BACKGROUND: There is controversy as to whether Helicobacter pylori and non-steroidal anti-inflammatory drugs interact to cause peptic ulcers. AIM: To study whether the eradication of H. pylori in patients on long-term non-steroidal anti-inflammatory drug therapy prevents the development of ulcers. METHODS:Patients infected with H. pylori whilst receiving long-term non-steroidal anti-inflammatory drug therapy, but with no ulcers at baseline endoscopy, were randomized to receive either triple antibiotic therapy (metronidazole 300 mg, clarithromycin 250 mg and amoxicillin 500 mg, given four times daily; n = 70) or placebo (n = 70) for 2 weeks. Non-steroidal anti-inflammatory drugs were continued throughout the study period. Endoscopy was repeated 12 weeks after the end of treatment. The development of ulcers was compared between the two groups. RESULTS: Endoscopy at 12 weeks revealed peptic ulcer development in five [7%; 95% confidence interval (CI), 2-16] of the patients who received triple therapy and in six (9%; 95% CI, 3-18) of those who received placebo (P = 1.00). No significant difference in the development of ulcers was found between patients with persistent H. pylori infection (7/80; 9%; 95% CI, 4-17) and those with the eradication of H. pylori (4/52; 8%; 95% CI, 2-19) (P = 1.00). CONCLUSIONS: The eradication of H. pylori in patients receiving long-term treatment with non-steroidal anti-inflammatory drugs did not prevent ulcer development. However, because the rate of ulcer development was low, a study with a larger sample size is required to confirm this finding.
RCT Entities:
BACKGROUND: There is controversy as to whether Helicobacter pylori and non-steroidal anti-inflammatory drugs interact to cause peptic ulcers. AIM: To study whether the eradication of H. pylori in patients on long-term non-steroidal anti-inflammatory drug therapy prevents the development of ulcers. METHODS:Patients infected with H. pylori whilst receiving long-term non-steroidal anti-inflammatory drug therapy, but with no ulcers at baseline endoscopy, were randomized to receive either triple antibiotic therapy (metronidazole 300 mg, clarithromycin 250 mg and amoxicillin 500 mg, given four times daily; n = 70) or placebo (n = 70) for 2 weeks. Non-steroidal anti-inflammatory drugs were continued throughout the study period. Endoscopy was repeated 12 weeks after the end of treatment. The development of ulcers was compared between the two groups. RESULTS: Endoscopy at 12 weeks revealed peptic ulcer development in five [7%; 95% confidence interval (CI), 2-16] of the patients who received triple therapy and in six (9%; 95% CI, 3-18) of those who received placebo (P = 1.00). No significant difference in the development of ulcers was found between patients with persistent H. pylori infection (7/80; 9%; 95% CI, 4-17) and those with the eradication of H. pylori (4/52; 8%; 95% CI, 2-19) (P = 1.00). CONCLUSIONS: The eradication of H. pylori in patients receiving long-term treatment with non-steroidal anti-inflammatory drugs did not prevent ulcer development. However, because the rate of ulcer development was low, a study with a larger sample size is required to confirm this finding.