Episode 39 – The TOAST Trial: Dexamethasone for Acute Pharyngitis
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Special Guest
Emergency Medicine Physician Assistant (EMPA)
Blog/Podcast: TOTAL EM
Twitter: @the_TOTAL_EM
What They Did:
- Multicenter, double-blind, placebo-controlled, parallel group randomized trial
- Conducted in 42 family practices in England
- Enrolled 576 adult patients with acute sore throat not requiring immediate antibiotic therapy
- Single dose of 10mg of dexamethasone or identical placebo
Outcomes:
- Primary: Proportion of patients with complete resolution of symptoms at 24hrs
- Secondary:
- Complete resolution at 48hrs
- Duration of moderately bad symptoms (Based on a Likert scale of 0 – 6; 0 = Normal and 6 = bad as it could be)
- Visual Analog Symptom Scales (0 – 100; 0 = No symptoms and 100 = worst imaginable)
- Health care attendance
- Days missed from work or education
- Consumption of delayed antibiotics or other medications
- Adverse events
Inclusion:
- ≥18 years of age
- Presenting to primary care appointment with acute sore throat and odynophagia thought to be infective in origin
- Onset of symptoms within the last 7d
- Capacity and willingness to consent and maintain a symptom diary
Main Exclusions:
- Pregnancy or breast feeding
- <1mo use of inhaled or oral corticosteroids
- <1mo adenotonsillectomy
- <14d taking antibiotics
- Clear alternative diagnosis (i.e. pneumonia)
- Known imunnodeficiency
- Requiring hospital admission
- Requiring immediate antibiotics
- Known dexamethasone allergy
Results:
- 565 adult patients eligible
- Oral Dexamethasone: 288
- Oral Placebo: 277
- Median Age: 34 years (Range: 26 – 45.5 years)
- 75.2% women
- 100% completed the intervention
- No difference in secondary outcomes
Strengths:
- Multicenter, double-blind, placebo-controlled, parallel group randomized trial
- Appropriate sample size to find a 18% increase in resolution with 90% power
- Participants who had no information for the primary outcome were included in the analysis as having no resolution of symptoms
- Primary outcome measure was collected from 93.6% of patients
Limitations:
- A less severely ill patient population may be what was studied due to exclusion of patients requiring immediate antibiotics
- Children were not studied in this trial
- Primary outcome is not a well validated outcome
- Study underpowered to detect a modest effect (<18%) on the primary outcome
Discussion:
- Although there was no difference in the primary outcome of complete resolution of symptoms at 24 hours there was a significant difference in complete resolution of symptoms at 48 hours. When calculating the NNT this gives you a value of 12.
- This study was underpowered for detecting a modest effect on the primary outcome.
- A larger study could potentially identify a statistically significant different between treatments that could not be detected here.
- The study was also not powered to detect a difference in adverse effect profiles.
- Patients in this trial may not have been experiencing severe enough symptoms to receive benefit with dexamethasone.
- Those participating in this study were excluded if they had symptoms or findings that were concerning for infection that required immediate antibiotics.
- This could imply that patients were in general more sick and would have been better patients to benefit from corticosteroids.
- Previous research supports this finding based on how corticosteroids have been used in other studies for adults and children.
- Since this was a study in primary care, patients may not have as severe of symptoms as if they went to the emergency department.
- Patients who present to the emergency department in general may be sicker than those who go to primary care.
- For that potential reason, patients who present to the emergency department may be more likely to benefit just like we specified for those with more severe symptoms in general.
- This could mean that the study is less applicable.
Author Conclusion: “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.”
Clinical Take Home Point: Corticosteroids may play a beneficial role in sore throat just like in other upper respiratory infections but the effect is more likely to be beneficial in those with more severe symptoms.
References:
- Hayward GN et al. Effect of Oral Dexamethasone Without Immediate Antibiotics vs Placebo on Acute Sore Throat in Adults: A Randomized Clinical Trial. JAMA 2017; 317(15): 1535 – 1543. PMID: 28418482
For More on This Topic Checkout:
- Chip Lange at TOTAL EM: Podcast #53 – Oral Dexamethasone for Sore Throats – A Bonus to a REBEL Cast Post
- Ken Milne at The SGEM: SGEM #203 – Let Me Clear My Sore Throat with a Corticosteroid
Post Peer Reviewed By: Anand Swaminathan (Twitter: @EMSwami)
The post REBEL Cast Episode 39 – The TOAST Trial: Dexamethasone for Acute Pharyngitis appeared first on REBEL EM - Emergency Medicine Blog.