Knowledge gaps in the management of refractory reflux-like symptoms: Healthcare provider survey.

BACKGROUND: Refractory reflux-like symptoms have a substantial impact on patients and healthcare providers. The aim of the survey was to qualitatively assess the needs and attitudes of practicing clinicians around the management of refractory reflux symptoms and refractory gastroesophageal reflux disease (rGERD). METHODS: An International Working Group for the Classification of Oesophagitis (IWGCO) steering committee invited clinicians to complete an online survey including 17 questions. KEY RESULTS: Of the 113 clinicians who completed the survey, 70% were GIs, 20% were primary care physicians, and 10% were other specialties. Functional heartburn was considered the most common reason for an incomplete response to proton pump inhibitor (PPI) therapy (82%), followed by stress/anxiety (69%). More GIs identified esophageal hypersensitivity as a cause, while more non-GIs identified esophageal dysmotility and non-reflux-related esophageal conditions. As the first step, most clinicians would order investigations (70-88%). Overall, 72% would add supplemental therapy for patients with partial response, but only 58% for those with non-response. Antacid/alginate was the most common choice overall, while non-GIs were more likely to add a prokinetic than were GIs (47.8 vs. 24.1%). Approximately 40% of clinicians would switch PPIs in patients with partial response, but only 29% would do so in non-responders. Preferences for long-term therapy were highly variable. The most common initial investigation was upper endoscopy. Choice of esophageal manometry and pH monitoring was more variable, with no clear preference for whether pH monitoring should be conducted on, or off, PPI therapy. CONCLUSIONS AND INFERENCES: The survey identified a number of challenges for clinicians, especially non-GI physicians, treating patients with refractory reflux-like symptoms or rGERD on a daily basis.

A new diagnostic paradigm for laryngopharyngeal reflux disease: correlation of impedance-pH monitoring and digital reflux scintigraphy results.

PURPOSE: No gold-standard investigation exists for laryngopharyngeal reflux (LPR). Multichannel intraluminal impedance (MII)-pH testing has uncertain utility in LPR. Meanwhile, reflux scintigraphy allows immediate and delayed visualisation of tracer reflux in the esophagus, pharynx, and lungs. The present study aimed to correlate MII-pH and scintigraphic reflux results in patients with primary LPR. METHODS: Consecutive patients with LPR underwent MII-pH and scintigraphic reflux studies. Abnormal values for MII-pH results were defined from existing literature. MII-pH and scintigraphic data were correlated. RESULTS: 105 patients with LPR [31 males (29.5%), median age 60 years (range 20-87)] were studied. Immediate scintigraphic reflux was seen in the pharynx in 94 (90.4%), and in the proximal esophagus in 94 (90.4%). Delayed scintigraphic contamination of the pharynx was seen in 101 patients (96.2%) and in the lungs of 56 patients (53.3%). For MII-pH, abnormally frequent reflux was seen in the distal esophagus in 12.4%, proximal esophagus in 25.7%, and in the pharynx in 82.9%. Patients with poor scintigraphic clearance had higher Demeester scores (p = 0.043), more proximal reflux episodes (p = 0.046), more distal acid reflux episodes (p = 0.023), and more prolonged bolus clearance times (p = 0.002). CONCLUSION: Reflux scintigraphy has a high yield in LPR patients. Scintigraphic time-activity curves correlated with validated MII-pH results. A high rate of pulmonary microaspiration was found in LPR patients. This study demonstrated a high level of pharyngeal contamination by scintigraphy and MII-pH, which supports the use of digital reflux scintigraphy in diagnosing LPR.

Untangling Nonerosive Reflux Disease From Functional Heartburn.

Heartburn is a common symptom in clinical practice, but as many as 70% of patients have normal findings from upper endoscopy. Most of these patients have nonerosive reflux disease (NERD) or functional esophageal disorders. NERD is the most common phenotype of gastroesophageal reflux disease, and functional heartburn is the most common cause for refractory heartburn. In patients with NERD, symptoms arise from gastroesophageal reflux and esophageal hypersensitivity, whereas in patients with functional heartburn, symptoms result from esophageal hypersensitivity. A diagnosis of NERD requires endoscopy and reflux testing, whereas a diagnosis of functional heartburn also requires esophageal manometry. NERD is treated most commonly with medical, endoscopic, and surgical antireflux approaches, whereas functional heartburn as well as NERD can be treated with neuromodulators, psychological intervention, and complementary medicine options.

Number of reflux episodes on pH-impedance monitoring associates with improved symptom outcome and treatment satisfaction in gastro-oesophageal reflux disease (GERD) patients with regurgitation.

OBJECTIVE: Number of reflux episodes, an adjunctive metric on pH-impedance monitoring, is incompletely studied. We aimed to determine if number of reflux episodes associates with therapeutic outcome in regurgitation predominant gastro-oesophageal reflux disease (GERD). DESIGN: We performed post hoc analysis of postintervention pH-impedance data from adult patients with moderate/severe regurgitation despite QD proton pump inhibitor (PPI), randomised to either two times a day PPI or magnetic sphincter augmentation (MSA) in 2:1 allocation. After 6 and 12 months, symptom response was defined by improvement in Foregut Symptom Questionnaire (FSQ) regurgitation score to none or minimal, ≥50% reduction in GERD health-related quality of life (HRQL) score and satisfaction with therapy. Univariate and multivariate analyses were performed to determine predictors of symptom improvement. RESULTS: Of 152 randomised patients, 123 (age 46.9±1.2 year, 43% female) had complete data. Symptom and satisfaction scores significantly improved after MSA compared with two times a day PPI. Both acid exposure time (13.4%±0.7% to 1.3±0.2%, p<0.001) and reflux episodes (86±4 to 48±4, p<0.001) declined with therapy. Reduction to <40 reflux episodes was significantly more frequent in those with symptom response by FSQ regurgitation score, GERD HRQL score and satisfaction with therapy (p≤0.03 for each); <35 episodes performed better on receiver operating characteristic analysis. On multivariate analysis, improvement in regurgitation score remained independently predictive of satisfaction with therapy (p<0.001 for each). In patients crossing over to MSA, >80 episodes pretreatment predicted improvement. CONCLUSIONS: Reduction of reflux episodes on pH-impedance to physiological levels associates with improved outcomes, while pathological levels predict improvement with MSA in regurgitation predominant GERD. TRAIL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02505945.

Effects of Diaphragmatic Breathing on the Pathophysiology and Treatment of Upright Gastroesophageal Reflux: A Randomized Controlled Trial.

INTRODUCTION: Uncontrolled results suggest that diaphragmatic breathing (DB) is effective in gastroesophageal reflux disease (GERD) but the mechanism of action and rigor of proof is lacking. This study aimed to determine the effects of DB on reflux, lower esophageal sphincter (LES), and gastric pressures in patients with upright GERD and controls. METHODS: Adult patients with pH proven upright GERD were studied. During a high-resolution impedance manometry, study patients received a standardized pH neutral refluxogenic meal followed by LES challenge maneuvers (Valsalva and abdominal hollowing) while randomized to DB or sham. After that, patients underwent 48 hours of pH-impedance monitoring, with 50% randomization to postprandial DB during the second day. RESULTS: On examining 23 patients and 10 controls, postprandial gastric pressure was found to be significantly higher in patients compared with that in controls (12 vs 7 mm Hg, P = 0.018). Valsalva maneuver produced reflux in 65.2% of patients compared with 44.4% of controls (P = 0.035). LES increased during the inspiratory portion of DB (42.2 vs 23.1 mm Hg, P < 0.001) in patients and healthy persons. Postprandial DB reduced the number of postprandial reflux events in patients (0.36 vs 2.60, P < 0.001) and healthy subjects (0.00 vs 1.75, P < 0.001) compared with observation. During 48-hour ambulatory study, DB reduced the reflux episodes on day 2 compared with observation on day 1 in both the patient and control groups (P = 0.049). In patients, comparing DB with sham, total acid exposure on day 2 was not different (10.2 ± 7.9 vs 9.4 ± 6.2, P = 0.804). In patients randomized to DB, esophageal acid exposure in a 2-hour window after the standardized meal on day 1 vs day 2 reduced from 11.8% ±6.4 to 5.2% ± 5.1, P = 0.015. DISCUSSION: In patients with upright GERD, DB reduces the number of postprandial reflux events pressure by increasing the difference between LES and gastric pressure. These data further encourage studying DB as therapy for GERD.

pH Scores in Hiatal Repair with Transoral Incisionless Fundoplication.

BACKGROUND AND OBJECTIVES: Transoral incisionless fundoplication is an alternative to traditional laparoscopic fundoplications. Recently, hiatal hernia repair combined with transoral incisionless fundoplication has become an accepted modification of the original procedure; however, outcomes information, particularly objective pH monitoring, has been sparse. We retrospectively review the subjective and objective outcomes of transoral incisionless fundoplication combined with hiatal hernia repair. METHODS: Ninety-seven consecutive patients presenting for reflux evaluation were reviewed for outcomes after evaluation and treatment. Fifty-five patients proceeded to hiatal hernia repair with transoral incisionless fundoplication. Twenty-nine patients (53%) were found to have matched preoperative and postoperative validated surveys and pH evaluations. RESULTS: There were no serious complications. The mean followup was 296 days (SD, 117 days). The mean Gastroesophageal Reflux Disease Health Related Quality of Life score improved from 33.7 (SD, 22.0) to 9.07 (SD, 13.95), P < .001. The mean Reflux Symptom Index score improved from 20.32 (SD, 13) to 8.07 (SD, 9.77), P < .001. The mean pH score improved from 35.3 (SD, 2.27) to 10.9 (SD, 11.5), P < .001. Twenty-two of the 29 patients were judged to have an intact hiatal repair with transoral incisionless fundoplication (76%). Of the 22 patients with an intact hiatal repair and intact fundoplication, 21 (95%) had normalized their pH exposure. CONCLUSIONS: In this retrospective review, hiatal hernia repair combined with transoral incisionless fundoplication significantly improved outcomes in patients with gastroesophageal reflux disease in both subjective Gastroesophageal Reflux Disease Health Related Quality of Life and Reflux Symptom Index measurements as well as in objective pH scores.

Nonerosive reflux disease: clinical concepts.

Esophageal symptoms can arise from gastroesophageal reflux disease (GERD) as well as other mucosal and motor processes, structural disease, and functional esophageal syndromes. GERD is the most common esophageal disorder, but diagnosis may not be straightforward when symptoms persist despite empiric acid suppressive therapy and when mucosal erosions are not seen on endoscopy (as for nonerosive reflux disease, NERD). Esophageal physiological tests (ambulatory pH or pH-impedance monitoring and manometry) can be of value in defining abnormal reflux burden and reflux-symptom association. NERD diagnosed on the basis of abnormal reflux burden on ambulatory reflux monitoring is associated with similar symptom response from antireflux therapy for erosive esophagitis. Acid suppression is the mainstay of therapy, and antireflux surgery has a definitive role in the management of persisting symptoms attributed to NERD, especially when the esophagogastric junction is compromised. Adjunctive approaches and complementary therapy may be of additional value in management. In this review, we describe the evaluation, diagnosis, differential diagnosis, and management of NERD.

Esophageal achalasia: current diagnosis and treatment.

INTRODUCTION: Esophageal achalasia is a primary esophageal motility disorder of unknown origin, characterized by lack of peristalsis and by incomplete or absent relaxation of the lower esophageal sphincter in response to swallowing. The goal of treatment is to eliminate the functional obstruction at the level of the gastroesophageal junction. Areas covered: This comprehensive review will evaluate the current literature, illustrating the diagnostic evaluation and providing an evidence-based treatment algorithm for this disease. Expert commentary: Today, we have three very effective therapeutic modalities to treat patients with achalasia - pneumatic dilatation, peroral endoscopic myotomy, and laparoscopic Heller myotomy with fundoplication. Treatment should be tailored to the individual patient, in centers where a multidisciplinary approach is available. Esophageal resection should be considered as a last resort for patients who have failed prior therapeutic attempts.

Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

This document serves as an update of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) 2009 clinical guidelines for the diagnosis and management of gastroesophageal reflux disease (GERD) in infants and children and is intended to be applied in daily practice and as a basis for clinical trials. Eight clinical questions addressing diagnostic, therapeutic and prognostic topics were formulated. A systematic literature search was performed from October 1, 2008 (if the question was addressed by 2009 guidelines) or from inception to June 1, 2015 using Embase, MEDLINE, the Cochrane Database of Systematic Reviews and the Cochrane Central Register of Controlled Clinical Trials. The approach of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) was applied to define and prioritize outcomes. For therapeutic questions, the quality of evidence was also assessed using GRADE. Grading the quality of evidence for other questions was performed according to the Quality Assessment of Studies of Diagnostic Accuracy (QUADAS) and Quality in Prognostic Studies (QUIPS) tools. During a 3-day consensus meeting, all recommendations were discussed and finalized. In cases where no randomized controlled trials (RCT; therapeutic questions) or diagnostic accuracy studies were available to support the recommendations, expert opinion was used. The group members voted on each recommendation, using the nominal voting technique. With this approach, recommendations regarding evaluation and management of infants and children with GERD to standardize and improve quality of care were formulated. Additionally, 2 algorithms were developed, 1 for infants <12 months of age and the other for older infants and children.

Management of Gastroesophageal Reflux Disease.

Management of gastroesophageal reflux disease (GERD) commonly starts with an empiric trial of proton pump inhibitor (PPI) therapy and complementary lifestyle measures, for patients without alarm symptoms. Optimization of therapy (improving compliance and timing of PPI doses), or increasing PPI dosage to twice daily in select circumstances, can reduce persistent symptoms. Patients with continued symptoms can be evaluated with endoscopy and tests of esophageal physiology, to better determine their disease phenotype and optimize treatment. Laparoscopic fundoplication, magnetic sphincter augmentation, and endoscopic therapies can benefit patients with well-characterized GERD. Patients with functional diseases that overlap with or mimic GERD can also be treated with neuromodulators (primarily antidepressants), or psychological interventions (psychotherapy, hypnotherapy, cognitive and behavioral therapy). Future approaches to treatment of GERD include potassium-competitive acid blockers, reflux-reducing agents, bile acid binders, injection of inert substances into the esophagogastric junction, and electrical stimulation of the lower esophageal sphincter.

Rethinking the laryngopharyngeal reflux treatment algorithm: Evaluating an alternate empiric dosing regimen and considering up-front, pH-impedance, and manometry testing to minimize cost in treating suspect laryngopharyngeal reflux disease.

OBJECTIVES/HYPOTHESIS: Empiric proton pump inhibitor (PPI) trials for laryngopharyngeal reflux (LPR) are common. A majority of the patients respond to acid suppression. This work intends to evaluate once-daily, 40 mg omeprazole and once-nightly, 300 mg ranitidine (QD/QHS) dosing as an alternative regimen, and use this study's cohort to evaluate empiric regimens prescribed for LPR as compared to up-front testing with pH impedance multichannel intraluminal impedance (MII) with dual pH probes and high-resolution manometry (HRM) for potential cost minimization. STUDY DESIGN: Retrospective cohort review and cost minimization study. METHODS: A chart review identified patients diagnosed with LPR. All subjects were treated sequentially and outcomes recorded. Initial QD/QHS dosing increased after 3 months to BID if no improvement and ultimately prescribed MII and HRM if they failed BID dosing. Decision tree diagrams were constructed to determine costs of two empiric regimens and up-front MII and HRM. RESULTS: Ninety-seven subjects met the criteria. Responders and nonresponders to empiric therapy were identified. Seventy-two subjects (74%) responded. Forty-eight (67% of responders and 49% of all) improved with QD/QHS dosing. Forty-nine (51%) subjects escalated to BID dosing. Twenty-four subjects (33% of responders and 25% of all) improved on BID therapy. Twenty-five subjects (26%) did not respond to acid suppression. Average weighted cost was $1,897.00 per patient for up-front testing, $3,033.00 for initial BID, and $3,366.00 for initial QD/QHS. CONCLUSIONS: An alternate QD/QHS regimen improved the majority who presented with presumed LPR. Cost estimates demonstrate that the QD/QHS regimen was more expensive than the initial BID high-dose PPI for 6 months. Overall per-patient cost appears less with up-front MII and HRM. LEVEL OF EVIDENCE: 4. Laryngoscope, 127:S1-S13, 2017.

Tri-comparison of Laparoscopic Nissen, Hill, and Nissen-Hill Hybrid Repairs for Uncomplicated Gastroesophageal Reflux Disease.

BACKGROUND: A randomized controlled trial (RCT) showed that laparoscopic Nissen fundoplication (LNF) and Hill (LHR) repairs are equivalent in treating uncomplicated GERD. We combined both repairs to create a laparoscopic Nissen-Hill Hybrid repair (HYB). The purpose of this study is to compare clinical and objective outcomes of a matched group of HYB to the two cohorts of the RCT. METHODS: A retrospective analysis of prospectively collected data from the RCT and a prospectively collected data base was performed. Data were collected preoperatively, postoperatively short-term (ST) at 6 weeks and mid-term (MT) at 6-12 months. Evaluation was standardized according to the RCT and included three quality of life metrics (QOLRAD, GERD-HRQL, Dysphagia), endoscopy, manometry, pH testing, and barium swallow. RESULTS: There were 51 HYB, 46 LNF, and 56 LHR patients. Age, BMI, follow-up, and gender were comparable. QOLRAD, HRQL, PPI use, DeMeester scores, and pH% time <4 significantly improved in all groups and were equivalent. Anatomic recurrence was seen in five LNF, four LHR, and two HYB patients. Reoperations were performed in three LHR, two LNF, and zero HYB patients. CONCLUSION: Tri-comparison shows that HYB is a promising alternative to LHR and LNF. Side effects were not increased and there were fewer reoperations for failure.

Foods Inducing Typical Gastroesophageal Reflux Disease Symptoms in Korea

BACKGROUND/AIMS: Several specific foods are known to precipitate gastroesophageal reflux disease (GERD) symptoms and GERD patients are usually advised to avoid such foods. However, foods consumed daily are quite variable according to regions, cultures, etc. This study was done to elucidate the food items which induce typical GERD symptoms in Korean patients. METHODS: One hundred and twenty-six Korean patients with weekly typical GERD symptoms were asked to mark all food items that induced typical GERD symptoms from a list containing 152 typical foods consumed daily in Korea. All patients underwent upper gastrointestinal endoscopy followed by 24-hour ambulatory esophageal pH monitoring. The definition of “GERD” was if either of the 2 studies revealed evidence of GERD, and “possible GERD” if both studies were negative. RESULTS: One hundred and twenty-six cases (51 GERD and 75 possible GERD) were enrolled. In 19 (37.3%) of 51 GERD cases and in 17 (22.7%) of 75 possible GERD cases, foods inducing typical GERD symptoms were identified. In the GERD group (n = 19), frequent symptom-inducers were hot spicy stews, rice cakes, ramen noodles, fried foods, and topokki. In the possible GERD group (n = 17), frequent symptom-inducers were hot spicy stews, fried foods, doughnuts, breads, ramen noodles, coffee, pizza, topokki, rice cakes, champon noodles, and hotdogs. CONCLUSIONS: In one-third of GERD patients, foods inducing typical symptoms were identified. Hot spicy stews, rice cakes, ramen noodles, fried foods, and topokki were the foods frequently inducing typical symptoms in Korea. The list of foods frequently inducing typical GERD symptoms needs to be modified based on their own local experiences.

Short-term and long-term effect of diaphragm biofeedback training in gastroesophageal reflux disease: an open-label, pilot, randomized trial.

This study investigated the effectiveness of diaphragm biofeedback training (DBT) for patients with gastroesophageal reflux disease (GERD). A total of 40 patients with GERD treated at the Peking Union Medical College Hospital between September 2004 and July 2006 were randomized to receive DBT and rabeprazole proton pump inhibitor (PPI) or rabeprazole alone. The DBT + rabeprazole group received DBT during the 8-week initial treatment; the rabeprazole group did not. During the 6-month follow up, all patients took acid suppression according to their reflux symptoms, and the patients in the DBT + rabeprazole group were required to continue DBT. The primary outcome (used for power analysis) was the amount of acid suppression used at 6 months. Secondary outcomes were reflux symptoms, health-related quality of life (HRQL), and esophageal motility differences after the 8-week treatment compared with baseline. Acid suppression usage significantly decreased in the DBT + rabeprazole group compared with the rabeprazole group at 6 months (P < 0.05). At 8 weeks, reflux symptoms and GERD-HRQL were significantly improved in both groups (P < 0.05), without difference between them. Crural diaphragm tension (CDT) and gastroesophageal junction pressure (GEJP) significantly increased in the DBT + rabeprazole group (P < 0.05), but without change in lower esophageal sphincter (LES) pressure. There was no significant change in CDT, GEJP, and LES pressure compared with baseline in the rabeprazole group. In conclusion, long-term DBT could reduce acid suppression usage by enhancing the anti-reflux barrier, providing a non-pharmacological maintenance therapy and reducing medical costs for patients with GERD.

Control of acid and duodenogastroesophageal reflux (DGER) in patients with Barrett's esophagus.

OBJECTIVES: Symptom eradication in patients with Barrett's esophagus (BE) does not guarantee control of acid or duodenogastroesophageal reflux (DGER). Continued reflux of acid and/or DGER may increase risk of neoplastic progression and may decrease the likelihood of columnar mucosa eradication after ablative therapy. To date, no study has addressed whether both complete acid and DGER control is possible in patients with BE. This prospective study was designed to assess the effect of escalating-dose proton pump inhibitor (PPI) therapy on esophageal acid and DGER. METHODS: Patients with BE (≥3 cm in length) underwent simultaneous ambulatory prolonged pH and DGER monitoring after at least 1 week off PPI therapy followed by testing on therapy after 1 month of twice-daily rabeprazole (20 mg). In those with continued acid and/or DGER, the tests were repeated after 1 month of double-dose (40 mg twice daily) rabeprazole. The primary study outcome was normalization of both acid and DGER. Symptom severity was assessed on and off PPI therapy employing a four-point ordinal scale. RESULTS: A total of 29 patients with BE consented for pH monitoring, of whom 23 also consented for both pH and DGER monitoring off and on therapy (83% male; mean age 58 years; mean body mass index 29; mean Barrett's length 6.0 cm). Median (interquartile range) total % time pH <4 and bilirubin absorbance >0.14 off PPI therapy were 18.4 (11.7-20.0) and 9.7 (5.0-22.2), respectively. In addition, 26/29 (90%) had normalized acid and 18/23 (78%) had normalized DGER on rabeprazole 20 mg. Among those not achieving normalization on 20 mg twice daily, 3/3 (100%) had normalized acid and 4/5 (80%) had normalized DGER on rabeprazole 40 mg twice daily. All subjects had symptoms controlled on rabeprazole 20 mg twice daily. Univariate analysis found no predictor for normalization of physiologic parameters based on demographics. CONCLUSIONS: Symptom control does not guarantee normalization of acid and DGER at standard dose of twice-daily PPI therapy. Normalization of acid and DGER can be achieved in 79% of BE patients on rabeprazole 20 mg p.o. twice daily, and in the majority of the remainder at high-dose twice-daily PPI. In patients undergoing ablative therapy, pH or DGER monitoring may not be needed to ensure normalization of reflux if patients are treated with high-dose PPI therapy.

No evidence for efficacy of radiofrequency ablation for treatment of gastroesophageal reflux disease: a systematic review and meta-analysis.

BACKGROUND & AIMS: A radiofrequency ablation technique known as Stretta was recommended by the Society of American Gastrointestinal and Endoscopic Surgeons as an alternative treatment for gastroesophageal reflux disease (GERD). However, randomized controlled trials of the efficacy of Stretta have produced conflicting findings, and those from previous systematic reviews were compromised as a result of deficiencies in study conduct and reporting of findings. We performed a systematic review to evaluate all evidence on the efficacy of Stretta for the management of GERD. METHODS: We searched MEDLINE and the Cochrane Central Register of Controlled Trials (The Cochrane Library) from inception until February 28, 2014, along with other databases, for randomized controlled trials of Stretta in patients with GERD. Primary outcomes were physiologic parameters of GERD, including normalization of esophageal pH values and augmentation of lower esophageal sphincter pressure (LESP). Secondary outcomes were health-related quality of life (HRQOL) and ability to stop the use of proton pump inhibitors (PPIs). For quality assurance purposes, 2 investigators were involved throughout the study. Data were pooled under a random-effects model. The systematic review was performed as per the standards of the Cochrane collaboration. RESULTS: We collected data from 4 trials and a total of 165 patients (153 patients were analyzed). Three trials compared Stretta vs sham, and 1 trial compared Stretta with PPI therapy. The overall quality of evidence was very low. The pooled results showed no difference between Stretta and sham or management with PPI in patients with GERD for the outcomes of mean (%) time the pH was less than 4 over a 24-hour time course, LESP, ability to stop PPIs, or HRQOL. CONCLUSIONS: In a meta-analysis of trials, we found that Stretta for patients with GERD does not produce significant changes, compared with sham therapy, in physiologic parameters, including time spent at a pH less than 4, LESP, ability to stop PPIs, or HRQOL.

Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE™) for gastroesophageal reflux disease: 6-month results from a multi-center prospective trial.

BACKGROUND: Both long-term proton pump inhibitor (PPI) use and surgical fundoplication have potential drawbacks as treatments for chronic gastroesophageal reflux disease (GERD). This multi-center, prospective study evaluated the clinical experiences of 69 patients who received an alternative treatment: endoscopic anterior fundoplication with a video- and ultrasound-guided transoral surgical stapler. METHODS: Patients with well-categorized GERD were enrolled at six international sites. Efficacy data was compared at baseline and at 6 months post-procedure. The primary endpoint was a ≥ 50 % improvement in GERD health-related quality of life (HRQL) score. Secondary endpoints were elimination or ≥ 50 % reduction in dose of PPI medication and reduction of total acid exposure on esophageal pH probe monitoring. A safety evaluation was performed at time 0 and weeks 1, 4, 12, and 6 months. RESULTS: 66 patients completed follow-up. Six months after the procedure, the GERD-HRQL score improved by >50 % off PPI in 73 % (48/66) of patients (95 % CI 60-83 %). Forty-two patients (64.6 %) were no longer using daily PPI medication. Of the 23 patients who continued to take PPI following the procedure, 13 (56.5 %) reported a ≥ 50 % reduction in dose. The mean percent of total time with esophageal pH <4.0 decreased from baseline to 6 months (P < 0.001). Common adverse events were peri-operative chest discomfort and sore throat. Two severe adverse events requiring intervention occurred in the first 24 subjects, no further esophageal injury or leaks were reported in the remaining 48 enrolled subjects. CONCLUSIONS: The initial 6-month data reported in this study demonstrate safety and efficacy of this endoscopic plication device. Early experience with the device necessitated procedure and device changes to improve safety, with improved results in the later portion of the study. Continued assessment of durability and safety are ongoing in a three-year follow-up study of this patient group.