PMID- 36600686
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230111
IS  - 1756-283X (Print)
IS  - 1756-2848 (Electronic)
IS  - 1756-283X (Linking)
VI  - 15
DP  - 2022
TI  - Efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy versus 
      bismuth-containing quadruple therapy for Helicobacter pylori infection: a 
      multicenter, randomized controlled clinical trial.
PG  - 17562848221142925
LID - 10.1177/17562848221142925 [doi]
LID - 17562848221142925
AB  - BACKGROUND: A high-dose proton pump inhibitor (PPI)-amoxicillin dual therapy has 
      been investigated for treatment of patients with Helicobacter pylori (H. pylori) 
      infection. Currently, the efficacy of this dual therapy remains inconclusive, 
      with controversial findings from various single-center clinical trials. 
      OBJECTIVES: To assess the efficacy and safety of high-dose dual therapy (HDDT) 
      compared with the bismuth-containing quadruple therapy (BQT) in treatment-naive 
      patients with H. pylori infection. DESIGN: A multicenter, open-label, randomized 
      controlled clinical trial. METHODS: Three hundred and forty treatment-naive 
      patients with H. pylori infection were prospectively recruited from seven 
      participating hospitals. The enrolled patients were randomized into one of two 
      treatment groups: the HDDT group (esomeprazole, 20 mg four times daily; 
      amoxicillin, 750 mg four times daily) and the BQT group (esomeprazole, 20 mg, 
      twice daily; bismuth potassium citrate, 600 mg, twice daily; amoxicillin, 1 g, 
      twice daily; metronidazole, 400 mg, four times daily). The primary outcome was 
      eradication rate, and secondary outcomes were safety and patient compliance. 
      RESULTS: The eradication rates in the HDDT group versus the BQT group were 86.47% 
      versus 87.06% on intention-to-treat (ITT) analysis, 91.88% versus 92.50% on 
      modified ITT (MITT) analysis, and 91.77% versus 93.04% on per-protocol (PP) 
      analysis, with no significant differences between the two groups. The patient 
      compliance rates in the HDDT group versus the BQT group were 97.02% versus 
      95.86%, and no significant difference was found between the two groups. Notably, 
      the HDDT group exhibited significantly lower incidence in the drug-induced 
      adverse events (AEs) compared to the BQT group (16.67% versus 47.94%). 
      CONCLUSION: HDDT is equally efficacious in eradicating H. pylori infection and 
      resulted in good patient compliance and safety compared with BQT. These findings 
      provide evidence in support of HDDT as a first-line treatment for H. pylori 
      infection. REGISTRATION: This clinical trial was registered at The Chinese 
      Clinical Trial Registry (trial registration number: ChiCTR2000039096).
CI  - (c) The Author(s), 2022.
FAU - Mei, Hao
AU  - Mei H
AUID- ORCID: 0000-0001-9608-9609
AD  - Department of Gastroenterology, Chongqing Key Laboratory of Digestive 
      Malignancies, Daping Hospital, Army Medical University (Third Military Medical 
      University), Chongqing 400042, P. R, China.
FAU - Guo, Yan
AU  - Guo Y
AD  - Department of Gastroenterology, Chongqing Key Laboratory of Digestive 
      Malignancies, Daping Hospital, Army Medical University (Third Military Medical 
      University), Chongqing 400042, P. R, China.
FAU - Zhao, Jing-Tao
AU  - Zhao JT
AUID- ORCID: 0000-0003-0689-0406
AD  - Department of Gastroenterology, Chongqing Key Laboratory of Digestive 
      Malignancies, Daping Hospital, Army Medical University (Third Military Medical 
      University), Chongqing 400042, P. R, China.
FAU - Yang, Jun
AU  - Yang J
AD  - Department of Gastroenterology, People's Hospital of Chongqing Banan District, 
      Chongqing, China.
FAU - Sun, Wen-Jing
AU  - Sun WJ
AD  - Department of Gastroenterology, The 13th People's Hospital of Chongqing, 
      Chongqing, China.
FAU - Zhang, De-Kui
AU  - Zhang DK
AD  - Department of Gastroenterology, Lanzhou University Second Hospital, Lanzhou, 
      China.
FAU - He, Ping
AU  - He P
AD  - Department of Gastroenterology, Yongchuan Hospital of Chongqing Medical 
      University, Chongqing, China.
FAU - Shi, Gang
AU  - Shi G
AD  - Department of Gastroenterology, Chongqing Red Cross Hospital, Chongqing, China.
FAU - Su, Na-Yun
AU  - Su NY
AD  - Department of Gastroenterology, Chongqing Key Laboratory of Digestive 
      Malignancies, Daping Hospital, Army Medical University (Third Military Medical 
      University), Chongqing 400042, P. R, China.
FAU - Han, Ran
AU  - Han R
AD  - Department of Gastroenterology, Guizhou Provincial People's Hospital, Guiyang, 
      China.
FAU - Lan, Chun-Hui
AU  - Lan CH
AUID- ORCID: 0000-0002-9232-7910
AD  - Department of Gastroenterology, Chongqing Key Laboratory of Digestive 
      Malignancies, Daping Hospital, Army Medical University (Third Military Medical 
      University), Chongqing 400042, P. R, China.
LA  - eng
PT  - Journal Article
DEP - 20221226
PL  - England
TA  - Therap Adv Gastroenterol
JT  - Therapeutic advances in gastroenterology
JID - 101478893
PMC - PMC9806404
OTO - NOTNLM
OT  - Helicobacter pylori
OT  - bismuth-containing quadruple therapy
OT  - drug-induced adverse event
OT  - eradication therapy
OT  - high-dose dual therapy
COIS- The authors declare that there is no conflict of interest.
EDAT- 2023/01/06 06:00
MHDA- 2023/01/06 06:01
PMCR- 2022/12/26
CRDT- 2023/01/05 02:14
PHST- 2022/07/21 00:00 [received]
PHST- 2022/10/25 00:00 [accepted]
PHST- 2023/01/05 02:14 [entrez]
PHST- 2023/01/06 06:00 [pubmed]
PHST- 2023/01/06 06:01 [medline]
PHST- 2022/12/26 00:00 [pmc-release]
AID - 10.1177_17562848221142925 [pii]
AID - 10.1177/17562848221142925 [doi]
PST - epublish
SO  - Therap Adv Gastroenterol. 2022 Dec 26;15:17562848221142925. doi: 
      10.1177/17562848221142925. eCollection 2022.