Extraesophageal Reflux Symptoms Research Articles

Lap. Nissen fundoplication leads to better respiratory symptom control than Toupet in the long term of 20 years

IntroductionHaving performed anti-reflux surgery for thirty years, it was important to reexamine our patients in the long term to enlarge the body of evidence concerning classical and extraesophageal symptoms that are differently controlled by Nissen or Toupet fundoplication.ObjectivesWe report a cohort of 155 GERD patients who underwent fundoplication within a tailored approach between 1994 and 2000. Changes in the perioperative functional outcome, GERD symptoms, and quality of life are being analyzed 10 and 20 years after the operation.ResultsThe operation resulted in a superior quality of life compared to a patient cohort treated with PPI therapy. We found that both surgical methods (laparoscopic Nissen fundoplication and laparoscopic Toupet fundoplication) cure classical symptoms equally (heartburn, regurgitation, and dysphagia). GERD patients receiving a Toupet fundoplication seem more likely to suffer from extraesophageal GERD symptoms 10 and 20 years after surgery than patients with a Nissen fundoplication. On the other hand, some patients with Nissen fundoplication report dysphagia even 10 and 20 years after surgery.ConclusionBoth the laparoscopic Nissen and Toupet fundoplications provide excellent symptom control in the long term. Moreover, the Nissen fundoplication seems to be superior in controlling extraesophageal reflux symptoms, but at the expense of dysphagia. In summary, tailoring the operation based on symptoms seems advantageous.

Association Between Inferior Turbinate Hypertrophy and Extraesophageal Reflux

To the authors' knowledge, no prior studies have examined the association between inferior turbinate hypertrophy (ITH) and extraesophageal reflux (EER). If EER were a cause or cofactor of ITH, antireflux treatment can be considered prior to surgical intervention. To evaluate EER presence and severity in patients with different degrees of ITH. Prospective multicentric cohort study conducted at 3 referral centers treating patients with EER and certified for 24-hour monitoring of oropharyngeal pH. The monitoring was performed between October 2020 and October 2021. A total of 94 adult patients with EER symptoms were recruited, 90 of whom were analyzed. Nasal endoscopy was performed to determine the degree of ITH, according to the Camacho classification. Presence and severity of EER were examined using 24-hour monitoring of oropharyngeal pH. Primary outcomes were presence of EER according to RYAN Score, total percentage of time below pH 5.5, and total numbers of EER events below pH 5.5. Of the 90 analyzed patients (median [IQR] age, 46 [33-58] years; 36 [40%] male patients), 41 had a maximum of second-degree ITH (group 1), and 49 patients had at least third-degree ITH (group 2), according to the Camacho classification. On the basis of the RYAN Score, EER was diagnosed more often in group 2 (69.4%) than in group 1 (34.1%; difference, 35.3% [95% CI, 13.5%-56.9%]). Moreover, compared with group 1, group 2 exhibited higher median total percentage of time below pH 5.5 (median [IQR], group 1: 2.1% [0.0%-9.4%], group 2: 11.2% [1.5%-15.8%]; difference, 9.1% [95% CI, 4.1%-11.8%]) and higher median total number of EER events (median [IQR], group 1: 6 [1-14] events, group 2: 14 [4-26] events; difference, 8 [95% CI, 2-15] events). Patients with proven EER demonstrated no difference in the degree of ITH between the right and left nasal cavity (Cohen g, -0.17 [95% CI, -0.50 to 0.30]), or between the anterior and posterior parts of the nasal cavity (Cohen g, -0.21 [95% CI, -0.50 to 0.17]). In this cohort study, patients with a higher degree of ITH had more severe EER. A possible association between severe ITH and EER was demonstrated.

The Effect of Hyaluronic Acid and Chondroitin Sulphate-Based Medical Device Combined with Acid Suppression in the Treatment of Atypical Symptoms in Gastroesophageal Reflux Disease.

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.

Prevalencia de mucosa gástrica heterotópica cervical y su relación con síntomas de reflujo gastroesofágico. Estudio observacional

Introduction. The heterotopic gastric mucosal patch or inlet patch is the presence of gastric columnar mucosa outside the stomach, most frequently located in the proximal esophagus. Its manifestations vary from esophageal and extraesophageal reflux symptoms to major complications, most of them being asymptomatic. Aim. To determine the prevalence of cervical heterotopic gastric mucosa in our environment and its association with esophageal and extraesophageal reflux symptoms. Material and methods. Prospective cross-sectional and observational study; consecutive patients who came to our institution between December 2018 and October 2019 for diagnostic upper gastrointestinal videoendoscopy were included, following a questionnaire on clinical manifestations. Results. A total of 1,408 patients were included. In 89 (6.3%), a cervical heterotopic gastric mucosal patch was described. The mean age of the patients without this condition was 54.6 and 55.5 in patients with it. The esophageal symptoms of gastroesophageal reflux (heartburn, regurgitation, and chest pain) in patients with cervical heterotopic gastric mucosa was observed in 40 (44.9% / p = 0.473), 12 (13.5% / p = 0.783) and 4 (4.5% / p = 0.199) patients respectively. The presence of extraesophageal symptoms (globus, chronic cough, dysphonia, and throat clearing) in patients with cervical heterotopic gastric mucosa was: 9 (10.1% / p = 0.011); 7 (7.9% / p = 0.155); 4 (4.5% / p = 0.458) and 9 (10.1% / p = 0.036) respectively. Conclusions. A statistically significant association was found between the presence of cervical heterotopic gastric mucosal patch and symptoms of globus (p = 0.011) and throat clearing (p = 0.036). It could be interpreted that this group of patients would benefit from the research and treatment of this condition with the intention of improving their symptoms.

Protection and regeneration of esophageal, pharyngeal, and laryngeal mucosa as a major element in therapy of patients with esophageal and extraesophageal reflux symptoms.

Treatment of esophageal and extraesophageal reflux syndromes is mainly focused on inhibiting the secretion of hydrochloric acid. In spite of the high efficacy of proton pump inhibitors, approx. 30-60% of GERD patients experience daily symptoms. Beside acid reflux, other factors such as abnormal esophageal peristalsis, visceral hypersensitivity, ineffective esophageal clearance mechanisms, and impaired mucosal barrier also play an important role in generating GERD symptoms. An additional therapeutic proposition is a procedure aimed at improving the defense mechanisms of esophageal mucosa rather than inhibiting the damage-inducing factors. The preparation consisting of hyaluronic acid (HA), chondroitin sulfate (SC) and poloxamer 407 protects against harmful factors (hydrochloric acid, pepsin) and accelerates mucosal healing and regeneration, constituting a substantial element of monotherapy or add-on therapy in patients with gastroesophageal reflux disease.

Software improvement for evaluation of laryngopharyngeal pH testing (Restech) - a comparison between DataView 3 and 4.

BACKGROUNDWhen gastroesophageal reflux contents reach above the upper esophageal sphincter, patients may, in addition to typical reflux symptoms, present with atypical, extraesophageal symptoms related to laryngopharyngeal reflux (LPR). Surgical treatment of LPR has shown to lead to 70% symptom improvement, however no gold standard for the diagnosis of LPR exists. In 2007, the Restech Dx-pH was released as a valid method to measure acid exposure above the upper esophageal sphincter. Recently, a new software update was introduced for analysis of measured pH data and calculation of composite scores. The effect of the changes applied to the new software version have not yet been analyzed.AIMTo compare results generated by DataView 3 to the most recently released DataView 4.METHODSAll patients with gastroesophageal reflux disease symptoms were seen in a specialized surgical outpatient clinic for gastrointestinal function testing. Retrospective chart review was performed of all patients presenting with suspected gastroesophageal reflux disease and extraesophageal reflux symptoms, who underwent laryngopharyngeal pH monitoring using the Restech Dx-pH system (Respiratory Technology Corp., Houston, TX, United States) and simultaneous esophageal pH monitoring. DataView 3 and DataView 4 were used to evaluate Restech studies obtained. Diary entries such as mealtimes, supine and upright periods, and symptoms were entered manually to ensure accuracy and precise conversion of data between both software versions. Paired t test was performed for statistical analysis of results.RESULTSA total of 174 patients (63.8% female) met inclusion criteria, all suffering from extraesophageal reflux symptoms as well as typical gastroesophageal reflux disease symptoms. Mean RYAN score upright was 48.77 in DataView 3 compared to 22.17 in DataView 4, showing a significant difference (aP = 0.0001). Similar results were shown for supine period (mean RYAN Score DataView 3 5.29 vs 1.42 in DataView 4, cP = 0.0001). For upright periods 80 patients showed a decrease of value of the RYAN score with a mean of -58.9 (mean 51.1% decrease). For supine position 25 patients showed a decrease of value of the RYAN score with a mean of -15.13 [range (-153.44)–(-0.01)], which equals a mean decrease of value of 44.5%. Ten patients showed no oropharyngeal acid exposure in DataView 3, but mild/moderate (n = 7) or severe (n = 3) acid exposure in DataView 4. Correlation with positive esophageal pH measurement was improved in all 10 patients.CONCLUSIONResults of both software versions cannot be compared to each other. However, our data suggests that DataView 4 may be an improvement of the Restech pH measurement in the evaluation of LPR.

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Model to Select On-Therapy vs Off-Therapy Tests for Patients With Refractory Esophageal or Extraesophageal Symptoms

It is not clear whether we should test for reflux in patients with refractory heartburn or extraesophageal reflux (EER) symptoms, such as cough, hoarseness, or asthma. Guidelines recommend testing patients by pH monitoring when they are on or off acid-suppressive therapies based on pretest probability of reflux, determined by expert consensus. However, it is not clear what constitutes a low or high pretest probability of reflux in these patients. We aimed to develop a model that clinicians can use at bedside to estimate pretest probability of abnormal reflux. We performed a prospective study of 471 adult patients with refractory heartburn (n= 214) or suspected EER symptoms (n= 257) who underwent endoscopy with wireless pH monitoring while they were off acid-suppressive treatment and assigned them to groups based on symptoms at presentation (discovery cohort). Using data from the discovery cohort, we performed proportional odds ordinal logistic regression to select factors (easy to obtain demographic criteria and clinical symptoms such as heartburn, regurgitation, asthma, cough, and hoarseness) associated with esophageal exposure to acid. We validated our findings in a cohort of 118 patients with the same features from 2 separate tertiary care centers (62% women; median age 59 years; 62% with cough as presenting symptom). Abnormal pH (>5.5% of time spent at pH <4) was found in 56% of patients with heartburn and 63% of patients with EER (P= .15). Within EER groups, abnormal pH was detected in a significantly larger proportion (80%) of patients with asthma compared with patients with cough (60%) or hoarseness (51%; P < .01). Factors significantly associated with abnormal pH in patients with heartburn were presence of hiatal hernia and body mass index >25 kg/m2. In patients with EER, the risk of reflux was independently associated with the presence of concomitant heartburn (odds ratio [OR] 2.0; 95% confidence interval [CI] 1.3-3.1), body mass index >25 kg/m2 (OR 2.1; 95% CI 1.5-3.1), asthma (OR 2.0; 95% CI 1.2-3.5), and presence of hiatal hernia (OR 1.9; 95% CI 1.2-3.1). When we used these factors to create a scoring system, we found that a score of ≤2 excluded patients with moderate to severe reflux, with a negative predictive value of 80% in the discovery cohort and a negative predictive value of 85% in the validation cohort. We developed a clinical model to estimate pretest probability of abnormal pH in patients who were failed byproton pump inhibitor therapy. This system can help guide clinicians at bedside in determining the most appropriate diagnostic test in this challenging group of patients.

Mucosal Impedance: a New Approach to Diagnosing Gastroesophageal Reflux Disease and Eosinophilic Esophagitis

In this review, we discuss current diagnostic testing modalities for both gastroesophageal reflux disease (GERD) and eosinophilic esophagitis (EoE) and then introduce mucosal impedance (MI), a novel technology that measures epithelial integrity in real time during endoscopy. We describe the advantages and disadvantages of MI as compared with traditional diagnostic testing. We review studies that demonstrate that GERD and EoE have distinct MI patterns, and that physicians can accurately diagnose and distinguish the two during endoscopy with minimal time added to the procedure. We also review studies showing that MI has the capability to assess treatment response in both GERD and EoE and that it can be used to diagnose GERD in patients with extraesophageal reflux symptoms. Mucosal impedance testing is a major advancement in the diagnosis of GERD and EoE. Future studies are planned to assess whether MI can be used as a treatment endpoint in EoE and whether it can be used to predict response to anti-reflux surgery.

Extraesophageal Symptoms and Diseases Attributed to GERD: Where is the Pendulum Swinging Now?

The purpose of this review is to outline the recent developments in the field of extraesophageal reflux disease and provide clinically relevant recommendations. The recommendations outlined in this review are based on expert opinion and on relevant publications from PubMed and EMbase. The Clinical Practice Updates Committee of the American Gastroenterological Association proposes the following recommendations: Best Practice Advice 1: The role of a gastroenterologist in patients referred for evaluation of suspected extra esophageal symptom is to assess for gastroesophageal etiologies that could contribute to the presenting symptoms. Best Practice Advice 2: Non-GI evaluations by ENT, pulmonary and/or allergy are essential and often should be performed initially in mostpatients as the cause of the extraesophageal symptom is commonly multifactorial or not esophageal inorigin. Best Practice Advice 3: Empiric therapy with aggressive acid suppression for 6-8 weeks with special focus on response of the extraesophageal symptoms can help in assessing association between reflux and extraesophageal symptoms. Best Practice Advice 4: No single testing methodology exists to definitively identify reflux as the etiology for the suspected extra esophageal symptoms. Best Practice Advice 5: Constellation of patient presentation, diagnostic test results and response to therapy should be employed in the determination of reflux as a possible etiology in extra esophageal symptoms. Best Practice Advice 6: Testing may need to be off or on proton pump inhibitor (PPI) therapy depending on patients' presenting demographics and symptoms in assessing the likelihood of abnormal gastroesophageal reflux. A. On therapy testing may be considered in those with high probability of baseline reflux (those with previous esophagitis, Barrett's esophagus or abnormal pH). B. Off therapy testing may be considered in those with low probability of baseline reflux with the goal of identifying moderate to severe reflux at baseline. Best Practice Advice 7: Lack of response to aggressive acid suppressive therapy combined with normal pH testing off therapy or impedance-pH testing on therapy significantly reduces the likelihood that reflux is a contributing etiology in presenting extraesophageal symptoms. Best Practice Advice 8: Surgical fundoplication is discouraged in those with extra esophageal reflux symptoms unresponsive to aggressive PPI therapy. Best Practice Advice 9: Fundoplication should only be considered in those with a mechanical defect (e.g., hiatal hernia), moderate to severe reflux at baseline off PPI therapy who have continued reflux despite PPI therapy and have failed more conservative non-GI treatments.

Sa1165 - Qualitative Evaluation of the Composition of Refluxate by 24-Hour Multichannel Esophageal Intraluminal Impedance and pH-Monitoring and its Relationship to Extraesophageal Reflux Disease

We presented a study focused on qualitative evaluation of the composition of refluxate and its relationship with extraesophageal symptoms. Gastroesophageal reflux disease (GERD) is a disease caused by backflow of gastric contents into the esophagus due to the failure of physiological antireflux mechanisms and can lead to esophageal and extraesophageal symptomatology. Extraesophageal reflux (EER) is a condition where refluxate penetrate above the upper esophageal sphincter (UES) in to the oral cavity, pharynx, upper and lower respiratory tract and leads to pathological changes. The examinations in our study were carried out using 24-hour multichannel intraluminal impedance and pH esophageal monitoring (MII-pH), which compared to the more commonly used conventional pH-monitoring can accurately detect reflux episodes at all pH levels and divide the episodes to acid reflux, weakly acidic reflux and nonacid reflux, and also provides information of the composition of refluxate (liquid, gas and mixture). We evaluated results of the examinations from 200 patients in two groups. The first group included 100 patients with classic GERD and in the second group were 100 patients with EER symptoms. We evaluated DeMeester score, the number of reflux episodes by pH, simultaneously the state of matter and the rate of penetration in the UES area. Patients with EER symptoms have more weakly acid reflux episodes and fewer acid reflux episodes compared to a group of patients with classical GERD symptoms while we found minor differences in the frequency of individual components of refluxate. In the group with EER we also observed lower values of DeMeester score, a higher number of gaseous reflux episodes and generally significantly higher number of penetration of refluxate of all states of matter to the UES area.

Relationship between functionalendoscopyand impedance-pHmeasurement.

Classic gastroenterological diagnostic tools have proven to be insufficient in identifying the causal relationship between extra-esophageal symptoms and presumed pathological reflux activity. Some new methodological approaches, such as functional endoscopy (video panendoscopy, VPE), are considered to be helpful. However, there are currently no data objectively verifying the success of this method. In aprevious study, we found agood correlation between the reflux symptom index (RSI) according to Belafsky and endoscopic findings. Impedance-pH measurement is considered to be the gold standard in esophageal reflux disease diagnostics. Therefore, the relationship between endoscopic findings and the results of impedance-pH monitoring is now studied in patients with extra-esophageal reflux symptoms. The pathological findings of the VPE correlate with impedance-pH measurements regarding the parameters "number of reflux episodes," "fraction time," and "DeMeester score."

Relationship between functional endoscopy and impedance-pH measurement. German version

Classic gastroenterological diagnostic tools are proving increasingly insufficient for analyzing the complex causal relationship between extra-esophageal symptoms and presumed pathological reflux activity. Some new methodological approaches, such as functional endoscopy (videopanendoscopy, VPE), are considered to be helpful. However, there are currently no data objectively verifying the usefulness of this method. In apilot study, agood correlation between the reflux symptom index (RSI) and endoscopic findings was shown. Impedance-pH measurement is considered to be the "gold standard" in esophageal reflux disease diagnostics. Therefore, the relationship between endoscopic findings and the results of impedance-pH monitoring are now studied in patients with extra-esophageal reflux symptoms. The investigation demonstrates that the pathological findings of VPE correlate well with impedance-pH measurements in terms of the parameters "number of reflux episodes", "fraction time", and "DeMeester score".

Association Between Response to Acid-Suppression Therapy and Efficacy of Antireflux Surgery in Patients With Extraesophageal Reflux.

The effectiveness of antireflux surgery (ARS) varies among patients with extraesophageal manifestations of gastroesophageal reflux disease (GERD). By studying a cohort of patients with primary extraesophageal symptoms and abnormal physiologic markers for GERD, we aimed to identify factors associated with positive outcomes from surgery, and compare outcomes to those with typical esophageal manifestations of GERD. We performed a retrospective cohort study to compare adult patients with extraesophageal and typical reflux symptoms who underwent de novo ARS from 2004 through 2012 at a tertiary care center. All 115 patients (79 with typical GERD and 36 with extraesophageal manifestations of GERD) had evidence of abnormal distal esophageal acid exposure based on pH testing or endoscopy. The principle outcome was time to primary symptom recurrence after surgery, based on patient reports of partial or total recurrence of symptoms at follow-up visits. Patients were followed up for a median duration of 66 months (interquartile range, 52-77 mo). The median time to recurrence of symptoms in the overall cohort was 68 months (11.5 months in the extraesophageal cohort vs >132 months in the typical cohort). Symptom recurrence after ARS was associated with having primarily extraesophageal symptoms (adjusted hazard ratio, 2.34; 95% confidence interval, 1.31-4.17) and poor preoperative symptom response to acid-suppression therapy (AST) (hazard ratio, 3.85; 95% confidence interval, 2.05-7.22). Patients with primary extraesophageal symptoms who had a full or partial preoperative AST response experienced lower rates of symptom recurrence compared to patients with poor AST response (P < .01). The rate of symptom recurrence was lowest among patients with primary typical reflux symptoms who had a partial or full symptom response to AST (P < .01). The severity of acid reflux on pH testing, symptom indices, severity of esophagitis, and hiatal hernia size were not associated with symptom response. In a retrospective study, we found the effectiveness of ARS to be less predictable in patients with extraesophageal symptoms of GERD than in patients with typical GERD. Response to AST before surgery was associated with ARS effectiveness in patients with extraesophageal reflux symptoms. Caution should be exercised when advocating ARS for patients with extraesophageal symptoms that do not respond to AST.

Esophageal Mucosal Impedance Pattern is Distinct in Patients With Extraesophageal Reflux Symptoms and Pathologic Acid Reflux

Current diagnostic tests for gastroesophageal reflux disease (GERD) do not consistently measure chronicity of reflux. Mucosal impedance (MI) is a minimally invasive measurement to assess esophageal conductivity changes due to GERD. We aimed to investigate MI pattern in patients with symptoms of extraesophageal reflux (EER) in a prospective longitudinal cohort study. Patients with potential symptoms of EER undergoing esophagogastroduodenoscopy (EGD) with wireless pH monitoring were studied. Participants included those with erosive esophagitis (E+), normal EGD/abnormal pH (E-/pH+), and normal EGD/normal pH (E-/pH-). MI was measured from the site of injury in patients with E+, as well as at 2, 5, and 10 cm above the squamocolumnar junction (SCJ) in all participants. Forty-one patients with symptoms of EER were studied. MI measurements at 2 cm above the SCJ were significantly (P = 0.04) different among the three groups, with MI lowest for E+ and greatest for E-/pH- patients. Although not statistically significant, there is a graded increase in median (interquartile range) MI axially along the esophagus at 5 cm (P = 0.20) and at 10 cm (P = 0.27) above the SCJ, with those with reflux (E+ and E-/pH+) having a lower MI than those without. Patients with symptoms of EER and evidence of acid reflux have an MI lower than those without at 2 cm above the SCJ, with a trend at 5 cm and 10 cm as well. MI may be a tool to assess presence of GERD in patients presenting with EER symptoms.

Gastroesophageal and extraesophageal reflux symptoms: similarities and differences.

The association between extraesophageal reflux (EER) and symptoms of gastroesophageal reflux disease (GERD) is inadequately understood. We used the Comprehensive Reflux Symptom Scale (CReSS) to evaluate EER and reflux-symptom prevalence in gastroenterology and otolaryngology outpatients and symptom awareness among UK gastroenterologists. Cross-sectional cohort survey. Six hundred thirty-nine participants were surveyed: 103 controls, 359 patients undergoing esophagogastroduodenoscopy (EGD), and 177 otolaryngology clinic patients with throat symptoms. Participants completed the CReSS questionnaire. The study was undertaken in the Endoscopy Unit and the Department of Otolaryngology-Head and Neck Surgery, Newcastle upon Tyne Hospitals, Newcastle-upon-Tyne, United Kingdom. Registered members of the British Gastroenterology Society were asked to rate how frequently reflux patients might complain of each CReSS item. The median CReSS total in volunteers (4) was significantly lower (P < .002) than in ear, nose, and throat (ENT) patients (26) or EGD patients with (42) or without (32) esophageal inflammation. All items were scored as ≥1 by >15% of ENT patients and 28% of EGD patients. Three major, robust CReSS factors: esophageal, pharyngeal, and upper airway emerged. Of 259 gastroenterologists, >20% scored 8 of the 34 symptoms as never being reported by reflux patients. Endorsement of each EER CReSS item by 28% to 58% of patients with endoscopic evidence of GERD supports the Montreal consensus on an EER-GERD continuum. Gastroenterologists vary considerably in their appreciation of EER symptom relevance. The advantages of CReSS include standardized, comprehensive capture of patient experience; discriminant validity of ENT and GERD patients from volunteers; and discrete esophageal, pharyngeal, and upper airway subscales. 4.

Fixed Dose Combination of Magaldrate Plus Domperidone Is More Effective than Domperidone Alone in the Treatment of Patients with Gastroesophageal Reflux Symptoms: A Randomized Double-Blind Study

Gastroeophageal reflux is a condition in which the acidified liquid content of the stomach backs up into the esophagus. The antiacid magaldrate and prokinetic domperidone are two drugs clinically used for the treatment of gastroesophageal reflux symptoms. However, the evidence of a superior effectiveness of this combination in comparison with individual drugs is lacking. A double-blind, randomized and comparative clinical trial study was designed to characterize the efficacy and safety of a fixed dose combination of magaldrate (800 mg)/domperidone (10 mg) against domperidone alone (10 mg), in patients with gastroesophageal reflux symptoms. One hundred patients with gastroesophageal reflux diagnosed by Carlsson scale were randomized to receive a chewable tablet of a fixed dose of magaldrate/domperidone combination or domperidone alone four times each day during a month. Magaldrate/domperidone combination showed a superior efficacy to decrease global esophageal (pyrosis, regurgitation, dysphagia, hiccup, gastroparesis, sialorrhea, globus pharyngeus and nausea) and extraesophageal (chronic cough, hoarseness, asthmatiform syndrome, laryngitis, pharyngitis, halitosis and chest pain) reflux symptoms than domperidone alone. In addition, magaldrate/domperidone combination improved in a statistically manner the quality of life of patients with gastroesophageal reflux respect to monotherapy, and more patients perceived the combination as a better treatment. Both treatments were well tolerated. Data suggest that oral magaldrate/domperidone mixture could be a better option in the treatment of gastroesophageal reflux symptoms than only domperidone.

Extra‐esophageal Reflux, NOSE score, and sleep quality in an adult clinic population

Gastroesophageal reflux disease and heartburn negatively impact sleep; the impact of extraesophageal reflux (EER) symptoms on sleep is unknown. This study's goal was to evaluate the association of EER and measures of nasal obstruction, mood, insomnia, hypersomnia, and obstructive sleep apnea (OSA) risk. Cross-sectional study. Tertiary care hospital. A prospective cohort of adult patients was evaluated using validated questionnaires for insomnia (PSQI), hypersomnia (ESS), OSA risk (STOP-Bang), sleep quality of life (FOSQ-10), EER reflux symptoms (RSI), nasal symptoms (NOSE), and measures of mood (HADA). Pharyngeal saliva samples underwent Western blot immunoassay for pepsin. Ninety-three adults (mean age 50.2 ± 15.2 years, 43% female) were evaluated. Reflux Symptom Index (RSI) was elevated in 32% of patients and significant heartburn symptoms were reported in only 12% of patients. Prevalence of pepsin (+) was 27%. Both RSI and NOSE were significantly associated with sleep measures related to insomnia (r = 0.48 and r = 0.50; P < 0.001, respectively), Quality of Life (QOL) (r = 0.30 and r = 0.34; P < 0.001, respectively), and hypersomnolance (r = 0.18 and P < 0.04; r = 0.29 and P < 0.01, respectively), but not apnea risk (all P < 0.05). Nasal symptoms and mood were associated with all non-OSA sleep metrics (r = 0.24). In multivariate analysis, both NOSE and RSI remained significantly associated with sleep measures. Insomnia, hypersomnia, and sleep QOL are associated with measures of EER, nasal symptoms, and mood but not OSA risk, supporting that disrupted sleep may be associated with EER and nasal symptoms independent of sleep apnea.

The role of impedance monitoring in patients with extraesophageal symptoms

Ambulatory esophageal impedance monitoring is commonly employed to assess for nonacid reflux in patients with extraesophageal reflux. We aimed to determine if on therapy impedance data can be predicted from off therapy upper endoscopy, manometry, or pH parameters. Prospective Cohort Study. Patients with extraesophageal reflux symptoms and either partial- or nonresponders to twice-daily PPI underwent impedance monitoring on twice-daily PPI, as well as manometry, upper endoscopy, and 48-hour wireless pH monitoring off acid-suppressive medications for 1 week. Percent time pH < 4 and number of reflux episodes were obtained. Multivariable linear regression was used to determine association between the impedance data on therapy and upper endoscopy, manometry, and pH parameters measured off therapy. Seventy-five patients (77% female, median BMI 29, 38% with hiatal hernia, and 19% with esophagitis) were studied both on and off therapy. Thirty-five percent had abnormal impedance monitoring on therapy and 84% had abnormal pH testing off therapy. There was no significant (P = 0.184) overall correlation between total number of impedance events and the baseline physiologic parameters of hiatal hernia, degree of acid reflux, or manometric findings, with only weak correlation (r = 0.54, P = 0.045) with % time pH < 4 among patients with esophagitis. In patients with suspected extraesophageal reflux refractory to PPI therapy, impedance measures on therapy cannot be predicted from traditional baseline esophageal physiologic parameters. We recommend caution regarding over-interpretation of impedance data. 2b.

Pharyngeal pH monitoring better predicts a successful outcome for extraesophageal reflux symptoms after antireflux surgery

Gastroesophageal reflux disease can be associated with extraesophageal symptoms (hoarseness, cough, asthma, and globus). However, these symptoms may have a multifactorial etiology. Proximal pH monitoring has been proposed as a means of identifying patients where reflux is the cause of the extraesophageal symptoms. The aim of this study was to determine whether proximal esophageal or pharyngeal pH monitoring better identified patients with extraesophageal symptoms that improved after antireflux surgery. A retrospective chart review was performed to identify all patients who had esophageal and pharyngeal pH monitoring before an antireflux operation. A composite score was used to define an abnormal result with each test. A successful outcome was defined as improvement or resolution of extraesophageal symptoms. There were 20 patients identified. Antireflux surgery led to a successful outcome in 14 patients (70 %). Restech better identified patients with extraesophageal symptoms who had a successful outcome with antireflux surgery (12 of 14 [86 %] based on abnormal Restech versus 5 of 10 [50 %] based on abnormal proximal probe, p = 0.06). Comparing only the 15 patients who had both proximal esophageal and pharyngeal pH monitoring, Restech again better identified those who had a successful outcome with antireflux surgery (9 of 10 [90 %] based on abnormal Restech versus 5 of 10 [50 %] based on abnormal proximal probe, p = 0.05). The positive and negative predictive values for symptomatic improvement after a fundoplication were better for an abnormal Restech score than for an abnormal proximal esophageal score (80 vs. 71 % and 60 vs. 38 %, respectively). In two patients with a successful outcome, Restech was the only positive test. In patients with extraesophageal reflux symptoms, proximal esophageal pH monitoring failed to identify half of the patients who had a successful outcome after antireflux surgery. In contrast, an abnormal Restech pH test was present in 90 % of patients with a successful outcome. Further, a negative Restech study more reliably indicated the absence of reflux-induced extraesophageal symptoms. Our results indicate that Restech pharyngeal pH monitoring should be utilized in the evaluation of patients with extraesophageal symptoms that may be associated with reflux disease.