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Effect of oral dexamethasone without immediate antibiotics vs placebo on acute sore throats in adults: a randomized clinical trial

Effect of oral dexamethasone without immediate antibiotics vs placebo on acute sore throats in adults: a randomized clinical trial
Effect of oral dexamethasone without immediate antibiotics vs placebo on acute sore throats in adults: a randomized clinical trial
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.
1538-3598
1535-1543
Little, Paul
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Hayward, Gail
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Hay, Alastair
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Moore, Michael
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Jawad, Sena
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Williams, Nicola
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Voysey, Merryn
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Cook, Johanna
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Allen, Julie
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Thompson, Matthew
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Perrera, Rafael
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Wolstenholme, Jane
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Harman, Kim
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Heneghan, Carl
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Little, Paul
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Hayward, Gail
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Hay, Alastair
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Moore, Michael
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Jawad, Sena
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Williams, Nicola
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Voysey, Merryn
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Cook, Johanna
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Allen, Julie
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Thompson, Matthew
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Perrera, Rafael
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Wolstenholme, Jane
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Harman, Kim
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Heneghan, Carl
ab54c700-8c86-420a-98b9-45e071b1c842

Little, Paul, Hayward, Gail, Hay, Alastair, Moore, Michael, Jawad, Sena, Williams, Nicola, Voysey, Merryn, Cook, Johanna, Allen, Julie, Thompson, Matthew, Perrera, Rafael, Wolstenholme, Jane, Harman, Kim and Heneghan, Carl (2017) Effect of oral dexamethasone without immediate antibiotics vs placebo on acute sore throats in adults: a randomized clinical trial. JAMA, 317 (15), 1535-1543. (doi:10.1001/jama.2017.3417).

Record type: Article

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.

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Accepted/In Press date: 20 March 2017
e-pub ahead of print date: 18 April 2017
Published date: 18 April 2017
Organisations: Primary Care & Population Sciences, FOS - Medicine

Identifiers

Local EPrints ID: 407672
URI: http://eprints.soton.ac.uk/id/eprint/407672
ISSN: 1538-3598
PURE UUID: 76d32030-1dfd-403b-b94d-9426ca1e9a95
ORCID for Paul Little: ORCID iD orcid.org/0000-0003-3664-1873
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509
ORCID for Kim Harman: ORCID iD orcid.org/0000-0002-5173-7753

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Date deposited: 22 Apr 2017 01:02
Last modified: 12 Jul 2024 04:07

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Contributors

Author: Paul Little ORCID iD
Author: Gail Hayward
Author: Alastair Hay
Author: Michael Moore ORCID iD
Author: Sena Jawad
Author: Nicola Williams
Author: Merryn Voysey
Author: Johanna Cook
Author: Julie Allen
Author: Matthew Thompson
Author: Rafael Perrera
Author: Jane Wolstenholme
Author: Kim Harman ORCID iD
Author: Carl Heneghan

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