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  Welcome to the 
Gastroesophageal Reflux Disease File
   
Patients all over the world have used the information in The Gastroesophageal Reflux Disease File since 1992, when the Center for Current Research—one of the first 80 companies on the Internet—was founded. Our highly trained researchers (all of whom hold Ph.D.s) have searched the advanced medical database at the National Library of Medicine and compiled a comprehensive collection of research descriptions on GERD and its care.
   
As you will see, the following research descriptions detail the findings published in the most respected journals in the field. Because the research descriptions are written in medical terms, most people will bring all or parts of the GERD File to their doctor for further explanation and discussion. Often your doctor will have access to full-text articles and other information that could be useful in planning a successful course of treatment and prevention. Note that the titles of the journals are abbreviated according to the National Library of Medicine's format; your doctor can provide the full title if you need it.
   
Thank you for accessing the GERD File. We truly hope the information fosters better health.
   
Sincerely,
Gregory A. Fraser, Ph.D.
Director of Research

Important Note: The following information is provided for your education. It should not be relied upon for personal diagnosis or treatment. If you believe that a particular therapy applies to you or someone you care about, be sure to consult a doctor before trying it.
   

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Latest Research on
Gastroesophageal Reflux Disease
     
Curr Allergy Asthma Rep. 2008 Mar;8(1):79-84.
Airway acidification and gastroesophageal reflux.
Hunt JF, Gaston B.
Pediatric Respiratory Medicine, University of Virginia School of Medicine, Box 800386, Charlottesville, VA 22908, USA. bmg3g@virginia.edu.

Although challenging to study, researchers recently recognized the relevance of airway pH to the pathophysiology of several respiratory diseases, ranging from asthma and cystic fibrosis to pneumonia. The airway epithelium is extraordinarily sensitive to acid. Gastroesophageal reflux can and does cause respiratory symptoms, through both neurally mediated pathways and direct aspiration. Direct aspiration has a variety of immunologic, biochemical, and physiologic effects that aggravate asthma and other respiratory diseases, yet strategies to diagnose and treat gastroesophageal reflux-related respiratory symptoms remain imprecise.

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J Pediatr Gastroenterol Nutr. 2008 Mar;46(3):352-4.
Clinical response to 2 dosing regimens of lansoprazole in infants with gastroesophageal reflux.
Khoshoo V, Dhume P.
West Jefferson Medical Center, 1111 Medical Center Blvd, South 650, Marrero, LA 70072, USA. vkhoshoo@sbcglobal.net

Proton pump inhibitors such as lansoprazole are used in the treatment of gastroesophageal reflux disease (GERD), but dosing guidelines for infants have not been determined. The objective of this study was to assess the clinical efficacy of 2 dosing regimens of lansoprazole in infants with GERD using the revised infant gastroesophageal reflux questionnaire scores (I-GERQ-R). Thirty consecutive infants (3-7 months) with GERD, whose conditions were diagnosed by I-GERQ-R scores of > or =16, were randomly assigned to receive 1 of 2 lansoprazole dosing regimens: 15 mg given once per day (group A) or approximately 7.5 mg given 2 times per day (group B). Matched infants in a control group were treated with an extensively hydrolyzed formula (group C). Daily I-GERQ-R scores were gathered, and the scores after 1 and 2 weeks of treatment were used for analysis. The mean pretreatment scores were similar in groups A, B, and C (26.6, 26.9, and 25.9, respectively). After treatment there was a similar drop in the mean scores in groups A and B (20.6 and 20.0, respectively), but not in group C (25.8). At the end of the first week of treatment, in group A, 5 of 15 infants (33%) had a significant reduction in their I-GERQ-R scores, whereas in group B, 10 of 15 infants (67%) had a significant reduction in their I-GERQ-R scores (P < 0.05). At the end of the second week of treatment, groups A and B had similar numbers of patients with significant improvement (60% and 67%), which was higher than in group C (3/15, 20%). Overall, there was no difference in the symptom response, as measured by I-GERQ-R scores, between 15 mg of lansoprazole given once per day and 7.5 mg given twice per day in infants with GERD, but the twice-daily regimen produced a faster symptom response. Both regimens were significantly better than treatment of infants with an extensively hydrolyzed formula.

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J Pediatr. 2008 Mar;152(3):310-4. Epub 2007 Nov 7. Comment in:
J Pediatr. 2008 Mar;152(3):301-3. J Pediatr. 2008 Mar;152(3):A1.
Efficacy of conservative therapy as taught in the primary care setting for symptoms suggesting infant gastroesophageal reflux.
Orenstein SR, McGowan JD.
University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.

OBJECTIVE: To determine the efficacy of non-pharmacologic conservative therapy for infant gastroesophageal reflux disease (GERD). STUDY DESIGN: Consenting parents of the first 50 screened infants who met inclusion/exclusion criteria including abnormal (>16/42) scores on the Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R; n = 40) were taught conservative therapy measures by each site's study nurse: feeding modifications, positioning, and tobacco smoke avoidance. We compared I-GERQ-R scores and symptom response details before and 2 weeks after institution of these measures with 2-tail Wilcoxon signed ranks test in the 37 infants (age range, 4-43 weeks; median age, 13 weeks) who completed the run-in. RESULTS: The median initial and final scores were 23 (16-36) and 18 (7-34; P < .000001). The median score change was -5 (+6--16). Scores of 78% improved at all; 59% improved at least the threshold of 5 points; 24% became normal. Scores for individual symptoms related
to regurgitation, crying, and arching improved significantly. CONCLUSIONS: Two weeks of conservative therapy measures taught in primary care improved 59% beyond the 5-point threshold and normalized 24% of infants with symptom severity diagnostic for GERD, as substantiated with a responsiveness-validated instrument.

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Aliment Pharmacol Ther. 2008 Mar 27 [Epub ahead of print]
Systematic review; gastroesophageal reflux disease and dental lesions.
Pace F, Pallotta S, Tonini M, Vakil N, Bianchi Porro G.
Division of Gastroenterology, Department of Clinical Sciences “L. Sacco”, University of Milan, Italy.

Background: Dental erosion (DE), which is the irreversible loss of tooth substance that does not involve bacteria ranging from a minimal loss of surface enamel to the partial or complete exposure of dentin by a chemical process, is acknowledged as an established extraesophageal manifestation of Gastroesophageal reflux (GERD). However, the real impact of GERD in the genesis of this lesion is unclear. Aims: To review the existing literature in order to assess the relationship between DE and GERD. Methods: Studies that assessed the prevalence of DE in individuals with GERD or viceversa were identified in Medline and the Cochrane Controlled Trials Register via a systematic research strategy Results: 17 studies met the selection criteria. Studies however differed greatly as far as design, population methods of diagnosing GERD, duration of follow-up and consequently findings. The median prevalence of DE in GERD patients was 24%, with a large range (5% - 47.5%), and the median prevalence of GERD in DE adults patients was 32.5% (range: 21%-83%) and in pediatric population 17% (range: 14%-87%). Children with GERD are found by the majority of studies at increased risk of developing dental erosions in comparison with healthy subjects, as are intellectually disabled people. Conclusion: This systematic review shows that there is a strong association between GERD and DE. The severity of dental erosions seems to be correlated with the presence of GERD symptoms, and also, at least in adults, with the severity of proximal esophageal or oral exposure to an acidic pH. The inspection of the oral cavity in search for dental erosions should become a routine manoeuvre in patients with GERD.

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World J Surg. 2008 Mar 29 [Epub ahead of print]
Laparoscopic Revisional Fundoplication with Circular Hiatal Mesh Prosthesis: The Long-term Results.
Granderath FA, Granderath UM, Pointner R.
Department of General, Visceral and Transplant Surgery, University Hospital of Tübingen, Hoppe-Seyler-Strasse 3, 72076, Tubingen, Germany, fagzellamsee@yahoo.com.

BACKGROUND: Failure of hiatal closure has proven to be the most frequent complication leading to revisional surgery after primary failed open or laparoscopic antireflux surgery. To prevent hiatal hernia recurrence some authors recommend the use of prosthetic meshes for reinforcement of the hiatal crura. The aim of the present prospective study was to evaluate the safety and effectiveness of a circular hiatal onlay mesh prosthesis applied during laparoscopic refundoplication after primary failed antireflux surgery with intrathoracic wrap migration. The follow-up period was 5 years. METHODS: A total of 33 patients underwent laparoscopic refundoplication for recurrent symptoms of gastroesophageal reflux disease after primary failed laparoscopic or open antireflux surgery. The underlying morphological complication for symptom recurrence in all patients was hiatal hernia recurrence with intrathoracic migration of the fundoplication. During revisional surgery, after breakdown of the former fundoplication, the esophageal hiatus was thoroughly revised and a circular polypropylene mesh was used to buttress the primarily simple sutured hiatal crura. Additionally, in all patients a refundoplication was performed. Recurrences, complications, functional data, esophagogastroduodenoscopy, and cinematographic X-ray results, as well as quality of life data, were evaluated for the 60-month follow-up period. RESULTS: All reoperations were successfully completed laparoscopically. Twenty-one patients underwent laparoscopic 360 degrees "floppy" Nissen refundoplication, and 12 patients underwent laparoscopic 270 degrees Toupet refundoplication. Hiatal closure was performed by placing a circular polypropylene sheet that had a 3-4 cm keyhole for the esophageal body. Of 24 patients who underwent redo-surgery before May 2000, no patient developed a recurrent hiatal hernia during the first 12 postoperative months. All 33 patients were re-evaluated and underwent complete diagnostic work-up over a follow-up period of 60 months postoperatively. During the long-term follow-up, a new recurrent hiatal hernia with intrathoracic wrap migration developed in 2 patients (6%). In both cases, slippage occurred anteriorly to the esophagus. Both patients were scheduled for repeat refundoplication. In all other patients no recurrence occurred for the complete follow-up period, and no mesh-related complications developed. CONCLUSIONS: Laparoscopic refundoplication for primary failed hiatal closure with the use of a circular mesh prosthesis is a safe and effective procedure to prevent hiatal hernia recurrence for short- and mid-term follow-up. However, for long-term follow-up, even with the placement of prosthetic mesh, re-recurrence occurs in some patients, leading to repeated surgery.

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J Clin Gastroenterol. 2008 Mar 24 [Epub ahead of print]
Recent Advances in the Surgical Treatment of Achalasia and Gastroesophageal Reflux Disease.
Elakkary E, Duffy A, Roberts K, Bell R.
Section of Gastrointestinal Surgery, Department of Surgery, Yale University, New Haven, CT.

Achalasia and gastroesophageal reflux disease (GERD) represent diverse physiologic disorders both of which result from lower esophageal sphincter (LES) dysfunction. Fortunately, both diseases are benign and amenable to surgically corrective therapies. Achalasia is characterized by destruction of the smooth muscle ganglion cells of the myenteric plexus (Auerbach) resulting in motor dysfunction, incomplete LES relaxation, and progressive esophageal dilation. GERD is frequently characterized by hypotonia or shortening of the LES. Local anatomical derangements such as a hiatal hernia (eg, sliding type I hernia) can predispose to GERD. Other predisposing factors for GERD include obesity, smoking, alcohol, and pregnancy. Transient LES relaxation is the most significant factor in the development of GERD. Transient LES relaxations last from 10 to 45 seconds and are not related to swallowing. The diagnostic workup of achalasia and GERD may include barium esophagram, upper gastrointestinal endoscopy, pH monitoring, and esophageal manometry. The different medical treatment options for achalasia comprise pharmacologic treatment, botulinum toxin, and balloon dilation. Surgical interventions include Heller myotomy, which is usually combined with a partial fundoplication. GERD is managed by treating the predisposing factors, using medications (ie, anatacids or proton pump inhibitors) and surgery (ie, fundoplication). Recently, endoluminal therapy has been employed in the treatment of GERD with promising short-term results.

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Arch Surg. 2008 Mar;143(3):267-74; discussion 274.
Surgical reintervention after antireflux surgery for gastroesophageal reflux disease: a prospective cohort study in 130 patients.
Furnée EJ, Draaisma WA, Broeders IA, Smout AJ, Gooszen HG.
University Medical Center Utrecht, Department of Surgery, HPG04-228, PO Box 85500, 3508 GA Utrecht, The Netherlands.

HYPOTHESIS: Surgical reintervention after antireflux surgery for gastroesophageal reflux disease is required in 3% to 6% of patients. The subjective outcome after reintervention has been reported in several studies, but objective results after these subsequent operations have rarely been published. The purpose of this study was to assess the symptomatic and objective outcomes in patients who underwent subsequent operation because of recurrent reflux symptoms or troublesome dysphagia after primary antireflux surgery. DESIGN: Prospective cohort study. SETTING: University medical center. PATIENTS: Between January 1, 1994, and March 31, 2005, 130 patients (mean [SD] age, 48.4 [14.1] years) undergoing surgical reintervention after antireflux surgery for gastroesophageal reflux disease were prospectively studied. MAIN OUTCOME MEASURES: Symptomatic outcome was determined by questionnaires. Esophageal manometry and 24-hour pH monitoring were performed to assess the objective outcome. RESULTS: A total of 144 reinterventions were performed in 130 patients, for recurrent reflux in 94 patients (65.3%) and for troublesome dysphagia in 50 patients (34.7%). Belsey Mark IV fundoplication through a left-sided thoracotomy was performed in 78 (54.2%) and a subsequent Nissen or partial fundoplication during 66 reinterventions (45.8%), including 16 laparoscopic procedures. After a mean (SD) follow-up of 60.1 (37.2) months, symptoms were absent or significantly improved in 70.3% of patients and esophageal acid exposure was normalized in 70.2% of patients after surgery. Postoperative complications occurred after 14 subsequent operations (9.7%). CONCLUSIONS: Surgical reintervention after antireflux surgery for gastroesophageal reflux disease yielded good symptomatic and objective results in 70% of patients in this prospective cohort study. Since the morbidity of this type of surgery is far from negligible, the expectations should be discussed in detail before additional operation.

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Am J Gastroenterol. 2008 Feb;103(2):267-75.
Management strategy for patients with gastroesophageal reflux disease: a comparison between empirical treatment with esomeprazole and endoscopy-oriented treatment.
Giannini EG, Zentilin P, Dulbecco P, Vigneri S, Scarlata P, Savarino V.
Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Genoa, Italy.

OBJECTIVES: Whether patients with typical gastroesophageal reflux disease (GERD) symptoms and without alarm features should be treated empirically or undergo endoscopy first is a debated issue. In this study, our aim was to assess the efficacy, and to compare the direct costs and impact on health-related quality of life (HRQL), of two treatment strategies (empirical vs endoscopy-oriented treatment) in a large population of patients with GERD. METHODS: In total, 612 patients were randomized to either empirical treatment with esomeprazole 40 mg once daily (od) (group 1, N = 309) or endoscopy and treatment according to endoscopic findings (group 2, N = 303, esomeprazole 40 mg od in patients with reflux esophagitis and esomeprazole 20 mg od in patients without esophagitis) for 4 wk, followed by esomeprazole 20 mg od maintenance treatment in both groups. Direct costs and HRQL were analyzed in both treatment arms. RESULTS: At the end of the acute treatment phase (week 4), 267 patients in group 1 (86.4%) and 265 patients in group 2 (87.5%) were considered responders to treatment (intention-to-treat analysis, P= 0.878). Empirical treatment proved to be cost-effective by saving 38.72 euros per treated patient. At the end of the maintenance phase (week 24), a similar proportion of patients responded to treatment in the two groups (71.8%vs 68.3%, P= 0.389). HRQL improved from baseline to week 24 in both groups (difference between study groups not significant). CONCLUSIONS: In patients with GERD, empirical treatment with esomeprazole proved to be cost-effective compared with endoscopy-oriented treatment, and did not negatively affect patient HRQL. These results should be taken into account in the management of GERD patients in clinical practice.

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Am J Surg. 2008 Jan;195(1):61-5.
Laparoscopic Nissen fundoplication with anterior versus posterior hiatal repair: long-term results of a randomized trial.
Wijnhoven BP, Watson DI, Devitt PG, Game PA, Jamieson GG.
Department of Surgery, Flinders University, Flinders Medical Centre, South Australia, Australia.

BACKGROUND: Postoperative dysphagia in patients after Nissen fundoplication might be related to the technique used for the closure of the esophageal hiatus. METHODS: A total of 102 patients with gastroesophageal reflux were randomized to undergo laparoscopic Nissen fundoplication with either anterior (47 patients) or posterior (55 patients) repair of the diaphragmatic hiatus. RESULTS: Clinical data at 5 years after surgery were available for 96% of patients enrolled in the trial. There was no significant difference between the 2 techniques for symptoms of dysphagia at the 5-year follow-up evaluation, although more patients who underwent posterior hiatal repair underwent further surgery for dysphagia-related symptoms (8 vs 2). Better control of heartburn was achieved in patients in the anterior hiatal repair group. Patients from both groups were equally satisfied with the overall outcome after surgery. CONCLUSIONS: At the 5-year follow-up evaluation, there was no significant difference in dysphagia between anterior closure and posterior hiatal repair.

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Aliment Pharmacol Ther. 2007 Dec 20 [Epub ahead of print]
Review article: Endoscopic anti-reflux procedures - an unfulfilled promise?
Pace F, Costamagna G, Penagini R, Repici A, Annese V.
U.O. e Cattedra di Gastroenterologia, Ospedale Universitario “L. Sacco”, Milano, Italy.

Background: The most recently published review concerning the endoscopic treatment of gastroesophageal reflux (GERD) dates back to 2005. Aim: To provide an updated review including all papers published up to 2007 Method: A Medline search from January 2005 to June 2007 was performed regarding endoscopic procedures aiming at treating GERD. In addition, we also retrieved the abstracts presented at DDW during the last three years. We included in the review both "mechanistic" studies, i.e. papers exploring the potential mechanism of action of the procedure/device, and studies trying to assess its clinical efficacy. Results: During the last three years, the number of published papers has declined, and some devices are not anymore available. The alleged mechanism(s) of action of the various devices or procedures is (are) still not completely elucidated; however, some concerns has arisen as far as durability and potential detrimental effects. Moreover, all the aspects of endoscopic therapy, except for its safety, are either insufficiently explored or not investigated at all, or assessed only in particularly selected patient subgroups. Conclusion: None of the proposed antireflux therapies has fulfilled the criteria of efficacy, safety, cost, durability and, possibly, of reversibility. There is at present no definite indication for endoscopic therapy of GERD. We suggest a list of recommendations to be followed when a new endoscopic therapeutic procedure is to be assessed for use in clinical practice.

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Surg Endosc. 2007 Dec 20 [Epub ahead of print]
Laparoscopic antireflux surgery in the elderly.
Grotenhuis BA, Wijnhoven BP, Bessell JR, Watson DI.
Department of Surgery, Flinders University, Room 3D211, Flinders Medical Centre, Bedford Park, South Australia, 5042, Australia, bagrotenhuis@hotmail.com.

BACKGROUND: Both gastroesophageal reflux and paraesophageal hernias are more common in the elderly, but often these patients are not referred for surgery because of their age. In this study we determined the outcome for laparoscopic antireflux surgery in patients aged 70 years or older, in whom either symptoms of gastroesophageal reflux or a large paraesophageal hernia was the indication for surgery. METHOD: From a prospectively maintained clinical database of patients undergoing laparoscopic antireflux surgery, all patients aged 70 years or older were identified and their outcome was determined. RESULTS: Two hundred ten patients were identified. In 129 a large paraesophageal hiatus hernia was the primary indication for surgery, and in 81 patients the indication was reflux. Mean operation time was significantly longer in patients undergoing surgery for a large hiatus hernia (109 vs. 72 min), and conversion to open surgery was required more often (11.6% vs. 4.4%), compared to patients with reflux alone. Follow-up information was available for 95% of patients. Postoperative symptom scores for heartburn and dysphagia improved significantly and patients' satisfaction with surgery was high. CONCLUSION: Laparoscopic antireflux surgery in patients aged 70 years or older has a satisfactory clinical outcome. Elderly patients should not be refused laparoscopic antireflux surgery only because of their age.

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Can J Gastroenterol. 2007 Dec;21(12):820-826.
Maintenance treatment of gastroesophageal reflux disease: An evaluation of continuous and on-demand therapy with rabeprazole 20 mg.
Morgan DG, O'Mahony MF, O'Mahony WF, Roy J, Camacho F, Dinniwell J, Horbay GL, Husein-Bhabha FA; for the RAB-GRD-3002 Study Group.
St Joseph's Healthcare, Hamilton, Canada.

OBJECTIVE: To evaluate continuous therapy (COT) and on-demand therapy (ODT) with rabeprazole 20 mg for maintenance in uninvestigated gastroesophageal reflux disease (GERD). METHODS: This randomized, open-label study enrolled 331 GERD (heartburn-predominant) patients with a pre-existing proton pump inhibitor history of one month or longer, to an acute four-week trial with 20 mg rabeprazole daily for heartburn management. Patients who achieved satisfactory heartburn control during the acute phase (three days or less of heartburn, with no more than one episode rated as moderate, and heartburn rated satisfactorily or completely controlled with minimal rescue antacid use in the seven days preceding randomization) were randomly assigned to six months of rabeprazole 20 mg given as either daily COT or daily ODT, which was initiated upon symptom recurrence and stopped upon symptom resolution. Rescue antacid usage was permitted and tracked. Primary efficacy was measured as the proportion of heartburn-free days over six months. RESULTS: For the 268 patients, the mean percentage of heartburn-free days for the COT group and for the ODT group were 90.3%+/-14.8% and 64.8%+/-22.3%, respectively (P<0.0001). COT was associated with an increased number of medication intake days (154+/-40.2) versus ODT (68+/-46.1), with less heartburn episodes observed with COT versus ODT, respectively (n=7, n=26, P<0.0001). Ninety-two per cent of COT patients and 79% of ODT patients were either 'satisfied' or 'very satisfied' with treatment. The mean usage of antacids was low and similar in both groups. COT and ODT regimens were safe and well-tolerated, with a similar incidence of adverse events. CONCLUSION: Results based on symptom assessments favour COT with rabeprazole 20 mg for maintenance therapy in patients with uninvestigated GERD; however, both therapy types are safe and acceptable treatment options for selected patients.

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ChemMedChem. 2007 Dec 12 [Epub ahead of print]
Gastroesophageal Reflux Disease (GERD): Is There More to the Story?
Vesper BJ, Altman KW, Elseth KM, Haines GK 3rd, Pavlova SI, Tao L, Tarjan G, Radosevich JA.
Center of Molecular Biology of Oral Diseases, College of Dentistry/Jesse Brown VAMC, University of Illinois at Chicago, Chicago, IL, 60612, USA, Fax: (+1)?312-996-9592.

Gastroesophageal reflux disease (GERD) affects both men and women worldwide, with the most common symptom of GERD being frequent heartburn. If left untreated, more serious diseases including esophagitis and/or esophageal cancer may result. GERD has been commonly held to be the result of gastric acid refluxing into the esophagus. Recent work, however, has shown that there are acid-producing cells in the upper aerodigestive tract. In addition, acid-producing bacteria located within the upper gastrointestinal tract and oral cavity may also be a contributing factor in the onset of GERD. Proton pump inhibitors (PPIs) are commonly prescribed for treating GERD; these drugs are designed to stop the production of gastric acid by shutting down the H(+)/K(+)-ATPase enzyme located in parietal cells. PPI treatment is systemic and therefore significantly different than traditional antacids. Although a popular treatment choice, PPIs exhibit substantial interpatient variability and commonly fail to provide a complete cure to the disease. Recent studies have shown that H(+)/K(+)-ATPases are expressed in tissues outside the stomach, and the effects of PPIs in these nongastric tissues have not been fully explored. Likewise, acid-producing bacteria containing proton pumps are present in both the oral cavity and esophagus, and PPI use may also adversely affect these bacteria. The use of PPI therapy is further complicated by the two philosophical approaches to treating this disease: to treat only symptoms or to treat continuously. The latter approach frequently results in unwanted side effects which may be due to the PPIs acting on nongastric tissues or the microbes which colonize the upper aerodigestive tract.

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Ann Otol Rhinol Laryngol. 2007 Nov;116(11):805-11.
Impact of treatment of gastroesophageal reflux on obstructive sleep apnea-hypopnea syndrome.
Friedman M, Gurpinar B, Lin HC, Schalch P, Joseph NJ.
Department of Otolaryngology and Bronchoesophagology, Rush University Medical Center, Chicago, IL, USA.

OBJECTIVES: We test the hypothesis that treatment of gastroesophageal reflux disease (GERD) can improve obstructive sleep apnea-hypopnea syndrome (OSAHS). METHODS: One hundred forty-six patients with OSAHS underwent a complete history-taking, physical examination, and laboratory testing, including questions related to GERD symptoms. Full-night attended polysomnography, 24-hour wireless pH study at the upper esophagus, snoring level evaluation, Epworth Sleepiness Scale, and quality-of-life surveys were completed for each patient. Patients who tested positive for GERD were treated with esomeprazole magnesium 40 mg once daily for 2 to 12 months. The 24-hour pH study was repeated, and those patients with elimination of GERD were reevaluated by polysomnography, snoring level evaluation, Epworth Sleepiness Scale, quality-of-life surveys, and subjective data collection. RESULTS: Forty-one patients completed single-dose treatment with esomeprazole, but the repeat 24-hour pH study showed that 9 patients had persistent GERD. In the 29 patients who completed phase 2 with normal pH study findings, the snoring level decreased from 9.7 +/- 0.5 to 7.9 +/- 1.3 (p < .0001), the Epworth Sleepiness Scale score decreased from 14.2 +/- 2.5 to 11.1 +/- 2.4 (p < .0001), the apnea-hypopnea index decreased from 37.9 +/- 19.1 to 28.8 +/- 11.5 (p = .006), and the minimum saturation of oxygen increased from 84.1% +/- 7.8% to 86.9% +/- 5.0% (p = .055). CONCLUSIONS: Treatment of GERD had a significant impact on the reduction of the apnea-hypopnea index, snoring, and daytime sleepiness. Elimination of GERD should be part of a comprehensive treatment plan for patients with OSAHS.

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Am Surg. 2007 Aug;73(8):748-52; discussion 752-3.
Ten-year follow up after laparoscopic Nissen fundoplication for gastroesophageal reflux disease.
Cowgill SM, Gillman R, Kraemer E, Al-Saadi S, Villadolid D, Rosemurgy A.
Digestive Disorders Center, Tampa General Hospital, Department of Surgery, University of South Florida College of Medicine, Tampa, Florida 33601, USA. scowgill@health.usf.edu

Laparoscopic Nissen fundoplication was first undertaken in the early 1990s. Appreciable numbers of patients with 10-year follow up are only now available. This study assesses long-term outcome and durability of outcome after laparoscopic Nissen fundoplication for treatment of gastro-esophageal reflux disease. Since 1991, 829 patients have undergone laparoscopic fundoplications and are prospectively followed. Two hundred thirty-nine patients, 44 per cent male, with a median age of 53 years (+/- 15 standard deviation) underwent laparoscopic Nissen fundoplications at least 10 years ago; 28 (12%) patients were "redo" fundoplications. Before and after fundoplication, among many symptoms, patients scored the frequency and severity of dysphagia, chest pain, vomiting, regurgitation, choking, and heartburn using a Likert scale (0 = never/not bothersome to 10 = always/very bothersome). Symptom scores before versus after fundoplication were compared using a Wilcoxon matched-pairs test.
Data are reported as median, mean +/- standard deviation, when appropriate. After fundoplication, length of stay was 2 days, 3 days +/- 4.8. Intra-operative inadvertent events were uncommon and without sequela: 1 esophagotomy, 1 gastrotomy, 3 cardiac dysrhythmias, and 3 CO2 pneumothoraces. Complications after fundoplication included: 1 postpneumonic empyema, 3 urinary retentions, 2 superficial wound infections, 1 urinary tract infection, 1 ileus, and 1 intraabdominal abscess. There were two perioperative deaths; 88 per cent of the patients are still alive. After laparoscopic Nissen fundoplication, frequency and severity scores dramatically improved for all symptoms queried (P < 0.001), especially for heartburn frequency (8, 8 +/- 3.2 versus 2, 3 +/- 2.8, P < 0.001) and severity (10, 8 +/- 2.9 versus 1, 2 +/- 2.5, P < 0.001). Eighty per cent of patients rate their symptoms as almost completely resolved or greatly improved, and 85 per cent note they would again have the laparoscopic fundoplication as a result of analysis of our initial experience, thereby promoting superior outcomes in the future. Nonetheless, follow up at 10 years and beyond of our initial experience documents that laparoscopic fundoplication durably provides high patient satisfaction resulting from long-term amelioration of the frequency and severity of symptoms of gastroesophageal reflux disease. These results promote further application of laparoscopic Nissen fundoplication.

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Dig Dis. 2007;25(3):188-96.
Therapy of gastroesophageal reflux: evidence-based approach to antireflux surgery.
Lundell L.
Department of Surgery, Karolinska University Hospital, Huddinge, Stockholm, Sweden. lars.lundell@karolinska.se

BACKGROUND: Due to the chronic, relapsing nature of gastroesophageal reflux disease, lifelong therapeutic options have to be considered and recommended in many patients. Accordingly, surgical repair has to be evaluated based on modern, evidence-based methodologies. METHODS: A careful review has been carried out of the relevant surgical literature also including trials incorporating direct comparisons between medical and surgical therapies. The outcome of such a survey has been structured according to the grading of evidence from highest grade I to the lowest III. RESULTS: Grade I evidence exists to show that antireflux surgery is more effective than proton pump inhibition in the control of reflux-related symptoms. Side effects are burdening surgical repair, many of which do not decrease over time. Data are not consistent to show any benefit of surgery whenever health economic outcomes are required. Minor differences are in favor of laparoscopic operations and it does matter who is doing the operation and how the repair is completed. Better data are requested to assess the true long-term efficacy (>10 years) of corresponding operations. CONCLUSION: Antireflux surgery is an effective and durable therapeutic modality in the long-term management of gastroesophageal reflux disease. 2007 S. Karger AG, Basel

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Dig Dis. 2007;25(3):175-8.
On-demand therapy is a valid strategy in GERD patients: pros and cons.
Leodolter A, Penagini R.
Medical Department, Ev.-Jung-Stilling Hospital, Academic Hospital of the University of Bonn, Siegen, Germany.

On-demand proton pump inhibitor (PPI) therapy is an attractive option for long-term management of gastroesophageal reflux disease (GERD). Controlled trials in non-erosive reflux disease (NERD) patients have shown sufficient symptom control in most patients with a high rate of willingness to continue treatment and substantial saving on PPI expenditure. However, due to the slow onset of action of PPIs, rescue antacids are often used when symptoms recur and several patients continue to experience some degree of heartburn. On-demand treatment is less cost-saving in patients with esophagitis, and symptomatic/endoscopic relapses occur frequently in severe grades. Data on the prevention of long-term sequelae of on-demand treatment are scarce, only indirect evidence being available. It is suggested that PPI continuous maintenance is more appropriate than on-demand therapy in patients with severe esophagitis, in those with Barrett's esophagus where chronic PPIs may reduce incidence of dysplasia, in uninvestigated elderly patients where esophagitis is more prevalent and it is more frequently complicated with gastrointestinal bleeding and possibly in uninvestigated or NERD patients with frequent clinical relapses. Finally, more appropriate outcome variables should be used in future trials in order to assess efficacy of on-demand treatment adequately. 2007 S. Karger AG, Basel

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Dig Dis. 2007;25(3):172-4.
Functional heartburn and non-erosive reflux disease.
Savarino V, Savarino E, Parodi A, Dulbecco P.
Dipartimento di Medicina Interna e Specialità Mediche, Università degli Studi di Genova, Genova, Italy. vsavarin@unige.it

Gastroesophageal reflux disease (GERD) is a common disorder in Western countries. For many years our attention has been focused on patients with erosive esophagitis, but in recent times we have realized that endoscopy-negative reflux disease is the most common presentation of this illness, affecting up to 70% of these individuals. Patients with the non-erosive form (NERD) are a heterogeneous group including various subpopulations with different mechanisms for their main symptom of heartburn: reflux of acidic and non-acidic gastric contents, mucosal hypersensitivity, intraesophageal distension by gas, intraduodenal infusion of fat, muscle contractions and psychological abnormalities. As to esophageal acid exposure, patients with NERD can be subdivided into those with abnormal and normal pH testing. The latter group includes patients with a positive correlation between symptoms and reflux events, in whom heartburn can be controlled by proton pump inhibitor (PPI) therapy. According to the recent Rome III criteria, they are still in the realm of GERD. An additional group is called functional heartburn, because this typical symptom is associated neither with an abnormal pH test nor with a positive symptom index. Their response to PPIs is very disappointing. Therefore, there is an increasing consensus on the fact that they do not have GERD and should be treated with drugs other than PPIs. 2007 S. Karger AG, Basel

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Dis Esophagus. 2007;20(5):416-9.
Quality of life convergence of laparoscopic and open anti-reflux surgery for gastroesophageal reflux disease.
Violette A, Velanovich V.
Division of General Surgery, Henry Ford Hospital, Detroit, Michigan, USA.

Although laparoscopic anti-reflux surgery (LARS) has become the surgical treatment of choice for gastroesophageal reflux disease (GERD), it is unclear whether the quality of life (QoL) advantage of LARS over open anti-reflux surgery (OARS) persists in the long term. The purpose of this study was to compare long-term QoL between LARS and OARS patients. A prospectively gathered database of all patients who underwent either LARS or OARS for symptomatic GERD was reviewed. Preoperatively, patients completed the GERD- health-related quality of life (HRQL) symptom severity questionnaire (best score 0, worst score 50), and the Medical Outcome Short Form (36) (SF-36) generic bodily QoL instrument (eight domains, physical functioning, PF; role - physical, RP; role - emotional, RE; bodily pain, BP; vitality, mental health, social functioning, SF; general health, best score 100, worst score 0). Postoperatively, patients completed both questionnaires at 6 weeks and a least 1 year. Data ar
e presented as medians and statistically analyzed using the Mann-Whitney U-test. A beta-error was determined to assess adequacy of sample size. A total of 289 patients underwent LARS and 124 OARS. At 6 weeks there were statistically significantly better scores for LARS in the domains of PF, RP, RE, BP and SF. However, after 1 year, there were no statistically significant differences. The beta-error for non-statistically significant differences were all < 0.2, which is considered an adequate sample size. Although LARS does produce better QoL scores in the early postoperative period, after 1 year, these scores converge.

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Dis Esophagus. 2007;20(5):411-5.
Effect of pantoprazole in older patients with erosive esophagitis.
Devault KR, Morgenstern DM, Lynn RB, Metz DC.
Department of Medicine, Mayo Clinic College of Medicine, Jacksonville, Florida, USA.

Several studies suggest that older adults with gastroesophageal reflux disease (GERD) are more likely to develop complications, including erosive esophagitis, but it is unclear whether erosive esophagitis is more difficult to treat in older patients. The purpose of this study was to determine if adults >/= 65 years with erosive esophagitis are more difficult to treat than younger adults. The study was a post hoc analysis of two double-blind, randomized, multicenter trials of patients with erosive esophagitis. Patients received pantoprazole 40 mg once daily, nizatidine 150 mg twice daily or placebo. Patients were evaluated for endoscopic healing at 4 and 8 weeks. Patients recorded typical reflux symptoms using a daily diary to note presence or absence of symptoms. Results showed that 44, 13 and 11 patients >/= 65 years and 210, 69, and 71 patients < 65 received pantoprazole 40 mg daily, nizatidine 150 mg twice daily, or placebo, respectively. Eighty-six percent (86%[76%, 97% CI]) of older and 83% (78%, 88% CI) of younger pantoprazole-treated patients were healed at 8 weeks; 46% (19%, 73% CI) and 35% (24%, 46% CI) of nizatidine-treated and 27% (1%, 54% CI) and 34% (23%, 45% CI) of placebo-treated were healed at 8 weeks. Median time to persistent absence of GERD-related symptoms was similar for older and younger patients treated with pantoprazole. We conclude that older patients with erosive esophagitis do not appear to have more difficult-to-treat disease. Erosive esophagitis is effectively healed and GERD symptoms are controlled in older patients using pantoprazole 40 mg daily.

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Arch Surg. 2007 Aug;142(8):785-901; discussion 791-2.
Laparoscopic reintervention for failed antireflux surgery: subjective and objective outcomes in 176 consecutive patients.
Khajanchee YS, O'Rourke R, Cassera MA, Gatta P, Hansen PD, Swanström LL.
Minimally Invasive Surgery Program, Department of Surgery, Legacy Health System, 1140 NW 22nd Ave, Ste 560, Portland, OR 97210, USA.

HYPOTHESIS: Laparoscopy has become the standard approach for surgical treatment of uncomplicated gastroesophageal reflux disease. Laparoscopic reintervention following failure of primary antireflux surgery (ARS) remains controversial. The purposes of this study were to assess outcomes in patients operated on for failed ARS, to describe reasons for failure of the primary surgery, and to identify factors predictive of failure of the revision. DESIGN: Retrospective analysis of prospectively collected data. SETTING: Tertiary-care teaching hospital. PATIENTS: A total of 176 patients (20 with multiple ARS) undergoing laparoscopic reintervention between September 12, 1993, and August 1, 2006, for failed ARS. INTERVENTIONS: Patients had preoperative subjective and/or objective documentation of failure after primary ARS: 131 patients had reoperative Nissen fundoplication, 28 patients had a partial wrap, and 17 patients had other procedures. MAIN OUTCOME MEASURES: Preoperative and postoperative symptom scores and results of objective studies were prospectively collected. Postoperative patients with symptom scores of 2 or greater and/or abnormal 24-hour pH study results (DeMeester score > 14.7) were considered to have treatment failures. Logistic regression was performed to identify variables significant for poor outcomes. RESULTS: Median follow-up was 9.2 months in 145 patients (82.4%). One hundred eight patients (74.5%) demonstrated excellent symptomatic outcomes (P = .001). Twenty of 37 patients with failures had reflux symptoms and 23 experienced dysphagia. Sixty-seven patients had 24-hour pH and manometry studies; 18 (11 asymptomatic) patients had a DeMeester score greater than 14.7. Odds of failure were higher among patients presenting with dysphagia (odds ratio, 3.38; 95% confidence interval, 1.35-8.40; P = .009) or requiring an esophageal-lengthening procedure (odds ratio, 5.77; 95% confidence interval, 1.38-24.11; P = .02). CONCLUSIONS: Laparoscopic reintervention following failed primary ARS provides excellent subjective and objective outcomes in most patients. Patients having laparoscopic reintervention for dysphagia relief or those requiring an esophageal-lengthening procedure have a significantly greater chance of a poor outcome.

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Surg Endosc. 2007 Aug 18; [Epub ahead of print]
Antireflux surgery for patients with end-stage lung disease before and after lung transplantation.
Gasper WJ, Sweet MP, Hoopes C, Leard LE, Kleinhenz ME, Hays SR, Golden JA, Patti MG.
Department of Surgery, University of California San Francisco, 521 Parnassus Avenue, Room C-341, San Francisco, CA, 94143, USA, pattim@surgery.ucsf.edu.

BACKGROUND: Gastroesophageal reflux disease (GERD) is prevalent among patients with end-stage lung disease (ESLD). This disease can lead to microaspiration and may be a risk factor for lung damage before and after transplantation. A fundoplication is the best way to stop reflux, but little is known about the safety of elective antireflux surgery for patients with ESLD. This study aimed to report the safety of laparoscopic fundoplication for patients with ESLD and GERD before or after lung transplantation. METHODS: Between January 1997 and January 2007, 305 patients were listed for lung transplantation, and 189 patients underwent the procedure. In 2003, routine esophageal studies were added to the pretransplantation evaluation. After the authors' initial experience, gastric emptying studies were added as well. RESULTS: A total of 35 patients with GERD or delayed gastric emptying were referred for surgical intervention. A laparoscopic fundoplication was performed for 32 patients (27 total and 5 partial). For three patients, a pyloroplasty also was performed. Two patients had a pyloroplasty without fundoplication. Of the 35 operations, 15 were performed before and 20 after transplantation. Gastric emptying of solids or liquids was delayed in 12 (92%) of 13 posttransplantation studies and 3 (60%) of 5 pretransplantation studies. All operations were completed laparoscopically, and 33 patients recovered uneventfully (94%). The median hospital length of stay was 2 days (range, 1-34 days) for the patients admitted to undergo elective operations. Hospitalization was not prolonged for the three patients who had fundoplications immediately after transplantation. CONCLUSIONS: The results of this study show that laparoscopic antireflux surgery can be performed safely by an experienced multidisciplinary team for selected patients with ESLD before or after lung transplantation, and that gastric emptying is frequently abnormal and should be objectively measured in ESLD patients.

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J Gastroenterol Hepatol. 2007 May;22(5):639-44.
Long-term gastroesophageal reflux disease therapy improves reflux symptoms in elderly patients: Five-year prospective study in community medicine.
Miyamoto M, Haruma K, Kuwabara M, Nagano M, Okamoto T, Tanaka M.
Department of General Internal Medicine, Prefectural Hiroshima Hospital, Hiroshima, Japan.

Background: Gastroesophageal reflux disease (GERD) impairs the patient's quality of life (QOL), but the effect of long-term maintenance therapy in elderly patients is unknown. Methods: We conducted a long-term prospective study. Forty-four GERD patients (11 males; mean age 74 years; QUEST score of at least 6 points) were enrolled in this study. Step-down therapy was selected (proton-pump inhibitor [PPI], histamine-2 receptor antagonist and prokinetic agents for 1 month, respectively). Optimal medication for each patient was continued for 5 years. The efficacy, safety of treatment and reflux symptoms were analyzed. The profiles of the patients who had to continue PPI maintenance therapy were also analyzed. Results: Reflux symptoms were reduced by the PPI based step-down therapy (baseline 13.8 times/month, after 3.2 times/month, P < 0.001). Reflux symptoms improved in 34 patients (77%). None of the 44 patients had to cease treatment because of side-effects and none experienced any complications during the 5-year period. The prevalence of Helicobacter pylori (Hp) infection in the PPI group (29%, 4/14) was significantly lower (P < 0.01) than in the other treatment group (72%, 21/29). The serum pepsinogen I/II ratio in the PPI treatment group (5.7 +/- 0.5) was significantly higher (P < 0.01) than in the others (4.0 +/- 0.3). The predictive factors for PPI maintenance therapy were Hp-negative status and serum pepsinogen I/II ratio >6.0 (odds ratio 12.0, 95% confidence interval 2.7-54.2). Conclusions: Long-term medication for GERD selected on the basis of the patient's profile (i.e. Hp status and gastric atrophy) improved reflux symptoms.

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Surg Endosc. 2007 May;21(5):697-706. Epub 2007 Mar 31.
Endoluminal GERD treatments: critical appraisal of current literature with evidence-based medicine instruments.
Torquati A, Richards WO.
Department of Surgery, Vanderbilt University School of Medicine, Nashville, TN, USA.

BACKGROUND: The literature of endoluminal treatment of gastroesophageal reflux disease (GERD) widely varies in the level of evidence presented for analysis. Therefore there is a need for a comprehensive evidence-based medicine (EBM) analysis of the current literature evidence of the three FDA-approved modalities used for endoluminal treatment of GERD. SEARCH STRATEGY: In January 2007, the MEDLINE database was searched for randomized controlled trials (RCTs), and controlled clinical trials of currently available endoluminal treatment of GERD. Database searches combined the specific endoluminal device keywords with the condition-specific keyword (e.g., GERD). DATA COLLECTION AND ANALYSIS: All relevant studies have been categorized according to the evidence they provide according to the guidelines for Levels of Evidence and Grades of Recommendation supplied by the Oxford Centre for Evidence-Based Medicine. MAIN RESULTS AND AUTHORS' CONCLUSION: Sixteen studies met the inclusion criteria, representing 787 patients. The methodological quality of most of the included studies was average; four studies were grade 1b (individual randomized trial), 10 were grade 2b (individual cohort study), and two were grade 3b (individual case-control study) There is grade 1b and 2b evidence demonstrating the EndoCinch plication is effective in reducing GERD symptoms at short-term follow up. However, in the majority of the studies analyzed, the procedure does not significantly reduce the acid exposure in the distal esophagus. The majority of the studies with long-term outcome showed disappointing outcomes, probably due to suture loss in the majority of patients. There is grade 1b and 2b evidence demonstrating that the Stretta procedure is effective in reducing GERD symptoms at short- and mid-term follow up. However, in the majority of the studies analyzed, the procedure did not reduce significantly the acid exposure in the distal esophagus. There is grade 1b and 2b evidence demonstrating that full-thickness plication is effective in reducing GERD symptoms, and acid exposure in the distal esophagus.

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Clin Gastroenterol Hepatol. 2007 Apr;5(4):439-44. Epub 2007 Mar 23.
The effects of dietary fat and calorie density on esophageal acid exposure and reflux symptoms.
Fox M, Barr C, Nolan S, Lomer M, Anggiansah A, Wong T.
Department of Gastroenterology, St Thomas' Hospital, London, United Kingdom. markfox_2@hotmail.co.uk

BACKGROUND & AIMS: The effects of diet on gastroesophageal reflux disease are not well understood. This study assessed the effects of dietary fat and calorie density on esophageal acid exposure and reflux symptoms in patients with reflux symptoms. METHODS: Patients referred for the investigation of reflux symptoms were recruited (most with nonerosive disease). A catheter-free system provided esophageal pH monitoring over 4 days in 4 dietary conditions. A high-fat (50%) vs low-fat (25%) diet (calorie-controlled), and a high-calorie (1000 kcal) vs low-calorie (500 kcal) diet (fat-controlled) were provided in randomized order, and meal volume was controlled. The effects of meal consistency also were studied. RESULTS: Complete data were available for 15 patients (6 men, 9 women; age, 48 y; range, 26-70 y; body mass index, 26 kg/m2; body mass index range, 21-35 kg/m2). Demographic variables and meal sequence had no effect on reflux parameters. Dietary composition had effects on esophageal acid exposure (F statistic [analysis of variance] = 7.4, P < .005) and symptoms (Friedman test = 24.2, P < .001). No effect of meal consistency was present. Esophageal acid exposure was greater during the high-calorie than the low-calorie diet (mean, 8.6% +/- 2.0% vs 5.2% +/- 1.4% time pH < 4/24 h; P < .01). No difference was observed between the high-fat and low-fat diets (mean, 8.6% +/- 2.0% vs 8.2% +/- 1.6% time pH < 4/24 h; P = NS). In contrast, the frequency of reflux symptoms was not affected by calorie density (median, 6; range, 2-12 vs median, 8; range, 2-13; P = NS) but was increased by the high-fat compared with the low-fat diet (median, 11; range, 5-18 vs median, 6; range, 2-12; P < .05). CONCLUSIONS: Calorie density determines the severity of esophageal acid exposure in gastroesophageal reflux disease after a meal; however, the percentage fat content of the diet has important effects on the frequency of reflux symptoms.

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Gastrointest Endosc. 2007 Mar;65(3):367-72. Comment in: Gastrointest Endosc. 2007 Mar;65(3):373-4. Gastrointest Endosc. 2007 Mar;65(3):375-6.
Sustained improvement in symptoms of GERD and antisecretory drug use: 4-year follow-up of the Stretta procedure.
Noar MD, Lotfi-Emran S.
Heartburn and Reflux Study Center, Endoscopic Microsurgery Associates, 7402 York Road, Towson, MD 21204, USA.

BACKGROUND: Approximately 20% of patients with GERD do not respond to medical therapy. The Stretta radiofrequency antireflux procedure represents an alternative to failed drug therapy for GERD. OBJECTIVE: The aim of this study was to assess symptom and medication changes after the Stretta procedure during a 4-year follow-up period. DESIGN: Prospective case series on intent-to-treat basis. SETTING: Community practice. PATIENTS: Patients with GERD with persistent symptoms despite twice-daily proton pump inhibitor (PPI) medications. INTERVENTIONS: The Stretta procedure was performed in drug-refractory patients with GERD diagnosed by the presence of endoscopically evidenced esophagitis or abnormal esophageal pH testing. Symptom assessment was performed with a validated health-related quality-of-life questionnaire (with and without medication) at baseline and 6, 12, 24, 36, and 48 months after treatment. Complications of the procedure and medication usage were analyzed. MAIN OUTCOME MEASUREMENTS: Significant changes in symptom scores, GERD quality-of-life parameters, and medication usage on the basis of clinical outcomes. RESULTS: We report on a series of 109 consecutive patients treated with the Stretta procedure who have reached 4-year follow-up. Complete long-term follow-up assessment was available in matched data for 109 patients at 12 months, 108 patients at 24 months, 102 patients at 36 months, and 96 patients at 48 months. A second procedure was performed in 13 patients. Heartburn scores decreased from 3.6 to 1.18 (P < .001), total heartburn score (GERD health-related quality-of-life questionnaire) decreased from 27.8 to 7.1 (P < .001), and patient satisfaction improved from 1.4 to 3.8 (P < .001) (see ). Medication usage decreased significantly from 100% of patients on twice-daily PPI therapy at baseline to 75% of patients showing elimination of medications or only as-needed use of antacids/over-the-counter PPIs at 48 months (P < 0.005). There were no serious complications of the procedure. LIMITATIONS: This is an uncontrolled, nonrandomized case series in consecutive patients that does not include long-term pH or motility studies. CONCLUSIONS: This study in drug-refractory patients with GERD found the Stretta procedure to be a safe, effective, and durable treatment that produced significant improvements in heartburn and quality of life and decreased medication usage during a 4-year period of follow-up.

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Gastrointest Endosc. 2007 Mar;65(3):361-6. Comment in: Gastrointest Endosc. 2007 Mar;65(3):373-4. Gastrointest Endosc. 2007 Mar;65(3):375-6.
Long-term results of radiofrequency energy delivery for the treatment of GERD: sustained improvements in symptoms, quality of life, and drug use at 4-year follow-up.
Reymunde A, Santiago N.
Gastroenterology Section, Ponce Gastroenterology Research, Damas Hospital, Ponce, Puerto Rico 00731, USA.

BACKGROUND: The Stretta endoscopic antireflux procedure has effectively controlled symptoms of patients with GERD refractory to proton pump inhibitor (PPI) medication up to 1 year. OBJECTIVE: The aim of this study was to evaluate the efficacy of the Stretta procedure for patients with GERD based on symptom control, quality of life (QOL), and medication use. DESIGN: Prospective single-center case series. SETTING: Academic endoscopy referral center. PATIENTS: Adults with GERD symptoms and partial response to daily antisecretory medication. INTERVENTION: We have used the Stretta procedure for patients with GERD diagnosed by endoscopic or pH testing since 2000. Our primary assessment was a validated health-related QOL score for heartburn and regurgitation and GERD symptoms index performed at baseline, 12, 36, and 48 months after treatment. A secondary outcome measure was the dose and the frequency of antisecretory pharmaceutical use. RESULTS: We performed the Stretta procedure in 83 consecutive patients with persistent GERD symptoms. Complete matched data for follow-up evaluations are reported at 12, 36, and 48 months. The mean GERD QOL score was 2.4 (baseline), 4.6 (36 months), and 4.3 (48 months, P < .001). The mean GERD symptom score was 2.7 (baseline), 0.3 (36 months), and 0.6 (48 months P < .001). Daily medication usage was 100% (baseline) and 13.6% (48 months, P < .001). LIMITATIONS: Nonrandomized study design, lack of control arm, and lack of 24-hour pH. CONCLUSIONS: For these GERD patients followed to 4 years, the Stretta procedure was a safe, effective, and durable treatment, with significant and sustained improvements in GERD symptoms, QOL, and PPI elimination.

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Ann Surg Innov Res. 2007 Feb 20;1:2.
The influence of psychological factors on the outcomes of laparoscopic Nissen fundoplication.
Biertho L, Sanjeev D, Sebajang H, Antony M, Anvari M.
Centre for Minimal Access Surgery, St, Joseph's Healthcare, McMaster University, Hamilton, ON, Canada. anvari@mcmaster.ca.

ABSTRACT: BACKGROUND: Psychological factors play a role in a variety of gastrointestinal illness, including gastroesophageal reflux disease (GERD). Their impact on the surgical outcomes of antireflux surgery is unknown. METHODS: This is a single institution prospective controlled trial, comparing patients undergoing a laparoscopic Nissen fundoplication for GERD (LNF Group, n = 17) to patients undergoing an elective laparoscopic cholecystectomy for biliary colic (Control Group, n = 10). All patients had a psychological assessment before surgery, at 3 months and 6 months after surgery (i.e. Symptom CheckList-90-R somatization subset (SCL-90-R), Depression Anxiety Stress Scales, Anxiety sensitivity index, Illness attitude scale and Beck Depression Inventory II). GERD symptoms were recorded in the LNF Group using a standardized questionnaire (score 0-60). Patients with post-operative GERD symptoms score above 12 at 6 months were evaluated specifically. Statistical analysis was performed using a Student T test, and statistical significance was set at 0.05. RESULTS: There was no significant difference in preoperative and postoperative psychological assessment between the two groups. In the LNF Group, 7 patients had persisting GERD symptoms at 6 months (GERD score greater than 12). The preoperative SCL-90-R score was also significantly higher in this subgroup, when compared to the rest of the LNF Group (18.2 versus 8.3, p < 0.05) and to the Control Group (18.2 versus 7.9, p < 0.05). There was no significant difference for the other psychological tests. CONCLUSION: The SCL-90-R Somatization Subset, reflecting the level of somatization in a patient, may be useful to predict poor outcomes after antireflux surgery. Cognisance of psychological disorders could improve the selection of an optimal treatment for GERD and help reduce the rate of ongoing symptoms after LNF.

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Chest. 2007 Feb;131(2):460-5.
Acidic and non-acidic reflux during sleep under conditions of powerful acid suppression.
Orr WC, Craddock A, Goodrich S.
Lynn Health Science Institute, 5300 N Independence, Suite 130, Oklahoma City, OK 73112, USA.

BACKGROUND: During sleep, individuals are uniquely vulnerable to acid reflux. Acid reflux during sleep has been studied by a number of investigators, but non-acid reflux is largely unexplored. METHODS: In this study, 15 individuals with significant subjective complaints of heartburn were treated with esomeprazole, 40 mg bid, and with placebo, in random order, for 1 week each. After 1 week of treatment, participants underwent combined impedence/pH monitoring and polysomnography. In both drug and placebo conditions, these procedures were done after participants consumed a meal designed to increase the likelihood of reflux events. RESULTS: Total reflux events and acid reflux events were significantly decreased with proton-pump inhibitor (PPI) treatment as compared to placebo. Nonacid reflux events were more common with PPI treatment as compared to placebo, but this result was not statistically significant. The ratio of non-acidic to acidic events was significantly greater with PPI treatment, however. Similar results were found for reflux events that occurred only during sleep. Proximal migration of acidic vs non-acidic reflux events was found to be similar. There was no difference in sleep architecture between placebo and drug conditions. CONCLUSION: PPI treatment reduced overall reflux events, but non-acidic reflux events were relatively more likely to occur with PPI treatment. The occurrence of these non-acidic reflux events on PPI might conceivably explain why some individuals continue to have symptoms after PPI treatment.

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Surg Endosc. 2007 Feb;21(2):167-74. Epub 2007 Jan 2.
The current role of laparoscopic surgery for gastroesophageal reflux disease in infants and children.
Lobe TE.
University of Tennessee Health Science Center, Memphis, TN, USA. lobet2@ihs.org

BACKGROUND: The benefits of surgery for gastroesophageal reflux disease (GERD) in infants and children have been questioned in the recent literature. The goal of this review was to determine the best current practice for the diagnosis and management of this disease. METHODS: The literature was reviewed for all recent English language publications on the management of GERD in 8- to 10-year-old patients. RESULTS: In infants and children, GERD has multiple etiologies, and an understanding of these is important for determining which patients are the best surgical candidates. Proton pump inhibitors (PPIs) have become the mainstay of current treatment for primary GERD. Although laparoscopic surgery appears to be better than open surgery, there remains some morbidity and complications that careful patient selection can minimize. CONCLUSION: Surgery for GERD should be performed only after failure of medical management or for specific problems that mandate it.

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Dig Dis Sci. 2007 Jan 9; [Epub ahead of print]
Effect of Antisecretory Therapy on Atypical Symptoms in Gastroesophageal Reflux Disease.
Dore MP, Pedroni A, Pes GM, Maragkoudakis E, Tadeu V, Pirina P, Realdi G, Delitala G, Malaty HM.
Istituto di Clinica Medica, Universita di Sassari, Viale San Pietro 8, Sassari, 07100, Italy, mpdore@uniss.it.

The effect of proton pump inhibitor (PPI) therapy on extraesophageal or atypical manifestations of gastroesophageal reflux disease (GERD) remains unclear. This study aimed to evaluate the prevalence of atypical manifestations in patients with acid reflux disease and the effect of PPI treatment. Patients with symptoms and signs suggestive of reflux were enrolled. Erosive esophagitis was stratified using the Los Angeles classification. Demographic data and symptoms were assessed using a questionnaire and included typical symptoms (heartburn, regurgitation, dysphagia, odynophagia), and atypical symptoms (e.g., chest pain, sialorrhea, hoarseness, globus sensation, chronic coughing, episodic bronchospasm, hiccup, eructations, laryngitis, and pharyngitis). Symptoms were reassessed after a 3-month course of b.i.d. PPI therapy. A total of 266 patients with a first diagnosis of GERD (erosive, 166; nonerosive, 100) were entered in the study. Presentation with atypical symptoms was approximately equal in those with erosive GERD and with nonerosive GERD, 72% vs 79% (P = 0.18). None of the study variables showed a significant association with the body mass index. PPI therapy resulted in complete symptom resolution in 69% (162/237) of the participants, 12% (28) had improved symptoms, and 20% (47) had minimal or no improvement. We conclude that atypical symptoms are frequent in patients with GERD. A trial of PPI therapy should be considered prior to referring these patients to specialists.

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J Pediatr Gastroenterol Nutr. 2007 Jan;44(1):41-4.
Effect of omeprazole on acid gastroesophageal reflux and gastric acidity in preterm infants with pathological acid reflux.
Omari TI, Haslam RR, Lundborg P, Davidson GP.
Department of Paediatrics, University of Adelaide, Australia. taher.omari@adelaide.edu.au

INTRODUCTION: Proton pump inhibitor (PPI) therapy is increasingly being used to treat premature infants with gastroesophageal reflux disease (GERD); however, the efficacy of PPI on acid production in this population has yet to be assessed in this patient group. The aim of this study was to determine the effect of 0.7 mg/kg/d omeprazole on gastric acidity and acid gastroesophageal reflux in preterm infants with reflux symptoms and pathological acid reflux on 24-h pH probe. METHODS: A randomized, double blind, placebo-controlled, crossover design trial of omeprazole therapy was performed in 10 preterm infants (34-40 weeks postmenstrual age). Infants were given omeprazole for 7 d and then placebo for 7 d in randomized order. Twenty-four-hour esophageal and gastric pH monitoring was performed on days 7 and 14 of the trial. RESULTS: Compared to placebo, omeprazole therapy significantly reduced gastric acidity (%time pH <4, 54% vs 14%, P < 0.0005), esophageal acid exposure (%time pH <4, 19% vs 5%, P < 0.01) and number of acid GER episodes (119 vs 60 episodes, P < 0.05). CONCLUSIONS: Omeprazole is effective in reducing esophageal acid exposure in premature infants with pathological acid reflux on 24-h pH probe; however, the far more complex issues of safety and efficacy have yet to be addressed.

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J Pediatr Gastroenterol Nutr. 2007 Jan;44(1):35-40.
Pharmacokinetics and pharmacodynamics of lansoprazole in children 13 to 24 months old with gastroesophageal reflux disease.
Heyman MB, Zhang W, Huang B, Chiu YL, Amer F, Winter HS.
University of California-San Francisco, San Francisco, CA 94143-0136, USA. mheyman@peds.ucsf.edu

OBJECTIVES: To evaluate the pharmacokinetics and pharmacodynamics of lansoprazole in children between 13 and 24 months of age with gastroesophageal reflux disease (GERD). METHODS: From the population of 66 children with symptomatic GERD, erosive esophagitis (> or = grade 2) or esophageal pH < 4 for > 4.2% of the 24-h period who participated in a phase I/II, open-label, multicenter (11 sites) US study, a subanalysis of 8 toddlers between 13 and 24 months of age was performed. All children were treated, based on body weight, with lansoprazole 15 mg once daily for 8 to 12 weeks. If a child were still symptomatic after 2 weeks of treatment, then the dose of lansoprazole could be increased to twice daily at the discretion of the investigator. Pharmacokinetic parameters were assessed at day 5. Twenty-four-hour median intragastric pH and the percentage of time intragastric pH > 3 or > 4 were assessed at baseline and at day 5 of treatment. Symptom response was assessed by investigator interview and daily diary. Safety was monitored by physical examinations including vital signs, adverse event assessments and laboratory evaluations. RESULTS: Pharmacokinetic analysis of 5 children found a mean time to reach maximum concentration of 1.4 h, maximal plasma concentrations of 894 ng/mL, area under the concentration time curve of 1906 ng * h/mL and a half-life of 0.66 h. Significant (P < or = 0.027) increases from baseline to day 5 were observed in mean 24-h intragastric pH (2.76-3.52) and the percentages of time pH were > 3 (29.46%-55.36%) and pH was > 4 (16.96%-40.77%). Six of the 8 children had improvement in their overall GERD symptom severity on the basis of investigator assessment, and a reduction was seen in the percentage of days with moderate, severe or very severe GERD symptoms compared with baseline. The dosage of lansoprazole was increased in 3 of the 8 children. Median fasting serum gastrin level increased from 65.0 pg/mL at baseline to 136.5 pg/mL at the final visit. Treatment-related events were mild constipation (1 subject) and mild diarrhea (1 subject). CONCLUSIONS: Although larger studies are needed to confirm these results, lansoprazole displays pharmacokinetic and pharmacodynamic parameters in children between 13 and 24 months of age that are similar to those results observed in older children as well as adults.

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Surg Innov. 2006 Dec;13(4):238-49.
A randomized controlled trial of laparoscopic nissen fundoplication versus proton pump inhibitors for treatment of patients with chronic gastroesophageal reflux disease: One-year follow-up.
Anvari M, Allen C, Marshall J, Armstrong D, Goeree R, Ungar W, Goldsmith C.
Centre for Minimal Access Surgery, Department of Surgery, St Joseph's Healthcare, 50 Charlton Ave E, Hamilton, ON, L8N 4A6 Canada. anvari@mcmaster.ca

A randomized controlled trial conducted in patients with gastroesophageal reflux disease compared optimized medical therapy using proton pump inhibitor (n = 52) with laparoscopic Nissen fundoplication (n = 52). Patients were monitored for 1 year. The primary end point was frequency of gastroesophageal reflux dis-ease symptoms. Surgical patients had improved symptoms, pH control, and overall quality of life health index after surgery at 1 year compared with the medical group. The overall gastroesophageal reflux disease symptom score at 1 year was unchanged in the medical patients, but improved in the surgical patients. Fourteen patients in the medical arm experienced symptom relapse requiring titration of the proton pump inhibitor dose, but 6 had satisfactory symptom remission. No surgical patients required additional treatment for symptom control. Patients controlled on long-term proton pump inhibitor therapy for chronic gastroesophageal reflux disease are excellent surgical candidates and should experience improved symptom control after surgery at 1 year.

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Surg Endosc. 2006 Dec 16; [Epub ahead of print]
Endoscopic full-thickness plication for the treatment of GERD: long-term multicenter results.
Pleskow D, Rothstein R, Kozarek R, Haber G, Gostout C, Lembo A.
Beth Israel Deaconess Medical Center, 330 Brookline Avenue, DA-501, Boston, Massachusetts, 02215, USA, alembo@bidmc.harvard.edu.

BACKGROUND: The purpose of the present study was to assess the long-term safety and durability of effect for endoscopic full-thickness plication for the treatment of symptomatic gastroesophageal reflux disease (GERD). The Plicator (NDO Surgical, Inc., Mansfield, MA) used delivers a transmural suture through the gastric cardia to restructure the antireflux barrier. Published reports have shown the Plicator procedure to be effective in reducing GERD symptoms and medication use at 1 year post-plication. METHODS: Twenty-nine patients with chronic heartburn requiring maintenance daily anti-secretory therapy were treated at five sites. Patients received a single full-thickness plication in the gastric cardia 1cm below the gastroesophageal junction (GE) junction. Re-treatments were not permitted. Patients were evaluated at baseline for GERD symptoms and medication use. Intermediate (12 month) and long-term subject follow-up (median follow-up: 36.4 months; range, 31.2-43.9 months) were completed to evaluate procedure safety and durability of effect. RESULTS: Twenty-nine patients completed the 12-month and 36-month follow-up. All procedure-related adverse events occurred acutely, and no new events were observed during extended follow-up. At 36-months post-procedure, 57% (16/28) of baseline proton pump inhibitor (PPI)-dependent patients remained off daily PPI therapy. Treatment effect remained stable from 12- to 36-months, with 21/29 patients off daily PPI at 12 months compared to 17/29 patients at 36-months. Median GERD- Health Related Quality of Life (HRQL) scores remained significantly improved at 36 months versus baseline off-meds scores (8 versus 19, p < 0.001). In addition, the proportion of patients achieving >/= 50% improvement in GERD-HRQL score was consistent from 12 months (59%) to 36 months (55%). CONCLUSIONS: Endoscopic full-thickness plication can reduce GERD symptoms and medication use for at least 3-years post-procedure. Treatment effect is stable from 1 to 3 years, and there are no long-term procedural adverse effects.

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Med Sci Monit. 2006 Dec 18;13(1):CR44-49 [Epub ahead of print]
The efficacy of hydrotalcite compared with OTC famotidine in the on-demand treatment of gastroesophageal reflux disease: A non-inferiority trial.
Konturek JW, Beneke M, Koppermann R, Petersen-Braun M, Weingartner U.
Elbe Clinic Stade-Buxtehude GmbH, Stade, Germany.

Background: Antacids and gastric acid inhibitors are effective in the self-treatment of gastroesophageal reflux disease (GERD). The aim was to investigate onset of action of the antacid hydrotalcite compared with the OTC H2-receptor antagonist famotidine in patients suffering from heartburn. Material/Methods: A total of 53 patients with endoscopically diagnosed GERD grade 0-1 took part in this open, randomized, parallel-group comparison trial: 26 patients received a single dose of 1000 mg hydrotalcite and 27 patients a single dose of 10 mg famotidine on the occasion of a symptomatic reflux episode. Severity of heartburn and accompanying symptoms were documented on a four-point verbal rating scale (VRS) at baseline and up to four hours after intake. Onset and duration of action were defined by the number of patients experiencing improvement of heartburn from severe or moderate to mild or none compared with baseline. Results: Hydrotalcite was significantly superior (p<0.001) to famotidine in increasing the proportion of responders within the first 45 minutes, starting 10 minutes after drug intake. Between 60 and 120 minutes, both compounds showed equal efficacy. Three hours after intake the response rate was 90.9% for hydrotalcite and 92.0% for famotidine. After four hours the response rates were 86.4% for hydrotalcite and 96.0% for famotidine. In both groups, no adverse events were observed. Conclusions: The results indicate that hydrotalcite relieves the symptoms of gastroesophageal reflux faster than OTC famotidine and is equally effective for up to two hours. It is a safe and effective self-medication for on-demand treatment of heartburn.
 

   
 
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