TOPPITS: Trial Of Proton Pump Inhibitors in Throat Symptoms. Study protocol for a randomised controlled trial
Watson, Gillian, O'Hara, James, Carding, Paul Nicholas, Lecouturier, Jan, Stocken, Deborah, Fouweather, Tony and Wilson, Janet. (2016) TOPPITS: Trial Of Proton Pump Inhibitors in Throat Symptoms. Study protocol for a randomised controlled trial. Trials. https://doi.org/10.1186/s13063-016-1267-7
|Authors||Watson, Gillian, O'Hara, James, Carding, Paul Nicholas, Lecouturier, Jan, Stocken, Deborah, Fouweather, Tony and Wilson, Janet|
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/design: 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. Discussion: 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.
|Keywords||ear; nose and throat; extra oesophageal reflux; gastro-oesophageal reflux disease; lansoprazole; laryngopharyngeal reflux; otolaryngology; proton pump inhibitor; reflux symptom index; throat voice|
|Publisher||Biomed Central Ltd|
|Digital Object Identifier (DOI)||https://doi.org/10.1186/s13063-016-1267-7|
|Open access||Open access|
|Research Group||School of Allied Health|
© 2016 Watson et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
|Place of publication||United Kingdom|
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