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• W2043670166 abstract "See “Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial,” by Hunter JG, Kahrilas PJ, Bell RCW, et al, on page 324. See “Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial,” by Hunter JG, Kahrilas PJ, Bell RCW, et al, on page 324. According to the “Montreal definition,” gastroesophageal reflux disease (GERD) is defined as “a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications.”1Vakil N. van Zanten S.V. Kahrilas P. et al.The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus.Am J Gastroenterol. 2006; 101: 1900-1920Crossref PubMed Scopus (2899) Google Scholar The most common symptoms are heartburn and regurgitation.1Vakil N. van Zanten S.V. Kahrilas P. et al.The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus.Am J Gastroenterol. 2006; 101: 1900-1920Crossref PubMed Scopus (2899) Google Scholar In 2012, Peery et al2Peery A.F. Dellon E.S. Lund J. et al.Burden of gastrointestinal disease in the United States: 2012 update.Gastroenterology. 2012; 143 (e1–e3): 1179-1187Abstract Full Text Full Text PDF PubMed Scopus (1490) Google Scholar noted that GERD was the most common outpatient gastrointestinal diagnosis, resulting in an estimated 8.9 million visits annually and the primary indication for upper endoscopy. Apart from impairing quality of life, GERD symptoms also increase the risk of complications such as erosive esophagitis and Barrett’s esophagus. Proton pump inhibitors (PPIs) and other medications have been the mainstay of therapy for the last 2 decades. Although PPIs are highly effective in relieving acid-related symptoms, a substantial number of patients complain of “breakthrough” symptoms despite high doses, are not completely satisfied with their therapy, and are concerned about side effects, particularly osteoporotic fractures.3Lee J. Youn K. Choi N.K. et al.A population-based case-control study: proton pump inhibition and risk of hip fracture by use of bisphosphonate.J Gastroenterol. 2013; 48: 1016-1022Crossref PubMed Scopus (42) Google Scholar, 4Fraser L.A. Leslie W.D. Targownik L.E. et al.The effect of proton pump inhibitors on fracture risk: report from the Canadian Multicenter Osteoporosis Study.Osteoporos Int. 2013; 24: 1161-1168Crossref PubMed Scopus (107) Google Scholar, 5Corley D.A. Kubo A. Zhao W. et al.Proton pump inhibitors and histamine-2 receptor antagonists are associated with hip fractures among at-risk patients.Gastroenterology. 2010; 139: 93-101Abstract Full Text Full Text PDF PubMed Scopus (250) Google Scholar Regurgitation, the spontaneous return of gastric contents into the esophagus, is in fact quite common and difficult to relieve, even with high-dose acid suppression, or for that matter, with any medical therapy. Today, patients with continued symptoms on acid suppression (so-called refractory GERD), especially those with regurgitation, are considered for surgery, traditionally with a Nissen fundoplication. This operation, although highly successful in expert hands, has fallen into disfavor because of side effects such as dysphagia, bloating, inability to vomit, and even diarrhea.6Galmiche J.P. Hatlebakk J. Attwood S. et al.Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial.JAMA. 2011; 305: 1969-1977Crossref PubMed Scopus (374) Google Scholar, 7DeMeester T.R. Bonavina L. Albertucci M. Nissen fundoplication for gastroesophageal reflux disease. Evaluation of primary repair in 100 consecutive patients.Ann Surg. 1986; 204: 9-20Crossref PubMed Scopus (821) Google Scholar Therefore, there is a clear need for treatments beyond PPIs that are safer and less invasive than traditional surgery to improve symptoms and quality of life in patients with refractory symptoms, particularly regurgitation. Several endoscopic therapies have been developed and tested in the hope of filling this “treatment gap.” In this issue of Gastroenterology, Hunter et al8Hunter J.G. Kahrilas P.J. Bell R.C.W. et al.Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial.Gastroenterology. 2015; 148: 324-333Abstract Full Text Full Text PDF PubMed Scopus (149) Google Scholar report the results of a randomized, blinded, sham-controlled trial comparing the efficacy of one of these endoscopic therapies for GERD, namely, transoral fundoplication (TF), with omeprazole for the treatment of troublesome regurgitation in patients with GERD who remained symptomatic on a PPI. The patient population included those with troublesome regurgitation defined per Montreal criteria as mild symptoms occurring for ≥2 days per week or moderate to severe symptoms occurring on >1 day per week, despite a minimum dosage of omeprazole 40 mg/d. The authors used the validated Reflux Disease Questionnaire to assess symptoms. We screened 696, and 121 were randomized 2:1 to either TF plus placebo or sham TF plus daily or twice daily omeprazole for 6 months. Patients who failed treatment were offered a cross-over to the other arm. The primary endpoint was relief of regurgitation. Patients with esophageal ulcer, stricture, Barrett’s esophagus >2 cm, hiatal hernia >2 cm in length, Los Angeles C or D esophagitis, esophageal dysmotility, or previous esophageal or gastric surgeries were excluded from the study. TF was performed only after proctoring ensured that the procedure would be performed in a similar fashion by all operators. Approximately 23 fasteners were applied endoscopically creating a valve that was 1 cm at either corner and 3 cm in the mid-portion. The primary endpoint, defined as the proportion of patients with resolution of troublesome regurgitation at the end of 6 months, was achieved (67% in TF/placebo vs 45% in sham/PPI; P = .023). Furthermore, the number of reflux episodes significantly declined in TF/Placebo group (135 vs 94 episodes at 6 months; P < .001) compared with the sham/PPI group (125 vs 122 episodes at 6 months; P = NS). However, at 6 months, heartburn scores (calculated by the Reflux Disease Questionnaire) declined similarly between the TF/placebo, from 2.6 (range, 1.5–3.6) to 0.5 (range, 0–1.6), and sham procedure/PPI groups, from 3.0 (range, 2.0–4.1) to 0.8 (range, 0–2; P = .94). Changes in regurgitation scores (using Reflux Disease Questionnaire) between the TF/placebo, from 3.5 (range, 3–4.3) to 0.5 (range, 0–1.5), and sham procedure/PPI groups, from 3.8 (range, 2.9–4.5) to 0.8 (range, 0–2), at 6 months were also similar (P = .07). Intra-esophageal pH was improved compared with baseline with TF (not PPI) but not “normalized.” The authors are to be commended for performing a rigorous, randomized, sham-controlled trial and enrolling patients who are the most difficult to treat medically. Subjects were appropriately selected through a full workup, including a pH monitoring study to document abnormal acid reflux. Having all operators submit a video for review before entering patients allowed for the procedure to be standardized as best as possible. The sham arm offers the best opportunity for a true placebo when an endoscopic procedure is performed. Patient selection was typical for endoscopic and device trials—relatively mild acid reflux, small hernia, and no complications. Despite this careful selection and statistical improvement for the primary endpoint, several issues should be highlighted. Thirty-six percent of the patients failed to achieve adequate symptom relief, frankly a high failure rate. The incremental improvement of TF over high-dose PPI is in essence small. A number needed to treat of 6 to achieve 1 success over high-dose omeprazole is, in this case, not a small number given that 1 in 3 will have less than adequate symptom relief with TF. Also, longer follow-up would be needed to determine if the successes observed would be sustained past the 6-month study period. Although not the primary endpoint, heartburn was not improved compared with PPI, suggesting that the procedure may not be useful for PPI-refractory heartburn patients. TF falls short of the pH/reflux control of a fundoplication; pH was improved, but by no means normalized. Although symptom relief and improvement in quality of life is most important to patients (and PPIs relieve symptoms without normalizing pH), we wonder if the modest improvement in pH and lack of normalization portend downstream failure of the procedure. The authors suggest that breakdown of the fasteners will not preclude future fundoplication, but it remains unknown whether it will preclude repeating the procedure or the use of other endoscopic therapies. The other endoscopic treatment currently available is the radiofrequency energy “Stretta” procedure. Low-power, temperature-controlled radiofrequency is delivered to the esophagus and is thought to lead to structural rearrangement of the lower esophageal sphincter smooth muscle fibers and decrease acid reflux on that basis. Several studies have shown significant improvement in heartburn scores and improvement in quality of life.9Arts J. Sifrim D. Rutgeerts P. et al.Influence of radiofrequency energy delivery at the gastroesophageal junction (the Stretta procedure) on symptoms, acid exposure, and esophageal sensitivity to acid perfusion in gastroesophageal reflux disease.Dig Dis Sci. 2007; 52: 2170-2177Crossref PubMed Scopus (57) Google Scholar, 10Kim M.S. Holloway R.H. Dent J. et al.Radiofrequency energy delivery to the gastric cardia inhibits triggering of transient lower esophageal sphincter relaxation and gastroesophageal reflux in dogs.Gastrointest Endosc. 2003; 57: 17-22Abstract Full Text Full Text PDF PubMed Scopus (79) Google Scholar, 11Noar M.D. Lotfi-Emran S. Sustained improvement in symptoms of GERD and antisecretory drug use: 4-year follow-up of the Stretta procedure.Gastrointest Endosc. 2007; 65: 367-372Abstract Full Text Full Text PDF PubMed Scopus (65) Google Scholar, 12Franciosa M. Triadafilopoulos G. Mashimo H. Stretta radiofrequency treatment for GERD: a safe and effective modality.Gastroenterol Res Pract. 2013; 2013: 783815Crossref PubMed Scopus (26) Google Scholar In a sham-controlled trial in 2003 by Corley et al,13Corley D.A. et al.Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial.Gastroenterology. 2003; 125: 668-676Abstract Full Text Full Text PDF PubMed Scopus (299) Google Scholar patients who underwent Stretta had significantly improved heartburn scores at 6 months, but no significant improvement in esophageal acid exposure times. Although the study showed promising results, this study also had strict inclusion/exclusion criteria, enrolling only a select subpopulation of GERD patients. Open-label, long-term studies have shown promising results and there is a recommendation from SAGES that it be considered in patients unwilling or unable to undergo fundoplication.13Corley D.A. et al.Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial.Gastroenterology. 2003; 125: 668-676Abstract Full Text Full Text PDF PubMed Scopus (299) Google Scholar Studies using the new generation radiofrequency device are currently ongoing and may address some of these issues. Laparoscopic magnetic sphincter augmentation with the LINX device is a new minimally invasive treatment modality for GERD. Ganz et al14Ganz R.A. Peters J.H. Horgan S. et al.Esophageal sphincter device for gastroesophageal reflux disease.N Engl J Med. 2013; 368: 719-727Crossref PubMed Scopus (202) Google Scholar in 2013 analyzed prospectively the efficacy and safety of LINX in a 3-year follow-up study in 100 patients. Improved heartburn and regurgitation, as well as improvement in extra-esophageal symptoms, were seen. Importantly, at 1 year 64% of patients (95% CI, 54-73) achieved the primary outcome, either normalizing or reducing their esophageal acid exposure by ≥50%. The most frequently reported adverse effect was dysphagia. It was seen early in 68% of patients, but decreased to 11% with mild dysphagia at 4 years of follow-up. Device removal was required in 6 patients owing to refractory dysphagia.14Ganz R.A. Peters J.H. Horgan S. et al.Esophageal sphincter device for gastroesophageal reflux disease.N Engl J Med. 2013; 368: 719-727Crossref PubMed Scopus (202) Google Scholar Despite its rigor, this was not a randomized, controlled trial. Heartburn relief has been maintained at a follow-up of ≤4 years. Almost all patients are able to belch and vomit if needed and do not complain of gas bloat.15Philip Katz K.D. Improvement in symptoms and QOL is sustained with minimal side effects 4 years after magnetic sphincter augmentation.Am J Gastroenterol. 2014; (Suppl: Abstract 100)Google Scholar Since publication, >2,500 implants have been performed, resulting in success similar to the trial by Hunter et al.8Hunter J.G. Kahrilas P.J. Bell R.C.W. et al.Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial.Gastroenterology. 2015; 148: 324-333Abstract Full Text Full Text PDF PubMed Scopus (149) Google Scholar Ultimately, the central issue in the treatment of GERD patients is this: “Is all GERD the same?” The short answer is “no.” As our understanding of GERD has evolved, it is clear that what we have defined as GERD1Vakil N. van Zanten S.V. Kahrilas P. et al.The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus.Am J Gastroenterol. 2006; 101: 1900-1920Crossref PubMed Scopus (2899) Google Scholar, 16Katz P.O. Gerson L.B. Vela M.F. Guidelines for the diagnosis and management of gastroesophageal reflux disease.Am J Gastroenterol. 2013; 108: 308-328Crossref PubMed Scopus (1253) Google Scholar can be generated by a wide variety of causes, including abnormal acid reflux, nonacid or weakly acidic reflux, visceral hypersensitivity to acid, and esophageal motility disorders, among others. However, it is all too common, even today, for physicians, patients, payors, and investigators to “lump” all patients with GERD symptoms together, expecting that they will respond similarly to a given therapy. Therapies are often compared in discussion as if they should all offer similar improvement in symptoms and quality of life, normalize pH, and last indefinitely. This approach has the potential to cause us to eliminate from consideration many therapies owing to unreasonable expectations for success. GERD should be considered as a constellation of symptoms that frequently occur together, but in fact are owing to several different end-organ responses to similar stimuli.17Zhang Q. Lehmann A. Rigda R. et al.Control of transient lower oesophageal sphincter relaxations and reflux by the GABA(B) agonist baclofen in patients with gastro-oesophageal reflux disease.Gut. 2002; 50: 19-24Crossref PubMed Scopus (282) Google Scholar, 18Smith J.L. Opekun A.R. Larkai E. et al.Sensitivity of the esophageal mucosa to pH in gastroesophageal reflux disease.Gastroenterology. 1989; 96: 683-689Abstract Full Text PDF PubMed Scopus (174) Google Scholar, 19Savarino E. Zentilin P. Tutuian R. et al.The role of nonacid reflux in NERD: lessons learned from impedance-pH monitoring in 150 patients off therapy.Am J Gastroenterol. 2008; 103: 2685-2693Crossref PubMed Scopus (214) Google Scholar, 20Kahrilas P.J. Boeckxstaens G. Failure of reflux inhibitors in clinical trials: bad drugs or wrong patients?.Gut. 2012; 61: 1501-1509Crossref PubMed Scopus (49) Google Scholar, 21Sharma P. Chey W. Hunt R. et al.Endoscopy of the esophagus in gastroesophageal reflux disease: are we losing sight of symptoms? Another perspective.Dis Esophagus. 2009; 22: 461-466Crossref PubMed Scopus (8) Google Scholar Acid, weakly acidic reflux, and visceral hypersensitivity all cause heartburn, but do not respond in the same way to acid-reducing therapies. Extra-esophageal symptoms of GERD do not respond with the same regularity to PPIs and surgery as heartburn.22Smith J.A. Decalmer S. Kelsall A. et al.Acoustic cough-reflux associations in chronic cough: potential triggers and mechanisms.Gastroenterology. 2010; 139: 754-762Abstract Full Text Full Text PDF PubMed Scopus (165) Google Scholar, 23Vaezi M.F.1 Richter J.E. Stasney C.R. et al.Treatment of chronic posterior laryngitis with esomeprazole.Laryngoscope. 2006; 116: 254-260Crossref PubMed Scopus (286) Google Scholar Regurgitation, as noted, responds poorly to PPIs compared with heartburn.24Kahrilas P.J. Jonsson A. Denison H. et al.Regurgitation is less responsive to acid suppression than heartburn in patients with gastroesophageal reflux disease.Clin Gastroenterol Hepatol. 2012; 10: 612-619Abstract Full Text Full Text PDF PubMed Scopus (89) Google Scholar Primary esophageal motility disorders and functional esophageal disorders are all unique entities that can present with the entire constellation of symptoms currently called GERD. Neither group responds to PPIs or any GERD therapy. Thus, moving forward, we must work to develop a menu of treatments that better tailors therapy to symptoms and underlying pathophysiology rather than the current “one size fits all” approach. Only through this evolution of how we approach patients with this symptom constellation, can we design trials and evaluate therapies to improve our treatment of these patients. So, does this study put TF and other endoscopic therapies back in the game as a “real” option for GERD treatment? Do endoscopic therapies have a role in those patients with proven refractory GERD who do not want or are not candidates for fundoplication? The TF procedure described in the current report seems to be safe in the hands of well-trained operators. With the limitations noted, it offers at least short-term improvement in regurgitation in patients whose symptoms are not relieved with PPIs. Although a longer follow-up of this cohort and additional studies is needed, it seems that these results with the TF device make it a viable option for treatment in carefully selected, well-informed patients, and puts endoscopic therapy “back in the game.” How it compares with other endoscopic and minimally invasive therapies remains a question for subsequent studies. Finally, it seems clear that future success in treatment of patients with GERD symptoms depends on appropriate subclassification of this heterogeneous disease, with targeted strategies based on pathophysiology, natural history, and response to treatment. Efficacy of Transoral Fundoplication vs Omeprazole for Treatment of Regurgitation in a Randomized Controlled TrialGastroenterologyVol. 148Issue 2PreviewTransoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD. Full-Text PDF Open AccessCovering the CoverGastroenterologyVol. 148Issue 2PreviewIn this issue of Gastroenterology, Hunter et al report on the results of a randomized, controlled trial that examined transoral fundoplication versus omeprazole treatment for gastroesophageal regurgitation. The study is known as RESPECT, which stands for the Randomized EsophyX vs Sham, Placebo-Controlled Transoral Fundoplication Trial, and was conducted in 8 academic and community medical centers in the United States. The study included adults with a history of symptoms of gastroesophageal reflux disease and persistent regurgitation despite proton pump inhibitor therapy. Full-Text PDF" @default.
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• W2043670166 title "Endoscopic Therapies for Gastroesophageal Reflux Disease: Back in the Game?" @default.
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