Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, Hybrid therapy, Bismuth containing quadruple therapy, Eradication
Brief summary
According the Maastricht IV consensus report publish in the Gut 2012, bismuth containing quadruple therapy was suggested to be the first choice for eradication therapy of Helicobacter pylori in the area with high clarithromycin resistance. Whether hybrid therapy or 14-day bismuth containing quadruple therapy can replace standard triple therapy as the recommended first-line treatment is unknown. The investigators compared the efficacy of 14-day hybrid therapy and 14-day bismuth containing quadruple therapy in first-line treatment.
Detailed description
For this randomly assigned to receive either a 14-day hybrid therapy (a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days) or a 14-day bismuth containing quadruple therapies (pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days).at a 1:1 ratio. Our primary outcomes was the eradication rate by intention-to-treat and per- protocol analyses
Interventions
pantoprazole 40 mg bid for 14 days, bismuth subcitrate 120 mg qid for 14 days, tetracycline 500 mg qid for 14 days, metronidazole 250 mg qid for 14 days
DRUGHybrid therapy
(pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days) followed by (pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days, clarithromycin 500 mg bid for 7 days, and metronidazole 500 mg bid for 7 days)
Sponsors
Kaohsiung Veterans General Hospital.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Which H. Pylori Was Eradicated | at the 6th week after the end of anti- H. pylori therapy | Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests are conducted to assess H. pylori status. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pantoprazole+Bismuth+Tetra+Metro pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days
pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days | 164 |
| Hybrid Therapy a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days
Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days | 166 |
| Total | 330 |
Baseline characteristics
| Characteristic | Hybrid Therapy | Pantoprazole+Bismuth+Tetra+Metro | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Categorical Between 18 and 65 years | 136 Participants | 134 Participants | 270 Participants |
| Age, Continuous | 54.48 years STANDARD_DEVIATION 11.45 | 53.46 years STANDARD_DEVIATION 12.28 | 53.97 years STANDARD_DEVIATION 11.86 |
| Region of Enrollment Taiwan | 166 Participants | 164 Participants | 330 Participants |
| Sex: Female, Male Female | 87 Participants | 70 Participants | 157 Participants |
| Sex: Female, Male Male | 79 Participants | 94 Participants | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 92 / 164 | 19 / 166 |
| serious Total, serious adverse events | 0 / 164 | 0 / 166 |
Outcome results
Primary
Number of Participants in Which H. Pylori Was Eradicated
Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests are conducted to assess H. pylori status.
Time frame: at the 6th week after the end of anti- H. pylori therapy
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pantoprazole+Bismuth+Tetra+Metro | Number of Participants in Which H. Pylori Was Eradicated | 154 participants |
| Hybrid Therapy | Number of Participants in Which H. Pylori Was Eradicated | 154 participants |