[Effectiveness of omeprazole, clarithromycin and amoxycillin therapy to eradicate Helicobacter pylori in patients with active peptic ulcer. Preliminary results of GENPY study]. / Efectividad de la combinación de omeprazol, claritromicina y amoxicilina en la erradicación de Helicobacter pylori en pacientes con ulcus péptico activo: resultados preliminares del Estudio GEHPY. Grupo de Estudio de Helicobacter pylori.

ABSTRACT

BACKGROUND: To compare the effectiveness of two length of the same therapy to eradicate Helicobacter pylori in patients with non complicated active peptic ulcer. PATIENTS AND METHODS: 223 patients visited at primary health centres. A randomised controlled trial was carried out to compare the results of 6 or 7 days of treatment with clarithromycin 500 mg, amoxicillin 1 g and omeprazole 20 mg, b.i.d. All patients received omeprazole for other 14 days. RESULTS: 108 patients were randomised to the 6 days group and 115 to the 7 days one. Both groups were comparable with respect to basic characteristics except for sex the proportion of men was higher in the 6 days group (p = 0.04). 91.4% of the patients received all the treatment correctly. By intention to treat analysis, eradication rates were 76.9% in the 6 days group and 77.4% in the seven days group (IC 95% of the difference from -10.5 to 11.6). There were not statistically significant differences in eradication rates in relation to age, sex, ulcer location, recurrence or tobacco consumption. CONCLUSIONS: Although eradication rates are lower than expected, in this study there are no differences between 6 or 7 days of therapy.