| Message: No evidence was found of benefit from PPI treatment in patients with persistent throat symptoms. RSI scores were similar between the lansoprazole and placebo groups after 16 weeks of treatment and at the 12 month follow-up.
Use of proton pump inhibitors to treat persistent throat symptoms: multicentre, double blind, randomised, placebo controlled trial
BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.m4903 (Published 07 January 2021)
Cite this as: BMJ 2021;372:m4903
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James O'Hara, consultant otolaryngologist-head and neck surgeon, honorary senior clinical lecturer1 2, Deborah D Stocken, professor3, Gillian C Watson, trial manager4, Tony Fouweather, statistician5, Julian McGlashan, consultant otolaryngologist-head and neck surgeon, honorary consultant assistant professor6, Kenneth MacKenzie, consultant otolaryngologist-head and neck surgeon, visiting professor7, Paul Carding, professor8, Yakubu Karagama, consultant otolaryngologist-head and neck surgeon9, Ruth Wood, data manager4, Janet A Wilson, professor of otolaryngology-head and neck surgery10
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Correspondence to: J O'Hara James.O%E2%80%99Hara@newcastle.ac.uk
Accepted 28 November 2020
Abstract
Objective To assess the use of proton pump inhibitors (PPIs) to treat persistent throat symptoms.
Design Pragmatic, double blind, placebo controlled, randomised trial.
Setting Eight ear, nose, and throat outpatient clinics, United Kingdom.
Participants 346 patients aged 18 years or older with persistent throat symptoms who were randomised according to recruiting centre and baseline severity of symptoms (mild or severe): 172 to lansoprazole and 174 to placebo.
Intervention Random blinded allocation (1:1) to either 30 mg lansoprazole twice daily or matched placebo twice daily for 16 weeks.
Main outcome measures Primary outcome was symptomatic response at 16 weeks measured using the total reflux symptom index (RSI) score. Secondary outcomes included symptom response at 12 months, quality of life, and throat appearances.
Results Of 1427 patients initially screened for eligibility, 346 were recruited. The mean age of the study sample was 52.2 (SD 13.7) years, 196 (57%) were women, and 162 (47%) had severe symptoms at presentation; these characteristics were balanced across treatment arms. The primary analysis was performed on 220 patients who completed the primary outcome measure within a window of 14-20 weeks. Mean RSI scores were similar between treatment arms at baseline: lansoprazole 22.0 (95% confidence interval 20.4 to 23.6) and placebo 21.7 (20.5 to 23.0). Improvements (reduction in RSI score) were observed in both groups—score at 16 weeks: lansoprazole 17.4 (15.5 to19.4) and placebo 15.6 (13.8 to 17.3). No statistically significant difference was found between the treatment arms: estimated difference 1.9 points (95% confidence interval −0.3 to 4.2 points; P=0.096) adjusted for site and baseline symptom severity. Lansoprazole showed no benefits over placebo for any secondary outcome measure , including RSI scores at 12 months: lansoprazole 16.0 (13.6 to 18.4) and placebo 13.6 (11.7 to 15.5): estimated difference 2.4 points (−0.6 to 5.4 points).
Conclusions No evidence was found of benefit from PPI treatment in patients with persistent throat symptoms. RSI scores were similar between the lansoprazole and placebo groups after 16 weeks of treatment and at the 12 month follow-up.
Trial registration ISRCTN Registry ISRCTN38578686 and EudraCT 2013-004249-17. |
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