Journal Article


A randomised, placebo controlled trial of extra-oesophageal reflux treatment in the management of upper respiratory symptoms [TOPPITS:Trial of Proton Pump Inhibitors in Throat Symptoms]

Abstract

Background. Persistent throat symptoms, such as throat clearing, globus sensation, voice change and catarrh are extremely common. On very limited evidence, they are increasingly attributed to “laryngopharyngeal reflux (LPR)” and treated with proton pump inhibitors (PPIs) in primary and secondary care. Methods. A double blind placebo controlled UK multicentre phase III trial randomly allocated adults with persistent throat symptoms 1:1 to either 30 mg of Lansoprazole or matched placebo twice daily for 16 weeks, stratified by centre and symptom severity. The primary outcome was patient-reported symptomatic response, measured by the total Reflux Symptom Index (RSI) score at the end of therapy. Secondary outcomes included safety, further symptoms and quality of life measures at 12-months. Results. 346 participants were randomised from 8 UK centres: mean (sd) age 52 (13), 196 (57%) female, 162 (47%) severe symptoms, balanced across randomised groups. Mean RSI scores (95% CI) were similar at baseline- Lansoprazole: 22.0 (20.4, 23.6), placebo: 21.7 (20.5, 23.0). Improvements (reduction in score) were observed in both groups at 16-weeks: Lansoprazole: 17.4 (15.5, 19.4), placebo: 15.6 (13.8, 17.3) (p=0.096 adjusted by site, severity). There was no statistically significant difference between randomised groups. No significant differences were observed in the secondary outcome measures. Conclusions. TOPPITS is the largest, definitive trial to assess PPI effectiveness for persistent throat symptoms. It found no advantage of Lansoprazole over placebo in a range of outcomes. The near routine use of PPIs for throat symptoms should be discontinued.

Attached files

Authors

O’Hara, James
Stocken, Deborah D.
Watson, Gillian C.
Fouweather, Tony
McGlashan, Julian
MacKenzie, Kenneth
Carding, Paul
Karagama Yakubu
Wood, Ruth
Wilson, Janet A.

Oxford Brookes departments

Oxford School of Nursing and Midwifery

Dates

Year of publication: 2021
Date of RADAR deposit: 2019-08-21


Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License


Related resources

This RADAR resource is the Accepted Manuscript of A randomised, placebo controlled trial of extra-oesophageal reflux treatment in the management of upper respiratory symptoms.[TOPPITS:Trial of Proton Pump Inhibitors in Throat Symptoms]
This RADAR resource Cites Lansoprazole for persistent throat symptoms in secondary care: The TOPPITS RCT

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