![](media/image1.png){width="5.96875in" height="0.41944444444444445in"}

Top of Form

## Complete Summary

#### GUIDELINE TITLE

Management of helicobacter pylori infection.

#### BIBLIOGRAPHIC SOURCE(S)

Singapore Ministry of Health. Management of helicobacter pylori
infection. Singapore: Singapore Ministry of Health; 2004 Sep. 25 p. \[29
references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 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)

*Helicobacter pylori* infection

#### GUIDELINE CATEGORY

Diagnosis\
Evaluation\
Management\
Prevention\
Risk Assessment\
Treatment

#### CLINICAL SPECIALTY

Family Practice\
Gastroenterology\
Internal Medicine\
Oncology\
Preventive Medicine

#### INTENDED USERS

Advanced Practice Nurses\
Allied Health Personnel\
Health Care Providers\
Nurses\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

To provide recommendations on

-   Who should be tested and treated for *Helicobacter pylori* infection

-   Treatment regimens for patients with *Helicobacter pylori* infection

#### TARGET POPULATION

-   Patients with suspected or diagnosed *Helicobacter pylori*
    infection, including patients with:

    -   Gastric ulcer (GU) or duodenal ulcer (DU)

    -   History of peptic ulcer bleeding or perforation

    -   Gastric mucosa-associated lymphoid tissue (MALT) lymphoma

    -   Early gastric cancer lesions

    -   Noncardiac gastric cancer

    -   Gastro-esophageal reflux disease (GERD)

    -   Dyspepsia

-   First degree relatives of gastric cancer patients

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Diagnosis/Evaluation**

1.  Serological tests (detection of immunoglobulin G antibodies to
    *Helicobacter pylori)*

2.  Urea breath test for *H. pylori*

3.  Biopsy urease test

4.  Histology (staining of biopsy specimen with hematoxylin and eosin)

5.  Culture and stool antigen test for *H. pylori*

6.  Gastrointestinal endoscopy

7.  Post treatment testing for *H. pylori*

8.  *Helicobacter pylori* cytotoxin associated gene A (CagA) protein
    status

9.  Endoscopic ultrasonography (EUS)

Note: Screening for *H. pylori* in certain population groups was
considered but not recommended.

**Treatment/Management**

*Combination Regimens*

1.  Proton pump inhibitor (PPI)\* + clarithromycin + amoxicillin

2.  PPI + clarithromycin + metronidazole (tinidazole as alternative)

3.  PPI + amoxicillin + metronidazole

4.  Colloidal bismuth subcitrate + metronidazole + tetracycline

5.  PPI + colloidal bismuth subcitrate + metronidazole + tetracycline

\*Proton pump inhibitors currently available include omeprazole,
lansoprazole, rabeprazole, pantoprazole, and esomeprazole.

#### MAJOR OUTCOMES CONSIDERED

-   Sensitivity and specificity of diagnostic tests for *Helicobacter
    pylori* (*H. pylori*)

-   *H. pylori* eradication rate

-   Relief of reflux symptoms in patients with gastro-esophageal reflux
    disease (GERD)

-   Prevention of gastric cancer

-   Remission of lymphoma in patients with gastric mucosa-associated
    lymphoid tissue (MALT) lymphoma

### 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

**Levels of Evidence**

**Level Ia**: Evidence obtained from meta-analysis of randomised
controlled trials

**Level Ib**: Evidence obtained from at least one randomised controlled
trial

**Level IIa**: Evidence obtained from at least one well-designed
controlled study without randomisation

**Level IIb**: Evidence obtained from at least one other type of
well-designed quasi-experimental study

**Level III**: Evidence obtained from well-designed non-experimental
descriptive studies, such as comparative studies, correlation studies
and case studies

**Level IV**: Evidence obtained from expert committee reports or
opinions and/or clinical experiences of respected authorities

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review

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

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus (Consensus Development Conference)

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

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

**Grades of Recommendations**

**Grade A** (evidence levels Ia, Ib): Requires at least one randomised
controlled trial as part of the body of literature of overall good
quality and consistency addressing the specific recommendation

**Grade B** (evidence levels IIa, IIb, III): Requires availability of
well conducted clinical studies but no randomised clinical trials on the
topic of recommendation

**Grade C** (evidence level IV): Requires evidence obtained from expert
committee reports or opinions and/or clinical experiences of respected
authorities. Indicates absence of directly applicable clinical studies
of good quality

**Good Practice Points**: Recommended best practice based on the
clinical experience of the guideline development group

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Not stated

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Not applicable

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Each recommendation is rated based on the level of the evidence and the
grade of recommendation. Definitions of the grades of the
recommendations (A, B, C, Good Practice Points) and level of the
evidence (Level I-Level IV) are presented at the end of the Major
Recommendations field.

**Diagnosis of *Helicobacter pylori* (*H. pylori*) infection**

**A** - Serological tests for *Helicobacter pylori* (*H. pylori*)
infection should be locally validated and have a sensitivity and
specificity of at least 90% (**Grade A Level Ib**)

**A** - The urea breath test (UBT) is a reliable test for *H. pylori*
before and after treatment. (**Grade A, Level Ib**)

**A**- Biopsy urease test is the endoscopic investigation of choice for
*H. pylori* infection. (**Grade A, Level Ib**)

**B** - Culture is an impractical means of diagnosing *H. pylori*
infection. (**Grade B, Level IIa**)

**B** - Post-treatment testing is desirable. (**Grade B, Level IIa**)

**A** - Stool antigen test (HpSA). (**Grade A, Level Ia**)

**Treatment of *H. pylori* Infection**

**A** - All gastric and duodenal ulcer patients who are infected with
*H. pylori* should be treated with eradication therapy. Patients with a
history of ulcer bleeding or perforation should also be treated.
(**Grade A, Level Ia**)

**A** - Routine testing for, and treatment of, *H. pylori* infection is
not recommended prior to initiating treatment with nonsteroidal
anti-inflammatory drugs (NSAIDs). For patients with a past history of
peptic ulcer disease or ulcer complications (perforation, bleeding, or
obstruction), testing for and treatment of *H. pylori* infection is
recommended. (**Grade A, Level Ib**)

**GPP** - In patients requiring long-term NSAID therapy, who have a
current or recent history of dyspepsia, appropriate investigation of the
dyspepsia and treatment for *H. pylori* infection, if documented to be
present, is recommended. (**GPP**)

**A** - Patients with nonulcer dyspepsia (i.e., dyspepsia after
investigation) can be considered for treatment of *H. pylori* infection
on a case-by-case basis. (**Grade A, Level Ia**)

**GPP** - Patients who are first degree relatives of gastric cancer
patients should be treated for *H. pylori* infection. (**GPP**)

**C** - Patients with gastro-oesophageal reflux disease and who require
long-term proton pump inhibitor (PPI) therapy should be treated for *H.
pylori* infection. (**Grade C, Level IV**)

***H. pylori* Infection and Gastric Cancer**

**C** - It is recommended that *H. pylori* infection be treated in
patients following resection of early gastric cancer. Screening
asymptomatic individuals for *H. pylori* infection as a means of
reducing the incidence of gastric cancer is not currently recommended.
(**Grade C, Level IV**)

**B** - Treatment for *H. pylori* infection is recommended in patients
with low-grade gastric mucosa-associated lymphoid tissue lymphoma.
(**Grade B, Level III**)

***H. pylori* Infection and Dyspepsia**

**C** - Screening all dyspeptic patients for *H. pylori* infection is
not recommended. (**Grade C, Level IV**)

**GPP** - It is possible to identify dyspeptic patients who require
early endoscopy based on the incidence of gastric cancer in a particular
country; the presence of alarm features such as weight loss, bleeding,
and anaemia; the age of presentation of the patient with the cut-off
depending on the age-specific incidence of gastric cancer in that
country. (**GPP**)

**A** - Dyspeptic patients, after full investigation (i.e., non-ulcer
dyspepsia) may be offered *H. pylori* eradication therapy. (**Grade A,
Level Ia**)

**Drug Regimens for *H. pylori* Infection**

**A** - In 1998, drug regimens for *H. pylori* infection could produce
an eradication rate of 90% or greater on a per-protocol analysis and 80%
or greater on an intent-to-treat analysis in properly designed clinical
trials. Based on these criteria, the following combination regimens are
recommended:

PPI in standard dose^(1)^ + clarithromycin 500 mg + amoxicillin 1,000 mg

PPI in standard dose^(1)^ + clarithromycin 500 mg + metronidazole 400 mg

^(1)^Proton Pump Inhibitor: lansoprazole 30 mg, omeprazole 20 mg

(**Grade A, Level Ia**)

Each of the above regimens should be given for seven days on a
twice-daily basis.

**A** - If clarithromycin is not available, either of the following two
regimens may be considered:

PPI in standard dose twice daily + Amoxicillin 1,000 mg twice daily +
Metronidazole 400 mg twice daily. For 7 days

Colloidal bismuth subcitrate 120 mg four times daily + Metronidazole 400
mg twice daily + Tetracycline 500 mg four times daily.  For 14 days

(**Grade A, Level Ib**)

**A** - In the event of a treatment failure with a PPI regimen
containing clarithromycin, \"salvage therapy\" is required. (**Grade A,
Level Ib**) (Malfertheiner et al., 2002)

A regiment for use after initial treatment failure is:

PPI in standard dose twice daily + Colloidal bismuth subcitrate 120 mg
four times daily + Metronidazole 400 mg twice daily + Tetracycline 500
mg four times daily

**[Definitions]{.underline}**:

**Grades of Recommendations**

**Grade A** (evidence levels Ia, Ib): Requires at least one randomised
controlled trial as part of the body of literature of overall good
quality and consistency addressing the specific recommendation

**Grade B** (evidence levels IIa, IIb, III): Requires availability of
well conducted clinical studies but no randomised clinical trials on the
topic of recommendation

**Grade C** (evidence level IV): Requires evidence obtained from expert
committee reports or opinions and/or clinical experiences of respected
authorities. Indicates absence of directly applicable clinical studies
of good quality

**Good Practice Points**: Recommended best practice based on the
clinical experience of the guideline development group

**Levels of Evidence**

**Level Ia**: Evidence obtained from meta-analysis of randomised
controlled trials

**Level Ib**: Evidence obtained from at least one randomised controlled
trial

**Level IIa**: Evidence obtained from at least one well-designed
controlled study without randomisation

**Level IIb**: Evidence obtained from at least one other type of
well-designed quasi-experimental study

**Level III**: Evidence obtained from well-designed non-experimental
descriptive studies, such as comparative studies, correlation studies
and case studies

**Level IV**: Evidence obtained from expert committee reports or
opinions and/or clinical experiences of respected authorities

#### CLINICAL ALGORITHM(S)

A clinical algorithm is provided for the management of new onset
uninvestigated dyspepsia

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### REFERENCES SUPPORTING THE RECOMMENDATIONS

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=5947)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each
recommendation (see \"Major Recommendations\").

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

**Overall Benefits**

-   Appropriate diagnosis, risk assessment, treatment, and prevention of
    *Helicobacter pylori* (*H. pylori*) infection

-   Better outcomes and improved quality of life of patients with *H.
    pylori* infection

#### POTENTIAL HARMS

-   In children false-negative tests for *Helicobacter pylori* (*H.
    pylori*) infection can occur from a few weeks to a few months after
    an infection but before an immune response occurs

-   Treatment of *H. pylori* infection in patients with nonulcer
    dyspepsia may aggravate symptoms in the short-term

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   These guidelines are not intended to serve as a standard of medical
    care. Standards of medical care are determined on the basis of all
    clinical data available for an individual case and are subject to
    change as scientific knowledge advances and patterns of care evolve.

-   The contents of this publication are guidelines to clinical
    practice, based on the best available evidence at the time of
    development. Adherence to these guidelines may not ensure a
    successful outcome in every case, nor should they be construed as
    including all proper methods of care or excluding other acceptable
    methods of care. Each physician is ultimately responsible for the
    management of his/her unique patient in the light of the clinical
    data presented by the patient and the diagnostic and treatment
    options available.

-   Users should supplement the guidelines with any new evidence that
    has emerged since publication.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

The desired clinical outcome is eradication of *Helicobacter pylori (H.
pylori)* in all patients in whom eradication is of proven benefit, i.e.
patients with complicated or uncomplicated *H. pylori*-associated peptic
ulcer disease.

Audit should look at:

-   Proportion of patients with upper gastrointestinal bleeding that are
    tested for *H. pylori* infection

-   The proportion of patients with bleeding peptic ulcer due to *H.
    pylori* infection that are offered eradication therapy.

-   Proportion of patients with peptic ulcer disease receiving long-term
    anti-secretory treatment that are offered eradication therapy.

-   Proportion of patients treated for gastric ulcer or complicated
    duodenal ulcer with *H. pylori* infection, who demonstrate cure of
    infection.

-   Proportion of peptic ulcer disease patients with *H. pylori*
    infection that relapse after treatment.

#### IMPLEMENTATION TOOLS

Audit Criteria/Indicators\
Clinical Algorithm\
Patient Resources\
Staff Training/Competency Material

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\
Staying Healthy

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Singapore Ministry of Health. Management of helicobacter pylori
infection. Singapore: Singapore Ministry of Health; 2004 Sep. 25 p. \[29
references\]

#### ADAPTATION

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

#### DATE RELEASED

2004 Sep

#### GUIDELINE DEVELOPER(S)

Gastroenterological Society of Singapore - Medical Specialty Society\
Singapore Ministry of Health - National Government Agency \[Non-U.S.\]

#### SOURCE(S) OF FUNDING

Singapore Ministry of Health (MOH)

#### GUIDELINE COMMITTEE

Workgroup on the Management of Helicobacter Pylori Infection

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Workgroup Members*: Professor Fock Kwong Ming, Division of
Gastroenterology, Changi General Hospital (Chairman); Associate
Professor Yeoh Khay Guan, Department of Medicine, National University
Hospital; Dr Lim Chee Chian, Department of General Medicine, Tan Tock
Seng Hospital; Dr Widjaja Luman, Department of Gastroenterology,
Singapore General Hospital; Dr Alexius Chee Eng Nam, Mt Elizabeth
Medical Centre; Dr Johnathan Pang Sze Kang, Ever Health Family Clinic &
Surgery

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[Singapore Ministry of Health Web
site](http://www.moh.gov.sg/mohcorp/publications.aspx?id=16340).

Print copies: Available from the Singapore Ministry of Health, College
of Medicine Building, Mezzanine Floor 16 College Rd, Singapore 169854.

#### AVAILABILITY OF COMPANION DOCUMENTS

The full text guideline and summary card are available for PDA download
in ISilo and MSReader formats from the [Singapore Ministry of Health Web
site](http://www.moh.gov.sg/mohcorp/publications.aspx?id=16340).

#### PATIENT RESOURCES

The following is available:

-   Management of helicobacter pylori infection. Singapore: Singapore
    Ministry of Health; 2005 Jan. 3 p.

Electronic copies: Available in Portable Document Format (PDF) from the
[Singapore Ministry of Health Web
site](http://www.hpp.moh.gov.sg/HPP/MungoBlobs/537/249/2004 Helicobacter_Pylori_Infection.pdf).

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This NGC summary was completed by ECRI on November 26, 2004.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions. Please contact the
Ministry of Health, Singapore by e-mail at <MOH_INFO@MOH.GOV.SG>.

### DISCLAIMER

#### NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce,
approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced
under the auspices of medical specialty societies, relevant professional
associations, public or private organizations, other government
agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline
developers, and are screened solely to determine that they meet the NGC
Inclusion Criteria which may be found at
<http://www.guideline.gov/about/inclusion.aspx> .

NGC, AHRQ, and its contractor ECRI Institute make no warranties
concerning the content or clinical efficacy or effectiveness of the
clinical practice guidelines and related materials represented on this
site. Moreover, the views and opinions of developers or authors of
guidelines represented on this site do not necessarily state or reflect
those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or
hosting of guidelines in NGC may not be used for advertising or
commercial endorsement purposes.

Readers with questions regarding guideline content are directed to
contact the guideline developer.

Bottom of Form

© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008