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Effect of Oral Dexamethasone Without Immediate Antibiotics vs Placebo on Acute Sore Throat in AdultsA Randomized Clinical Trial

Educational Objective
To learn whether oral corticosteroids may provide symptomatic therapy for patients with acute sore throat.
1 Credit CME
Key Points

Question  Does a single dose of dexamethasone in the absence of antibiotics provide symptom relief for acute sore throat in adults presenting to primary care?

Findings  In this randomized clinical trial including 565 adults, the proportion of participants in the dexamethasone group achieving complete symptom resolution at 24 hours was not significantly different from those taking placebo. But at 48 hours significantly more in the dexamethasone group experienced complete resolution than did those in the placebo group.

Meaning  Among adults presenting to primary care practices with acute sore throat, a single dose of oral dexamethasone did not increase the likelihood of symptom resolution at 24 hours but did increase the likelihood at 48 hours.

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

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Article Information

Corresponding Author: Gail Nicola Hayward, DPhil, MRCGP, Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, United Kingdom (gail.hayward@phc.ox.ac.uk).

Author Contributions: Dr Hayward and Mrs Voysey had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Hayward, Hay, Moore, Cook, Thompson, Little, Perera, Wolstenholme, Heneghan.

Acquisition, analysis, or interpretation of data: Hayward, Hay, Jawad, Williams, Voysey, Cook, Allen, Little, Wolstenholme, Harman, Heneghan.

Drafting of the manuscript: Hayward, Moore, Jawad, Williams, Voysey, Allen.

Critical revision of the manuscript for important intellectual content: Hayward, Hay, Jawad, Cook, Thompson, Little, Perera, Harman, Heneghan.

Statistical analysis: Jawad, Williams, Voysey, Wolstenholme, Heneghan.

Obtained funding: Hayward, Hay, Moore, Little, Perera, Wolstenholme, Heneghan.

Administrative, technical, or material support: Moore, Cook, Allen, Thompson, Harman.

Supervision: Hay, Moore, Little.

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Thompson reported that he has received funding from Alere Inc to conduct research on C-reactive protein point-of-care tests, has received funding from Roche Molecular Diagnostics for consultancy work, and is a cofounder of Phoresa Inc, which is developing point-of-care tests for primary care. Dr Heneghan reported that he has received expenses from the World Health Organization (WHO) and has received grants from the National Institute for Health Research (NIHR), the NIHR School of Primary Care Research, the Wellcome Trust, and WHO.

Funding/Support: This work was supported by the National Institute for Health Research School for Primary Care Research (NIHR SPCR).

Role of the Funder/Sponsor: The sponsor had no involvement in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: The views expressed herein are those of the authors and not necessarily those of the NIHR, the National Health Service or the UK Department of Health.

Additional Contributions: We thank the teams at Oxford, Bristol, and Southampton for managing sites, enabling recruitment, and facilitating follow-up.

References
1.
Petersen  I, Johnson  AM, Islam  A, Duckworth  G, Livermore  DM, Hayward  AC.  Protective effect of antibiotics against serious complications of common respiratory tract infections: retrospective cohort study with the UK General Practice Research Database.  BMJ. 2007;335(7627):982.PubMedGoogle ScholarCrossref
2.
Gulliford  M, Latinovic  R, Charlton  J, Little  P, van Staa  T, Ashworth  M.  Selective decrease in consultations and antibiotic prescribing for acute respiratory tract infections in UK primary care up to 2006.  J Public Health (Oxf). 2009;31(4):512-520.PubMedGoogle ScholarCrossref
3.
Barnett  ML, Linder  JA.  Antibiotic prescribing to adults with sore throat in the United States, 1997-2010.  JAMA Intern Med. 2014;174(1):138-140.PubMedGoogle ScholarCrossref
4.
Gulliford  MC, Dregan  A, Moore  MV,  et al.  Continued high rates of antibiotic prescribing to adults with respiratory tract infection: survey of 568 UK general practices.  BMJ Open. 2014;4(10):e006245.PubMedGoogle ScholarCrossref
5.
Hawker  JI, Smith  S, Smith  GE,  et al.  Trends in antibiotic prescribing in primary care for clinical syndromes subject to national recommendations to reduce antibiotic resistance, UK 1995-2011: analysis of a large database of primary care consultations.  J Antimicrob Chemother. 2014;69(12):3423-3430.PubMedGoogle ScholarCrossref
6.
Spinks  A, Glasziou  PP, Del Mar  CB.  Antibiotics for sore throat.  Cochrane Database Syst Rev. 2013;11(11):CD000023.PubMedGoogle Scholar
7.
 Respiratory Tract Infections—Antibiotic Prescribing: Prescribing of Antibiotics for Self-Limiting Respiratory Tract Infections in Adults and Children in Primary Care. London, England: National Institute for Health and Clinical Excellence; 2008.
8.
Pelucchi  C, Grigoryan  L, Galeone  C,  et al.  Guideline for the management of acute sore throat.  Clin Microbiol Infect. 2012;18(suppl 1):1-28. PubMedGoogle ScholarCrossref
9.
Mygind  N, Nielsen  LP, Hoffmann  HJ,  et al.  Mode of action of intranasal corticosteroids.  J Allergy Clin Immunol. 2001;108(1)(suppl):S16-S25.PubMedGoogle ScholarCrossref
10.
Zalmanovici Trestioreanu  A, Yaphe  J.  Intranasal steroids for acute sinusitis.  Cochrane Database Syst Rev. 2013;12(12):CD005149.PubMedGoogle Scholar
11.
Russell  KF, Liang  Y, O’Gorman  K, Johnson  DW, Klassen  TP.  Glucocorticoids for croup.  Cochrane Database Syst Rev. 2011;(1):CD001955.PubMedGoogle Scholar
12.
Weinberger  M.  Safety of oral corticosteroids.  Eur J Respir Dis Suppl. 1982;122:243-251.PubMedGoogle Scholar
13.
Hayward  G, Thompson  MJ, Perera  R, Glasziou  PP, Del Mar  CB, Heneghan  CJ.  Corticosteroids as standalone or add-on treatment for sore throat.  Cochrane Database Syst Rev. 2012;10:CD008268.PubMedGoogle Scholar
14.
Watson  L, Little  P, Moore  M, Warner  G, Williamson  I.  Validation study of a diary for use in acute lower respiratory tract infection.  Fam Pract. 2001;18(5):553-554.PubMedGoogle ScholarCrossref
15.
Centor  RM, Witherspoon  JM, Dalton  HP, Brody  CE, Link  K.  The diagnosis of strep throat in adults in the emergency room.  Med Decis Making. 1981;1(3):239-246. PubMedGoogle ScholarCrossref
16.
Little  P, Stuart  B, Hobbs  FD,  et al; DESCARTE Investigators.  Antibiotic prescription strategies for acute sore throat: a prospective observational cohort study.  Lancet Infect Dis. 2014;14(3):213-219.PubMedGoogle ScholarCrossref
17.
Venekamp  RP, Bonten  MJ, Rovers  MM, Verheij  TJ, Sachs  AP.  Systemic corticosteroid monotherapy for clinically diagnosed acute rhinosinusitis: a randomized controlled trial.  CMAJ. 2012;184(14):E751-E757. PubMedGoogle ScholarCrossref
18.
Venekamp  RP, Thompson  MJ, Hayward  G,  et al.  Systemic corticosteroids for acute sinusitis.  Cochrane Database Syst Rev. 2014;3(3):CD008115.PubMedGoogle Scholar
19.
Olympia  RP, Khine  H, Avner  JR.  Effectiveness of oral dexamethasone in the treatment of moderate to severe pharyngitis in children.  Arch Pediatr Adolesc Med. 2005;159(3):278-282.PubMedGoogle ScholarCrossref
20.
Bulloch  B, Kabani  A, Tenenbein  M.  Oral dexamethasone for the treatment of pain in children with acute pharyngitis: a randomized, double-blind, placebo-controlled trial.  Ann Emerg Med. 2003;41(5):601-608.PubMedGoogle ScholarCrossref
21.
Wei  JL, Kasperbauer  JL, Weaver  AL, Boggust  AJ.  Efficacy of single-dose dexamethasone as adjuvant therapy for acute pharyngitis.  Laryngoscope. 2002;112(1):87-93.PubMedGoogle ScholarCrossref
22.
Niland  ML, Bonsu  BK, Nuss  KE, Goodman  DG.  A pilot study of 1 vs 3 days of dexamethasone as add-on therapy in children with streptococcal pharyngitis.  Pediatr Infect Dis J. 2006;25(6):477-481.PubMedGoogle ScholarCrossref
23.
Little  P, Hobbs  FD, Moore  M,  et al; PRISM Investigators.  Clinical score and rapid antigen detection test to guide antibiotic use for sore throats: randomised controlled trial of PRISM (primary care streptococcal management).  BMJ. 2013;347:f5806.PubMedGoogle ScholarCrossref
24.
Kiderman  A, Yaphe  J, Bregman  J, Zemel  T, Furst  AL.  Adjuvant prednisone therapy in pharyngitis: a randomised controlled trial from general practice.  Br J Gen Pract. 2005;55(512):218-221. PubMedGoogle Scholar
25.
Tasar  A, Yanturali  S, Topacoglu  H, Ersoy  G, Unverir  P, Sarikaya  S.  Clinical efficacy of dexamethasone for acute exudative pharyngitis.  J Emerg Med. 2008;35(4):363-367.PubMedGoogle ScholarCrossref
26.
Bird  JH, Biggs  TC, King  EV.  Controversies in the management of acute tonsillitis: an evidence-based review.  Clin Otolaryngol. 2014;39(6):368-374. PubMedGoogle ScholarCrossref
27.
Lee  YJ, Jeong  YM, Lee  HS, Hwang  SH.  The efficacy of corticosteroids in the treatment of peritonsillar abscess: a meta-analysis.  Clin Exp Otorhinolaryngol. 2016;9(2):89-97.PubMedGoogle ScholarCrossref
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