Guidelines Issued for Management of GERD

News Author: Laurie Barclay, MD

October 28, 2008 — The American Gastroenterological Association has issued a medical position statement and technical review on the management of gastroesophageal reflux disease (GERD). Both documents are published in the October issue of Gastroenterology.

“In the development of this medical position statement, 12 broad questions pertinent to diagnostic and management strategies for patients with…GERD were developed by interaction among the authors of the technical review, representatives from the American Gastroenterological Association (AGA) Institute Council, and the AGA Institute Clinical Practice and Quality Management Committee,” write Stephen W. Hiltz, MD, MBA, AGAF, and colleagues, who authored the guidelines. “The questions were designed to encapsulate the major management issues encountered in patients with GERD in current clinical practice. The issue of management of Barrett’s esophagus was intentionally excluded, because this will be the focus of a subsequent medical position statement.”

The available evidence regarding each question was obtained from a comprehensive search of the literature, reviewed, and evaluated in the quality of pertinent data. The technical review document summarizes details of development and literature search methodology and results of the literature search for each of the questions.

Conclusions on the basis of evidence from the literature, or from expert opinion when quality evidence was lacking, were graded with use of US Preventive Services Task Force grades. None of the formulated practice recommendations were deemed to be sufficiently unequivocal for the authors to propose that they become performance measures to assess quality of care.

According to the Montreal definition, GERD was defined as a condition that develops when the reflux of stomach content causes troublesome symptoms and/or complications. The reviewers concluded that much of the treatment of patients with GERD, except for those with esophageal GERD syndromes, was based on uncontrolled trials, clinical experience, or expert opinion vs high-quality, randomized controlled clinical trials.

Specific Grade A recommendations, meaning that the practice is strongly recommended on the basis of good evidence that it improves important health outcomes, are as follows:

• For patients with esophageal GERD syndromes, treatment with antisecretory drugs is recommended for healing esophagitis, symptomatic relief, and maintenance of esophageal healing. In this setting, proton pump inhibitors (PPIs) are more effective than histamine₂ receptor antagonists (H₂RAs), which, in turn, are more effective than placebo.
• Once PPIs have proven clinically effective for the treatment of patients with esophagitis, therapy should be continued long-term and titrated down to the lowest effective dose on the basis of symptom control.
• When treatment with antireflux surgery or PPIs is thought to be similarly effective in a patient with an esophageal GERD syndrome, PPI therapy is considered safer and is therefore preferred as initial treatment.
• Antireflux surgery should be recommended when a patient with an esophageal GERD syndrome cannot tolerate acid suppressive therapy, even if pharmacotherapy is effective.
• In patients with suspected reflux chest pain syndrome, an empiric trial of twice-daily PPI therapy is recommended after careful evaluation for a cardiac cause.

Specific Grade B recommendations, meaning that the practice is recommended on the basis of fair evidence that it improves important health outcomes, are as follows:

• Overweight or obese patients with esophageal GERD syndromes should be advised to lose weight.
• In selected patients who have troublesome heartburn or regurgitation when recumbent, it may be helpful to elevate the head of the bed. On the basis of patient symptoms and triggers, other lifestyle modifications may be helpful, such as avoiding eating late at night or avoiding certain foods or activities.
• Patients with an esophageal syndrome in whom symptoms do not respond adequately to once-daily PPI therapy should have twice-daily PPI therapy.
• When symptom control is the main goal in patients with a symptomatic esophageal syndrome without esophagitis, a short course or as-needed use of antisecretory drugs is recommended. PPIs are more effective than H₂RAs for short-term treatment, and H₂RAs are more effective than placebo.
• For patients with an esophageal GERD syndrome with troublesome dysphagia, endoscopy with biopsy should be performed. At least 5 samples should be obtained to evaluate for eosinophilic esophagitis. Biopsies should be directed to any areas of suspected metaplasia, dysplasia, or to normal mucosa if there are no apparent visual abnormalities.
• Endoscopy and biopsy targeting any area of suspected metaplasia, dysplasia, or malignant neoplasm are also recommended for patients with a suspected esophageal GERD syndrome who have not responded to an empiric trial of twice-daily treatment with PPI therapy.
• When results on endoscopy are normal in these patients, manometry should be performed to localize the lower esophageal sphincter for potential subsequent pH monitoring, to assess peristaltic function before surgery, and to diagnose equivocal presentations of the major motor disorders. Compared with conventional manometry, high-resolution manometry appears to be more sensitive for the diagnosis of atypical cases of achalasia and distal esophageal spasm.
• Ambulatory impedance pH, catheter pH, or wireless pH monitoring with PPIs withheld for 7 days is recommended to assess patients with a suspected esophageal GERD syndrome who have not responded to an empiric trial of PPI therapy, and who have normal endoscopy results and no major abnormality on manometry results. For the detection of pathologic esophageal acid exposure, wireless pH monitoring is more sensitive than catheter studies because of the extended period of recording for 48 hours, and it also appears to have better recording accuracy vs some catheter designs.
• Antireflux surgery should be considered in patients who have an esophageal GERD syndrome with persistent troublesome symptoms, particularly regurgitation, despite PPI therapy. However, the potential benefits of antireflux surgery should be balanced against the potential harms of new symptoms related to the surgery, such as dysphagia, flatulence, inability to belch, and postoperative bowel symptoms.
• For patients who have an esophageal GERD syndrome along with a suspected extraesophageal GERD syndrome, such as laryngitis or asthma, acute or maintenance treatment therapy with once- or twice-daily PPIs or H₂RAs should be considered.

Specific Grade D recommendations, meaning that the practice is not recommended on the basis of fair evidence that it is ineffective or that the harms outweigh the benefits, are as follows:

• Metoclopramide should not be used as monotherapy or adjunctive therapy in patients with esophageal or suspected extraesophageal GERD syndromes.
• In the absence of a concomitant esophageal GERD syndrome, patients with potential extraesophageal GERD syndromes, such as laryngitis or asthma, should not be treated acutely with once- or twice-daily PPIs or H₂RAs.
• Routine endoscopy to evaluate for disease progression is not recommended in patients with erosive or nonerosive reflux disease.
• In patients with an esophageal syndrome who previously had erosive esophagitis, less than daily dosing of PPI therapy as maintenance therapy is not recommended.
• Patients with an esophageal syndrome with or without tissue damage whose symptoms are well controlled with medical therapy should not undergo antireflux surgery.
• In patients with Barrett’s metaplasia, antireflux surgery as an antineoplastic measure is not recommended.

The technical review was supported by the Public Health Service. The authors of the technical review have disclosed various financial relationships with AstraZeneca, TAP Pharmaceutical Products, Inc, Proctor & Gamble, CCS Medical, Barrx Medical, Santarus, and/or Restech.

Gastroenterology. 2008;135:1383-1391, 1392-1413.

Clinical Context

The American Gastroenterological Association updates its recommendations for the management of GERD in its current position statement, and it begins by defining GERD. The authors note that finding an appropriate standard definition of GERD is difficult because the threshold distinction between physiologic reflux and reflux disease remains arbitrary.

However, the authors recommend the following definition as the most appropriate for GERD: “A condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications.” The remainder of the article focuses on diagnostic testing and treatment of GERD.

Study Highlights

• Regarding lifestyle changes, weight loss should be recommended to overweight or obese patients with GERD. Other measures, such as elevating the head of the bed and avoiding late meals, may also be helpful, but there was insufficient evidence to recommend lifestyle changes for all patients with GERD. Instead, advice on lifestyle changes should be focused on appropriate patients.
• PPIs are more effective than H₂RAs in the treatment of GERD. Patients who do not respond to once-daily PPI therapy should be treated with twice-daily PPIs.
• The use of metoclopramide as monotherapy or adjunctive therapy for GERD is discouraged.
• Endoscopy should generally be the first procedure performed for patients with alarm symptoms associated with GERD, including weight loss, dysphagia, and abdominal mass. Endoscopy should also be offered to patients in whom twice-daily therapy with PPI fails.
• If endoscopy results are normal and PPI therapy continues to fail, manometry may be considered to measure esophageal peristaltic function and localize the lower esophageal sphincter for potential subsequent pH monitoring.
• pH monitoring may be performed in patients with normal endoscopy and manometry findings.
• Chronic cough, laryngitis, and asthma have associations with GERD, but acid-suppressive therapy is most effective for these extraesophageal syndromes when there is a concomitant esophageal GERD syndrome.
• The practice of routine endoscopic monitoring of patients with GERD to preclude progression to erosive esophagitis or dysplasia is discouraged.
• Once symptom control is established in GERD, PPIs may be titrated down to the lowest dose on the basis of symptom control. However, on-demand therapy for symptoms in patients with a history of erosive esophagitis has been associated with a higher risk for recurrence of erosive disease. These patients should be considered for continuous PPI therapy.
• For patients without a history of erosive disease and resolution of symptoms, the risks associated with cessation of PPI therapy for GERD appear to be minimal.
• The authors find insufficient evidence to recommend bone density studies, calcium supplementation, screening for infection with Helicobacter pylori, or other routine precautions because of a history of PPI use.
• PPI therapy is similar to antireflux surgery in efficacy against GERD, but PPI therapy should be considered first because of superior safety. Antireflux surgery might particularly help patients who respond to PPIs but who are intolerant of the associated adverse effects of this drug class.
• The balance of benefits and harms is too close to recommend antireflux surgery for patients with extraesophageal GERD symptoms despite PPI therapy. Antireflux surgery is associated with dysphagia, flatulence, an inability to belch, and other bowel symptoms.
• Antireflux surgery should not be used to prevent progression to cancer in patients with Barrett’s metaplasia.

Pearls for Practice

• When a diagnostic test for GERD is required, endoscopy is usually ordered before manometry or pH monitoring.
• The current position statement recommends the use of twice-daily PPI therapy for patients with GERD in whom treatment with daily PPI therapy fails. Long-term PPI therapy may be discontinued in patients without GERD symptoms except in those with a history of erosive esophagitis. There is insufficient evidence to recommend for or against routine bone density scanning or calcium supplementation in patients receiving PPIs.

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