Treatment of Acute Pharyngitis with Corticosteroids

From Wiki Journal Club
Jump to: navigation, search
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.
PubMedFull text
[[Category:]]

Clinical Question

In patients with acute pharyngitis, will the use of dexamethasone alone as compared to no treatment provide symptom relief while being safe and effective?

Bottom-line Recommendation

In adults with acute pharyngitis, a single dose of oral dexamethasone did not increase symptom improvement within 24 hours, but there was a significant increase in symptom improvement within 48 hours. There were adverse events in 2.8% of patients, and those that did occur were not life-threatening.

Major Points

Acute pharyngitis is a condition that affects many patients. These patients are often prescribed antibiotics to treat their sore throat, but corticosteroids could be used instead of antibiotics to reduce inflammation. Corticosteroids inhibit the formation of proinflammatory mediators that cause inflammation and pain.

This study was completed in 2015 in South and West England. It was a multicenter, individually randomized, double-blind, placebo-controlled, parallel group trial with an intention-to-treat analysis. There were 576 patients, age 18 years and older, randomized within this trial. These patients presented to a primary care physician complaining of onset of a sore throat within the last 7 days. These patients were determined to have an infection, but did not require immediate antibiotics. Out of the 576 patients that were randomized, 349 did not receive a prescription for delayed antibiotics, and 227 did receive a prescription for delayed antibiotics. 293 participants were randomized to receive dexamethasone, and 283 participants were randomized to receive placebo. The primary outcome was that 22.6% of patients had symptom relief within 24 hours while taking dexamethasone (p= 0.14). The secondary outcome was that 35.4% of patients had symptom relief within 48 hours while taking dexamethasone (p=0.03).

This study also correlates with another study done in 2017. The other study was a meta-analysis of randomized controlled trials which found that corticosteroids are associated with a decrease in pain when used with antibiotics in patients with pharyngitis. The current study’s secondary outcome was supported by this other article.

Guidelines

IDSA for Group A Streptococcal Pharyngitis:

  • Patients with acute GAS pharyngitis should be treated with an appropriate antibiotic at an appropriate dose for a duration likely to eradicate the organism from the pharynx (usually 10 days). Based on their narrow spectrum of activity, infrequency of adverse reactions, and modest cost, penicillin or amoxicillin is the recommended drug of choice for those non-allergic to these agents (strong, high)
  • Treatment of GAS pharyngitis in penicillin-allergic individuals should include a first generation cephalosporin (for those not anaphylactically sensitive) for 10 days, clindamycin or clarithromycin for 10 days, or azithromycin for 5 days (strong, moderate)
  • Adjunctive therapy may be useful in the management of GAS pharyngitis
  • If warranted, use of an analgesic/antipyretic agent such as acetaminophen or an NSAID for treatment of moderate to severe symptoms or control of high fever associated with GAS pharyngitis should be considered as an adjunct to an appropriate antibiotic (strong, high)
  • Aspirin should be avoided in children (strong, moderate)
  • Adjunctive therapy with a corticosteroid is not recommended (weak, moderate)

Study Design

  • Multicenter, individually randomized, double-blind, placebo-controlled, parallel group trial
  • N = 576 randomized patients
    • Experimental arm = 293 patients
    • Standard = 283 patients
  • Setting = South and West England
  • Enrollment = April 12, 2013-February 27, 2015
  • Mean follow up: 24 hours
  • Analysis type = intention-to-treat
  • Primary outcome = Complete resolution of sore throat at 24 hours

Population

Inclusion criteria

  • 18 years or older
  • Presented to a primary care clinician (general practitioner or practice nurse)
  • Acute symptoms (onset within the last 7 days) of sore throat
  • Odynophagia (pain on swallowing)
  • Clinician judged symptoms to be caused by an infection but that did not need immediate antibiotics
  • Capacity and willingness to give consent and complete the trial paperwork

Exclusion criteria

  • Recent (<1 month) use of inhaled or oral corticosteroids or adenotonsillectomy
  • Recent use (<14 days) of antibiotics
  • Clear alternative diagnosis (eg, pneumonia)

Baseline Demographics

  • Median age:
    • Dexamethasone: 36.7
    • Placebo: 37.0
  • Men:
    • Dexamethasone: 42 (24.3%)
    • Placebo: 46 (27.2%)
  • Working/In School:
    • Dexamethasone: 122 (70.5%)
    • Placebo: 134 (79.3%)
  • Smoker:
    • Dexamethasone: 28 (16.2%)
    • Placebo: 26 (15.4%)
  • Mean days duration of sore throat:
    • Dexamethasone: 3.99
    • Placebo: 4.14
  • Pharyngeal inflammation:
    • Dexamethasone: 144
    • Placebo: 148

Interventions

  • Single dose of 10 mg of dexamethasone by mouth (n = 293) or identical placebo (n = 283)
  • Some patients received delayed antibiotic therapy (n= 227)
  • Follow up- 24 hours and 48 hours

Outcomes

Primary Outcome

Dexamethasone vs placebo at 24 hours
22.6% vs 17.7%; P= 0.14; RR= 1.28; NNT= 20
At 24 hours, participants receiving dexamethasone were not more likely than those receiving placebo to have complete symptom resolution.

Secondary Outcomes

Dexamethasone vs placebo at 48 hours
35.4% vs 27.1%; P= 0.03; RR= 1.31; NNT= 12
There were no significant differences in any other secondary outcomes.

Subgroup Analysis

Dexamethasone without antibiotics
24.9% resolution; RR= 1.31; P= 0.19; NNT=17
Dexamethasone with antibiotics
19.1% resolution; RR= 1.19; P= 0.55; NNT=29
Placebo without antibiotics
18.9% resolution; RR= 1.31; P= 0.19
Placebo with antibiotics
15.7% resolution; RR= 1.19; P=0.55

Adverse Events

5 serious adverse events. 2 in dexamethasone group, 1 related to the trial:

  • Hospital admission with parapharyngeal abscess
  • Hospital admission with peritonsillar abscess
  • Hospital admission with severe tonsillitis
  • Hospital admission with pneumonia with subsequent death after hospital discharge

Criticisms

  • Some patients initiated antibiotics before other patients, not equal duration for antibiotic therapy
  • The study compared multiple variables which makes it unclear as to what the study is comparing
  • Because the patients did not take the antibiotics for the same duration, it is unclear as to whether the positive outcomes were from the antibiotics, the corticosteroids, or both.
  • Adverse event table or figure is missing, no percentages provided

Funding

National Institute for Health Research School for Primary Care Research (NIHR SPCR).