Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children (Review)

Jefferson, Tom, Jones, Mark A., Doshi, Peter, Del Mar, Chris B., Heneghan, Carl J., Hama, Rokuro and Thompson, Matthew J. (2012) Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children (Review). Cochrane Database of Systematic Reviews, 21 1 Art. No.:CD008965: 217-221. doi:10.1002/14651858.CD008965.pub3

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Author Jefferson, Tom
Jones, Mark A.
Doshi, Peter
Del Mar, Chris B.
Heneghan, Carl J.
Hama, Rokuro
Thompson, Matthew J.
Title Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children (Review)
Journal name Cochrane Database of Systematic Reviews   Check publisher's open access policy
ISSN 1469-493X
Publication date 2012-01-01
Sub-type Critical review of research, literature review, critical commentary
DOI 10.1002/14651858.CD008965.pub3
Open Access Status File (Publisher version)
Volume 21
Issue 1 Art. No.:CD008965
Start page 217
End page 221
Total pages 217
Place of publication Oxford, United Kingdom
Publisher John Wiley and Sons
Language eng
Subject 2726 Microbiology (medical)
2725 Infectious Diseases
Abstract In recent years there has been much debate and controversy surrounding the efficacy and safety of neuraminidase inhibitors for influenza, in part because the data underlying certain efficacy claims were not available for independent scrutiny. In 2014, a Cochrane review was published, based exclusively on an almost complete set of clinical study reports and other regulatory documents. Clinical study reports can run to thousands of pages, providing an extensive amount of information on the planning, conduct and results of each trial. After a protracted campaign to obtain the reports, the manufacturers of the medications provided them unconditionally. The review authors subsequently published the underlying documents simultaneously with the Cochrane review, endorsing the concept of open science. In the following commentary, the background to and results of this review are summarized and put into clinical context.
Formatted abstract
Planning for outbreaks of influenza is a high priority public health issue for national governments. Neuraminidase inhibitors (NIs) are thought to help reduce the symptoms of influenza with several possible mechanisms proposed. NIs have been stockpiled with a view to their widespread use in the event of a pandemic. However, the evidence base for this class of agents remains a source of debate. In a previous review we have documented substantial risks of publication bias of trials of NIs for influenza (60% of patient data from phase III treatment trials of oseltamivir have never been published) and reporting bias in the published trials. Our confidence in the
conclusions of previous versions of this review has been subsequently undermined. Since we have become aware of a large number of unpublished trials of NIs in the management of influenza, this review updates and merges existing reviews in this area.
To review clinical study reports of placebo-controlled randomised trials, regulatory comments and reviews (’regulatory information’) of the effects of the NIs oseltamivir and zanamivir for influenza in all age groups and appraise trial programmes, rather than single studies.  Clinical study reports are very detailed, unpublished clinical trial data containing in-depth descriptions of protocol rationale, methods analysis plans, trial results and organisational documents (such as contracts). A series of clinical studies designed and conducted by one sponsor represents a trial programme of a drug indication (for example treatment of influenza).
Search methods
We searched trial registries, cross-referencing published and unpublished sources and corresponded with manufacturers and regulators.  We searched the archives of the US Food and Drug Administration (FDA) and European and Japanese regulators. The evidence in this review reflects searches to obtain relevant information up to 12 April 2011.
Selection criteria
We included regulatory information based on assessments of randomised controlled trials (RCTs) conducted in people of any age who had either confirmed or suspected influenza, or who had been exposed to influenza in the local community or place of residence. We included information which had been made available by our deadline.
Keyword Randomized Controlled Trials
Respiratory Tract Complications
B Virus Infections
Inhaled Zanamivir
Double blind
Oseltamivir Treatment
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Critical review of research, literature review, critical commentary
Collections: Non HERDC
School of Public Health Publications
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Citation counts: TR Web of Science Citation Count  Cited 29 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 90 times in Scopus Article | Citations
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Created: Thu, 10 Jan 2013, 00:42:55 EST by Geraldine Fitzgerald on behalf of School of Public Health