Nonresorbable copolymer implantation for gastroesophageal reflux disease: a randomized sham-controlled multicenter trial

BACKGROUND & AIMS: This aim was to determine whether endoscopic implantation of a biocompatible nonresorbable copolymer (Enteryx; Boston Scientific Corp, Natick, MA) is a more effective therapy for gastroesophageal reflux disease (GERD) than a sham procedure. METHODS: In a randomized, single-blind, prospective, multicenter clinical trial, 64 patients with GERD were enrolled whose symptoms were well controlled by proton pump inhibitor (PPI) therapy and rapidly recurred after cessation of PPI therapy. Thirty-two patients were assigned to Enteryx implantation and 32 to a sham procedure consisting of standard upper endoscopy. Patients in both groups with unsatisfactory symptom relief after 3 months were eligible for re-treatment by Enteryx implantation. The primary study end point was > or =50% reduction in PPI use. Secondary end points included > or =50% improvement in GERD score and the proportion of patients not undergoing re-treatment procedure. Follow-up evaluations were performed at 3 and 6 months. RESULTS: The percentage of Enteryx-treated patients achieving a > or =50% reduction in PPI use (81%) was greater than that of the sham group (53%), with a rate ratio of 1.52 (confidence interval [CI], 1.06-2.28; P=.023). A higher proportion of the Enteryx (68%) than sham group (41%) ceased PPI use completely (rate ratio, 1.67; CI, 1.03-2.80; P=.033). GERD health-related quality of life heartburn score improvement > or =50% was achieved by 67% of the Enteryx group versus 22% of the sham group (rate ratio, 3.05; CI, 1.55-6.33; P <.001). More Enteryx-treated (81%) than sham-treated (19%) patients did not undergo re-treatment (rate ratio, 4.33; CI, 2.23-9.29; P <.001). CONCLUSIONS: Enteryx implantation more effectively reduces PPI dependency and alleviates GERD symptoms than a sham procedure.     

Enteryx implantation for GERD: expanded multicenter trial results and interim postapproval follow-up to 24 months

BACKGROUND: Enteryx implantation in the esophagus is an alternative therapy for patients with proton pump inhibitor (PPI) dependent GERD. Although this treatment resulted in highly significant improvement at 6 and 12 months, longer follow-up is needed to more fully assess the durability of these positive effects. METHODS: An open-label, international clinical trial was conducted in 144 PPI-dependent patients with GERD with follow-up at 6 and 12 months. In addition, the durability and the safety of the treatment were assessed for 24 months in 64 patients enrolled in a postapproval study. The primary study outcome measure was usage of PPI. Secondary outcomes in the multicenter trial were GERD health-related quality of life (GERD-HRQL) symptom score and esophageal acid exposure. RESULTS: At 12 months, PPI use was reduced > or =50% in 84%: 95% confidence interval (CI) [76%, 90%] and was eliminated in 73%: 95% CI[64%, 81%] of evaluable patients (intent-to-treat analysis 78%: 95% CI[70%, 84%] and 68%: 95% CI[60%, 76%], respectively). A GERD-HRQL < or =11 was attained in 78%: 95% CI[69%, 85%] of evaluable patients. Esophageal acid exposure (total time pH <4) was reduced by 31%: 95% CI[17%, 43%]. At 24 months, a > or =50% or greater reduction in PPI use was achieved in 72%: 95% CI[59%, 82%] and PPI use was eliminated in 67%: 95% CI[54%, 78%] of patients. CONCLUSIONS: This investigation provides evidence for sustained effectiveness and safety of implantation of Enteryx in the esophagus in PPI-dependent patients with GERD.     

Reduced medication dependency and improved symptoms and quality of life 12 months after enteryx implantation for gastroesophageal reflux

BACKGROUND: The need is well recognized for additional data on endoluminal therapies for gastroesophageal reflux disease (GERD). This prospective multicenter clinical trial was designed to assess safety and effectiveness of Enteryx, a nonresorbable copolymer implanted into the lower esophagus, in reducing usage of proton pump inhibitors (PPIs) and improving reflux symptoms and quality of life. METHODS: Enteryx implantation was performed under fluoroscopic visualization without general anesthesia in 93 patients with symptomatic GERD responsive to and relapsing upon cessation of PPI therapy. Subjective and objective data were collected up to 12 months postprocedure. The criterion for treatment success was reduction in PPI dosage of > or =50%. RESULTS: At 12 months, treatment success was attained in 86% (confidence interval, 77%-93%) of 74 evaluable patients and elimination of PPI therapy in 65% (confidence interval, 53%-76%). The treatment success rate by intent-to-treat analysis was 69% (confidence interval, 58%-78%). Reflux-related heartburn (P < 0.0001), regurgitation symptoms (P = 0.0005), and physical (P < 0.0001) and mental quality of life (P = 0.0012) scores improved. The most frequent complications were chest pain (77%), dysphagia/odynophagia (27%), and sensation of fever (26%). CONCLUSIONS: Enteryx implantation provides an effective and safe alternative for management of gastroesophageal reflux, reducing medication dependency and symptoms and enhancing quality of life.     

Endoluminal gastroplasty (EndoCinch) versus endoscopic polymer implantation (Enteryx) for treatment of gastroesophageal reflux disease: 6-month results of a prospective, randomized trial

OBJECTIVES: The aim of this study was to compare and determine the efficiency and safety of two newly introduced endoscopic antireflux procedures in the treatment of gastroesophageal reflux disease (GERD). METHODS: In a prospective, randomized trial, endoluminal gastroplasty (EndoCinch) was compared with polymer injection (Enteryx) employing 51 consecutive patients dependent on proton pump inhibitor therapy. Follow-up evaluation included drug consumption, symptoms, quality-of-life scoring, endoscopy, pH monitoring, manometry, and documentation of adverse events. RESULTS: Twenty-six patients were assigned to EndoCinch treatment, 23 patients received Enteryx implantation, and two patients dropped out before applying endoscopic therapy. At 6 months, proton pump inhibitor therapy could be stopped or dosage was reduced by > or =50% in 20 of 26 (77%) EndoCinch-treated patients and in 20 of 23 patients treated by Enteryx (87%, p= 0.365), which differed significantly in both groups compared to the pre-interventional status (p < 0.0001). Esophageal acid reflux (pH < 4) decreased from 14.5% to 9.6% in EndoCinch-treated patients (p= 0.071) and from 15.5% to 13.9% in patients treated by Enteryx (p= 0.930). Heartburn symptom score, modified DeMeester score, gastrointestinal life quality index, and SF-36 physical health survey score improved significantly in both groups postinterventionally (p < 0.0001). Approximately 25% of the patients in both groups required retreatment in an attempt to achieve symptom control. CONCLUSIONS: This is the first prospective, randomized study directly comparing two endoscopic anti-GERD techniques. EndoCinch and Enteryx seem to be equally successful in the treatment of GERD significantly reducing the proton pump inhibitor dosages, and also by improving symptoms of patients. Both endoluminal antireflux procedures may be promising therapeutic options; long-term evaluation will have to show if the positive initial results can be maintained.     

Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: A randomized, sham-controlled trial

BACKGROUND & AIMS: The aim of this study was to determine the effectiveness of endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease (GERD) in comparison with a sham procedure. METHODS: Patients with symptomatic GERD requiring maintenance proton pump inhibitor (PPI) therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary end point was > or =50% improvement in GERD health-related quality of life (HRQL) score. Secondary end points included medication use and esophageal acid exposure. RESULTS: By intention-to-treat analysis, at 3 months, the proportion of patients achieving > or =50% improvement in GERD-HRQL score was significantly greater in the active group (56%) compared with the sham group (18.5%; P < .001). Complete cessation of PPI therapy was higher among patients in the active group than in the sham group by intention-to-treat analysis (50% vs 24%; P = .002). The percent reduction in median percent time pH < 4 was significantly improved within the active group versus baseline (7 vs 10, 18%, P < .001) but not in the sham group (10 vs 9, -3%, P = .686). Between-group analysis revealed the active therapy to be superior to the sham in improving median percent time pH < 4 (P = .010). There were no perforations or deaths. CONCLUSIONS: Endoscopic full-thickness plication more effectively reduces GERD symptoms, PPI use, and esophageal acid exposure than a sham procedure.     

Radiofrequency energy delivery to the gastroesophageal junction for the treatment of GERD

BACKGROUND: In this multi-center study, the feasibility, safety, and efficacy of radiofrequency (RF) energy delivery to the gastroesophageal junction (GEJ) for the treatment of gastroesophageal reflux disease (GERD) were investigated. METHODS: Forty-seven patients with classic symptoms of GERD (heartburn and/or regurgitation), a daily anti-secretory medication requirement, and at least partial symptom response to drugs were enrolled. All patients had pathologic esophageal acid exposure by 24-hour pH study, a 2 cm or smaller hiatal hernia, grade 2 or less esophagitis, and no significant dysmotility or dysphagia. RF energy was delivered with a catheter and thermocouple-controlled generator to create submucosal thermal lesions in the muscle of the GEJ. GERD symptoms and quality of life were assessed at 0, 1, 4, and 6 months with the short-form health survey (SF-36). Anti-secretory medications were withdrawn 7 days before each assessment of symptoms and pH/motility study. Medication use, endoscopic findings, esophageal acid exposure, and motility were assessed at 0 and 6 months. RESULTS: Thirty-two men and 15 women underwent treatment. At 6 months there were improvements in the median heartburn score (4 to 1, p < or = 0.0001), GERD score (26 to 7, p < or = 0.0001), satisfaction (1 to 4, p < or = 0.0001), mental SF-36 (46.2 to 55.5, p = 0.01), physical SF-36 (41.1 to 51.9, p < or = 0.0001), and esophageal acid exposure (11.7% to 4.8%, p < or = 0.0001). Esophagitis was present in 25 patients before treatment (15 grade 1 and 10 grade 2) and 8 had esophagitis at 6 months (4 grade 1 and 4 grade 2, p = 0.005). At 6 months, 87% no longer required proton pump inhibitor medication. There was no significant change in median lower esophageal sphincter pressure (14.0 to 12.0 mm Hg, p = 0.19), peristaltic amplitude (64 to 66 mm Hg, p = 0.71), or lower esophageal sphincter length (3.0 to 3.0, p = 0.28). There were 3 self-limited complications (fever for 24 hours, odynophagia lasting for 5 days, and a linear mucosal injury that was healed after 3 weeks). CONCLUSION: RF energy delivery significantly improved GERD symptoms, quality of life, and esophageal acid exposure while eliminating the need for anti-secretory medication in the majority of patients with a heterogeneous spectrum of clinical disease severity but with minimal active esophagitis or hiatal hernia.     

Impact of endoscopic suturing of the gastroesophageal junction on lower esophageal sphincter function and gastroesophageal reflux in patients with reflux disease

OBJECTIVES: Plication of the gastroesophageal junction by endoscopic suturing has been reported to improve symptoms and reduce acid exposure in patients with gastroesophageal reflux disease (GERD). The mechanisms underlying these effects are not well defined. The aims of our study were to determine the impact of endoscopic suturing of the gastroesophageal junction on lower esophageal sphincter (LES) function in patients with GERD. METHODS: In 15 patients (7 males) with GERD (heartburn, % time esophageal pH < 4 greater than 4%, +/- history of erosive esophagitis within 6 months), two plications were performed circumferentially 1 cm below the gastroesophageal junction. Endoscopy and combined postprandial esophageal manometry and pH monitoring were performed before and 6 months after treatment; 24-h ambulatory pH monitoring and symptom assessment were also performed before, and at 6 and 12 months after treatment. RESULTS: Six months after treatment, the rate of transient LES relaxations (tLESRs) was decreased by 37% (p < 0.05) and basal LES pressure had increased from 4.3 +/- 2.2 mmHg to 6.2 +/- 2.1 mmHg (p < 0.05). The rate of postprandial reflux events and acid exposure time were not altered. Endoscopic suturing significantly reduced 24-h esophageal acid exposure from 9.6% (9.0-12.1) to 7.4% (3.9-10.1) at 6 months, due predominantly to a reduction in upright acid exposure. The reduction in total 24-h acid exposure was sustained to 12 months. At repeat endoscopy, only one plication was evident in 6 patients (40%) at 6 months. Seven patients (47%) remained off medications at 6 and 12 months follow-up. CONCLUSIONS: In patients with GERD, endoscopic suturing of the gastroesophageal junction results in a reduction in the rate of tLESRs, and an increase in basal LES pressure. These changes in LES function result in only a modest reduction in gastroesophageal reflux.     

Childhood GERD is a risk factor for GERD in adolescents and young adults

OBJECTIVE: The clinical course of gastroesophageal reflux disease (GERD) in children without comorbid illness (neurological deficits, congenital esophageal anomalies, chronic obstructive airway conditions) is unclear. Whether GERD in childhood progresses or predisposes to GERD in adulthood remains unknown. METHODS: We identified a cohort of individuals endoscopically diagnosed with GERD in childhood between 1990 and 1996. We excluded patients with comorbid illnesses. Eligible persons were contacted by telephone in person or through a household member and requested to complete a validated (in adults) symptom questionnaire between February 2001 and February 2003. Respondents were invited to undergo an upper endoscopy or to share results of any endoscopic examination performed within the past 12 months. We calculated the proportion of persons with GERD symptoms (monthly, weekly), and with current use of antisecretory medications (histamine-2-receptor antagonists [H2RA], proton pump inhibitors [PPI]). RESULTS: A total of 207 persons satisfied the inclusion and exclusion criteria and were contacted. Of those, 80 (39%) completed the questionnaire and 14/80 (18%) had an upper endoscopy. The mean age of participants was 20 years (SD = 4, range 10-40); most were Caucasian (73%), and 60% were female. GERD was documented at a mean age of 5 years (approximately a 15-yr duration of follow-up). Most participants (64/80, 80%) had at least monthly heartburn and/or acid regurgitation reported within the past 12 months; 18/80 (23%) reported at least weekly symptoms, and an additional three patients were asymptomatic but taking antisecretory therapy (H2RA or PPI). If all nonresponders were considered free of symptoms, then at least 31% had monthly symptoms, and 9% had weekly symptoms. Overall, 24 (30%) were currently taking either H2RA or PPI, and 19 patients had undergone fundoplication. There were no statistically significant differences between those who reported monthly GERD symptoms, weekly GERD symptoms, or no GERD symptoms as far as demographic features, age of GERD onset, receipt of fundoplication, or current GERD treatment. At endoscopy, three patients had mild to moderate erosive esophagitis. CONCLUSIONS: GERD in otherwise normal children can persist through adolescence and adulthood in a significant proportion of patients who continue to have GERD symptoms and signs, and use antisecretory medications. Childhood GERD is a risk factor for GERD in adolescence and adulthood.     

Predictors of outcome in an open label, therapeutic trial of high-dose omeprazole in laryngitis

BACKGROUND: Gastroesophageal reflux is implicated in some cases of laryngitis. There are no established predictors of response to acid suppression therapy in suspected reflux laryngitis. AIM: In a population with laryngitis, the aim is to determine whether (a) omeprazole 20 mg tds (3 months) improves symptoms and laryngitis, and (b) the outcome in response to potent acid suppression can be predicted by esophageal and/or pharyngeal parameters during ambulatory pH monitoring or by other pretreatment variables. METHODS: From the 70 consecutive patients with laryngitis screened, 20 patients met the inclusion criteria (dysphonia >3 months; laryngoscopically demonstrated laryngitis); and 50 patients were excluded because of one or more criteria indicating alternative causes for laryngeal injury. The primary outcome measure was improvement of at least one level in a 4-point laryngitis grading at 3 months. Twenty-four-hour dual, pharyngo-esophageal pH monitoring was performed at baseline. Secondary outcomes (symptom questionnaire; computerized voice analysis) were measured at baseline, and at 6 and 12 wk. RESULTS: Response rates at 6 and 12 wk were 47% and 63%, respectively. GERD symptoms (heartburn (p= 0.03) and regurgitation (p= 0.0001)) improved. However, neither baseline GERD symptoms nor endoscopic findings predicted laryngoscopic or symptomatic response. Neither baseline laryngitis grade (p= 0.46) nor esophageal acid exposure on pH testing (p= 0.3) predicted outcome. Four of 20 patients demonstrated pharyngeal regurgitation on pH testing, all four of whom responded to potent acid suppression (p= 0.2). Computerized voice measures were not predictive of outcome, although fundamental frequency (Fo) was inversely related to baseline laryngoscopic grade. CONCLUSION: In a carefully defined population of patients with laryngitis (a) 63% have a laryngoscopic response to 3 months of potent acid suppression without significant improvement in laryngeal symptoms; (b) neither voice measures, esophageal acid exposure time, symptoms nor severity of laryngitis predict outcome; and (c) although numbers were small, all patients with a positive pharyngeal pH study responded to therapy and pharyngeal pH-metry may prove useful; (4) available evidence supports an empiric trial of high-dose proton pump inhibitors (PPI), for at least 12 wk, as the initial diagnostic step for suspected reflux laryngitis.     

A novel endoscopic submucosal dissection technique for proton pump inhibitor-refractory gastroesophageal reflux disease

Abstract

Objectives: Although drug treatment is the usual first-line therapy for gastroesophageal reflux disease (GERD), not all patients receive satisfactory relief from drug therapy, alone. We developed an endoscopic fundoplication technique using endoscopic submucosal dissection (ESD); the technique is referred to as ESD for GERD (ESD-G). This study investigated the safety and efficacy of this novel technique in patients with drug-refractory GERD. Patients and methods: ESD-G narrows the hiatal opening through ESD of the esophagogastric junction (EGJ) mucosa. For safety reasons, the range of mucosal resection was limited to half (1/2 or 1/4 +1/4) of the circumference of the EGJ lumen. ESD-G was performed on 13 patients with proton pump inhibitor (PPI)-refractory GERD. GERD symptoms, PPI dose, and 24-h esophageal pH monitoring results were compared before and 6 months after the procedure. Results. In 12 cases, symptoms significantly improved after ESD-G. Five patients demonstrated improved esophagitis, three were able to discontinue PPI therapy, and three were able to reduce their PPI dosage following surgery. The esophageal pH <4 holding time ratio was also decreased after ESD-G. Conclusions. ESD-G may be useful for PPI-refractory GERD patients.     

Enteryx implant for gastroesophageal reflux disease

Opinion statement Although pharmacologic therapy is safe and effective for gastroesophageal reflux disease (GERD), patients requiring chronic drug treatment often seek alternatives. Surgical alternatives to chronic drug treatment are associated with increased morbidity and long-term failure rates in more than 50% of surgically treated patients. Newer endoluminal therapies using modifications of standard endoscopy techniques are under evaluation as alternatives to chronic drug treatment or surgical intervention for GERD. Appropriate patient selection is KEY. Patients considered for any endoluminal therapy should have well documented GERD and demonstrated appropriate and successful response to medical therapy with a proton pump inhibitor (PPI). The Enteryx implant is an injectable biocompatible polymer approved by the US Food and Drug Administration for the management of GERD symptoms. Clinical trial data indicate that the Enteryx procedure is a safe and effective GERD treatment that manages symptoms of GERD and addresses the underlying anatomic and functional aspects of the disorder. Multicenter clinical trials have shown that the Enteryx procedure safely and effectively eliminates or significantly reduces PPI use in approximately 84% of patients at 1 year and 72% of patients at two years. The risk-benefit profile of this procedure and alternative treatment options should be carefully evaluated for each patient considered a candidate for Enteryx and all endoluminal therapies. Randomized-controlled studies comparing the Enteryx procedure to placebo and cost-effective analyses comparing treatment options will further define the use of the Enteryx implant in patients with GERD.     

The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial

BACKGROUND: This multicenter prospective study investigated the longer-term (12 month) safety and efficacy of radiofrequency energy delivery for the treatment of GERD. METHODS: A prospective study was conducted of 118 patients with chronic heartburn and/or regurgitation who required antisecretory medication daily and had demonstrated pathologic esophageal acid exposure, a sliding hiatal hernia (相似文献   

Clinical trials evaluating endoscopic GERD treatments: is it time for a moratorium on the clinical use of these procedures?

Perendoscopic treatments of gastroesophageal reflux have been used in clinical practice following FDA approval of the first two devices in 2000. A number of clinical trials predominantly short-term have been performed almost uniformly demonstrating patient improvement in GERD symptomatology and reduction or elimination of antacids. However, only two of these endo reflux treatment trials have included the essential elements of strict patient entry criteria, randomization, attempts at blending, and intention-to-treat analysis. Two new endoscopic antireflux trials are published in this issue of the journal. The first study compares the EndoCinch sewing device to the Enteryx copolymer injection procedure. The second report compares the EndoCinch technique to the laparoscopic fundoplication procedure. Unfortunately, both studies lack a sham-control population and have other important flaws in design. Basically, all these techniques improved GERD symptoms and well-being and decreased the patients PPI requirement during follow-up period. However, none of the endoscopic procedures reduced acid reflux impressively or improved lower esophageal sphincter tone, a consistent negative outcome with all these techniques. Morbidity was associated with all the procedures and Enteryx has been withdrawn recently from clinical use by the manufacturer because of significant complications. The efficacy durability and safety of these devices in treating GERD patients is in question. A moratorium on the continued use of the procedures in clinical practice seems appropriate at this time.     

Is the Proton Pump Inhibitor Test Helpful in Patients with Laryngeal Symptoms?

Background and Objectives

The association of gastroesophageal reflux disease (GERD) and laryngeal symptoms is not clear. We aimed to examine the symptomatic and endoscopic relations between GERD and laryngeal symptoms and also to evaluate the response to a 2-week proton pump inhibitor (PPI) trial.

Methods

Seventy-two patients experiencing persistent laryngeal symptoms ≥2/week were enrolled. The laryngeal symptoms using the 1-week laryngeal symptom score (LSS) and the typical reflux symptoms including heartburn and acid regurgitation were assessed. Transnasal-esophagogastroduodenoscopy (TN-EGD) and ambulatory 24-h esophageal pH monitoring were performed. The patients were classified into a GERD group and a non-GERD group. The GERD group was defined as the cases of the presence of typical reflux symptoms and/or reflux esophagitis and/or pathologic acid exposure. Patients were treated with 30 mg of lansoprazole bid for 14 days.

Results

Thirty-nine patients (54 %) were diagnosed with GERD on the basis of typical reflux symptoms, EGD, and/or pH testing. There was no significant association between the LSS and the presence of typical reflux symptoms. Also, the presence of laryngitis was not significantly related to reflux esophagitis. The 2-week PPI trial showed no significant difference in the improvement in laryngeal symptoms between the GERD and non-GERD groups.

Conclusions

There was no significant symptomatic and endoscopic association between GERD and laryngeal symptoms. Therefore, GERD does not appear to be the sole cause of these symptoms. Additionally, a 2-week PPI trial is not long enough to be a diagnostic tool in patients with laryngeal symptoms.     

Endoscopic full-thickness plication for the treatment of GERD: 12-month follow-up for the North American open-label trial

BACKGROUND: The aim of this study was to assess the intermediate-term (12-month) safety and efficacy of endoscopic full-thickness plication in patients with symptomatic GERD. METHODS: Sixty-four patients with chronic heartburn that required maintenance antisecretory therapy received a single, endoscopically placed, full-thickness plication in the gastric cardia 1 cm distal to the gastroesophageal junction. At baseline and 12 months after plication, patients completed the GERD Health Related Quality of Life questionnaire, Gastrointestinal Symptom Rating Scale, and SF-36 Health Survey, as well as a medication use diary. Ambulatory 24-hour pH monitoring and esophageal manometry were obtained at baseline and 3 months after plication. At 6 months after plication, the 24-hour pH study was repeated. RESULTS: Of the 57 patients who completed the 12-month follow-up, 40 (70%) were no longer taking a proton pump inhibitor. Median GERD Health Related Quality of Life scores were improved compared with baseline while taking medication (19.0 vs. 5.0; p < 0.0001) and while not taking medication (13.0 vs. 5.0; p < 0.002). At 6 months after the procedure, an improvement in distal esophageal acid exposure was demonstrated in 40 of 51 patients (80%), with a decrease of 39% in the median percentage of time the pH was less than 4 (p < 0.0001). Normal pH scores were observed in 30% of patients. All procedure-related adverse events occurred acutely, as previously reported, and no new adverse event was observed during extended follow-up. CONCLUSIONS: Full-thickness plication at the gastroesophageal junction is an effective endoscopic procedure for treatment of patients with symptoms caused by GERD. It reduces reflux symptoms and antisecretory medication use over at least a 1-year period.     

The role of esophageal pH monitoring in symptomatic patients on PPI therapy

BACKGROUND: Ambulatory pH monitoring while on therapy is often recommended in gastroesophageal reflux disease (GERD) patients with continued symptoms. However, to date, little data exist to justify this indication. AIM: To assess the role of pH monitoring in symptomatic patients despite aggressive therapy with typical or extra esophageal GERD. METHODS: Retrospective review of 2,291 ambulatory pH tracings (1999-2003) identified subgroup of studies performed on proton pump inhibitor (PPI) therapy. Patients with prior fundoplication or Barrett's esophagus were excluded. Patients grouped on predominant presenting GERD symptoms: typical (heartburn and regurgitation) or extra esophageal (chest pain, cough, hoarseness, sore throat, shortness of breath, asthma). The distribution of abnormal pH parameters in each group calculated and univariate analyses assessed the probability of abnormal pH in each group. Abnormal cutoff values traditionally used in clinical practice and more stringent cutoff values used to determine distribution of abnormality as a function of cutoff values. RESULTS: A total of 250 patients (mean age 54.3 yrs, 59% female) underwent pH monitoring on either daily (b.i.d.) or twice daily (q.d.) on PPI therapy: 115 (46%) with extra esophageal and 135 (54%) with typical GERD symptoms. Extra esophageal GERD patients were more likely to undergo pH monitoring on b.i.d. PPIs (OR = 2.7; 95% CI = 1.6-4.4; p < 0.01). 52 (93%) of typical and 74 (99%) of extra esophageal GERD patients on b.i.d. PPIs tested normal. The odds of a normal pH values were 11 times higher for patients on b.i.d. PPIs (OR = 11.4; 95% CI = 4.3-30.1, p < 0.01) than those on q.d. PPIs. CONCLUSIONS: 1) The likelihood of an abnormal esophageal pH for symptomatic GERD patients on b.i.d. PPI is very small. 2) In this group of patients failing b.i.d. PPIs causes other than GERD should be sought.     

Influence of Radiofrequency Energy Delivery at the Gastroesophageal Junction (the Stretta Procedure) on Symptoms,Acid Exposure,and Esophageal Sensitivity to Acid Perfusion in Gastroesophagal Reflux Disease

Several studies have demonstrated that radiofrequency energy delivery at the gastroesophageal junction (the Stretta procedure) induces symptom relief in gastroesophageal reflux disease (GERD), although improvement of acid exposure on pH monitoring was usually limited. A role for decreased esophageal sensitivity has been suggested. Our aim was to evaluate the influence of Stretta on symptoms, acid exposure, and sensitivity to esophageal acid perfusion in GERD. Thirteen patients with established proton pump inhibitor (PPI)-dependent GERD (three males; mean age, 51±10 years) participated in the study. Before and 6 months after the procedure symptom score, pH monitoring and Bernstein acid perfusion test were performed. The latter was done by infusing HCl (pH 0.1) at a rate of 6 ml/min 15 cm proximal to the gastroesophageal junction for a maximum of 30 min or until the patients experienced heartburn. Results were compared by Student’s t-test. Stretta procedure time was 51±4 min and no complications occurred. After 6 months, the symptom score was significantly improved (12.5±2.0 to 7.5±2.1; P<0.05), seven patients no longer needed daily PPI, and acid exposure was significantly decreased (11.6%±1.6% to 8.5%±1.8% of time pH<4; P<0.05). The time needed to induce heartburn during acid perfusion decreased from 9.5±2.3 to 18.1±3.4 min (P=0.01), and five patients became insensitive to 30-min acid perfusion, versus none at baseline (P=0.04). In conclusion, the Stretta procedure induces subjective improvement of GERD symptoms and decreases esophageal acid exposure. In addition, esophageal acid sensitivity is decreased 6 months after the Stretta procedure. The mechanism underlying this finding and its relevance to symptom control require further studies.     

Endoscopic therapy for GERD: Does it have a future?

Approximately 20% of patients with gastroesophageal reflux disease (GERD) have symptoms refractory to long-term proton pump inhibitor (PPI) therapy. Furthermore, PPI therapy is expensive. Fundoplication is considered the gold standard of GERD therapy in terms of normalization of esophageal acid exposure and symptom control; however, this exposes the patient to the risks of surgery and anesthesia. Therefore, an endoscopic approach to treating GERD that obviates the need for PPIs and avoids surgical morbidity is desirable. Several endoscopic methods have been used, including radiofrequency ablation, implantation of foreign substances as bulking agents, and various tissue apposition strategies. The emerging field of GERD endotherapy is promising, but more rigorous, sham-controlled, long-term studies are required to elucidate its exact role in clinical practice. This review discusses the evolution of these concepts, describes specific endoscopic devices that have been developed, and explores the future of endotherapies as viable treatment alternatives for GERD.     

Prevalence of eosinophilic esophagitis in patients with gastroesophageal reflux symptoms: A cross-sectional study from a tertiary care hospital in North India

Background

Eosinophilic esophagitis (EoE) is being recognized increasingly all over the globe; Indian data is however sparse. We screened patients with symptoms of gastroesophageal reflux disease (GERD) for presence of EoE in them.

Methods

Consecutive patients with symptoms suggestive of GERD underwent gastroduodenoscopy and esophageal biopsies, obtained from both the upper esophagus (5 cm below the upper esophageal sphincter) and lower esophagus (5 cm above gastroesophageal junction), as well as from any other endoscopically visible abnormal mucosa. Demographic and clinical characteristics, endoscopic findings, peripheral blood eosinophilic count, and history of use of proton-pump inhibitors (PPIs) were analyzed. Stool examination was done to rule out parasitoids. EoE was diagnosed if number of mucosal eosinophil infiltrate was >20 per high-power field. In the latter, Warthin-Starry stain was performed to rule out presence of H elicobacter pylori.

Results

Of 190 consecutive patients with symptoms of GERD screened, esophageal biopsies were available in 185 cases. Of them, 6 had EoE, suggesting a prevalence of 3.2% among patients with GERD. On univariate analysis, history of allergy, non-response to PPI, and absolute eosinophil counts and on multivariable analysis, history of allergy and no response to PPIs were significant predictors of EoE. Presence of EOE did not correlate with severity of reflux symptoms.

Conclusion

In this hospital-based study from northern part of India, prevalence of EoE in patients with GERD was 3.2%. EoE should be considered as a diagnostic possibility, especially in those with history of allergy, no-response to PPI, and absolute eosinophil count of ≥250/cumm.