Evidence map›Paper›PMID 33414239›Full record

Trial reportBMJ (Clinical research ed.)2021

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

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

Open access · hybridAbstract readMulticenter StudyPragmatic Clinical Trial
In one paragraph

Trial report in BMJ (Clinical research ed.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
7.2field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it, 61 citations in OpenAlex.

  1. Pooled it
  2. Randomized Controlled Trial of Upper Esophageal Sphincter Assist Device in Laryngopharyngeal Reflux Disease.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2026
    Trial
  3. Optimizing Evaluation of Gastroesophageal Reflux With Atypical Symptoms: Cost-Effectiveness and Cost-Minimalization Analysis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2026
    Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. [Treatment status and progress of laryngopharyngeal reflux disease].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2025
    Article
  10. Review
  11. The role of an anti-reflux diet in the treatment of chronic cough caused by laryngopharyngeal reflux.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025
    Observational
  12. Article
  13. Chronic cough as a disease.ERJ open research · 2024
    Review
  14. Article
  15. Article
  16. Article
  17. Review article: Diagnosis and management of laryngopharyngeal reflux.Alimentary pharmacology & therapeutics · 2024
    Review
  18. Review
  19. Review
  20. Somatic anxiety in patients with laryngopharyngeal reflux.Laryngoscope investigative otolaryngology · 2023
    Article
4 · The record

Corrections and comments

  • Commented on by
    2022
5 · Who and what money

Authors and funding

10 authors at 7 institutions in 1 country.

James O'HaraFreeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne NE7 7DN, UK James.O'Hara@newcastle.ac.uk.ORCID 0000-0002-4096-3296
Deborah D StockenClinical Trials Research, Leeds Institute of Clinical Trials Research University of Leeds, Leeds, UK.
Gillian C WatsonNewcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.ORCID 0000-0003-2466-0268
Tony FouweatherPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.ORCID 0000-0002-2292-0495
Julian McGlashanNottingham University Hospitals, Nottingham, UK.
Kenneth MacKenzieNHS Greater Glasgow and Clyde. Visiting Professor, University of Strathclyde, Glasgow, UK.ORCID 0000-0002-2952-7717
Paul CardingOxford Institute of Nursing, Midwifery and Allied Health Research, Oxford Brookes University, Oxford, UK.
Yakubu KaragamaGuy's and St Thomas' NHS Foundation Trust, London, UK.
Ruth WoodNewcastle Clinical Trials Unit, Newcastle University, Newcastle, UK.ORCID 0000-0002-8296-1774
Janet A WilsonPopulation Health Sciences Institute, Newcastle University and Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.ORCID 0000-0002-6416-5870
Newcastle University · GBNewcastle upon Tyne Hospitals NHS Foundation Trust · GBGuy's and St Thomas' NHS Foundation Trust · GBNottingham University Hospitals NHS Trust · GBOxford Brookes University · GBUniversity of Leeds · GBUniversity of Strathclyde · GB

Funding

Department of Health 12/01/04
6 · The paper itself

Abstract

objectiveTo assess the use of proton pump inhibitors (PPIs) to treat persistent throat symptoms.

designPragmatic, double blind, placebo controlled, randomised trial.

settingEight ear, nose, and throat outpatient clinics, United Kingdom.

participants346 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.

interventionRandom blinded allocation (1:1) to either 30 mg lansoprazole twice daily or matched placebo twice daily for 16 weeks.

main outcome measuresPrimary 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.

resultsOf 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).

conclusionsNo 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 registrationISRCTN Registry ISRCTN38578686 and EudraCT 2013-004249-17.

Indexed as

AdultAgedAged, 80 and overDouble-Blind MethodEsophagitis, PepticFemaleGastroesophageal RefluxHumansLansoprazoleMaleMiddle AgedPharyngitisProton Pump InhibitorsQuality of LifeUnited KingdomLansoprazoleProton Pump Inhibitors

Identifiers

PMID33414239
PMCPMC7789994
OpenAlexW3120892249

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.