Ping-I Hsu1, Feng-Woei Tsay2, John Y Kao3, Nan-Jing Peng4, Kuo-Wang Tsai5, Tzung-Jiun Tsai2, Chao-Hung Kuo6, Sung-Shuo Kao2, Huay-Min Wang2, Yan-Hua Chen2, Chang-Bih Shie1, Deng-Chyang Wu7. 1. Division of Gastroenterology and Hepatology, Department of Internal Medicine, An Nan Hospital, China Medical University, Tainan, Taiwan. 2. Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan. 3. Department of Internal Medicine, Division of Gastroenterology, Michigan Medicine, University of Michigan, Ann Arbor, Michigan, USA. 4. Department of Nuclear Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan. 5. Department of Medical Education and Research, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan. 6. Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung, Taiwan. 7. Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Abstract
BACKGROUND: Concomitant therapy is a recommended first-line treatment for H. pylori infection in most national or international consensuses. Reverse hybrid therapy is a modified 14-day concomitant therapy without clarithromycin and metronidazole in the final 7 days. AIM: To test whether 14-day reverse hybrid therapy is non-inferior to 14-day concomitant therapy in the first-line treatment of H. pylori infection. METHODS:H. pylori-infected adult patients were randomly assigned to receive either reverse hybrid therapy (dexlansoprazole 60 mg o.d. plus amoxicillin 1 g, b.d. for 14 days, and clarithromycin 500 mg plus metronidazole 500 mg b.d. for initial 7 days) or concomitant therapy (dexlansoprazole 60 mg once o.d. plus amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg b.d. for 14 days). H. pylori status was assessed 6 weeks after the end of treatment. RESULTS:H. pylori-infected participants (n = 248) were randomized to receive either 14-day reverse hybrid therapy (n = 124) or 14-day concomitant therapy (n = 124). Intention-to-treat analysis demonstrated that the two therapies had comparable eradication rate (95.2% vs 93.5%; 95% confidence interval, -4.0% ~ 7.4%; P = 0.582). However, reverse hybrid therapy had a much lower frequency of adverse events than concomitant therapy (20.2 % vs. 38.7%, P = 0.001). The two therapies exhibited comparable drug adherence (93.5% vs 87.9%, P = 0.125). CONCLUSIONS:14-day reverse hybrid therapy and 14-day concomitant therapy are equivalent in efficacy for the first-line treatment of H pylori infection. However, reverse hybrid therapy has fewer adverse events compared to concomitant therapy. This article is protected by copyright. All rights reserved.
RCT Entities:
BACKGROUND: Concomitant therapy is a recommended first-line treatment for H. pyloriinfection in most national or international consensuses. Reverse hybrid therapy is a modified 14-day concomitant therapy without clarithromycin and metronidazole in the final 7 days. AIM: To test whether 14-day reverse hybrid therapy is non-inferior to 14-day concomitant therapy in the first-line treatment of H. pyloriinfection. METHODS:H. pylori-infected adult patients were randomly assigned to receive either reverse hybrid therapy (dexlansoprazole 60 mg o.d. plus amoxicillin 1 g, b.d. for 14 days, and clarithromycin 500 mg plus metronidazole 500 mg b.d. for initial 7 days) or concomitant therapy (dexlansoprazole 60 mg once o.d. plus amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg b.d. for 14 days). H. pylori status was assessed 6 weeks after the end of treatment. RESULTS:H. pylori-infected participants (n = 248) were randomized to receive either 14-day reverse hybrid therapy (n = 124) or 14-day concomitant therapy (n = 124). Intention-to-treat analysis demonstrated that the two therapies had comparable eradication rate (95.2% vs 93.5%; 95% confidence interval, -4.0% ~ 7.4%; P = 0.582). However, reverse hybrid therapy had a much lower frequency of adverse events than concomitant therapy (20.2 % vs. 38.7%, P = 0.001). The two therapies exhibited comparable drug adherence (93.5% vs 87.9%, P = 0.125). CONCLUSIONS: 14-day reverse hybrid therapy and 14-day concomitant therapy are equivalent in efficacy for the first-line treatment of H pylori infection. However, reverse hybrid therapy has fewer adverse events compared to concomitant therapy. This article is protected by copyright. All rights reserved.