HELICOBACTER-PYLORI ERADICATION AS A SURROGATE MARKER FOR THE REDUCTION OF DUODENAL-ULCER RECURRENCE

Objectives: An abundance of data exists documenting the association of H. pylori eradication with the reduction in duodenal ulcer recurrence . Aim: To evaluate the validity of using H. pylori eradication as a su rrogate marker for the reduction in duodenal ulcer recurrence using ri gorously controlled studies. Methods: Three controlled clinical trials were conducted in patients with uncomplicated, active duodenal ulcers , Patients were treated with various combinations of omeprazole and am oxycillin. Ulcer healing and H. pylori eradication were assessed. For patients whose duodenal ulcer healed, duodenal ulcer recurrence was de termined over a 6-month period in patients with H. pylori eradication and those remaining positive for H. pylori at least 4 weeks after trea tment. To support the data obtained from these clinical trials, a sear ch of the medical literature was conducted to identify additional huma n clinical trials in which duodenal ulcer recurrence rates were measur ed and categorized by H. pylori status at least 1 month post-treatment . Results: In 11 controlled trials, the overall 6-18-month duodenal ul cer recurrence rate was 54% among patients remaining positive for H. p ylori at least 4 weeks after treatment compared to 6% among patients w ith H, pylori eradication following treatment. This finding was corrob orated by the uncontrolled trials, in which the duodenal ulcer recurre nce rate was 64% among patients found to be H. pylori-positive and 6% for patients found to be H, pylori-negative at least 4 weeks after tre atment. A time course of duodenal ulcer recurrence rates using pooled data from both controlled and uncontrolled studies demonstrated that d uodenal ulcer recurrence rates for H. pylori-negative patients persist ed for up to 4 years following treatment. Duodenal ulcer recurrence ra tes for H. pylori-positive patients increased for the first year, then levelled off. A comparison of the duodenal ulcer recurrence rates for different treatment regimens revealed that eradication regimens based on omeprazole plus antibiotics and bismuth plus antibiotics exhibited similar duodenal ulcer recurrence rates for H. pylori-positive and -n egative patients. Conclusion: Regardless of treatment regimens, H. pyl ori eradication produced a consistent and significant reduction in duo denal ulcer recurrence. Therefore H. pylori eradication, 4 weeks post- therapy, can be used as a surrogate marker for reduced duodenal ulcer recurrence in investigational clinical trials.