• Trials · Jan 2014

    Randomized Controlled Trial Multicenter Study

    Oral corticosteroid use for clinical and cost-effective symptom relief of sore throat: study protocol for a randomized controlled trial.

    • Johanna Cook, Gail Hayward, Matthew Thompson, Alastair D Hay, Michael Moore, Paul Little, Kim Harman, Jane Wolstenholme, Rafael Perera, Merryn Voysey, Julie Allen, Maria Breen, and Carl Heneghan.
    • Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK. gail.hayward@phc.ox.ac.uk.
    • Trials. 2014 Jan 1;15:365.

    BackgroundManagement of acute sore throat poses a significant burden on UK general practices, with almost 10% of registered patients attending their GP with sore throat every year. Nearly half of all patients presenting with acute sore throat are treated with antibiotics, despite their limited effect. In a recent systematic review we demonstrated that a single dose of steroids reduced the severity and time to resolution of sore throat. However, all of the trials included looked at the use of steroids alongside antibiotics and only one was in a primary care setting. This trial aims to assess the efficacy and cost-effectiveness of a single oral dose of corticosteroids on symptoms of sore throat in patients receiving either a delayed antibiotic prescription or no antibiotics at all in UK primary care.Methods/DesignA double-blind, two arm, randomized, placebo controlled trial in adults (≥ 18 years of age) presenting to primary care with acute sore throat (DiscussionThis will be the first randomized controlled trial of oral corticosteroids in adults presenting to primary care with sore throat in the UK, and the first to examine the clinical and cost-effectiveness of oral corticosteroids for the treatment of sore throat in the absence of antibiotics.Trial RegistrationThis trial is registered with Current Controlled Trials on 26 March 2013, registration number: ISRCTN17435450.

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