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:
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
