Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, Proton pump inhibitor, Eradication
Brief summary
Reverse hybrid therapy is a one-step two-phase treatment for Helicobacter pylori infection with less cost than standard triple therapy. Whether reverse hybrid therapy can replace standard triple therapy as the recommended first-line treatment is unknown. The investigators compared the efficacy of 12-day reverse hybrid therapy and 12-day standard triple therapy in first-line treatment.
Detailed description
For this multicentre, single-blind, and randomized-controlled trial (REHYTRI study), the investigator recruited patients with H pylori infection. Using a computer-generated randomization sequence, the investigator randomly allocated patients to either 12-day reverse hybrid therapy (pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg, amoxicillin 1 g for another 5 days; with all drugs given twice daily) or a 12-day standard triple therapy (pantoprazole 40 mg, clarithromycin 500 mg, amoxicillin 1 g for 12 days; with all drugs given twice daily) at a 1:1 ratio. Our primary outcome was the eradication rate by intention-to-treat and per-protocol analyses.
Interventions
pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days
pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Veterans General Hospital.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
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 | Evaluate eradication outcome by endoscopy urease test and histology or urea breath test |
Countries
Taiwan
Participant flow
Recruitment details
1. recruitment period: Oct 2012 - Mar 2015 2. Type of location: Kaohsiung Veterans General Hospital and Kaohsiung Medical University Chung-Ho Memorial Hospital
Pre-assignment details
None were excluded following participant enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Reverse Hybrid Therapy pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily
Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days | 220 |
| Standard Triple Therapy pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily
Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days | 220 |
| Total | 440 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 4 |
Baseline characteristics
| Characteristic | Standard Triple Therapy | Reverse Hybrid Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 67 Participants | 66 Participants | 133 Participants |
| Age, Categorical Between 18 and 65 years | 153 Participants | 154 Participants | 307 Participants |
| Age, Continuous | 53.4 years STANDARD_DEVIATION 12.2 | 52.6 years STANDARD_DEVIATION 12.9 | 52.83 years STANDARD_DEVIATION 12.58 |
| Region of Enrollment Taiwan | 220 participants | 220 participants | 440 participants |
| Sex: Female, Male Female | 101 Participants | 106 Participants | 207 Participants |
| Sex: Female, Male Male | 119 Participants | 114 Participants | 233 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 220 | 15 / 220 |
| serious Total, serious adverse events | 0 / 220 | 0 / 220 |
Outcome results
Primary
Number of Participants in Which H. Pylori Was Eradicated
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
Time frame: at the 6th week after the end of anti- H. pylori therapy
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reverse Hybrid Therapy | Number of Participants in Which H. Pylori Was Eradicated | 206 participants |
| Standard Triple Therapy | Number of Participants in Which H. Pylori Was Eradicated | 191 participants |
p-value: <0.05Chi-squared