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## Complete Summary

#### GUIDELINE TITLE

Initial management of dyspepsia and GERD.

#### BIBLIOGRAPHIC SOURCE(S)

Institute for Clinical Systems Improvement (ICSI). Initial management of
dyspepsia and GERD. Bloomington (MN): Institute for Clinical Systems
Improvement (ICSI); 2006 Jul. 53 p. \[100 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Dyspepsia and GERD.
Bloomington (MN): Institute for Clinical Systems Improvement (ICSI);
2004 Jul. 50 p.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory and/or
warning information has been released.

-   [May 2, 2007, Antidepressant
    drugs](http://www.fda.gov/medwatch/safety/2007/safety07.htm#Antidepressant):
    Update to the existing black box warning on the prescribing
    information on all antidepressant medications to include warnings
    about the increased risks of suicidal thinking and behavior in young
    adults ages 18 to 24 years old during the first one to two months of
    treatment.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

-   Dyspepsia, including gastric ulcer dyspepsia; duodenal ulcer
    dyspepsia; or non-ulcer (functional) dyspepsia

-   Gastroesophageal reflux disease (GERD)

#### GUIDELINE CATEGORY

Diagnosis\
Evaluation\
Management\
Treatment

#### CLINICAL SPECIALTY

Family Practice\
Gastroenterology\
Internal Medicine\
Radiology

#### INTENDED USERS

Advanced Practice Nurses\
Allied Health Personnel\
Health Care Providers\
Health Plans\
Hospitals\
Managed Care Organizations\
Nurses\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

-   To increase the use of recommended methods for evaluating dyspepsia

-   To increase appropriate pharmaceutical treatment of patients with
    dyspepsia

-   To decrease complications associated with peptic ulcer disease

-   To improve functional outcomes and satisfaction of patients with
    dyspepsia

-   To increase the use of initial treatment recommendations for
    evaluating gastroesophageal reflux disease (GERD)

-   To increase appropriate treatment for patients who have ongoing
    symptoms after initial treatment recommendations

#### TARGET POPULATION

Adult males and non-pregnant adult females with symptoms of epigastric
pain or discomfort on greater than 25% of days over the past 4 weeks.
Individuals with nausea, heartburn or acid regurgitation are eligible
.This guideline does not stipulate the exact symptoms that define
dyspepsia, thus allowing the clinician some latitude in identifying the
patients to whom this guideline can be applied.

Patients with atypical symptoms (e.g., laryngopharyngeal reflux \[LPR\],
odynophagia, water brash, globus sensation, laryngitis, chronic cough,
asthma, and chest pain) are not covered in this guideline but may be
included if either heartburn or regurgitation are the primary presenting
symptoms.

This guideline does not apply to patients whose symptoms are
characteristic of biliary tract disease, pancreatic disease, or
irritable bowel syndrome.

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Dyspepsia**

**Diagnostic Assessment**

1.  Medical history including history of prior documented ulcer

2.  Evaluate symptoms, with particular attention to presence of alarm
    features

3.  Endoscopy

4.  Multiphase upper gastrointestinal (UGI) studies

5.  *Helicobacter pylori (H. pylori)* testing (stool antigen, serology,
    or urea breath testing \[UBT\])

6.  Evaluation for increased risk of gastric cancer

7.  Biopsy for *H. pylori*

**Treatment**

1.  Eradicative therapy for *H. pylori*  consisting of proton pump
    inhibitor (PPI) in combination with other drugs, including
    antibiotics (e.g., clarithromycin, amoxicillin, tetracycline,
    metronidazole) and bismuth

2.  Acid suppression with full-dose PPI in absence of *H. pylori*

3.  Discontinuation of nonsteroidal anti-inflammatory drugs

4.  Smoking cessation

5.  Referral to gastroenterology for refractory cases

**Gastroesophageal Reflux Disease (GERD)**

**Diagnostic Assessment**

1.  Flexible esophagogastroduodenoscopy

2.  24-hour pH monitoring

**Treatment**

1.  Behavioral/lifestyle modifications

    -   Dietary changes (avoid caffeine, chocolate, fats, alcohol,
        decaffeinated tea and coffee, caffeinated soft drinks, citrus
        juices, peppermint, and spearmint)

    -   Weight loss

    -   Avoiding large meals

    -   Body positioning (avoid lying down after eating, elevating head
        of bed)

    -   Tobacco cessation

2.  Changing medications that can lower the lower esophageal sphincter
    (LES), such as theophylline, calcium channel blockers, and
    barbiturates

3.  Use of antacids and over-the-counter PPIs

4.  Step-down therapy

5.  PPIs or histamine-2-receptor antagonists for patients with
    refractory reflux

#### MAJOR OUTCOMES CONSIDERED

-   Efficacy of *Helicobacter pylori* testing (positive or negative)

-   Sensitivity, specificity, positive and negative predictive value of
    diagnostic instruments

-   Efficacy/side effects of medications

-   Recurrence of peptic ulcer disease

-   Recurrence of esophagitis

-   Incidence and risk factors of gastric cancer

-   Healing rates

-   Costs of diagnostic tests and treatments

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Key conclusions (as determined by the work group) are supported by a
conclusion grading worksheet that summarizes the important studies
pertaining to the conclusion. Individual studies are classed according
to the system presented below, and are designated as positive, negative,
or neutral to reflect the study quality.

**Conclusion Grades**:

**Grade I**: The evidence consists of results from studies of strong
design for answering the question addressed. The results are both
clinically important and consistent with minor exceptions at most. The
results are free of any significant doubts about generalizability, bias,
and flaws in research design. Studies with negative results have
sufficiently large samples to have adequate statistical power.

**Grade II**: The evidence consists of results from studies of strong
design for answering the question addressed, but there is some
uncertainty attached to the conclusion because of inconsistencies among
the results from the studies or because of minor doubts about
generalizability, bias, research design flaws, or adequacy of sample
size. Alternatively, the evidence consists solely of results from weaker
designs for the question addressed, but the results have been confirmed
in separate studies and are consistent with minor exceptions at most.

**Grade III**: The evidence consists of results from studies of strong
design for answering the question addressed, but there is substantial
uncertainty attached to the conclusion because of inconsistencies among
the results of different studies or because of serious doubts about
generalizability, bias, research design flaws, or adequacy of sample
size. Alternatively, the evidence consists solely of results from a
limited number of studies of weak design for answering the question
addressed.

**Grade Not Assignable**: There is no evidence available that directly
supports or refutes the conclusion.

**Study Quality Designations**:

The quality of the primary research reports and systematic reviews are
designated in the following ways on the conclusion grading worksheets:

**Positive**: indicates that the report or review has clearly addressed
issues of inclusion/exclusion, bias, generalizability, and data
collection and analysis.

**Negative**: indicates that these issues (inclusion/exclusion, bias,
generalizability, and data collection and analysis) have not been
adequately addressed.

**Neutral**: indicates that the report or review is neither
exceptionally strong nor exceptionally weak.

**Not Applicable**: indicates that the report is not a primary reference
or a systematic review and therefore the quality has not been assessed.

**Classes of Research Reports**:

A.  Primary Reports of New Data Collection:

> Class A:

-   Randomized, controlled trial

> Class B:

-   Cohort study

> Class C:

-   Nonrandomized trial with concurrent or historical controls

-   Case-control study

-   Study of sensitivity and specificity of a diagnostic test

-   Population-based descriptive study

> Class D:

-   Cross-sectional study

-   Case series

-   Case report

B.  Reports that Synthesize or Reflect upon Collections of Primary
    Reports:

> Class M:

-   Meta-analysis

-   Systematic review

-   Decision analysis

-   Cost-effectiveness analysis

> Class R:

-   Consensus statement

-   Consensus report

-   Narrative review

> Class X:

-   Medical opinion

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

*Helicobacter pylori* testing without endoscopy, followed by eradication
treatment for patients with positive results is a cost-effective
approach for initial long-term management of dyspepsia. (See Conclusion
Grading Worksheet C -- Annotation #10 in the original guideline
document).

Additional cost-benefit analyses have been reviewed, including analyses
of initial endoscopy and proton pump inhibitors. Refer to the original
guideline document for details.

#### METHOD OF GUIDELINE VALIDATION

Clinical Validation-Pilot Testing\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

**Institute Partners: System-Wide Review**

The guideline draft, discussion, and measurement specification documents
undergo thorough review. Written comments are solicited from clinical,
measurement, and management experts from within the member medical
groups during an eight-week period of \"Critical Review.\"

Each of the Institute\'s participating medical groups determines its own
process for distributing the guideline and obtaining feedback.
Clinicians are asked to suggest modifications based on their
understanding of the clinical literature coupled with their clinical
expertise. Representatives from all departments involved in
implementation and measurement review the guideline to determine its
operational impact. Measurement specifications for selected measures are
developed by the Institute for Clinical Systems Improvement (ICSI) in
collaboration with participating medical groups following general
implementation of the guideline. The specifications suggest approaches
to operationalizing the measure.

**Guideline Work Group: Second Draft**

Following the completion of the \"Critical Review\" period, the
guideline work group meets 1 to 2 times to review the input received.
The original guideline is revised as necessary, and a written response
is prepared to address each of the suggestions received from medical
groups. Two members of the Preventive Services Steering Committee
carefully review the Critical Review input, the work group responses,
and the revised draft of the guideline. They report to the entire
committee their assessment of two questions: (1) Have the concerns of
the medical groups been adequately addressed? (2) Are the medical groups
willing and able to implement the guideline? The committee then either
approves the guideline for pilot testing as submitted or negotiates
changes with the work group representative present at the meeting.

**Pilot Test**

Medical groups introduce the guideline at pilot sites, providing
training to the clinical staff and incorporating it into the
organization\'s scheduling, computer, and other practice systems.
Evaluation and assessment occurs throughout the pilot test phase, which
usually lasts for three months. Comments and suggestions are solicited
in the same manner as used during the \"Critical Review\" phase.

The guideline work group meets to review the pilot sites\' experiences
and makes the necessary revisions to the guideline, and the Preventive
Services Steering Committee reviews the revised guideline and approves
it for implementation.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**Note from the National Guideline Clearinghouse (NGC) and the Institute
for Clinical Systems Improvement (ICSI)**: In addition to updating their
clinical guidance, ICSI has developed a new format for all guidelines.
Key additions and changes include: combination of the annotation and
discussion section; the addition of \"Key Points\" at the beginning of
most annotations; the inclusion of references supporting the
recommendations; and a complete list of references in the Supporting
Evidence section of the guideline. For a description of what has changed
since the previous version of this guidance, refer to [Summary of
Changes -- July
2006](http://www.icsi.org/guidelines_and_more/guidelines__order_sets___protocols/other_health_care_conditions/dyspepsia_gerd/dyspepsia___gerd_.html).

The recommendations for the management of dyspepsia are presented in the
form of a primary algorithm,
[Dyspepsia](http://www.guideline.gov/algorithm/5174/NGC-5174_1.html),
with 21 components, and a secondary algorithm, [Gastroesophageal Reflux
Disease
(GERD)](http://www.guideline.gov/algorithm/5174/NGC-5174_2.html), with
an additional 13 components (for a total of 34 components), accompanied
by detailed annotations. Clinical highlights and selected annotations
(numbered to correspond with the algorithm) follow.

Class of evidence (A-D, M, R, X) and conclusion grade (I-III and Not
Assignable) definitions are repeated at the end of the \"Major
Recommendations\" field.

**Clinical Highlights**

-   Send patients with dyspepsia plus one of the following alarm
    features for urgent endoscopic evaluation. Suggested time frames for
    the urgency of endoscopy are provided with each of the alarm
    features listed. (*Annotations #3, 4*)

    -   Melena (*within 1 day if ill*)

    -   Hematemesis (*within 1 day if ill*)

    -   Persistent vomiting (*7-10 days*)

    -   Anemia (*7-10 days*)

    -   Acute onset of total dysphagia (*within 1 day*)

    -   Weight loss greater than 5% (involuntary) (*7-10 days*)

-   Patients 55 years of age and older with symptoms of uncomplicated
    dyspepsia should be evaluated with nonurgent upper endoscopy.
    (*Annotation #8*)

-   Patients with dyspepsia, but no alarm features or reflux symptoms,
    should receive *Helicobacter pylori* testing and if positive,
    eradicative therapy. (*Annotations #5, 6, 10, 11*)

-   Stool antigen is the preferred test for *H. pylori* in
    uninvestigated dyspepsia. (*Annotation #6*)

-   Patients with dyspepsia and negative testing results for *H. pylori*
    should be treated empirically with proton pump inhibitors (PPIs).
    (*Annotation #12*)

-   Patients age 50 or older and who have had symptoms of GERD for 10
    years or more should be considered for endoscopy during initial
    management. (*Annotation #25*)

-   Patients with gastroesophageal reflux should receive single trial
    step-down therapy. (*Annotations #25, 29, 30, 31, 34*)

-   Patients with GERD usually require long-term PPI therapy.
    (*Annotation #34*)

-   Patients with GERD usually do not require *H. pylori* testing.
    (*Annotation #34*)

[**Dyspepsia Algorithm
Annotations**](http://www.guideline.gov/algorithm/5174/NGC-5174_1.html)

1.  **Symptoms of Dyspepsia or GERD**

> **Key Points**:

-   Dyspepsia is defined as pain or discomfort felt to arise in the
    upper gastrointestinal tract with symptoms on greater than 25% of
    the days over the past four weeks.

-   GERD is the probable diagnosis if the patient has heartburn
    (retrosternal pain) or acid regurgitation (a sour or bitter taste in
    mouth) as the dominant symptom.

> **Dyspepsia**
>
> This guideline does not stipulate the exact symptoms that define
> dyspepsia, thus allowing the clinician some latitude in identifying
> the patients to whom this guideline can be applied.
>
> In this guideline, dyspepsia is defined as pain or discomfort felt to
> arise in the upper gastrointestinal (GI) tract with symptoms on
> greater than 25% of days over the past 4 weeks. Patients with
> epigastric pain or discomfort, or nausea are eligible. The emphasis is
> on pain or discomfort which is present in the epigastrium. The upper
> GI tract includes the stomach, distal esophagus and proximal duodenum.
> Patients should have symptoms at least seven days a month. This
> guideline should not be applied to patients with symptoms that are
> occasional (i.e., one day a week or less) or acute (i.e., present less
> than one week). However, patients with symptoms every day for seven
> days are eligible. Most of the patients will have symptoms which the
> clinician feels are suspicious for either peptic ulcer disease (PUD)
> or gastroesophageal reflux disease (GERD).
>
> Many other conditions may present with upper abdominal pain. This
> guideline should not be applied to patients in whom the clinician is
> suspicious of biliary tract disease or pancreatic disease. Thus,
> patients with right upper quadrant pain, inter-scapular pain, or pain
> that radiates straight through to the back should not be included.
> Similarly, patients with fever, jaundice, pruritis or other signs of
> biliary obstruction should not be included.
>
> Irritable bowel syndrome (IBS) is a common condition which may
> manifest as upper abdominal pain. Like dyspepsia, IBS represents a
> constellation of symptoms. An international panel of experts defined
> IBS as chronic or recurrent abdominal pain, relieved by defecation or
> associated with a change in the frequency or consistency of stool.
>
> Many patients who meet the definition of dyspepsia will also meet the
> definition of IBS. Physicians should use discretion in utilizing this
> guideline. Patients with typical IBS symptoms and minimal upper gut
> symptoms should not be included, whereas patients with typical
> dyspepsia and minimal bowel complaints should be included. Patients
> with significant overlap should be included if the dyspepsia symptoms
> are the primary reason for the patient to seek medical care.
>
> **GERD**
>
> GERD is the probable diagnosis if the patient has heartburn
> (retrosternal pain) or acid regurgitation (a sour or bitter taste in
> mouth) as the dominant symptom. These symptoms are sought because
> their presence is associated with a probability of 89% and 95%,
> respectively, of GERD based on studies using esophageal pH monitoring
> as the reference standard. The goal is to minimize the number of
> patients with ulcer referred to the GERD algorithm.
>
> In this guideline, the focus is on the most prominent symptoms of
> heartburn and acid regurgitation. Atypical manifestations such as
> laryngopharyngeal reflux (LPR), odynophagia, water brash, globus
> sensation, laryngitis, chronic cough, asthma and chest pain are other
> possible presentations. With some of these symptoms their causes could
> be multiple and there is some controversy as to the role GERD plays.
> Patients with these symptoms may be included if either heartburn or
> regurgitation are the primary presenting symptoms, but providers
> clinical judgment should be used.
>
> ***Evidence supporting this recommendation is of classes: C, R***

3.  **Are There Alarm Features?**

> Alarm features should be sought in all patients presenting with
> dyspepsia. If alarm features are present, endoscopy should be
> performed (suggested time frames for urgency of endoscopy are provided
> with each of the alarm features listed). Alarm features is a term that
> is used frequently in the dyspepsia literature to describe clinical
> features that may suggest underlying disease that should be diagnosed
> and treated without the delay of an empiric therapeutic trial. Alarm
> features frequently cited are:

-   Anemia (*7-10 days*)

-   Acute onset dysphagia (*within 1 day*)

-   Hematemesis (*within 1 day if ill*)

-   Melena (*within 1 day if ill*)

-   Persistent vomiting (*7-10 days*)

-   Weight loss greater than 5% (involuntary) (*7-10 days*)

> ***Evidence supporting this recommendation is of class: D***

4.  **Endoscopy for Alarm Features/Out of Guideline**

> **Key Points**:

-   Patients with alarm features need urgent endoscopic evaluation.

> Endoscopy is the procedure of choice for evaluation of dyspepsia. A
> single contrast barium study is not an acceptable alternative.
> Multiphase upper gastrointestinal (UGI) studies performed by
> radiologists with specific training in gastrointestinal radiology are
> an acceptable alternative to endoscopy. In some settings endoscopy may
> be done by a general surgeon.
>
> If specialty radiologic expertise with multiphase barium UGI is
> available, UGI study should be viewed as an alternative to endoscopy.
> Otherwise, endoscopy provides greater sensitivity for the diagnosis of
> peptic ulcer disease. \[*Conclusion Grade III: See Conclusion Grading
> Worksheet A - of the original guideline document - Annotation #4
> (Endoscopy)*\].
>
> ***Evidence supporting this recommendation is of classes: A, C***

5.  **Prior Documented Ulcer?**

> In patients presenting with dyspepsia and a prior documented ulcer,
> referral to either a gastroenterologist or direct-access endoscopy is
> appropriate. Documentation of the prior ulcer must include an
> endoscopy or barium UGI report confirming the presence of an ulcer.

6.  ***H. pylori* Testing, Eradication/Case Management**

> **Key Point**:

-   Testing and treatment of *H. pylori* is the cornerstone of the
    management of peptic ulcer disease.

-   Maintenance PPI treatment is not indicated for those experiencing
    symptom resolution after treatment. Patients with complicated peptic
    ulcer disease may be considered for maintenance treatment using PPI
    at one-half the therapeutic dose after successful treatment.

-   Documenting *H. pylori* eradication should be limited to those with
    a history of complicated peptic ulcer disease.

> Case management should begin with *H. pylori* testing. Several tests
> are available with different sensitivity, specificity, and costs
> (refer to the \"Diagnostic Tests for *Helicobacter Pylori\"* Table in
> the original guideline document). Those who are positive should
> receive eradicative therapy. (Refer to Main Algorithm Annotation #10,
> \"Is *H. pylori* Infection Present?\" and Annotation #11, \"Treatment
> for *H. pylori*.\").
>
> Stool antigen is now the non-invasive office test of choice due to its
> high positive likelihood ratio (LR) over serologic testing. Stool
> antigen can also be used as a test of cure while serology cannot.
>
> Recall that the patient must discontinue PPI for 2 weeks for Urea
> Breath Test (UBT) and stool antigen testing.
>
> Patients who continue nonsteroidal anti-inflammatory drugs (NSAIDs)
> during treatment for peptic ulcers should have the duration of PPI
> treatment extended to twelve weeks total.
>
> Symptoms continuing for a month or more into treatment should prompt
> endoscopy regardless of initial treatment. Further evaluation may be
> necessary.
>
> Maintenance PPI treatment is not indicated for those experiencing
> symptom resolution after treatment. Patients with complicated peptic
> ulcer disease may be considered for maintenance treatment using PPI at
> one-half the therapeutic dose after successful treatment. Documenting
> *H. pylori* eradication should be limited to those with a history of
> complicated peptic ulcer disease.
>
> ***Evidence supporting this recommendation is of classes: A, C, D, M,
> R***

8.  **Is Patient Age 55 or Older, or at Increased Risk of Gastric
    Cancer?**

> **Key Points**:

-   A small number of patients presenting with dyspepsia will have
    gastric cancer.

-   When treating an immigrant population from East Asia and East
    Europe, the higher risk of gastric cancer may be considered an alarm
    feature prompting early endoscopy.

> Environmental and genetic factors along with a number of disorders are
> associated with an increased risk of gastric cancer. The precursor
> conditions associated with increased risk for gastric cancer include
> chronic atrophic gastritis and intestinal metaplasia, pernicious
> anemia, benign gastric ulcer disease, *H. pylori* infection,
> Menetrier\'s disease, gastric adenomatous polyps, immunodeficiency
> syndromes, and Barrett\'s esophagus.
>
> Genetic and environmental factors for an increased risk of gastric
> cancer include a family history of gastric cancer, blood type A,
> hereditary nonpolyposis colon cancer syndrome, low consumption of
> fruits and vegetables, consumption of salted, smoked, or poorly
> preserved foods, cigarette smoking, alcohol use, and obesity.
>
> Esophagogastroduodenoscopy, performed within 4 weeks, may be
> appropriate in patients age 55 or over who have no obvious
> environmental and genetic risks because the incidence of gastric
> cancer is increased, but no study to date has shown improved outcomes.
> \[*Conclusion Grade II: See Conclusion Grading Worksheet B of the
> original guideline document - Annotation #8*
> (Esophagogastroduodenoscopy)\].
>
> Initial endoscopy may be cost-effective in this age group; however,
> sensitivity analysis shows the cost effectiveness is driven by the
> cost of endoscopy and so will vary.
>
> ***Evidence supporting this recommendation is of classes: A, C, D***

10. **Is *H. pylori* Infection Present?**

> **Key Points**:

-   In most patients with dyspepsia, testing for *H. pylori* infection
    is the first step.

> An approach to possible gastric or duodenal ulcer disease should
> include a strategy to eliminate *H. pylori*. Sensitive and specific
> point-of-care testing is commercially available and can provide 5 to
> 10 minute turnaround using whole blood, serum, or plasma. *H. pylori*
> urea breath testing (UBT) has similar sensitivity and superior
> specificity. If the cost and availability of UBT is similar to
> serology in the local practice environment, it would be the preferred
> test.
>
> *H. pylori* testing without endoscopy, followed by eradication
> treatment for patients with positive results, is a cost-effective
> approach for initial long-term management of dyspepsia. \[*Conclusion
> Grade II: See Conclusion Grading Worksheet C- of the original
> guideline document, - Annotation #10 (H. Pylori Testing)*\]
>
> The UBT is the test of choice in those situations where post-treatment
> testing is required. Post-treatment testing is not generally
> recommended. This testing may however be indicated in selected
> patients with complicated ulcer disease, low-grade gastric mucosa
> associated lymphoid tissue (MALT) lymphoma and following resection of
> early gastric cancer.
>
> If testing is performed for eradication, it should be delayed at least
> 4 weeks after the completion of therapy and/or the use of proton pump
> inhibitors. This permits a differentiation between suppression and
> eradication of H. pylori. Serology is not useful in this situation as
> antibody levels commonly remain elevated for months to years after
> successful treatment.
>
> ***Evidence supporting this recommendation is of classes: A, C, M,
> R***

11. **Treatment for *H. pylori***

> **Key Points**:

-   Many regimens are effective in treating *H. pylori*. However, all
    regimens require more than one drug.

> There are multiple regimens U.S. Food and Drug Administration (FDA)
> approved for treatment of *H. Pylori*. In addition, many more are
> published in the literature. The two therapies listed in the original
> guideline document are equally effective in eradicating *H. pylori*
> (95% effective) and in preventing gastrointestinal ulcer recurrence
> (80% effective). These two therapies represent a combination of ease
> of adherence and cost. Patient adherence is very important. The
> patient can and should take all drugs simultaneously. The choice of
> regimen may be influenced by frequency of dosing or patient tolerance
> or highly variable local acquisition costs.
>
> Regardless of which therapy course is chosen, patients with
> significant symptoms at presentation may continue to use a standard
> dose of a PPI for 3 extra weeks at the end of the combination drug
> treatment. The optimal rates of eradication are obtained within 14-day
> dosing but 7-day dosing are almost similar.
>
> See the original guideline document for examples of two treatment
> therapies with specific 7- to 14-day dosing.

12. **Empiric Trial of Full Dose PPI/Address NSAID Use**

> **Key Points**:

-   Patients without *H. pylori* should receive acid-suppression therapy
    to block acids.

-   Dyspeptic patients may have peptic ulcers even if testing for *H.
    pylori* is negative. A symptomatic response to 4 weeks of PPI
    suggests that an 8 to 12 week course of PPI may be curative. If
    aspirin or NSAIDs can\'t be stopped, the odds of a response to a PPI
    and the rapidity of that response are increased.

> **Empiric Trial**
>
> The available delayed-release proton pump inhibitors (PPIs --
> omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole)
> appear to be equivalent in efficacy in the management of acid-peptic
> disorders when given in equipotent acid-suppressive doses. Adverse
> event profiles for these delayed-release formulations are also
> similar. Full-dose therapy for four weeks as an empiric trial is
> recommended.
>
> Please refer to the original guideline document for generic names,
> trade names and dosing suggestions of proton pump inhibitors (PPI).
>
> **NSAIDs**
>
> **Patients on nonsteroidal anti-inflammatory drugs (NSAIDs)**
>
> Patients on NSAIDs should have these discontinued if possible. If it
> is not possible to discontinue NSAIDs, a duration of PPI therapy of 12
> weeks is recommended. This recommendation is based on well documented
> higher healing rates in patients with gastric as well as duodenal
> ulcers treated for a duration of twelve weeks compared to eight weeks.
> (See also Main Algorithm Annotation #17 \"Case Management/Out of
> Guideline\").
>
> ***Evidence supporting this recommendation is of classes: A, D, R***

13. **Symptoms Persist \>4 Weeks?**

> Although ulcer healing may take 8 weeks or more, the majority of
> patients with a gastric or duodenal ulcer have improvement in symptoms
> at 4 weeks. Moreover, study shows that the yield of
> esophagogastroduodenoscopy is improved by limiting evaluation to those
> with persistent symptoms persisting despite a short course of therapy.
>
> ***Evidence supporting this recommendation is of classes: A, D***

14. **Management of Symptomatic Relapse**

> Dyspepsia often comes and goes. Some patients will experience
> recurrent symptoms despite symptom resolution with the initial
> management. In past guidelines, these patients were referred for
> endoscopy primarily to exclude the possibility of cancer. However, the
> diagnostic yield of endoscopy in this situation is low. Patients who
> are thought to be at very low risk of gastric cancer (based primarily
> on younger age) may be managed without endoscopy. If the patient had
> an *H. pylori* infection previously (Annotation #10, \"Is *H. pylori*
> Infection Present?\") then testing for eradication with either a stool
> antigen test or a breath test would be reasonable. If persistent *H.
> pylori* infection is identified, then retreatment with a regimen
> different from the regimen used earlier (Annotation #11, \"Treatment
> for *H. pylori*\") would be appropriate. If the patient was *H.
> pylori* negative either at time of initial management or at the time
> of the testing of eradication then another trial of acid suppression
> could be considered (Annotation #12, \"Empiric Trial of Full Dose
> PPI/Address NSAID Use\"). If symptoms resolve, no further care is
> necessary. If symptoms persist then an endoscopy should be considered.
>
> ***Evidence supporting this recommendation is of class: X***

16. **Endoscopy Positive?**

> Endoscopy is the procedure of choice in most situations for evaluation
> of dyspepsia. If an ulcer is seen, a biopsy for *H. pylori* should be
> taken. A single contrast barium study is not an acceptable
> alternative. Multiphasic UGI studies performed by radiologists with
> specific training in gastrointestinal radiology are an acceptable
> alternative to endoscopy.

17. **Case Management/Out of Guideline**

> Patients with an ulcer should have an *H. pylori* breath test if their
> stomach was not biopsied at the time of endoscopy. Treatment to
> eradicate *H. pylori* should be provided to those infected. If
> previously treated for *H. pylori*, a different regimen should be used
> and provided. Metronidazole should be substituted for amoxicillin in
> the patient who has received amoxicillin previously. If not infected
> with *H. pylori*, review NSAID use and smoking history as appropriate.
> If esophagitis is seen, refer to the GERD Algorithm (#22).
>
> Specific referral to gastroenterology may need to be considered for
> refractory cases.
>
> Also refer to Annotation #6, \"*H. pylori* Testing, Eradication/Case
> Management.\"
>
> ***Evidence supporting this recommendation is of class: C***

18. **Continue Treatment for 8 Weeks Total Course and Then Stop**

> **Key Points**:

-   Patients with dyspepsia should not receive therapy indefinitely.

> Data on healing rates in both gastric and duodenal ulcers suggest that
> treatment with antiulcer agents should be continued to complete a
> course of eight weeks. The most effective agent for the majority of
> patients is PPI. Patients who continue NSAIDs during treatment for
> peptic ulcers, particularly gastric ulcers, should have the duration
> of PPI treatment extended to twelve weeks total.
>
> See original guideline document for more discussion related to
> treatment of duodenal ulcer, gastric ulcer healing, and NSAID use.
>
> ***Evidence supporting this recommendation is of classes: A, R***

19. **Functional Dyspepsia**

> **Key Points**:

-   When no structural or biochemical abnormalities are identified to
    explain symptoms, patients may be given a diagnosis of functional or
    non-ulcer dyspepsia.

> Additional testing may be necessary, but overtesting, overtreatment,
> and over-referral should be avoided. Short-term empiric trials could
> be considered.
>
> Patients presenting with dyspepsia will frequently have no
> identifiable abnormalities on endoscopy. When no structural or
> biochemical abnormalities are identified to explain their symptoms,
> these patients may be given a diagnosis of functional or non-ulcer
> dyspepsia. Such patients require reassurance, and further diagnostic
> testing should be kept to a minimum. No medical treatment is clearly
> of proven benefit. At present, no firm recommendations can be made
> regarding the management of non-ulcer dyspepsia. Further care for
> functional dyspepsia should be done on a case by case basis.
> Eradication of *H. pylori* (if not already done), treatment with a PPI
> (if not already done), prokinetic or low-dose tricyclic
> antidepressant, and exploration of the contribution of psychologic
> distress may prove beneficial. Elimination of certain foods (e.g.,
> caffeine, alcohol, fat, etc.) or medications (e.g., NSAIDs) may help.
>
> Specific referral to gastroenterology may need to be considered for
> refractory cases.
>
> ***Evidence supporting this recommendation is of classes: A, R***

[**Gastroesophageal Reflux Disease (GERD) Algorithm
Annotations**](http://www.guideline.gov/algorithm/5174/NGC-5174_2.html)

22. **Symptoms of GERD**

> **Key Points**:

-   The goal is to minimize the number of patients with ulcer referred
    to the GERD algorithm.

> GERD is the probable diagnosis if the patient has heartburn
> (retrosternal pain) or acid regurgitation (a sour or bitter taste in
> mouth) as the dominant symptom. These symptoms are sought because
> their presence is associated with a probability of 89% and 95%,
> respectively, of GERD based on studies using esophageal pH monitoring
> as the reference standard. The goal is to minimize the number of
> patients with ulcer referred to the GERD algorithm.
>
> Atypical manifestations of GERD such as laryngopharyngeal reflux
> (LPR), odynophagia, water brash, globus sensation, laryngitis, chronic
> cough, asthma, and chest pain can also be the presenting symptoms for
> multiple other medical diagnoses. As previously mentioned, the role of
> GERD in several of these entities is uncertain and controversial.
> Therefore, these symptoms fall out of the scope of this guideline.

23. **Are there Alarm Features?**

> Alarm features should be sought in all patients presenting with GERD.
> If alarm features are present, endoscopy should be performed
> (suggested time frames for urgency of endoscopy have been provided in
> italics behind each of the alarm features listed). Alarm features is a
> term that is used frequently in the dyspepsia literature to describe
> clinical features that may suggest underlying disease that should be
> diagnosed and treated without the delay of an empiric therapeutic
> trial. Alarm features frequently cited are:

-   Anemia (*7-10 days*)

-   Acute onset of total dysphagia (*within 1 day*)

-   Hematemesis (*within 1 day if ill*)

-   Melena (*within 1 day if ill*)

-   Persistent vomiting (*7-10 days*)

-   Weight loss greater than 5% (involuntary) (*7-10 days*)

> For further discussions, please refer to \"The Significance of
> Complicated Dyspepsia\" section in Annotation #3 in the original
> guideline document.

25. **Initial Management (8 Weeks)**

> **Key Points**:

-   Patients with GERD may be treated without initial endoscopy.

> Initial treatment of GERD should consist of an eight-week trial of PPI
> therapy, more long-term behavioral modifications, and possibly
> endoscopy, designed to help reduce reflux both structurally and
> promoting proper function of the lower esophageal sphincter (LES), and
> also reducing acidity of gastric juices.
>
> Please refer to the original guideline document for generic names,
> trade names and dosing suggestions of proton pump inhibitors (PPI).

1.  Dietary changes

    A.  Avoid caffeine, chocolate, fats, alcohol, caffeinated and
        decaffeinated tea and coffee, caffeinated soft drinks, citrus
        juices, peppermint, and spearmint.

    B.  Weight loss if indicated.

    C.  Avoid large meals that may increase intra-abdominal pressure.

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2.  Avoid lying down after eating for 2 to 3 hours.

3.  Elevate the head of the bed by 6 to 8 inches.

4.  Avoid use of tobacco, with promotion of tobacco and nicotine
    cessation. Also consider changing medications that can lower the LES
    pressure (i.e., Theophylline, calcium channel blockers, and
    barbiturates).

5.  Use of antacids on an as needed basis as well as the use of
    over-the-counter PPI may be of benefit.

> These modifications may also take longer than eight weeks to implement
> for the best effect (i.e., weight loss and tobacco and alcohol abuse).
> These factors should be rediscussed with the patient in each
> subsequent phase of treatment for GERD.
>
> For patients age 50 and more or who have had symptoms for 10 years or
> more, consider endoscopy prior to treatments to evaluate for
> Barrett\'s esophagus.
>
> Following up at 8 weeks to see if there has been some improvement in
> symptoms may be done. If there is no improvement, the patient should
> be referred for endoscopy.
>
> If these modifications have already been tried by the patient and have
> been successful, then advancement to maintenance therapy would be
> appropriate.
>
> ***Evidence supporting this recommendation is of class: R***

27. **Endoscopy**

> **Key Points**:

-   Patients who don\'t respond to therapy need endoscopic evaluation.

> Flexible esophagogastroduodenoscopy should be used for the initial
> evaluation of esophageal symptoms in patients suspected of having GERD
> with refractory heartburn, odynophagia, or extra-esophageal symptoms.
> Endoscopy permits direct inspection and biopsy of the esophageal
> lining, aiding detection of grade 1 or grade 2 esophagitis\--changes
> not apparent on x-rays. Endoscopy also permits detection and biopsy of
> Barrett\'s esophagus and eosinophilic esophagitis.
>
> ***Evidence supporting this recommendation is of classes: C, D, X***

28. **Positive?**

> Patients with erosions, ulcerations, strictures or intestinal
> metaplasia (Barrett\'s esophagus) are considered to have a positive
> endoscopy. Patients who have either a normal esophageal examination or
> only distal esophageal erythema are considered to have a negative
> endoscopy.
>
> Esophagitis as seen at endoscopy is thought to be highly specific for
> the diagnosis of GERD. Although infectious, caustic and pill-induced
> esophagitis occurs, the vast majority of patients with linear erosions
> in their distal esophagus will have gastroesophageal reflux.
> Esophagitis is graded on a continuum from mild to severe. Mild,
> non-erosive esophagitis is common at endoscopy and may not correlate
> well with the patient\'s symptoms. For this reason, esophagitis of
> moderate severity is recommended before making a positive diagnosis of
> GERD.
>
> ***Evidence supporting this recommendation is of class: C***

29. **Case Management for Negative Endoscopy**

> **Key Points**:

-   The diagnosis of GERD can be challenging in patients who don\'t
    respond to therapy and have negative endoscopies.

> Diagnosing GERD can be difficult in patients with atypical symptoms,
> noncardiac chest pain, or normal endoscopy. Many diagnostic tests to
> find pathological reflux have been developed. Few of them have
> withstood rigorous scientific testing and lack relevance to clinical
> management.
>
> Manometry defines lower esophageal sphincter pressure accurately but
> does not identify the presence of significant reflux. The water siphon
> test (sipping water in supine position during a barium esophagram) has
> a sensitivity of only 60% and a false positive rate of 30%.
>
> Spot esophageal pH measurements are only 58% sensitive in esophagitis
> patients and measure esophageal pH only briefly. The standard
> esophagram also performs poorly in esophagitis patients (sensitivities
> range from 5% in grade 1 and 18% in grade 2 to 60% in grade 4).
> Gastroesophageal reflux scintiscanning has been reported to be 90%
> sensitive by one medical center; however, this result has not been
> readily reproducible, remains quite expensive, and has not been widely
> accepted as clinically useful.
>
> Therefore, 24-hour pH monitoring has been adopted as the diagnostic
> standard.  24-hour pH monitoring measures longer periods, captures
> transient pH changes not associated with symptoms, and can be coded
> into a scientific scoring system yielding acceptable sensitivities.
> These strengths make it the most useful test in patients with
> surreptitious disease and normal endoscopy. However, pH monitoring
> does not provide evidence of causality.
>
> PPIs are capable of marked acid suppression and may allow a
> simultaneous empiric, therapeutic, and diagnostic trial.
>
> Alternatively, a trial and practical experience suggest short-term
> administration of high-dose proton pump inhibitors (PPIs) can reduce
> symptoms and offer a reasonably accurate diagnostic discrimination in
> selected groups of patients with suspected GERD. All patients with
> complaints of heartburn do not necessarily have GERD. Patients who
> don\'t respond to therapy, and have negative pH studies should be
> considered to have functional heartburn. These patients should be
> individually managed, as are patients with other functional
> gastrointestinal disorders (i.e., irritable bowel syndrome, non-ulcer
> dyspepsia.)
>
> Therefore, the administration of high-dose PPI appears useful as a
> diagnostic and therapeutic trial in selected groups of patients with
> non-cardiac chest pain, atypical symptoms, or a normal endoscopy.
>
> Specific referral to gastroenterology may need to be considered for
> refractory cases.
>
> ***Evidence supporting this recommendation is of class: C***

30. **Case Management for Refractory Reflux**

> **Key Points**:

-   Some patients with GERD need higher doses of medication or
    consideration of surgery.

> Patients with erosive esophagitis or worse should be treated with
> proton pump inhibitors (PPI) in a double therapeutic dose. If
> Esomeprazole (Nexium®) has not been used at this point, it would be
> reasonable to try a therapeutic trial. Patients intolerant of PPIs may
> receive a quadruple therapeutic dose of H~2~RA. Failure to respond
> should prompt doubling the dose of the antisecretory medication and
> referral to gastroenterology. Duration of treatment should be
> indefinite within a single trial of step-down.
>
> Patients requiring long-term maintenance therapy, or those who are
> incompletely controlled on maintenance therapy with a single trial of
> step-down, may wish a surgical opinion regarding fundoplication or
> bariatric surgery (body mass index \[BMI\] greater than 35), or GI
> opinion regarding endoscopic approaches.
>
> Essential elements in case management of esophagitis that is erosive
> or worse (moderate or worse) include selection of cost-effective
> treatment, the need for maintenance treatment, consideration of
> surgical treatment, and the need for referral to gastroenterology.
>
> Relief of symptoms and healing of esophagitis are dependent on the
> degree and duration of acid suppression. Routine therapeutic doses of
> PPI are only fair at best in treating this minority subset of patients
> at the more severe end of the disease spectrum. For acute healing, a
> two-month course of standard dose PPIs (lansoprazole, omeprazole,
> rabeprazole, pantoprazole, esomeprazole) is recommended. Cost analyses
> are limited to decision models but suggest that PPIs are
> cost-effective compared to branded H~2~RA. When compared to generic
> cimetidine, PPIs are of equivalent cost-effectiveness; consequently,
> the clinically superior treatment (i.e., PPIs) should be favored.
>
> The challenge of treating erosive or more severe esophagitis is the
> very high rate of relapse with discontinuation of treatment or with
> step down treatment. The relapse rate is greater than 90% at 6 months.
> Because of that, ongoing support for lifestyle modifications is
> essential. However, present evidence from clinical trials would
> suggest that the treatment providing symptom relief and healing should
> be continued long-term. The most cost-effective approach is
> established for those with peptic ulcers. Long-term PPIs are superior.
> For those with less severe esophagitis, decision models are divided on
> the preferred approach: continuation of PPIs, or PPIs only after
> failure of one trial of step down therapy.
>
> Decisions regarding referral to gastroenterology and surgery should be
> at the discretion of patient and physician. Long-term use of PPIs is
> established as safe. For those on a usual dose of PPIs with good
> symptom control, this is acceptable long-term treatment. For those not
> controlled or requiring a double dose of PPIs, referral to
> gastroenterology or surgery should be considered. Decision modeling of
> laparoscopic fundoplication versus long-term PPIs does not establish a
> preferred cost-effective option. Controlled studies of this question
> are underway.
>
> Specific referral to gastroenterology may need to be considered for
> refractory cases.
>
> ***Evidence supporting this recommendation is of classes: A, M, R***

31. **Encourage Single Trial Step-Down Therapy**

> **Key Points**:

-   All patients with GERD should have one attempt at discontinuation
    therapy.

> Patients with uncomplicated reflux may benefit from step-down therapy.
> Step-down therapy gradually reduces the intensity of treatment as
> tolerated to maintain the patient in remission. Lifestyle
> modifications should be continued indefinitely. Patients whose initial
> symptoms were controlled by lifestyle measures initially may require
> only occasional PPIs.
>
> The availability of OTC PPI and associated cost reduction permits the
> use of this therapy for initial management of GERD. The use of initial
> PPI has been shown to reduce heartburn severity and duration compared
> to the use of H~2~RA. This was the case when H~2~RA was used alone,
> used in a program that permitted use of PPI either initially, followed
> by PPI (\"step down\"), or after a failed trial of H~2~RA (\"step
> up\").
>
> ***Evidence supporting this recommendation is of classes: A, D, R***

34. **Return to Chronic PPI Therapy**

> **Key Points**:

-   Most patients with GERD need therapy long term.

> Most patients with typical reflux symptoms will respond to acid
> suppressive therapy. This guideline encourages trying to reduce the
> therapy over time but many patients will stay on such therapy for
> months if not years. As long as these patients are not symptomatic,
> they do not require an endoscopy.
>
> Some groups have suggested, however, that patients with reflux should
> have an endoscopy to screen for Barrett\'s esophagus (BE). BE is a
> change in the lining of the esophagus from the normal squamous mucosa
> to a metaplastic intestinal columnar mucosa. Patients with BE are at
> increased risk of adenocarcinoma of the esophagus and thus patients
> with BE are placed into endoscopic surveillance programs.
>
> The American College of Gastroenterology recommends: \"Patients with
> chronic GERD symptoms are those most likely to have Barrett\'s
> esophagus and should undergo endoscopy.\"
>
> At present there are no data to demonstrate the cost-effectiveness of
> such a strategy. Patients with longer duration of symptoms (greater
> than 10 years) are more likely to have BE. White men are at increased
> risk.
>
> Selecting patients on the basis of risk would improve the
> cost-effectiveness but has not been incorporated into guidelines.
> Given the absence of clear evidence of benefit, screening for
> Barrett\'s esophagus in patients with GERD cannot be advocated in all
> patients.
>
> Patients requiring long-term maintenance therapy, or those who are
> incompletely controlled on maintenance therapy with a single trial of
> step-down, may wish a surgical opinion regarding fundoplication or
> bariatric surgery (BMI greater than 35), or a gastroenterology opinion
> regarding endoscopic approaches.
>
> ***Evidence supporting this recommendation is of class: R***

**Definitions**:

**Conclusion Grades**:

**Grade I**: The evidence consists of results from studies of strong
design for answering the question addressed. The results are both
clinically important and consistent with minor exceptions at most. The
results are free of any significant doubts about generalizability, bias,
and flaws in research design. Studies with negative results have
sufficiently large samples to have adequate statistical power.

**Grade II**: The evidence consists of results from studies of strong
design for answering the question addressed, but there is some
uncertainty attached to the conclusion because of inconsistencies among
the results from the studies or because of minor doubts about
generalizability, bias, research design flaws, or adequacy of sample
size. Alternatively, the evidence consists solely of results from weaker
designs for the question addressed, but the results have been confirmed
in separate studies and are consistent with minor exceptions at most.

**Grade III**: The evidence consists of results from studies of strong
design for answering the question addressed, but there is substantial
uncertainty attached to the conclusion because of inconsistencies among
the results of different studies or because of serious doubts about
generalizability, bias, research design flaws, or adequacy of sample
size. Alternatively, the evidence consists solely of results from a
limited number of studies of weak design for answering the question
addressed.

**Grade Not Assignable**: There is no evidence available that directly
supports or refutes the conclusion.

**Classes of Research Reports**:

A.  Primary Reports of New Data Collection:

> Class A:

-   Randomized, controlled trial

> Class B:

-   Cohort study

> Class C:

-   Nonrandomized trial with concurrent or historical controls

-   Case-control study

-   Study of sensitivity and specificity of a diagnostic test

-   Population-based descriptive study

> Class D:

-   Cross-sectional study

-   Case series

-   Case report

B.  Reports that Synthesize or Reflect upon Collections of Primary
    Reports:

> Class M:

-   Meta-analysis

-   Systematic review

-   Decision analysis

-   Cost-effectiveness analysis

> Class R:

-   Consensus statement

-   Consensus report

-   Narrative review

> Class X:

-   Medical opinion

#### CLINICAL ALGORITHM(S)

Detailed and annotated clinical algorithms are provided for:

-   [Dyspepsia](http://www.guideline.gov/algorithm/5174/NGC-5174_1.html)

-   [Gastroesophageal Reflux Disease
    (GERD)](http://www.guideline.gov/algorithm/5174/NGC-5174_2.html)

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is classified for selected
recommendations (see \"Major Recommendations\").

In addition, key conclusions contained in the Work Group\'s algorithm
are supported by a grading worksheet that summarizes the important
studies pertaining to the conclusion. The type and quality of the
evidence supporting these key recommendations (i.e., choice among
alternative therapeutic approaches) is graded for each study.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate evaluation and initial management of epigastric discomfort,
including management of patients with dyspepsia and gastroesophageal
reflux disease (GERD)

#### POTENTIAL HARMS

The proton pump inhibitors (PPIs) are metabolized via hepatic cytochrome
P450 enzymes, with CYP2C19 having the dominant role. However, the
dominance of this route varies significantly among the PPIs. The
specific P450 enzymes involved in PPI metabolism and the potential for
interactions among these agents shows variation. Omeprazole is
metabolized largely via CYP2C19, and the potential for interactions thus
appears to be the greatest among the PPIs. If this metabolic pathway
becomes saturated, there is the possibility for interactions with many
drugs, including warfarin, diazepam, and phenytoin. While rabeprazole is
also metabolized by this isoenzyme, it apparently possesses significant
affinity for CYP3A4; very few interactions have been documented with
rabeprazole. Lansoprazole is metabolized principally via CYP3A4, and
interactions with theophylline have been reported. As the metabolism of
pantoprazole primarily involves CYP2C19 O-demethylation, significant
CYP3A4 and CYP1A induction is not seen. This agent has the lowest
potential for P450 metabolism and drug interactions.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   These clinical guidelines are designed to assist clinicians by
    providing an analytical framework for the evaluation and treatment
    of patients, and are not intended either to replace a clinician\'s
    judgment or to establish a protocol for all patients with a
    particular condition. A guideline will rarely establish the only
    approach to a problem.

-   This clinical guideline should not be construed as medical advice or
    medical opinion related to any specific facts or circumstances.
    Patients are urged to consult a health care professional regarding
    their own situation and any specific medical questions they may
    have.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

Once a guideline is approved for release, a member group can choose to
concentrate on the implementation of that guideline. When four or more
groups choose the same guideline to implement and they wish to
collaborate with others, they may form an action group.

In the action group, each medical group sets specific goals they plan to
achieve in improving patient care based on the particular guideline(s).
Each medical group shares its experiences and supporting measurement
results within the action group. This sharing facilitates a
collaborative learning environment. Action group learnings are also
documented and shared with interested medical groups within the
collaborative.

Currently, action groups may focus on one guideline or a set of
guidelines such as hypertension, lipid treatment and tobacco cessation.

The following detailed measurement strategies are presented to help
close the gap between clinical practice and the guideline
recommendations.

*Priority Aims and Suggested Measures for Health Care Systems*

1.  To increase the use of recommended methods for evaluating dyspepsia.

> Possible measures of accomplishing this aim:

a.  Percentage of patients evaluated for dyspepsia with discussion
    regarding appropriate *Helicobacter pylori* testing.

b.  Percentage of patients evaluated for dyspepsia without standard
    single-phase contrast studies.

c.  Percent of patients evaluated for dyspepsia with endoscopy prior to
    receiving a therapeutic trial who do not have an alarm feature
    present.

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2.  To increase appropriate pharmaceutical treatment of patients with
    dyspepsia.

> Possible measures of accomplishing this aim:

a.  Percentage of patients with dyspepsia positive for *H. pylori* who
    receive antibiotic therapy.

b.  Percentage of patients with dyspepsia treated with antibiotics for
    positive *H. pylori* who receive effective therapy.

c.  Percentage of patients with dyspepsia treated with a proton pump
    inhibitor (PPI) without previous endoscopic examination.

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3.  To decrease complications associated with peptic ulcer disease.

> Possible measure of accomplishing this aim:

a.  Number or rate of hospital admissions for ulcer hemorrhage.

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4.  To improve functional outcomes and satisfaction of patients with
    dyspepsia.

> Possible measures of accomplishing this aim:

a.  Percentage of patients with dyspepsia with improved symptoms
    following treatment as measured by a dyspepsia-specific health
    status instrument.

b.  Percentage of patients with dyspepsia who report that they are
    satisfied or very satisfied following treatment for dyspepsia.

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5.  Increase the use of initial treatment recommendations for evaluating
    gastroesophageal reflux disease (GERD).

> Possible measures for accomplishing this aim:

a.  Percentage of patients with GERD following behavioral modification
    recommendations.

b.  Percentage of patients with GERD treated with PPI for an 8-week
    period.

c.  Percentage of patients with GERD reporting relief of symptoms after
    8-week trial of PPI.

d.  Percentage of patients with GERD and control of symptoms with a PPI
    who have had a trial of step down therapy.

e.  Percentage of patients with GERD who are not tested for *H. pylori*.

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6.  To increase appropriate treatment for patients who have ongoing
    symptoms after initial treatment recommendations.

> Possible measures for accomplishing this aim:

a.  Percentage of patients with continued symptoms of GERD after an
    8-week trial of PPI having an endoscopy.

b.  Percentage of patients age 50 (and over) who have GERD or a history
    of GERD for 10 years or more who have been evaluated with endoscopy.

c.  Percentage of patients with ongoing symptoms of GERD (see annotation
    #1) and a body mass index \[BMI\] greater than 35 referred for
    surgical opinion regarding fundoplication or bariatric surgery.

At this point in development for this guideline, there are no
specifications written for the possible measures listed above. The
Institute for Clinical Systems Improvement (ICSI) will seek input from
medical groups on what measures are of most use as they implement the
guideline. In a future revision of the guideline, measurement
specifications may be included.

#### IMPLEMENTATION TOOLS

Clinical Algorithm\
Pocket Guide/Reference Cards

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Institute for Clinical Systems Improvement (ICSI). Initial management of
dyspepsia and GERD. Bloomington (MN): Institute for Clinical Systems
Improvement (ICSI); 2006 Jul. 53 p. \[100 references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

1998 Oct (revised 2006 Jul)

#### GUIDELINE DEVELOPER(S)

Institute for Clinical Systems Improvement - Private Nonprofit
Organization

#### GUIDELINE DEVELOPER COMMENT

Organizations participating in the Institute for Clinical Systems
Improvement (ICSI): Affiliated Community Medical Centers, Allina Medical
Clinic, Altru Health System, Aspen Medical Group, Avera Health,
CentraCare, Columbia Park Medical Group, Community-University Health
Care Center, Dakota Clinic, ENT Specialty Care, Fairview Health
Services, Family HealthServices Minnesota, Family Practice Medical
Center, Gateway Family Health Clinic, Gillette Children\'s Specialty
Healthcare, Grand Itasca Clinic and Hospital, HealthEast Care System,
HealthPartners Central Minnesota Clinics, HealthPartners Medical Group
and Clinics, Hutchinson Area Health Care, Hutchinson Medical Center,
Lakeview Clinic, Mayo Clinic, Mercy Hospital and Health Care Center,
MeritCare, Mille Lacs Health System, Minnesota Gastroenterology,
Montevideo Clinic, North Clinic, North Memorial Care System, North
Suburban Family Physicians, Northwest Family Physicians, Olmsted Medical
Center, Park Nicollet Health Services, Pilot City Health Center, Quello
Clinic, Ridgeview Medical Center, River Falls Medical Clinic, Saint
Mary\'s/Duluth Clinic Health System, St. Paul Heart Clinic, Sioux Valley
Hospitals and Health System, Southside Community Health Services,
Stillwater Medical Group, SuperiorHealth Medical Group, University of
Minnesota Physicians, Winona Clinic, Ltd., Winona Health

ICSI, 8009 34th Avenue South, Suite 1200, Bloomington, MN 55425;
telephone, (952) 814-7060; fax, (952) 858-9675; e-mail:
<icsi.info@icsi.org>; Web site: [www.icsi.org](http://www.icsi.org/).

#### SOURCE(S) OF FUNDING

The following Minnesota health plans provide direct financial support:
Blue Cross and Blue Shield of Minnesota, HealthPartners, Medica,
Metropolitan Health Plan, PreferredOne, and UCare Minnesota. In-kind
support is provided by the Institute for Clinical Systems Improvement\'s
(ICSI) members.

#### GUIDELINE COMMITTEE

Committee on Evidence-Based Practice

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Work Group Members*: G. Richard Locke, MD (Work Group Leader) (Mayo
Clinic) (Gastroenterology); Stephanie Broderson, MD (Sioux Valley
Hospitals and Health System) (Family Medicine); Jon McAreavey, MD (Brown
Clinic) (Family Medicine); John Sandgren, MD (Aspen Medical Group)
(Gastroenterology); Nicholas Talley, MD (Mayo Clinic)
(Gastroenterology); Angela Fitch, MD (Fairview Health Services)
(Internal Medicine); Nancy Jaeckels (Institute for Clinical Systems
Improvement) (Measurement/Implementation Advisor); Ann-Marie Evenson,
RHIT (Institute for Clinical Systems Improvement) (Facilitator)

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

In the interest of full disclosure, ICSI has adopted a policy of
revealing relationships work group members have with companies that sell
products or services that are relevant to this guideline topic. The
reader should not assume that these financial interests will have an
adverse impact on the content of the guideline, but they are noted here
to fully inform readers. Readers of the guideline may assume that only
work group members listed below have potential conflicts of interest to
disclose.

G. Richard R. Locke, MD is a consultant for Boehringer Ingelheim, Glaxo
SmithKline, Solvay, and Novartis and receives research grant support
from AstraZeneca, Forest Laboratories, Glaxo SmithKline, TAP, Boehringer
Ingelheim, Novartis, and Janssen Pharmaceutica.

Nicholas J. Talley, MD is a consultant for Altana, AstraZeneca, Axcan,
Chugai, BBMed, Giaconda, Glaxo-SmithKline, Kosan, KV Pharmaceuticals,
Medscape, ProEd Communications, Renovis Inc., Solvay, Strategic
Consultants International, Takeda Pharmaceuticals Inc., TAP, Therapeutic
Gastrointestinal Group, Theravance, and Yamanouchi. He also receives
research grant support from Merck, Novartis, TAP, Axcan, Boehringer
Ingelheim, and Forest.

No other work group members have potential conflicts of interest to
disclose.

ICSI\'s conflict of interest policy and procedures are available for
review on ICSI\'s website at [www.icsi.org](http://www.icsi.org/).

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Dyspepsia and GERD.
Bloomington (MN): Institute for Clinical Systems Improvement (ICSI);
2004 Jul. 50 p.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [Institute for Clinical Systems
Improvement (ICSI) Web
site](http://www.icsi.org/guidelines_and_more/guidelines__order_sets___protocols/).

Print copies: Available from ICSI, 8009 34th Avenue South, Suite 1200,
Bloomington, MN 55425; telephone, (952) 814-7060; fax, (952) 858-9675;
Web site: [www.icsi.org](http://www.icsi.org/); e-mail:
<icsi.info@icsi.org>.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   Initial management of dyspepsia and GERD. Executive summary.
    Bloomington (MN): Institute for Clinical Systems Improvement, 2006
    Jul. 1 p. Electronic copies: Available from the [Institute for
    Clinical Systems Improvement (ICSI) Web
    site](http://www.icsi.org/guidelines_and_more/guidelines__order_sets___protocols/other_health_care_conditions/dyspepsia_gerd/dyspepsia___gerd_.html).

-   ICSI pocket guidelines. April 2006 edition. Bloomington (MN):
    Institute for Clinical Systems Improvement, 2006. 298 p.

Print copies: Available from ICSI, 8009 34th Avenue South, Suite 1200,
Bloomington, MN 55425; telephone, (952) 814-7060; fax, (952) 858-9675;
Web site: [www.icsi.org](http://www.icsi.org/); e-mail:
<icsi.info@icsi.org>.

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on October 9, 2002. The
information was verified by the guideline developer on October 21, 2002.
This summary was updated by ECRI on October 13, 2000, December 4, 2002
and most recently on April 18, 2003. The updated information was
verified by the guideline developer on May 22, 2003. This summary was
updated by ECRI on September 16, 2004. This NGC summary was updated by
ECRI on September 25, 2006. This summary was updated by ECRI Institute
on November 9, 2007, following the U.S. Food and Drug Administration
advisory on Antidepressant drugs.

#### COPYRIGHT STATEMENT

This NGC summary (abstracted Institute for Clinical Systems Improvement
\[ICSI\] Guideline) is based on the original guideline, which is subject
to the guideline developer\'s copyright restrictions.

The abstracted ICSI Guidelines contained in this Web site may be
downloaded by any individual or organization. If the abstracted ICSI
Guidelines are downloaded by an individual, the individual may not
distribute copies to third parties.

If the abstracted ICSI Guidelines are downloaded by an organization,
copies may be distributed to the organization\'s employees but may not
be distributed outside of the organization without the prior written
consent of the Institute for Clinical Systems Improvement, Inc.

All other copyright rights in the abstracted ICSI Guidelines are
reserved by the Institute for Clinical Systems Improvement, Inc. The
Institute for Clinical Systems Improvement, Inc. assumes no liability
for any adaptations or revisions or modifications made to the abstracts
of the ICSI Guidelines.

### DISCLAIMER

#### NGC DISCLAIMER

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Date Modified: 11/3/2008