Colloidal bismuth pectin: An alternative to bismuth subcitrate for the treatment of Helicobacter pylori-positive duodenal ulcer

Background. Bismuth triple therapy provides consistently good results in He licobacter pylori eradication worldwide, whereas quadruple therapy using a combination of omeprazole and bismuth triple regimen has produced cure rate s in excess of 90%. The prevalence of metronidazole-resistant strains was 2 6.8% in our area. Colloidal bismuth pectin (CBP) is a new, lower-priced bis muth salt made in China. The purpose of this study was to investigate the e fficacy and safety of CBP triple and quadruple regimens in the treatment of H. pylori-positive duodenal ulcer. Materials and Methods. In this prospective trial, 205 patients with H. pylo ri-positive duodenal ulcer were allocated randomly to receive one of four r egimens: metronidazole, 200 mg; amoxicillin, 250 mg; and colloidal bismuth subcitrate (CBS), 120 mg (group 1), or CBP, 100 mg qid (group 2) for 2 week s, then continued CBS, 240 mg, or CBP, 200 mg bid for a further 2 weeks. A quadruple regimen using a combination of omeprazole, 20 mg bid, and CBS tri ple therapy (group 3) or CBP triple therapy (group 4), respectively, was gi ven to patients for 1 week, followed by omeprazole, 20 mg once daily for a further 3 weeks. Further endoscopy was performed at least 4 weeks after ces sation of the treatment. H. pylori status was determined by histology, a C- 14 urea breath test, and a urease test. Results. The per-protocol H. pylori cure rates were 85% (22 of 26 patients) , 90% (35 of 39), 96% (46 of 48), and 95% (75 of 79) for groups 1 through 4 . In the intention-to-treat analysis, cure rates were 79% (22 of 28), 83% ( 35 of 42), 90% (46 of 51), and 89% (75 of 84), respectively. The cure rates of quadruple therapy were higher than those of triple therapy; an 8.2% dif ference was not statistically significant (95% confidence interval [CI], 2. 3-18.7%). The ulcer-healing rates were 88%, 87%, 98%, and 97%, respectively , for groups 1 through 4. The ulcer pain was relieved more rapidly in quadr uple- than in triple-therapy regimens. Two patients discontinued treatment prematurely owing to drug-related side effects. Conclusion. One-week quadruple therapy is highly effective and safe in H. p ylori eradication in Chinese patients. CBP is as effective as CBS.