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Gaviscon® Advance alone versus co-prescription of Gaviscon® Advance and proton pump inhibitors in the treatment of laryngopharyngeal reflux

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Objectives Management of laryngopharyngeal reflux (LPR) typically comprises alginates and proton pump inhibitors (PPIs) alone or in combination, yet evidence to support any particular treatment regimen is lacking. We sought to evaluate the efficacy of Gaviscon® Advance alone versus co-prescription with a PPI in treating LPR. Methods One hundred consecutive LPR patients with a reflux symptom index (RSI) score > 10 attending our joint voice clinic (JVC) were studied prospectively. All were treated with Gaviscon® Advance four times daily. If patients had been started on a PPI prior to their JVC attendance, this was optimised to a twice-daily dosing regimen and continued. RSI scores were recorded at first attendance and 3 months post-treatment via postal questionnaire. Scores were analysed using t tests and Levene’s test for equality of variances. ResultsFollow-up RSI scores were returned by 72 patients, 39 of whom were treated with Gaviscon® Advance only (group A) and 33 with Gaviscon® Advance + PPI (group B). Mean pre-treatment RSI scores were similar between groups [group A: 19.2, 95% confidence interval (CI) ± 2.4; group B: 21.3, 95% CI ± 3.2 (p = 0.65)]. No significant differences were observed with respect to 3-month post-treatment RSI scores [group A: 9.9, 95% CI ± 2.8; group B: 12.6, 95% CI ± 4.2 (p = 0.82)] and change in RSI scores [group A: 9.3, 95% CI ± 3.0; group B: 8.7, 95% CI ± 2.9 [p = 0.75]). Conclusions Gaviscon® Advance alone is effective in treating symptoms of LPR, while co-prescription with a high-dose PPI offers no additional benefit.
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European Archives of Oto-Rhino-Laryngology (2018) 275:2515–2521
https://doi.org/10.1007/s00405-018-5079-0
LARYNGOLOGY
Gaviscon® Advance alone versusco-prescription ofGaviscon® Advance
andproton pump inhibitors inthetreatment oflaryngopharyngeal
reflux
MarkD.Wilkie1· HelenM.Fraser2· HemalRaja1
Received: 30 March 2018 / Accepted: 26 July 2018 / Published online: 30 July 2018
© Springer-Verlag GmbH Germany, part of Springer Nature 2018
Abstract
Objectives Management of laryngopharyngeal reflux (LPR) typically comprises alginates and proton pump inhibitors (PPIs)
alone or in combination, yet evidence to support any particular treatment regimen is lacking. We sought to evaluate the
efficacy of Gaviscon® Advance alone versus co-prescription with a PPI in treating LPR.
Methods One hundred consecutive LPR patients with a reflux symptom index (RSI) score > 10 attending our joint voice
clinic (JVC) were studied prospectively. All were treated with Gaviscon® Advance four times daily. If patients had been
started on a PPI prior to their JVC attendance, this was optimised to a twice-daily dosing regimen and continued. RSI scores
were recorded at first attendance and 3months post-treatment via postal questionnaire. Scores were analysed using t tests
and Levene’s test for equality of variances.
Results Follow-up RSI scores were returned by 72 patients, 39 of whom were treated with Gaviscon® Advance only (group
A) and 33 with Gaviscon® Advance + PPI (group B). Mean pre-treatment RSI scores were similar between groups [group A:
19.2, 95% confidence interval (CI) ± 2.4; group B: 21.3, 95% CI ± 3.2 (p = 0.65)]. No significant differences were observed
with respect to 3-month post-treatment RSI scores [group A: 9.9, 95% CI ± 2.8; group B: 12.6, 95% CI ± 4.2 (p = 0.82)] and
change in RSI scores [group A: 9.3, 95% CI ± 3.0; group B: 8.7, 95% CI ± 2.9 [p = 0.75]).
Conclusions Gaviscon® Advance alone is effective in treating symptoms of LPR, while co-prescription with a high-dose
PPI offers no additional benefit.
Keywords Laryngopharyngeal reflux/drug therapy· Gastroesophageal reflux/drug therapy· Proton pump inhibitors/
therapeutic use· Alginates/administration and dosage· Laryngitis/drug therapy· Drug combinations· Treatment outcome
Introduction
Laryngopharyngeal reflux (LPR) refers to the retrograde
flow of gastric contents into the hypopharynx and larynx,
and is considered by many as an extra-oesophageal mani-
festation of traditional gastro-oesophageal reflux disease
(GORD) [1, 2]. Mechanistically, however, LPR remains
incompletely understood but proposed mechanisms include
direct contact with erosive gastric refluxate (both acidic
stomach contents and duodenal conjugated bile acids and
pepsin), as well as vagally mediated reflex responses to low
pH in the distal oesophagus, such as excessive coughing and
throat clearing, which themselves lead to mucosal changes
[3, 4].
Nonetheless, it is now widely recognised that LPR may be
attributable to numerous upper aerodigestive tract symptoms
such as globus pharyngeus, dysphonia, chronic cough, and
throat discomfort, and as such LPR is frequently encoun-
tered and diagnosed in otolaryngology clinics [1, 2]. Indeed,
it has been estimated that symptoms suggestive of LPR are
present in 25% of primary care attenders in the United King-
dom (UK) and in excess of 60,000 such patients are referred
to secondary care otolaryngology services each year [5].
Similarly, it is estimated that 20–60% of the United States
population are affected by such symptoms, 10% of whom
* Mark D. Wilkie
mdwilkie@doctors.org.uk
1 Department ofOtorhinolaryngology – Head andNeck
Surgery, Warrington andHalton Hospitals NHS Foundation
Trust, Lovely Lane, WarringtonWA51QG, UK
2 Department ofSpeech andLanguage Therapy, Bridgewater
Community Healthcare NHS Foundation Trust, Lister Road,
RuncornWA71TW, UK
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... Emerging literature suggests an emerging role of alginates for the treatment of LPR. Studies have investigated their efficacy against placebo [16,17] or their use alone against the combination on PPIs and alginates [18]. However, to the best of our knowledge, no study compared the efficacy of alginates to the efficacy of PPIs in patients with LPR. ...
... Consequently, investigation on alternative treatments is a current challenge. Recently, alginates emerged as an option for the treatment of LPR [16,18]. For the first time, the present non-inferiority RCT compared the efficacy of PPIs (omeprazole) and the efficacy of the alginates suspension Gastrotuss® for the treatment of symptoms and signs of LPR. ...
... A significant reduction of the RSI was reported also by Tseng et al. in a RCT comparing alginates (Alginos) to placebo after 8-weeks of treatments in 80 patients with LPR, although it did not significantly differ to the RSI reduction of the placebo [17]. Another study compared the effect of the alginate (Gaviscon ® Advance) alone to the efficacy of the alginate as an add-on treatment to PPIs in 72 patients with LPR [18]. After 3 months, the authors observed a reduction of LPR symptoms, as measured by the RSI, in around 90% of the sample with no significant difference between the treatment groups. ...
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Purpose Proton pump inhibitors (PPIs) are commonly prescribed for laryngopharyngeal reflux (LPR), but their efficacy remains debated. Alginates is an option for the treatment of LPR with few adverse effects. The study aimed to investigate the non-inferiority of an alginate suspension (Gastrotuss®) compared to PPIs (Omeprazole) in reducing LPR symptoms and signs. Methods A non-inferiority randomized controlled trial was conducted. Fifty patients with laryngopharyngeal symptoms (Reflux Symptom Index -RSI- ≥ 13) and signs (Reflux Finding Score -RFS- ≥ 7) were randomized in two treatment groups: (A) Gastrotuss® (20 ml, three daily doses) and, (B) Omeprazole (20 mg, once daily). The RSI and the RFS were assessed at baseline and after 2 months of treatment. Results Groups had similar RSI and RFS scores at baseline. From pre- to 2-month posttreatment, the mean RSI significantly decreased (p = 0.001) in alginate and PPI group (p = 0.003). The difference between groups in the RSI change was not significant (95%CI: − 4.2–6.7, p = 0.639). The mean RFS significantly decreased in alginate (p = 0.006) and PPI groups (p = 0.006). The difference between groups in the mean change RFS was not significant (95%CI: − 0.8; 1.4, p = 0.608). Conclusion After 2 months of treatment, LPR symptoms and signs are significantly reduced irrespective of the treatment. Alginate was non-inferior to PPIs and may represent an alternative treatment to PPIs for the treatment of LPR.
... McGlashan et al. (2009) reported that treatment with a liquid alginate suspension four times daily significantly reduced RSI scores in patients with LPR at 2 months and 6 months compared with a control group [109]. Wilkie et al. (2018) found that an alginate-based formulation was comparable to an alginate co-prescribed with a PPI in reducing RSI scores, encompassing chest pain and cough, in patients with extraesophageal symptoms [110]. ...
... McGlashan et al. (2009) reported that treatment with a liquid alginate suspension four times daily significantly reduced RSI scores in patients with LPR at 2 months and 6 months compared with a control group [109]. Wilkie et al. (2018) found that an alginate-based formulation was comparable to an alginate co-prescribed with a PPI in reducing RSI scores, encompassing chest pain and cough, in patients with extraesophageal symptoms [110]. ...
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Introduction: Gastro-esophageal reflux disease (GERD) is a common gastrointestinal disorder that occurs when backflow of the gastric contents into the esophagus results in troublesome symptoms. Though GERD has been extensively studied in Western populations, literature on the management of GERD in patients in Africa and Middle East (AME) is scarce. Areas covered: In this review, we provide an overview of the management of mild-to-moderate GERD in AME. Here we focus on the efficacy and safety of currently available treatments for GERD to help physicians and community pharmacists appropriately manage patients with mild-to-moderate GERD in the primary healthcare setting, detailing specific situations and patient scenarios that are relevant to the region, including management of GERD during Ramadan and post-bariatric surgery. Expert opinion: Under-appreciation of the burden of GERD in the region has resulted in a lack of consensus on management. Barriers that currently prevent the adoption of treatment guidelines in the primary healthcare setting may include lack of availability of local guidelines and referral systems, a paucity of region-specific research, and dogmatic adherence to traditional practice. By increasing awareness, strengthening knowledge, and by more effective utilization of resources, physicians and pharmacists could optimize GERD management strategies to better support patients.
... Le traitement idéal pourrait donc associer régime ± IPP ± alginate ± magaldrate (Fig. 6). Les IPP restent importants pour les reflux acides ou mixtes étant donné qu'ils alcalinisent le pH des remontées gazeuses et liquidiennes acides, réduisant ainsi l'activité de la pepsine [4,87,88]. Par contre, pour les reflux nonacides, ceux-ci présentent un intérêt moindre [88]. En cas de reflux acide, ou mixte, l'ajout d'un alginate après les repas prend tout son sens afin de réduire les remontées gazeuses au niveau des VADS. ...
... En cas de reflux acide, ou mixte, l'ajout d'un alginate après les repas prend tout son sens afin de réduire les remontées gazeuses au niveau des VADS. Une récente étude a d'ailleurs montré qu'un traitement associant IPP et Gaviscon advance ® était comparable à un traitement basé sur la prise de Gaviscon advance ® seul [87]. Une enquête européenne montre que les reflux non-acides sont considérés par bon nombre d'ORL comme résistants à tout traitement anti-reflux [71]. ...
Article
Résumé Cette revue systématique de la littérature a été réalisée à l’aide des critères Patient/problem Intervention Comparison Outcomes. La prévalence reflux laryngopharyngé reste méconnue même si diverses études suggèrent que 10 à 30 % des patients consultant en oto-rhino-laryngologie présentent des plaintes de reflux. Depuis plus de 20 ans, le nombre de publications s’intéressant à l’épidémiologie, la présentation clinique, au diagnostic, et au traitement du reflux laryngopharyngé a fortement augmenté sans toutefois fournir une évolution de la prise en charge. En regard du développement de la pH-impédancemétrie et des techniques de détection de la pepsine dans les sécrétions des voies aérodigestives supérieures, nous sommes en mesure de proposer une nouvelle approche diagnostique basée sur l’association de scores cliniques, des résultats de la pH-impédancemétrie, et de la détection de pepsine salivaire. Sur le plan thérapeutique, cette approche permet de personnaliser le traitement en regard du profil de reflux du patient (acide, non-acide, mixte ; position debout ou allongée) orienté par la pH-impédancemétrie. Ainsi, le traitement actualisé du reflux laryngopharyngé pourrait associer des mesures hygiénodiététiques, la prise d’inhibiteurs de la pompe à protons, d’alginate et de malgaldrate durant trois mois au terme desquels une adaptation du traitement serait réalisée.
... The authors of this study did not consider this necessary, primarily because alginates combined with alkalinising substances and the combination of O. ficus-indica and O. europaea extracts have already been tested in clinical trials versus placebo in the treatment of GERD or in clinical trials versus PPIs in the treatment of LPR. Thus, the individual ingredients of MDL have a history of testing that confirms their efficacy[20,33,34]. Furthermore, this study was carried out in the context of the authors' usual clinical activity. ...
... In addition, alginates inhibit pepsin and bile salts. For this reason, alginates are particularly well-suited in the case of nonacid or mixed reflux or for patients with postprandial symptoms and, according to a recent article, could have similar efficiency to that of PPIs + alginate [25,26]. However, published RCT data are currently lacking. ...
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Extraesophageal reflux symptoms are increasingly common in the Western population and their clinical management is still controversial. Although therapy with proton-pump inhibitors (PPIs) represents the gold standard, to date, many patients are refractory to this treatment. The aim of this study was to evaluate, in patients with a recent diagnosis of GERD experiencing extraesophageal symptoms, the efficacy and safety of a 6-week treatment with PPI acid suppression in combination with Gerdoff® (a hyaluronic acid and chondroitin sulphate-based medical device) compared to PPI monotherapy. The trial verified the reduction in symptom frequency and severity by evaluating the proportion of Responders and Non-Responder patients after 6 weeks of treatment, compared to baseline. The effects of Gerdoff® + PPI treatment on extraesophageal symptoms were also evaluated after a 12-week follow up only in Responder patients. The analysis of the change in total Reflux Symptoms Index (RSI) score from baseline to the other time points showed that the extent of the decrease from baseline was higher in the Gerdoff® + PPI group than in the PPI group at any time point. However, the comparison between groups did not show statistically significant differences at any time point. A statistically significant difference, in favor of the Gerdoff® + PPI group, was observed for individual RSI items. Even if the trial showed some limitations, this is the first published study on the efficacy of a medical device containing hyaluronic acid and chondroitin sulphate with antacid in the treatment of extraesophageal reflux symptoms.
... In addition, alginate has a significant inhibitory effect on pepsin [87]. Wilkie et al. [88] confirmed that alginate alone effectively relieved LPRD symptoms, but no additional benefit was found when used in combination with high-dose PPIs. Darwish et al. [89] found that alginate raft-forming formulations containing nizatidine rapidly relieved burning symptoms. ...
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Study background: The objective of this study was to make a Randomized Controlled Trial (RCT) of laryngopharyngeal reflux treatment based on a sufficient number of patients (referring to our Cochrane review 2009). Material and methods: In order to detect differences prospectively of treatment effect in a randomized controlled trial, the following treatments of Laryngopharyngeal Reflux (LPR) were compared: lifestyle advice, lifestyle advice combined with proton pump inhibitor, and life style advice combined with proton pump inhibitor and alginate. Subjective complaints of LPR were stored and the objective evaluation of interarytenoids oedema of the larynx was evaluated visually on high speed films, with minimum of 2000 frames per second, a supplement of routine acoustical measures were made. Results: A total of 237 patients were randomized based on the planned statistical power calculation of 90% to detect a difference of 20%, under the assumption that the true difference was 5% and that the standard deviation was 25%. The differences between the three groups were found not to be statistically significant, but there was a general positive effect of treatment. Conclusion: Lifestyle guidance, lifestyle guidance added with esomeprazole and lifestyle guidance added with esomeprazole and alginate were all effective in this RCT for treatment effect of laryngopharyngeal reflux based on subjective complaints and documented with high speed films with minimum 2000 frames per second.
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To determine in true vocal fold (TVF) atrophy patients if symptoms of throat clearing and mucus sensation, attributed to laryngopharyngeal reflux (LPR), are due to glottic insufficiency. Is the TVF atrophy population being prescribed proton pump inhibitors unnecessarily? A retrospective review of patients with TVF atrophy but no other underlying laryngeal pathology seen at a tertiary voice center from July 2009 to May 2012 was conducted. Patient demographics, symptoms, LPR diagnosis, interventions, and pre-intervention and post-intervention Voice Handicap Index-10 (VHI) and Reflux Symptom Index (RSI) scores were recorded. Twenty-six patients met inclusion criteria, and 85% were treated for LPR. Throat clearing and mucus sensation (85%), dysphonia (54%), and globus sensation (46%) were recorded. Interventions included LPR medical management (65%), vocal fold augmentation (23%), and voice therapy (12%). Reflux Symptom Index scores improved in all groups. Voice Handicap Index-10 and RSI scores normalized in patients treated with augmentation. Globus was never present in patients who received augmentation. Throat clearing and mucus sensation may be due to underlying glottic insufficiency and changes of the aging larynx rather than LPR. High VHI and RSI scores normalized with TVF augmentation. Further work is needed to evaluate symptom presentation and risk versus benefit of treatment options, especially if it avoids unnecessary proton pump inhibitor trials.
Article
Objectives/hypothesis: To characterize the videoendoscopic laryngeal findings in patients with a prior established diagnosis of laryngopharyngeal reflux disease (LPR) as the sole etiology for their chief complaint of hoarseness. We hypothesized that many, if not all, of these patients would present with discrete laryngeal pathology, divergent from LPR. Study design: Prospective, nonintervention. Methods: Patients presenting to a tertiary laryngology practice with an established diagnosis of LPR as the sole etiology of their hoarseness were included. All subjects completed the Voice Handicap Index and Reflux Symptom Index, in addition to a questionnaire regarding their reflux diagnosis and prior treatment. Laryngoscopic examinations were reviewed by the laryngologist caring for the patients. Reliability of findings was assessed by interpretation of videoendoscopic findings by three outside laryngologists not involved in the care of the patients. Results: Laryngeal pathology distinct from LPR was identified in all 21 patients felt to be causative of the chief complaint of dysphonia. Specifically, the most common findings were benign mucosal lesions and vocal fold paresis (29% each), followed by muscle tension dysphonia (14%). Two patients were found to have vocal fold leukoplakia, of which one was confirmed to be a microinvasive carcinoma upon removal. Conclusion: LPR may be overdiagnosed; other etiologies must be considered for patients with hoarseness who fail empiric LPR treatment. Level of evidence: 4.
Article
A literature review regarding the use of laryngopharyngeal mucosal signs in diagnosing laryngopharyngeal reflux (LPR). Literature review. A search of MEDLINE in February 2012 using the terms laryngopharyngeal reflux, laryngitis, mucosa, appearances, and signs (English language only). One or more laryngopharyngeal mucosal signs associated with LPR were identified in 64% to 93% of healthy volunteers (3% >5 signs) and in 17% to 85% of gastroesophageal reflux disease sufferers (Reflux Finding Score [RFS] >7 in 24%). Reinke's edema, pseudosulcus, ventricular obliteration, vocal cord nodules, and granulomas have in some, but not all studies, been shown to be more prevalent in those with pH-proven pharyngeal reflux. Pseudosulcus, interarytenoid thickening, and Reinke's edema were more prevalent in those symptomatic of LPR than those not. The use of multiple mucosal signs may improve detection of reflux sufferers from asymptomatic controls. The RFS has a sensitivity and specificity of 87.8% and 37.5%, respectively, for picking up pH-proven pharyngeal reflux individuals. Inter- and intrarater reliability for identifying signs is fair to good in most studies. The limited evidence for each mucosal finding should be considered in making the diagnosis of LPR. Further quality research in to mucosal findings in LPR is needed.