Therapy For Gastroesophageal Reflux Disease Research Articles

Patient or Physician - Who Is Able to Evaluate Gastroesophageal Reflux Disease Symptoms Better?

Patient or Physician - Who Is Able to Evaluate Gastroesophageal Reflux Disease Symptoms Better?

Quels sont les caractéristiques distinctives entre les patients ayant un RGO fréquent et les reflueurs occasionnels ?

Background The aim of this study was to determine the prevalence and clinical spectrum of gastroesophageal reflux disease (GERD) in Tunisia and to compare the characteristics and disease management of subjects complaining of at least weekly and less frequent gastroesophageal reflux symptoms. Methods Five hundred subjects living in Tunisia were interviewed face to face. The questionnaire consisted of 30 questions relating to subject attributes, lifestyle factors, medical history, reflux-related symptom characteristics, consultation behavior, previous treatments for GERD and description of the last episode. Results The mean age was 42.3 ± 17.3 years and 75.6% were females. Sixty percent of the responders reported at least one GERD symptom. The prevalence of frequent GERD was 24%. Only 22.3% had sought medical advice about GERD symptoms in the last year. Of those who had consulted, 75% of individuals waited over 6 months before consulting a physician. Compared with subjects with occasional gastroesophageal reflux symptoms, those with frequent symptoms suffered from more severe symptoms, (OR: 3.5; CI 95%: 1.9–6.4), had more often sought medical advice (OR: 2.9 CI 95%: 1.6–5.2) and had more often used a drug therapy for GERD (OR: 2.2; CI 95%:1.3–3.8). In the multivariate analysis, work status, frequency and intensity of symptoms, duration of symptoms and association of atypical symptoms were associated with a higher frequency of medical consultation for GERD symptoms. Conclusion GERD symptoms are common in the Tunisian population. The population with frequent GERD exhibits more severe symptoms and greater healthcare use.

Comparative Evaluation Of Efficiency Of Proton Pomp Inhibitors Of The First And Second Generations In Treating Gastroesophageal Reflux Disease

Comparative assessment of clinical efficiency of omeprazole and rabeprazole in treating gastroesophageal reflux disease (GERD). 65 patients with a verified diagnosis GERD were examined. Comparative clinical investigations of using ofomeprazole and rabeprazole have revealed effectiveness of both drugs in the therapy of GERD. However, rabeprazoleshowed antisecretory action in the earlier periods, providing stable clinical remission of GERD and early scarring of erosivelesions of the esophageal mucosa, compared with omeprazole

Medical or Surgical Therapy for Gastroesophageal Reflux Disease?

Galmiche J-P, Hatlebakk J, Attwood S, et al. (Department of Gastroenterology and Hepatology, Nantes University, CIC INSERM, Nantes, France). Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial. JAMA 2011;305:1969–1977.

Modern Treatment for Gastroesophageal Reflux Disease

Context: Gastroesophageal reflux disease (GERD) is a chronic, relapsing disease with symptoms that have negative effects on daily life. Two treatment options are long-term medication or surgery. Objective: To evaluate optimized esomeprazole therapy vs standardized laparoscopic antireflux surgery (LARS) in patients with GERD. Design, Setting, and Participants: The LOTUS trial, a 5-year exploratory randomized, open, parallel-group trial conducted in academic hospitals in 11 European countries between October 2001 and April 2009 among 554 patients with well-established chronic GERD who initially responded to acid suppression. A total of 372 patients (esomeprazole, n = 192; LARS, n = 180) completed 5-year follow-up. Interventions: Two hundred sixty-six patients were randomly assigned to receive esomeprazole, 20 to 40 mg/d, allowing for dose adjustments; 288 were randomly assigned to undergo LARS, of whom 248 actually underwent the operation. Main Outcome Measure: Time to treatment failure (for LARS, defined as need for acid suppressive therapy; for esomeprazole, inadequate symptom control after dose adjustment), expressed as estimated remission rates and analyzed using the Kaplan-Meier method. Results: Estimated remission rates at 5 years were 92% (95% confidence interval [CI], 89%-96%) in the esomeprazole group and 85% (95% CI, 81%-90%) in the LARS group (log-rank P = .048). The difference between groups was no longer statistically significant following best-case scenario modeling of the effects of study dropout. The prevalence and severity of symptoms at 5 years in the esomeprazole and LARS groups, respectively, were 16% and 8% for heartburn (P = .14), 13% and 2% for acid regurgitation (P Conclusion: This multicenter clinical trial demonstrated that with contemporary antireflux therapy for GERD, either by drug-induced acid suppression with esomeprazole or by LARS, most patients achieve and remain in remission at 5 years. Trial Registration: clinicaltrials.gov Identifier: NCT00251927

Laparoscopic Antireflux Surgery vs Esomeprazole Treatment for Chronic GERD

Gastroesophageal reflux disease (GERD) is a chronic, relapsing disease with symptoms that have negative effects on daily life. Two treatment options are long-term medication or surgery. To evaluate optimized esomeprazole therapy vs standardized laparoscopic antireflux surgery (LARS) in patients with GERD. The LOTUS trial, a 5-year exploratory randomized, open, parallel-group trial conducted in academic hospitals in 11 European countries between October 2001 and April 2009 among 554 patients with well-established chronic GERD who initially responded to acid suppression. A total of 372 patients (esomeprazole, n = 192; LARS, n = 180) completed 5-year follow-up. Interventions Two hundred sixty-six patients were randomly assigned to receive esomeprazole, 20 to 40 mg/d, allowing for dose adjustments; 288 were randomly assigned to undergo LARS, of whom 248 actually underwent the operation. Time to treatment failure (for LARS, defined as need for acid suppressive therapy; for esomeprazole, inadequate symptom control after dose adjustment), expressed as estimated remission rates and analyzed using the Kaplan-Meier method. Estimated remission rates at 5 years were 92% (95% confidence interval [CI], 89%-96%) in the esomeprazole group and 85% (95% CI, 81%-90%) in the LARS group (log-rank P = .048). The difference between groups was no longer statistically significant following best-case scenario modeling of the effects of study dropout. The prevalence and severity of symptoms at 5 years in the esomeprazole and LARS groups, respectively, were 16% and 8% for heartburn (P = .14), 13% and 2% for acid regurgitation (P < .001), 5% and 11% for dysphagia (P < .001), 28% and 40% for bloating (P < .001), and 40% and 57% for flatulence (P < .001). Mortality during the study was low (4 deaths in the esomeprazole group and 1 death in the LARS group) and not attributed to treatment, and the percentages of patients reporting serious adverse events were similar in the esomeprazole group (24.1%) and in the LARS group (28.6%). This multicenter clinical trial demonstrated that with contemporary antireflux therapy for GERD, either by drug-induced acid suppression with esomeprazole or by LARS, most patients achieve and remain in remission at 5 years. clinicaltrials.gov Identifier: NCT00251927.

Response of Regurgitation to Proton Pump Inhibitor Therapy in Clinical Trials of Gastroesophageal Reflux Disease

The typical symptoms of gastroesophageal reflux disease (GERD) are heartburn and regurgitation. Extensive analysis has characterized heartburn and its responsiveness to proton pump inhibitor (PPI) therapy, but regurgitation has received relatively little attention. This study aimed to evaluate the response of regurgitation to PPI therapy in GERD trials. Studies were identified by systematic searches in PubMed and Embase, as well as searching congress abstracts and the reference lists of Cochrane reviews. Regurgitation was not an entry criterion or the primary end point in any of the 31 clinical trials reporting the response of regurgitation to PPI treatment in GERD. The definitions of regurgitation and responsiveness varied among trials and over half used investigator assessment of response. Owing to these inconsistencies, no meta-analysis was attempted. In seven placebo-controlled trials of PPI therapy, the therapeutic gain for regurgitation response averaged 17% relative to placebo and was >20% less than that observed for heartburn. Studies comparing PPIs with histamine-2 receptor antagonists or prokinetics found the comparator drug response similar to the placebo response rates seen in the placebo-controlled trials. The therapeutic gain with PPIs over placebo or comparator agents for the relief of regurgitation is modest, and considerably lower than for heartburn. Thus, regurgitation is likely to be an important factor for determining incomplete response to PPI treatment in GERD. Future trials would benefit from using regurgitation as a primary end point, applying an unambiguous definition of the symptom and of a positive treatment response, and using a validated patient-reported instrument for regurgitation assessment.

Balancing the Risks and Benefits of Proton Pump Inhibitors

Balancing the Risks and Benefits of Proton Pump Inhibitors

Arbaclofen Placarbil in GERD: A Randomized, Double-Blind, Placebo-Controlled Study

It has been shown that arbaclofen placarbil (AP) inhibits reflux in gastroesophageal reflux disease (GERD) following single oral dosing. This study evaluated the efficacy and safety of AP over 4 weeks in subjects with symptomatic GERD. One hundred fifty-six subjects with heartburn and/or regurgitation ≥3 days/week and either no history of taking proton pump inhibitors (PPIs naive, n=58) or at least partial symptom response to PPI therapy (PPI responsive, n=98) were enrolled in this randomized, double-blind, placebo-controlled trial. All GERD therapies including PPIs were discontinued 2 weeks before randomization to AP 20, 40, or 60 mg daily, 30 mg twice daily, or placebo for 4 weeks. Randomization was stratified by prior PPI use. In the primary analysis, change from baseline in weekly heartburn events between AP and placebo for the entire study group was not statistically significant. However, a significant interaction was observed between prior PPI use and response to AP treatment. In pre-planned secondary analyses of the PPI-responsive subgroup, percent reductions from baseline in weekly heartburn events were greater for each AP dose vs. placebo (P<0.05) and the percentage of subjects who reported complete resolution of heartburn during week 4 was higher in each AP treatment group (21, 28, 30, and 50% for AP 20, 40, 60 mg daily, and 30 mg twice daily, respectively) compared with placebo (6%) (P<0.05 for 30 mg twice daily). Corresponding analyses of the PPI-naive subgroup showed no significant differences. AP was well tolerated; withdrawals due to adverse events were infrequent. AP was not superior to placebo in reducing the number of weekly heartburn events over 4 weeks in the primary analysis of the entire study population. Exploratory subgroup analyses suggest that response to PPI treatment before the study was associated with a response to AP treatment.

Prospective evaluation of the relationship between acute exacerbations of COPD and gastroesophageal reflux disease diagnosed by questionnaire

Little is known about the relationship between acute exacerbations of COPD (AECOPD) and gastroesophageal reflux disease (GERD). The aim of this study was to investigate the effects on AECOPD of GERD diagnosed by a questionnaire. The subjects were 221 consecutive patients with stable COPD who were evaluated using the Frequency Scale for Symptoms of GERD (FSSG) and a prospective survey of AECOPD for one year. Patients taking drugs for acid suppression were excluded. The association between the frequency of AECOPD and the presence of GERD or FSSG score was examined. Based on the FSSG, the prevalence of GERD was 26.7%. AECOPD and hospitalization due to AECOPD were significantly more frequent in patients with GERD than in those without GERD, with crude relative risks of 3.42 and 3.66, respectively. Multivariate analyses showed that GERD and COPD stage IV were significant predictors of hospitalization due to AECOPD, independent of respiratory therapies or patient characteristics. The severity of GERD symptoms, as measured by the FSSG score, was significantly correlated with the frequencies of AECOPD and hospitalization due to AECOPD. Similar correlations were seen for the FSSG subscores for acid reflux and gastric dysmotility. This prospective cohort study showed that GERD appears to be a predictive factor for hospitalization due to AECOPD and that severer GERD symptoms may be associated with more frequent AECOPD. Thus, further studies are warranted to evaluate the preventive effect of the therapy for GERD on AECOPD.

Perspectives on gastroesophageal reflux disease in primary care: the REFLEX study of patient-physician agreement

BackgroundPhysicians may be unaware of the severity and extent of gastroesophageal reflux disease (GERD) in their patients. The aim of this study was to evaluate patient-physician agreement concerning proton pump inhibitor (PPI) treatment.Methods1818 French primary-care physicians and 5174 adult patients with GERD who were taking PPIs answered questions regarding symptoms and treatment satisfaction. Patient-physician agreement was scored using the Kappa (κ) method.ResultsThere was moderate patient-physician agreement for PPI treatment satisfaction (κ = 0.60), PPI prescription adherence (κ = 0.57) and use of over-the-counter gastrointestinal medications (κ = 0.44-0.51). Patient satisfaction with PPI therapy and PPI treatment adherence rates were both ~90%. There was poor patient-physician agreement concerning PPI therapy expectations (κ = 0.22-0.33). Residual reflux symptoms occurred in 61% of patients. Physicians underestimated residual symptom severity compared with their patients (κ = 0.43-0.47), though there was good agreement regarding the presence (κ = 0.62-0.78) and frequency (κ = 0.61-0.66) of these symptoms and their effect on patients' daily life (κ = 0.64).ConclusionsPatient-physician agreement regarding PPI therapy for GERD was moderate or good for the presence of residual symptoms and moderate for treatment satisfaction, but poor for treatment expectations. PPI treatment resulted in high satisfaction rates, but residual symptoms were fairly common and their severity was underestimated by physicians.

A review of clinical practice guidelines for reflux disease: Toward creating a clinical protocol for the otolaryngologist

Reflux disease, including gastroesophageal reflux disease (GERD) and laryngopharyngeal reflux (LPR), is an extremely common condition that is diagnosed and treated routinely in an otolaryngology practice. There is great variability in the methods of both diagnosis and treatment amongst otolaryngologists. Our aim is to review current clinical practice guidelines on reflux disease, to identify areas of agreement and controversy, and to begin to work toward a clinical protocol for reflux disease for the otolaryngologist. Literature review with discussion. A PubMed search was performed looking for clinical practice guidelines on either GERD or LPR. Five hundred seventy articles were identified and the most clinically relevant practice guidelines were selected. Thirteen key articles were identified. Eleven of these come from the gastroenterology literature, and none of them come from the otolaryngology literature. There appears to be a consensus on empiric medication trial as first-line therapy for presumed uncomplicated GERD and on prioritizing early identification of patients with severe disease complications. Areas of controversy include the definition of GERD and LPR, which diagnostic algorithm to use in which patient, and the long-term management of medical therapy. Although there are many clinical aspects of reflux disease that still remain a mystery, there is enough literature to support a rudimentary clinical protocol at this time. As further data become available from outcomes measurements, such a protocol may result in improved quality and standardization.

Gastro-Esophageal Reflux and Chronic Cough

Gastro-esophageal reflux disease (GERD) is a highly prevalent disorder which has been implicated in the pathophysiology of chronic cough. However there is much uncertainty as to the precise clinical association between the two. Despite this clinicians frequently consider GERD as an important aggravating factor and often consider trials of antireflux therapy without much evidence base. In this article we aim to summarise the existing literature on definition, epidemiology and clinical presentation of GERD and cough, highlighting current thinking on the pathophysiological and mechanistic association between gut and lung and its relevance to GERD associated cough. In addition we aim to discuss current approaches to the evaluation of patients with suspected reflux cough and how ‘state of the art’ and emerging technologies can more accurately identify such patients and in particular those most likely to benefit from treatment. Finally we provide a review of a number of trials of medical and surgical therapy in GERD associated cough and debate on some of the pertinent issues surrounding efficacy and safety of such treatment. Keywords: Gastro-esophageal reflux, cough, pathophysiology, antireflux therapy, epidemiology, extraesophageal syndromes, laryngopharyngeal reflux (LPR), laparoscopic techniques, acid regurgitation, proton pump inhibitors, halitosis, dental erosions, chronic hoarseness, supraesophageal, lower esophageal sphincter, Transient Lower Esophageal Sphincter Relaxations, body mass index (BMI), upper esophageal sphincter (UES), lignocaine, ipatropium bromide (anti-cholinergic), tachykinins, tracheal mucociliary transport, Microaspiration, macroaspiration, prokinetic agents, hiatus hernia, multichannel intraluminal impedance, video-fluoroscopy, impedance-pH catheter, antimony pH sensors, symptom sensitivity index (SSI), Symptom Association Probability (SAP), Omeprazole, metoclopramide, cisapride, domperidone, Baclofen, autonomic neuropathy, Arbaclofen placarbil, achlorhydria, pneumonia, clostridium difficile infection (CDI), cystic fibrosis

Proton Pump Inhibitors in Pediatrics: Evaluation of Efficacy in GERD Therapy

Gastroesophageal reflux (GER) is defined as the passage of gastric contents into the esophagus. It occurs in healthy infants and can be considered physiological process. Uncomplicated GER can present with recurrent vomiting or regurgitation without any other symptoms and is usually managed by educating, reassuring, and guiding the parent without other intervention. GER disease (GERD) refers to the appearance of troublesome symptoms or complications (erosive esophagitis, ulceration, Barrett's esophagus) and may warrant acid suppression. Proton Pump Inhibitors (PPIs) are the most effective pharmacologic agents available for the treatment of children with GERD. In the pediatric practice only omeprazole, lansoprazole and esomeprazole are available over the first year of life. The empiric use in infants with nonspecific symptoms (excessive crying, regurgitation, feeding refusal, chronic cough) is frequent without randomized controlled study. Our paper will focus on the correct indications, dosages, duration of treatment and safety of PPI use in pediatric population.

A Review of the Diagnosis and Management of Reflux Disease: Toward Creating a Clinical Protocol for the Otolaryngologist

Objectives: Reflux disease, including gastroesophageal reflux disease (GERD) and laryngopharyngeal reflux (LPR), is an extremely common condition which is diagnosed and treated routinely in an otolaryngology practice. There is great variability in the methods of both diagnosis and treatment amongst otolaryngologists. Our aim is to review current clinical practice guidelines on reflux disease, to identify areas of agreement and of controversy, and to begin to work toward a clinical protocol for reflux disease for the otolaryngologist. Study Design: Literature review with discussion. Methods: A PubMed search was performed looking for clinical practice guidelines on either GERD or LPR. Five hundred and seventy articles were identified and the most clinically relevant practice guidelines were selected. Results: Thirteen key articles were identified. Eleven of these come from the gastroenterology literature, and none of them come from the otolaryngology literature. There appears to be a consensus on empiric medication trial as first line therapy for presumed uncomplicated GERD and on prioritizing early identification of patients with severe disease complications. Areas of controversy include the definition of GERD and LPR, which diagnostic algorithm to use in which patient, and the long term management of medical therapy. Conclusions: While there are many clinical aspects of reflux disease that still remain a mystery, there is enough literature to support a rudimentary clinical protocol at this time. As further data become available from outcomes measurements, such a protocol may result in improved quality and standardization. A Review of the Diagnosis and Management of Reflux Disease: Toward Creating a Clinical Protocol for the Otolaryngologist

Proton pump inhibitor step-down therapy for GERD: A multi-center study in Japan

To investigate the predictors of success in step-down of proton pump inhibitor and to assess the quality of life (QOL). Patients who had heartburn twice a week or more were treated with 20 mg omeprazole (OPZ) once daily for 8 wk as an initial therapy (study 1). Patients whose heartburn decreased to once a week or less at the end of the initial therapy were enrolled in study 2 and treated with 10 mg OPZ as maintenance therapy for an additional 6 mo (study 2). QOL was investigated using the gastrointestinal symptom rating scale (GSRS) before initial therapy, after both 4 and 8 wk of initial therapy, and at 1, 2, 3, and 6 mo after starting maintenance therapy. In study 1, 108 patients were analyzed. Their characteristics were as follows; median age: 63 (range: 20-88) years, sex: 46 women and 62 men. The success rate of the initial therapy was 76%. In the patients with successful initial therapy, abdominal pain, indigestion and reflux GSRS scores were improved. In study 2, 83 patients were analyzed. Seventy of 83 patients completed the study 2 protocol. In the per-protocol analysis, 80% of 70 patients were successful for step-down. On multivariate analysis of baseline demographic data and clinical information, no previous treatment for gastroesophageal reflux disease (GERD) [odds ratio (OR) 0.255, 95% CI: 0.06-0.98] and a lower indigestion score in GSRS at the beginning of step-down therapy (OR 0.214, 95% CI: 0.06-0.73) were found to be the predictors of successful step-down therapy. The improved GSRS scores by initial therapy were maintained through the step-down therapy. OPZ was effective for most GERD patients. However, those who have had previous treatment for GERD and experience dyspepsia before step-down require particular monitoring for relapse.

Surgical therapy of gastro-oesophageal reflux disease

Surgery should always be looked upon as complementary to medical therapy in the long-term management of patients with chronic GORD. Available medical therapies are effective and adequate for the control of disease manifestations in the great majority of GORD patients. For patients who have a suboptimal disease control under medical therapy and in those who for various reasons want to discuss an alternative to medical long-term therapy, the following message can be transmitted. Anti reflux surgery is a well-documented effective long-term therapeutic alternative to control GORD. The outcome after surgery is dependent on the experience and quality of the surgeon. These operations are safe but mortality can never attain a zero level and the morbidity has to be realised. Anti reflux surgery has to be centralised within each country. With the aim of optimising the outcome of anti reflux surgery, the surgeon has to perform and master a delicate act of balance on the choice between various fundoplication procedures. On one hand we have the total fundoplication with its proved efficacy regarding reflux control but with it associated somewhat more frequent mechanical side-effects. The posterior partial fundoplication has obvious advantages with less postfundoplication complaints without compromising the level of reflux control and can therefore often be recommended. Most studies present very promising results following anterior partial fundoplications. The spectrum of postfundoplication symptoms can be minimised provided that the surgeon fully comprehend the mechanism of action of these procedures and adhere to technical perfectionism. Evaluation and management of failures after anti reflux surgery have to be centralised within each country.

The evolution of proton pump inhibitors for the treatment of gastroesophageal reflux disease

This article reviews the diagnosis and current treatment options for gastroesophageal reflux disease (GERD) available to nurse practitioners, with a focus on advances in proton pump inhibitor (PPI) therapy. Review of scientific literature and clinical management guidelines for GERD treatment and PPI therapy from the PubMed database, Google Scholar, and other World Wide Web resources. A number of safe and effective treatment options exist for GERD. Recent developments in PPI technology may begin to address unmet needs in PPI therapy. GERD is commonly diagnosed and treated by nurse practitioners in the primary care setting. Acid suppression therapy is the primary medical therapy for GERD. PPI therapy provides symptomatic relief of heartburn and regurgitation, as well as effective healing and maintenance of erosive esophagitis. Newer PPIs lengthen the duration of acid suppression and allow for more flexibility in dosing, which may improve medication adherence and decrease episodes of acid breakthrough.

Concomitant irritable bowel syndrome is associated with failure of step-down on-demand proton pump inhibitor treatment in patients with gastro-esophageal reflux disease

The predictors for treatment failure of on-demand proton pump inhibitor (PPI) therapy in gastro-esophageal reflux disease (GERD) patients are unclear. We studied the efficacy and predictors for treatment failure of step-down on-demand PPI therapy in patients with non-erosive reflux disease (NERD) and those with low grade erosive esophagitis. Consecutive symptomatic GERD patients who had positive esophageal pH studies and complete symptom resolution with initial treatment of esomeprazole were given step-down on-demand esomeprazole for 26 weeks. Patients with esophagitis of Los Angeles (LA) grade C or above and recent use of PPI were excluded. Treatment failure was defined as an inadequate relief of reflux symptoms using global symptom assessment. Potential predictors of treatment failure were determined using multivariate analysis. One hundred and sixty three NERD and 102 esophagitis patients were studied. The 26-week probability of treatment failure was 36.2% (95% CI: 23.9-46.5%) in NERD group and 20.1% (95% CI: 10.9-28.3%) in esophagitis group, respectively (P = 0.021). Irritable bowel syndrome (adjusted HR: 2.1, 95% CI: 1.5-3.8, P = 0.01), in addition to daily reflux symptom (adjusted hazard ratio: 2.7, 95% CI: 1.9-4.2, P = 0.001) and concomitant dyspepsia (adjusted hazard ratio: 1.7, 95% CI: 1.1-2.8, P = 0.04), were independent predictors for treatment failure. Compared to patients with esophagitis, NERD patients have higher failure rate of on-demand PPI therapy. Concomitant irritable bowel syndrome, in addition to daily reflux symptom and dyspepsia, is associated with the failure of on-demand PPI in these patients.

Outcome of Medical versus Surgical Therapies for Gastroesophageal Reflux Disease: Meta-analysis of Randomized Controlled Trials

Outcome of Medical versus Surgical Therapies for Gastroesophageal Reflux Disease: Meta-analysis of Randomized Controlled Trials