Although dyspepsia is a common problem, at least 50 percent of cases are classified as functional, i.e., not related to identifiable pathology such as peptic ulcer disease or gastroesophageal reflux. The situation is further complicated by the recognition that up to one half of dyspeptic patients test positive for Heliobacter pylori infection and may benefit from eradication of this organism. The most cost-effective management of dyspepsia remains controversial. Many experts advocate endoscopy in all patients with dyspepsia; others recommend initial medical treatment with endoscopy reserved for use in patients who have specific symptoms or fail medical therapy. Another suggested strategy is based on testing for H. pylori and eradication of the organism if it is present. Various decision models have been constructed that support the cost-effectiveness of the test-and-eradicate strategy, but the latter has not been directly compared with other approaches in clinical trials. Lassen and colleagues assessed the efficacy and safety of the test-and-eradicate strategy against initial endoscopy of dyspeptic patients.
Adult patients with dyspepsia were referred from 65 general practitioners in Denmark. Patients had symptoms of epigastric pain with or without other symptoms for at least two weeks but had no indications of upper gastrointestinal bleeding, anemia, weight loss or jaundice. Exclusions included recent use of ulcer-healing medications, pregnancy, current serious illness, prior upper gastrointestinal surgery or contraindication to endoscopy. All patients were interviewed and randomized to the testing strategy group or the prompt endoscopy group.
The 250 patients assigned to the test-and-eradicate group were investigated with a13C-urea breath test, and those who tested positive were treated with lansoprazole, metronidazole and amoxicillin for two weeks. If symptoms persisted after one month of treatment, patients were offered endoscopy. Patients who tested negative for H. pylori were examined by endoscopy if they had any history of aspirin or nonsteroidal anti-inflammatory drug use. Other patients who tested negative were treated with a proton-pump inhibitor (PPI) for one month and examined by endoscopy if symptoms persisted. The patients randomized to endoscopy were treated with PPIs, eradication therapy or a combination of these therapies for duodenal ulcers, reflux esophagitis or gastritis, based on the endoscopic findings. Patients completed symptom diaries and rated dyspeptic symptoms on visual analog scales at entry and at one-month and one-year follow-up visits (see accompanying table). Data were also gathered about visits to physicians, hospital utilization and days lost from work for one year after entry into the study.
The two groups of patients were well matched except that those assigned to prompt endoscopy had a median duration of dyspeptic symptoms of 7.9 years compared with a median of 3.2 years in the test-and-eradicate group. Overall, the median age of the participants was 45 years, and 28 percent tested positive for H. pylori. At one-year follow-up, no significant difference was found between the two treatment strategies in measures of symptoms, quality of life, days lost from work, visits to general practitioners or hospital admissions. More patients in the test-and-eradicate group were dissatisfied with treatment (12 compared with 4 percent). During follow-up, fewer endoscopies were performed in the test-and-eradicate group, and the use of PPIs was also lower. This group had more testing and use of eradication therapy than the endoscopy group. Fourteen (13 percent) of the patients discontinued eradication therapy because of side effects. Eradication was achieved in 99 (87 percent) of those in whom it was attempted. No patients were diagnosed with gastric or esophageal cancer during follow-up. In two patients in the endoscopy group, cancer was diagnosed at the initial examination.
The authors conclude that the test-and-eradicate strategy was as efficient as prompt endoscopy in relieving symptoms and improving quality of life but associated with lower patient satisfaction with treatment. They caution that the selection of a strategy must take into account patient symptoms, particularly those that could indicate serious pathology, including malignancy. They further discuss the cost of endoscopy in the selection of treatment, because the cost of the procedure varies widely.