Effect of oral dexamethasone without immediate antibiotics vs placebo on acute sore throat in adults: a Randomized Clinical Trial
<strong>Importance:</strong> 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. <strong>Objective:</strong> To assess the clinical effectivenes...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Journal article |
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American Medical Association
2017
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| _version_ | 1797057177858342912 |
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| author | Hayward, G Hay, A Moore, M Jawad, S Williams, N Voysey, M Cook, J Allen, J Thompson, M Little, P Perera, R Wolstenholme, J Harman, K Heneghan, C |
| author_facet | Hayward, G Hay, A Moore, M Jawad, S Williams, N Voysey, M Cook, J Allen, J Thompson, M Little, P Perera, R Wolstenholme, J Harman, K Heneghan, C |
| author_sort | Hayward, G |
| collection | OXFORD |
| description | <strong>Importance:</strong> 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. <strong>Objective:</strong> To assess the clinical effectiveness of oral corticosteroids for acute sore throat in the absence of antibiotics. <strong>Design, Setting and Participants:</strong> Double-blind placebo controlled randomised trial (April 2013 to February 2015, 28 day follow-up completed April 2015) conducted in 42 family practices in South and West England, enrolling 576 adults (691 assessed, 82 not eligible, 33 declined) recruited on the day of presentation to primary care with acute sore throat not requiring immediate antibiotic therapy. Exclusion criteria included recent corticosteroids or antibiotics. <strong>Intervention:</strong> Single oral dose of 10mg dexamethasone (n=293) or identical placebo (n=283). <strong>Main outcome measures:</strong> 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 analogue symptom scales (0-100mm; no symptom to worst imaginable), healthcare attendance, days missed from work or education, consumption of delayed antibiotics or other medications, adverse events. Results: Among 565 eligible patients who were randomized (median age 34 years; 75.2% women, 100% completed the intervention), 288 received dexamethasone and 277 placebo. The proportion of participants with complete resolution of symptoms at 24 hours was not significantly different between dexamethasone (65/288) and placebo (49/277) groups; (Risk difference (RD) 4.7%; 95%CI -1.8% to 11.2%; Relative Risk (RR) 1.28; 95%CI 0.92 to 1.78, p=.14) Results were similar in those receiving no antibiotics or delayed antibiotics. At 48 hours, more participants experienced complete resolution in the dexamethasone group; (RD 8.7%; 95%CI 1.2% to 16.2%; RR 1.31; 95%CI 1.02 to 1.68, p=.03); a difference also observed in patients not offered delayed antibiotics (RD 10.3%; 95%CI 0.6% to 20.1%; RR 1.37; 95%CI 1.01 to 1.87, p=.046). There were no significant differences in any other secondary outcomes. <strong>Conclusions and Relevance:</strong> 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. |
| first_indexed | 2024-03-06T19:32:33Z |
| format | Journal article |
| id | oxford-uuid:1df32e42-c6c3-4658-9f86-7d3154ee9f2d |
| institution | University of Oxford |
| last_indexed | 2024-03-06T19:32:33Z |
| publishDate | 2017 |
| publisher | American Medical Association |
| record_format | dspace |
| spelling | oxford-uuid:1df32e42-c6c3-4658-9f86-7d3154ee9f2d2022-03-26T11:13:48ZEffect of oral dexamethasone without immediate antibiotics vs placebo on acute sore throat in adults: a Randomized Clinical TrialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:1df32e42-c6c3-4658-9f86-7d3154ee9f2dSymplectic Elements at OxfordAmerican Medical Association2017Hayward, GHay, AMoore, MJawad, SWilliams, NVoysey, MCook, JAllen, JThompson, MLittle, PPerera, RWolstenholme, JHarman, KHeneghan, C<strong>Importance:</strong> 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. <strong>Objective:</strong> To assess the clinical effectiveness of oral corticosteroids for acute sore throat in the absence of antibiotics. <strong>Design, Setting and Participants:</strong> Double-blind placebo controlled randomised trial (April 2013 to February 2015, 28 day follow-up completed April 2015) conducted in 42 family practices in South and West England, enrolling 576 adults (691 assessed, 82 not eligible, 33 declined) recruited on the day of presentation to primary care with acute sore throat not requiring immediate antibiotic therapy. Exclusion criteria included recent corticosteroids or antibiotics. <strong>Intervention:</strong> Single oral dose of 10mg dexamethasone (n=293) or identical placebo (n=283). <strong>Main outcome measures:</strong> 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 analogue symptom scales (0-100mm; no symptom to worst imaginable), healthcare attendance, days missed from work or education, consumption of delayed antibiotics or other medications, adverse events. Results: Among 565 eligible patients who were randomized (median age 34 years; 75.2% women, 100% completed the intervention), 288 received dexamethasone and 277 placebo. The proportion of participants with complete resolution of symptoms at 24 hours was not significantly different between dexamethasone (65/288) and placebo (49/277) groups; (Risk difference (RD) 4.7%; 95%CI -1.8% to 11.2%; Relative Risk (RR) 1.28; 95%CI 0.92 to 1.78, p=.14) Results were similar in those receiving no antibiotics or delayed antibiotics. At 48 hours, more participants experienced complete resolution in the dexamethasone group; (RD 8.7%; 95%CI 1.2% to 16.2%; RR 1.31; 95%CI 1.02 to 1.68, p=.03); a difference also observed in patients not offered delayed antibiotics (RD 10.3%; 95%CI 0.6% to 20.1%; RR 1.37; 95%CI 1.01 to 1.87, p=.046). There were no significant differences in any other secondary outcomes. <strong>Conclusions and Relevance:</strong> 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. |
| spellingShingle | Hayward, G Hay, A Moore, M Jawad, S Williams, N Voysey, M Cook, J Allen, J Thompson, M Little, P Perera, R Wolstenholme, J Harman, K Heneghan, C Effect of oral dexamethasone without immediate antibiotics vs placebo on acute sore throat in adults: a Randomized Clinical Trial |
| title | Effect of oral dexamethasone without immediate antibiotics vs placebo on acute sore throat in adults: a Randomized Clinical Trial |
| title_full | Effect of oral dexamethasone without immediate antibiotics vs placebo on acute sore throat in adults: a Randomized Clinical Trial |
| title_fullStr | Effect of oral dexamethasone without immediate antibiotics vs placebo on acute sore throat in adults: a Randomized Clinical Trial |
| title_full_unstemmed | Effect of oral dexamethasone without immediate antibiotics vs placebo on acute sore throat in adults: a Randomized Clinical Trial |
| title_short | Effect of oral dexamethasone without immediate antibiotics vs placebo on acute sore throat in adults: a Randomized Clinical Trial |
| title_sort | effect of oral dexamethasone without immediate antibiotics vs placebo on acute sore throat in adults a randomized clinical trial |
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