusitis. However, about 80% of participants treated without antibiotics improved within two weeks. Clinicians need to weigh the small benefits of antibiotic treatment against the potential for adverse effects at both the individual and general population levels.

Antibiotics for acute maxillary sinusitis.

BACKGROUND: Expert opinions vary on the appropriate role of antibiotics for sinusitis, one of the most commonly diagnosed conditions among adults in ambulatory care. OBJECTIVES: We examined whether antibiotics are effective in treating acute sinusitis, and if so, which antibiotic classes are the most effective. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2007, Issue 3); MEDLINE (1950 to May 2007) and EMBASE (1974 to June 2007). SELECTION CRITERIA: Randomized controlled trials (RCTs) comparing antibiotics with placebo or antibiotics from different classes for acute maxillary sinusitis in adults. We included trials with clinically diagnosed acute sinusitis, whether or not confirmed by radiography or bacterial culture. DATA COLLECTION AND ANALYSIS: At least two review authors independently screened search results, extracted data and quality assessed trials. Risk ratios (RR) were calculated for differences in the intervention and control groups to see whether or not the treatment was a failure. In meta-analysing the placebo-controlled studies, the data across antibiotic classes were combined. Primary outcomes were the clinical failure rates at 7 to 15 days and 16 to 60 days follow up. MAIN RESULTS: Fifty-seven studies were included in the review; six placebo-controlled studies and 51 studies comparing different classes of antibiotics. Five studies involving 631 participants provided data for comparison of antibiotics to placebo, when clinical failure was defined as a lack of cure or improvement at 7 to 15 days follow up. These studies found a slight statistical difference in favor of antibiotics, compared to placebo, with a pooled RR of 0.66 (95% confidence interval (CI) 0.44 to 0.98). However, the clinical significance of the result is equivocal, also considering that cure or improvement rate was high in both the placebo group (80%) and the antibiotic group (90%). Based on six studies, when clinical failure was defined as a lack of total cure, there was significant difference in favor of antibiotics compared to placebo with a pooled RR of 0.74 (95% CI 0.65 to 0.84) at 7 to 15 days follow up. None of the antibiotic preparations was superior to each other. AUTHORS' CONCLUSIONS: Antibiotics have a small treatment effect in patients with uncomplicated acute sinusitis in a primary care setting with symptoms for more than seven days. However, 80% of participants treated without antibiotics improve within two weeks. Clinicians need to weigh the small benefits of antibiotic treatment against the potential for adverse effects at both the individual and general population level.

The cost-effectiveness of a new percutaneous ventricular assist device for high-risk PCI patients: mid-stage evaluation from the European perspective.

OBJECTIVE: A new and smaller percutaneous ventricular assist device (pVAD, Impella, Abiomed, Danvers, MA) has been developed to provide circulatory support in hemodynamically unstable patients and to prevent hemodynamic collapse during high-risk percutaneous coronary interventions (PCI). The objective of the study was to assess the cost-effectiveness of this specific device compared to the intra-aortic balloon pump (IABP) from the European perspective. Additional analysis on extracorporeal membrane oxygenation was conducted for observational purposes only, given its use in some European countries. METHODS: A combination of a decision tree and Markov model was developed to assess the cost-effectiveness of the small, pVAD. The short-term (30-day) effectiveness and safety (early survival, risk of bleeding, and stroke) were modeled, as well as long-term risk of major adverse cardiovascular events (recurrent myocardial infarction, stroke, and heart failure). The short-term effectiveness and safety data for the device were obtained from two registries (the Europella and USpella), both of which are large multi-center studies in high-risk patient groups. Probabilities of long-term major adverse cardiovascular events were obtained from various published clinical studies. The economic analysis was conducted from a German statutory health insurance perspective and only direct medical costs were included. Cost-effectiveness was estimated over a 10-year time horizon. RESULTS: Compared with IABP, the pVAD generated an incremental quality-adjusted life-year (QALY) of 0.22 (with Euro-registry data) and 0.27 (with US-registry data). The incremental cost-effectiveness ratio (ICER) of the device varied between €38,069 (with Euro-registry data) and €31,727 (with US-registry data) per QALY compared with IABP. KEY LIMITATIONS: Unadjusted, indirect comparisons of short-term effectiveness and safety between the interventions were used in the model. Cost and utility data were retrieved from various sources. Therefore, differences in patient populations may bias the estimated cost-effectiveness. CONCLUSIONS: Compared with IABP, the pVAD is a cost-effective intervention for high-risk PCI patients, with ICERs well-below the conventional cost-effectiveness threshold.