Background: Traditional treatment for Helicobacter pylori (H.
pylori) includes proton pump inhibitors and triple therapy, and this treatment
has become unsuitable for eliminating H. pylori. Most learned societies
recommend concomitant quadruple therapy (QC) as a first-line alternative
therapy for this bacterial infection. Currently, there is a notable absence of
studies in Tunisia that directly compare the efficacy and outcomes of triple
therapy versus quadruple therapy.
Aim: The aim of this study is to compare the efficacy and safety
of triple therapy (TT) with QC for the eradication of H. pylori infection.
Methods: A parallel double-blind randomized controlled trial was
conducted. The diagnosis of H. pylori infection was made by pathological
examination of gastric biopsies. Patients were randomly assigned to two
treatment groups: either QC (esomeprazole 80 mg, amoxicillin 2000 mg,
clarithromycin 1000 mg, and metronidazole 1000 mg daily) or triple therapy
(esomeprazole 80 mg, amoxicillin 2000 mg, and clarithromycin 1000 mg daily in
divided doses) for 14 days. The efficacy of the treatment is defined by H.
pylori eradication attested by a negative breath test performed 6 weeks after
the completion of treatment. The significance level was set at p < 0.05 for
all statistical tests. Variables significant at 20% in univariate analysis were
introduced into binary logistic regression for a multivariate analysis.
Results: Ninety-two patients were included. Forty-two patients
belonged to the QC group and 50 to the TT group. No significant difference was
noted between the two groups concerning the rate of H. pylori eradication
either by intention to treat (81% vs. 72% respectively, p = 0.31) or
per-protocol (81.6% vs. 76.1% respectively, p = 0.54). Likewise, there was no
difference between the two groups in terms of tolerance to treatment (59.5% for
QC vs. 58% for TT, p = 0.88). No factor has been associated with treatment
failure. Eradication regimens should be based on the best locally effective
regimen, ideally using individual susceptibility testing, or antibiotic
consumption data and clinical outcome data.
Conclusion: There was no significant difference in the rate of HP
eradication between the QC and the 14-day triple therapy.
Author
(s) Details
Mohamed
Hichem Loghmari
Department of Hepato-Gastroenterology, Fattouma Bourguiba
University Hospital, Monastir, Tunisia.
Firas
Aissaoui
Department of Hepato-Gastroenterology, Fattouma Bourguiba
University Hospital, Monastir, Tunisia.
Arwa
Guediche
Department of Hepato-Gastroenterology, Fattouma Bourguiba
University Hospital, Monastir, Tunisia.
Wided
Bouhlel
Department of Hepato-Gastroenterology, Fattouma Bourguiba
University Hospital, Monastir, Tunisia.
Mejda
Zakhama
Department of Hepato-Gastroenterology, Fattouma Bourguiba
University Hospital, Monastir, Tunisia.
Nabil
B. Chaabene
Department of Hepato-Gastroenterology, Fattouma Bourguiba
University Hospital, Monastir, Tunisia.
Amel
Rehaiem
Department of Hepato-Gastroenterology, Fattouma Bourguiba
University Hospital, Monastir, Tunisia.
Nouha Ben Abdeljalil
Department of Pathological Anatomy, Fattouma
Bourguiba University Hospital, Monastir, Tunisia.
Manel
Njima
Department of Pathological Anatomy, Fattouma Bourguiba University
Hospital, Monastir, Tunisia.
Abdelfetteh
Zakhama
Department of Pathological Anatomy, Fattouma Bourguiba University
Hospital, Monastir, Tunisia.
Yosr
Kadri
Microbiology Laboratory, Fattouma Bourguiba University Hospital,
Monastir, Tunisia.
Maha
Mastouri
Microbiology Laboratory, Fattouma Bourguiba University Hospital,
Monastir, Tunisia.
Leila
Safer
Department of Hepato-Gastroenterology, Fattouma Bourguiba
University Hospital, Monastir, Tunisia.
Please see the book here:- https://doi.org/10.9734/bpi/mmrnp/v4/2146
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