Helicobacter pylori eradication as a surrogate marker for the reduction of duodenal ulcer recurrence

Abstract

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 surrogate marker for the reduction in duodenal ulcer recurrence using rigorously 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 amoxycillin. Ulcer healing and H. pylori eradication were assessed. For patients whose duodenal ulcer healed, duodenal ulcer recurrence was determined over a 6‐month period in patients with H. pylori eradication and those remaining positive for H. pylori at least 4 weeks after treatment. To support the data obtained from these clinical trials, a search of the medical literature was conducted to identify additional human clinical trials in which duodenal ulcer recurrence rates were measured and categorized by H. pylori status at least 1 month post‐treatment. Results: In 11 controlled trials, the overall 6–18‐month duodenal ulcer recurrence rate was 54% among patients remaining positive for H. pylori at least 4 weeks after treatment compared to 6% among patients with H. pylori eradication following treatment. This finding was corroborated by the uncontrolled trials, in which the duodenal ulcer recurrence 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 treatment. A time course of duodenal ulcer recurrence rates using pooled data from both controlled and uncontrolled studies demonstrated that duodenal ulcer recurrence rates for H. pylori‐negative patients persisted for up to 4 years following treatment. Duodenal ulcer recurrence rates 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 ‐negative patients. Conclusion: Regardless of treatment regimens, H. pylori eradication produced a consistent and significant reduction in duodenal 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.

The management of Helicobacter pylori infection in primary care: a systematic review of the literature

“…5,7,8,10 PU recurrence is markedly decreased after H.pylori eradication. 2,3,8,9 DU recurrence after completion of H.pylori eradication therapy was 6% in H.pylorinegative patients 3,6 (20% in a more recent study 2 ) and 54% 3 or 67% 6 in H.pylori-positive patients. The matching figures for GU were 4 and 59%, respectively.…”

“…6 The association between H.pylori eradication and decreased ulcer recurrence is so strong that H.pylori eradication can be used as a surrogate efficacy end point in clinical studies of DU therapies. 3,6 Evidence also shows that successful H.pylori eradication will improve ulcer healing by 15-20% regardless of diagnosis. 4,9 Comparison between H.pylori-negative and positive patients gives healing rates in GU, DU and PU of 88% versus 73%, 95% versus 76% and 95% versus 76%, respectively.…”

“…[2][3][4][5][6][7][8][9][10] There is a strong association between H.pylori infection and PUD. Helicobacter pylori is found in Ͼ90% of duodenal ulcer (DU) patients and 70-90% of gastric ulcer (GU) patients.…”

Search and treat strategy to eliminate Helicobacter pylori associated ulcer disease

“…Such disease management programmes will almost certainly turn out to be cost effective and will improve the health and well being of the target population. Economic gains will be reached through a decrease in the expenditure on acid reducing drugs,4-7 a decrease in absenteeism from work, a reduction in doctor visits, and in the long run in a decrease in hospital admissions for ulcer bleeding or perforation 3…”

“…We can cure patients that before were suffering from a chronic recurrent ailment. After curing the infection, H pylori associated ulcers do not recur, nor do ulcer complications 3. Quality of life improves, use of medication diminishes or stops, and the number of doctor visits, hospital admissions, and absenteeism from work decreases.…”