PMID- 35939559 OWN - NLM STAT- MEDLINE DCOM- 20220920 LR - 20221015 IS - 1523-5378 (Electronic) IS - 1083-4389 (Print) IS - 1083-4389 (Linking) VI - 27 IP - 5 DP - 2022 Oct TI - Optimized dual therapy for treatment-naive patients of Helicobacter pylori infection: A large-scale prospective, multicenter, open-label, randomized controlled study. PG - e12922 LID - 10.1111/hel.12922 [doi] LID - e12922 AB - BACKGROUND: The efficacy and safety of high-dose amoxicillin (AMX) and proton pump inhibitors (PPI) dual therapy raises much more attention in recent years. Comparative studies among the dual therapies are required to explore more suitable regimens. This study compared the efficacy, adverse events, and patient compliance of three different high-dose dual regimens in treatment-naive patients of Helicobacter pylori (H. pylori) infection. MATERIALS AND METHODS: The study was a prospective, multicenter, open-label, randomized controlled trial, including H. pylori-infected treatment-naive patients at 12 tertiary hospitals in China. The eligible subjects received high-dose AMX and esomeprazole (ESO) dual therapy of different regimens. They were randomly assigned to group A (ESO 20 mg plus AMX 750 mg, Qid for 14 days), group B (ESO 40 mg Bid plus AMX 1 g Tid for 14 days), or group C (ESO 20 mg plus AMX 1 g, Tid for 14 days). The eradication rates, adverse events, and patient compliance of the three groups were compared. RESULTS: Between April 2021 and January 2022, a total of 1080 subjects were screened and 945 were randomized. The eradication rates in groups A, B, and C were 88.6% (95% CI 84.5%-91.9%), 84.4% (95% CI 80.0%-88.3%), and 86.7% (95% CI 82.4%-90.2%; p = .315), respectively, based on intention-to-treat analysis; 90.3% (95% CI 86.4%-93.3%), 85.5% (95% CI 81.1%-89.2%), and 87.8% (95% CI 83.6%-91.2%; p = .197), respectively, according to modified intention-to-treat analysis; and 90.4% (95% CI 86.5%-93.5%), 85.8% (95% CI 81.4%-89.5%), and 88.3% (95% CI 84.1%-91.7%; p = .202) in per-protocol analysis. History of antibiotics use in 2 years reduced eradication effect in group B (ESO 40 mg Bid, AMX 1 g Tid). The modified intention-to-treat eradication rates were 81.4% vs 90.0% among those with or without a history of antibiotics use in group B (p = .031). The adverse event rates were 13.7%, 12.7%, and 12.1% in groups A, B, and C, respectively (p = .834). Patient compliance of the three groups was similar. CONCLUSIONS: Two optimized AMX and PPI dual regimens (ESO 40 mg Bid or 20 mg Tid plus AMX 1 g Tid for 14 days) had similar efficacy, safety and compliance as compared with classical dual regimen (ESO 20 mg plus AMX 750 mg Qid for 14 days) in H. pylori-infected treatment-naive patients. CI - (c) 2022 The Authors. Helicobacter published by John Wiley & Sons Ltd. FAU - Han, Ying-Ying AU - Han YY AD - Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. FAU - Long, Hui AU - Long H AD - Department of Gastroenterology, Tianyou Hospital Affiliated to Wuhan University of Science and Technology, Wuhan, China. FAU - Lin, Ya AU - Lin Y AD - Department of Gastroenterology, Wenchang People's Hospital, Wenchang, China. FAU - He, Qiong AU - He Q AD - Department of Gastroenterology, Wuhan Red Cross Hospital, Wuhan, China. FAU - Chen, Wei-Gang AU - Chen WG AD - Department of Gastroenterology, The First Affiliated Hospital of Shihezi University Medical College, Shihezi, China. FAU - Ding, Xiang-Wu AU - Ding XW AD - Department of Gastroenterology, Wuhan Fourth Hospital, Wuhan, China. FAU - Zhou, Lin AU - Zhou L AD - Department of Gastroenterology, Suizhou Central Hospital, Suizhou, China. FAU - An, Ping AU - An P AD - Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China. FAU - Wang, Fen AU - Wang F AUID- ORCID: 0000-0002-1387-1126 AD - Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha, China. FAU - Zhang, Zhen-Yu AU - Zhang ZY AD - Department of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. FAU - Hu, Yun-Lian AU - Hu YL AD - Department of Gastroenterology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China. FAU - Li, Pei-Yuan AU - Li PY AUID- ORCID: 0000-0002-6300-1460 AD - Division of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. AD - Department of Gastroenterology, Wenchang People's Hospital, Wenchang, China. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20220808 PL - England TA - Helicobacter JT - Helicobacter JID - 9605411 RN - 0 (Anti-Bacterial Agents) RN - 0 (Proton Pump Inhibitors) RN - 804826J2HU (Amoxicillin) RN - N3PA6559FT (Esomeprazole) SB - IM MH - Amoxicillin/pharmacology MH - Anti-Bacterial Agents/adverse effects MH - Drug Therapy, Combination MH - Esomeprazole/therapeutic use MH - *Helicobacter Infections/drug therapy MH - *Helicobacter pylori MH - Humans MH - Prospective Studies MH - Proton Pump Inhibitors/adverse effects MH - Treatment Outcome PMC - PMC9541209 OTO - NOTNLM OT - Helicobacter pylori OT - eradication rate OT - high-dose dual therapy OT - optimized COIS- All authors declare no conflicts of interest. EDAT- 2022/08/09 06:00 MHDA- 2022/09/21 06:00 PMCR- 2022/10/07 CRDT- 2022/08/08 14:13 PHST- 2022/07/09 00:00 [revised] PHST- 2022/05/16 00:00 [received] PHST- 2022/07/13 00:00 [accepted] PHST- 2022/08/09 06:00 [pubmed] PHST- 2022/09/21 06:00 [medline] PHST- 2022/08/08 14:13 [entrez] PHST- 2022/10/07 00:00 [pmc-release] AID - HEL12922 [pii] AID - 10.1111/hel.12922 [doi] PST - ppublish SO - Helicobacter. 2022 Oct;27(5):e12922. doi: 10.1111/hel.12922. Epub 2022 Aug 8.