Evaluation of a new bismuth-free triple therapy in nude mice and humans.

OBJECTIVES

To evaluate the efficacy of a new triple therapy (amoxycillin, metronidazole, plaunotol) in eradicating Helicobacter pylori in a nude mouse model and in humans.

MATERIALS AND METHODS

In an animal study we used 215 nude mice infected with H. pylori to assess the ability of single, dual and triple therapy to eradicate H. pylori from the mouse stomach. The number of H. pylori in the mouse stomach and extent of the gastritis was assessed from 1 to 4 weeks after treatment. In a human study, we enrolled 78 H. pylori-positive patients with recurrent peptic ulcer diseases, 29 of whom were given triple therapy (amoxycillin and metronidazole for 1 week and plaunotol for 4 weeks). Patients in the control group (n = 49) were given a histamine H2-receptor antagonist. All patients were assessed 5 and 11 months after completion of therapy.

RESULTS

In the mouse model, both the number of H. pylori and the gastritis score were significantly lower in the triple therapy group than in any other treatment group assessed 1-4 weeks after completion of therapy. In the human study, the triple therapy eradicated H. pylori from the stomachs of 25 out of 29 patients (86%), compared to the control group in which none of the 49 patients were free of H. pylori in the stomach 11 months after completion of therapy. There were no reported side effects with this triple therapy. None of the H. pylori-eradicated patients showed a recurrence of peptic ulcer disease; three of the four patients whose H. pylori was not eradicated by triple therapy showed a peptic ulcer recurrence within the study period, whereas 16 out of 49 patients in the control group had a peptic ulcer recurrence.

CONCLUSIONS

This new triple therapy was effective in the eradication H. pylori, had very few side effects and greatly reduced the rate of recurrent peptic ulcers.