Has the impact of Helicobacter pylori therapy on ulcer recurrence in the United States been overstated? A meta-analysis of rigorously designed trials.

OBJECTIVE: The aim of this study was to assess the effect of H. pylori eradication on ulcer recurrence in North American duodenal ulcer patients by examining only treatment studies that met rigorous methodologic criteria. METHODS: Data sources were computerized bibliographic searches from 1983, review of reference lists, communication with companies that manufacture medications used for H. pylori therapy in the U.S., and H. pylori investigators, review of open presentations to the Food and Drug Administration, and review of abstracts from annual scientific meetings. Criteria for study inclusion were double blind, randomized North American trials of H. pylori therapy for duodenal ulcer, scheduled endoscopic follow-up exams for > or = 6 months, and H. pylori cure documented > or = 4 wk after completion of therapy by at least two endoscopic biopsy tests. Seven relevant trials were identified. Data were abstracted independently and disagreement was resolved by consensus. We obtained missing data and identified erroneous assessments through contact with an author or sponsor of all studies. RESULTS: The common odds ratio for ulcer recurrence was 0.20 (95% CI, 0.13-0.31) and 2.8 patients would need to be successfully treated to prevent one ulcer recurrence at 6 months. The pooled ulcer recurrence rate at 6 months in patients with H. pylori eradication was 20%. CONCLUSION: Results of North American studies of highest methodological quality confirm that H. pylori eradication markedly decreases ulcer recurrence. Nevertheless, 20% of patients in these studies had ulcer recurrence within 6 months, despite successful cure of infection and no reported use of NSAIDs. Non-H. pylori, non-NSAID ulcers may be more common in the U.S. than previously believed.

Insulin resistance and development of diabetes mellitus associated with megestrol acetate therapy.

We describe a case of diabetes mellitus induced by megestrol acetate in a patient with the acquired immunodeficiency syndrome. Metabolic studies including an arginine infusion test excluded an insulinopenic state and suggested insulin resistance as the underlying mechanism for hyperglycaemia. Withdrawal of megestrol acetate resulted in rapid correction of all metabolic abnormalities and eliminated the need for exogenous insulin therapy.

Relationship between Helicobacter pylori eradication and reduced duodenal and gastric ulcer recurrence: a review.

BACKGROUND & AIMS: The aim of this study was to determine whether the current literature supports the use of Helicobacter pylori cure as the primary efficacy end point in peptic ulcer clinical trials. This could potentially reduce the complexity of future trials. METHODS: Published articles containing information on both H. pylori eradication and ulcer recurrence were searched with MEDLINE. Abstracts were found by reviewing references from both primary and review articles. RESULTS: Fourteen duodenal ulcer and five gastric ulcer studies satisfied requisite inclusion criteria. Ulcer recurrence was significantly less common among H. pylori-cured patients vs. noncured patients (6% vs. 67% for patients with duodenal ulcers; 4% vs. 59% for patients with gastric ulcers). For H. pylori-cured patients, duodenal ulcer recurrence was higher in studies using two endoscopic tests compared with three tests (9% vs. 3%) and higher in abstracts compared with published articles (14% vs. 4%). Timing of H. pylori eradication (4 weeks vs. < / = 12 weeks) and ulcer recurrence assessment (6 months vs. < / = 12 months) was not significantly related to duodenal ulcer recurrence. CONCLUSIONS: The current literature strongly suggests that H. pylori eradication 4 weeks after therapy should be used as the primary efficacy end point for reduced gastric and duodenal ulcer recurrence for the purpose of clinical trial design.