Triple therapy with bismuth, metronidazole, and tetracycline or amoxicillin is effective for the treatment of Helicobacter pylori, but side effects are common. Sucralfate inhibits H. pylori hemagglutinin, protease, and lipase and thus might affect colonization of the bacterium in the stomach.
Objective: We compared the efficacy and side effects of triple therapy with sucralfate versus triple therapy with bismuth plus omeprazole in the treatment of H. pylori-associated duodenal ulcer (DU).
Methods: One hundred and fifty DU patients were recruited in this study; 71 cases were randomized to receive bismuth 120 mg q.i.d., metronidazole 400 mg q.i.d., and tetracycline 500 mg q.i.d. (BMT) for 1 wk, and 79 cases were randomized to receive sucralfate 1 g q.i.d., metronidazole 400 mg q.i.d., and tetracycline 500 mg q.i.d. (SMT) for 1 wk. For the ulcer treatment, BMT patients were also given omeprazole 20 mg daily for 4 wk, and SMT patients received sucralfate for 4 wk from day of randomization.
Results: Fifty-three patients in the BMT group and 60 in the SMT group finished the treatment and follow-up at 8 wk. H. pylori was eradicated in 49 out of 53 (92%) patients in the BMT group and in 45 out of 60 (75%) patients in the SMT group (p = 0.0057). Forty-nine (92%) patients who received omeprazole and BMT and 53 (88%) patients who received SMT had healed DU at 8 wk (p = 0.34). Side effects related to medication were reported in 38 (71.7%) patients in the BMT group and in 42 (70%) patients in the SMT group. On an intention-to-treat basis, there was no difference in ulcer healing between the BMT group (93.1%) and the SMT group (89.7%). H. pylori eradication was achieved in 84.4 and 66.2% in the BMT and SMT groups, respectively (p = 0.018).
Conclusion: Therapy of sucralfate, tetracycline, and metronidazole for 1 wk has a satisfactory but lower success rate in eradication of H. pylori when compared with the conventional triple therapy plus omeprazole. Side effects of this therapy are no fewer than the conventional triple therapy.