PMID- 32030921
OWN - NLM
STAT- MEDLINE
DCOM- 20200316
LR  - 20200316
IS  - 1598-6357 (Electronic)
IS  - 1011-8934 (Print)
IS  - 1011-8934 (Linking)
VI  - 35
IP  - 5
DP  - 2020 Feb 10
TI  - Comparison of 7- and 14-Day Eradication Therapy for Helicobacter pylori with 
      First- and Second-Line Regimen: Randomized Clinical Trial.
PG  - e33
LID - 10.3346/jkms.2020.35.e33 [doi]
LID - e33
AB  - BACKGROUND: Although Helicobacter pylori is a key cause of gastric cancer 
      development, its eradication rate has been decreasing by standard regimens. For 
      successful eradication, duration of treatment has been issued for overcoming 
      antibiotics resistance. We were to compare the eradication rate of 7-day vs. 
      14-day treatment in first- and second-line regimens. METHODS: This study was an 
      open-label randomized controlled trial. A total of 369 H. pylori-infected 
      patients were enrolled and assigned either to 7-day or 14-day proton pump 
      inhibitor (PPI)-based standard triple therapy (STT; 
      PPI-clarithromycin-amoxicillin). Bismuth-containing quadruple therapy was used as 
      second-line therapy. Eradication success was defined as a negative (13)C-urea 
      breath test. RESULTS: In first-line treatment, eradication rate was 78.5% 
      (106/135) and 78.6% (114/143) in the 7-day and 14-day treatment in per-protocol 
      (PP) analysis (P = 0.805). In intention-to-treat (ITT) analysis, eradication rate 
      was 64.0% (114/178) and 66.0% (126/191), respectively (P = 0.924). There was no 
      significant difference in drug compliance (81.5% vs. 84.3%, P = 0.320). In 
      second-line therapy, eradication rate was not significantly different in both 
      treatments of PP analysis (91.7% [33/36] vs. 100% [45/45], P = 0.084). In the ITT 
      analysis, eradication rate was 79.6% (35/44) and 90.4% (47/52), respectively (P = 
      0.080). Drug compliances were not significantly different between the two groups 
      (95.5% vs. 98.1%, P = 0.728). CONCLUSION: PPI-based STT for H. pylori is not 
      efficient as a first-line therapy both in 7 days and 14 days in Korea. Although 
      bismuth-containing quadruple therapy for 14 days as a second line therapy tend to 
      show higher eradication rate compared to 7-day therapy, this should be elucidated 
      by further larger scaled studies. TRIAL REGISTRATION: ClinicalTrials.gov 
      Identifier: NCT02487511.
CI  - (c) 2020 The Korean Academy of Medical Sciences.
FAU - Kim, Tae Ho
AU  - Kim TH
AUID- ORCID: 0000-0003-2015-5176
AD  - Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of 
      Medicine, The Catholic University of Korea, Seoul, Korea.
FAU - Park, Jae Myung
AU  - Park JM
AUID- ORCID: 0000-0002-1534-7467
AD  - Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of 
      Medicine, The Catholic University of Korea, Seoul, Korea.
FAU - Cheung, Dae Young
AU  - Cheung DY
AUID- ORCID: 0000-0003-4150-3555
AD  - Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of 
      Medicine, The Catholic University of Korea, Seoul, Korea.
FAU - Oh, Jung Hwan
AU  - Oh JH
AUID- ORCID: 0000-0002-9274-882X
AD  - Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of 
      Medicine, The Catholic University of Korea, Seoul, Korea. ojh@catholic.ac.kr.
LA  - eng
SI  - ClinicalTrials.gov/NCT02487511
GR  - Korean College of Helicobacter and Upper Gastrointestinal Research fund/Korea
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20200210
PL  - Korea (South)
TA  - J Korean Med Sci
JT  - Journal of Korean medical science
JID - 8703518
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Proton Pump Inhibitors)
RN  - 804826J2HU (Amoxicillin)
RN  - H1250JIK0A (Clarithromycin)
RN  - U015TT5I8H (Bismuth)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Amoxicillin/therapeutic use
MH  - *Anti-Bacterial Agents/therapeutic use
MH  - *Bismuth/therapeutic use
MH  - Breath Tests
MH  - Clarithromycin/therapeutic use
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - *Helicobacter Infections/drug therapy
MH  - *Helicobacter pylori/drug effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Proton Pump Inhibitors/therapeutic use
PMC - PMC7008067
OTO - NOTNLM
OT  - Drug Resistance
OT  - Helicobacter pylori
OT  - Proton Pump Inhibitors
OT  - Stomach Neoplasms
OT  - Treatment Outcome
COIS- The authors have no potential conflicts of interest to disclose.
EDAT- 2020/02/08 06:00
MHDA- 2020/03/17 06:00
PMCR- 2020/02/10
CRDT- 2020/02/08 06:00
PHST- 2019/08/15 00:00 [received]
PHST- 2019/12/24 00:00 [accepted]
PHST- 2020/02/08 06:00 [entrez]
PHST- 2020/02/08 06:00 [pubmed]
PHST- 2020/03/17 06:00 [medline]
PHST- 2020/02/10 00:00 [pmc-release]
AID - 35.e33 [pii]
AID - 10.3346/jkms.2020.35.e33 [doi]
PST - epublish
SO  - J Korean Med Sci. 2020 Feb 10;35(5):e33. doi: 10.3346/jkms.2020.35.e33.