One-week therapy with pantoprazole versus ranitidine bismuth citrate plus two antibiotics for Helicobacter pylori eradication

Aim A combination of omeprazole plus amoxycillin (Amo) and clarithromycin ( Cla) for 7 days has been studied extensively. However, the role of other pr oton pump inhibitors, such as pantoprazole (Pan), in this therapy is not we ll known. On the other hand, ranitidine bismuth citrate (RBC) also seems to be effective when combined with Amo and Cia. Our aim was to evaluate and t o compare these two novel short-term triple therapies (Pan+Amo+Cla and RBCAmo+Cla) for treatment of Helicobacter pylori. Methods In a randomized clinical trial 150 consecutive patients (38 with du odenal ulcer, 112 with non-ulcer dyspepsia) infected by H. pylori were stud ied prospectively. Exclusion criteria were: previous ii. pylori eradication therapy, gastroerosive drug use, gastric surgery, and associated diseases. One of two regimens was given for 7 days: Pan (40 mg b.i.d.), Amo (1 g b.i .d.), Cia (500 mg b.i.d.) (group Pan+Amo+Cla, n = 75); or RBC (400 mg b.i.d .), Amo (1 g b.i.d.), Cia (500 mg b.i.d.) (group RBC+Amo+Cla, n = 75). All drugs were administered together after meals. Compliance was evaluated by r eturn tablet count Data were analysed by univariate (chi(2)) and multivaria te (multiple logistic regression) analysis. Eradication was defined as a ne gative C-13-urea breath test 1 month after completing therapy. Results The distribution of studied variables (age, gender, smoking, duoden al ulcer/non-ulcer dyspepsia) was similar in both therapy groups. Per-proto col eradication was achieved in 48/71 (68%) in group Pan+Amo+Cla, and in 61 /70 (87%) in group RBC+Amo+Cla (P = 0.01). Intention-to-treat (ITT) eradica tion was achieved in, respectively, 48/75 (64%) and in 61/75 (81%) (P = 0.0 3). The RBC+ Amo+Cla regimen was more effective than Pan+Amo+Cla in non-ulc er dyspepsia patients (ITT, 84% vs 58%; P = 0.005), but statistically signi ficant differences were not demonstrated in duodenal ulcer patients (72% vs 80%). In the multivariate analysis the odds ratio for the effect of the ty pe of therapy on H. pylori eradication in patients with non-ulcer dyspepsia was 3.8 (95% CI, 1.6-9.3; P = 0.003). No relevant adverse effects were rep orted with any regimen. Conclusion A RBC+Amo+Cla regimen for only 1 week is a promising therapy for H. pylori infection, due to its high efficacy, simple posology, and excell ent tolerability. Combination of Pan with Amo and Cia, although effective i n duodenal ulcer patients, but in non-ulcer dyspepsia has not achieved the favourable results previously reported with other proton pump inhibitors. ( C) 2000 Lippincott Williams & Wilkins.