None listed
Conditions
Brief summary
Helicobacter pylori (H. pylori) infection is an important causal factor in a wide range of upper gastrointestinal diseases and is associated with significant morbidity and mortality. Traditionally, 10-d standard triple therapy (STT) comprising a proton pump inhibitor (PPI) plus two antibiotics (clarithromycin and amoxicillin or metronidazole) is the first-line option for empiric H. pylori eradication. However, the effectiveness of STT has declined to unacceptable levels in many regions of the world mainly due to antibiotic resistance. A novel form of sequential therapy (SQT) consisting of 5 days dual therapy (PPI plus amoxicillin) followed by 5 days triple therapy (PPI plus clarithromycin plus tinidazole or metronidazole) has recently been developed. Several systematic reviews have concluded SQT is associated with a good eradication efficacy and safety, and have shown it to be more effective than STT. Based on this evidence, SQT appears to offer an effective therapeutic option to replace STT for first-line treatment of H pylori. However, the majority of evidence supporting the use of SQT comes from Italy indicating that publication bias may compromise the data. At present, STT remains the most widely used treatment approach for H. pylori eradication in China, where there is high prevalence of H. pylori infection and high resistance rates of clarithromycin and metronidazole. It remains unknown whether the SQT regimen is suitable for Chinese patients with H. pylori infection. The primary objective of the present study was to compare the eradication rates of H. pylori infection associated with STT and SQT regimens. We also investigated the effects of different patterns of antibiotic resistance on H. pylori eradication and attempted to determine the factors that influenced eradication efficacy. The safety and compliance to each regimen were also compared.
Interventions
Arm 1: Sequential therapy comprised esomeprazole 20 mg and amoxicillin 1 g taken twice a day for 5 days followed by esomeprazole 20 mg, clarithromycin 500 mg and tinidazole 500 mg taken twice a day for 5 days. All drugs are oral capsules or tablets.
Arm 2: 10-day standard triple therapy comprised esomeprazole 20 mg, clarithromycin 500 mg and amoxicillin 1 g taken twice a day for 10 days. All drugs are oral capsules or tablets.
Patients were asked to return within 1 to 3 days after treatment to a
Arm 1: Sequential therapy comprised esomeprazole 20 mg and amoxicillin 1 g taken twice a day for 5 days followed by esomeprazole 20 mg, clarithromycin 500 mg and tinidazole 500 mg taken twice a day for 5 days. All drugs are oral capsules or tablets. Arm 2: 10-day standard triple therapy comprised esomeprazole 20 mg, clarithromycin 500 mg and amoxicillin 1 g taken twice a day for 10 days. All drugs are oral capsules or tablets. Patients were asked to return within 1 to 3 days after treatment to assess the compliance with therapy. Compliance, determined by pill counts, was defined as good when more than 90% of the prescribed drugs were taken. Patients who had taken fewer than 80% of the treatment drugs (poor compliance) were excluded from per-protocol analysis.
Sponsors
Sanren Lin
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Consecutive patients with dyspepsia who had been referred for upper endoscopy at four tertiary hospitals in Beijing, Shanghai, Wuhan and Guangzhou were included in the study. Patients with positive Helicobacter pylori cultures were recruited into the study. None of the patients had previously received treatment for Helicobacter pylori infection.
Exclusion criteria
Patients who had received proton pump inhibitor, H2-receptor blockers, bismuth salts or antibiotics in the previous 4 weeks were excluded from entering the study. None of the patients had a history of gastrointestinal malignancy, previous gastric or esophageal surgery, Zollinger-Ellison syndrome, severe concomitant cardiovascular, respiratory, hematological, renal, hepatic or neurological diseases. Women who were pregnant or lactating were excluded from the study, as were those known to be allergic to any of the study drugs.
Outcome results
None listed