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The value of a liquid alginate suspension (Gaviscon Advance) in the management of laryngopharyngeal reflux

European Archives of Oto-Rhino-Laryngology volume 266, pages 243–251 (2009)Cite this article

Abstract

Laryngopharyngeal reflux (LPR) refers to the backflow of stomach contents into the laryngopharynx. Increasing evidence has demonstrated that LPR is a contributing factor in some cases of hoarseness, vocal fatigue, voice breaks, cough and globus and chronic throat clearing. However, several randomised placebo-controlled trials of proton pump inhibitors in the treatment of LPR have been reported with the majority showing no significant benefit in patient symptom scores over placebo. The aim of this pilot clinical study was to investigate whether any improvement in LPR-related symptoms, using the Reflux Symptom Index (RSI), and clinical findings, using the Reflux Finding Score (RFS), could be achieved with treatment with a liquid alginate suspension compared to control (no treatment). Patients presenting with the symptoms of LPR to the Otorhinolaryngology Outpatient Department at the Queen’s Medical Centre, Nottingham, UK were considered eligible if they had an RSI of greater than 10 and an RFS greater than 5 based on a fibreoptic examination of the larynx. A total of 49 patients were randomised into the open, parallel group study; 24 patients were randomised to receive 10 ml liquid alginate suspension (Gaviscon® Advance) four times daily after meals and at bedtime, and 25 patients into the control group (no treatment). Patients were assessed pre-treatment and at 2, 4 and 6 months post treatment. Mean (SD) RSI and RFS pre-treatment scores were 23.9 (7.0) and 10.4 (3.6) for the treatment group and 24.6 (7.4) and 10.3 (3.3) for the control group, respectively. Significant differences between treatment and control were observed for RSI at the 2-month (11.2 (7.0) vs. 16.8 (6.4), P = 0.005) and 6-month (11.2 (8.1) vs. 18.3 (9.4), P = 0.008) assessments and for RFS at the 6-month (7.1 (2.8) vs. 9.5 (3.4), P = 0.005) assessment. Significant improvement in symptom scores and clinical findings were achieved with liquid alginate suspension (Gaviscon® Advance) compared to control and further evaluation for the management of patients presenting with LPR is warranted.

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Abbreviations

ANCOVA:

Analysis of covariance

FDA:

Food and Drug Administration

GCP:

Good clinical practice

GORD:

Gastro-oesophageal reflux disease

GOR:

Gastro-oesophageal reflux

ICH:

International conference on harmonisation

ITT:

Intention to treat

LOCF:

Last observation carried forward

LPR:

Laryngopharyngeal reflux

PPI:

Proton pump inhibitor

RFS:

Reflux Finding Score

RSI:

Reflux Symptom Index

SD:

Standard deviation

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Authors and Affiliations

  1. Department of Otorhinolaryngology Head and Neck Surgery, Queen’s Medical Centre, Nottingham University Hospital, Nottingham, NG7 2UH, UK

    Julian A. McGlashan

  2. Reckitt Benckiser Healthcare (UK) Ltd., Dansom Lane, Hull, HU8 7DS, UK

    Lesley M. Johnstone & John Sykes

  3. Technostics Limited, The Deep Business Centre, Tower Street, Hull, HU1 4BG, UK

    Vicki Strugala & Peter W. Dettmar

Authors
  1. Julian A. McGlashan
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  2. Lesley M. Johnstone
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  3. John Sykes
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  4. Vicki Strugala
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  5. Peter W. Dettmar
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Corresponding author

Correspondence to Peter W. Dettmar.

Additional information

Disclosures: Peter Dettmar and Vicki Strugala are consultants to Reckitt Benckiser Healthcare. Lesley Johnstone and John Sykes are employees of Reckitt Benckiser Healthcare. This research was funded by Reckitt Benckiser Healthcare (UK) Ltd.

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McGlashan, J.A., Johnstone, L.M., Sykes, J. et al. The value of a liquid alginate suspension (Gaviscon Advance) in the management of laryngopharyngeal reflux. Eur Arch Otorhinolaryngol 266, 243–251 (2009). https://doi.org/10.1007/s00405-008-0708-7

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  • DOI: https://doi.org/10.1007/s00405-008-0708-7

Keywords

  • Laryngopharyngeal reflux
  • Alginates
  • Gastro-oesophageal reflux
  • Larynx