Liya Zhou1, Jianzhong Zhang2, Minhu Chen3, Xiaohua Hou4, Zhaoshen Li5, Zhiqiang Song6, Lihua He7, Sanren Lin6. 1. 1] Department of Gastroenterology, Peking University Third Hospital, Beijing, China [2] These authors contributed equally to this work. 2. 1] Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China [2] These authors contributed equally to this work. 3. Department of Gastroenterology, First Affiliated Hospital of SunYat-sen University, Guangzhou, China. 4. Division of Gastroenterology, Union Hospital of Tongji Medical College, Huazhong University of Technology and Science, Wuhan, China. 5. Department of Digestive Diseases, Changhai Hospital of Second Military Medical University, Shanghai, China. 6. Department of Gastroenterology, Peking University Third Hospital, Beijing, China. 7. Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.
Abstract
OBJECTIVES: Studies conducted in large populations of patients and providing full information on Helicobacter pylori (H. pylori) antibiotic resistance are needed to determine the efficacy of sequential therapy (SQT) against this pathogen. This study compared eradication rates with SQT and standard triple therapy (STT), and evaluated the impact of antibiotic resistance on outcomes. METHODS: The study population included adults with positive H. pylori culture presenting at four centers in China between March 2008 and December 2010. Patients were randomly assigned to 10 days of treatment with esomeprazole, amoxicillin, and clarithromycin (STT; n=140) or to 5 days of treatment with esomeprazole and amoxicillin, followed by 5 days of esomeprazole, clarithromycin, and tinidazole (SQT; n=140). Eradication was assessed 8-12 weeks after treatment. RESULTS: There was no significant difference between the eradication rates achieved with STT (66.4% (95% confidence interval (CI) 59.3-74.3)) and SQT (72.1% (65.0-79.3); P=0.300) in either the intention-to-treat analysis or the per-protocol analysis (72.7% (65.6-79.7) and 76.5% (69.7-83.3), respectively; P=0.475). Clarithromycin resistance (CLA-R, odds ratio (OR)=8.34 (3.13-22.26), P<0.001) and metronidazole resistance (MET-R, OR=7.14 (1.52-33.53), P=0.013) both independently predicted treatment failure in the SQT group. Patients in the SQT group with dual CLA-R and MET-R had a lower eradication rate (43.9%) than those with isolated CLA-R (88.9%, P=0.024) or isolated MET-R (87.8%, P<0.001). CONCLUSIONS:H. pylori eradication rates with STT and SQT were compromised by antibiotic resistance. SQT may be suitable in regions with high prevalence of isolated CLA-R, but it is unsatisfactory when both CLA-R and MET-R are present.
RCT Entities:
OBJECTIVES: Studies conducted in large populations of patients and providing full information on Helicobacter pylori (H. pylori) antibiotic resistance are needed to determine the efficacy of sequential therapy (SQT) against this pathogen. This study compared eradication rates with SQT and standard triple therapy (STT), and evaluated the impact of antibiotic resistance on outcomes. METHODS: The study population included adults with positive H. pylori culture presenting at four centers in China between March 2008 and December 2010. Patients were randomly assigned to 10 days of treatment with esomeprazole, amoxicillin, and clarithromycin (STT; n=140) or to 5 days of treatment with esomeprazole and amoxicillin, followed by 5 days of esomeprazole, clarithromycin, and tinidazole (SQT; n=140). Eradication was assessed 8-12 weeks after treatment. RESULTS: There was no significant difference between the eradication rates achieved with STT (66.4% (95% confidence interval (CI) 59.3-74.3)) and SQT (72.1% (65.0-79.3); P=0.300) in either the intention-to-treat analysis or the per-protocol analysis (72.7% (65.6-79.7) and 76.5% (69.7-83.3), respectively; P=0.475). Clarithromycin resistance (CLA-R, odds ratio (OR)=8.34 (3.13-22.26), P<0.001) and metronidazole resistance (MET-R, OR=7.14 (1.52-33.53), P=0.013) both independently predicted treatment failure in the SQT group. Patients in the SQT group with dual CLA-R and MET-R had a lower eradication rate (43.9%) than those with isolated CLA-R (88.9%, P=0.024) or isolated MET-R (87.8%, P<0.001). CONCLUSIONS:H. pylori eradication rates with STT and SQT were compromised by antibiotic resistance. SQT may be suitable in regions with high prevalence of isolated CLA-R, but it is unsatisfactory when both CLA-R and MET-R are present.