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Omeprazole/Bismuth Biskalcitrate/Metronidazole/Tetracycline Combo Effective Helicobacter Pylori Metronidazole Resistance

Helicobacter pylori metronidazole resistance in patients with duodenal ulcers can be largely overcome with a regimen of omeprazole, bismuth biskalcitrate, metronidazole and tetracycline (OBMT).

According to researchers in the United States and Canada, OBMT in a single-triple capsule is as effective and well tolerated as the widely used omeprazole, amoxicillin, and clarithromycin (OAC) regimen.

This multi-centre trial, led by L. Laine from the University of Southern California School of Medicine, Los Angeles, compared the efficacy of bismuth-based quadruple therapy with OBMT, using a single-triple capsule of BMT, versus triple therapy with OAC in treating 275 patients. H. Pylori metronidazole resistance was found in 40% of their subjects.

Two groups were randomly assigned from these subjects who had active duodenal ulcer or were diagnosed within the last five years and with H. Pylori infection recorded by (13)C-urea breath test plus histology or culture.

One group of 138 patients received a 10-day course of OBMT using a single-triple capsule containing bismuth biskalcitrate 140 mg, metronidazole 125 mg, and tetracycline 125 mg, given as three capsules four times a day with twice daily omeprazole 20 mg.

The second group of 137 were given a 10- day course of OAC, omeprazole 20 mg plus amoxicillin 1 g and clarithromycin 500 mg, all twice daily.

Two negative urea breath tests were used to confirm eradication at one and two months.

Rates for modified intent-to-treat eradication for OBMT were 87.7% and 83.2% for OAC (95% CI = -3.9%-12.8%; p = 0.29).

OBMT was found to eradicate 91.7% metronidazole-sensitive and 80.4% metronidazole-resistant strains (p = 0.06). In the OAC group eradication was 92.1% for clarithromycin sensitive and 21.4% clarithromycin-resistant strains (p < 0.001).

Adverse events were seen in 58.5% of OBMT subjects and 59.0% of those in the OAC group.
Am J Gastroenterol 2003 Mar;98:3:562-7. "Bismuth-based quadruple therapy using a single capsule of bismuth biskalcitrate, metronidazole, and tetracycline given with omeprazole versus omeprazole, amoxicillin, and clarithromycin for eradication of helicobacter pylori in duodenal ulcer patients: a prospective, randomized, multicenter, north american trial"

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