BACKGROUND:Quadruple therapy appears to be more effective than standard triple therapy in the management of patients with Helicobacter pylori infection who harbor drug-resistant organisms. No data are available on the relative efficacies of triple and quadruple drug regimens from India. METHODS:Consecutive patients with peptic ulcer and H. pylori infection were randomized to receive lansoprazole 30 mg twice daily along with either amoxycillin (500 mg four times daily) and clarithromycin (500 mg twice a day) (Group A), or tri-potassium dicitrato bismuthate (120 mg four times daily), metronidazole (400 mg thrice daily) and tetracycline (500 mg 4 times daily) (Group B) for 10 days. Presence of H. pylori infection was looked for using an in-house urease test and histology before starting treatment, and 30 days after completion of treatment. RESULTS: Twenty-nine of 35 patients in Group A and 24 of 33 in Group B had eradication of infection (82.8% and 72.7% by intention-to-treat analysis, and 87.9% and 85.7% by per protocol analysis, respectively; p = ns). Side-effects occurred in 4 (12%) and 5 (18%) patients in Groups A and B, respectively (p = ns); discontinuation of drugs was required in two patients in group B. CONCLUSIONS:Quadruple therapy for initial treatment of H. pylori infection does not offer any advantage over standard triple therapy in Indian patients.
RCT Entities:
BACKGROUND: Quadruple therapy appears to be more effective than standard triple therapy in the management of patients with Helicobacter pylori infection who harbor drug-resistant organisms. No data are available on the relative efficacies of triple and quadruple drug regimens from India. METHODS: Consecutive patients with peptic ulcer and H. pyloriinfection were randomized to receive lansoprazole 30 mg twice daily along with either amoxycillin (500 mg four times daily) and clarithromycin (500 mg twice a day) (Group A), or tri-potassium dicitrato bismuthate (120 mg four times daily), metronidazole (400 mg thrice daily) and tetracycline (500 mg 4 times daily) (Group B) for 10 days. Presence of H. pyloriinfection was looked for using an in-house urease test and histology before starting treatment, and 30 days after completion of treatment. RESULTS: Twenty-nine of 35 patients in Group A and 24 of 33 in Group B had eradication of infection (82.8% and 72.7% by intention-to-treat analysis, and 87.9% and 85.7% by per protocol analysis, respectively; p = ns). Side-effects occurred in 4 (12%) and 5 (18%) patients in Groups A and B, respectively (p = ns); discontinuation of drugs was required in two patients in group B. CONCLUSIONS: Quadruple therapy for initial treatment of H. pyloriinfection does not offer any advantage over standard triple therapy in Indian patients.