TOAST
Trial question
What is the effect of oral dexamethasone in adult patients with acute sore throat?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
75.0% female
25.0% male
N = 565
565 patients (425 female, 140 male).
Inclusion criteria: adult patients presenting to primary care with acute sore throat not requiring immediate antibiotic therapy.
Key exclusion criteria: recent use of inhaled or oral corticosteroids or antibiotics; recent adenotonsillectomy; a clear alternative diagnosis.
Interventions
N=288 dexamethasone (a single oral dose of 10 mg).
N=277 placebo (matching placebo).
Primary outcome
Complete resolution of symptoms within 24 hours
22.6%
17.7%
22.6 %
17.0 %
11.3 %
5.7 %
0.0 %
Dexamethasone
Placebo
No significant
difference ↔
No significant difference in complete resolution of symptoms within 24 hours (22.6% vs. 17.7%; RR 1.28, 95% CI 0.92 to 1.78).
Secondary outcomes
Significant increase in complete resolution of symptoms within 48 hours (35.4% vs. 27.1%; RR 1.31, 95% CI 1.02 to 1.68).
No significant difference in median time to onset of pain relief (27.5 hours vs. 27 hours; HR 1.106, 95% CI 0.85 to 1.44).
No significant difference in median time to complete symptom resolution (65.8 hours vs. 60 hours; HR 1.043, 95% CI 0.78 to 1.39).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In adult patients presenting to primary care with acute sore throat not requiring immediate antibiotic therapy, dexamethasone was not superior to placebo with respect to complete resolution of symptoms within 24 hours.
Reference
Gail Nicola Hayward, Alastair D Hay, Michael V Moore et al. Effect of Oral Dexamethasone Without Immediate Antibiotics vs Placebo on Acute Sore Throat in Adults: A Randomized Clinical Trial. JAMA. 2017 Apr 18;317(15):1535-1543.
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