Comparison of Omeprazole, Metronidazole and Clarithromycin with Omeprazole/Amoxicillin Dual-Therapy for the Cure of <i>Helicobacter pylori</i> Infection

Abstract

In this randomized, multicenter trial, we evaluated the effectiveness and side effect profile of a modified omeprazole-based triple therapy to cure Helicobacter pylori infection. The control group consisted of patients treated with standard dual therapy comprising omeprazole and amoxicillin. One hundred and fifty-seven H. pylori infected patients with duodenal ulcers were randomly assigned to receive either a combination of omeprazole 10 mg, clarithromycin 250 mg and metronidazole 400 mg (OCM) given three times daily for 10 days (n = 81), or a combination of omeprazole 20 mg and amoxicillin 1 g (OA) given twice daily for 14 days (n = 76). Prior to treatment and after 2 and 6 weeks, gastric biopsies from the antrum and corpus were obtained for histology and H. pylori culture. H. pylori infection was cured in 97.4% after OCM and in 65.8% after OA in the per-protocol analysis (p < 0.001) (intention-to-treat analysis: 93.4% and 63.2%, respectively). H. pylori was successfully cultured in 122 patients (77%). The overall rate of metronidazole resistance was 19.7% (24/122), no primary resistance to clarithromycin or amoxicillin was found. In the OCM group, all patients infected with metronidazole-sensitive H. pylori strains (n = 51) and those infected with strains of unknown susceptibility to metronidazole (n = 14) were cured (100%), while 77% (10/13) of those harboring metronidazole-resistant strains were cured of the infection (p = 0.36). Side effects leading to premature termination of treatment occurred in 2.5% of the patients in the OCM group and in 1.4% of the OA group. We conclude that combined treatment with omeprazole, clarithromycin and a higher dose of metronidazole is highly effective in curing H. pylori infection, and that this regimen remains very effective in the presence of metronidazole-resistant strains.

Meta‐analysis: the effect of antibiotic resistance status on the efficacy of triple and quadruple first‐line therapies for Helicobacter pylori

“… ANB, 27–32 0, NTB, 27, 33–45 ANG, 33, 40 38, 41, 46–66 CNG, 22, 31, 53, 54, 57, 60–64, 67–90 ACG, 38, 59, 62, 63, 67, 70, 78, 84, 87, 91–105 MTBG, 34, 38, 39, 58, 99, 106–116 ACMG 82, 117 and CMBR 31, 67, 111, 113, 118 …”

“…Clarithromycin, nitroimidazole and a gastric acid inhibitor The most commonly tested regimen in our analysis treated 3128 subjects with clarithromycin, a nitroimidazole and a gastric acid inhibitor (CNG; Table 1). CNG treatment arms came from studies conducted in North America (two studies, 11 arms), South America (one study, two arms), Europe (21 studies, 58 arms), Asia (nine studies, 24 arms) and Australia (one study, four arms) 22, 31, 53, 54, 57, 60–64, 67–90 . The duration of CNG treatment ranged from 5 to 14 days.…”

Identification of candidate antigens for serologic detection of Helicobacter pylori‐infected patients with gastric carcinoma

“…For our retrospective study, we used serum samples that have been obtained from consecutive H. pylori ‐positive patients with either DU or GC who participated in previous clinical trials 20, 21, 22, 23. All patients were white and recruited from a comparable catchment area at clinical centers throughout the southern part of Germany between 1995 and 2001.…”

The effect of combining antibiotics on resistance: A systematic review and meta-analysis

“…Between study heterogeneity was estimated with I 2 , using the criteria for I 2 Dickstein 2020 26 Gerecht 1989 30 Black 1982 21 Rubinstein 1995 53 Pogue 2021 51 Parry 2007 48 Cometta 1994 23 Parry 1977 49 Durante−Mangoni 2013 28 Markowitz 1992 41 Hoepelman 1988 35 Jo 2021 39 Dawson 2015 24 Macnab 1994 40 Jacobs 1993 38 Gibson 1989 31 Hodson 1987 34 Smith 1999 56 Mc Carty 1988 44 Wurzer 1997 61 Stack 1998 57 Hultén 1997 36 Miehlke 1998 46 May 1997 43 Chaisson 1997 22 Dubé 1997 27 Fournier 1999 29 Bender 1979 20 Dekker 1987 25 Winston 1990 60 Winston 1986 59 Pujol 2021 52 Paul 2015 50 Walsh 1993 58 Harbarth 2015 33 Parras 1995 47 Menon 1986 45 Mavromanolakis 1997 42 Schaeffer 1985 55 Haase 1984 32 Schaeffer 1981 54 Iravani 1981 37 Dickstein 2020 26 Black 1982 21 Pogue 2021 51 Parry 2007…”