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JAMA. 2017 Apr 18;317(15):1535-1543. doi: 10.1001/jama.2017.3417.

Effect of Oral Dexamethasone Without Immediate Antibiotics vs Placebo on Acute Sore Throat in Adults: A Randomized Clinical Trial.

Author information

1
Nuffield Department of Primary Care Health Sciences, University of Oxford, United Kingdom.
2
Centre for Academic Primary Care, NIHR School for Primary Care Research, School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom.
3
Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom.
4
Department of Family Medicine, University of Washington, Seattle.
5
Nuffield Department of Population Health, University of Oxford, United Kingdom.

Abstract

Importance:

Acute sore throat poses a significant burden on primary care and is a source of inappropriate antibiotic prescribing. Corticosteroids could be an alternative symptomatic treatment.

Objective:

To assess the clinical effectiveness of oral corticosteroids for acute sore throat in the absence of antibiotics.

Design, Setting, and Participants:

Double-blind, placebo-controlled randomized trial (April 2013-February 2015; 28-day follow-up completed April 2015) conducted in 42 family practices in South and West England, enrolled 576 adults recruited on the day of presentation to primary care with acute sore throat not requiring immediate antibiotic therapy.

Interventions:

Single oral dose of 10 mg of dexamethasone (n = 293) or identical placebo (n = 283).

Main Outcomes and Measures:

Primary: proportion of participants experiencing complete resolution of symptoms at 24 hours. Secondary: complete resolution at 48 hours, duration of moderately bad symptoms (based on a Likert scale, 0, normal; 6, as bad as it could be), visual analog symptom scales (0-100 mm; 0, no symptom to 100, worst imaginable), health care attendance, days missed from work or education, consumption of delayed antibiotics or other medications, adverse events.

Results:

Among 565 eligible participants who were randomized (median age, 34 years [interquartile range, 26.0-45.5 year]; 75.2% women; 100% completed the intervention), 288 received dexamethasone; 277, placebo. At 24 hours, 65 participants (22.6%) in the dexamethasone group and 49 (17.7%) in the placebo group achieved complete resolution of symptoms, for a risk difference of 4.7% (95% CI, -1.8% to 11.2%) and a relative risk of 1.28 (95% CI; 0.92 to 1.78; P = .14). At 24 hours, participants receiving dexamethasone were not more likely than those receiving placebo to have complete symptom resolution. At 48 hours, 102 participants (35.4%) in the dexamethasone group vs 75 (27.1%) in the placebo group achieved complete resolution of symptoms, for a risk difference of 8.7% (95% CI, 1.2% to 16.2%) and a relative risk of 1.31 (95% CI, 1.02 to 1.68; P = .03). This difference also was observed in participants not offered delayed antibiotic prescription, for a risk difference of 10.3% (95% CI, 0.6% to 20.1%) and a relative risk of 1.37 (95% CI, 1.01 to 1.87; P = .046). There were no significant differences in any other secondary outcomes.

Conclusions and Relevance:

Among adults presenting to primary care with acute sore throat, a single dose of oral dexamethasone compared with placebo did not increase the proportion of patients with resolution of symptoms at 24 hours. However, there was a significant difference at 48 hours.

Trial Registration:

isrctn.org Identifier: ISRCTN17435450.

PMID:
28418482
PMCID:
PMC5470351
DOI:
10.1001/jama.2017.3417
[Indexed for MEDLINE]
Free PMC Article

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