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308 PRACTICE GUIDELINES nature publishing groupsee related editorial on page x
CME
Guidelines for the Diagnosis and Management of
Gastroesophageal Reflux Disease
Philip O. Katz, MD1, Lauren B. Gerson, MD, MSc2 and Marcelo F. Vela, MD, MSCR3
Downloaded from http://journals.lww.com/ajg by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC1y0abggQZXdgGj2MwlZLeI= on 07/05/2021
Am J Gastroenterol 2013; 108:308–328; doi:10.1038/ajg.2012.444; published online 19 February 2013
Gastroesophageal reflux disease (GERD) is arguably the most (further research would be expected to have an important impact
common disease encountered by the gastroenterologist. It is on the confidence in the estimate of the effect and would be likely
equally likely that the primary care providers will find that com- to change the estimate). The strength of a recommendation was
plaints related to reflux disease constitute a large proportion of graded as “strong” when the desirable effects of an intervention
their practice. The following guideline will provide an overview clearly outweigh the undesirable effects and as “conditional” when
of GERD and its presentation, and recommendations for the there is uncertainty about the trade-offs.
approach to diagnosis and management of this common and It is important to be aware that GERD is defined by consensus
important disease. and as such is a disease comprising symptoms, end-organ effects
The document will review the presentations of any risk factors and complications related to the reflux of gastric contents into
for GERD, the diagnostic modalities and their recommendation the esophagus, oral cavity, and/or the lung. Taking into account
for use and recommendations for medical, surgical and endo- the multiple consensus definitions previously published (3–5),
scopic management including comparative effectiveness of differ- the authors have used the following working definition to define
ent treatments. Extraesophageal symptoms and complications will the disease: GERD should be defined as symptoms or compli-
be addressed as will the evaluation and management of “refrac- cations resulting from the reflux of gastric contents into the
tory” GERD. The document will conclude with the potential risks esophagus or beyond, into the oral cavity (including larynx)
and side effects of the main treatments for GERD and their impli- or lung. GERD can be further classified as the presence of
cations for patient management. symptoms without erosions on endoscopic examination (non-
Each section of the document will present the key recommen- erosive disease or NERD) or GERD symptoms with erosions
dations related to the section topic and a subsequent summary present (ERD).
of the evidence supporting those recommendations. An overall
summary of the key recommendations is presented in Table 1.
A search of OVID Medline, Pubmed and ISI Web of Science was SYMPTOMS AND EPIDEMIOLOGY
conducted for the years from 1960–2011 using the following major Epidemiologic estimates of the prevalence of GERD are based pri-
search terms and subheadings including “heartburn”, “acid regur- marily on the typical symptoms of heartburn and regurgitation. A
gitation”, “GERD”, “lifestyle interventions”, “proton pump inhibitor systematic review found the prevalence of GERD to be 10–20% of
(PPI)”, “endoscopic surgery,” “extraesophageal symptoms,” “Nissen the Western world with a lower prevalence in Asia (6). Clinically
fundoplication,” and “GERD complications.” We used systematic troublesome heartburn is seen in about 6% of the population (7).
reviews and meta-analyses for each topic when available followed Regurgitation was reported in 16% in the systematic review noted
by a review of clinical trials. above. Chest pain may be a symptom of GERD, even the pre-
The GRADE system was used to evaluate the strength of the senting symptom (2,3). Distinguishing cardiac from non-cardiac
recommendations and the overall level of evidence (1,2). The level chest pain is required before considering GERD as a cause of chest
of evidence could range from “high” (implying that further research pain. Although the symptom of dysphagia can be associated with
was unlikely to change the authors’ confidence in the estimate of uncomplicated GERD, its presence warrants investigation for a
the effect) to “moderate” (further research would be likely to have potential complication including an underlying motility disorder,
an impact on the confidence in the estimate of effect) or “low” stricture, ring, or malignancy (8). Chronic cough, asthma, chronic
1
Division of Gastroenterology, Einstein Medical Center, Philadelphia, Pennsylvania, USA; 2Division of Gastroenterology and Hepatology, Stanford University School
of Medicine, Stanford, California, USA; 3Division of Gastroenterology, Baylor College of Medicine & Michael E. DeBakey VA Medical Center, Houston, Texas, USA.
Correspondence: Lauren B. Gerson, MD, MSc, Division of Gastroenterology and Hepatology, Stanford University School of Medicine, 450 Broadway Street,
4th Floor Pavilion C, MC: 6341, Redwood City, California 94063, USA. E-mail: lgersonmd@yahoo.com
Received 22 May 2012; accepted 10 December 2012
The American Journal of GASTROENTEROLOGY VOLUME 108 | MARCH 2013 www.amjgastro.com
, Guidelines for the Diagnosis and Management of GERD 309
Table 1. Summary and strength of recommendations
Establishing the diagnosis of Gastroesophageal Reflux Disease (GERD)
1. A presumptive diagnosis of GERD can be established in the setting of typical symptoms of heartburn and regurgitation. Empiric medical therapy with a proton pump
inhibitor (PPI) is recommended in this setting. (Strong recommendation, moderate level of evidence)
2. Patients with non-cardiac chest pain suspected due to GERD should have diagnostic evaluation before institution of therapy. (Conditional recommendation, moderate
level of evidence). A cardiac cause should be excluded in patients with chest pain before the commencement of a gastrointestinal evaluation (Strong recommendation,
low level of evidence)
3. Barium radiographs should not be performed to diagnose GERD (Strong recommendation, high level of evidence)
4. Upper endoscopy is not required in the presence of typical GERD symptoms. Endoscopy is recommended in the presence of alarm symptoms and for screening
of patients at high risk for complications. Repeat endoscopy is not indicated in patients without Barrett’s esophagus in the absence of new symptoms. (Strong recom-
mendation, moderate level of evidence)
5. Routine biopsies from the distal esophagus are not recommended specifically to diagnose GERD. (Strong recommendation, moderate level of evidence)
6. Esophageal manometry is recommended for preoperative evaluation, but has no role in the diagnosis of GERD. (Strong recommendation, low level of evidence)
7. Ambulatory esophageal reflux monitoring is indicated before consideration of endoscopic or surgical therapy in patients with non-erosive disease, as part of the
evaluation of patients refractory to PPI therapy, and in situations when the diagnosis of GERD is in question. (Strong recommendation, low level of evidence).
Ambulatory reflux monitoring is the only test that can assess reflux symptom association (strong recommendation, low level of evidence).
8. Ambulatory reflux monitoring is not required in the presence of short or long-segment Barrett’s esophagus to establish a diagnosis of GERD. (Strong
recommendation, moderate level of evidence)
9. Screening for Helicobacter pylori infection is not recommended in GERD patients. Treatment of H. pylori infection is not routinely required as part of antireflux therapy.
(Strong recommendation, low level of evidence)
Management of GERD
1. Weight loss is recommended for GERD patients who are overweight or have had recent weight gain. (Conditional recommendation, moderate level of evidence)
2. Head of bed elevation and avoidance of meals 2–3 h before bedtime should be recommended for patients with nocturnal GERD. (Conditional recommendation,
low level of evidence)
3. Routine global elimination of food that can trigger reflux (including chocolate, caffeine, alcohol, acidic and/or spicy foods) is not recommended in the treatment of
GERD. (Conditional recommendation, low level of evidence)
4. An 8-week course of PPIs is the therapy of choice for symptom relief and healing of erosive esophagitis. There are no major differences in efficacy between the different
PPIs. (Strong recommendation, high level of evidence)
5. Traditional delayed release PPIs should be administered 30–60 min before meal for maximal pH control. (Strong recommendation, moderate level of
evidence). Newer PPIs may offer dosing flexibility relative to meal timing. (Conditional recommendation, moderate level of evidence)
6. PPI therapy should be initiated at once a day dosing, before the first meal of the day. (Strong recommendation, moderate level of evidence). For patients with partial
response to once daily therapy, tailored therapy with adjustment of dose timing and/or twice daily dosing should be considered in patients with night-time symptoms,
variable schedules, and/or sleep disturbance. (Strong recommendation, low level of evidence).
7. Non-responders to PPI should be referred for evaluation. (Conditional recommendation, low level of evidence, see refractory GERD section).
8. In patients with partial response to PPI therapy, increasing the dose to twice daily therapy or switching to a different PPI may provide additional symptom relief. (Conditional
recommendation, low level evidence).
9. Maintenance PPI therapy should be administered for GERD patients who continue to have symptoms after PPI is discontinued, and in patients with complications
including erosive esophagitis and Barrett’s esophagus. (Strong recommendation, moderate level of evidence). For patients who require long-term PPI therapy, it should be
administered in the lowest effective dose, including on demand or intermittent therapy. (Conditional recommendation, low level of evidence)
10. H2-receptor antagonist (H2RA) therapy can be used as a maintenance option in patients without erosive disease if patients experience heartburn relief. (Conditional
recommendation, moderate level of evidence). Bedtime H2RA therapy can be added to daytime PPI therapy in selected patients with objective evidence of night-time
reflux if needed, but may be associated with the development of tachyphlaxis after several weeks of use. (Conditional recommendation, low level of evidence)
11. Therapy for GERD other than acid suppression, including prokinetic therapy and/or baclofen, should not be used in GERD patients without diagnostic evaluation.
(Conditional recommendation, moderate level of evidence)
12. There is no role for sucralfate in the non-pregnant GERD patient. (Conditional recommendation, moderate level of evidence)
13. PPIs are safe in pregnant patients if clinically indicated. (Conditional recommendation, moderate level of evidence)
Surgical options for GERD
1. Surgical therapy is a treatment option for long-term therapy in GERD patients. (Strong recommendation, high level of evidence)
2. Surgical therapy is generally not recommended in patients who do not respond to PPI therapy. (Strong recommendation, high level of evidence)
3. Preoperative ambulatory pH monitoring is mandatory in patients without evidence of erosive esophagitis. All patients should undergo preoperative
manometry to rule out achalasia or scleroderma-like esophagus. (Strong recommendation, moderate level of evidence)
4. Surgical therapy is as effective as medical therapy for carefully selected patients with chronic GERD when performed by an experienced surgeon.
(Strong recommendation, high level of evidence)
5. Obese patients contemplating surgical therapy for GERD should be considered for bariatric surgery. Gastric bypass would be the preferred operation in these patients.
(Conditional recommendation, moderate level of evidence)
6. The usage of current endoscopic therapy or transoral incisionless fundoplication cannot be recommended as an alternative to medical or traditional surgical therapy.
(Strong recommendation, moderate level of evidence)
© 2013 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY
, 310 Katz et al.
Table 1. Continued
Potential risks associated with PPIs
1. Switching PPIs can be considered in the setting of side-effects. (Conditional recommendation, low level of evidence)
2. Patients with known osteoporosis can remain on PPI therapy. Concern for hip fractures and osteoporosis should not affect the decision to use PPI long-term except in
patients with other risk factors for hip fracture. (Conditional recommendation, moderate level of evidence)
3. PPI therapy can be a risk factor for Clostridium difficile infection, and should be used with care in patients at risk. (Moderate recommendation, moderate level of
evidence)
4. Short-term PPI usage may increase the risk of community-acquired pneumonia. The risk does not appear elevated in long-term users. (Conditional recommendation,
moderate level of evidence)
5. PPI therapy does not need to be altered in concomitant clopidogrel users as there does not appear to be an increased risk for adverse cardiovascular events.
(Strong recommendation, high level of evidence)
Extraesophageal presentations of GERD: Asthma, chronic cough, and laryngitis
1. GERD can be considered as a potential co-factor in patients with asthma, chronic cough, or laryngitis. Careful evaluation for non-GERD causes should be undertaken in
all of these patients. (Strong recommendation, moderate level of evidence).
2. A diagnosis of reflux laryngitis should not be made based solely upon laryngoscopy findings. (Strong recommendation, moderate level of evidence)
3. A PPI trial is recommended to treat extraesophageal symptoms in patients who also have typical symptoms of GERD. (Strong recommendation, low level of evidence)
4. Upper endoscopy is not recommended as a means to establish a diagnosis of GERD-related asthma, chronic cough, or laryngitis. (Strong recommendation, low level of
evidence)
5. Reflux monitoring should be considered before a PPI trial in patients with extraesophageal symptoms who do not have typical symptoms of GERD.
(Conditional recommendation, low level of evidence)
6. Non-responders to a PPI trial should be considered for further diagnostic testing and are addressed in the refractory GERD section below. (Conditional recommendation,
low level of evidence)
7. Surgery should generally not be performed to treat extraesophageal symptoms of GERD in patients who do not respond to acid suppression with a PPI. (Strong
recommendation, moderate level of evidence)
GERD refractory to treatment with PPIs
1. The first step in management of refractory GERD is optimization of PPI therapy. (Strong recommendation, low level of evidence)
2. Upper endoscopy should be performed in refractory patients with typical or dyspeptic symptoms principally to exclude non-GERD etiologies. (Conditional recommendation,
low level of evidence)
3. In patients in whom extraesophageal symptoms of GERD persist despite PPI optimization, assessment for other etiologies should be pursued through concomitant
evaluation by ENT, pulmonary, and allergy specialists. (Strong recommendation, low level of evidence)
4. Patients with refractory GERD and negative evaluation by endoscopy (typical symptoms) or evaluation by ENT, pulmonary, and allergy specialists (extraesophageal
symptoms), should undergo ambulatory reflux monitoring. (Strong recommendation, low level of evidence)
5. Reflux monitoring off medication can be performed by any available modality (pH or impedance-pH). (Conditional recommendation, moderate level evidence). Testing on
medication should be performed with impedance-pH monitoring in order to enable measurement of nonacid reflux. (Strong recommendation, moderate level of evidence).
6. Refractory patients with objective evidence of ongoing reflux as the cause of symptoms should be considered for additional antireflux therapies, which may include
surgery or TLESR inhibitors. (Conditional recommendation, low level of evidence). Patients with negative testing are unlikely to have GERD and PPI therapy should be
discontinued. (Strong recommendation, low level of evidence)
Complications Associated with GERD
1. The Los Angeles (LA) classification system should be used when describing the endoscopic appearance of erosive esophagitis. (Strong recommendations, moderate level
of evidence). Patients with LA Grade A esophagitis should undergo further testing to confirm the presence of GERD. (Conditional recommendation, low level of evidence)
2. Repeat endoscopy should be performed in patients with severe erosive reflux disease after a course of antisecretory therapy to exclude underlying Barrett’s esophagus.
(Conditional recommendation, low level of evidence)
3. Continuous PPI therapy is recommended following peptic stricture dilation to improve dysphagia and reduce the need for repeated dilations. (Strong recommendation,
moderate level of evidence)
4. Injection of intralesional corticosteroids can be used in refractory, complex strictures due to GERD. (Conditional recommendation, low level of evidence)
5. Treatment with a PPI is suggested following dilation in patients with lower esophageal (Schatzki) rings. (Conditional recommendation, low level of evidence)
6. Screening for Barrett’s esophagus should be considered in patients with GERD who are at high risk based on epidemiologic profile. (Conditional
recommendation, moderate level of evidence)
7. Symptoms in patients with Barrett’s esophagus can be treated in a similar fashion to patients with GERD who do not have Barrett’s esophagus. (Strong recommendation,
moderate level of evidence)
8. Patients with Barrett’s esophagus found at endoscopy should undergo periodic surveillance according to guidelines. (Strong recommendation, moderate level of evidence)
ENT, ear, nose, and throat; GERD, gastroesophageal reflux disease; LA, Los Angeles; PPI, proton pump inhibitor.
The American Journal of GASTROENTEROLOGY VOLUME 108 | MARCH 2013 www.amjgastro.com
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