Effectiveness of ranitidine bismuth citrate, clarithromycin, and metronidazole therapy for treating Helicobacter pylori

OBJECTIVE: There are limited data available from the United States on the e ffectiveness of ranitidine bismuth citrate (RBC) plus two antibiotics to tr eat Helicobacter pylori. Therefore, the following study was undertaken to e valuate RBC with two antibiotics, which have been used successfully in comb ination, to treat H. pylori. METHODS: Adults with and without abdominal symptoms, who had never received H. pylori eradication therapy, were tested for the presence of H, pylori i nfection either by in-office rapid serology assays or histology. Positive s ubjects were administered the C-13-urea breath test. Subjects who had a pos itive urea breath test were then treated with RBC 400 mg b.i.d., clarithrom ycin 500 mg b.i.d., and met ronidazole 500 mg b.i.d. for 10 days. Four to 6 wk after completing antibiotics all subjects were asked to return for a se cond urea breath test to assess treatment success. RESULTS: Forty-seven of the 50 subjects enrolled into this study completed the antibiotic regimen and returned for a repeat urea breath test. Thirty-s even subjects were negative for H. pylori by urea breath test and 10 were p ositive, resulting in a 79% eradication rate. Seven subjects (14%) stopped their medication because of side effects. When analysis was performed on th e 40 subjects who took greater than or equal to 80% of their medication (pe r-protocol), the eradication rate was 90%. CONCLUSIONS: The combination of RBC with clarithromycin and metronidazole s uccessfully treated H. pylori infection after only 10 days of therapy. The per-protocol eradication rate from this study was similar to that seen with Food and Drug Administration (FDA)-approved regimens. In conclusion, RBC p lus clarithromycin and metronidazole should be considered as a first-line t reatment regimen for H. pylori infection, and may only need to be taken for a period of 10 days, as opposed to 14 days for FDA-approved regimens. (C) 1999 by Am. Cell. of Gastroenterology.