OBJECTIVE

To compare the efficacy of ranitidine bismuth citrate (RB) combined with two antibiotics during seven days in comparison with OCA-7 for treatment of Helicobacter pylori.

METHODS

In a randomized clinical trial 200, consecutive patients infected by Helicobacter pylori were studied prospectively. One of two regimens was given for 7 days; OCA-7 (omeprazole 20 mg b.i.d., amoxycillin 1 gr b.i.d., clarithromycin 500 mg b.i.d.) or RBCA (RB 400 b.i.d., amoxicillin 1 gr b.i.d., clarithromycin 500 mg b.i.d.). Eradication was defined as a negative breath test one month after therapy.

RESULTS

112 male and 88 female with a mean age of 48 years (range 18-82). 100 patients were randomized to OCA-7 and 100 patients to RBCA-7. Overall 186 patients completed the treatment. Intention to-treat eradication was in the group OCA-7 of 72% and 73% in group RBCA-7. Per-protocol eradication was in the group OCA-7 of 78% and 77% in group RBCA-7 (p = 0.3). Five patients in the group OCA-7 and nine in the group RBCA-7, had side effects, three of these patients did not complete therapy by diarrhea.

CONCLUSIONS

RB with two antibiotics is as effective and safe as OCA-7 for the eradication of Helicobacter pylori.