Oral steroids do not reduce symptom severity or duration for nonasthmatic adults with acute lower respiratory tract infection when compared with placebo, a study found.
“This trial suggests that oral corticosteroids should not be used in adult primary care patients without asthma or chronic obstructive pulmonary disease who do not require treatment with an immediate antibiotic,” the researchers write.
Alastair G. Hay, FRCGP, from the University of Bristol, United Kingdom, and colleagues published their findings in the August 22/29 issue of JAMA.
The randomized, placebo-controlled trial took place at 54 family practices in England between July 2013 and October 2014. It included 401 adults whose mean age was 47 years, and who were 63% women and 17% smokers. Participants had acute cough and at least one lower respiratory tract symptom that did not need immediate antibiotic treatment. They had no history of chronic obstructive pulmonary disease or need for asthma medication within the last 5 years.
The researchers randomly assigned participants to receive oral prednisolone tablets (n = 199) 40 mg/day or matched placebo (n = 202) once daily for 5 days.
Participants measured their peak expiratory flow twice daily for 28 days or until symptoms cleared. They reported cough symptoms for 28 days beyond that.
Analyses adjusted results for age, sex, influenza vaccine, smoking, and possible differences in baseline factors.
Both groups had similar median duration of moderately bad or worse cough, at about 5 days in both groups (fully adjusted hazard ratio, 1.09; 95% confidence interval, 0.87 – 1.37; P = .44).
The prednisolone group had slightly lower median symptom severity than placebo (scale, 1 – 6), but the results were not significant when adjusted for potential confounders (1.99 vs 2.16; fully adjusted, −0.17; 95% confidence interval, −0.37 to 0.04; P = .11).
Likewise, the two groups showed no significant differences for other symptoms of acute lower respiratory tract infection, antibiotic use, and nonserious adverse events.
No serious adverse events were reported.
The Oral Steroids for Acute Cough trial is the largest so far to evaluate steroids for acute lower respiratory tract infection in primary care. It is also the first to evaluate oral instead of inhaled steroids.
The authors note several study limitations. Providers selected which patients could participate, and participants self-reported their symptoms, which may have biased the study. Adherence was not measured, although a similar lack of effect and similar adverse events suggests little difference in adherence between the two groups.
Acute lower respiratory tract infection represents one of the most commonly seen conditions in primary care. Symptoms include sputum, chest pain, shortness of breath, and wheeze. Patients can also have symptoms similar to an asthma exacerbation, such as airway inflammation and reduced forced expiratory volume. Although steroids are effective in asthma, insufficient evidence exists for their use in acute lower respiratory tract infection, even though they are increasingly used for this purpose.
The results suggest oral steroids should not be used to treat acute lower respiratory tract infection in the type of patients included in this study; however, questions remain about their benefits in other groups of patients.
“Further research is needed to establish effectiveness in primary care patients with more severe infections, such as those with elevated C-reactive protein levels or requiring immediate antibiotic treatment, and larger studies or meta-analysis are needed to address effects in subgroups, such as those with longer preconsultation illness and nonsmokers,” the authors conclude.
The study was funded by National Institute for Health Research School for Primary Care Research. One coauthor reports receiving funding from Alere Inc and Roche Molecular Diagnostics and is a cofounder of Phoresa Inc, which is developing point-of-care tests for primary care.
JAMA. 2017;318:721-730. Article
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