Efficacy and safety of rifaximin associated with standard triple therapy (omeprazole, clarithromycin and amoxicillin) for H. pylori eradication: A phase IV pilot clinical trial.

BACKGROUND: A progressive decrease in Helicobacter pylori eradication rates has been described over the years, driving the need for new antibiotic treatments. AIM: To evaluate the efficacy and safety of the addition of rifaximin (Spiraxin®) to standard triple therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori. METHODS: Independent prospective clinical trial (EUDRACT no.: 2013-001080-23). Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment. A full blood test was performed in the first five patients enrolled to evaluate the safety of the treatment. H. pylori eradication was confirmed with the 13C-urea breath test at least four weeks after the end of treatment with rifaximin 400mg/8h, clarithromycin 500mg/12h, amoxicillin 1g/12h and omeprazole 20mg/12h for 10 days. RESULTS: Forty patients were consecutively enrolled, 53% woman, mean age 44 years. Indication for eradication: 60% non-investigated dyspepsia, 38% functional dyspepsia and 2% gastric ulcer. Four patients did not attend the eradication confirmatory breath test. The eradication rate was 61% (95% CI: 45-77%) for the protocol and 55% (40-70%) for intention-to-treat. About 76% of the patients experienced adverse events (35% diarrhea, 14% nausea and 24% metallic taste), none of which was serious. The blood tests did not show significant alterations. CONCLUSION: Acceptable H. pylori eradication rates are not achieved with rifaximin associated with standard triple therapy for 10 days.

Terapia convencional y secuencial en el tratamiento de Helicobacter pylori en pacientes del estado Carabobo, Venezuela / Conventional and Sequential Therapy in the Treatment of Helicobacter pylori in Patients of Carabobo State, Venezuela

Introducción: la tendencia mundial, especialmente en países suramericanos, es al incremento de la casuística de morbilidad por Helicobacter pylori que causa gastritis crónica tan severas que abonan el terreno para el desarrollo de neoplasias, a esta situación desfavorable para la población se suma el aumento de reportes no concluyente sobre eficacia de la terapia convencional y secuencial, principales opciones para tratar esta bacteria.Objetivo: determinar en una muestra de la población venezolana, la eficacia de la terapia secuencial y estándar en el tratamiento de Helicobacter pylori. Método: se realizó un estudio de tipo descriptivo y retrospectivo, basado en la revisión de registros clínicos. La muestra estuvo constituida por 84 individuos con diagnóstico de infección con estabacteria, en quienes se determinó género, diagnóstico de infección, terapia utilizada y diagnóstico pos-tratamiento. Resultados: el 67,9% de los pacientes no tuvo infección post tratamiento, de estos el 50,9% habían recibido terapia estándar y 49,1% secuencial, sin diferencias significativas entre ambas.Conclusiones: en la muestra estudiada la terapia estándar y secuencial resultaron igualmente efectivas y en moderada proporción en el tratamiento de la infección por este microorganismo. Este trabajo constituye el primero realizado en población venezolana.(AU)

Introduction: the worldwide trend, particularly in South American countries, is the increase in the casuistry of morbidity Helicobacter pylori that causes chronic gastritis so severe that fertile ground for the development of malignancies, this unfavorable situation for the population increase adds inconclusive reports on the effectiveness of conventional and sequential main therapy options for treating H. pylori.Objective: to determine, in a first approach, from a sample of the Venezuelan population, the efficacy of sequential therapy and standard in the treatment of H. pylori in an attempt to provide information to help answer the question about which therapy is most effective.Methods: a descriptive and retrospective study, based on a review of medical records was performed. The sample consisted of 84 individuals with a diagnosis of H. pylori infection in people gender, diagnosis of infection, diagnosis and therapy used post-treatment was determined.Results: 67.9% were patients without post infection treatment, 50.9% of these subjects had received standard therapy and 49.1% sequential, without significant differences between the two.Conclusions: in the studied sample and standard sequential therapy were equally effective in moderate proportion and in the treatment of H. pylori infection and also that this work is the first study in Venezuelan population