Jun-Won Chung1, Jae Pil Han2, Kyoung Oh Kim1, Su Young Kim1, Su Jin Hong2, Tae Ho Kim3, Chang Whan Kim3, Joon Sung Kim4, Byung-Wook Kim5, Byoung Wook Bang6, Hyung Gil Kim7, Sung-Cheol Yun8. 1. Division of Gastroenterology, Department of Internal Medicine, Gachon University, Gil Medical Center, Incheon, Republic of Korea. 2. Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea. 3. Division of Gastroenterology, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Republic of Korea. 4. Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Republic of Korea. 5. Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Republic of Korea. Electronic address: bleok@naver.com. 6. Division of Gastroenterology, Department of Internal Medicine, Inha University College of Medicine, Incheon, Republic of Korea. 7. Division of Gastroenterology, Department of Internal Medicine, Inha University College of Medicine, Incheon, Republic of Korea. Electronic address: kimhg@inha.ac.kr. 8. Clinical Epidemiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
Abstract
BACKGROUND: The resistance of Helicobacter pylori to antibiotics has increased the need for new empirical, first-line treatments. However, the efficacy of sequential therapy (ST) and concomitant therapy (CT) compared with triple therapy (TT) has not been adequately evaluated. AIM: In this study, we evaluated the efficacy of these empirical three regimens. METHODS: The 517 patients enrolled in the study were prospectively randomized to receive 10 days of TT (n=171), ST (n=170), and CT (n=176) at 5 university-affiliated hospitals from May 2013 to March 2015. The post-treatment H. pylori status was determined using the (13)C-urea breath test. RESULTS: The baseline characteristics were similar among the three groups. The intention-to-treat eradication rates were 62.6%, 70.6%, and 77.8% in the TT, ST, and CT groups, respectively (p<0.01). The corresponding per-protocol eradication rates were 82.8%, 89.5%, and 94.4%, respectively (p<0.01). There were no significant differences in the compliance, side effects, and follow-up loss rates. CONCLUSION: A higher eradication rate was achieved with empirical 10-day ST, and CT than with the TT regimen, with similar rates of compliance and treatment side effects.
RCT Entities:
BACKGROUND: The resistance of Helicobacter pylori to antibiotics has increased the need for new empirical, first-line treatments. However, the efficacy of sequential therapy (ST) and concomitant therapy (CT) compared with triple therapy (TT) has not been adequately evaluated. AIM: In this study, we evaluated the efficacy of these empirical three regimens. METHODS: The 517 patients enrolled in the study were prospectively randomized to receive 10 days of TT (n=171), ST (n=170), and CT (n=176) at 5 university-affiliated hospitals from May 2013 to March 2015. The post-treatment H. pylori status was determined using the (13)C-urea breath test. RESULTS: The baseline characteristics were similar among the three groups. The intention-to-treat eradication rates were 62.6%, 70.6%, and 77.8% in the TT, ST, and CT groups, respectively (p<0.01). The corresponding per-protocol eradication rates were 82.8%, 89.5%, and 94.4%, respectively (p<0.01). There were no significant differences in the compliance, side effects, and follow-up loss rates. CONCLUSION: A higher eradication rate was achieved with empirical 10-day ST, and CT than with the TT regimen, with similar rates of compliance and treatment side effects.