ACG Guidelines

American College of Gastroenterology Issues Guidelines for Treatment of Helicobacter pylori Infection

News Author: Laurie Barclay, MD CME Author: Désirée Lie, MD, MSEd Authors and Disclosures

CME/CE Released: 08/21/2007; Reviewed and Renewed: 08/20/2008; Valid for credit through 08/20/2009

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August 21, 2007 -- The American College of Gastroenterology (ACG) has issued guidelines for treatment of Helicobacter pylori infection and published them in the August issue of the American Journal of Gastroenterology.

\" Helicobacter pylori ( H. pylori) remains one of the most common worldwide human infections and is associated with a number of important upper gastrointestinal (GI) conditions including chronic gastritis, peptic ulcer disease (PUD), and gastric malignancy,\" write William D. Chey, MD, FACG, AGAF, FACP, from the University of Michigan Medical Center in Ann Arbor, Michigan, and Benjamin C.Y. Wong, MD, PhD, FACG, FACP, from the University of Hong Kong, and colleagues from the Practice Parameters Committee of the ACG. \"The prevalence of H. pylori is closely tied to socioeconomic conditions and accordingly, this infection is more common in developing countries than in developed countries such as the United States. Regardless, it has been estimated that 30 - 40% of the U.S. population is infected with H. pylori.\"

Since the ACG last published guidelines for the management of H pylori infection in 1998, considerable new evidence has become available regarding diagnosis and treatment. Therefore, the Practice Parameters Committee and Governing Board of the ACG issued this updated management guideline to facilitate clinical management of patients with H pylori infection. The investigators searched Medline, PubMed, and the Cochrane Database for available evidence underlying these guidelines, which include summary recommendations and more detailed descriptions of supporting evidence and rationale.

Endoscopic or nonendoscopic methods can be used to diagnose H pylori. Choice of diagnostic workup in a specific patient should consider the need for endoscopy, pretest probability of infection, local availability of testing methods, and test performance characteristics and costs.

For populations with a low pretest probability of H pylori infection, the nonendoscopic urea breath and fecal antigen tests have a better positive predictive value than do antibody tests. Antibody testing identifies an immunologic reaction to the infection, whereas the urease tests and fecal antigen test identify the presence of active H pylori infection.

Established indications for eradication of H pylori include PUD, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, and uninvestigated dyspepsia.

There is still controversy regarding whether to test for H pylori in the presence of functional dyspepsia, gastroesophageal reflux disease (GERD), nonsteroidal anti-inflammatory drug (NSAID) use, iron-deficiency anemia, or risk factors for developing gastric cancer. However, a subset of patients with functional dyspepsia benefit from H pylori eradication, and recent evidence suggests a link between H pylori infection and unexplained iron-deficiency anemia.

To confirm eradication of H pylori infection, testing should be performed in patients with PUD who were treated for H pylori, those with persistent dyspeptic symptoms following the test-and-treat strategy, those with H pylori-associated MALT lymphoma, and those who are status post resection of early gastric cancer.

Accepted first-line treatments for H pylori are a 10- to 14-day course of proton pump inhibitor (PPI), clarithromycin, and amoxicillin or metronidazole; or of PPI, bismuth, tetracycline, and metronidazole.

In part because of increasing H pylori resistance to clarithromycin, rates of eradication for first-line treatment with a PPI, clarithromycin, and amoxicillin have decreased to 70% to 85% worldwide. Seven-day regimens may have lower eradication rates than 14-day regimens.

\"The most important predictors of treatment failure following anti- H. pylori therapy include poor compliance and antibiotic resistance,\" the study authors write. \"It is critical for clinicians to stress the importance of taking the medications as prescribed to minimize the likelihood of treatment failure and development of antibiotic resistance.... There is limited evidence to suggest that smoking, alcohol consumption, and diet may also adversely affect the likelihood of successful eradication.\" Another therapeutic option for first-line treatment is a 7- to 14-day course of bismuth-containing quadruple regimens. Although sequential therapy for 10 days has appeared promising in European trials, this regimen has not yet been validated in North America and therefore cannot yet be recommended as a standard first-line treatment. Sequential treatment consists of a 5-day course of a PPI and amoxicillin, followed by an additional 5 days of a PPI, clarithromycin, and tinidazole. Bismuth quadruple therapy is the most widely used salvage regimen for persistent H pylori infection. Evidence from recent trials suggest that combination therapy with a PPI, levofloxacin, and amoxicillin for 10 days is more effective and better tolerated than is bismuth quadruple therapy for treatment of patients with persistent infection, but this has not yet been validated in the United States.

Several recent trials studies have compared alternatives with bismuth-based quadruple salvage therapy, such as rifabutin, with rates of eradication ranging from 38% to 91%; furazolidone, with rates of eradication ranging from 52% to 90%; and levofloxacin-based triple therapy.

\"Whether levofloxacin resistance is absolute as is the case with clarithromycin or more relative as with metronidazole remains to be determined as well,\" the study authors conclude. \"While awaiting data on antimicrobial resistance and efficacy from the United States, given the shortage of effective,

validated salvage regimens, it seems reasonable to consider levofloxacin-based triple therapy in circumstances where bismuth or clarithromycin-based therapies are not an option.\" Am J Gastroenterol. 2007;102:1808-1825.

Clinical Context H pylori remains among the most common of infections worldwide and is associated with GI conditions including chronic gastritis, PUD, and gastric malignancy with 30% to 40% of the US population infected mainly through childhood acquisition. The ACG published guidelines for the management of H. pylori infection in 1998, and this guideline is an update of recent changes and controversies in the diagnosis and management of H pylori infection.

This update is based on searches conducted on Medline, PubMed, and the Cochrane Databases and lists recommendations for testing, treatment, and management of resistant cases.

Study Highlights

Indications for diagnosis and treatment

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Testing is indicated in those with active PUD, a past history of documented ulcer, and MALT lymphoma.

Testing should only be performed if the clinician plans to treat positive results. The test used depends on likelihood of upper GI endoscopy.

In patients who have not been receiving a PPI within 1 to 2 weeks or an antibiotic or bismuth within 4 weeks of endoscopy, the rapid urease test is inexpensive and accurate. For those who have been treated, testing should include biopsies from the gastric body and antrum for histologic examination.

Culture or polymerase chain reaction is recommended for testing antibiotic sensitivity but is not widely available.

Culture is not as sensitive as rapid urease test or histologic examination.

Among nonendoscopic tests, the urea breath test is the most reliable for diagnosis and for confirming eradication 4 weeks after treatment.

The monoclonal fecal antigen test can be used to establish eradication. Antibody tests are unreliable.

The test-and-treat strategy is recommended for patients younger than age 55 years with uninvestigated dyspepsia with no \"alarm\" features (eg, bleeding or anemia). Bismuth-based triple therapy for 10 to 14 days is the accepted first-line treatment. 12-month ulcer remission is 97% for gastric ulcer and 98% for duodenal ulcer with successful eradication vs 61% and 65%, respectively, with persistent infection. Treatment is superior to no treatment of recurrence of gastric and duodenal ulcer. Recurrent ulcer bleeding is reduced by 17% and 4%, with ulcer healing treatment alone and ulcer healing treatment followed by maintenance therapy, respectively. H pylori eradication is associated with 64% remission of MALT lymphoma.

 Testing for eradication is indicated for patients with H pylori-associated ulcer, those with persistent dyspeptic symptoms after treatment, MALT lymphoma, and those who have undergone resection of early gastric cancer.

 Alternative salvage therapies for persistent H pylori infection include bismuth-based quadruple therapy for 7 to 14 days and levofloxacin-based triple therapy for 10 days.

Areas of controversy

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A subset of patients with functional dyspepsia may benefit from eradication of H pylori. The decision to treat functional dyspepsia by eradication of H pylori should be individualized based on risk for PUD and malignancy.

The relationship between H pylori and GERD is not well defined.

Evidence does not support worsening of GERD in patients with duodenal ulcer. Therapy for H pylori should not be withheld related to this concern.

25 studies suggest that H pylori infection and use of NSAIDs are independent risk factors for peptic ulcer and bleeding.

Any patient with an ulcer should be tested for H pylori, regardless of use of NSAIDs or aspirin.

Emerging evidence suggests that eradication of H pylori can improve iron-deficiency anemia, but further trials are needed.

Studies suggest that eradication of H pylori in patients at risk for gastric cancer or with preneoplastic lesions may prevent progression and improve outcomes.

An international task force favors testing and treating first-degree relatives of patients with gastric cancer for H pylori infection to reduce the risk for cancer.

Sequential therapies for persistent infection need to be validated before use in the United States.

Pearls for Practice  Diagnostic tests used for H pylori depend on use of endoscopy; and bismuth-based triple therapy is the first-line treatment of choice with alternatives available for persistent infection.

 The study suggests that the potential benefits of treating patients at risk for gastric cancer, iron-deficiency anemia, or functional dyspepsia to eradicate H pylori are controversial.

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