Jyh-Chin Yang1, Chun-Jung Lin2, Hong-Long Wang3, Jin-De Chen4, John Y Kao5, Chia-Tung Shun6, Chien-Wei Lu2, Bor-Ru Lin7, Ming-Jium Shieh8, Ming-Chu Chang8, Yu-Ting Chang8, Shu-Chen Wei8, Lin-Chih Lin9, Wen-Chun Yeh10, Jen-Shin Kuo8, Chien-Chih Tung7, Yew-Loong Leong11, Teh-Hong Wang8, Jau-Min Wong8. 1. Department of Internal Medicine, Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan. Electronic address: jcyang47@ntu.edu.tw. 2. School of Pharmacy, National Taiwan University, Taipei, Taiwan. 3. Department of Statistics, National Taipei University, New Taipei City, Taiwan. 4. Department of Internal Medicine, National Taiwan University Hospital Bei-Hu Branch, Taipei, Taiwan. 5. Division of Gastroenterology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan. Electronic address: jykao@med.umich.edu. 6. Department of Forensic Medicine and Pathology, Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan. 7. Department of Integrated Diagnostics and Therapeutics, Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan. 8. Department of Internal Medicine, Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan. 9. Department of Internal Medicine, Non-Profit Proprietary Miners Hospital, Keelung, Taiwan. 10. Department of Internal Medicine, New Taipei City Hospital San Chung Branch, New Taipei City, Taiwan. 11. Department of Internal Medicine, West Garden Hospital, Taipei, Taiwan.
Abstract
BACKGROUND & AIMS: The efficacy of treatment of Helicobacter pylori infection has decreased steadily because of increasing resistance to clarithromycin, metronidazole, and levofloxacin. Resistance to amoxicillin is generally low, and high intragastric pH increases the efficacy of amoxicillin, so we investigated whether a combination of a high-dose proton pump inhibitor and amoxicillin (dual therapy) was more effective than standard first-line or rescue therapies in eradicating H pylori. METHODS: We performed a large-scale multihospital trial to compare the efficacy of a high-dose dual therapy (HDDT) with that of standard therapies in treatment-naive (n = 450) or treatment-experienced (n = 168) patients with H pylori infection. Treatment-naive patients were randomly assigned to groups given HDDT (rabeprazole 20 mg and amoxicillin 750 mg, 4 times/day for 14 days, group A1), sequential therapy for 10 days (group B1), or clarithromycin-containing triple therapy for 7 days (group C1). Treatment-experienced patients were randomly assigned to groups given HDDT for 14 days (group A2), sequential therapy for 10 days (B2), or levofloxacin-containing triple therapy for 7 days (C2). H pylori infection was detected by using the (13)C-urea breath test. We evaluated factors associated with treatment outcomes. RESULTS: In the intention-to-treat analysis, H pylori was eradicated in 95.3% of patients in group A1 (95% confidence interval [CI], 91.9%-98.8%), 85.3% in B1 (95% CI, 79.6%-91.1%), and 80.7% in group C1 (95% CI, 74.3%-87.1%). Infection was eradicated in 89.3% of patients in group A2 (95% CI, 80.9%-97.6%), 51.8% in group B2 (95% CI, 38.3%-65.3%), and 78.6% (95% CI, 67.5%-89.7%) in group C2. The efficacy of HDDT was significantly higher than that of currently recommended regimens, irrespective of CYP2C19 genotype. Bacterial resistance to drugs was associated with treatment failure. There were no significant differences between groups in adverse events or patient adherence. CONCLUSIONS:HDDT is superior to standard regimens as empirical first-line or rescue therapy for H pylori infection, with similar safety profiles and tolerability. ClinicalTrials.gov number: NCT01163435.
RCT Entities:
BACKGROUND & AIMS: The efficacy of treatment of Helicobacter pylori infection has decreased steadily because of increasing resistance to clarithromycin, metronidazole, and levofloxacin. Resistance to amoxicillin is generally low, and high intragastric pH increases the efficacy of amoxicillin, so we investigated whether a combination of a high-dose proton pump inhibitor and amoxicillin (dual therapy) was more effective than standard first-line or rescue therapies in eradicating H pylori. METHODS: We performed a large-scale multihospital trial to compare the efficacy of a high-dose dual therapy (HDDT) with that of standard therapies in treatment-naive (n = 450) or treatment-experienced (n = 168) patients with H pylori infection. Treatment-naive patients were randomly assigned to groups given HDDT (rabeprazole 20 mg and amoxicillin 750 mg, 4 times/day for 14 days, group A1), sequential therapy for 10 days (group B1), or clarithromycin-containing triple therapy for 7 days (group C1). Treatment-experienced patients were randomly assigned to groups given HDDT for 14 days (group A2), sequential therapy for 10 days (B2), or levofloxacin-containing triple therapy for 7 days (C2). H pylori infection was detected by using the (13)C-urea breath test. We evaluated factors associated with treatment outcomes. RESULTS: In the intention-to-treat analysis, H pylori was eradicated in 95.3% of patients in group A1 (95% confidence interval [CI], 91.9%-98.8%), 85.3% in B1 (95% CI, 79.6%-91.1%), and 80.7% in group C1 (95% CI, 74.3%-87.1%). Infection was eradicated in 89.3% of patients in group A2 (95% CI, 80.9%-97.6%), 51.8% in group B2 (95% CI, 38.3%-65.3%), and 78.6% (95% CI, 67.5%-89.7%) in group C2. The efficacy of HDDT was significantly higher than that of currently recommended regimens, irrespective of CYP2C19 genotype. Bacterial resistance to drugs was associated with treatment failure. There were no significant differences between groups in adverse events or patient adherence. CONCLUSIONS:HDDT is superior to standard regimens as empirical first-line or rescue therapy for H pylori infection, with similar safety profiles and tolerability. ClinicalTrials.gov number: NCT01163435.
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