Dataset Information

Use of proton pump inhibitors to treat persistent throat symptoms: multicentre, double blind, randomised, placebo controlled trial.

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.

SUBMITTER: O'Hara J

PROVIDER: S-EPMC7789994 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Use of proton pump inhibitors to treat persistent throat symptoms: multicentre, double blind, randomised, placebo controlled trial.

O'Hara James J Stocken Deborah D DD Watson Gillian C GC Fouweather Tony T McGlashan Julian J MacKenzie Kenneth K Carding Paul P Karagama Yakubu Y Wood Ruth R Wilson Janet A JA

BMJ (Clinical research ed.) 20210107

<h4>Objective</h4>To assess the use of proton pump inhibitors (PPIs) to treat persistent throat symptoms.<h4>Design</h4>Pragmatic, double blind, placebo controlled, randomised trial.<h4>Setting</h4>Eight ear, nose, and throat outpatient clinics, United Kingdom.<h4>Participants</h4>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.<h4>Inte ...[more]

PMID: 33414239

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Dataset Information

Use of proton pump inhibitors to treat persistent throat symptoms: multicentre, double blind, randomised, placebo controlled trial.

Objective

Design

Setting

Participants

Intervention

Main outcome measures

Results

Conclusions

Trial registration

Publications

Use of proton pump inhibitors to treat persistent throat symptoms: multicentre, double blind, randomised, placebo controlled trial.

Similar Datasets

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