BACKGROUND: This double-blind, randomized study evaluated the efficacy of dual and triple therapies including ranitidine for treatment of Helicobacter pylori infection. MATERIALS AND METHODS:Dyspeptic patients (n = 105) with a positive rapid urease test formed the intention-to-treat population (ITT). All patients were assigned to 14 days treatment with ranitidine 300 mg b.i.d and clarithromycin 750 mg b.i.d. Group A (n = 53) also received a placebo twice daily, while group B (n = 52) received lymecycline 300 mg b.i.d. Treatment with ranitidine, 150 mg b.i.d, was continued for an additional 30 days. H. pylori infection was verified by culture. Twelve weeks after antibiotic treatment, H. pylori status was investigated by culture and 14C-urea breath test (UBT). The per-protocol (PP) group consisted of 73 patients (A, n = 38; B, n = 35). RESULTS:Cure rates were 87% (95% C.I. = 72% to 94%) vs. 72% (95% C.I. = 58% to 83%) in the ITT-group and 89% (95% C.I. = 73% to 97%) vs. 87% (95% C.I. = 72% to 96%) in the PP-population (culture and UBT) when triple and dual therapies were compared. In all patients who were not cured, clarithromycin resistance of H. pylori was acquired. Side effects were experienced by 54% of patients. CONCLUSIONS: The difference in efficacy between the two treatment regimens was not significant. However, the cure rates in this study are comparable to combination treatments with omeprazole. Treatment failures were due to acquired clarithromycin resistance.
RCT Entities:
BACKGROUND: This double-blind, randomized study evaluated the efficacy of dual and triple therapies including ranitidine for treatment of Helicobacter pylori infection. MATERIALS AND METHODS: Dyspeptic patients (n = 105) with a positive rapid urease test formed the intention-to-treat population (ITT). All patients were assigned to 14 days treatment with ranitidine 300 mg b.i.d and clarithromycin 750 mg b.i.d. Group A (n = 53) also received a placebo twice daily, while group B (n = 52) received lymecycline 300 mg b.i.d. Treatment with ranitidine, 150 mg b.i.d, was continued for an additional 30 days. H. pylori infection was verified by culture. Twelve weeks after antibiotic treatment, H. pylori status was investigated by culture and 14C-urea breath test (UBT). The per-protocol (PP) group consisted of 73 patients (A, n = 38; B, n = 35). RESULTS: Cure rates were 87% (95% C.I. = 72% to 94%) vs. 72% (95% C.I. = 58% to 83%) in the ITT-group and 89% (95% C.I. = 73% to 97%) vs. 87% (95% C.I. = 72% to 96%) in the PP-population (culture and UBT) when triple and dual therapies were compared. In all patients who were not cured, clarithromycin resistance of H. pylori was acquired. Side effects were experienced by 54% of patients. CONCLUSIONS: The difference in efficacy between the two treatment regimens was not significant. However, the cure rates in this study are comparable to combination treatments with omeprazole. Treatment failures were due to acquired clarithromycin resistance.
Authors: B Björkholm; M Sjölund; P G Falk; O G Berg; L Engstrand; D I Andersson Journal: Proc Natl Acad Sci U S A Date: 2001-11-20 Impact factor: 11.205