Is the combination of a long-acting beta-agonist and an inhaled corticosteroid as safe and effective as an inhaled corticosteroid alone?
The combination of fluticasone and salmeterol, with the steroid dose adjusted for disease severity, reduces the number of severe asthma exacerbations more than fluticasone alone (number needed to treat [NNT] = 50 over 26 weeks), with no difference in terms of potential harms such as intubation or asthma-related death. (LOE = 1b)(www.essentialevidenceplus.com)
Stempel DA, Raphiou I, Kral KM, et al, for the AUSTRI Investigators. Serious asthma events with fluticasone plus salmeterol versus fluticasone alone. N Engl J Med 2016;374(19):1822-1830.
Study design: Randomized controlled trial (double-blinded)
Funding source: Industry
Setting: Outpatient (any)
This study was performed by GlaxoSmithKline at the behest of the FDA because of enduring concerns about the safety of long-acting beta-agonists. The authors identified patients with moderate to severe asthma who had experienced at least one exacerbation in the previous year that required systemic steroids or hospitalization (but no such episode in the previous month). The 11,751 included patients from 694 centers were randomized to receive fluticasone-salmeterol or fluticasone alone. The dose of fluticasone alone was stratified into 3 subgroups based on disease severity: 100 mcg, 250 mcg, and 500 mcg. In the combination treatment group, salmeterol 50 mcg was combined with fluticasone at 100 mcg, 250 mcg, and 500 mcg, again according to disease severity. All medications were given twice daily. Patients were 12 years and older (mean age = 43 years) and most patients were from North America or Europe. Groups were balanced at the beginning of the study and analysis was by intention to treat. Outcomes were adjudicated by members of the research team who were masked to treatment assignment.The primary efficacy endpoint was the first severe asthma exacerbation, defined as the use of systemic steroids for at least 3 days, asthma-related hospitalization, or an emergency department visit resulting in systemic steroid administration. There were fewer severe asthma exacerbations in the fluticasone-salmeterol group than in the group that received fluticasone alone (8% vs 10%; P < .001; NNT = 50 over 26 weeks). The primary safety outcome (a composite of asthma-related deaths, asthma-related intubations, and asthma-related hospitalizations) was similar between groups: 36 events in the fluticasone-salmeterol group and 38 events in the fluticasone-only group. There were 3 deaths in the fluticasone-salmeterol group and 6 in the fluticasone-only group, none of which were adjudicated as being related to asthma.
Mark H. Ebell, MD, MS
University of Georgia
In patients with chronic or recurrent sinus symptoms, does nasal irrigation or steam inhalation improve symptoms?
This study confirms the benefit of nasal irrigation in patients with chronic sinus symptoms seen in earlier US studies. The US studies had somewhat larger benefits, but this may be because of a more intensive intervention that included coached practice and more follow-up contacts. This study also confirms the lack of benefit of steam inhalation. Primary care physicians should instruct patients how to use a neti pot to perform daily nasal irrigation for their chronic sinus symptoms. (LOE = 1b)(www.essentialevidenceplus.com)
Little P, Stuart B, Mullee M, et al, for the SNIFS Study Team. Effectiveness of steam inhalation and nasal irrigation for chronic or recurrent sinus symptoms in primary care: a pragmatic randomized controlled trial. CMAJ 2016;188(13):940-949.
Study design: Randomized controlled trial (nonblinded)
Funding source: Government
Setting: Outpatient (primary care)
Although commonly recommended, nasal irrigation and steam inhalation as treatments for chronic sinus symptoms have been poorly studied. In this large UK trial, patients with moderate to severe sinus symptoms in 1 of 72 general practices were invited to participate. They were randomized to receive 1 of 4 strategies: (1) usual care, (2) advice to use nasal irrigation with a SinuCleanse Neti Pot, including an instructional video, (3) advice to use steam inhalation for 5 minutes a day, and (4) advice to use both interventions. Approximately 70% of the patients were women, their mean age was 52 years, and the mean duration of sinus symptoms was 19 years. Of the 2294 patients invited to participate, 960 were randomized, 871 completed the baseline questionnaire, 671 provided 3-month data, and 623 provided 6-month data. Adherence to the recommended interventions was reasonable: a median of 20 days of nasal irrigation per month, and a similar rate of using steam inhalation. At 6 months, using the validated Rhinosinusitis Disability Index, a clinically significant improvement was seen more often in patients using nasal irrigation than in those who did not (44% vs 37%; number needed to treat = 13). On the other hand, using the aptly named SNOT-20 score, no difference was seen between groups. Other potential benefits of nasal irrigation included fewer reported headaches, less likelihood of seeking care for sinus symptoms, and less use of over-the-counter medications. Steam inhalation did not have any benefit.
In patients with respiratory tract infections (bronchitis, sinusitis, pharyngitis), is a delayed prescription strategy as effective as immediate treatment and as accepted by patients?
In almost 400 Spanish primary care patients with mild to moderate symptoms of respiratory infection of less than 1 week's duration, both a "take-and-hold" prescription and a "come back and pick up, if necessary" prescription produced a similar clinical response -- and similar patient satisfaction score -- as immediate antibiotic treatment, while decreasing overall antibiotic use. Other studies of this patient population have shown that patients prefer the security of a prescription, delayed or not, over withholding antibiotic treatment. The effect of legitimizing an illness by awarding a prescription should not be underestimated. (LOE = 1b)(www.essentialevidenceplus.com)
de la Poza Abad M, Mas Dalmau G, Moreno Bakedano M, et al, for the Delayed Antibiotic Prescription (DAP) Group. Prescription strategies in acute uncomplicated respiratory infections. A randomized clinical trial. JAMA Intern Med 2016;176(1):21-29.
These researchers evaluated 398 adults with acute, uncomplicated respiratory infections from 23 primary care centers in Spain. The patients had acute pharyngitis (46%), acute bronchitis (32%), rhinosinusitis (20%), or exacerbation of mild-to-moderate chronic obstructive pulmonary disease (2%). The physicians had "reasonable doubt as to whether to treat with an antibiotic." Patients were, on average, on the younger side (mid-40s), half were smokers or former smokers, almost no patients (< 2%) were febrile, and they reported mild to moderate symptoms for an average of 6 days. Patients were randomized, using concealed allocation, to 1 of 4 potential prescription strategies. One group was given an antibiotic to begin at once; 2 groups were given a delayed prescription, either a "take and hold prescription" or a "come back and pick up, if necessary prescription"; and the final group was not given any prescription. The average duration of symptoms was significantly longer in patients not given a prescription as compared with patients given an immediate antibiotic, with the duration in patients given delayed prescriptions somewhere in between but not significantly different from the immediate prescription. The duration of moderate or severe symptoms was lessened significantly with immediate treatment as compared with delayed prescriptions, but the average difference in duration was 0.5 day to 1.0 day. Patients in the delayed prescription groups experienced fewer days absent from work or unable to do their daily activities. Patient satisfaction was similar across all groups. Prescription use was decreased by two-thirds with the delayed prescription approaches.
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
POEMs are provided by Essential Evidence Plus, a point-of-care clinical decision support system published by Wiley-Blackwell. For more information, please see http://www.essentialevidenceplus.com(www.essentialevidenceplus.com).
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Top 20 POEMs of 2016