Effect of Oral Prednisolone on Symptom Duration and Severity in Nonasthmatic Adults With Acute Lower Respiratory Tract Infection

Abstract

IMPORTANCE Acute lower respiratory tract infection is common and often treated inappropriately in primary care with antibiotics. Corticosteroids are increasingly used but without sufficient evidence.OBJECTIVE 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.INTERVENTIONS Two 20-mg prednisolone tablets (n = 199) or matched placebo (n = 202) once daily for 5 days. MAIN OUTCOMES AND MEASURESThe 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. RESULTS 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.

Steroids do not reduce lower respiratory symptoms in non-asthmatic adults, study finds

“…The results, reported in JAMA ,1 showed no significant effect of prednisolone on the duration or severity of symptoms. The median duration of cough was five days (interquartile range 3 to 8 days) in patients given prednisolone and was also five days (3 to 10 days) in the placebo group (adjusted hazard ratio 1.11 (95% confidence interval 0.89 to 1.39); P=0.36).…”

“…Oral corticosteroids do not reduce the severity or duration of symptoms of acute lower respiratory tract infections in adults without asthma, a randomised study has reported,1 prompting the researchers to advise against using steroids in these patients.…”

Prescribing systemic steroids for acute respiratory tract infections in United States outpatient settings: A nationwide population-based cohort study

“…For acute sinusitis, meta-analysis of RCTs has deemed systemic steroids to be ineffective as monotherapy, and the small benefit in symptom relief when used as an adjuvant therapy with antibiotics could possibly be explained by attrition bias [8]. An RCT also revealed that systemic steroids are ineffective in the treatment of lower respiratory tract infections [4]. All the prior RCTs investigating systemic steroid use in community-acquired pneumonia recruited hospitalized patients; among them, steroids as adjuvant therapy to proper antibiotics were shown to reduce mortality and morbidity only in patients with severe pneumonia but not for those with nonsevere pneumonia, casting doubt on generalizing the effectiveness to the ambulatory settings [26].…”

“…Using systemic corticosteroids in the treatment of acute respiratory tract infections (ARTIs) in the outpatient settings is not recommended by clinical guidelines [1][2][3]. Data from randomized control trials (RCTs) show that systemic steroids are ineffective in the treatment of lower respiratory tract infections [4]. Similar-albeit more limited-data also show the lack of effectiveness of steroid use in the common cold [5] and otitis media [6].…”

HATRIC: a study of Pelargonium sidoides root extract EPs®7630 (Kaloba®) for the treatment of acute cough due to lower respiratory tract infection in adults—study protocol for a double blind, placebo-controlled randomised feasibility trial

“…The collection of diary scores will not be limited to the time during which study medication is being used, to allow the capture of total symptom duration. The diary has previously been validated and is sensitive to change and internally reliable [25,26].…”