Oral corticosteroids for symptom relief of sore throat: a double-blind randomised placebo controlled trial in UK primary care
Management of acute sore throat poses a significant burden on UK General Practice. Almost 10% of registered patients attend their GP with sore throat every year and loss of productivity associated with sore throat has been estimated at £370 million annually. Nearly half of all patients presenting with this condition are treated with antibiotics, despite their limited effect. Corticosteroids may offer an alternative symptomatic treatment. In a recent systematic review we demonstrated that patients receiving a single dose of oral steroids were three times more likely to experience complete resolution of symptoms at 24 hours. However, all of the included trials assessed the benefit of corticosteroids in addition to antibiotics and only one was in a primary care setting.
The TOAST (Treatment Options without Antibiotics for Sore Throat) trial is a double-blind placebo controlled randomised trial in 3 UK centres. The trial aims to assess the clinical and cost effectiveness of a single dose of 10mg oral dexamethasone in adults presenting to UK Primary care with acute sore throat. Participants are recruited on the day of presentation to their GP practice, where the recruiting clinician will offer either a delayed antibiotic prescription or no antibiotic prescription based on clinical assessment. Randomisation is stratified according to offer of delayed antibiotic and recruiting centre. Our sample size of 566 patients will allow us to detect a clinically significant benefit in those participants not receiving antibiotics with 90% power.Our primary outcome is complete resolution of symptoms at 24 hours, reported by patients via text or telephone contact. Secondary outcomes include: complete resolution at 48 hours, use of delayed antibiotic prescription, repeat attendance at primary care, A and E or out-of-hours centres within 1 month, use of over-the-counter and prescription medications, adverse events and cost effectiveness.
Recruitment will be complete by mid March and full results will be available for presentation in July. The primary analysis will be intention to treat assuming no resolution for missing data. The proportion of participants reporting complete resolution of symptoms at 24 hours will be compared between two treatment arms using a log binomial regression model adjusting for whether participants are prescribed antibiotics. Symptom resolution in those participants who have not been offered delayed antibiotics will be compared in the same way.
The prospect of achieving rapid symptomatic relief with a single dose of oral steroids has exciting implications; both for the possibility of reducing unnecessary antibiotic prescriptions and in reducing the economic burden of sore throat.
- Gail Hayward, University of Bristol, Bristol, UK
- Matthew Thompson
- Alastair Hay, University of Southampton, Southampton, UK
- Michael Moore, University of Washington, Seattle, USA
- Paul Little, University of Washington, Seattle, USA
- Rafael Perrera, University of Bristol, Bristol, UK
- Merryn Voysey, University of Bristol, Bristol, UK
- Julie Allen, University of Bristol, Bristol, UK
- Johanna Cook, University of Bristol, Bristol, UK
- Kim Harman, University of Southampton, Southampton, UK
- Jane Wolstenholme, University of Bristol, Bristol, UK
- Carl Heneghan, University of Bristol, Bristol, UK