Comparing the Efficacy of Reverse Hybrid Therapy and Bismuth Quadruple Therapy

Kaohsiung Veterans General Hospital

Status: Completed

Conditions: Helicobacter Pylori Infection

Treatments: Drug: pantoprazole+bismuth+tetra+metro; Drug: (panto+amox+clar+metr)+(panto+amox)

Study type: Interventional

Funder types: Other

Identifiers

NCT02547038

VGHKS15-CT2-10

Details and patient eligibility

About

Reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy remained unanswered.

Full description

A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol and intention-to-treat analyses, respectively. Recently, the investigators demonstrated that the eradication rate of reverse hybrid therapy was higher than that of standard triple therapy. However, whether reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy remained unanswered.

Enrollment: 352 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion criteria

• previous H pylori-eradication therapy
• ingestion of antibiotics or bismuth within the prior 4 weeks
• patients with allergic history to the medications used
• patients with previous gastric surgery
• the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
• pregnant women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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352 participants in 2 patient groups

pantoprazole+bismuth+tetra+metro

Experimental group

Description:

pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days

Treatment:

Drug: pantoprazole+bismuth+tetra+metro

(panto+amox+clar+metr)+(panto+amox)

Active Comparator group

Description:

a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

Treatment:

Drug: (panto+amox+clar+metr)+(panto+amox)