title: Oral corticosteroid use for clinical and cost-effective symptom relief of sore throat: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Management 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
  A double-blind, two arm, randomized, placebo controlled trial in adults (≥ 18 years of age) presenting to primary care with acute sore throat (<seven days). Participants are recruited on the day of presentation to their GP practice. GPs or nurses assess eligibility, record baseline clinical features and obtain a throat swab for bacterial culture. Participants are being randomized to treatment arms at a ratio of 1:1. Treatment arms will be stratified according to whether patients are being given a delayed antibiotic prescription or no antibiotic prescription and by recruiting centre (Oxford, Bristol or Southampton). Outcome data is being collected at 24 and 48 hours via text message or telephone call, from days 0 to 7 using a patient symptom diary and at one month via a GP notes review.
  
  
  CONCLUSIONS
  This 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.
  
  
  BACKGROUND
  This trial is registered with Current Controlled Trials on 26 March 2013, registration number: ISRCTN17435450.
authors.forename: Johanna
authors.initials: J
authors.lastname: Cook
authors.affiliation: 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.
authors.forename: Gail
authors.initials: G
authors.lastname: Hayward
authors.forename: Matthew
authors.initials: M
authors.lastname: Thompson
authors.forename: Alastair D
authors.initials: AD
authors.lastname: Hay
authors.forename: Michael
authors.initials: M
authors.lastname: Moore
authors.forename: Paul
authors.initials: P
authors.lastname: Little
authors.forename: Kim
authors.initials: K
authors.lastname: Harman
authors.forename: Jane
authors.initials: J
authors.lastname: Wolstenholme
authors.forename: Rafael
authors.initials: R
authors.lastname: Perera
authors.forename: Merryn
authors.initials: M
authors.lastname: Voysey
authors.forename: Julie
authors.initials: J
authors.lastname: Allen
authors.forename: Maria
authors.initials: M
authors.lastname: Breen
authors.forename: Carl
authors.initials: C
authors.lastname: Heneghan
mesh_terms: D000284:Administration, Oral; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage* / Q000191:economics*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003907:Dexamethasone / Q000008:administration & dosage* / Q000191:economics*; D004311:Double-Blind Method; D016527:Drug Costs; D004359:Drug Therapy, Combination; D004739:England; D005260:Female; D006801:Humans; D008297:Male; D010612:Pharyngitis / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics* / Q000382:microbiology; D011320:Primary Health Care / Q000191:economics; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D019564:Unnecessary Procedures / Q000191:economics
chemical_list: D000305:Adrenal Cortex Hormones; D000900:Anti-Bacterial Agents; D003907:Dexamethasone