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Revista Colombiana de Gastroenterologia

Print version ISSN 0120-9957

Abstract

CASTANO LLANO, Rodrigo et al. Randomized study of seven days of standard treatment for Helicobacter Pylori vs. ten days of standard treatment for Helicobacter Pylori with one year follow-ups of patients. Rev Col Gastroenterol [online]. 2012, vol.27, n.2, pp.80-87. ISSN 0120-9957.

Background: The increasing resistance of H pylori to antibiotics has led to failures of eradication treatment. For this reason we intend to modify both the duration of treatment and the regime of antibiotics. Methods: After random allocation, the standard treatment with omeprazole 20 mg orally every 12 hours, amoxicillin 1 g VO every 12 hours and clarithromycin 500 mg orally every 12 hours for 7 days (group 1) was compared with the same antibiotic regime over 10 days (group 2). Patients had either non-ulcer dyspepsia (NUD) or ulcer dyspepsia (UD). Effectiveness of eradication was evaluated with breathe tests. A year later, clinical responses to each therapy were compared for patients with NUD and DU. The tolerance to therapy was also evaluated for each group. Results: 149 patients were randomly assigned to group 1 and 144 patients to group 2. The eradication rate as measured by ITT analysis was 67.8% in group 1 and 74.3% in group 2 (p = 0.24). It was 72.1% and 81. 1% (p = 0.08) respectively for per protocol analysis. The eradication rate was similar for both groups independently of the degree of H pylori infection (p = 0.22). Differences in the degree of infection and the presence of NUD or DU (p = 0.19) were not found. Adverse effects were more frequent in group 2 (27.5% vs. 36.1%), but without statistical relevance (p = 0.4). The eradication rate was similar for patients with NUD (73.8% vs. 81,1%) and DU (64.3% vs. 73%). Follow up examinations one year later showed that the clinical manifestations were not related to the whether or not bacteria had been eradicated (p = 0.7). Nevertheless, the clinical response of patients with DU was better than for those with NUD. Conclusions: Standard therapy for either 7 or 10 days is insufficient for eradication of H pylori independent of the degree of H pylori infection or the type of endoscopic finding (NUD or DU). Both therapies show suboptimal eradication rates and poor clinical responses at one year follow-up in the group with NUD

Keywords : Helicobacter pylori; eradication therapy; peptic ulcer disease; functional dyspepsia; non ulcer dyspepsia.

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