Pedro Boal Carvalho1, Joana Magalhães1, Francisca Dias de Castro1, Bruno Rosa1, José Cotter2. 1. Serviço de Gastrenterologia. Hospital da Senhora da Oliveira. Guimarães. Portugal. 2. Serviço de Gastrenterologia. Hospital da Senhora da Oliveira. Guimarães. Portugal. Life and Health Sciences Research Institute. School of Health Sciences. Universidade do Minho. Braga. Portugal. ICVS/3B's. PT Government Associate Laboratory. Guimarães/Braga. Portugal.
Abstract
INTRODUCTION: Helicobacter pylori eradication has become increasingly difficult as resistances to several antibiotics develop. We aimed to compare Helicobacter pylori eradication rates between triple therapy and sequential therapy in a naive Portuguese population. MATERIAL AND METHODS: Prospective randomized trial including consecutive patients referred for first-line Helicobacter pylori eradication treatment. EXCLUSION CRITERIA: previous gastric surgery/neoplasia, pregnancy/lactancy, allergy to any of the drugs. The compared eradication regimens were triple therapy (pantoprazol, amoxicillin and clarithromycin 12/12 hours, 14 days) and sequential therapy (pantoprazol 12/12 hours for 10 days, amoxicillin 12/12 hours for days 1 - 5 and clarithromycin plus metronidazol 12/12 hours during days 6 - 10). Eradication success was confirmed with urea breath test. Statistical analysis was performed with SPSS v21.0 and a p-value < 0.05 was considered statistically significant. RESULTS:Included 60 patients, 39 (65%) female with mean age 52 years (SD ± 14.3). Treatment groups were homogeneous for gender, age, indication for treatment and smoking status. No statistical differences were encountered between sequential and triple therapy eradication rates (86.2% vs 77.4%, p = 0.379), global eradication rate was 82%. Tobacco consumption was associated with a significantly lower eradication success (54.5 vs 87.8%, p = 0.022). DISCUSSION: In this randomized controlled trial in a naive Portuguese population, we found a satisfactory global Helicobacter pylori eradication rate of 82%, with no statistical differences observed in the efficacy of the treatment between triple and sequential regimens. CONCLUSION: These results support the use of either therapy for the first-line eradication of Helicobacter pylori.
RCT Entities:
INTRODUCTION:Helicobacter pylori eradication has become increasingly difficult as resistances to several antibiotics develop. We aimed to compare Helicobacter pylori eradication rates between triple therapy and sequential therapy in a naive Portuguese population. MATERIAL AND METHODS: Prospective randomized trial including consecutive patients referred for first-line Helicobacter pylori eradication treatment. EXCLUSION CRITERIA: previous gastric surgery/neoplasia, pregnancy/lactancy, allergy to any of the drugs. The compared eradication regimens were triple therapy (pantoprazol, amoxicillin and clarithromycin 12/12 hours, 14 days) and sequential therapy (pantoprazol 12/12 hours for 10 days, amoxicillin 12/12 hours for days 1 - 5 and clarithromycin plus metronidazol 12/12 hours during days 6 - 10). Eradication success was confirmed with urea breath test. Statistical analysis was performed with SPSS v21.0 and a p-value < 0.05 was considered statistically significant. RESULTS: Included 60 patients, 39 (65%) female with mean age 52 years (SD ± 14.3). Treatment groups were homogeneous for gender, age, indication for treatment and smoking status. No statistical differences were encountered between sequential and triple therapy eradication rates (86.2% vs 77.4%, p = 0.379), global eradication rate was 82%. Tobacco consumption was associated with a significantly lower eradication success (54.5 vs 87.8%, p = 0.022). DISCUSSION: In this randomized controlled trial in a naive Portuguese population, we found a satisfactory global Helicobacter pylori eradication rate of 82%, with no statistical differences observed in the efficacy of the treatment between triple and sequential regimens. CONCLUSION: These results support the use of either therapy for the first-line eradication of Helicobacter pylori.