Management Of GERD Research Articles

New Options for the Management of GERD

Novel GERD treatment modalities have emerged over the past decade as alternatives to proton pump inhibitors or traditional laparoscopic Nissen fundoplication. Four new devices—LINX, TIF, EndoStim and Stretta—have attempted to improve upon the limitations of these traditional therapies. While each is promising, only the LINX device addresses the patient’s symptoms, achieves objective control of acid and has limited the need for additional therapies. Further comparative research and longer term follow-up are necessary to determine the role of these therapies in the algorithm of GERD management.

Commentary on “Rickenbacher et al. Fundoplication versus medical management of gastroesophageal reflux disease: systematic review and meta-analysis.” Surg Endosc. doi: 10.1007/s00464-013-3140-z

In their review article, Rickenbacher et al. [1] used a metaanalysis to show that surgical management of GERD is more effective than medical therapy in regards to shortand medium-term, patient-relevant outcomes. One of the seven trials cited by the group was the LOTUS trial [2]. In Table 5, they cite the symptoms of dysphagia, bloating, and flatulence reported in the LOTUS trial as more frequent in the medical group. However, upon review of the original source material, Galmiche et al. [2] report significantly higher rates of dysphagia, bloating, and flatulence at 5 years in the surgical group versus the medical group. No significant difference at 5 years was observed between groups for heartburn severity, epigastric pain, or diarrhea. The LOTUS trial was a major component of this metaanalysis and was interpreted incorrectly. Based on the interpretation, the group concludes that evidence is inconsistent regarding the prevalence of gastrointestinal symptoms associated with surgery. The data appear to demonstrate that such GI symptoms are actually consistently more frequent with surgical therapy. As the debate continues on the nuanced approach to the management of GERD, it is important to clarify the results of the large, randomized-control trials comparing medical and surgical therapy before conclusions are drawn.

Tu1862 Observations of Acid Reflux and Motor Function in Distal Esophagus Using Simultaneous Measurements of Intra-Esophageal pH and Pressure in 8 Directions With Novel Sensor Catheter

G A A b st ra ct s they met criteria for achalasia based on the current Chicago Classification. Of 158 patients (M:F 48:110, age 56.6±15), lower esophageal sphincter pressure (LESP), integrated relaxation pressure (IRP), distal contractile integral (DCI), contractile front velocity (CFV), intrabolus pressure, and distal latency were obtained and reviewed. The data was collected using ManoView ESO 3.0. For statistical analysis, the Spearman correlation was used to investigate the associations between the main outcomes and BMI and abdominal circumference. Results: 54/158 patients were considered obese with a BMI ≥ 30 with a maximum BMI of 67.3 kg m-2. Within the obese group, 21/54 had a hiatal hernia (HH) and 6/21 had .3cm fixed HH. Within the non-obese group, 35/105 had a HH and 14/35 had a fixed HH. Obesity and increased abdominal circumference were significantly associated with increased intragastric pressure in both supine (Spearman correlation coefficient r=0.55, p,0.001; r=0.52, p,0.001 respectively) and upright position (r=0.62, p,0.001; r=0.57, p,0.001 respectively), with upright more prominent. Obesity and increased abdominal circumference were also significantly associated with increased intrabolus pressure during both swallows in both postures (r ranged from 0.31 to 0.47, Figure). The LESP, IRP, DCI, CFV and distal latency were not significantly affected by BMI or abdominal circumference. Conclusion: The results from this study suggest an increased resistance from esophagogastric junction in patients with obesity. The increased resistance is likely a result of increased gastroesophageal pressure gradient, and may have an impact on acid clearance resulting in increased severity and incidence of GERD. This is important in the patients with ineffective peristaltic function, a common condition seen in patients with GERD. Encouraging obese patients to lose weight, specifically abdominal fat, should be a priority in the management of GERD.

A Cost Effectiveness Analysis (CEA) of Lower Esophageal Sphincter (LES) Electrical Stimulation Therapy (EST), Laparoscopic Fundoplication (LF) and Proton Pump Inhibitor (PPI) Therapy for Management of Refractory GERD

Purpose: Management of patients with refractory GERD remains unsatisfactory. Recent trials of LES-EST (EndoStim® LES Stimulator, EndoStim BV, Netherlands) has been encouraging (Am J Gastro 2011; 106: S6). LES-EST offers a minimally invasive, safe and effective treatment for GERD. We performed a CEA of LES-EST for the long-term management of refractory GERD. Methods: In a third-party-payer perspective Markov decision analysis model, in a cohort of refractory GERD patients (incomplete symptom response on bid PPI) 3 mutually exclusive, competing strategies were examined. Strategy I, patients followed on bid PPI, no additional intervention; Strategy II and III the patients were managed with LF or LES-EST, respectively. Discounted cost and utility values for long-term PPI therapy and LF were obtained from published information; for LES-EST, data were obtained from the results of the recent trials and when definite data (such as durability of response) was not available, uncertainty analyses were incorporated using second order Monte Carlo and threshold analyses. Incremental Cost-Effectiveness Ratio (ICER) of different strategies was the main outcome measure, the model time horizon was 10 years given that published information on outcomes of LF is limited to 10 years and the minimum battery life of the stimulator is 10 years. The model was biased against LES-EST by incorporating the most favorable reported rates of primary success, complication and durability of LF. Results: In the baseline analysis, LES-EST (strategy III) dominated LF (strategy II), while ICER of bid PPI (strategy I) was > $90K per QALY (Table). Compared to LF, odds ratio of being completely off PPI with LES-EST was 5.8 (95% CI, 5.4-6.2). Threshold analyses showed cost of PPI and EndoStim® LES stimulator, and % patients in the cohort with incomplete control of GERD symptoms on PPI are the critical determinants of CEA of LES-EST.Table: Cost effectiveness analysisConclusion: LES-EST for management of refractory GERD is dominant strategy (less costly and more effective) compared to LF and is the preferred strategy compared to PPI in long-term cost-effectiveness. Longer-term clinical data on LES-EST is needed to conclusively establish its effectiveness for the treatment of refractory GERD.Figure: [1511] Sensitivity analysis (2-way) comparing cost of LES-EST with cost of LF with star showing coordinates of baseline estimates.Disclosure: A. Das - Grant/Research Support. L. Rodriguez - Grant/Research Support. P. Siersema - Grant/Research Support. This research was supported by an industry grant from EndoStim, BV, The Hague, Netherland.

Rectus Abdominus Fascial Sheath Usage for Crural Reinforcement During Surgical Management of GERD

Many materials are currently being used to reinforce the crural repair. Perforation, intensive fibrosis, and price are limiting the usage of these materials. Our purpose was to seek an alternative, cheap, always available, and inert material to use for cruroplasty reinforcement. Twenty-four patients participated and were randomly divided into 2 groups (graft+laparoscopic Nissen fundoplication and laparoscopic Nissen fundoplication alone) with 12 patients in each group. Total operation time, postoperative dysphagia rate, dysphagia improvement time, postoperative pain, recurrence, and incisional hernia rate were compared. There was no difference in terms of study parameters between both groups except for the mean operation time. Autograft hiatoplasty seems to be a good alternative for crural reinforcement. It provides safe reinforcement, has the same dysphagia rates as meshless hiatoplasty, and avoids potential complications of redo surgery by minimizing extensive fibrosis. Furthermore, the rectus abdominus sheath is always available and inexpensive.

Sleeve gastrectomy and crural repair in obese patients with gastroesophageal reflux disease and/or hiatal hernia

BackgroundGastroesophageal reflux disease (GERD) with or without hiatal hernia (HH) is now recognized as an obesity-related co-morbidity. Roux-en-Y gastric bypass has been proved to be the most effective bariatric procedure for the treatment of morbidly obese patients with GERD and/or HH. In contrast, the indication for laparoscopic sleeve gastrectomy (SG) in these patients is still debated. Our objective was to report our experience with 97 patients who underwent SG and HH repair (HHR). The setting was a university hospital in Italy. MethodsFrom July 2009 to December 2011, 378 patients underwent a preoperative workup for SG. In 97 patients, SG was performed with HHR. The clinical outcome was evaluated considering GERD symptom resolution or improvement, interruption of antireflux medications, and radiographic evidence of HH recurrence. ResultsBefore surgery, symptomatic GERD was present in 60 patients (15.8%), and HH was diagnosed in 42 patients (11.1%). In 55 patients (14.5%), HH was diagnosed intraoperatively. The mean follow-up was 18 months. GERD remission occurred in 44 patients (73.3%). In the remaining 16 patients, antireflux medications were diminished, with complete control of symptoms in 5 patients. No HH recurrences developed. “De novo” GERD symptoms developed in 22.9% of the patients undergoing SG alone compared with 0% of patients undergoing SG plus HHR. ConclusionSG with HHR is feasible and safe, providing good management of GERD in obese patients with reflux symptoms. Small hiatal defects could be underdiagnosed at preoperative endoscopy and/or upper gastrointestinal contrast study. Thus, a careful examination of the crura is always recommended intraoperatively.

Mo1090 Long-Term Treatment With High Dose, but Not Regular Dose of PPI is Necessary for Management of PPI-Resistant Erosive GERD

Mo1090 Long-Term Treatment With High Dose, but Not Regular Dose of PPI is Necessary for Management of PPI-Resistant Erosive GERD

Mo1092 Does the Japanese GERD Management Guideline Adapt to GERD Treatment of Gastroenterology Physicians?

Mo1092 Does the Japanese GERD Management Guideline Adapt to GERD Treatment of Gastroenterology Physicians?

Gaviscon® vs. omeprazole in symptomatic treatment of moderate gastroesophageal reflux. a direct comparative randomised trial

BackgroundMedical management of GERD mainly uses proton pump inhibitors. Alginates also have proven efficacy. The aim of this trial was to compare short-term efficacy of an alginate (Gaviscon®, 4 × 10 mL/day) and omeprazole (20 mg/day) on GERD symptoms in general practice.MethodsA 14-day multicentre randomised double-blind double-dummy non-inferiority trial compared Gaviscon® (4 × 10 mL/day) and omeprazole (20 mg/day) in patients with 2-6 day heartburn episodes weekly without alarm signals. The primary outcome was the mean time to onset of the first 24-h heartburn-free period after initial dosing. Secondary outcomes were the proportion of patients without heartburn by D7, pain relief by D7, and reduction in pain intensity by D7 and D14.Results278 patients were recruited; 120 were included in the Gaviscon® group and 121 in the omeprazole group for the per protocol non-inferiority analysis. The mean time to onset of the first 24-h heartburn-free period after initial dosing was 2.0 (± 2.2) days for Gaviscon® and 2.0 (± 2.3) days for omeprazole (p = 0.93); mean intergroup difference was 0.01 ± 1.55 days (95% CI = -0.41 to 0.43): i.e., less than the lower limit of the 95% CI of -0.5 days predetermined to demonstrate non-inferiority. The mean number of heartburn-free days by D7 was significantly greater in the omeprazole group: 3.7 ± 2.3 days vs. 3.1 ± 2.1 (p = 0.02). On D7, overall quality of pain relief was slightly in favour of omeprazole (p = 0.049). There was no significant difference in the reduction in pain intensity between groups by D7 (p = 0.11) or D14 (p = 0.08). Tolerance and safety were good and comparable in both groups.ConclusionGaviscon® was non-inferior to omeprazole in achieving a 24-h heartburn-free period in moderate episodic heartburn, and is a relevant effective alternative treatment in moderate GERD in primary care.Trial registrationISRCTN62203233.

Laparoscopic fundoplication with double sided posterior gastropexy: A different surgical technique

BackgroundLaparoscopic Nissen Fundoplication has become the gold standard surgical procedure for management of gastroesophageal reflux disease. Nissen fundoplication provides an effective barrier against reflux. The aim of this study was to evaluate early postoperative outcomes of a different surgical technique, laparoscopic fundoplication with double sided posterior gastropexy. MethodsData of 46 patients who underwent laparoscopic fundoplication with double sided posterior gastropexy between February 2010 and December 2011 were collected. Surgically, after Nissen fundoplication was completed, 2–4 sutures were passed through the uppermost parts of the posterior and anterior wall of the gastric wrap and then passed gently 1 cm above the celiac artery from the denser fibers of uppermost part of the arcuate ligament. Demographic data, preoperative and postoperative assesments of sympthomatic and functional outcomes of patients were recorded. Length of hospital stay, operative time, early postoperative complications and complications at 1 year follow up, early recurrence rate were also recorded. ResultsThis technique resulted in good symptomatic and clinical outcomes. Only one patient out of 45 patients was reoperated. The early recurrence rate was 2.2%. ConclusionLaparoscopic Nissen fundoplication with double sided posterior gastropexy may prevent paraesophageal herniation. It is a reasonably feasible and effective method in surgical management of GERD.

Nissen Fundoplication in Patients With Cystic Fibrosis and Severe GERD. Impact on Lung Disease

PURPOSE: Patients with cystic fibrosis (CF) have progressive lung disease. GER is common and can contribute to respiratory symptoms. This study was done to evaluate efficacy of surgical management of GERD (Nissen fundoplication) in patients with CF and GERD with worsening respiratory symptoms who failed medical therapy of GERD.

Nissen Fundoplication in Patients With Cystic Fibrosis. Impact on Nutrition

PURPOSE: Patients with cystic fibrosis (CF) have progressive lung disease. GER in patients with CF can contribute to respiratory symptoms and nutritional failure. This study was done to evaluate efficacy of Nissen fundoplication and Gastrostomy tube in patients with CF and GERD and with worsening respiratory symptoms who fail medical therapy of GERD. Improvement, if any, was quantified by comparing changes in weight and BMI, lung function and pulmonary disease activity within two years before and after surgical management of GERD in children and adults with CF.

GERD-related Chronic Cough

GERD-related Chronic Cough

Is laparoscopic surgery cost-effective?

A Markov model using data from a randomized, controlled trial has demonstrated that laparoscopic fundoplication is a cost-effective intervention for the management of chronic GERD. However, there are some limitations of the model, discussed below, which suggest that the results should be viewed cautiously until longer follow-up is reported.

Pro: Impedance Testing Is Useful in the Management of GERD

Pro: Impedance Testing Is Useful in the Management of GERD

Con: Impedance–pH Testing Does Not Commonly Alter Management of GERD

Con: Impedance–pH Testing Does Not Commonly Alter Management of GERD

Impact of gastroesophageal reflux disease on work absenteeism, presenteeism and productivity in daily life: a European observational study

BackgroundThe RANGE (Retrospective ANalysis of GastroEsophageal reflux disease [GERD]) study assessed differences among patients consulting a primary care physician due to GERD-related reasons in terms of: symptoms, diagnosis and management, response to treatment, and effects on productivity, costs and health-related quality of life. This subanalysis of RANGE determined the impact of GERD on productivity in work and daily life.MethodsRANGE was conducted at 134 primary care sites across six European countries (Germany, Greece, Norway, Spain, Sweden and the UK). All subjects (aged ≥18 years) who consulted with their primary care physician over a 4-month identification period were screened retrospectively, and those consulting at least once for GERD-related reasons were identified (index visit). From this population, a random sample was selected to enter the study and attended a follow-up appointment, during which the impact of GERD on productivity while working (absenteeism and presenteeism) and in daily life was evaluated using the self-reported Work Productivity and Activity Impairment Questionnaire for patients with GERD (WPAI-GERD).ResultsOverall, 373,610 subjects consulted with their primary care physician over the 4-month identification period, 12,815 for GERD-related reasons (3.4%); 2678 randomly selected patients attended the follow-up appointment. Average absenteeism due to GERD was highest in Germany (3.2 hours/week) and lowest in the UK (0.4 hours/week), with an average of up to 6.7 additional hours/week lost due to presenteeism in Norway. The average monetary impact of GERD-related work absenteeism and presenteeism were substantial in all countries (from €55/week per employed patient in the UK to €273/patient in Sweden). Reductions in productivity in daily life of up to 26% were observed across the European countries.ConclusionGERD places a significant burden on primary care patients, in terms of work absenteeism and presenteeism and in daily life. The resulting costs to the local economy may be substantial. Improved management of GERD could be expected to lessen the impact of GERD on productivity and reduce costs.

Pharmacological treatment of GERD – a look beyond PPIs?

BACKGROUND: Approximately 20–30% of patients with gastro-esophageal reflux symptoms report inadequate symptom relief while on PPI therapy. Persisting acid or nonacid reflux can be demonstrated in 40–50% of them suggesting that there is room for anti-reflux therapy in these patients. Transient lower esophageal sphincter relaxations (TLESRs) are the main mechanism of all type of reflux, i.e. both acid and weakly acidic reflux episodes. Therefore, controlling the occurrence of TLESRs appears to be a relevant therapeutic objective in GERD. METHODS: Review on the pharmacological therapy of TLESRs for GERD management. RESULTS: Many compounds have been shown to decrease the number of TLESRs, but the most promising classes are GABAB agonists and mGluR5 antagonists both of which have orally formulations available for human use. The GABAB agonist baclofen, prescribed for the treatment of spasticity for many years, has been shown to decrease the number of TLESRs, esophageal acid exposure, and reflux symptoms. Considering the poor tolerability of this compound, more selective GABAB agonists are currently in development. ADX10059, a mGluR5 negative allosteric modulator, has been shown to decrease GER in both healthy subjects and GERD patients and has entered in phase IIb studies. CONCLUSIONS: Compounds that target TLESR activity represent a promising new therapeutic option for patients who suffer from GERD symptoms. These drugs will probably be developed as add-on therapy in combination with PPIs provided the tolerability and safety issues are resolved.

A pharmacist's perspective on GERD management*

A pharmacist's perspective on GERD management*

Pharmacist-specific guidelines for the medical management of GERD in adults*

Pharmacist-specific guidelines for the medical management of GERD in adults*