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Improved Neonatal Outcomes With Probiotics

Improved Neonatal Outcomes With Probiotics Opinion VIEWPOINT Evidence is a spectrum. The US Food and Drug Admin- otic products in the trials. As readers are aware, Coch- Andi L. Shane, MD, istration (FDA) Guidance for Industry states that “[w]ith rane reviews are very conservative with the wording of MPH, MSc Division of Infectious regard to quantity, it has been FDA’s position that Con- their conclusions and data interpretation; however, Al- Diseases, Department gress generally intended to require at least two ad- faleh et al state that their “updated review of available of Pediatrics, Emory equate and well-controlled studies, each convincing on evidence supports a change in practice.” It is difficult to University School of Medicine, and Hubert its own, to establish effectiveness.” However, in prac- find such a definitive conclusion statement in other con- Department of Global tice, care is often changed if standard of care is limited, temporaneous Cochrane reviews. Health, Rollins School if the underlying disease is severe, or if the new treat- Owing to the increased use of probiotics in pediat- of Public Health, ment is comparatively safe. In October 2012, a commen- ric practice, representatives from the American Acad- Atlanta, Georgia. tary in JAMA stated that “[u]nlike treatments used in http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Pediatrics American Medical Association

Improved Neonatal Outcomes With Probiotics

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Publisher
American Medical Association
Copyright
Copyright 2013 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
2168-6203
eISSN
2168-6211
DOI
10.1001/jamapediatrics.2013.2590
pmid
23921788
Publisher site
See Article on Publisher Site

Abstract

Opinion VIEWPOINT Evidence is a spectrum. The US Food and Drug Admin- otic products in the trials. As readers are aware, Coch- Andi L. Shane, MD, istration (FDA) Guidance for Industry states that “[w]ith rane reviews are very conservative with the wording of MPH, MSc Division of Infectious regard to quantity, it has been FDA’s position that Con- their conclusions and data interpretation; however, Al- Diseases, Department gress generally intended to require at least two ad- faleh et al state that their “updated review of available of Pediatrics, Emory equate and well-controlled studies, each convincing on evidence supports a change in practice.” It is difficult to University School of Medicine, and Hubert its own, to establish effectiveness.” However, in prac- find such a definitive conclusion statement in other con- Department of Global tice, care is often changed if standard of care is limited, temporaneous Cochrane reviews. Health, Rollins School if the underlying disease is severe, or if the new treat- Owing to the increased use of probiotics in pediat- of Public Health, ment is comparatively safe. In October 2012, a commen- ric practice, representatives from the American Acad- Atlanta, Georgia. tary in JAMA stated that “[u]nlike treatments used in

Journal

JAMA PediatricsAmerican Medical Association

Published: Oct 1, 2013

References