CLINICAL QUESTION: Which strategy is preferable in the initial treatment of H pylori-positive patients with dyspepsia: empiric eradication therapy or endoscopy-based management?
BACKGROUND: The role of esophagogastroduodenoscopy (EGD) in the management of H pylori disease has been increasingly challenged as less invasive diagnostic tests have become available. Empiric eradication therapy is a common strategy employed in H pylori-positive dyspeptic patients. This strategy, however, has not been compared with treatment on the basis of pathologic findings using EGD in a randomized clinical trial.
POPULATION STUDIED: Study participants were all referred to specialty clinics with symptoms of ulcerlike dyspepsia. Patients aged older than 45 years, those exhibiting any alarm symptoms (eg, weight loss, history of gastrointestinal bleeding, dysphagia), and those with a recent history of treatment for H pylori were excluded. A total of 104 patients met the inclusion criteria.
STUDY DESIGN AND VALIDITY: Patients with ulcerlike dyspepsia who were positive for H pylori were randomized to either empiric eradication therapy (omeprazole, tinadazole, and clarithromycin given twice daily for 1 week) or management on the basis of findings from the EGD. Randomization was stratified to take into account risk factors including gender, tobacco use, and alcohol intake. Patients in the EGD group received eradication therapy if findings indicated peptic ulcer disease. Patients with nonulcer dyspepsia were treated symptomatically. Follow-up included a breath test for H pylori in all patients who received eradication therapy. Those patients who were still positive received second-line eradication therapy. Patients in the empiric eradication group who had no improvement in their dyspepsia scores underwent EGD even if H pylori-negative. Symptoms were reassessed at 6 weeks and 3, 6, and 12 months; H pylori status and quality of life were reassessed during the 12-month review. The study design has 3 limitations. First, since each participant did not undergo an endoscopic evaluation, it is possible that the 2 groups differed in pathology. The authors attempted to control for this by randomization and stratification of patients into risk categories. Second, the study was not blinded; participants may have been affected by the knowledge of their H pylori status or their endoscopic findings. Finally, criteria for ulcerlike dyspepsia are not clearly defined.
OUTCOMES MEASURED: The primary outcomes were a validated symptom score for dyspepsia and an overall quality-of-life score (The Medical Outcomes Study Short Form-36). Secondary outcomes included the rate of H pylori eradication and the use of symptomatic therapy at the 12-month follow-up.
RESULTS: Patients in the empiric eradication and EGD groups were similar at baseline with respect to dyspepsia scores. At 12 months, dyspepsia scores had improved in both groups, with a significantly better score in the empiric eradication group than in the EGD group (3.37 vs 5.08, P <.05). Quality-of-life scores were significantly improved in both groups compared with baseline. There was a significant difference between the 2 groups in only one parameter of quality of life; physical role functioning improved in the empiric eradication group and declined in the EGD group. Eradication rates were similar in the 2 groups (79% in the empiric eradication group vs 78% in the EGD group). More patients in the empiric eradication group were not using H2-antagonist or proton pump inhibitor therapy at 12 months (76% vs 63%). Only 27% of the patients in the empiric eradication group required EGD.
There is no apparent benefit to initial endoscopic evaluation in young H pylori-positive patients with ulcerlike dyspepsia. Empiric eradication therapy yields better symptom control and avoids unnecessary invasive testing. This study reminds us that even though eradication is achieved, more than half of these patients will continue to have symptoms requiring prescription therapy. The authors warn us that the population studied consisted of secondary referrals, so the results should be generalized to the primary care setting with caution.