Podcast #53 - Oral Dexamethasone for Sore Throats: A Bonus to a REBEL Cast Post

We are having a special episode to add to what we did with Salim Rezaie on REBEL Cast recently as a guest.  While we were there, we talked a lot about the TOAST trial and reviewed our own clinical use of dexamethasone.  It is definitely worth your time to visit his page and listen to that podcast.  However, we wanted to add our own little supplement to the #FOAMed world by adding a detailed analysis of the paper in true BEEM fashion.  Please check all of this out for a more thorough understanding of the topic.

Title:
Effect of Oral Dexamethasone Without Immediate Antibiotics vs Placebo on Acute Sore Throat in Adults (the TOAST trial)
 
Case:
A 24 y/o female with no past significant medical history and who is not pregnant comes to your department complaining of a sore throat.  A resident sees the patient and says she reports a subjective fever without cough at home and that over-the-counter medications have not controlled her pain.  Her rapid strep test is negative and you have a lower suspicion for bacterial infection thinking it is most likely viral at this time.  The patient is hoping to get something in addition to what she has at home to control her symptoms.  Your resident asks about giving dexamethasone without antibiotics.
 
Background:
Corticosteroids inhibit transcription of pro-inflammatory mediators in airway endothelial cells responsible for pharyngeal inflammation and symptoms of pain.  They have been used in other upper respiratory tract infections such as acute sinusitis and croup.  In adults, previous studies with dexamethasone are in combination with antibiotics but studies of children have included dexamethasone without antibiotics.  This study is unique as it is evaluating the benefits of oral corticosteroids for acute sore throat in primary care in the absence of antibiotics.
 
Clinical Question:
Does a single dose of dexamethasone in the absence of antibiotics provide symptom relief for acute sore throat in adults presenting for primary care?
 
Reference:

• Population: Patients aged 18 years or more presenting to primary care with sore throat and odynophagia (pain with swallowing) for less than 7 days that is judged clinically to not be caused by an infection that required immediate antibiotics for which the patient was willing and had the capacity to give consent and complete the trial paperwork.      
  • Exclusion Criteria: Patients who used inhaled or oral corticosteroids in the last month, adenotonsillectomy, antibiotic use less than two weeks ago, or a clear alternative diagnosis such as pneumonia was made. 
• Intervention: Single oral dose of 10mg of dexamethasone. 
• Comparison: Identical placebo.
• Outcome: Proportion of participants experiencing complete resolution of symptoms at 24 hours.

 
Author’s Conclusions:
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.
 
Quality Checklist for Randomized Clinical Trials:

1. The study population included or focused on those in the ED. No, this study was performed in primary care settings in the United Kingdom
2. The patients were adequately randomized. Yes
3. The randomization process was concealed. Yes
4. The patients were analyzed in the groups to which they were randomized. Yes
5. The study patients were recruited consecutively (i.e. no selection bias). No, the treating primary care clinician had to first make the determination whether or not the patient needed immediate antibiotics
6. The patients in both groups were similar with respect to prognostic factors. Yes
7. All participants (patients, clinicians, outcome assessors) were unaware of group allocation. Yes
8. All groups were treated equally except for the intervention. Yes
9. Follow-up was complete (i.e. at least 80% for both groups). Yes
10. All patient-important outcomes were considered. Yes
11. The treatment effect was large enough and precise enough to be clinically significant. No

 
Key Results:
A total 576 patients were randomized for which 565 eligible randomized patients were assessed with 288 receiving dexamethasone and 277 receiving placebo.  At 24 hours, 65 participants (22.6%) receiving dexamethasone and 49 (17.7%) receiving placebo reported complete resolution but this was not statistically significant (P=0.14).  However, at 48 hours 102 participants (35.4%) in the dexamethasone group and 75 (27.1%) in the placebo group experienced complete resolution of symptoms (P=0.03).
 
Key Points of Debate:

• There were eight secondary outcomes.
  • All secondary outcomes were considered exploratory.
  • However, this can be concerning for data mining and the secondary finding of the 48 hour resolution may be more noise.
  • We must also be cautious since the primary outcome was not statistically significant.
  • The secondary outcome of resolution at 48 hours could be potentially another point to study in the future for confirmation.
• The return rate of symptom diaries or follow-up questionnaires was 75%.
  • Although similar to previous study return rates, poor completion rates could result in lower rates of accuracy.
  • Other forms of follow-up may have been more effective to obtain better results for some of the outcomes measured.
• 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.

 
Comparing Conclusions:
We generally agree that for adults presenting to primary care with acute sore throat that a single dose of oral dexamethasone may not increase the rate of resolution compared to a placebo but that it appears to be better at 48 hours.
 
Our Bottom Line:
We agree that corticosteroids may play a beneficial role in sore throat just like in other upper respiratory infections but that this effect is more likely to be beneficial in those with more severe symptoms.
 
Case Resolution:
You discuss with both the patient and the resident that corticosteroids could be beneficial in helping improve symptoms and leading to resolution but that there is some potentially conflicting data.  After shared decision making of the risks, benefits, and potential complications the patient agrees to try a single dose of dexamethasone while the throat culture is pending.  On follow-up with her PCP two days later her culture is negative and she has resolution of her sore throat.
 
Clinical Application:
At this time, corticosteroids such as dexamethasone do appear to be beneficial but are not without risks and should carefully be used in appropriate patients with avoidance in groups when possible such as those with diabetes mellitus.
 
What do I tell my patient?
A single dose of dexamethasone is commonly used in emergency departments for a variety of upper respiratory conditions such as acute sinusitis and croup.  There is growing evidence of benefit in sore throat and given the severity of your symptoms without relief of home measures, this could potentially be beneficial for you.  Corticosteroids are not without risk though and should be avoided when possible.
 
Conclusion:
Thank you for listening to the podcast and reading the blog.  Please let us know what you think by giving us feedback here in the comments section or contacting us on Twitter or Facebook.  Remember to look us up on Libsyn and on iTunes.  If you have any questions you can also comment below, email at thetotalem@gmail.com, or send a message from the page.  We hope to talk to everyone again soon.  ​Until next time, continue to provide total care everywhere.

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