Randomized controlled trial comparing 7-day triple, 10-day sequential, and 7-day
concomitant therapies for Helicobacter pylori infection.
Author(s): Hsu PI(1), Wu DC(2), Chen WC(1), Tseng HH(3), Yu HC(1), Wang HM(1), Kao SS(1),
Lai KH(1), Chen A(4), Tsay FW(5).
Affiliation(s): Author information:
(1)Division of Gastroenterology, Department of Internal Medicine, Kaohsiung
Veterans General Hospital and Faculty of Medicine, School of Medicine, National
Yang-Ming University, Kaohsiung, Taipei, Taiwan. (2)Division of Gastroenterology,
Department of Internal Medicine, Kaohsiung Medical University Hospital,
Kaohsiung, Taiwan. (3)Department of Pathology, Kaohsiung Veterans General
Hospital and National Yang-Ming University, Kaohsiung, Taiwan. (4)Institute of
Biomedical Sciences, National Sun Yat-Sen University, Kaohsiung, Taiwan.
(5)Division of Gastroenterology, Department of Internal Medicine, Kaohsiung
Veterans General Hospital and Faculty of Medicine, School of Medicine, National
Yang-Ming University, Kaohsiung, Taipei, Taiwan Cheng Shiu University, Kaohsiung,
Taiwan fwchaie@vghks.gov.tw.
Publication date & source: 2014, Antimicrob Agents Chemother. , 58(10):5936-42
With the rising prevalence of antimicrobial resistance, the failure rate of the
standard triple therapy for Helicobacter pylori infection is increasing.
Sequential therapy and concomitant therapy have been recommended to replace
standard triple therapy for H. pylori eradication in regions with high
clarithromycin resistance. The aim of this prospective, randomized, and
controlled study was to simultaneously assess the efficacies of 10-day sequential
and 7-day concomitant therapies versus a 7-day standard triple therapy for
treating H. pylori infection. Consecutive H. pylori-infected subjects were
randomly assigned to a 7-day standard triple therapy (pantoprazole,
clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy
(pantoprazole and amoxicillin for 5 days, followed by pantoprazole,
clarithromycin, and metronidazole for a further 5 days), or a 7-day quadruple
therapy (pantoprazole, clarithromycin, amoxicillin, and metronidazole for 7
days). H. pylori status was confirmed 6 weeks after therapy. Three hundred seven
H. pylori-infected participants were randomized to receive triple (n = 103),
sequential (n = 102), or concomitant (n = 102) therapies. The eradication rates
by an intention-to-treat analysis in the three treatment groups were 81.6% (95%
confidence interval [CI], 74.1% to 89.0%), 89.2% (95% CI, 83.2% to 95.2%), and
94.1% (95% CI, 89.5% to 98.7%). The seven-day concomitant therapy had a higher
eradication rate than did the 7-day triple therapy (difference, 12.5%; 95% CI,
3.7% to 21.3%). There were no significant differences in the eradication rates
between the sequential and standard triple therapies. All three treatments
exhibited similar frequencies of adverse events (8.7%, 8.8%, and 13.7%,
respectively) and drug compliance (99.0%, 98.0%, and 100.0%, respectively). In
conclusion, the seven-day concomitant therapy is superior to the 7-day standard
triple therapy for H. pylori eradication. Additionally, it is less complex than
the 10-day sequential therapy because the drugs are not changed halfway through
the treatment course. (This study has been registered at ClinicalTrials.gov under
registration no. NCT1769365.).
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