Downloaded from http://adc.bmj.com/ on February 10, 2015 - Published by group.bmj.com
Review
ARCHIVIST
When two trials conflict: bronchiolitis and hypertonic saline The editors of JAMA Pediatrics must have been flummoxed when they received two papers at the same time describing the same interventional trial, with completely different results. Both were trials comparing 3% with 0.9% nebulised saline in bronchiolitis, and both were conducted in the emergency departments (EDs) of US children’s hospitals. The editors took the brave decision to publish them simultaneously with an accompanying editorial. Both trials recruited infants under two years presenting to ED with a first episode of clinically diagnosed bronchiolitis, and both excluded those with pre-existing cardio-respiratory conditions. Both were double-blind and both used hospital admission rates and a clinical scoring system, either Respiratory Distress Assessment Instrument (RDAI) or Respiratory Assessment Change Score (RACS), as outcomes. The larger trial, from California, randomised about 400 infants; all were pre-medicated with a beta-2 agonist, nebulised albuterol, and then given up to three 4 ml doses of saline (Wu S and colleagues. JAMA Pediatr 2014;168:657–63). The 3% saline group had a significantly lower rate of hospital admission compared to the 0.9 % group (29% vs 43%; adjusted OR 0.49 [95% CI 0.3 to 0.9]). Length of stay for those hospitalised differed, but not significantly (3.9 vs 3.1 days; p=0.2). The RDAI score improved in both groups but did not differ between them. The smaller trial, from Ohio, randomised 62 infants, and also gave each participant albuterol as well as nasal suctioning before the saline dose (Florin T and colleagues. JAMA Pediatr 2014;168:664–70). Here, only one dose of saline was given. This trial found no differences in admission rates, and actually found significantly less clinical improvement in the 3% group, as assessed by RACS ( p=0.01). So as this winter’s bronchiolitis season begins in the North, what are we to do? It’s tempting to use a low-cost, apparently harmless intervention in the ED that might prevent a few admissions. Current UK guidelines offer no advice. A 2013 Cochrane review, pre-dating these trials, suggests that hypertonic saline might reduce in-patient stay in those hospitalised. The editorial in JAMA picks over the reasons why the findings may have differed (Grewal S and Klassen T. JAMA Pediatr 2014;168:607–9). There may have been differing severity levels, scoring systems, population characteristics, etc, but they conclude that numbers of participants were simply not great enough to reach firm conclusions: which is why we need systematic reviews and meta-analyses, and organisations such as Cochrane that can put all the available data, including these papers, together for us. Competing interests None. Provenance and peer review Commissioned; internally peer reviewed. Accepted 3 September 2014 Published Online First 17 September 2014 Arch Dis Child 2014;99:1054. doi:10.1136/archdischild-2014-307480
1054
Hull J. Arch Dis Child 2014;99:1050–1054. doi:10.1136/archdischild-2013-305322
Downloaded from http://adc.bmj.com/ on February 10, 2015 - Published by group.bmj.com
When two trials conflict: bronchiolitis and hypertonic saline Arch Dis Child 2014 99: 1054 originally published online September 17, 2014
doi: 10.1136/archdischild-2014-307480 Updated information and services can be found at: http://adc.bmj.com/content/99/11/1054
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To request permissions go to: http://group.bmj.com/group/rights-licensing/permissions To order reprints go to: http://journals.bmj.com/cgi/reprintform To subscribe to BMJ go to: http://group.bmj.com/subscribe/
Review
ARCHIVIST
When two trials conflict: bronchiolitis and hypertonic saline The editors of JAMA Pediatrics must have been flummoxed when they received two papers at the same time describing the same interventional trial, with completely different results. Both were trials comparing 3% with 0.9% nebulised saline in bronchiolitis, and both were conducted in the emergency departments (EDs) of US children’s hospitals. The editors took the brave decision to publish them simultaneously with an accompanying editorial. Both trials recruited infants under two years presenting to ED with a first episode of clinically diagnosed bronchiolitis, and both excluded those with pre-existing cardio-respiratory conditions. Both were double-blind and both used hospital admission rates and a clinical scoring system, either Respiratory Distress Assessment Instrument (RDAI) or Respiratory Assessment Change Score (RACS), as outcomes. The larger trial, from California, randomised about 400 infants; all were pre-medicated with a beta-2 agonist, nebulised albuterol, and then given up to three 4 ml doses of saline (Wu S and colleagues. JAMA Pediatr 2014;168:657–63). The 3% saline group had a significantly lower rate of hospital admission compared to the 0.9 % group (29% vs 43%; adjusted OR 0.49 [95% CI 0.3 to 0.9]). Length of stay for those hospitalised differed, but not significantly (3.9 vs 3.1 days; p=0.2). The RDAI score improved in both groups but did not differ between them. The smaller trial, from Ohio, randomised 62 infants, and also gave each participant albuterol as well as nasal suctioning before the saline dose (Florin T and colleagues. JAMA Pediatr 2014;168:664–70). Here, only one dose of saline was given. This trial found no differences in admission rates, and actually found significantly less clinical improvement in the 3% group, as assessed by RACS ( p=0.01). So as this winter’s bronchiolitis season begins in the North, what are we to do? It’s tempting to use a low-cost, apparently harmless intervention in the ED that might prevent a few admissions. Current UK guidelines offer no advice. A 2013 Cochrane review, pre-dating these trials, suggests that hypertonic saline might reduce in-patient stay in those hospitalised. The editorial in JAMA picks over the reasons why the findings may have differed (Grewal S and Klassen T. JAMA Pediatr 2014;168:607–9). There may have been differing severity levels, scoring systems, population characteristics, etc, but they conclude that numbers of participants were simply not great enough to reach firm conclusions: which is why we need systematic reviews and meta-analyses, and organisations such as Cochrane that can put all the available data, including these papers, together for us. Competing interests None. Provenance and peer review Commissioned; internally peer reviewed. Accepted 3 September 2014 Published Online First 17 September 2014 Arch Dis Child 2014;99:1054. doi:10.1136/archdischild-2014-307480
1054
Hull J. Arch Dis Child 2014;99:1050–1054. doi:10.1136/archdischild-2013-305322
Downloaded from http://adc.bmj.com/ on February 10, 2015 - Published by group.bmj.com
When two trials conflict: bronchiolitis and hypertonic saline Arch Dis Child 2014 99: 1054 originally published online September 17, 2014
doi: 10.1136/archdischild-2014-307480 Updated information and services can be found at: http://adc.bmj.com/content/99/11/1054
These include:
Email alerting service
Receive free email alerts when new articles cite this article. Sign up in the box at the top right corner of the online article.
Notes
To request permissions go to: http://group.bmj.com/group/rights-licensing/permissions To order reprints go to: http://journals.bmj.com/cgi/reprintform To subscribe to BMJ go to: http://group.bmj.com/subscribe/
