Simplified 10-day bismuth triple therapy for cure of Helicobacter pylori infection: experience from clinical practice in a population with a high frequency of metronidazole resistance.

OBJECTIVE

To evaluate the cure rate of Helicobacter pylori infection, including the impact of in vitro metronidazole resistance (M-R), and the side effects of a simplified 10-day bismuth triple therapy in routine clinical practice.

METHODS

From September 1995 to March 1996, 248 consecutive H. pylori-positive patients received 10 days of bismuth subnitrate 150 mg, oxytetracycline 500 mg, and metronidazole 400 mg, all t.id. Before treatment, upper endoscopy, including biopsy specimens for microbiological analysis and IgG serology were performed. M-R was found in 45% of females and 36% of males. At least 2 months after treatment, H. pylori status was assessed by the 14C urea breath test (n = 131), endoscopy (n = 37), urea breath test and endoscopy (n = 63), or solely by IgG serology (n = 7). Ten patients withdrew. IgG serology was performed again after 1 yr.

RESULTS

H. pylori infection was cured in 205 patients: 86% by all-patients-treated analysis and 83% by intention-to-treat analysis. When patients were classified according to pretreatment metronidazole susceptibility, cure of infection was achieved in 76% of females harboring M-R strains versus 96% of those with sensitive strains (p = 0.002) and in 81% versus 88% (p = 0.34) of males with M-R versus sensitive strains, respectively. Twelve patients (5 %) had to stop treatment prematurely because of severe side effects, but eight of them were treated successfully. One case of H. pylori infection (0.6 %) was detected at 1-yr follow-up.

CONCLUSIONS

Ten-day bismuth triple therapy t.i.d. was effective in curing H. pylori infection in the context of routine clinical practice. The efficacy was reduced in females harboring M-R strains.