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Does a moderate dose of oral corticosteroid reduce the duration or severity of acute lower respiratory tract infection in adults without asthma presenting to primary care?
In this randomized trial of 401 adults with symptoms of acute lower respiratory tract infection, treatment with oral prednisolone, 40 mg/d for 5 days, compared with placebo did not significantly reduce the median duration of moderately bad or worse cough (5 days in each group) or the mean severity of symptoms between days 2 and 4 (1.99 vs 2.16 points out of 6).
These findings do not support the use of oral steroids for the treatment of acute lower respiratory tract infection in the absence of asthma.
Acute lower respiratory tract infection is common and often treated inappropriately in primary care with antibiotics. Corticosteroids are increasingly used but without sufficient evidence.
To assess the effects of oral corticosteroids for acute lower respiratory tract infection in adults without asthma.
Design, Setting, and Participants
Multicenter, placebo-controlled, randomized trial (July 2013 to final follow-up October 2014) conducted in 54 family practices in England among 401 adults with acute cough and at least 1 lower respiratory tract symptom not requiring immediate antibiotic treatment and with no history of chronic pulmonary disease or use of asthma medication in the past 5 years.
Two 20-mg prednisolone tablets (n = 199) or matched placebo (n = 202) once daily for 5 days.
Main Outcomes and Measures
The primary outcomes were duration of moderately bad or worse cough (0 to 28 days; minimal clinically important difference, 3.79 days) and mean severity of symptoms on days 2 to 4 (scored from 0 [not affected] to 6 [as bad as it could be]; minimal clinically important difference, 1.66 units). Secondary outcomes were duration and severity of acute lower respiratory tract infection symptoms, duration of abnormal peak flow, antibiotic use, and adverse events.
Among 401 randomized patients, 2 withdrew immediately after randomization, and 1 duplicate patient was identified. Among the 398 patients with baseline data (mean age, 47 [SD, 16.0] years; 63% women; 17% smokers; 77% phlegm; 70% shortness of breath; 47% wheezing; 46% chest pain; 42% abnormal peak flow), 334 (84%) provided cough duration and 369 (93%) symptom severity data. Median cough duration was 5 days (interquartile range [IQR], 3-8 days) in the prednisolone group and 5 days (IQR, 3-10 days) in the placebo group (adjusted hazard ratio, 1.11; 95% CI, 0.89-1.39; P = .36 at an α = .05). Mean symptom severity was 1.99 points in the prednisolone group and 2.16 points in the placebo group (adjusted difference, −0.20; 95% CI, −0.40 to 0.00; P = .05 at an α = .001). No significant treatment effects were observed for duration or severity of other acute lower respiratory tract infection symptoms, duration of abnormal peak flow, antibiotic use, or nonserious adverse events. There were no serious adverse events.
Conclusions and Relevance
Oral corticosteroids should not be used for acute lower respiratory tract infection symptoms in adults without asthma because they do not reduce symptom duration or severity.
ISRCTN.com Identifier: ISRCTN57309858
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Corresponding Author: Alastair D. Hay, FRCGP, Centre for Academic Primary Care, NIHR School for Primary Care Research, Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Rd, Clifton, Bristol BS8 2PS, England (email@example.com).
Accepted for Publication: July 21, 2017.
Author Contributions: Dr Brookes had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Hay, Little, Harnden, Thompson, Wang, Kendrick, Brookes, May, Carroll, El-Gohary, Moore.
Acquisition, analysis, or interpretation of data: Harnden, Wang, Kendrick, Orton, Brookes, Young, May, Hollinghurst, Carroll, Downing, Timmins, Lafond, Moore.
Drafting of the manuscript: Hay, Kendrick, Orton, Brookes, Young, Downing, Timmins, Lafond, El-Gohary, Moore.
Critical revision of the manuscript for important intellectual content: Hay, Little, Harnden, Thompson, Wang, Kendrick, Orton, Brookes, Young, May, Hollinghurst, Carroll, Lafond, Moore.
Statistical analysis: Brookes, Young, May.
Obtained funding: Hay, Little, Harnden, Wang, Kendrick, Orton, Moore.
Administrative, technical, or material support: Thompson, Orton, Downing, Timmins, Lafond, Moore.
Supervision: Hay, Little, Harnden, Wang, Kendrick, Brookes, May, Hollinghurst, Lafond.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Thompson reports that he has received funding from Alere Inc to conduct research on C-reactive protein point-of-care tests, has received funding from Roche Molecular Diagnostics for consultancy work, and is a cofounder of Phoresa Inc, which is developing point-of-care tests for primary care. No other disclosures were reported.
Funding/Support: This article presents independent research funded by the National Institute for Health Research (NIHR) School for Primary Care Research (grant reference 117a). Dr Hay is funded by an NIHR Research Professorship (NIHR-RP-02-12-012). The study sponsor was the University of Bristol.
Role of the Funder/Sponsor: Neither the funder nor the sponsor had no involvement in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Disclaimer: The views expressed herein are those of the authors and not necessarily those of the NIHR, the National Health Service, or the UK Department of Health.
Additional Contributions: We thank the participants, the recruiting primary care sites, the NIHR Clinical Research Network, and all members of the OSAC team. We also thank the members of the trial steering committee (who provided independent supervision on behalf of the funder and sponsor) and the data monitoring committee (who oversaw safety), the Nottingham University Hospitals NHS Trust pharmacy, and the University Hospitals Bristol NHS Foundation Trust. We thank Mark Ebell, MD, University of Georgia, who (without compensation) conducted a secondary data analysis to estimate the use of oral prednisolone for acute lower respiratory tract infection using administrative data from the southeastern United States.
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