Adding Bismuth to Rabeprazole-based First-line Triple Therapy Does Not Improve the Eradication of Helicobacter Pylori

Study Overview
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Brief Summary
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This randomized controlled study aimed to evaluate whether adding bismuth to the standard first-line triple therapy could improve the eradication rate of Helicobacter pylori (H. pylori). A total of 162 patients with H. pylori infection were randomly assigned to either the 7-day triple therapy group (n = 81) or the bismuth plus triple therapy group (n = 81). The triple therapy (RAK) contained the twice-daily dosage of rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg. In the RBAK group, bismuth subcitrate 360 mg twice daily was added to the RAK regimen.

Detailed Description
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Once confirmed with H. pylori infection and having signed the informed consent, participants were randomly assigned to either the standard triple-therapy group (RAK: rabeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg, all twice daily for 7 days) or the bismuth plus standard triple-therapy group (RBAK: rabeprazole 20 mg, bismuth subcitrate 360 mg, amoxicillin 1 g and clarithromycin 500 mg, all twice daily for 7 days). A computer-generated random number was chosen for randomization. The patients and physicians were not blinded to the therapy assigned. After completion of H. pylori eradication therapy, participants were asked to come back for collection of the information on any adverse event of drug compliance. In order to avoid false negative results, they were also asked to have a 4-week proton pump inhibitor, antibiotic and bismuth washout period before further examination of H. pylori status. The second endoscopy with rapid urea test, histology and culture or 13 C-urea breath test (UBT) for those who refused endoscopic exams was carried out at the end of the washout period. Those who did not return to confirm their H. pylori status were deemed as treatment failure in intention-to-treat (ITT) analysis.

Official Title
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Adding Bismuth to Rabeprazole-based First-line Triple Therapy Does Not Improve the Eradication of Helicobacter Pylori

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: RAK therapy
* Drug: RBAK therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or non-pregnant female aged more than 20 y/r H.pylori-infected mental and legal ability to give a written informed consent Exclusion Criteria: allergy to any drug in the study prior gastric surgery, severe concomitant diseases (e.g., decompensate liver cirrhosis, uremia, gastric cancer) previous H. pylori eradication therapy pregnancy or lactation.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RAK therapy<br>rabeprazole+amoxicillin+clarithromycin | Drug: RAK therapy<br>* rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg twice-daily<br>* Other names: rabeprazole, amoxicillin, clarithromycin;|
| Active Comparator: RBAK therapy<br>rabeprazole+amoxicillin+clarithromycin+bismuth subcitrate | Drug: RBAK therapy<br>* rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg, bismuth subcitrate 360mg twice-daily<br>* Other names: rabeprazole, amoxicillin, clarithromycin, bismuth subcitrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of H.pylori eradication | Helicobacter pylori eradication was assessed by ¹³C-urea breath test. [cutoff value(<4‰)] | 4 weeks after finishing study drugs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of drug compliance | good drug compliance measure by no of subjects taking >80% medicines | 4 weeks after finishing study drugs | 
| rate of side effects | Score side effects were mild, moderate or severe according to their influence on daily activities | 4 weeks after finishing study drugs |