Comparison of Bismuth Containing Quadruple Therapy and Based Tailored Therapy for H. Pylori Infection

Not Applicable

Conditions: Antibiotics
Helicobacter Pylori Infection
Compliance, Patient
Drug Resistance

Interventions: Diagnostic Test: CLO test
Diagnostic Test: Helicobacter pylori PCR test

Brief Summary: As the antibiotic resistance increases, the eradication rate of triple therapy is decreasing. Recent guideline recommend the use of bismuth-containing quadruple therapy in areas where clarithromycin resistance is greater than 15%. However, the ideal treatment would be the tailored therapy which choose the antibiotics depending on the antibiotic resistance. This study compared the eradication rates, safety and complicance of tailored therapy compared with empirical bismuth quadruple therapy in the naive patients with H. pylori infection.

Detailed Description: In order to be eligible for first-line H. pylori eradication therapy, at least 80% of eradication rate should be achieved by intention to treat (ITT) analysis. However, the triple therapy (PPI, clarithromycin, amoxicillin) is losing 1st-line therapy because of increasing antibiotic resistance. The most common cause of failure in triple therapy is clarithromycin resistance.

In the past, clarithromycin resistance was rarely observed in Korea, but the resistance rate has increased rapidly during the last 10 years, up to 37.3%.

As an alternative, Korean guidelines of Helicobacter pylori eradication in 2013 recommend that bismuth-containing antibiotics (not containing clarithromycin) should be considered in areas with high clarithromycin resistance as in Korea. However, there is a lack of research on the efficacy of bismuth-containing quadruple therapy as a 1st-line therapy. The aim of this prospectivce randomized study is to investingate the efficacy, conpliance, adverse events and cost-effectiveness between bismuth containing quadruple therapy and tailored therapy in areas with high clarithromycin resistance

Recruitment & Eligibility

Inclusion Criteria

Participants with peptic ulcer, s/p ESD due to early gastric cancer/gastric adenoma, Maltoma
Ability and willingness to participate in the study and to sign and give informed consent
confirmed H. pylori infection

Exclusion Criteria

Previous H. pylori eradication therapy
Less than 18 years old
With history of H. pylori infection treatment
With previous gastric surgery
Major systemic diseases
Pregnancy or lactation
Allergy to any of the study drugs
Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Arm && Interventions

Group	Intervention	Description
Bismuth containing quadruple therapy	CLO test	If CLO test is positive, Bismuth containing quadruple therapy (rabeprazole 20 mg bid, metronidazole 5100 mg tid, bismuth 300 mg qid, tetracycline 500mg qid) are prescribed for 7 days If CLO test is negative, no intervention is needed
tailored therapy	Helicobacter pylori PCR test	If H. pylori PCR is negative, no intervention is needed If H. pylori PCR is positive and mutation is negative, triple regimen (rabeprazole 20 mg bid, amoxacillin 1000 mg bid, clarithromycin 500mg bid) are prescribed for 7 days is given If H. pylori PCR is positive and mutation is positive, Bismuth containing quadruple therapy (rabeprazole 20 mg bid, metronidazole 5100 mg tid, bismuth 300 mg qid, tetracycline 500mg qid) are prescribed for 7 days is given

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication rate	Six weeks after completion of therapy	Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test or CLO test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value). or negative from CLO test

Secondary Outcome Measures

Name	Time	Method
Rate of adverse effects	within 7 days after completion of therapy	During the 7-day treatment period, the subjects kept a diary to score any possible side effects or discomforts. The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities).
Compliance rate	within 7 days after completion of therapy	Compliance was deﬁned as poor when they had taken less than 80% of the total medication.
Medical cost	two months after completion of therapy ]	Summation of diagnostic fee, cost of medication and 2-line therapy cost if the 1st line therapy fails