title: TOPPITS: Trial Of Proton Pump Inhibitors in Throat Symptoms. Study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Persistent throat symptoms and Extra Oesophageal Reflux (EOR) are among the commonest reasons for attendance at a secondary care throat or voice clinic. There is a growing trend to treat throat symptom patients with proton pump inhibitors (PPIs) to suppress stomach acid, but most controlled studies fail to demonstrate a significant benefit of PPI over placebo. In addition, patient views on PPI use vary widely.
  
  
  METHODS
  A UK multi-centre, randomised, controlled trial for adults with persistent throat symptoms to compare the effectiveness of treatment with the proton pump inhibitor (PPI) lansoprazole versus placebo. The trial includes a six-month internal pilot, during which three sites will recruit 30 participants in total, to assess the practicality of the trial and assess the study procedures and willingness of the patient population to participate. If the pilot is successful, three additional sites will be opened to recruitment, and a further 302 participants recruited across the six main trial sites. Further trial sites may be opened, as necessary. The main trial will continue for a further 18 months. Participants will be followed up for 12 months from randomisation, throughout which both primary and secondary outcome data will be collected. The primary outcome is change in Reflux Symptom Index (RSI) score, the 'area standard' for this type of assessment, after 16 weeks (four months) of treatment. Secondary outcomes are RSI changes at 12 months after randomisation, Quality of Life assessment at four and 12 months, laryngeal mucosal changes, assessments of compliance and side effects, and patient-reported satisfaction.
  
  
  CONCLUSIONS
  TOPPITS is designed to evaluate the relative effectiveness of treatment with a proton pump inhibitor versus placebo in patients with persistent throat symptoms. This will provide valuable information to clinicians and GPs regarding the treatment and management of care for these patients, on changes in symptoms, and in Quality of Life, over time.
  
  
  BACKGROUND
  ISRCTN38578686 . Registered 17 April 2014.
authors.affiliation: Newcastle Clinical Trials Unit, Faculty of Medical Sciences, Newcastle upon Tyne, NE2 4AE, UK. gillian.watson@newcastle.ac.uk.
authors.forename: Gillian
authors.initials: G
authors.lastname: Watson
authors.affiliation: Ear, Nose and Throat Department, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, NE7 7DN, UK.
authors.forename: James
authors.initials: J
authors.lastname: O'Hara
authors.affiliation: School of Allied and Public Health, Faculty of Health Sciences, Australian National Catholic University, Brisbane Campus, Queensland, 4014, Australia.
authors.forename: Paul
authors.initials: P
authors.lastname: Carding
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, NE2 4AZ, UK.
authors.forename: Jan
authors.initials: J
authors.lastname: Lecouturier
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, NE2 4AZ, UK.
authors.forename: Deborah
authors.initials: D
authors.lastname: Stocken
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, NE2 4AZ, UK.
authors.forename: Tony
authors.initials: T
authors.lastname: Fouweather
authors.affiliation: Ear, Nose and Throat Department, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, NE7 7DN, UK.|Institute of Health and Society, Newcastle University, Newcastle upon Tyne, NE2 4AZ, UK.
authors.forename: Janet
authors.initials: J
authors.lastname: Wilson
mesh_terms: D002985:Clinical Protocols; D005240:Feasibility Studies; D005764:Gastroesophageal Reflux / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D064747:Lansoprazole / Q000627:therapeutic use*; D057045:Laryngopharyngeal Reflux / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D010612:Pharyngitis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D010865:Pilot Projects; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D014832:Voice Disorders / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*
chemical_list: D054328:Proton Pump Inhibitors; D064747:Lansoprazole
keywords: Ear; Extra oesophageal reflux; Gastro-oesophageal reflux disease; Lansoprazole; Laryngopharyngeal reflux; Otolaryngology; Proton pump inhibitor; Reflux Symptom Index; Throat; Voice; nose and throat